acupuncture for headache, refractory

MaHTAS Technology Review

TECHNOLOGY REVIEW (MINI-HTA)

ACUPUNCTURE FOR

HEADACHE, REFRACTORY

NEURALGIA, BELL’S PALSY,

POST-STROKE, GUILLAIN

BARRE AND TRANSVERSE

MYELITIS

Malaysian Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia 008/2020


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Malaysian Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Government Office Complex 62590, Putrajaya Tel: 603 8883 1229 Available online via the official Ministry of Health Malaysia website: http://www.moh.gov.my e-ISBN: 978-967-19299-9-5

DISCLAIMER This technology review (mini-HTA) is prepared to assist health care decision-makers and health care professionals in making well-informed decisions related to the use of health technology in health care system, which draws on restricted review from analysis of best pertinent literature available at the time of development. This technology review has been subjected to an external review process. While effort has been made to do so, this document may not fully reflect all scientific research available. Other relevant scientific findings may have been reported since the completion of this technology review. MaHTAS is not responsible for any errors, injury, loss or damage arising or relating to the use (or misuse) of any information, statement or content of this document or any of the source materials. Please contact [email protected] if further information is required.

SUGGESTED CITATION: Fatin NM and Izzuna MMG. Acupuncture for headache, refractory

neuralgia, Bell’s palsy, post-stroke, Guillain Barre and transverse myelits. Technology Review.

Ministry of Health Malaysia: Malaysian Health Technology Assessment Section (MaHTAS);

2020. 87 p. Report No.: 008/2020. e-ISBN: 978-967-19299-9-5

DISCLOSURE: The author of this report has no competing interest in this subject and the

preparation of this report is entirely funded by the Ministry of Health Malaysia.

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Ms. Fatin Nabila Mokhtar Research Officer Assistant Director Malaysian Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia

Dr. Izzuna Mudla Mohamed Ghazali Public Health Physician Deputy Director Malaysian Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia

Dr. Eow Gaik Bee Head of Neurology Department Hospital Pulau Pinang Ministry of Health Malaysia Dr. Jaspal Kaur A/P Marik Singh Senior Principal Assistant Director Traditional and Complementary Medicine Practice Section Ministry of Health Malaysia

AUTHOR

REVIEWER

EXTERNAL REVIEWERS (alphabetical order)

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Background Headache is a major neurobiological disorder, affecting one third of the world’s population. It is estimated that up to 10 million people visit the general practitioner for chronic headache in the United States. Headache can be classified as migraine, tension-type, sinus and cluster. Tension-type headache should not be confused with migraine, which is characterised by recurrent attacks of mostly one-sided, severe headache, although some patients suffer from both types of headaches. Tension-type headache is the most common type of primary headache and the disability attributable to it is larger worldwide than that due to migraine. Neuralgia is a stabbing, burning, and often severe pain due to an irritated or damaged nerve. The nerve may be anywhere in the body, and the damage may be caused by several factors including aging, diseases such as diabetes or multiple sclerosis and an infection, such as shingles. It is a sudden, brief and recurrent (refractory condition) pain of the nerve.

Bell’s palsy, also known as acute idiopathic facial paralysis, is an acute peripheral facial neuropathy which is the most common cause of lower motor neuron facial palsy. The incidence of Bell’s palsy is about 11 to 40 per 100,000 adults each year, and Bell’s palsy is known as a non-fatal disease. Most patients recover spontaneously within three weeks.

Motor dysfunction is a frequent and widely recognised complication that often follows stroke. Stroke represents the third leading cause of mortality in Malaysia. Preliminary data found that, on average, 92 stroke admissions occurred each day across all Malaysian healthcare facilities nationwide. Of these admissions, 40.0% of stroke afflicted patients were of younger age-groups (less than 60 years old). Post-stroke survivors were often burdened with disabilities, with estimates of almost seven out of 10 stroke-afflicted survivors being activities of daily living (ADL)-dependent. Guillain Barre is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system; the network of nerves located outside of the brain and spinal cord. Guillain Barre can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently. Guillain Barre is estimated to affect about one person in 100,000 each year. Transverse myelitis is one of the rarest diseases of the nervous system affecting one or more segments of the spinal cord. Approximately 40.0% of patients with transverse myelitis have pain as their presenting long-term symptom. Despite extensive research efforts on numerous treatment modalities, patient still pursuit for alternative treatment in attempt to further improve the outcome of the disease as mentioned above, such as acupuncture. Acupuncture is defined as the needling of specific points of the body. It is one of the most widely used complementary therapies in many countries. It is claimed that being a relatively simple, inexpensive and safe treatment compared to other conventional interventions, acupuncture has

EXECUTIVE SUMMARY

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been well accepted by Chinese patients and is widely used to improve motor, sensation, speech and other neurological functions in patients. As a therapeutic intervention, acupuncture is also increasingly practiced in some Western countries. Hence, this technology review was requested by Neurology Department, Hospital Pulau Pinang, to provide the best available evidence related to acupuncture for the above purpose. Objective/aim To evaluate the efficacy, safety and cost-effectiveness related to acupuncture for neurological disorder; headache, refractory neuralgia, Bell’s palsy, post-stroke, Guillain Barre and transverse myelitis. Results and conclusions A total of 445 titles were identified through the Ovid interface and PubMed. There were 25 articles included in this review which consist of seven systematic reviews and meta-analysis, one systematic review alone, 13 randomised controlled trials (RCT), and two retrospective studies, one prospective observational study and one cost effectiveness and cost analysis study. There was substantial evidence on acupuncture on headache, Bell’s palsy and post-stroke. However, most of the studies have high risk of bias due to inappropriate randomised sequence generation, lack of allocation concealment, inadequate level of blinding, poor description of patient withdrawals from the studies and the adverse events and hence, varying the quality of the included trials. Nevertheless, the evidence showed that acupuncture may reduce headache frequency and improve response rate to treatment. The evidence was inconclusive for Bell’s palsy. As for post-stroke patients, the evidences showed acupuncture may improve ADL. As for other outcomes means, the results were inconclusive. For refractory neuralgia, Guillain Barre and transverse myelitis, there was insufficient evidence to assess the efficacy of acupuncture in these group patients. There were studies reported on adverse events namely, haematoma and ecchymosis, migraine attacks and headache after treatment, pain and fatigue, seizure, and stomach discomfort. Meanwhile, none of the clinical trials reported any serious adverse events. Acupuncture was approved by United States of Food and Drug Administration (USFDA) in 1996 and classified as Class II (special control). In term of cost-effectiveness, acupuncture was suggested to be clinically relevant benefit and cost-effective in certain sectors. In Malaysia, the cost per session varies according to scope of treatment ranges between RM35 to RM315. However, acupuncture service is being provided for RM20 per session at Traditional and Complementary Medicine Unit in Ministry of Health hospitals as per Perintah Fi (Perubatan) (Pindaan) 2017.

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Methods Electronic databases were searched through the Ovid interface; Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present EMBASE - 1946 to April 17 2020, EBM Reviews – Health Technology Assessment 4th Quarter 2016, EBM Reviews – Cochrane Database of Systematic Reviews 2005 to May 1, 2020, EBM Reviews – Cochrane Central Register of Controlled Trials March 2020, EBM Reviews – Database of Abstracts of Review of Effects 1st Quarter 2016, EBM Reviews – NHS Economic Evaluation Database 1st Quarter 2016. Searches were also run in PubMed, INAHTA and US FDA. Google was used to search for additional web-based materials and information. Additional articles were identified from reviewing the references of retrieved articles. Last search was conducted on 6 May 2020.

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Disclaimer and Disclosure i Authors ii External Reviewers ii Executive Summary iii Table of Contents vi-v Abbreviations vi

1.0 BACKGROUND 1-2

2.0 OBJECTIVE/ AIM 2

3.0 TECHNCAL FEATURES 2

4.0 METHODS 3-4 4.1 Searching 4.2 Selection

5.0 RESULTS 5-31 5.1 Selection of the included studies 5.2 Critical appraisal of the included studies 5.3 Efficacy/ Effectiveness 5.4 Safety 5.5 Cost analysis and cost-effectiveness 5.6 Limitations

6.0 CONCLUSION 31

7.0 REFERENCES 33-35

8.0 APPENDICES 36-87 8.1 Appendix 1 - Search Strategy 8.2 Appendix 2 - Hierarchy of evidence for effectiveness/ diagnostic 8.3 Appendix 3 - Evidence tables

TABLE OF CONTENTS

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ADL Activities of daily living CASP Critical Appraisal Skills Programme CI Confidence interval cTCM Complex Traditional Chinese Medicine ERR Effective rate ratio FMA Fugl-Meyer Assessment GRADE Grading of Recommendations Assessment, Development and Evaluation HTA Health Technology Assessment ICD International Classification of Diseases ICER Incremental cost-effectiveness ratio IQR Interquartile range LCCNPAP Lyndhurst Centre Central Neuropathic Pain Acupuncture Protocol MA Meta-analysis MaHTAS Malaysian Health Technology Assessment Section MD Mean difference MSEP Minor Symptom Evaluation Profile MOH Ministry of Health OR Odds ratio QALY Quality adjusted life year QoL Quality of life ROB Risk of bias RR Risk ratio RCT Randomised controlled trial SD Standard deviation SF Short-form SMD Standardised mean difference SODM Standard error of the mean SR Systematic review US FDA United States Food and Drug Administration VAS Visual analog scale WMD Weight mean difference

ABBREVIATIONS

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Headache is a major neurobiological disorder, affecting one third of the world’s population. It is estimated that up to 10 million people visit the general practitioner for chronic headache in the United States.1 Headache can be classified as migraine, tension-type, sinus and cluster. Tension-type headache should not be confused with migraine, which is characterised by recurrent attacks of mostly one-sided, severe headache, although some patients suffer from both types of headaches. Tension-type headache is the most common type of primary headache and the disability attributable to it is larger worldwide than that due to migraine.2 Neuralgia is a stabbing, burning, and often severe pain due to an irritated or damaged nerve. The nerve may be anywhere in the body, and the damage may be caused by several factors including aging, diseases such as diabetes or multiple sclerosis and an infection, such as shingles. It is a sudden, brief and recurrent (refractory condition) pain of the nerve.3

Bell’s palsy, also known as acute idiopathic facial paralysis, is an acute peripheral facial neuropathy which is the most common cause of lower motor neuron facial palsy. The incidence of Bell’s palsy is about 11 to 40 per 100,000 adults each year,4 and Bell’s palsy is known as a non-fatal disease. Most patients recover spontaneously within three weeks.5

Motor dysfunction is a frequent and widely recognised complication that often follows stroke.6 Stroke represents the third leading cause of mortality in Malaysia.7 Preliminary data found that, on average, 92 stroke admissions occurred each day across all Malaysian healthcare facilities nationwide. Of these admissions, 40.0% of stroke afflicted patients were of younger age- groups (less than 60 years old). Post-stroke survivors were often burdened with disabilities, with estimates of almost seven out of 10 stroke-afflicted survivors being activities of daily living (ADL)-dependent.8 Guillain Barre is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system; the network of nerves located outside of the brain and spinal cord. Guillain Barre can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently. Guillain Barre is estimated to affect about one person in 100,000 each year.9 Transverse myelitis is one of the rarest diseases of the nervous system affecting one or more segments of the spinal cord.10 Approximately 40.0% of patients with transverse myelitis have pain as their presenting long-term symptom.11 Despite extensive research efforts on numerous treatment modalities, patient still pursuit for alternative treatment in attempt to further improve the outcome of the disease as mentioned above, such as acupuncture. It is one of the most widely used complementary therapies in many countries.12 It is claimed that being a relatively simple, inexpensive and safe treatment compared to other conventional interventions, acupuncture has been well accepted by Chinese patients and is widely used to improve motor, sensation, speech and other neurological functions

1.0 BACKGROUND


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in patients. As a therapeutic intervention, acupuncture is also increasingly practiced in some Western countries.13,14 Hence, this technology review was requested by the Neurology Department, Hospital Pulau Pinang, to provide the best available evidence related to acupuncture for the above purpose.

To evaluate the efficacy, safety and cost-effectiveness related to acupuncture for neurological disorder; headache, refractory neuralgia, Bell’s palsy, post-stroke, Guillain Barre and transverse myelitis.

Traditional acupuncture includes the stimulation of precise points on the body through penetration by solid filiform needles developed by the Meridian notions. Stimulating these points is believed to promote the body's natural healing capabilities and enhance its function. It can be associated with the application of heat, pressure, or laser light to these same points. There are two very different ways of looking at acupuncture; from the traditional Chinese medicine and modern international perspective.15 Figure 1 shows several types of acupuncture. (a) (b) (c) Figure 1: 1(a) normal acupuncture, 1(b) electro-acupuncture, 1(c) moxibustion acupuncture. In traditional Chinese medicine, acupuncture is linked to the belief that disease is caused by disruptions to the flow of energy in the body (called qi, pronounced "chee"). In the Western view, acupuncture likely works by stimulating the central nervous system (the brain and spinal cord) to release chemicals called neurotransmitters and hormones. These chemicals dull pain, boost the immune system and regulate various body functions.16

2.0 OBJECTIVE/ AIM

3.0 TECHNICAL FEATURES


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4.1 Searching Electronic databases were searched through the Ovid interface:

Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present EMBASE - 1946 to April 17 2020

EBM Reviews – Health Technology Assessment 4th Quarter 2016

EBM Reviews – Cochrane Database of Systematic Reviews 2005 to May 1, 2020

EBM Reviews – Cochrane Central Register of Controlled Trials March 2020

EBM Reviews – Database of Abstracts of Review of Effects 1st Quarter 2016

EBM Reviews – NHS Economic Evaluation Database 1st Quarter 2016

Searches were also run in PubMed, INAHTA and US FDA. Google was used to search for additional web-based materials and information. Additional articles were identified from reviewing the references of retrieved articles. Last search was conducted on 24 May 2021. Appendix 1 shows the detailed search strategies. 4.2 Selection A reviewer screened the titles and abstracts against the inclusion and exclusion criteria and then evaluated the selected full text articles for final article selection. The inclusion and exclusion criteria were:

Inclusion criteria

Population Headache, refractory neuralgia, Bell’s palsy, post-stroke, Guillain Barre and transverse myelitis

Interventions Acupuncture, traditional body needling, moxibustion, electric acupuncture, electro-acupuncture, laser acupuncture

Comparators Placebo acupuncture, sham acupuncture, scalp acupuncture, other conventional treatment

Outcomes Headache: headache frequency, duration with headache, headache intensity and headache score, response rate, quality of life, medication score/ days with medication, use of alternative treatments and Minor Symptom Evaluation Profile (MSEP) Refractory neuralgia: Pain intensity Bell’s palsy: Effective rate, response rate and medication use Post-stroke: Motor function, activities of daily living (ADL), neurological deficit effect, quality of life, and other paratmeters Guillain Barre: Pain intensity

4.0 METHODS


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Transverse myelitis: Pain intensity, sleep disturbance assessment and psychological status assessment, bladder and bowel function Adverse events

Study design Health Technology Assessment (HTA) reports, Systematic Review (SR) and Meta-Analysis, Randomised Control Trial (RCT), Non-randomised Control Trial (RCT), cohort studies, cross-sectional studies, case studies

Type of publication

English, full text articles

Exclusion criteria

Study design

Studies conducted in animals, narrative reviews.

Type of publication

Non English full text articles

Relevant articles were critically appraised using Critical Appraisal Skills Programme (CASP) checklist and evidence graded according to the US/Canadian Preventive Services Task Force (See Appendix 2). Data were extracted from included studies using a pre-designed data extraction form (evidence table as shown in Appendix 3) and presented in tabulated format with narrative summaries. No meta-analysis was conducted for this review.


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5.1 Selection of the included studies A total of 445 titles were retrieved. After removing duplicates, applying inclusion and exclusion criteria, finally 25 studies were included in this review. Out of 25 studies included, there were seven systematic reviews and meta-analysis, one systematic review alone, 13 RCT, and two retrospective studies, one prospective observational study and one cost effectiveness and cost analysis study as shown in Figure 2. The studies included were conducted in China, South Korea, India, Turkey, United States, German, United Kingdom, Sweden, Brazil, Italy and Canada.

5.0 RESULTS


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Figure 2: Flow chart of study selection

Number of additional records

identified from other sources

(n=6491)

Number of records after duplicates removed (n=6900)

Number of records identified

through electronic databases

searching (n=445)

Number of records

screened (n=36)

Number of records

excluded (n=5)

Number of full-text

articles assessed

for eligibility (n=31)

Number of full-text

articles excluded

(n=6) with reasons:

- Irrelevant study design

Number of full-text articles

included in quantitative

synthesis (n=25)


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5.2 Critical appraisal of the included studies

The risk of bias assessment for RCT was assessed using Cochrane Risk of Bias Assessment tool (ROB 2.0) reference. For other study designs, a few important domains were selected to assess the risk of bias. This is achieved by answering a pre-specified question of those criteria assessed and assigning a judgement relating to the risk of bias as either:

+ Indicates YES (low risk of bias)

? indicates UNKNOWN risk of bias

- Indicates NO (high risk of bias)

Risk of bias assessment of the included studies are summarised according to their study design as below.

Criteria assessed

Auth

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right ty

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pers

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Sele

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Assessm

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Sun et al.17 + + ? ?

Zhang et al.29 + + + +

Li et al.30 + + + +

Kim et al.32 + + + +

Zhan et al.33 + + + +

Yang et al.34 + + + -

Kong et al.37 + + + +

Junhua et al.39 + + + +

Wu et al.40 + + - ?

Figure 3a: Assessment of risk of bias of Systematic Review


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Figure 3b: Assessment of risk of bias of RCT

(Cochrane ROB 2.0 reference: Traffic Light Plot)

Figure 3c: Assessment of risk of bias of RCT

(Cochrane ROB 2.0 reference: Summary Plot)


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5.3 Efficacy/ Effectiveness 5.3.1. Headache Ten studies reported the efficacy of acupuncture, of which one was a systematic review with meta-analysis and nine RCTs. 5.3.1.1. Headache frequency A systematic review with meta-analysis by Sun Y et al. (2008) evaluated the efficacy of acupuncture for treatment of chronic headache. Following databases were searched: CENTRAL, MEDLINE, CINAHLS and Scopus up to November 2007 and database of a Chinese medical journal. Thirty-one of 102 potentially relevant studies involving 3916 participants met the inclusion criteria. Seventeen studies included patients with migraine, 10 included patients with tension-type headache and four included patients with mixed chronic headache. The quality of the more recent trials was higher than the previous trials, with more emphasis on proper randomisation, allocation concealment and description of patient dropout. For acupuncture versus medication treatment, two trials reported the SMD in headache frequency was in favour of the acupuncture group. Days with headache per month and attacks (frequency) per months was -0.22 (95% CI: -0.41, -0.03) and -1.22 (95% CI: -2.34, -0.10) respectively.17, level I Wang K et. al (2007) conducted an RCT to examine the effect of acupuncture-like electrical stimulation on chronic tension-type headache in a randomised, double-blinded, placebo-controlled study. Thirty-six adult patients (more than 18 years old) diagnosed with chronic tension-type headache were divided randomly into the treatment and placebo (control) group with 18 in each. The number of headache attacks in the two weeks (Treat-1) during the treatment period was slightly decreased from 10.5 ± 4.6 to 9.5 ± 5.9 and to 8.4 ± 5.7 in the treatment group. There were also slight decreased of headache attack frequency from 11.5 ± 4.0 to 10.6 ± 3.8 at Treat-1 and to 10.7 ± 3.8 in the placebo group. However, there was no significant difference between the two groups (p=0.169) (see Figure 4). After treatment, two out of 36 patients reported that their headache pain had been totally relieved, four patients felt much better, seven patients felt slightly better, 22 patients felt no change, and one patients felt slightly worse.18, level I

Figure 4: Headache attacks over the two-weeks period.18, level I


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Another RCT by Gottschling S et al. (2008) was conducted to investigate whether active laser acupuncture reduced headache frequency more effectively than placebo laser acupuncture in children with migraine or tension-type headache. The 48 patients diagnosed with unilateral or bilateral headache or migraine or tension-type headache (children with age less and equal than 17 years old) were randomly divided into active laser acupuncture group and placebo laser acupuncture group, with 24 patients in each. The study was carried out between October 2006 and March 2007 at two medical centres. The results showed that there was a significant decrease in headache frequency compared to baseline in the active laser treatment group. The mean improvement in headache frequency was significantly greater in the treatment group than the placebo group. From baseline to week five to eight, the number of days decreased by 7.0 days in the active acupuncture group compared to 1.2 days in the placebo group. The difference between active acupuncture versus placebo acupuncture was 5.4 days (p<0.001). The decrease in headache frequency in the placebo group was not significant compared to baseline (p=0.145). Whereas, the headache frequency in the placebo group reached baseline level in weeks nine to 12, headache frequency in the active acupuncture group stayed low until the study endpoint (p<0.001) (see Figure 5).19, level I Figure 5: Headache frequency. Arrow indicating time phase when weekly acupuncture sessions took place. White stars indicating significant changes compared to baseline. Black stars indicating significant differences between placebo and active acupuncture with * indicating (p<0.05) and ** indicating (p<0.001). Data are presented as means. Error bars indicate standard error of the mean (SODM).19, level I

An RCT by Alecrim-Andrade J et al. (2008) was conducted to assess the efficacy of acupuncture in migraine prophylaxis. Thirty-seven patients who were diagnosed with migraine (with or without aura) were divided randomly into the real acupuncture and sham acupuncture groups with 19 and 17 in each. The study was conducted between December 2001 and June 2003 with six months of follow up. The differences with statistical significance between groups appeared in the second month of the treatment. Greater improvement was observed in the real acupuncture group. From the third month of the treatment to the late post-treatment follow-up, the statistical difference between groups disappeared (see Figure 6).20, level I


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Figure 6: Percentage of patients with reduction of 40.0% or more in migraine attacks frequency in the real and sham acupuncture groups compared with the baseline period. Diary 2 = first month of the treatment, diary 3 = second month of the treatment, diary 4 = third month of the treatment, diary 5 = first month after the treatment, and diary 6 = sixth month after the treatment. In this figure, the p value referred to the differences between groups.20, level I

Gildir S et al. (2019) conducted an RCT to explore the effectiveness of trigger point dry needling in patients with chronic tension-type headache. One hundred and sixty-one adult patients (age 20 to 50 years old) who were diagnosed with chronic tension-type headache were divided randomly into a dry needling and sham dry needling groups, with 80 and 81 in each. The trial was carried out between April and August 2017 with one month of follow up. The Friedman test revealed a statistically significant differences between measurements in both groups (all p values were less than 0.05). In the dry needling and sham dry needling group, pairwise comparisons revealed that there were statistically significant differences for headache frequency (p<0.05) (see Table 1).21, level I Table 1: Comparisons of headache intensity, frequency and headache duration at prior to treatment, at the end of therapy and at a one-month follow up, x±s, (95% CI).21,

level I

Another RCT by Tavola T et al. (1992) was conducted to evaluate the efficacy of acupuncture in the treatment of headache pain. Thirty patients who were diagnosed with tension-type headache were allocated randomly into Chinese traditional acupuncture and sham acupuncture group, with 15 in each. The patients were followed up for 12 months. The results reported that the frequency of episodes decreased significantly over time (from baseline period [t0] to t3) (F<time>=16, 34;


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df=3, 84; p<0.001). The mean decrease of episode frequency from the t0 to t3 was 44.3% and 21.4% in acupuncture and placebo-treated patients, respectively.22, level I

5.3.1.2. Duration with headache Vickers AJ et al. (2004) conducted an RCT to determine the effects of a policy of using acupuncture, compared with a policy of avoiding acupuncture, on headache in primary care patients with chronic headache disorders. Four-hundreds and one adult patients (age 18 to 65 years old) who were diagnosed with migraine or tension-type headache were randomly assigned to acupuncture and no acupuncture groups, with 205 and 196 in each. The recruitment took place between November 1999 and January 2001 with one year of follow up. The result showed that differences between groups were not sensitive to the definition of headache day.23, level I Another RCT by Linde K et al. (2005) was conducted to investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. Three-hundreds and two patients (adults of age 18 to 65 years old) who were diagnosed with migraine (with or without aura) were divided randomly into acupuncture, sham acupuncture and waiting list control groups, with 145, 81 and 76 in each. According to Figure 7, between baseline and week nine to 12 the number of days with headache of moderate or severe intensity decreased by a mean (standard deviation [SD] of 2.2 (2.7) days in the acupuncture group versus 2.2 (2.7) days in the sham acupuncture group and 0.8 (2.2) days in the waiting list group (difference acupuncture versus sham acupuncture, 0.0 days; 95% CI: -0.7, 0.7; p=0.96; acupuncture versus waiting list, 1.4 days, 95% CI: 0.8, 2.1; p=0.001). Response differences in the waiting list group became apparent after the first four weeks of treatment and increased until week 12. Furthermore, results in the sham acupuncture group tended to be slightly better than those in the acupuncture group, however the differences were not significant.24, level I

Figure 7: Number of days with moderate to severe headache.24, level I

Melchart D et al. (2005) conducted an RCT to investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. A total of 270 adult patients (age 18 to 65 years old) who were diagnosed with episodic or chronic tension-type headache were assigned to acupuncture, minimal acupuncture and no acupuncture (waiting list) groups randomly, with 132, 63 and 75 in each group. The follow up took place for six


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months. From baseline to week nine to 12, the number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture versus minimal acupuncture, 0.6 days, 95% CI: 1.5, 2.6; p=0.58; acupuncture versus waiting list, 5.7 days, 95% CI: 4.2, 7.2; p<0.001).25, level

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There was a significant decrease in monthly headache hours in the active acupuncture group compared to baseline with the mean improvement being greater in the active acupuncture group. The mild benefit of placebo acupuncture disappeared after eight weeks from baseline whereas the beneficial effect of active laser acupuncture lasted until the end of the follow up. The monthly headache hours decreased almost solely due to a reduction of the headache frequency.19, level I It was reported that greater improvement was observed in the real acupuncture group. From the third month of the treatment to the late post-treatment follow-up, the statistical difference between groups disappeared (see Figure 8).20, level I

Figure 8: Total of migraine days in each diary (one month) in the real and the sham acupuncture groups. Diary 1 = baseline period, diary 2 = first month of the treatment, diary 3 = second month of the treatment, diary 4 = third month of the treatment, diary 5 = first month after the treatment, and diary 6 = sixth month after the treatment. In this figure, the p value is referred to the differences between groups.20, level I

5.3.1.3. Headache intensity and headache score For acupuncture versus sham acupuncture groups, the pooled data showed there was no significant difference between acupuncture and sham groups at either early follow-up period. Combined data from three trials in migraine headache also did not show any difference. However, combined data from seven trials at the late follow-up period showed a weight mean difference (WMD) of -2.62 mm in favour of acupuncture (95% CI: -5.07, -0.17). For acupuncture versus medication treatment groups, the patients receiving acupuncture from two trials reported significant improvement at the early follow-up period (WMD: -8.54 mm, 95% CI: -15.52, -1.57) but the result was heterogeneous (see Figure 9).17, level I Furthermore, the average headache intensity was lower at Treat-1 (two weeks) and Treat-2 (up to four weeks) compared with the baseline. The pain intensity decreased from 4.9 ± 1.1 to 3.9 ± 1.6 at Treat-1, and to 3.3 ± 1.8 at Treat-2 in the treatment group. The effect size was 0.73 (95% CI: 1.93, 0.08) and 1.03 (95% CI: 2.58, 0.53).18, level I


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Figure 9: Headache intensity in acupuncture versus sham-controlled trials for tension-type headache. WMD weighted mean difference; CI confidence interval.18, level I

Gottschling S et al. (2008) reported that the pain intensity in the active treatment group decreased significantly compared to baseline. The improvement in the active acupuncture group was greater than in the placebo group. Nevertheless, there was a significant beneficial effect of placebo laser acupuncture in weeks one to four and 13 to 16 from baseline (p=0.024; p=0.004). The effect of the active laser acupuncture on pain severity was weaker than the other parameters but still significantly superior compared to placebo acupuncture at all times points (p<0.001).19, level I Meanwhile, for dry needling and sham dry needling groups, pairwise comparisons revealed that there were statistically significant differences for headache intensity (p<0.05).21, level I

Severity of headache was recorded by using a daily diary four times a day on a six-point Likert scale (0 = no headache, 5 = intense, incapacitating headache) and the total summed to give a headache score. In the primary analysis mean headache scores were significantly lower in the acupuncture group. Scores fell by 34.0% in the acupuncture group compared with 16.0% in controls (p=0.0002). When the pre-specified cut-off of 35.0% was used as a clinically significant reduction in headache score, 22.0% more acupuncture patients improved than controls, equivalent to a number needed to treat of 4.6 (95% CI: 9.1, 3.0). The effects of acupuncture seemed to be long lasting; although few patients continued to receive acupuncture after the initial three-months treatment period (25, 10, and six patients received treatment after three, six and nine months respectively), headache scores were lower at 12 months than at the follow-up after treatment.23 level I 5.3.1.4. Response rate Response rate was an overall assessment of improvement after treatment. Response was defined as at least 33.0% improvement by assessing headache index or by overall evaluation. For acupuncture versus sham acupuncture, 14 trials reported data on the proportions of patients responding to treatment at an early follow-up period. Combined data demonstrated a statistically significant higher response rate in the acupuncture group compared with sham acupuncture. Five-hundred ten of 961 (53.0%) acupuncture patients. A significant difference was also found in subgroup analysis for tension-type headache. Risk ratio was 1.26 (95% CI: 1.10, 1.44) without heterogeneity (I2=0). However, there was no significant difference between treatment groups for migraine. Only two studies reported the response rate at late follow-up in


15

which combined data show that RR was 1.22 (95% CI: 1.04, 1.43), again without heterogeneity (I2=0) (see Figure 10).17, level I Figure 10: Response rate in acupuncture versus sham-controlled trials for chronic headache. RR relative risk; CI confidence interval.17, level I

For acupuncture versus medication treatments groups, the pooled data from seven trials showed 62.0% of patients receiving acupuncture had a significantly higher response rate to treatment, compared with 45.0% of patients receiving medication at the early follow-up period. Risk ratio was 1.80 (95% CI: 1.16, 2.81). This significant difference was also found at one-year follow-up in one study.17, level I

5.3.1.5. Quality of life (QoL) Various scales and questionnaires were provided to assess health-related quality of life (QoL). The combined data of four studies by Sun Y et al. (2008) showed no significant difference between acupuncture and sham acupuncture in both physical and mental health, in either the early follow up or late follow up period. For acupuncture versus medication treatments groups, three trial reported suitable data for health-related QoL in the early-period. Pooled data from three trials showed that acupuncture produced significantly better physical function in the early follow-up period (WMD: 4.16, 95% CI: 1.33, 6.98). However, no significant difference was found in mental health. One study reported that patient well-being improved in the physiotherapy treatment group only when compared to acupuncture.17, level I

The short-form (SF-36) health status questionnaire was completed at baseline, three months and one year. Every three months after randomisation, patients completed additional questionnaires that monitored use of headache treatments and days sick from work or other usual activity. The results reported that SF-36 data generally favoured acupuncture, although differences reached statistical significance only for physical role functioning, energy and change in health.23, level I Table 2 shows


16

statistically significant differences between the groups on the following subscales. The Mann-Whitney U test revealed statistically significant differences between the groups on the subscales of physical functioning, role physical, bodily pain and vitality. General Linear Model revealed statistically significant differences between the groups on the general health, social functioning, role emotional and mental health subscales after controlling for the differences of the initial measurements.21, level I

Table 2: Comparisons of the Short Form-36 subscales’ scores of groups at the one-month follow-up, x±s, (95% CI).21, level I

5.3.1.6. Medication score/ days with medication Medication use was assessed by asking patients to describe the exact proprietary name of the drugs that they were taking and the number of doses of each. Medication scores at follow-up were lower in the acupuncture group. Although differences between groups did not reach statistical significance for all end-points. Total medication taken by patients after randomisation, weekly use fell by 23.0% in controls, but by 37.0% in the acupuncture group (adjusted difference between groups 15.0%, 95% CI: 3, 27, p=0.01).23, level I Other three studies reported that there was a reduction in the total intake of rescue medications in control and intervention groups. However, there were no statistical significant differences between them.18,20,22, level l

5.3.1.7. Use of alternative treatments and Minor Symptom Evaluation Profile

(MSEP) Sodenberg EI et al. (2011) conducted an RCT to study the comparison of three non-pharmacologic treatments; acupuncture, relaxation training and physical training on subjective well-being patients with chronic tension-type headache. Eighty-eight of adult patients (age 18 to 65 years old) who were diagnosed with chronic tension-type headache were randomly assigned to acupuncture, physical training and relaxation training groups, with 29, 30, and 29 in each. The patients were followed up for six months. The Minor Symptom Evaluation Profile questionnaire (MSEP) was used to assess central nervous system (CNS)-related symptoms. The MSEP comprised of 24 self-administered standardised items using a visual analogue scale (VAS); low scale values reflect positive feeling, high scale values reflect negative feeling. The items were categorised into three dimensions; contentment (happiness, self-control, well-being), vitality (enthusiasm, endurance, responsiveness) and sleep (nocturnal, quality, insomnia).26, level I For between-group comparisons, no difference in MSEP was found immediately after treatment among the three treatment groups, when total scores were compared. At the three-months follow-up, the proportion of individuals with an improved total score


17

was significantly greater in the physical training group compared with the acupuncture group (p=0.036). At the six-months follow-up, the proportion of individuals with improved levels was maintained in the physical training group and slightly increased in the relaxation training group. No significant differences were found at the six-month follow-up. Vitality was significantly higher in the relaxation training group compared with the acupuncture group at the six-months follow-up (see Table 3). Sleep was also significantly higher in the relaxation training group compared with the acupuncture group at the six-months follow-up. When the contentment dimensions were compared, no significant difference was found.26, level I Table 3: Proportions of individuals with an improved vitality dimension score of at least 10 or at least 25 VAS units, by treatment group.26, level I

Meanwhile for within-group comparisons, in the acupuncture group (n=30), total MSEP scores of 17 (56.7%) patients were improved immediately three and six months after treatment compared with baseline. In the physical training group (n=30), total scores were improved in 19 patients (63.3%) immediately after training and in 26 (86.7%) and 24 (80.0%) patients at the three-month and six-month follow-ups, respectively, compared with baseline. In the relaxation training group (n=30), total scores were improved in 23 (76.7%) patients immediately after treatment and in 20 (66.7%) and 22 (73.0%) patients at the three-month and six-month follow-ups, respectively, when compared with baseline.26, level I 5.3.2. Refractory neuralgia There was no comparative study retrieved to show the efficacy of acupuncture on refractory neuralgia. 5.3.3. Bell’s palsy Three studies reported the efficacy of acupuncture, of which, two were systematic reviews with meta-analysis and one RCT. Zhang R et al. (2019) conducted a systematic review with meta-analysis to investigate whether Bell’s palsy patients would benefit from acupuncture treatment comparing with drug therapy. The search was done without language restrictions via: PUBMED, EMBASE, CENTRAL, CNKI, Wan Fang Database up to July 2018. Eligible studies included RCT with intervention of manual acupuncture therapy (combined or not


18

combined with moxibustion) and compared with drug therapy. Two investigators independently extracted the information from each study. A 323 potentially relevant studies were found, of which 11 publications (1256 patients who were diagnosed with Bell’s palsy; facial paralysis or idiopathic facial paralysis or herpetic facial paralysis) fit the criteria for inclusion. Of those 11 publications, three trials used acupuncture combined with moxibustion, and the rest eight trials used traditional acupuncture. The results however, should be interpreted cautiously, because of the poor quality of included studies due to the insufficient information. Analysis of the risk of bias indicated that the high-risk bias of the included studies was mainly due to the fact that the study process was not blinded or unreported, and assessment of the results were not blinded or unreported. The outcomes were measured on the cure rate and total effective rate. The total cure rates for the acupuncture and drug groups were 59.7% and 32.5%, respectively. Acupuncture treatment was associated with an increased cure rate (RR=1.77, 95% CI: 1.41, 2.21), with significant heterogeneity in the pooled results (I2=67%, p=.0008) (see Figure 11). The total effective rates in the acupuncture and drug groups were 96.9% and 83.0%, respectively. Acupuncture therapy was associated with an increased total effective rate (RR=1.18, 95% CI: 1.07, 1.31, with significant heterogeneity in the pooled results (I2=90%, p<.00001). The authors concluded that acupuncture seemed to be an effective therapy for Bell’s palsy.27, level I

Figure 11: Meta-analysis on acupuncture for cured rate on Bell’s palsy.27, level I

Another systematic review with meta-analysis was conducted by Li P et al. (2015) to assess the efficacy of acupuncture for Bell’s palsy. Two investigators independently extracted the information from studies which were retrieved via: PUBMED, EMBASE, CENTRAL up to July 2014. Eligible studies included RCTs that limited the intervention acupuncture technique to conventional stimulation of points by needle insertion and electric acupuncture stimulation. A 249 potentially relevant studies were found, of which 14 publications fit the criteria for inclusion. Of those 14 publications, five studies used electro-acupuncture technique and nine studies used conventional acupuncture. Almost all studies included were of poor methodological quality and all the selected studies were considered at high risk of bias or unclear bias. The total effective response rates in 13 trials were reported in the acupuncture and control groups, were 95.48% and 82.81%, respectively. Acupuncture therapy was associated with an increased total effective response rate (RR 1.14, 95% CI: 1.04, 1.25, p=0.005), with significant heterogeneity among the included studies (I2=87%). In the subgroup analysis, eight articles compared acupuncture plus drug therapy against drug therapy in patients with Bell’s palsy and eleven studies compared acupuncture


19

against other interventions. The total effective response rates of these two groups were 96.47% and 96.33%, respectively. Significant associations were observed in both groups (acupuncture plus drug group: RR 1.14, 95% CI: 1.08, 1.20, p<0.00001; acupuncture group: RR 1.11, 95% CI: 1.00, 1.24, p=0.05). No heterogeneity was found in the acupuncture plus drug subgroup (I2=19%, p=0.29). However, there seemed to be huge degree of heterogeneity in the acupuncture versus other intervention subgroup (I2=90%, p<0.00001) and that versus drug therapy subgroup (I2=84%, p<0.00001). A total of six studies compared acupuncture against drug therapy, and the result showed significant association in these two groups (RR 1.18, 95% CI: 1.02, 1.36, p=0.02). There were three studies comparing acupuncture against blank control. However, the meta-analysis of these three studies was not performed due to unavailability of data. The authors concluded that, the current available evidence was insufficient to support that acupuncture was an effective therapy for Bell’s palsy due to the poor quality of included researches.28,

level I Zhang CY et al. (2016) conducted an RCT to evaluate the effects of the traits of personality on the objective outcome when different acupuncture techniques were used in treating patients with Bell’s palsy. The 316 adult patients (age 18 to 65 years old) who were diagnosed with facial nerve weakness were allocated randomly into acupuncture (with de qi) and acupuncture (without de qi) control groups. The outcome was measured on the House-Brackmann score: a score to grade the degree of nerve damage in a facial nerve palsy (grade I - normal, grade II - slight dysfunction, grade III - moderate dysfunction, grade IV - moderate severe dysfunction, grade V – total dysfunction, grade VI - total paralysis), and 16 Personality Factors (16PF): an assessment tool used to establish a person’s personality, usually in the form of a test consisting of a questionnaire. After six months, it was found that more patients had complete recovery in de qi group (89.8%) than control group (70.8%) (adjusted for age, gender, treatment center, interval between onset of palsy and start of treatment, House-Brackmann score on day one; adjusted odds ratio [OR]: 4.16, 95% CI: 2.23, 7.78). For the comparison between the groups, see Table 4. It was found that in both groups, the score of experience and belief in acupuncture questionnaire, gender, age, education status, occupation, and attention had no prominent effects on objective outcome after six months. The authors concluded that the needle sensation of fullness could predict better facial function and personality traits might influence outcomes of acupuncture treatment.29, level I Table 4: Analyses of factors associated with complete recovery for Bell’s palsy.29, level

I


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5.3.4. Post-stroke Nine studies reported the efficacy of acupuncture, of which five were systematic reviews with meta-analysis, one systematic review without meta-analysis and three RCTs. 5.3.4.1. Motor function Zhan J et al. (2018) conducted a systematic review with meta-analysis to assess the effectiveness and safety of electro-acupuncture combined with rehabilitation therapy and/or conventional drugs for improving post-stroke motor dysfunction. They searched the following English electronic databases: China National Knowledge Infrastructure, Chinese Biological Medicine Database, Chinese Scientific Journal Database (VIP), Cochrane Library, MEDLINE, EMBASE, PUBMED and Cochrane up to December 2016. Eligible studies included RCTs that evaluated clinical efficacy of electro-acupuncture in adult patients (age more than 18 years old) with non- electro-acupuncture. The review included 19 RCTs involving 1434 patients; all trials were conducted in China only. Of those 19 publications, 16 trials compared electro-acupuncture plus conventional drugs and rehabilitation therapy with conventional drugs plus rehabilitation therapy. Three trials gave electro-acupuncture and rehabilitation therapy to the experimental groups, while the control groups only received rehabilitation therapy. Most of the included trials had methodological defects. The funnel plots of Fugl-Meyer Assessment Scale (FMA) and Egger’s tests suggested a potential publication bias. These issues potentially lead to high risk of bias.30, level I The outcome of interest was measured in 13 trials with 1010 patients. There were no significant differences in treatment duration in the meta-regression model (adjusted R2: 0.124, t=−1.57, p=0.144). The FMA score in the electro-acupuncture group increased more than those in the non-electro-acupuncture group, and there was a significant difference (WMD 10.79, 95% CI: 6.39, 15.20, p<0.001). For FMA of upper extremity (FMA-U), one trial with 98 participants used the FMA for upper extremity to evaluate the function of the upper extremity, and the difference between the electro-acupuncture group and the non-electro-acupuncture group was significant (p<0.050). Furthermore, the FMA for lower extremity (FMA-L) was also assessed in four trials with 234 participants. There was a significant difference between the electro-acupuncture group and the non-electro-acupuncture group in the FMA-L (WMD 5.16, 95% CI: 3.78, 6.54, p<0.001). In the subgroup analysis (electro-acupuncture plus rehabilitation therapy and conventional drugs versus rehabilitation therapy plus conventional drugs), 10 trials used FMA to measure the motor function of 796 participants with post-stroke motor dysfunction. A random-effects model was used to analyse the effect on FMA due to significant heterogeneity. There was a significant difference between electro-acupuncture combined with rehabilitation therapy and conventional drugs versus rehabilitation therapy plus conventional drugs (WMD 8.03, 95% CI: 5.17, 10.90, p<0.001). Three trials with 214 participants applied FMA to compare the effectiveness of electro-acupuncture plus rehabilitation therapy against rehabilitation therapy alone. Meta-analyses with a random-effects model were performed on three trials to evaluate the effect on FMA in this subgroup analysis owing to statistical heterogeneity. There was a significant difference in these three trials favouring electro-acupuncture plus rehabilitation therapy plus conventional drugs against rehabilitation therapy plus conventional drugs only (WMD 20.90, 95% CI: 18.61, 23.19, p<0.001).30, level I


21

Another systematic review with meta-analysis by Yang A et al. (2016) was conducted to determine the efficacy and safety of acupuncture therapy in people with subacute and chronic stroke. The search included 10 computerised literatures such as Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, China Biological Medicine Database, Chinese Science and Technique Journals Database, China National Infrastructure and Wan Fang database up to July 2015. All RCTs that compared acupuncture with needling, with placebo acupuncture, sham acupuncture and no acupuncture in the treatment of patients in the subacute or chronic stage were included. The methodological quality of most of the included trials was not high. The quality of evidence for the main outcomes was low or very low based on the assessment using GRADE. Many studies did not provide detailed information on the severity of the disease, the exact time of starting the acupuncture treatment, the modalities of acupuncture technique and acupuncturist's background, and possible adverse effects relevant to acupuncture treatment. The result found that there was no evidence of effectiveness in terms of changes in motor function between real acupuncture and sham acupuncture among people with stroke in the convalescent stage.31, level I Sze FKH et al. (2002) conducted an RCT to examine whether acupuncture has additional value to standard post-stroke motor rehabilitation. One hundred and six Chinese patients who were diagnosed with haemorrhagic or ischaemic stroke were divided randomly into Traditional Chinese manual acupuncture and no acupuncture groups, with 31 (the patients were divided into group 1A; received five weeks [± 1 week] of inpatient rehabilitation, followed by five weeks [± 1 week] of day hospital rehabilitation, and group 1B; received three weeks [± 1 week] of inpatient rehabilitation, followed by seven weeks [± 1 week] of day hospital rehabilitation) and 22 (the patients also divided into group 2A and 2B, who received the same routine as group 1A and 1B) in each. No differences were seen between the intervention arm and the control arm in either group 1 or group 2, when comparing impairment scores of FMA of Physical Performance - Motor subsection (FMAM) and FMA at 10 weeks.32,

level I Another RCT was conducted by Johansson BB et al. (2001) to study effects of acupuncture and transcutaneous electrical nerve stimulation on functional outcome and quality of life after stroke versus a control group that received subliminal electrostimulation. One hundred and fifty patients with acute stroke were allocated into acupuncture, transcutaneous electrical nerve stimulation and subliminal electrostimulation control groups randomly, with 48, 51 and 51 in each. Overall motor function showed that in intention-to-treat analyses, no clinically meaningful or statistically significant differences existed. Moreover, most patients in all groups were unable to score more than zero in the Nine Hole Peg Test, which was used to assess fine motor function of the affected hand.33, level I Junhua Z et al. (2009) conducted a systematic review to determine whether complex Traditional Chinese Medicine (cTCM) treatments improves post-stroke motor recovery. Two independent reviewers searched the following electronic databases through December 2007: PubMed, EMBASE, CBM, the Cochrane Library, and other Chinese journal databases. All RCTs that compared cTCM with acupuncture (with or without physical exercise) were included. A total of 11235 potentially relevant studies


22

were found, of which 34 publications (4521 patients with ischaemic or haemorrhagic stroke) fit the criteria for inclusion. All the included studies were single-centre, parallel-design and randomised. In general, the methodological quality of the trials included was poor. According to the Cochrane handbook, all of the trials included were of low quality classified as “C”. A strong publication bias was present in the review as the asymmetry of the funnel plot was reported. The results showed that four of the 12 trials of cTCM versus acupuncture alone showed statistically significant higher effective rate ratio (ERR) after treatment with the cTCM ([ERR=1.37: 95% CI: 1.02, 1.85], [ERR=1.38; 95% CI: 1.06, 1.80], [ERR=1.57; 95% CI: 1.18, 2.08], [ERR=1.11: 95% CI: 1.03, 1.20]). The remaining eight trials did not show statistically significant differences between the experimental and control groups. In two other trials the control group included acupuncture plus physical exercise, only one showed a statistically significant result (ERR=1.16; 95% CI: 1.04, 1.31).36, level I 5.3.4.2. Activities of daily living (ADL) Kong JC et al. (2010) conducted a systematic review with meta-analysis to critically evaluate the effectiveness of acupuncture as an adjunct to mainstream stroke rehabilitation. The study searched 20 computerised literatures which were MEDLINE, AMED, CINAHL, EMBASE, PsycINFO, British Nursing Index, Cochrane Library, Asian journals and 12 major Korean traditional medicine journals up to October 2009. The RCTs that compared acupuncture and electro-acupuncture with sham acupuncture and sham electro-acupuncture in the treatments of patients with acute, subacute and chronic stage of stroke were included. Applicable follow up were six months. The PEDro score was used to determine the quality of clinical trials and consists of a checklist of 10 scored yes-or-no questions pertaining to the internal validity and the statistical information provided (high quality = 6-10, fair quality = 4-5 and poor quality ≤ 3). The quality of the study showed that the mean PEDro score was 6.6 (standard deviation [SD] 1.5), with a range of four to nine points. The Cochrane risk of bias varied. The results showed that seven trials tested the effects of acupuncture on activities of daily living (ADL) according to the Barthel Index: the measurement of the degree of assistance required by an individual on 10 items of mobility and self-care ADL (a higher number being a reflection of greater ability to function independently following hospital discharge), the modified Barthel Index, or the Sunaas Index of ADL. Two of these studies (both from China) showed favourable effects on ADL.34, level I Zhan J et al. (2018) reported that the effect of electro-acupuncture on ADL was analysed using a random-effects model, due to significant heterogeneity in 12 trials with 970 participants. The improvement of ADL in the electro-acupuncture group was better than that in the non-electro-acupuncture group (SMD 1.37, 95% CI: 0.79, 1.96, P<0.00001). In the subgroup analysis (electro-acupuncture plus rehabilitation therapy and conventional drugs versus rehabilitation therapy plus conventional drugs), a random-effects model was used to analyse the effect on ADL due to significant heterogeneity. There was a significant difference between electro-acupuncture combined with rehabilitation therapy and conventional drugs versus rehabilitation therapy plus conventional drugs (WMD 8.03, 95% CI: 5.17, 10.90, p<0.001). Electro-acupuncture plus rehabilitation therapy and conventional drugs for the improvement of ADL was better than that of rehabilitation therapy plus conventional drugs (SMD 1.29, 95% CI: 0.55, 2.02, p<0.001). Meta-analyses with a random-effects model were performed on three trials to evaluate the effect on ADL in this subgroup analysis also owing to statistical


23

heterogeneity. There was a significant difference in these three trials (WMD 20.90, 95% CI: 18.61, 23.19, p<0.001). In the comparison of electro-acupuncture plus rehabilitation therapy versus rehabilitation therapy alone in the three trials, the improvement in ADL was statistically significant (SMD 1.63, 95% CI: 1.01, 2.25, p<0.00001) (see Figure 12).30, level I

Figure 12: Forest plot and meta-analysis of activities of daily living. CD, conventional drugs; EA, electro-acupuncture; RT, rehabilitation therapy.30, level I

Yang A et al. (2016) reported that, compared with no acupuncture, for people with stroke in the convalescent phase, acupuncture had beneficial effects on the improvement of dependency (ADL) measured by Barthel Index (nine trials, 616 participants; mean difference (MD) 9.19, 95% CI: 4.34, 14.05; GRADE very low).31, level

I However, one study reported that neither at three nor 12-months follow up did any statistically significant differences occured between three groups (acupuncture, transcutaneous electrical nerve stimulation and subliminal electrostimulation).33, level I

5.3.4.3. Neurological deficit effect Four trials evaluated the effects of acupuncture on neurologic deficits using the National Institutes of Health Stroke Scale, the European Stroke Scale, or the Scandinavian Stroke Scale. A lower score typically indicated normal function in that specific ability, while a higher score indicated some level of impairment. One of the four studies showed positive therapeutic effects. However, the three trials did not show a significant difference between the two groups (n=216; SMD 0.20, 95% CI: −0.23, 0.62; I2=59%).34, level I Yang A et al. (2016) also reported on neurological deficit effect. Compared with no acupuncture, for people with stroke in the convalescent phase, acupuncture had beneficial effects on the global neurological deficiency (seven trials, 543 participants; odds ratio (OR)=3.89, 95% CI: 1.78, 8.49; GRADE low).31, level I Zhang S et al. (2015) conducted an RCT from April 2001 to February 2002 (pilot phase) and from February 2002 to February 2004 (main study) to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. Eight-


24

hundreds and sixty-two adult patients (age 18 to 65 years old) who were diagnosed with acute ischaemic stroke were divided randomly into traditional Chinese acupuncture (plus routine ischaemic stroke treatment) and routine ischaemic stroke treatment control groups, with 427 and 435 in each. The patients were followed up for six months. For the evaluation on neurological deficit, at the end of the scheduled treatment period, there was also a significantly greater change of Scandinavian Stroke Scale score from baseline in acupuncture group (9.70±7.85) than in control group (7.57±12.58; p=0.03), which indicated that patients in acupuncture group had greater reduction in their neurological deficit.35, level I

5.3.4.4. Quality of life (QoL) Kong JC et al. (2010) reported that, of the five trials that assessed the effects of acupuncture treatment on QoL, none showed favourable effects. A meta-analysis of the data from the two studies that involved patients in the chronic stage of stroke (one was excluded due to incomplete data) also did not show favourable effects of acupuncture on function according to the Modified Ashworth Scale: a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform; 0 indicates no increase in muscle tone, 4 indicates affected part(s) rigid in flexion or extension, (n=58; MD 0.01, 95% CI: −0.65, 0.67; I2=0%).34, level I Furthermore, there was also no evidence of differences in the changes of QoL between real acupuncture and sham acupuncture for people with stroke in the convalescent stage. However, the score on energy was more favourable in the acupuncture group than in the two other groups, but the differences did not reach statistical significance (see Table 5).33, level I

Table 5: Quality-of-Life domains in the Nottingham Health Profile in patients randomised to acupuncture; high-intensity, low-frequency transcutaneous electrical nerve stimulation; and subliminal stimulation.33, level I

5.3.4.5. Other parameters A systematic review with meta-analysis was conducted by Wu P et al. (2010) to comprehensively assess the efficacy of acupuncture in post-stroke rehabilitation. The search was done without language restrictions via: MEDLINE, AMED, CINAHL, Alt Health Watch, Nursing and Allied Health Collection: Basic and Cochrane Database of Systematic Reviews, CNKI, CBM up to September 2009. Eligible studies included RCTs that evaluated the clinical efficacy of acupuncture in adult patients (age more


25

than 18 years old) with disability due either to ischaemic or haemorrhagic stroke. A total of 463 potentially relevant studies were found, of which 56 publications fit the criteria for inclusion. Of those 56 publications, 16 trials used electro-acupuncture, 24 trials used both scalp and body acupuncture, 28 trials used body acupuncture only and four studies used scalp acupuncture only for the treatment groups. The overall quality of the studies was fair and most studies have small sample size (median n=86; range, 16 to 241). In general, randomisation and allocation concealment were poorly reported. Seven studies adequately reported allocation concealment. Assessor blinding was reported in a total of 16 studies.37, level I Positive results were reported in 45 studies. Six studies reported a positive benefit only in a subgroup analysis. No significant differences between acupuncture intervention and control were reported in five studies. Thirty-eight trials provided numeric data for meta-analyses, the results of which yielded a highly significant odd ratio (OR) demonstrating efficacy in post-stroke rehabilitation with acupuncture compared with no acupuncture (OR=4.33, 95% CI: 3.09, 6.08; I2=72.4% (see Figure 13). Randomisation, modes of delivery, method of control, study of source country and reporting of randomisation might explain some of the heterogeneity observed between the studies.37, level I


26

Figure 13: Efficacy in post-stroke rehabilitation with acupuncture compared with no

acupuncture.37 level I

Berg Balance Scale was conducted to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 items list with each item consisting of a five-points ordinal scale ranging from zero to four, with zero indicating the lowest level of function and four the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. The assessment was done in one trial with 120 participants. The improvement of Berg Balance Scale in the electro-acupuncture group was preferable to that in the non-electro-acupuncture group (p<0.050).30, level I Zhang S et al. (2015) reported on death, dependency level and institutional care of the patients at six months. Fewer patients had died or were dependent in the acupuncture group (113/410, 27.6%) than in control group (137/405, 33.0%) at three


27

months, the tendency continued at six months (80/385 [20.7%] versus 102/396 [25.8%]), but the difference was not statistically significant (OR=0.75; 95% CI: 0.54, 1.05). There was also no significant difference in death or institutional care between the two groups at six months (8.0% versus 7.6%; OR=1.06; 95% CI: 0.63, 1.79). Pre-planned subgroup analysis showed that only when patients who received 10 sessions or more of acupuncture were included in the analysis, a significant difference was detected at six months (57/298 [19.1%] versus 102/396 [25.8%]; OR=0.68; 95% CI: 0.47, 0.98; number needed to treat 15). However, death occurred in 6.2% and 4.5% of patients in the two groups, respectively (OR=1.39%; 95% CI: 0.74, 2.60).35, level I

Compared with no acupuncture, Yang A et al. (2016) reported that acupuncture had beneficial effects on the improvement of cognitive function measured by the Mini-Mental State Examination (five trials, 278 participants; MD2.54, 95% CI: 0.03, 5.05; GRADE very low). Mini-Mental State Examination is a test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. Hamilton Depression Scale is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. An improvement was reported on depression measured by the Hamilton Depression Scale (six trials, 552 participants; MD: -2.58, 95% CI: -3.28, -1.87; GRADE very low). The swallowing function measured by drinking test (two trials, 200 participants; MD: -1.11, 95% CI: -2.08, -0.14; GRADE very low), and pain measured by the VAS (two trials, 118 participants; MD: -2.88, 95% CI: -3.68, -2.09; GRADE low) also showed some improvements.31, level I

5.3.5. Guillain Barre Only one study reported on efficacy of acupuncture. Rapson LM et al. (2003) conducted a retrospective study to investigate the effects of an EA protocol for the treatment of below-level central neuropathic pain developed at the Toronto Rehabilitation Institute, Lyndhurst Center, Toronto, Ontario, Canada. Patients who were referred to the Lyndhurst Acupuncture Clinic by staff physiatrists were selected. Thirty-six inpatients with spinal cord injury due to traumatic and non-traumatic causes were recruited, however only one patient was diagnosed with Guillain Barre syndrome as a cause of spinal cord injury. The selected patients were divided into electro-acupuncture and non-electro-acupuncture groups. The study described the outcomes of individuals with traumatic and non-traumatic spinal cord injury who were treated according to an electro-acupuncture protocol that was developed at the Lyndhurst Center, called the Lyndhurst Centre Central Neuropathic Pain Acupuncture Protocol (LCCNPAP). The pain ratings were assessed using the 11-points VAS. Two of the authors independently examined each patients’ chart information and identified which pain characteristic(s) applied to each patient. Disagreements were resolved by a third investigator's independent review of the raw data. A significance level of p<0.05 was set for the χ2 statistical analyses. According to patient self-reports, of the 36 patients identified, 24 experienced improvements in response to the LCCNPAP including the only one patient with Guillain Barre syndrome after one treatment. The VAS showed a reduction of pain at discharge which was from seven to two.38


28

5.3.6. Transverse myelitis (TM) Two studies reported the efficacy of acupuncture. Wu J et al. (2018) conducted a prospective observational study to preliminarily explore the effect of electro-acupuncture on bladder and bowel dysfunction in patients with transverse myelitis. Sixteen patients who had acute or subacute-onset complete or incomplete transverse spinal cord injury, simultaneous bladder and bowel dysfunction or isolated bladder dysfunction caused by transverse myelitis were recruited. Participants were treated with electro-acupuncture at bilateral (BL) BL32, BL33, and BL35 once a day, five times a week for the first four weeks, and once every other day, three times a week for the following four weeks. The patients were then followed up for six months. Bladder and bowel function, and the safety of electro-acupuncture, were assessed. For the assessment of bladder function, after eight weeks of treatment, five (5/16, 31.0%) patients resumed normal voiding, three (6/16, 38.0%) regained partially normal voiding, and five (5/16, 31.0%) had no change. After treatment, the residual urine volume decreased by 100 mL (interquartile range [IQR] 53–393 mL; p<0.05) in nine patients with bladder voiding dysfunction; in 11 patients with urinary incontinence, the number of weekly urinary incontinence episodes, 24-hours urinary episodes, and nocturia episodes per night diminished by 14(95% CI: 5, 22), 5(95% CI: 1, 9), and 4(95% CI: 0, 7) episodes, respectively (all p<0.05) (see Table 6). For bowel function assessment, after eight weeks of treatment in eight patients with faecal retention, four (4/8, 50.0%) resumed normal bowel movements, three (3/8, 38.0%) regained partially normal bowel movements, and one (1/8, 13.0%) had no change. These effects were sustained after six months. The authors concluded that electro-acupuncture might be a promising alternative for the management of bladder and bowel dysfunction in patients with transverse myelitis.39 Table 6: Outcomes for bladder function assessment.39

Rapson LM et al. (2003) reported in retrospective study, the only one patient with transverse myelitis as a cause of spinal cord injury experienced improvement after the two treatments. The VAS showed that the patient could not do scale at discharge due to language difficulty, but the burning pain was reported as much better.38


29

5.4 Safety There were studies reported on adverse events namely, haematoma and ecchymosis,17,20,24,25,31,32,34, level I migraine attacks and headache after treatment,17,23-

25, level I pain and fatigue,21,24,25, level I seizure,34, level I and stomach discomfort.36, level I Meanwhile, none of the trials in four studies reported any adverse events.19,30,33,34, level

I Acupuncture was approved by United States of Food and Drug Administration (USFDA) in 1996 and classified as Class II (special control); acupuncture needles must comply with the following special controls:

1. Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109.

2. Device material biocompatibility. 3. Device sterility.42

5.5 Cost analysis and cost-effectiveness There was only one retrievable study on cost-effectiveness and cost-analysis of acupuncture for headache. A multicentre, RCT was conducted by Witt CM et al. (2008) to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. Adult patients; age more and equal than 18 years who were diagnosed with primary headache for more than 12 months and at least having two headaches per month were recruited. The 3182 patients were allocated randomly into acupuncture and control groups, with 1613 and 1569 in each. The International Classification of Diseases (ICD)-10 codes was used to identify costs due only to headache and related conditions. These codes were also provided by the insurance companies for all resources such as days of lost work. In the Germany, an arbitrary and hypothetical threshold of maximum €50000 per quality-adjusted life year (QALY) was used.40, level I For cost-analysis, the mean overall costs incurred by acupuncture patients during the treatment period were €857.47 (95% CI: 790.86, 924.07) and €527.34 (95% CI: 459.81, 594.88) in control patients (p<0.001). Three months after randomisation, the mean cost difference between the two treatment groups [total overall: €330.12 (95% CI: 235.27, 424.98), was primarily due to the acupuncture costs in the acupuncture group [€365.64 (95% CI: 362.19, 369.10)]. In acupuncture patients, the overall cost difference between baseline and the end of the three-month treatment period was €362.05 (95% CI: 293.78, 430.32) compared with €7.05 (95% CI: -62.17, 76.27) in control patients (p<0.001). Excluding the costs of acupuncture revealed that there was no significant overall cost differences between the two study groups. Also in single cost components no significant differences between the two study groups could be detected (see Table 7). Over three-months, costs were higher in the acupuncture group compared with the control [€857.47; 95% CI: 790.86, 924.07, versus €527.34 (459.81, 594.88), p<0.001, MD: €330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [€365.64 (362.19, 369.10)]. The incremental cost-effectiveness ratio (ICER) was €11657 per QALY gained.40, level I


30

In Malaysia, the cost per session varies according to scope of treatment ranges between RM35 to RM315.41, level 1 However, acupuncture service is being provided for RM20 per session at Traditional and Complementary Medicine Unit in Ministry of Health hospitals as per Perintah Fi (Perubatan) (Pindaan) 2017.43

Table 7: Mean costs and cost differences (costs during the three-months treatment period–costs during the three months prior to study initiation) in EURO per patient for acupuncture and control group.40, level I

The cost-effectiveness analysis showed that a gain of 0.0301 ± 0.004 QALYs was observed in the acupuncture group compared with the control group, with additional costs [overall: €350.85 (95% CI: 216.63, 485.07), diagnosis-specific: €365.38 (95% CI: 341.74, 389.02)]. The ICER was €11657 (overall) and €12140 (diagnosis-specific) per QALY gained. Therefore, for the assumed threshold value of €50000, the additional acupuncture intervention would appear to be cost-effective.40, level I Sensitivity analysis reported that for migraine, it was found that acupuncture treatment in men seems to be more cost-effective than in women (ICER men €-810 versus women €19 228). In contrast, for tension-type headache, the acupuncture treatment was more cost effective for women (ICER men €34775 versus women €4109; adjusted ICER men €12599 versus women €2619). The cost acceptability curves represented the probability of cost effectiveness against different threshold values ranging from €0 to €50000 (see Figure 14). The authors concluded that by using acupuncture in addition to routine care to treat patients with primary headache resulted in a marked and clinically relevant benefit and was cost-effective.40, level I


31

Figure 14: Probability that acupuncture treatment in patients suffering from headache is cost-effective against different threshold values of society’s willingness to pay.40, level

I 5.6 Limitations This review has several limitations. The selection of the studies and appraisal was done by one reviewer. Although there was no restriction in language during the search, only English full text articles were included in the report. The most important limitation was the methodological quality of the included trials which had a high risk of bias. The inappropriate randomised sequence generation, lack of allocation concealment, and an inadequate level of blinding could cause selection or study quality bias. Another weakness is the poor description of patient withdrawals from the studies and the adverse events. There was substantial evidence on acupuncture on headache, Bell’s palsy and post-stroke. However, most of the studies have high risk of bias due to inappropriate randomisation sequence generation, lack of allocation concealment, inadequate level of blinding, poor description of patient withdrawals from the studies and the adverse events and hence, varying the quality of the included trials. Nevertheless, the evidence showed that acupuncture may reduce headache frequency and improve response rate to treatment. The evidence was inconclusive for Bell’s palsy. As for post-stroke patients, the evidence showed acupuncture may improve ADL. As for other outcomes means, the results were inconclusive. For refractory neuralgia, Guillain Barre and transverse myelitis, there was insufficient evidence to assess the efficacy of acupuncture. There were studies reported on adverse events namely, haematoma and ecchymosis,

migraine attacks and headache after treatment, pain and fatigue, seizure, and stomach discomfort. Meanwhile, none of the clinical trials reported any serious adverse events.

6.0 CONCLUSION


32

Acupuncture was approved by United States of Food and Drug Administration (USFDA) in 1996 and classified as Class II (special control). In terms of cost-effectiveness, acupuncture was suggested to have clinically relevant benefit and cost-effective in certain sectors. In Malaysia, the cost per session varies according to scope of treatment ranges between RM35 to RM315. However, acupuncture service is being provided for RM20 per session at Traditional and Complementary Medicine Unit in Ministry of Health hospitals as per Perintah Fi (Perubatan) (Pindaan) 2017..


33

1. Mason D. Migraine and other headaches. J N Z Med Assoc. 2004; 117; 1196

2. Stovner LJ, Hagen K, Jensen R et al. The global burden of headache: a documentation

of headache prevalence and disability worldwide. Cephalalgia. 2007; 27(3): 193–210. MEDLINE: 17381554

3. Ellis ME. Neuralgia. Available at https://www.healthline.com/health/neuralgia Accessed on 4 June 2020

4. Hauser WA, Karnes WE, Annis J et al. Incidence and prognosis of Bell’s palsy in the population of Rochester, Minnesota. Mayo Clin Proc. 1971; 46: 258–64

5. Cave JA. Recent developments in Bell’s palsy: Does a more recent single research paper trump a systematic review? BMJ. 2004; 329: 1103

6. Zhan J, Pan R, Zhou M et al. Electroacupuncture as an adjunctive therapy for motor dysfunction in acute stroke survivors: a systematic review and meta-analyses. BMJ Open. 2018; 8. DOI: 10.1136/ bmjopen-2017-017153

7. Institute for Health Metrics and Evaluation. Statistics data. Available at http://www.healthdata.org/malaysia Accessed on 4 June 2020

8. Project Monitoring Stroke Burden in Malaysia. Use of linked national data sources. Unpublished data. Accessed on 4 June 2020

9. Guillain-Barré Syndrome Fact Sheet. Available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet Accessed on 4 June 2020

10. Altrocchi PH. Acute transverse myelopathy. Arch Neurol. 1963; 9: 111-119

11. Kerr D. Transverse myelitis. In: Johnson RT, Griffin JW, McArthur JC, eds. Current therapy in neurologic disease. Mosby Inc; 2002; 176-180

12. Bodeker G, Ong CK, Grundy C et al. WHO global atlas of traditional, complementary and alternative medicine. WHO Center for Health Development. 2005

13. Johansson K, Lindgren I, Widner H et al. Can sensory stimulation improve the functional outcome in stroke patients? Neurology. 1993; 43: 2189–2192

14. NIH Consensus Conference. Acupuncture. JAMA. 1998; 280: 1518–1524

15. Pyne D, Shenker NG. Demystifying acupuncture. Rheumatology. 2008; 47 (8): 1132–1136. DOI:10.1093/rheumatology/ken161

16. Acupuncture. Australian Acupuncture and Chinese Medicine Association Ltd. Available at http://www.acupuncture.org.au/Health_Services/Acupuncture.asp Accessed on 4 June 2020

17. Sun Y, Gan TJ. Acupuncture for the management of chronic headache: a systematic

review. International Anesthesia Research Society. 2008; 107(6): 2038-2047. DOI: 10.1213/ane0b013e318187c76a

7.0 REFERENCES

https://www.healthline.com/health/neuralgia

http://www.healthdata.org/malaysia

https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet

https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet

http://www.acupuncture.org.au/Health_Services/Acupuncture.asp


34

18. Wang K, Svensson P, Arendt-Nielsen L. Effect of acupuncture-like electrical stimulation on chronic tension-type headache: a randomised, double blinded, placebo-controlled trial. Clin J Pain. 2007; 23(4): 316-322

19. Gottschling S, Meyer S, Gribova I et al. Laser acupuncture in children with headache: a double-blind, randomised, bicenter, place-controlled trial. Pain. 2008; 405-412. DOI: 10.1016/j.pain.2007.10.004

20. Alecrim-Andrade J, Maciel-Junior JA, Carne X et al. Acupuncture in migraine prevention: a randomised sham controlled study with 6-months posttreatment follow-up. Clin J Pain. 2008; 24(2): 98-105

21. Gildir S, Tuzun EH, Eroglu G et al L. A randomised trial of trigger point dry needling versus sham needling for chronic tension-type headache. Medicine. 2019; 98(8). DOI: http://dx.doi.org/10.1097/MD.0000000000014520

22. Tavola T, Gala C, Conte G et al. Traditional Chinese acupuncture in tension-type headache: a controlled study. Pain. 1992; 48: 325-329

23. Vickers AJ, Rees RW, Zollman CE et al. Acupuncture of chronic headache disorders in primary care: randomised controlled trial and economic analysis. Health Technol Assess. 2004; 8(48)

24. Linde K, Streng A, Jurgens S et al. Acupuncture for patients with migraine: a randomised controlled trial. JAMA. 2005; 293(17): 2118 – 2125

25. Melchart D, Streng A, Hoppe A et al. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005; 1-7. DOI: 10.1136/bmj.38512.405440.8F

26. Sodenberg EI, Carlsson JY, Stener-Victorin E et al. Subjective well-being in patients with chronic tension-type headache: effect of acupuncture, physical training and relaxation training. Clin J Pain. 2011; 27(5): 448-556

27. Zhang R, Wu T, Wang R et al. Compare the efficacy of acupuncture with drugs in the

treatment of Bell’s palsy: a systematic review and meta-analysis of RCTs. Medicine. 2019; 98 (19). e15566

28. Li P, Qiu T, Qin C. Efficacy of acupuncture for Bell’s palsy: a systematic review and meta-analysis of randomised controlled trials. PLoS ONE. 2015; 10(5). e0121880

29. Zhang CY, Xu SB, Huang B et al. Needle sensation and personality factors influence therapeutic effect of acupuncture for treating Bell’s palsy: a secondary analysis of multicentre randomised controlled trial. Chin Med J. 2016; 129: 1789-1794

30. Zhan J, Pan R, Zhou Met al. Electroacupuncture as an adjunctive therapy for motor dysfunction in acute stroke survivors: a systematic review and meta-analyses. BMJ Open. 2018; 8. DOI: 10.1136/ bmjopen-2017-017153

31. Yang A, Wu HM, Tang JL et al. Acupuncture for stroke rehabilitation. cochrane database of systematic reviews. 2016; 8. CD004131. DOI: 10.1002/14651858.CD004131.pub3

32. Sze FKH, Wong E, Yi X et al. Does acupuncture have additional value to standard poststroke motor rehabilitation? Stroke. 2002; 33: 186-194

http://dx.doi.org/10.1097/MD.0000000000014520


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33. Johansson BB, Haker E, von Arbin M et al. Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation: a randomised, controlled trial. Stroke. 2001; 32: 707-713

34. Kong JC, Lee MS, Shin BC et al. Acupuncture for functional recovery after stroke: a systematic review of sham-controlled randomised clinical trials. CMAJ. 2010; 182(16): 1723-1729. DOI: 10.1503/cmaj.091113

35. Zhang S, Wu B, Liu M et al. Acupuncture efficacy on ischemic stroke recovery. Stroke. 2015; 46: 1301-1306. DOI: 10.1161/STROKEAHA.114.007659

36. Junhua Z, Menniti-Ippolito M, Xiumei G et al. Complex traditional Chinese medicine for poststroke: a systematic review. Stroke. 2009; 40: 2797-2804. DOI: 10.1161/STROKEAHA.109.555227

37. Wu P, Mills E, Moher D et al. Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomised trials. Stroke. 2010; 41: 171-179. DOI: 10.1161/STROKEAHA.109.573576

38. Rapson LM, Wells N, Pepper J et al. Acupuncture as a promising treatment for below level central neurapaathic pain: a retrospective study. The Journal of Spinal Cord Medicine. 2003; 26(1): 21-26. DOI: 10.1080/10790268.2003.11753655

39. Wu J, Cheng Y, Qin Z et al. Effects of electroacupuncture on bladder and bowel

function in patients with transverse myelitis: a prospective observational study. Acupunct Med. 2018; 36: 261-266. DOI: 10.1136/acupmed-2016-011225

40. Witt CM, Reinhold T, Jena S et al. Cost-effectiveness of acupuncture treatment in patients with headache. Cephalalgia. 2008; 28: 334-345. DOI: 10.1111/j.1468-2982.2007.01504.x

41. Syful Azlie. Technology review: acupuncture for post-stroke rehabilitation. Ministry of Health Malaysia. 2015

42. USFDA. Sec. 880.5580 Acupuncture needle. 2019.

43. Senarai Caj Dalam Perintah Fi (Perubatan) (Pindaan) 2017. Available at http://hrpz2.moh.gov.my/v3/uploads/Pekeliling/Senarai%20Caj%20Perintah%20FI%20Pindaan%202017.pdf. Accessed on 24 May 2021.

http://hrpz2.moh.gov.my/v3/uploads/Pekeliling/Senarai%20Caj%20Perintah%20FI%20Pindaan%202017.pdf

http://hrpz2.moh.gov.my/v3/uploads/Pekeliling/Senarai%20Caj%20Perintah%20FI%20Pindaan%202017.pdf


36

8.1 Appendix 1: Search strategy

Ovid MEDLINE® In-Process & Other Non-Indexed Citations and Ovid MEDLINE® 1946 to 17 April 2020

1. HEADACHE/ 2. bilateral headache*.tw. 3. cephalalgia*.tw. 4. cephalgia*.tw. 5. cephalodynia*.tw. 6. cranial pain*.tw. 7. generalized headache*.tw. 8. head pain*.tw. 9. headache*.tw. 10. hemicrania.tw. 11. ocular headache*.tw. 12. orthostatic headache*.tw. 13. periorbital headache*.tw. 14. retro ocular headache*.tw. 15. sharp headache*.tw. 16. throbbing headache*.tw. 17. unilateral headache*.tw. 18. vertex headache.tw. 19. HEADACHE DISORDERS/ 20. cephalgia syndrome*.tw. 21. (chronic adj1 headache*).tw. 22. headache syndrome*.tw. 23. intractable headache*.tw. 24. NEURALGIA/ 25. atypical neuralgia*.tw. 26. (ilio* adj1 neuralgia*).tw. 27. nerve pain*.tw. 28. neuralgias.tw. 29. neurodynia*.tw. 30. neuropathic pain*.tw. 31. paroxysmal nerve pain*.tw. 32. perineal neuralgia*.tw. 33. stump neuralgia*.tw. 34. supraorbital neuralgia*.tw. 35. vidian neuralgia.tw. 36. BELL PALSY/ 37. (acute i* adj1 facial neuropathy).tw. 38. bell* pals*.tw. 39. herpetic facial paralys*.tw. 40. (idiopathic acute adj1 facial neuropathy).tw. 41. FACIAL PARALYSIS/ 42. central facial paralys*.tw. 43. facial pals*.tw. 44. facial paresis.tw. 45. hemifacial paralysis.tw. 46. lower motor neuron facial palsy.tw. 47. peripheral facial paralysis.tw. 48. STROKE/ 49. acute cerebrovascular accident*.tw. 50. acute stroke.tw. 51. apoplexy.tw. 52. brain vascular accident.tw. 53. cerebral stroke*.tw. 54. cerebrovascular accident*.tw.

8.0 APPENDICES


37

55. cerebrovascular apoplexy.tw. 56. cerebrovascular stroke*.tw. 57. strokes.tw. 58. STROKE REHABILITATION/ 59. stroke rehabilitation.tw. 60. GUILLAIN-BARRE SYNDROME/ 61. acute autoimmune neuropat*.tw. 62. (acute in* adj1 poly*).tw. 63. acute inflammatory poly*.tw. 64. familial guillain-barre syndrome*.tw. 65. guillain* barre syndrome*.tw. 66. landry* guillain barre syndrome.tw. 67. MYELITIS, TRANSVERSE/ 68. acute* transverse myelitis.tw. 69. demyelinative myelitis.tw. 70. necrotizing myelitis.tw. 71. paraneoplastic myelitis.tw. 72. post* myelitis.tw. 73. (transverse adj1 syndrome*).tw. 74. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or

19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52 or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64 or 65 or 66 or 67 or 68 or 69 or 70 or 71 or 72 or 73

75. ACUPUNCTURE/ 76. Acupuncture.tw. 77. ACUPUNCTURE THERAPY/ 78. acupotom*.tw. 79. acupuncture therapy.tw. 80. acupuncture treatment*.tw. 81. 75 or 76 or 77 or 78 or 79 or 80 82. 74 and 81

OTHER DATABASES

EBM Reviews - Cochrane Central Register of Controlled Trials

EBM Reviews - Cochrane database of systematic reviews

EBM Reviews - Health Technology Assessment

EBM Reviews – NHS Economic Evaluation Database PubMeD HEADACHE[MeSH Terms]) OR bilateral headache*[Text Word]) OR cephalalgia*[Text Word]) OR cephalgia*[Text Word]) OR cephalodynia*[Text Word]) OR cranial pain*[Text Word]) OR generalized headache*[Text Word]) OR head pain*[Text Word]) OR headache*[Text Word]) OR hemicrania[Text Word]) OR ocular headache*[Text Word]) OR orthostatic headache*[Text Word]) OR periorbital headache*[Text Word]) OR retro ocular headache*[Text Word]) OR sharp headache*[Text Word]) OR throbbing headache*[Text Word]) OR unilateral headache*[Text Word]) OR vertex headache[Text Word]) OR HEADACHE DISORDERS[MeSH Terms]) OR cephalgia syndrome*[Text Word]) OR headache syndrome*[Text Word]) OR intractable headache*[Text Word]) OR NEURALGIA[MeSH Terms]) OR atypical neuralgia*[Text Word]) OR nerve pain*[Text Word]) OR neuralgias[Text Word]) OR neurodynia*[Text Word]) OR neuropathic pain*[Text Word]) OR paroxysmal nerve pain*[Text Word]) OR perineal neuralgia*[Text Word]) OR stump neuralgia*[Text Word]) OR supraorbital neuralgia*[Text Word]) OR vidian neuralgia[Text Word]) OR BELL PALSY[MeSH Terms]) OR bell* pals*[Text Word]) OR herpetic facial paralys*[Text Word]) OR FACIAL PARALYSIS[MeSH Terms]) OR central facial paralys*[Text Word]) OR facial pals*[Text Word]) OR facial paresis[Text Word]) OR hemifacial paralysis[Text Word]) OR lower motor neuron facial pals[Text Word]) OR peripheral facial paralysis[Text Word]) OR STROKE[MeSH Terms]) OR acute cerebrovascular accident*[Text Word]) OR acute

Same MeSH, keywords,

limits used as per

MEDLINE search


38

stroke[Text Word]) OR apoplexy[Text Word]) OR brain vascular accident[Text Word]) OR cerebral stroke*[Text Word]) OR cerebrovascular accident*[Text Word]) OR cerebrovascular apoplexy[Text Word]) OR cerebrovascular stroke*[Text Word]) OR strokes[Text Word]) OR STROKE REHABILITATION[MeSH Terms]) OR stroke rehabilitation[Text Word]) OR GUILLAIN-BARRE SYNDROME[MeSH Terms]) OR acute autoimmune neuropat*[Text Word]) OR acute inflammatory poly*[Text Word]) OR familial guillain-barre syndrome*[Text Word]) OR guillain* barre syndrome*[Text Word]) OR landry* guillain barre syndrome[Text Word]) OR MYELITIS, TRANSVERSE[MeSH Terms]) OR acute* transverse myelitis[Text Word]) OR demyelinative myelitis[Text Word]) OR necrotizing myelitis[Text Word]) OR paraneoplastic myelitis[Text Word]) OR post* myelitis[Text Word])) AND ((((((ACUPUNCTURE[MeSH Terms]) OR Acupuncture[Text Word]) OR ACUPUNCTURE THERAPY[MeSH Terms]) OR acupotom*[Text Word]) OR acupuncture therapy[Text Word]) OR acupuncture treatment*[Text Word])


39

8.2 Appendix 2: Hierarchy of evidence for effectiveness/ diagnostic

I Evidence obtained from at least one properly designed randomised controlled trial.

II-I Evidence obtained from well-designed controlled trials without

randomization.

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group.

II-3 Evidence obtained from multiple time series with or without the

intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III Opinions or respected authorities, based on clinical experience;

descriptive studies and case reports; or reports of expert committees. SOURCE: US/CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris 2001)


8.3 Appendix 3: Evidence tables

Evidence Table : Efficacy

Question : What is the effectiveness of acupuncture for headache?

Bibliographic

citation

Study

Type / Methodology

LE Number of

patients and

patient

characteristics

Intervention Comparison Length of

follow up (if

applicable)

Outcome measures/

Effect size

General

comments

1. Sun Y, Gan

TJ.

Acupuncture

for the

Management

of Chronic

Headache: A

Systematic

Review.

International

Anesthesia

Research

Society. 2008;

107(6):2038-

2047. DOI:

10.1213/ane0b

013e318187c7

6a

UNITED

STATES

Systematic Review with

Meta-analysis

Objective:

To evaluate the efficacy of

acupuncture for treatment

of chronic headache.

Method:

The search was done

without language

restrictions via:

CENTRAL, MEDLINE,

CINAHL, Scopus to

November 2007, and

Database of a Chinese

medical journal.

Eligible studies included

randomised control trials

evaluating acupuncture

for chronic headache. Two

independent reviewers

extracted information.

I

Adult patients (age

> 18 years).

At least one

clinical outcome

related to

headache:

headache

intensity and

frequency, global

assessment of

headache, health-

related quality of

life (QoL).

The 31 RCTs

included 3916

participants (only

25 trials included

in the meta-

analysis);

migraine (17),

tension-type

headache (10),

mixed chronic

headache (4).

Traditional

acupuncture

Sham

acupuncture,

medication

treatment, or

physiotherap

y

Early

follow up:

eight

weeks –

three

months

Late follow

up: six –

12 months

Study Description

A 102 potentially relevant studies were found, of which

31 publications fit the criteria for inclusion. Of those 31

publications, 16 trials included a sham acupuncture

control group, eight a medication treatment control

group and two a comparator group receiving

physiotherapy.

Study Quality

The quality of the more recent trials was higher than

the previous trials, with more emphasis on proper

randomisation, allocation, concealment and

description of patient dropout.

Outcome Measures

Acupuncture vs sham acupuncture

i) Response Rate

Fourteen trials reported data on the proportions of

patients responding to treatment at an early follow-

up period. Combined data demonstrated a

statistically significant higher response rate in the

acupuncture group compared with sham

acupuncture. A significant difference was also

found in subgroup analysis for tension-type

headache. RR was 1.26 (95% CI: 1.10, 1.44)

without heterogeneity (I2=0). However, there was


41



Bibliographic

citation

Study

Type / Methodology

LE Number of

patients and

patient

characteristics


follow up (if

applicable)

Outcome measures/

Effect size

General

comments

Only data in early and late

follow up were analysed to

facilitate pooling.

Dichotomous data were

analysed using Risk Ratio

(random effects model). I2

test was used to assess

heterogeneity. Subgroup

analysis, sensitivity

analysis and additional

sensitivity analysis were

performed using RevMan

version 4.2 (Cochrane

collaboration).

no significant difference between treatment

groups for migraine.

Only two studies reported the response rate at late

follow-up in which combined data show that RR

was 1.22 (95% CI: 1.04, 1.43), again without

heterogeneity (I2=0).

ii) Headache intensity

Pooled data showed there was no significant

difference between acupuncture and sham groups

at either early follow-up period. Combined data

from three trials in migraine headache also did not

show any difference.

However, combined data from seven at the late

follow-up period showed a WMD of -2.62 mm was

in favour of acupuncture (95% CI: -5.07, -0.17),

whereas data from trials in tension-type headache

showed that acupuncture significantly reduced the

headache score at either the early follow-up or late

follow-up period, where WMD was -3.77 mm (95%

CI: -7.00, -0.55) and -3.66 mm (95% CI: -6.54, -

0.79), respectively.

iii) Health-related QoL

Combined data of four studies showed no

significant difference between acupuncture and

sham acupuncture in both physical and mental

health, in either the early follow up or late follow up

period.


42



Bibliographic

citation

Study

Type / Methodology

LE Number of

patients and

patient

characteristics


follow up (if

applicable)

Outcome measures/

Effect size

General

comments

Acupuncture vs medication treatment

i) Headache intensity

Patients receiving acupuncture from two trials

reported significant improvement at the early

follow-up period (WMD: -8.54 mm, 95% CI: -15.52,

-1.57) but the result was heterogeneous.

ii) Headache frequency

Two trials reported the standardized mean

difference in headache frequency was also in

favour of the acupuncture group. Days with

headache per month and attacks (frequency) per

months was -0.22 (95% CI: -0.41, -0.03) and -1.22

(95% CI: -2.34, -0.10) respectively.

iii) Response rate

Pooled data from seven trials showed 62% of

patients receiving acupuncture had a significantly

higher response rate to treatment, compared with

45% of patients receiving medication at the early

follow-up period. RR was 1.80 (95% CI: 1.16,

2.81). This significant difference was also found at

one-year follow-up in one study.

iv) Health-related QoL

Three trial reported suitable data for health-related

QoL in the early-period. Pooled data from three

trials showed that acupuncture produced

significantly better physical function in the early

follow-up period (WMD: 4.16, 95% CI: 1.33, 6.98).


43



Bibliographic

citation

Study

Type / Methodology

LE Number of

patients and

patient

characteristics


follow up (if

applicable)

Outcome measures/

Effect size

General

comments

However, no significant difference was found in

mental health.

Acupuncture vs physiotherapy (nonpharmalogical

controls)

Three studies found that nonpharmacological

therapies, including physiotherapy and massage

were significantly better than acupuncture for

chronic headache.

A recently published study found similar effects

between acupuncture and physiotherapy for

tension-type headache. However, only one study

reported that patient well-being improved only in

the physiotherapy treatment group.

Conclusion

Acupuncture was more effective for the treatment of

chronic headache when compared with sham

acupuncture and medication treatment.


44

Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for headache?

Bibliographic citation

Study Type / Methodology

LE Number of patients and

patient characteristics

Intervention Comparison Length of follow up (if applicable)

Outcome measures/ Effect size

General comments

2. Vickers AJ, Rees RW, Zollman CE, McCarney R, Smith CM, Ellis N, Fisher P, Van Haselen R, Wonderling D, Grieve R. Acupuncture of Chronic Headache Disorders in Primary Care: Randomised Controlled Trial and Economic Analysis. Health Technol Assess. 2004; 8(48)

Randomised Controlled Trial Objective:

To determine the effects of a policy of using acupuncture, compared with a policy of avoiding acupuncture, on headache in primary care patients with chronic headache disorders. Method:

Recruitment took place between November 1999 and January 2001. The evaluation was done on the headache score, medication score, headache days and health status score (using Short Form Survey, SF-36).

I

Adult patients (age 18 – 65 years). Diagnosed as migraine or tension-type headache. 401 patients; 205 acupuncture, 196 no acupuncture.

Acupuncture No acupuncture (usual care)

One year Headache score

In the primary analysis mean headache scores were significantly lower in the acupuncture group. Scores fell by 34% in the acupuncture group compared with 16% in controls (p = 0.0002).

When the pre-specified cut-off of 35% was used as a clinically significant reduction in headache score, 22% more acupuncture patients improved than controls, equivalent to a number needed to treat of 4.6 [95% confidence interval (CI) 9.1 to 3.0].

The effects of acupuncture seemed to be long lasting; although few patients continued to receive acupuncture after the initial 3-month treatment period (25, ten, and six patients received treatment after three, six and nine months respectively), headache scores were lower at 12 months than at the follow-up after treatment.

Medication score

Medication scores at follow-up were lower in the acupuncture group, although differences between groups did not reach statistical significance for all end-points.

Total medication taken by patients after randomisation, weekly use fell by 23% in controls, but by 37% in the acupuncture group (adjusted difference between groups 15%, 95% CI 3 to 27%, p = 0.01).

Headache days

The result showed that differences between groups were not sensitive to the definition of headache day.

Health status score SF-36


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General comments

SF-36 data generally favoured acupuncture, although differences reached statistical significance only for physical role functioning, energy and change in health.

Conclusion

The study suggested that acupuncture led to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine.


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General comments

3. Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for Patients with Migraine: A Randomised Controlled Trial. JAMA. 2005; 293(17): 2118 – 2125 GERMAN


To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. Method:

The study was held between April 2002 and January 2003 approximately 2000 patients with headaches. The evaluation was done on: Primary outcome: the difference in number of days with headache of moderate or severe intensity; Secondary outcome: the number of migraine attacks, total number of headache days, proportion of treatment responders and days with medication.

I

Adult patients (age 18 – 65 years). Diagnosed with migraine (with or without aura). 302 patients; 145 acupuncture, 81 sham acupuncture, 76 waiting list control.

Acupuncture Sham acupuncture, waiting list control

Primary outcome

Between baseline and week nine to 12 the number of days with headache of moderate or severe intensity decreased by a mean (SD) of 2.2 (2.7) days in the acupuncture group vs 2.2 (2.7) days in the sham acupuncture group and 0.8 (2.2) days in the waiting list group (difference acupuncture vs sham acupuncture, 0.0 days; 95% confidence interval [CI], −0.7 to 0.7 days; P=.96; acupuncture vs waiting list, 1.4 days, 95% CI, 0.8 to 2.1 days; P.001.

Secondary outcome

The proportion of responders (reduction of headache days with moderate or severe pain by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group.

Compared with the waiting list control group, patients receiving acupuncture or sham acupuncture fared significantly better for most secondary outcome measures; however, there were no significant differences between the acupuncture group and the sham acupuncture group.

Response differences in the waiting list group became apparent after the first 4 weeks of treatment and increased until week 12.

Conclusion

Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.


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General comments

4. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummeslberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in Patients with Tension-type Headache: Randomised Controlled Trial. BMJ. 2005; 1-7. DOI: 10.1136/bmj.38512.405440.8F GERMAN


To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. Method:

The investigation took place between March 2002 and January 2004. The evaluation was done on: Primary outcome: the difference in number of days with headache between the four weeks before randomisation and weeks nine to 12 after randomisation. Secondary outcome: headache diary from weeks nine to 12, and pain questionnaire at week 12.

I

Adult patients (age 18 – 65 years). Diagnosed with episodic or chronic tension-type headache. 270 patients; 132 acupuncture, 63 minimal acupuncture, 75 no acupuncture (waiting list).

Acupuncture Minimal acupuncture, no acupuncture

Six months Primary outcome

From baseline to week nine to 12, the number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval − 1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 4.2 to 7.2 days, P < 0.001).

Secondary outcome

Compared with the waiting list control group, patients receiving acupuncture or minimal acupuncture fared significantly better for most secondary outcome measures; however, no significant differences were found between the acupuncture and the minimal acupuncture group.

The improvements seen in the acupuncture and minimal acupuncture group persisted during the follow-up period. The patients in the waiting list group who received acupuncture in weeks 13 to 20 also showed significant improvements after treatment, although not to the same extent as the patients who had received immediate treatment.

Conclusion

The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache.


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General comments

5. Wang K, Svensson P, Arendt-Nielsen L. Effect of Acupuncture-like Electrical Stimulation on Chronic Tension-type Headache: A Randomised, Double Blinded, Placebo-controlled Trial. Clin J Pain. 2007; 23(4): 316-322 DENMARK


To examine the effect of acupuncture-like electrical stimulation on chronic tension-type headache in a randomised, double-blinded, placebo-controlled study. Method:

The evaluation was done on headache pain description, daily headache duration, average headache intensity, frequency of headache attacks, and use of medication.

I

Adult patients (> 18 years) Diagnosed with chronic tension-type headache. 36 patients; 18 treatment group, 18 placebo group.

Acupuncture Sham acupuncture

Headache pain description

After treatment, 2/36 patients reported that their headache pain had been totally relieved, 4/36 patients felt much better, 7/36 patients felt slightly better, 22/36 patients felt no change, and 1/36 patients felt slightly worse.

Daily headache duration

It indicated a 30% reduction at Treat-1, 17% at Treat-2, and 13% at the end of recording of Post-3 in the treatment group. It also indicated a 14% reduction at Treat-1, 12% at Treat-2, and 12% at the Post-3 in the placebo group.

However, a direct comparison of the changes in headache duration between the treatment and placebo group was not significant (P>0.253) with a change from 8.6 ± 7.4 to 6.0 ± 7.7 (effect size: 0.34; 95% CI: 7.67 to 2.54) in the treatment group and 9.8 ± 8.0 to 8.4 ± 8.9 (effect size: 0.17; 95% CI: 4.34 to 7.14) in the placebo group (effect size: 0.41; 95% CI: 0.11 to 0.45).

In the post-treatment period the differences between the treatment and placebo group became less apparent.

Average headache intensity

The average headache intensity was lower at Treat-1 and Treat-2 compared with the baseline. The pain intensity decreased from 4.9 ± 1.1 to 3.9 ± 1.6 at Treat-1, and to 3.3 ± 1.8 at Treat-2 in the treatment group. The effect size was 0.73 (CI: 1.93 to 0.08) and 1.03 (CI: 2.58 to 0.53).

The pain intensity also decreased from 5.4 ± 1.5 to 5.1 ± 1.7 at Treat-1, and to 5.1 ± 2.0 at Treat-2


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General comments

in placebo group and the effect size was 0.58 (CI: 0.15 to 2.02).

However, there was no significant difference in pain intensity changes between the two groups (P>0.061). The effect size was 0.57 and the mean difference between group was <16% (CI: -0.03 to 0.34).

Frequency of headache attacks

The number of headache attacks in the two weeks (Treat-1) during the treatment was slightly decreased from 10.5 ± 4.6 to 9.5 ± 5.9 and to 8.4 ± 5.7 in the treatment group. The effect size was 0.47 (CI: 8.08 to 1.48).

There were also slight decreases from 11.5 ± 4.0 to 10.6 ± 3.8 at Treat-1 and to 10.7 ± 3.8 in the placebo group. The effect size was 0.23 (CI: 1.74 to 3.54).

Use of medication

The consumption of analgesics decreased from 26.1 ± 23.3 to 16.9 ± 22.9 at Treat-1 (two weeks) in treatment group. The effect size was 0.40 (CI: 8.10 to 6.44).

There were no apparent changes in analgesic consumption at any stage in the placebo group.

The mean difference between the groups was <34%, and the effect size was 0.57 (CI: -0.75 to 0.06).

The direct comparison between the two groups did, however, not indicate any significant differences (P>0.095).


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General comments

Conclusion

Acupuncture-like electrical stimulation might have some promising effects on tension-type headache-related pain and importantly seemed to reduce the use of analgesic agents in people with tension-type headache but the effect was difficult to differentiate from a placebo control.


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General comments

6. Sodenberg EI, Carlsson JY, Stener-Victorin E, Dahlof C. Subjective Well-being in Patients with Chronic Tension-type Headache: Effect of Acupuncture, Physical Training and Relaxation Training. Clin J Pain. 2011; 27(5): 448-556 SWEDEN


To study the comparison of three non-pharmacologic treatments; acupuncture, relaxation training and physical training on subjective well-being patients with chronic tension-type headache. Method:

The evaluation was done on the Minor Symptom Evaluation Profile (MSEP); contentment, vitality and sleep.

I

Adult patients (age 18 - 65 years) Diagnosed with chronic tension-type headache. 88 patients; 29 acupuncture, 30 physical training, 29 relaxation training

Acupuncture Physical training, relaxation training

Six months Between-group comparisons

No difference in MSEP was found immediately after treatment among the 3 treatment groups, when total scores were compared.

At the three-month follow-up, the proportion of individuals with an improved total score was significantly greater in the physical training group compared with the acupuncture group (P=0.036).

At the six-month follow-up, the proportion of individuals with improved levels was maintained in the physical training group and slightly increased in the relaxation training group. No significant differences were found at the six-month follow-up.

Vitality was significantly higher in the relaxation training group compared with the acupuncture group at the six-month follow-up.

Sleep was also significantly higher in the relaxation training group compared with the acupuncture group at the six-month follow-up.

When the contentment dimensions were compared no significant difference was found.

Within-group comparisons

In the acupuncture group (n=30), total MSEP scores of 17 (56.7%) patients were improved immediately after and three and six months after treatment compared with baseline.

In the physical training group (n=30), total scores were improved in 19 patients (63.3%) immediately after training and in 26 (86.7%) and 24 (80.0%) patients at the three-month and six-month follow-ups, respectively, compared with baseline.

In the relaxation training group (n=30), total scores were improved in 23 (76.7%) patients immediately after treatment and in 20 (66.7%) and 22 (73.0%)


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General comments

patients at the three-month and six-month follow-ups, respectively, when compared with baseline.

Conclusion

Physical training and relaxation training seemed to be preferable non-pharmacologic treatments for improvement of central nervous system-related symptoms and subjective well-being for patients with chronic tension-type headache.


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General comments

7. Gottschling S, Meyer S, Gribova I, Distler L, Berrang J, Gortner L, Graf N, Shamdeen MG. Laser Acupuncture in Children with Headache: A Double-blind, Randomised, Bicenter, Place-controlled Trial. Pain. 2008; 405-412. DOI: 10.1016/j.pain.2007.10.004 GERMAN


To investigate whether active laser acupuncture reduced headache frequency more effectively than placebo laser acupuncture in children with migraine or tension-type headache. Method:

The study was carried out between October 2006 and March 2007 at two medical centres. The evaluation was done on the headache frequency, duration of headache and pain intensity.

I

Children (age ≤17 years). Diagnosed with unilateral/ bilateral headache or migraine or tension-type headache. 48 patients; 24 active laser acupuncture, 24 placebo laser acupuncture.

Active laser acupuncture

Placebo laser acupuncture

Headache frequency

There was a significant decrease in headache frequency compared to baseline in the active laser treatment group.

The mean improvement in headache frequency was significantly greater in the treatment group than the placebo group.

From baseline to week five to eight, the number of days decreased by 7.0 days in the active acupuncture group compared to 1.2 days in the placebo group.

The difference active acupuncture vs. placebo acupuncture was 5.4 days (p < 0.001).

The decrease in headache frequency in the placebo group was not significant compared to baseline (p = 0.145).

Whereas, the headache frequency in the placebo group reached baseline level in weeks nine to 12, headache frequency in the active acupuncture group stayed low until the study endpoint (p < 0.001).

Duration of headache

There was a significant decrease in monthly headache hours in the active acupuncture group compared to baseline with the mean improvement being greater in the active acupuncture group.

The mild benefit of placebo acupuncture disappeared after eight weeks from baseline whereas the beneficial effect of active laser acupuncture lasted until the end of the follow up.

The monthly headache hours decreased almost solely due to a reduction of the headache frequency.

Pain intensity


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General comments

Pain intensity in the active treatment group decreased significantly compared to baseline.

Again the improvement in the active acupuncture group was greater than in the placebo group.

Nevertheless, there was a significant beneficial effect of placebo laser acupuncture in weeks one to four and 13 to16 from baseline (p = 0.024; p = 0.004).

The effect of the active laser acupuncture on pain severity was weaker than on the above-mentioned parameters but still significantly superior compared to placebo acupuncture at all time points (p < 0.001).

Conclusion

Laser acupuncture could provide a significant benefit for children with headache with active laser treatment being clearly more effective than placebo laser treatment.


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General comments

8. Alecrim-Andrade J, Maciel-Junior JA, Carne X, Vasconcelos GMS, Correa-Filho HR. Acupuncture in Migraine Prevention: A Randomised Sham Controlled Study with 6-months Posttreatment Follow-up. Clin J Pain. 2008; 24(2): 98-105 BRAZIL


To assess the efficacy of acupuncture in migraine prophylaxis. Method:

The study was conducted between December 2001 and June 2003. The evaluation was done on the migraine attacks frequency, migraine days, duration of pain (hours), rescue medication and associated symptoms.

I

Patients with migraine with or without aura. 37 patients; 19 real acupuncture, 17 sham acupuncture.

Real acupuncture

Sham acupuncture

Six months Migraine attacks frequency, migraine days, duration of pain

Differences with statistical significance between groups appeared in the second month of the treatment in three parameters: number of days with migraine per month (P = 0.006), the total duration of migraine pain in hours per month (P = 0.025), and reduction of ≥40% in the frequency of migraine attacks (P = 0.004).

Greater improvement was observed in the real acupuncture group. From the third month of the treatment to the late post-treatment follow-up, the statistical difference between groups disappeared.

Rescue medication

There was a reduction in the total intake of rescue medications in both groups. However, there were no statistical significant differences between them.

Associated symptoms

There were no statistical significant differences between groups in the associated symptoms (nausea and vomiting).

In the analysis within each group appeared a significant and progressive reduction in the frequency of nausea during migraine attacks in the real acupuncture group from the first month of acupuncture through to the late post-treatment follow-up. The same was not observed in the sham group.

Conclusion

Analysis within each group demonstrated that the sham and real acupuncture had effects in almost all pain parameters evaluated.


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General comments

9. Gildir S, Tuzun EH, Eroglu G, Eker L. A Randomised Trial of Trigger Point Dry Needling Versus Sham Needling for Chronic Tension-type Headache. Medicine. 2019; 98(8). DOI: http://dx.doi.org/10.1097/MD.0000000000014520 TURKEY


To explore the effectiveness of trigger point dry needling in patients with chronic tension-type headache. Method:

The trial was carried out between April and August 2017. The evaluation was done on the headache intensity, frequency and duration, and health-related quality of life (HRQoL); physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (V), social functioning (SF), role emotional (RE) and mental health (MH).

I

Adult patients (age 20 – 50 years). Diagnosed with chronic tension-type headache. 161 patients; 80 dry needling, 81 sham dry needling.

Dry needling (DN)

Sham dry needling (SDN)

One month Headache intensity, frequency and duration

The result showed a statistically significant differences between measurements in both groups (all P values < .05).

In the DN group, pairwise comparisons revealed that there were statistically significant differences for all headache variables groups (all P values < .05), with the exception of headache duration in the period from post-treatment to follow-up (P=.089).

In the SDN group, pairwise comparisons revealed that there were statistically significant differences for all headache variables (all P values < .05).

HRQoL

A statistically significant differences was showed between the groups on the subscales of PF, RP, BP, V, GH, SF, RE, and MH.

The Mann-Whitney U test revealed statistically significant differences between the groups on the subscales of SF, RF, P, and V. General Linear Model (GLM) revealed statistically significant differences between the groups on the GH, SF, RE, and MH subscales after controlling for the differences of the initial measurements.

Conclusion

The results of this clinical trial suggested that trigger point dry needling in patients with chronic tension-type headache was effective and safe in reducing headache intensity, frequency and duration, and increasing health-related quality of life.


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General comments

10. Tavola T, Gala C, Conte G, Invernizzi G. Traditional Chinese Acupuncture in Tension-type Headache: A Controlled Study. Pain. 1992; 48: 325-329 ITALY


To evaluate the efficacy of acupuncture in the treatment of headache pain. Method:

The evaluation was done on the headache frequency, intensity, duration, headache index and analgesic consumption.

I

Diagnosed with tension-type headache. 30 patients; 15 Chinese traditional acupuncture, 15 sham acupuncture.

Chinese traditional acupuncture

Sham acupuncture

12 months Headache frequency

The frequency of episodes decreased significantly over time (from t0 to t3) (F < time > = 16, 34; df = 3, 84; P < 0.001).

The mean decrease of episode frequency from the baseline period to t3 was 44.3% and 21.4% in acupuncture and placebo-treated patients, respectively.

Headache index

Even the headache index decreased significantly over time (F < time > = 19, 75; df 3, 84; P < 0.0001), but no significance was found for the time/treatment interaction. Between the baseline period and t3, the headache index decreased by a mean of 58.3% and 27.8% in acupuncture and placebo treated patients, respectively

Analgesic consumption

The analgesic consumption decreased significantly over time (F < time > = 10, 09; df = 3, 84; P < 0.0001>, with time x treatment interaction approaching significance (F < time x treatment > = 2. 69; df = 3, 84; P = 0.0513).

In the acupuncture and placebo groups, the mean decrease of analgesic assumption was 57.7% and 21.7%, respectively.

Follow up (six and 12 months)

There were no differences between the two groups relative to intensity and duration of headache episodes, while the frequency of episodes, headache index and consumption of analgesics decreased significantly over time.


58

Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for Bell’s Palsy?







General comments

1. Zhang R, Wu T, Wang R, Wang D, Liu Q. Compare the Efficacy of Acupuncture with Drugs in the Treatment of Bell’s Palsy: A Systematic Review and Meta-analysis of RCTs. Medicine. 2019; 98 (19). e15566. CHINA

Systematic Review with Meta-analysis Objective:

To investigate whether Bell’s palsy patients would benefit from acupuncture treatment comparing with drug therapy. Method:

The search was done without language restrictions via: PUBMED, EMBASE, CENTRAL, CNKI, Wan Fang Database to July 2018. Eligible studies included randomised clinical trials with intervention of acupuncture therapy. Two investigators independently extracted the information from each study. The statistical heterogeneity was set at the I2 statistic >50% and/or Cochrane Q test P<0.10.

I

Patients with Bell’s palsy (facial paralysis/ idiopathic facial paralysis/ herpetic facial paralysis). The 11 RCTs included 1258 patients; 646 in treatment group, 612 in control group.

Manual acupuncture (combined/ not combined with moxibustion)

Drug therapy Study Description

A 323 potentially relevant studies were found, of which 11 publications fit the criteria for inclusion. Of those 11 publications, three trials used acupuncture combined with moxibustion, and the rest eight trials used traditional acupuncture. Study Quality

The results should be interpreted cautiously, because of the poor quality of included studies due to the insufficient information. Risk of Bias of the Trials

Analysis of the risk of bias indicated that the high-risk bias of the included studies was mainly due to the fact that the study process was not blinded or unreported, and assessment of the results were not blinded or unreported. Outcome Measures

Primary outcome: cure rate

The total cure rates for the acupuncture and drug groups were 59.7% and 32.5%, respectively.

Acupuncture treatment was associated with an increased cure rate (RR=1.77, 95% CI: 1.41–2.21, with significant heterogeneity in the pooled results (I2=67%, P=.0008).

Secondary outcome: total effective rate

The total effective rates in the acupuncture and drug groups were 96.9% and 83.0%, respectively.

Acupuncture therapy was associated with an increased total effective rate (RR=1.18, 95% CI: 1.07–1.31, with significant heterogeneity in the pooled results (I2=90%, P<.00001).


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General comments

Conclusion

Acupuncture seemed to be an effective therapy for Bell’s palsy.


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General comments

2. Li P, Qiu T, Qin C. Efficacy of Acupuncture for Bell’s Palsy: A Systematic Review and Meta-analysis of Randomised Controlled Trials. PLoS ONE. 2015; 10(5). e0121880.


To assess the efficacy of acupuncture for Bell’s palsy. Method:

The search was done without language restrictions via: PUBMED, EMBASE, CENTRAL to July 2014. Eligible studies included randomised controlled trials that limited the intervention acupuncture technique to conventional stimulation of points by needle insertion and electric acupuncture stimulation. Two investigators independently extracted the information from each study. Relative risks (RR) with 95% confidence intervals (CI) were evaluated for dichotomous outcomes. Fixed effects or random

I

Patients with Bell’s palsy. The 14 RCTs included 1541 participants.

Conventional acupuncture, electro-acupuncture

Other intervention protocols; drug therapy, electro-therapeutic apparatus, Chinese traditional manipulation,stellate ganglion block therapy

Study Description

A 249 potentially relevant studies were found, of which 14 publications fit the criteria for inclusion. Of those 14 publications, five studies used electro-acupuncture technique and nine studies used conventional acupuncture. Study Quality

Almost all studies included were of poor methodological quality. Risk of Bias of the Trials

All the selected studies were considered at high risk of bias or unclear bias. Outcome Measures

Total effective response rate The total effective response rates (13 trials) in the acupuncture and control groups were 95.48% and 82.81%, respectively. Acupuncture therapy was associated with an increased total effective response rate (RR 1.14, 95% CI: 1.04–1.25, P = 0.005), with significant heterogeneity among the included studies (I2 = 87%). Subgroup analysis

Eight articles compared (acupuncture plus drug therapy) against (drug therapy) in patients with Bell’s palsy and eleven studies compared (acupuncture) against (other interventions). The total effective response rates of these two groups were 96.47% and 96.33%, respectively. Significant associations were observed in both groups (acupuncture plus drug group: RR 1.14,


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General comments

effects were used, depending on the existence of heterogeneity. A value of P less than 0.05 was considered to be statistically significant.

95% CI 1.08–1.20, P < 0.00001; acupuncture group: RR 1.11, 95% CI 1.00–1.24, P = 0.05).

No heterogeneity was found in the (acupuncture plus drug) subgroup (I2 = 19%, P = 0.29). However, there seemed to be huge degree of heterogeneity in the acupuncture versus other intervention subgroup (I2 = 90%, P < 0.00001) and that versus drug therapy subgroup (I2 = 84%, P < 0.00001).

A total of six studies compared (acupuncture) against (drug therapy), and the result showed significant association in these two groups (RR 1.18, 95% CI 1.02–1.36, P = 0.02).

There were three studies compared acupuncture against blank control. However, the meta-analysis of these three studies was unable to perform because two of these studies’ data was unavailable.

Conclusion

The current available evidence was insufficient to support that acupuncture was an effective therapy for Bell’s palsy due to the poor quality of included researches.


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Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for Bell’s palsy?







General comments

3. Zhang CY, Xu SB, Huang B, Du P, Zhang GB, Luo X, Huang GY, Xie MJ, Zhou ZK, Wang W. Needle Sensation and Personality Factors Influence Therapeutic Effect of Acupuncture for Treating Bell’s Palsy: A Secondary Analysis of Multicentre Randomised Controlled Trial. Chin Med J. 2016; 129: 1789-1794 CHINA


To find the effects of the traits of personality on the objective outcome when different acupuncture techniques were used in treating patients with Bell’s palsy. Method:

The evaluation was done on the facial nerve function (House-Brackmann [HB] score) and 16 Personality Factor Questionnaire (16PF); Social Boldness Score, Vigilance Score, Tension Score.

I

Adult patients (age 18 – 65 years) with facial nerve weakness. 316 patients; 159 to intervention group, 157 to control group.

Acupuncture with de qi

Acupuncture without de qi

After six months, more patients had complete recovery in de qi group (89.8%) than control group (70.8%) (adjusted for age, gender, treatment center, interval between onset of palsy and start of treatment, HB score on day 1; adjusted odds ratio [OR]: 4.16, 95% confidence interval [CI]: 2.23–7.78).

In de qi group, low HB score on day 1 (OR: 0.13, 95% CI: 0.03–0.45) and low Social Boldness score (OR: 0.63, 95% CI: 0.41–0.97) in 16PF were associated with the better facial function.

In control group, low HB score on day 1 (OR: 0.25, 95% CI: 0.13–0.50) and low Vigilance score (OR: 0.66, 95% CI: 0.50–0.88) and high Tension score (OR: 1.41, 95% CI: 1.12–1.77) in 16PF were associated with better facial function.

The de qi (treatment) group’s score of needle sensation of fullness was 0.58, more than the control group, and the de qi group’s HB score at month 6 was 0.32, less than the control group.

It was found that in both groups, the score of experience and belief in acupuncture questionnaire, gender, age, education status, occupation, and attention had no prominent effects on objective outcome after 6 months.

Conclusion

The needle sensation of fullness could predict better facial function and personality traits might influence outcomes of acupuncture treatment.


63

Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for post-stroke?







General comments

1. Wu P, Mills E, Moher D, Seely D. Acupuncture in Poststroke Rehabilitation: A Systematic Review and Meta-Analysis of Randomised Trials. Stroke. 2010; 41: 171-179. DOI: 10.1161/STROKEAHA.109.573576 CANADA


To comprehensively assess the efficacy of acupuncture in post-stroke rehabilitation. Method:

The search was done without language restrictions via: MEDLINE, AMED, CINAHL, Alt Health Watch, Nursing and Allied Health Collection: Basic and Cochrane Database of Systematic Reviews, CNKI, CBM to September 2009. Eligible studies included randomised clinical trials that evaluated the clinical efficacy of acupuncture in adult patients with disability after stroke. Three reviewers assessed eligibility based on the full-text papers and conducted data extraction independently using a standard pre-piloted form.

I

Adult patients (age > 18 years) with disability due either to ischemic or hemorrhagic stroke. The 56 RCTs included 5650 patients; 3156 in treatment groups, 2494 in control group.

Electro-acupuncture, scalp and body acupuncture, body only acupuncture, scalp only acupuncture

Sham acupuncture, no acupuncture

Study Description

A 463 potentially relevant studies were found, of which 56 publications fit the criteria for inclusion. Of those 56 publications, 16 trials used electro-acupuncture, 24 trials used both scalp and body acupuncture, 28 trials used body acupuncture and four studies used scalp only for the treatment groups. Study Quality

The overall quality of the studies was fair and most studies were small (median n=86; range, 16 to 241). Risk of Bias of the Trials

In general, randomization and allocation concealment were poorly reported. Seven studies adequately reported allocation concealment. Assessor blinding was reported in a total of 16 studies. Outcome Measures

Positive results were reported in 45 studies. Six studies reported a positive benefit only in a subgroup analysis.

No significant differences between acupuncture intervention and control were reported in 5 studies.

Thirty-eight trials provided numeric data for meta-analyses, the results of which yielded a highly significant OR demonstrating efficacy in post-stroke rehabilitation with acupuncture compared with no acupuncture (OR=4.33, 95% CI: 3.09 to 6.08; I2 =72.4%.

Randomisation, modes of delivery, method of control, study of source country and reporting of randomisation might explain some of the heterogeneity observed between the studies

Conclusion


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General comments

A summary OR was calculated based on pooled dichotomous results. I2 was used to infer heterogeneity and meta regression was conducted to determine if specific covariates explained heterogeneity.

Randomized clinical trials demonstrated that acupuncture might be effective in the treatment of post-stroke rehabilitation.


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General comments

2. Kong JC, Lee MS, Shin BC, Song YS, Ernst E. Acupuncture for Functional Recovery After Stroke: A Systematic Review of Sham-controlled Randomised Clinical Trials. CMAJ. 2010; 182(16): 1723-1729. DOI: 10.1503/cmaj.091113 SOUTH KOREA


To critically evaluate all of the currently available randomized sham-controlled trials of acupuncture as an adjunct to mainstream stroke rehabilitation. Method:

The search was done without language restrictions via: MEDLINE, AMED, CINAHL, EMBASE, PsycINFO, British Nursing Index, Cochrane Library, Asian journals and 12 major Korean traditional medicine journals to October 2009. Eligible studies included randomised clinical trials regardless of time of treatment or the length of the treatment period. Two reviewers independently identified eligible articles and

I

Patients with acute, subacute and chronic stage of stroke. The 10 RCTs included 711 participants; seven trials for acute/ subacute stage of stroke, three trials for chronic stage of stroke.

Acupuncture, electro-acupuncture

Sham acupuncture, sham electro-acupuncture

Six months Study Description

A 664 potentially relevant studies were found, of which 10 publications fit the criteria for inclusion. Of those 10 publications, two trials used sham electro-stimulation on acupoints, the other eight used sham acupuncture. Study Quality

The mean PEDro score was 6.6 (standard deviation [SD] 1.5), with a range of four to nine points. Risk of Bias of the Trials

The Cochrane risk of bias varied. Outcome Measures

Neurologic deficit: Four trials tested the effects of acupuncture on neurologic deficits using the National Institutes of Health Stroke Scale, the European Stroke Scale, or the Scandinavian Stroke Scale. One of the four studies showed positive therapeutic effects.

Activities of daily living (ADL): Seven trials tested the effects of acupuncture on ADL according to the Barthel Index, the modified Barthel Index, or the Sunaas Index of ADL. Two of these studies (both from China) showed favourable effects on activities of daily living.

Quality of Life (QoL): Of the five trials that assessed the effects of acupuncture treatment on QoL, none showed favourable effects.

Meta-analysis

A post-hoc sensitivity analysis that excluded the two trials from China with a high risk of bias failed to show significant effects of acupuncture (n = 244;


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General comments

extracted data according to pre-defined criteria. In the absence of clinical heterogeneity, the results were synthesized in a meta-analysis. Heterogeneity was assumed if the p value was less than 0.10 in the χ2 test and the I2 value was above 75%.

standard mean difference 0.07, 95% CI –0.18 to 0.32; I2 = 0%.

For global neurologic deficits, none of the three trials included in the meta-analysis showed a significant difference in favour of acupuncture (n = 216; standard mean difference 0.20, 95% CI −0.23 to 0.62; I2 = 59%).

A meta-analysis of the data from the other two studies that involved patients in the chronic stage of stroke (one was excluded due to incomplete data) did not show favourable effects of acupuncture on function according to the Modified Ashworth Scale (n = 58; mean difference 0.01, 95% CI −0.65 to 0.67; I2 = 0%).

Conclusion

The meta-analyses of data from rigorous randomized sham controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke.


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3. Kim MK, Choi RY, Lee MS, Lee H, Han CH. Contralateral Acupuncture Versus Ipsilateral Acupuncture in the Rehabilitation of Post-stroke Hemiplegic Patients: A Systematic Review. BMC Complementary and Alternative Medicine. 2010; 10(41). DOI: 10.1186/1472-6882-10-41 SOUTH KOREA


To summarise and critically evaluate the evidence for and against the effectiveness of contralateral acupuncture (CAT) for post-stroke rehabilitation as compared to ipsilateral acupuncture (IAT). Method:

The search was done without language restrictions via: MEDLINE, EMBASE, CINAHL, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Methodology Register, a Chinese medical database (CNKI), three Japanese medical databases, six Korean medical databases, and four major Korean traditional medical journals to June 2010.

I

Post-stroke hemiplegic patients. The eight RCTs included 534 patients; six trials followed two-arm parallel group design, two trials followed four-arm parallel group design.

CAT (electro-acupuncture [EA]/ manual acupuncture)

IAT (electro-acupuncture [EA]/ manual acupuncture)

Study Description

A 119 potentially relevant studies were found, of which eight publications fit the criteria for inclusion. Of those eight publications, four of the RCTs included subjects with cerebral infarction, while the other four included subjects with either cerebral infarction or intracranial hemorrhage. Study Quality

Patient blinding was assumed when the control intervention was indistinguishable from acupuncture, even if the word “blinding” was not used in the report. Risk of Bias of the Trials

Three of the included RCTs described the sequence generation and they all used proper methods. It was not clear whether group assignment was adequately concealed in any of the included trials. All of the included trials were rated as ‘U’ or ‘N’ for patient blinding, and two studies were rated as ‘Y’ for outcome assessor blinding. For incomplete outcome data reporting, one study did not clearly report how many patients were analysed. (Y=Yes, N=No, U=Unclear). Outcome Measures

Response rate

Six of the included trials examined the effects of CAT as compared to IAT on response rate. Only one trial showed a favourable effect of CAT.

A meta-analysis, however, showed that CAT had superior effects compared to IAT on response rate (n = 361; RR, 1.12; 95% CIs, 1.04 to 1.22, P = 0.005; heterogeneity: χ2 = 2.71, P = 0.75, I2 = 0%).


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General comments

Eligible studies included prospective randomized clinical trials comparing the clinical effects of CAT to those of IAT. Disagreements were resolved by discussion between the two reviewers. The data was pooled across studies using a random effects model (when appropriate). The chi square, tau2 and Higgins I2 tests were used to assess heterogeneity.

Subgroup analysis also showed favourable effects of CAT for patients with cerebral infarction (n = 261; RR, 1.15; 95% CIs, 1.04 to 1.27, P = 0.006; heterogeneity: χ2 = 0.65, P = 0.88, I2 = 0%).

Further analysis including patients with cerebral infarction and intracranial hemorrhage, however, failed to find these favourable effects (n = 100; RR, 1.11; 95% CIs 0.85 to 1.46, P = 0.43; heterogeneity: χ2 = 1.78, P = 0.18, I2 = 44%).

Activities of Daily Living (ADL)

Three of the RCTs assessed the effects of CAT on ADL compared to IAT. Only one trial showed favourable effects of CAT.

A meta-analysis of these studies failed to show superior effects for CAT compared to IAT with regard to ADL (n = 193; SMD, 0.17; 95% CIs, -0.20 to 0.54, P = 0.37; heterogeneity: χ2 = 4.65, P = 0.20, I2 = 36%).

Neurological Deficit Score (NDS)

Two of the RCTs assessed the effects of EA-CAT compared to EA-IAT on NDS. Only one trial showed the significant superior effects of EA-CAT.

A meta-analysis failed to show significant difference between the two methods (n = 121; WMD, 2.23; 95% CIs, -1.35 to 5.77, P = 0.22; heterogeneity: χ2 = 2.48, P = 0.12, I2 = 60%).

Motor function

Four RCTs tested the effects of CAT for motor function on Fugl-Meyer Assessment (FMA). Only two trials showed favourable effects of CAT.

A meta-analysis of these studies failed to show superior effects for CAT compared to IAT (n = 220;


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General comments

WMD, 6.70; 95% CIs, -0.34 to 13.73, P = 0.06) with heterogeneity (χ2 = 20.88, P = 0.0.001, I2 = 86%).

Conclusion

The results of the systematic review and meta-analysis suggested that there was limited evidence for CAT being superior to IAT in the treatment of cerebral infarction.


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4. Zhan J, Pan R, Zhou M, Tan F, Huang Z, Dong J, Wen Z. Electroacupuncture as an Adjunctive Therapy for Motor Dysfunction in Acute Stroke Survivors: A Systematic Review and Meta-analyses. BMJ Open. 2018; 8. DOI: 10.1136/ bmjopen-2017-017153 CHINA


To assess the effectiveness and safety of electro-acupuncture (EA) combined with rehabilitation therapy (RT) and/or conventional drugs (CD) for improving post-stroke motor dysfunction (PSMD). Method:

The search was done via: the China National Knowledge Infrastructure, Chinese Biological Medicine Database, Chinese Scientific Journal Database (VIP), Cochrane Library, MEDLINE, EMBASE, PUBMED and Cochrane to December 2016. Two authors independently extracted information from the included trials. The information was entered into an Excel-formatted table.

I

Adult patients (age > 18 years). Patients with acute stage of stroke (onset of the first stroke with motor dysfunction). The 19 RCTs included 1434 patients; all trials were conducted in China.

Electro-acupuncture (EA)

Non EA Study Description

A 892 potentially relevant studies were found, of which 19 publications fit the criteria for inclusion. Of those 19 publications, 16 trials compared (EA plus CD and RT) with (CD plus RT). Three trials gave EA and RT to the experimental groups, while the control groups only received RT. Study Quality

Most of the included trials had methodological defects, and the funnel plots of Fugl-Meyer Assessment Scale (FMA) and Activities of Daily Living (ADL) suggested a potential publication bias. These issues potentially lead to low quality of evidence. Risk of Bias of the Trials

Thirteen trials and 12 trials respectively showed a difference in FMA and ADL between the EA and the non-EA groups.

Outcome Measures Primary outcomes

Fugl-Meyer Assessment Scale (FMA)

The outcome was mentioned in 13 trials with 1010 patients.

There were no significant differences in treatment duration in the meta-regression model (adjusted R2: 0.124, t=−1.57, P=0.144).

The FMA score in the EA group increased more than those in the non-EA group, and there was a significant difference (WMD 10.79, 95%CI 6.39 to 15.20, P<0.001).

FMA for upper extremity (FMA-U)


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General comments

A fixed-effects model was chosen to pool the data (for insignificant heterogeneity); otherwise, a random-effects model was used after considering clinical homogeneity.

One trial with 98 participants used the FMA for upper extremity to evaluate the function of the upper extremity, and the difference between the EA group and the non-EA group was obvious (P<0.050).

FMA for lower extremity (FMA-L)

The function of the lower extremity was assessed in four trials with 234 participants. There was a significant difference between the EA group and the non-EA group in the FMA-L (WMD 5.16, 95%CI 3.78 to 6.54, P<0.001).

Secondary outcomes

Activities of Daily Living (ADL)

The effect of EA on ADL was analysed using a random-effects model, due to significant heterogeneity in 12 trials with 970 participants.

The improvement of ADL in the EA group was better than that in the non-EA group (SMD 1.37, 95%CI 0.79 to 1.96, P<0.00001).

Response/ Effective rate (ER)

Two trials with a total of 171 participants showed that there was no significant difference in ER between EA and non-EA groups (RR 1.13, 95%CI 1.00 to 1.27, P=0.050; fixed-effects model).

Berg Balance Scale (BBS)

The assessment was done in one trial with 120 participants. The improvement of BBS in the EA group was preferable to that in the non-EA group (P<0.050).


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General comments

Subgroup analysis (EA plus RT and CD) versus (RT plus CD)

Ten trials used FMA to measure the motor function of 796 participants with PSMD. A random-effects model was used to analyse the effect on FMA and ADL in this subgroup analysis due to significant heterogeneity.

There was a significant difference between (EA combined with RT and CD) versus (RT plus CD) (WMD 8.03, 95%CI 5.17 to 10.90, P<0.001).

(EA plus RT and CD) for the improvement of ADL was better than that of (RT plus CD) (SMD 1.29, 95%CI 0.55 to 2.02, P<0.001).

(EA plus RT) versus (RT alone)

Three trials with 214 participants applied FMA to compare the effectiveness of (EA plus RT) against (RT alone). Meta-analyses with a random-effects model were performed to evaluate the effect on FMA and ADL in this subgroup analysis owing to statistical heterogeneity. There was a significant difference in these three trials (WMD 20.90, 95%CI 18.61 to 23.19, P<0.001).

In the comparison of (EA plus RT) versus (RT alone) in the three trials, the difference in ADL was obvious (SMD 1.63, 95%CI 1.01 to 2.25, P<0.00001).

Conclusion

EA as a complementary therapy seemed to have clinical benefits in terms of improving the function of extremities, ADL and balance function.


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General comments

5. Yang A, Wu HM, Tang JL, Xu L, Yang M, Liu GJ. Acupuncture for Stroke Rehabilitation. Cochrane Database of Systematic Reviews. 2016; 8. CD004131. DOI: 10.1002/14651858.CD004131.pub3 CHINA


To determine the efficacy and safety of acupuncture therapy in people with subacute and chronic stroke. Method:

The search was done via: Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, China Biological Medicine Database, Chinese Science and Technique Journals Database, China National Infrastructure, Wan Fang database to July 2015. Two review authors independently selected trials for inclusion, assessed quality, extracted and cross-checked the data. The data was pooled using the random-effects model but the fixed-effect model was used too to

I

Patients with ischaemic or haemorrhagic stroke, in the subacute or chronic stage. The 31 RCTs included 2257 participants; all the trials used computed tomography (CT) or magnetic resonance imaging (MRI) to confirm the diagnosis of stroke.

Acupuncture with needling

Placebo acupuncture, sham acupuncture, no acupuncture.

> Three months

Study Description

A 5874 potentially relevant studies were found, of which 31 publications fit the criteria for inclusion. Of those 31 publications, two trials compared real acupuncture plus baseline treatment with sham acupuncture plus baseline treatment, and the remaining 29 trials compared acupuncture plus baseline medication or treatment with baseline medication or treatment alone. Study Quality

The methodological quality of most of the included trials was not high. The quality of evidence for the main outcomes was low or very low based on the assessment by the system of Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Risk of Bias of the Trials

Many studies did not provide detailed information on the severity of the disease, the exact time of starting the acupuncture treatment, the modalities of acupuncture technique and acupuncturist's background, and possible adverse effects relevant to acupuncture treatment.

Publication bias might be present, as indicated by the asymmetric funnel plot for the effect of acupuncture on the improvement of dependency measured by the Barthel Index.

Outcome Measures

Real acupuncture plus baseline treatment with sham acupuncture plus baseline treatment

There was no evidence of differences in the changes of motor function and quality of life


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General comments

ensure robustness of the model chosen and susceptibility to outliers.

between real acupuncture and sham acupuncture for people with stroke in the convalescent stage.

Acupuncture plus baseline treatment versus baseline treatment alone

Compared with no acupuncture, for people with stroke in the convalescent phase, acupuncture had beneficial effects on the improvement of dependency (activity of daily living [ADL])

measured by Barthel Index (BI) (nine trials, 616 participants; mean difference (MD) 9.19, 95% confidence interval (CI) 4.34 to 14.05; GRADE very low);

global neurological deficiency (seven trials, 543

participants; odds ratio (OR) 3.89, 95% CI 1.78 to 8.49; GRADE low);

and specific neurological impairments

including motor function measured by Fugl-Meyer Assessment (FMA) (four trials, 245 participants; MD6.16, 95% CI 4.20 to 8.11; GRADE low);

cognitive function measured by the Mini-Mental

State Examination (MMSE) (five trials, 278 participants; MD2.54, 95% CI 0.03 to 5.05; GRADE very low);

depression measured by the Hamilton

Depression Scale (HDS) (six trials, 552 participants; MD -2.58, 95% CI -3.28 to -1.87; GRADE very low);

swallowing function measured by drinking test

(two trials, 200 participants; MD -1.11, 95% CI -2.08 to -0.14; GRADE very low);

pain measured by the Visual Analogue Scale

(VAS) (two trials, 118 participants; MD -2.88, 95% CI -3.68 to -2.09; GRADE low).


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General comments

Conclusion

Acupuncture may have beneficial effects on improving dependency, global neurological deficiency, and some specific neurological impairments for people with stroke in the convalescent stage, with no obvious serious adverse events.


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General comments

6. Junhua Z, Menniti-Ippolito M, Xiumei G, Firenzuoli F, Boli Z, Massari M, Hongcai S, Yuhong H, Ferrelli R, Limin H, Fauci A, Guerra R, Raschetti R. Complex Traditional Chinese Medicine for Poststroke: A Systematic Review. Stroke. 2009; 40: 2797-2804. DOI: 10.1161/STROKEAHA.109.555227 CHINA

Systematic Review Objective:

To determine whether complex Traditional Chinese Medicine (cTCM) treatments improves post-stroke motor recovery. Method:

The search was done via: PubMed, EMBASE, CBM, the Cochrane Library, and other Chinese journal databases to December 2007. Two reviewers independently examined titles and abstracts of the trials for inclusion, based on the selection criteria outlined. Statistical analysis was performed using software provided by the Cochrane Collaboration (Review Manager 5).

I

Patients with ischaemic or haemorrhagic stroke. The 34 RCTs included 4521 patients; 11 trials included patients with ischemic stroke only, 23 included patients with ischemic and hemorrhagic stroke.

cTCM Acupuncture (with/ without physical exercise)

Study Description

A 11235 potentially relevant studies were found, of which 34 publications fit the criteria for inclusion. All the included studies were single-center, parallel-design and randomised. Study Quality

In general, the methodological quality of the trials included was poor. According to the Cochrane handbook, all of the trials included were of low quality classified as “C”. Risk of Bias of the Trials

A strong publication bias was present in the review as the asymmetry of the funnel plot was reported. Outcome Measures

Effective Rate Ratio (ERR): cTCMs Versus Acupuncture

Four of the 12 trials of cTCM versus acupuncture alone showed statistically significant higher ERR after treatment with the cTCM ([ERR, 1.37: 95% CI, 1.02 to 1.85], [ERR, 1.38; 95% CI, 1.06 to 1.80], [ERR, 1.57; 95% CI, 1.18 to 2.08], [ERR, 1.11: 95% CI, 1.03 to 1.20]).

The remaining eight trials did not show statistically significant differences between the experimental and control groups.

In two other trials the control group included acupuncture plus physical exercise, only one showed a statistically significant result (ERR, 1.16; 95% CI, 1.04 to 1.31).


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General comments

7. Sze FKH, Wong E, Yi X, Woo J. Does Acupuncture Have Additional Value to Standard Poststroke Motor Rehabilitation? Stroke. 2002; 33: 186-194 CHINA


To examine whether acupuncture has additional value to standard post-stroke motor rehabilitation. Method:

The evaluation was done on the Fugl-Meyer Assessment of Physical Performance (FMA), Barthel Index (BI), Functional Independence Measure (FIM), Abbreviated Mental Test (AMT), and NIH Stroke Scale (NIHSS).

I

Chinese patients with hemorrhagic or ischemic stroke. 106 patients; 31 to group 1A and 1B, 22 to group 2A and 2B. Group 1: Received five weeks (± 1 week) of inpatient rehabilitation, followed by five weeks (± 1 week) of day hospital rehabilitation. Group 2: Received three weeks (± 1 week) of inpatient rehabilitation, followed by seven weeks (± 1 week) of day hospital rehabilitation. Group A: intervention group. Group B: control group.

Traditional Chinese manual acupuncture

No acupuncture

No differences were seen between the intervention arm and the control arm in either group 1 or group 2, when comparing impairment scores of FMAM and FMA, or disability scores of FIM-cognition, FIM-motor, FIM, and BI at 10 weeks.

The median score changes of FMAM, FMA, FIM-cognitive, FIM-motor, FIM, and BI over 10 weeks from baseline also did not show statistical difference between the two arms.

In fact, both arms showed similar improvement in motor impairment and disability, and the improvement was faster in the first five weeks.

Conclusion

Traditional Chinese manual acupuncture on the body has no additional value to standard post-stroke motor rehabilitation.


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General comments

8. Zhang S, Wu B, Liu M, Li N, Zeng X, Liu H, Yang Q, Han Z, Rao P, Wang D. Acupuncture Efficacy on Ischemic Stroke Recovery. Stroke. 2015; 46: 1301-1306. DOI: 10.1161/STROKEAHA.114.007659 CHINA


To assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. Method:

The study was carried out in two phases; April 2001 to February 2002 for pilot study, and February 2002 to February 2004 for main study. The evaluation was done on death/ dependency, death/ institutional care, death, and neurological deficit score (used Scandinavian Stroke Scale)

I

Adult patients (age 18 – 65 years). Diagnosed with acute ischemic stroke. 862 patients; 427 allocated to acupuncture group, 435 allocated to control group.

Traditional Chinese acupuncture (with routine ischemic stroke treatment)

Routine ischemic stroke treatment

Six months Primary outcome

Death/ dependency at six months

Fewer patients had died or were in the acupuncture group (113/410, 27.6%) than in control group (137/405, 33%) at three months, the tendency continued at six months (80/385 [20.7%] versus 102/396 [25.8%]), but the difference was not statistically significant (OR, 0.75; 95% CI, 0.54–1.05).

Death/ institutional care at six months

There was also no significant difference in death or institutional care between the two groups at six months (8.0% versus 7.6%; OR, 1.06; 95% CI, 0.63–1.79).

Pre-planned subgroup analysis showed that only when patients who received ≥10 sessions of acupuncture were included into analysis, a significant difference was detected at six months (57/298 [19.1%] versus 102/396 [25.8%]; OR, 0.68; 95% CI, 0.47–0.98; number needed to treat 15).

Secondary outcome

Death at six months

Death occurred in 6.2% and 4.5% of patients in the two groups, respectively (OR, 1.39%; 95% CI, 0.74–2.60).

Neurological deficit score

At the end of the scheduled treatment period, there was significantly greater change of Scandinavian Stroke Scale score from baseline in acupuncture group (9.70±7.85) than in control group (7.57±12.58; P=0.03), which indicated that


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General comments

patients in acupuncture group had greater reduction in their neurological deficit.

Conclusion

Acupuncture seemed to be safe in the subacute phase of ischemic stroke.


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General comments

9. Johansson BB, Haker E, von Arbin M, Britton M, Langstrom G, Terent A, Ursing D, Asplund K. Acupuncture and Transcutaneous Nerve Stimulation in Stroke Rehabilitation: A Randomised, Controlled Trial. Stroke. 2001; 32: 707-713 SWEDEN


To study effects of acupuncture and transcutaneous electrical nerve stimulation (TENS) on functional outcome and quality of life after stroke versus a control group that received subliminal electrostimulation. Method:

The evaluation was done on activities of daily living (ADL) (used Barthel Index [BI]), overall motor function (used Rivermead Mobility Index), fine motor function (used Nine Hole Peg Test), and quality of life (QoL) (used Nottingham Health Profile).

I

Patients with acute stroke. 150 patients; 48 allocated to acupuncture group, 51 allocated to TENS group, 51 to subliminal (control) group.

Acupuncture TENS, subliminal electrostimulation

12 months Overall motor function In intention-to-treat analyses, no clinically meaningful or statistically significant differences existed in overall motor function. Fine motor function Most patients in all groups were unable to score more than zero in the Nine Hole Peg Test, which was used to assess fine motor function of the affected hand. Barthel’s ADL Index Neither at three or 12-months follow-up did any statistically significant differences occur between the three groups. QoL The score on energy was more favourable in the acupuncture group than in the two other groups, but the differences did to not reach statistical significance. Conclusion

When compared with a control group that received subliminal electrostimulation, treatment during the subacute phase of stroke with acupuncture or transcutaneous electrical nerve stimulation with muscle contractions had no beneficial effects on functional outcome or life satisfaction.


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Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for Guillain Barre?







General comments

1. Rapson LM, Wells N, Pepper J, Majid N, Boon H. Acupuncture as a Promising Treatment for Below Level Central Neurapaathic Pain: A Retrospective Study. The Journal of Spinal Cord Medicine. 2003; 26(1): 21-26. DOI: 10.1080/10790268.2003.11753655 CANADA

Retrospective Study Objective:

To investigate the effects of an electro-acupuncture protocol for the treatment of below-level central neuropathic pain developed at the Toronto Rehabilitation Institute, Lyndhurst Center, Toronto, Ontario, Canada. Method:

Patients who were referred to the Lyndhurst Acupuncture Clinic by staff physiatrists were selected. The study described the outcomes of individuals with traumatic and non-traumatic SCI who were treated according to an electro-acupuncture protocol that was developed at the Lyndhurst Center, called the Lyndhurst Center Central Neuropathic Pain Acupuncture Protocol (LCCNPAP).

Inpatients with spinal cord injury (SCI) from traumatic and non-traumatic causes. 36 patients; only one patient had Guillain Barre syndrome (GBS) as a cause of SCI.

Electro-acupuncture

No acupuncture

Of the 36 patients identified, 24 experienced improvement (according to patient self-reports) in response to the LCCNPAP; only one patient with GBS as a cause of SCI experienced improvement after one treatment.

The VAS showed a reduction of pain at discharge; from seven to two.


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Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for Guillain Barre?







General comments

The pain ratings were assessed using the 11 -point VAS (0 = no pain, 10 = the most pain imaginable). Two of the authors independently examined each patient's chart information and identified which pain characteristic(s) applied to each patient. Disagreements were resolved by a third investigator's independent review of the raw data. A significance level of P < 0.05 was set for the x2 statistical analyses.


83

Evidence Table : Efficacy Question : What is the effectiveness of acupuncture for transverse myelitis?







General comments

1. Rapson LM, Wells N, Pepper J, Majid N, Boon H. Acupuncture as a Promising Treatment for Below Level Central Neurapaathic Pain: A Retrospective Study. The Journal of Spinal Cord Medicine. 2003; 26(1): 21-26. DOI: 10.1080/10790268.2003.11753655 CANADA

Retrospective Study Objective:

To investigate the effects of an electro-acupuncture protocol for the treatment of below-level central neuropathic pain developed at the Toronto Rehabilitation Institute, Lyndhurst Center, Toronto, Ontario, Canada. Method:

Patients who were referred to the Lyndhurst Acupuncture Clinic by staff physiatrists were selected. The study described the outcomes of individuals with traumatic and non-traumatic SCI who were treated according to an electro-acupuncture protocol that was developed at the Lyndhurst Center, called the Lyndhurst Center Central Neuropathic Pain Acupuncture Protocol (LCCNPAP).

Inpatients with spinal cord injury (SCI) from traumatic and non-traumatic causes. 36 patients; only one patient had transverse myelitis as a cause of SCI.

Electro-acupuncture

No acupuncture

Of the 36 patients identified, 24 experienced improvement (according to patient self-reports) in response to the LCCNPAP; only one patient with transverse myelitis as a cause of SCI experienced improvement after the two treatments.

The VAS showed that the patient could not do scale at discharge due to language difficulty, but the burning pain was reported as much better.


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General comments

The pain ratings were assessed using the 11 -point VAS (0 = no pain, 10 = the most pain imaginable). Two of the authors independently examined each patient's chart information and identified which pain characteristic(s) applied to each patient. Disagreements were resolved by a third investigator's independent review of the raw data. A significance level of P < 0.05 was set for the x2 statistical analyses.


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General comments

2. Wu J, Cheng Y, Qin Z, Liu X, Liu Z. Effects of Electroacupuncture on Bladder and Bowel Function in Patients with Transverse Myelitis: A Prospective Observational Study. Acupunct Med. 2018; 36: 261-266. DOI: 10.1136/acupmed-2016-011225 CHINA

Prospective Observational Study Objective:

To preliminarily explore the effect of electro-acupuncture (EA) on bladder and bowel dysfunction in patients with transverse myelitis (TM). Method:

Participants were treated with EA at bilateral BL32, BL33, and BL35 once a day, five times a week for the first four weeks, and once every other day, three times a week for the following four weeks. Patients were then followed up for six months. Bladder and bowel function, and the safety of EA, were assessed.

Sixteen patients: Had acute or subacute-onset complete or incomplete transverse spinal cord injury; Had simultaneous bladder and bowel dysfunction or isolated bladder dysfunction caused by TM.

Electro-acupuncture

Six months Assessment of bladder function

After eight weeks of treatment, five (5/16, 31%) patients resumed normal voiding, three (6/16, 38%) regained partially normal voiding, and five (5/16, 31%) had no change.

After treatment, the residual urine volume decreased by 100 mL (IQR 53–393 mL; P<0.05) in nine patients with bladder voiding dysfunction; in 11 patients with urinary incontinence, the number of weekly urinary incontinence episodes, 24-hour urinary episodes, and nocturia episodes per night diminished by 14 (95% CI 5 to 22), 5 (95% CI 1 to 9), and 4 (95% CI 0 to 7) episodes, respectively (all P<0.05).

Assessment of bowel function

After eight weeks of treatment in eight patients with faecal retention, four (4/8, 50%) resumed normal bowel movements, three (3/8, 38%) regained partially normal bowel movements, and one (1/8, 13%) had no change. These effects were sustained after six months.

Conclusion

EA might be a promising alternative for the management of bladder and bowel dysfunction in patients with transverse myelitis.


86

Evidence Table : Cost Question : What is the cost effectiveness/ cost analysis for headache?







General comments

1. Witt CM, Reinhold T, Jena S, Brinkhaus B, Willich SN. Cost-effectiveness of Acupuncture Treatment in Patients with Headache. Cephalalgia. 2008; 28: 334-345. DOI: 10.1111/j.1468-2982.2007.01504.x GERMAN

Cost effectiveness and cost analysis Objective:

To assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. Method:

The multicentre, randomised controlled trial was carried out. The International Classification of Diseases (ICD)-10 was used to identify costs due only to headache and related conditions. In the Germany, an arbitrary and hypothetical threshold of maximum €50000 per QALY was used.

Adult patients (age ≥ 18 years). Diagnosed with primary headache (>12 months) and at least two headaches per month. 3182 patients; 1613 acupuncture, 1569 controls.

Acupuncture + routine care

Routine care alone

Cost analysis

The mean overall costs incurred by acupuncture patients during the treatment period were €857.47 (95% CI 790.86, 924.07) and €527.34 (95% CI 459.81, 594.88) in control patients (P < 0.001).

Three months after randomization, the mean cost difference between the two treatment groups [total overall: €330.12 (95% CI 235.27, 424.98), was primarily due to the acupuncture costs in the acupuncture group [€365.64 (95% CI 362.19, 369.10)].

In acupuncture patients, the overall cost difference between baseline and the end of the three-month treatment period was €362.05 (95% CI 293.78, 430.32) compared with €7.05 (95% CI -62.17, 76.27) in control patients (P < 0.001).

Excluding the costs of acupuncture reveals that there were no significant overall cost differences between the two study groups. Also in single cost components no significant differences between the two study groups could be detected.

Over three-months costs were higher in the acupuncture group compared with the control [€857.47; 95% confidence interval 790.86, 924.07, vs. €527.34 (459.81, 594.88), P < 0.001, mean difference: €330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [€365.64 (362.19, 369.10)]. The ICER was €11 657 per QALY gained.

Cost effectiveness analysis

A gain of 0.0301 ± 0.004 QALYs was observed in the acupuncture group compared with the control group.


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Evidence Table : Cost Question : What is the cost effectiveness/ cost analysis for headache?







General comments

However, this gain was associated with additional costs [overall: €350.85 (95% CI 216.63, 485.07), diagnosis-specific: €365.38 (95% CI 341.74, 389.02)]. The ICER was €11657 (overall) and €12140 (diagnosis-specific) per QALY gained. Therefore, for the assumed threshold value of €50000, the additional acupuncture intervention would appear to be cost-effective.

Sensitivity analysis

For migraine it was found that acupuncture treatment in men seems to be more cost-effective than in women (ICER men €-810 versus women €19 228).

In contrast, a reverse situation was observed for tension-type headache (TTH). Therefore, the acupuncture treatment was assessed as a more cost effective treatment for women (ICER men €34775 versus women €4109; adjusted ICER men €12599 versus women €2619).

The cost acceptability curves represented the probability of cost effectiveness against different threshold values ranging from €0 to €50 000. In female patients, acupuncture treatment reaches a maximum overall cost effectiveness probability of approximately 100% versus a probability of approximately nearly 100% (98.8%) in men

Conclusion

This study has shown that using acupuncture in addition to routine care to treat patients with primary headache resulted in a marked and clinically relevant benefit and was cost-effective.

acupuncture for headache, refractory

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