vitamin b12 in low back pain

8/10/2019 Vitamin B12 in Low Back Pain

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tical benefits of B -vitamins given in high dose,and in particular vitamin B 12, in painful disor-ders of spinal nerve roots in the absence of

typical signs of a nutritional deficiency have al-ready been demonstrated. This compound, af-ter conversion into co-enzymat ic forms such a smethylcobalamin, is involved in the synthesisof nucleic acid and protein, based on the tra ns-methylation reaction, as well as the metabo-lism of phospholipids and catecholamines. Themethyl group is used in the synthesis of me-thionine from homocysteine as well as the syn-thesis of phosphatidylcholine, a phospholipidimportant in the cell membrane structure. Pa rtof phosphatidylcholine becomes choline and is

used in the synthesis of acetylcholine, a no-table neurotransmitter.Animal models demonstrated that B-vita-

mins yield antinociceptive and antiinflamma-tory properties in the rat tail pressure test 1,and are able to significantly decrease the re-sponses evoked in spinal dorsal horn nocicep-tive neurons in the ca t2.

From a clinical standpoint, several studieshave documented the positive influence of B -vitamins of painful symptoms due to degenera-tive disorders of the lumbar spine, and have in-dicated tha t less nonsteroidal antiinflammatory

drugs (NSAI D s) are needed fo r pain reliefwhen combined with B-vitamins3,4. Further in-vestigations conformed the efficacy of VitaminB 12 in the treatment of peripheral neuropathy

5.In the present investigation, w e have studied

the efficacy and safety of intramuscular vita-min B 12 (Tricortin

1000 ampoules)* for thetreatment of low ba ck pain in patients with me-chanical or irritative lumbago.

European Review for Medical and Pharmacological Sciences

53

Abstract. Objectives:The objective ofthis double-blind randomised, placebo-con-trolled study was to examine the efficacy and

safety intramuscular vitamin B12 (Tricortin 1000)in the treatment of low back pain in patients withmechanical or irritative lumbago.

Methods:60 patients aged between 18 and 65years with lumbago or sciatic neuritis of mechani-cal origin without need for surgical procedureswere enrolled. Patients had to present with aproven medical history for back pain (lasting from6 months to 5 years) and a pain intensity [as eval-uated with a Visual Analogic Scale (VAS)] equal orgreater than 60 mm. Efficacy primary end-pointwas evaluated by means of a visual analogic scale(VAS) and a Disability Questionnaire (DQ).Consumption of paracetamol during the study pe-riod was the secondary efficacy end-point.

Results: Both treatment groups experienced asharp decrease in pain and disability. However,comparison between groups at the end of thetreatment period showed a statistically signifi-cant difference in favour of the active treatmentboth for VAS and DQ (p< 0.0001 and p< 0.0002,respectively). Consumption of paracetamolproved significantly higher in the placebo groupthan in the active treatment (p< 0.0001).

Conclusions:The efficacy and safety of par-enteral Vitamin B12 in alleviating low back painand related disability and in decreasing the con-sumption of paracetamol was confirmed in pa-tients with no signs of nutritional deficiency.

Key Words:

Vitamin B12, low back pain, paracetamol.

Introduction

Vitamins of the B group are known for theirestablished therapeutical role in neurologicdiseases related to a deficiency of these essen-

tial nutritional factors. Besides that, therapeu-

Vitamin B1 2 in low back pain: a randomised,double-blind, placebo-controlled study

G. LETIZIA MAURO, U. MARTORANA, P. CATALDO, G. BRANCATO, G. LETIZIA

Clinica Ortopedica e Traumatologica con Fisioterapia e Medicina dello Sport, University of Palermo- Palermo (Italy)

2000; 4: 53-58

*Fidia S.p.A., Via Ponte della Fabbrica, 3a

35031 Abano Terme (PD) - Italy


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Patients and M ethods

Patients

T h e s t u d y w a s a p p r o v e d b y t h eInstitutional R eview B oard o f the P alermoU niversity H ospital, P alermo, Ita ly, a s spe-cial postmarketing survei l lance. Pat ientswere given an explanation of the study, andth e i r i n f o r m ed w r i t t en con sen t w as ob -tained. All patients were selected from theo u t p a t i e n t cl in i c o f t h e D e p a r t m e n t o fO r t h o p a e d i c s o f P a l e r m o U n i ve r si t yHospital.

Inclusion criteria included subjects a gedbetw een 18 and 65 years with lumbago or sci-

atic neuritis of mechanical origin withoutneed for surgical procedures. Patients had topresent with a proven medical history forback pain (lasting from 6 months to 5 years)and a pa in intensity [as evaluated w ith a visu-al analogic scale (VAS)] equal or greater than60 mm.

Exclusion criteria included pregnancy, con-comitant treatment with drugs known for atoxic effect on the peripheral nerve, severeconcurren t i l lnesses , and in to lerance toparacetamol (which was the only al lowed

NSAID).The assessors were given no informationabout treatment assignment.

Pat ients who met the select ion cr i ter iawere randomly divided into two treatmentgroups (active treatment and placebo) of 30patients each. The mean age SD at the startof the study was 48.8 13.1 years in the ac-tive treatment group and 50.4 13.6 in the

placebo group; there was no significant be-tween-group difference (Mann-Whitney Utest). There were 8 males and 22 females inthe active treatment group and 3 males and27 females in the placebo group; this differ-ence was not significant (Chi-square test).B aseline pain (as evaluated by VAS f rom 0 to100 mm), and functional disability (evaluatedby a va lidat ed disability questionnaire; D Q )were more severe in the act ive treatmentgroup (Table I ).

Methods

Treatments

B oth active trea tment (Tricortin 1000 2mL ampoules containing 1000 mg VitaminB 12) and placebo (2 mL ampoules) were ad-ministered once daily by the intramuscularroute fo r a 2-week period.

EfficacyVAS was evaluated according to Scott &

Huskisson6 by means of a graduated rule

with a total length of 100 mm; absence ofpain corresponded to the position at 0 mm,and maximum pain to the position at 100mm.

Functional disability was scored using avalidated disability questionnaire (D Q) 7 con-sisting of 24 questions, each item correspond-ing to a single score. D isab ility could thenrange fro m 0 to 24.

G. Letizia Mauro, U. Martorana, P. Cataldo, G. Brancato, G. Letizia

Tricortin group (n = 3 0 ) Placebo group (n = 3 0 ) P*

Age (y) 48.8 13.1 50.4 13.6 0.6443Sex (n)

Male 8 3 0.0953#

Female 22 27

P ain (VAS) 75.5 8.9 70.6 7.9 0.0327FunctionalD isability (D Q) 13.2 2.7 11.5 2.1 0.0105

Table I. Clinical dat a of t he 2 study groups.

All values are expressed as mean SD .*Per Ma nn-Whitney U test.#

Per Chi-square test.


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SafetySafety o f treatments was a ssessed by mea-

suring vital signs (heart rate, diastolic andsystolic blood pressure) in each patients inbasal conditions and at the end of therapy.The occurrence of adverse events was moni-tored a ccording to standa rd pharmacovigi-lance procedures. If a serious event wouldhave occurred, the breaking of the randomi-sation code was a llowed.

Concurrent drugsPatients were allowed to take any drugs

not related to low back pain, if they neededthem, according to their individual clinicalcondition. Patients needing drugs with a po-

tential toxic effect on the peripheral nervoussystem were excluded from the study. In bo thtreatment groups, standard doses of paraceta-mol (1-6 500 mg t ablets/da y) w ere given forback pain, if needed. Paracetamol account-ability was included as an indirect mean toevaluate treat ments (secondary end-point).

Statistical analysisSample size was calculated in order to de-

te r m i n e a m i n im u m d i f f e r en ce b e tw eengroups of 15 mm at the VAS scale, assuming

a standard deviation of 20 mm and a studypotency (1-) equal to 80%.

All s tat is t ical tests used were 2-tai led .Within-group comparisons were performedusing the Wilcoxon test for paired samples;betw een-group comparisons were mad e usingthe Mann-Whitney U test (except for sex dis-tribution, which was analysed with the chi-square test , and paracetamol consumptionwhich was ana lysed by the unpaired Student ttest with Welchs correction to account fornon-equal variances). Statistical significancewa s corroborat ed by a nalysis of variance andanalysis of co-variance tests. The a priori lev-el of significance was = 0.05. All ana lyseswere performed using the SAS stat is t icalpackage (SAS Institute, Ca ry, NC, U SA).

Results

B oth trea tment groups experienced a sharpdecrease in pain and disability. In patientstreated w ith active treatment the pairing wassignificantly effective (p = 0.0011; Spea rmansapproximat ion rs = 0.5366) a nd VAS scalemeasurement low ered from 75.53 8.9 to9.53 16.5 mm (p < 0.0001); in pa tients t rea t-ed with placebo, VAS scores decreased from

70. 63 7. 9 t o 3 6. 83 27. 4 (p < 0.0001)(Figure 1). However, comparison between

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Vitamin B12 in low back pain: a randomised, double-blind, placebo-controlled study

Figure 1 .

VAS

0 -T 0 - P 15 -T 15 - P0

25

50

75

1000 -T

15 -T

0 - P

15 - P

p < 0.0001 vs.placebo

Treatment groups (T = Tricortin; P = placebo) at day O and day 15

mm


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groups at the end of the treatment periodshowed a statistically significant d ifference infavour of t he active treatment (p < 0.0001).

The ana lysis of the D isab ility Q uestionnaireshowed a similar pat tern. Tota l scores declinedfrom 13.27 2.7 to 2.43 2.6 in the activetreatment group (p < 0.0001) and again paringproved to be effective (p = 0.0131; Spearma nsapproximation rs = 0.4057), and f rom 11.53 2.2 to 5.80 3.3 in the placebo group (p

vitamin b12 in low back pain

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