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Homoeopathy for induction of labour (Review)

Smith CA

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 3

http://www.thecochranelibrary.com

Homoeopathy for induction of labour (Review)

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

http://www.thecochranelibrary.com/

http://www.thecochranelibrary.com/



T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis 1.3. Comparison 1 Homoeopathy versus placebo, Outcome 3 Caesarean section. . . . . . . . . . . 13

Analysis 2.1. Comparison 2 Homoeopathy versus placebo, Outcome 1 Vaginal delivery not achieved within 24 hours. 14

Analysis 3.1. Comparison 3 Homoeopathy versus placebo, Outcome 1 Augmentation with oxytocin. . . . . . . 14

Analysis 4.1. Comparison 4 Homoeopathy versus placebo, Outcome 1 Instrumental delivery. . . . . . . . . 15

Analysis 5.2. Comparison 5 Homoeopathy versus placebo, Outcome 2 Length of labour. . . . . . . . . . . 15 Analysis 6.1. Comparison 6 Homoeopathy versus placebo, Outcome 1 Difficult labour. . . . . . . . . . . 16

16 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16 WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iHomoeopathy for induction of labour (Review)




[Intervention Review]

Homoeopathy for induction of labour

Caroline A Smith1

1Centre for Complementary Medicine Research, The University of Western Sydney, Penrith South DC, Australia

Contact address: Caroline A Smith, Centre for Complementary Medicine Research, The University of Western Sydney, Locked Bag

1797, Penrith South DC, New South Wales, 1797, Australia. [email protected].

Editorial group: Cochrane Pregnancy and Childbirth Group.

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 3, 2010.

Review content assessed as up-to-date: 13 January 2010.

Citation: Smith CA. Homoeopathy for inductionof labour.CochraneDatabase of SystematicReviews 2003, Issue4. Art. No.: CD003399.

DOI: 10.1002/14651858.CD003399.


A B S T R A C T

Background

This is one of series of reviews of cervical ripening and labour induction using standardised methodology. Homoeopathy involves

the use, in dilution, of substances which cause symptoms in their undiluted form. A type of herb, ’caulophyllum’ is one type of

homoeopathic therapy that has been used to induce labour.

Objectives

To determine the effects of homoeopathy for third trimester cervical ripening or induction of labour.

Search methods

The Cochrane Pregnancy and Childbirth Group’s Trials Register (1 December 2009), and bibliographies of relevant papers.

Selection criteria

Randomised controlled trials comparing homeopathy used for third trimester cervical ripening or labour induction with placebo/no

treatment or other methods listed above it on a predefined list of labour induction methods.

Data collection and analysis

A generic strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved

a two-stage method of data extraction. The initial data extraction was done centrally.

Main results

Two trials, involving 133 women, were included in the review. The trials were placebo controlled and double blind, but the quality was

not high. Insufficient information was available on the method of randomisation and the study lacked clinically meaningful outcomes.This trials demonstrated no differences in any primary or secondary outcome between the treatment and control group.

Authors’ conclusions

There is insufficient evidence to recommend the use of homoeopathy as a method of induction. It is likely that the demand for comple-

mentary medicine will continue and women will continue to consult a homoeopath during their pregnancy. Although caulophyllum

is a commonly used homoeopathic therapy to induce labour, the treatment strategy used in the one trial in which it was evaluated may

not reflect routine homoeopathy practice. Rigorous evaluations of individualised homeopathic therapies for induction of labour are

needed.

1Homoeopathy for induction of labour (Review)


mailto:[email protected]

mailto:[email protected]



P L A I N L A N G U A G E S U M M A R Y

Homoeopathy for induction of labour

There is not enough evidence to show the effect of homoeopathy for inducing labour. Sometimes it is necessary to induce labour

(getting labour started artificially) when a pregnant woman or her unborn child are at risk. Homoeopathy involves the use of diluted

substances which in their undiluted form, cause certain symptoms. The principle is that a homoeopathic substance will stimulate thebody and healing functions so that a state of balance is gained and symptoms are relieved. The review of two trials, involving 133

women, found there was not enough evidence to show the effect of a homoeopathy as a method of induction. More research is needed.

B A C K G R O U N D

Sometimes it is necessary to bring on labour artificially because

of safety concerns for the mother or baby. This review is one of a

series of reviews of methods of labour induction using a standard-

ised protocol. For more detailed information on the rationale for

this methodological approach, please refer to the currently pub-

lished ’generic’ protocol (Hofmeyr 2009). The generic protocol

describes how a number of standardised reviews will be combined

to compare various methods of preparing the cervix of the uterus

and inducing labour.

Homoeopathy is used around the world and is most widely used

in Europe and India. Homoeopathy is a form of pharmacological

therapy based on the concept that a substance which gives rise

to specific symptoms, when given in pharmacological doses tohealthy individuals, can be used to treat patients presenting with

the same symptoms. This is described as the Law of Similars.

Homoeopathy seeks to strengthen the body’s immune system, the

principle of the treatment being that the homoeopathic substance

will stimulate the body and healing functions so that a state of

balance is attained and the symptoms are relieved. Homoeopathic

remedies are all natural medicines, with some remedies derived

from herbs, minerals or other natural substances.

Homeopathic remedies are applied as potencies as a result of tiny

and highly diluted amounts of the substances from which they are

derived. They are prepared by a process of step by step repeated

dilution and vigorous shaking, which is thought to make them ca-pable of stimulating the body’s own defence system. The resulting

potency is labelled on the basis of the ratio of dilutent and diluted

agent (D = decimal dilution = 1/10 diluted agent/dilutent; C =

centesimal dilution = 1/100 diluted agent/dilutent) and the num-

berof dilution steps (e.g. C5 indicates 5 dilution steps 1/100). The

repetitive dilutions are thought to produce results more quickly,

act on symptoms more effectively and are less likely to lead to side

effects than the original substances.

The resulting homoeopathic medicine may contain very few or

no single molecules of the original solute. For this reason many

scientists have suggested the clinical effects resulting from ho-

moeopathic remedies are due to the placebo effect (Vandenbrouke1997). However, data from two meta-analyses of placebo con-

trolled clinical trials have found a greater therapeutic effect from

homoeopathy compared with the placebo (Boissel 1996; Linde

1997). The precise biophysical mechanismunderlying homoeopa-

thy remains undefined.

There are different traditions in the prescribing of homoeopathic

formulations. Classical homoeopathy refers to the practitioner pre-

scribing a single therapy to treat the individual’s illness based on

the patient’s general constitution. This involves consideration of

the individual’s current illness, medical history, personality and be-

haviour. Other practitioners prescribe a combination of homoeo-

pathic therapies, ’complex homoeopathy’, on the basis of a con-ventional diagnosis. Clinical homoeopathy uses the same remedy

in patients presenting with a homogenous pathology or constella-

tion of symptoms. There is no evidence that describes the benefits

of one approach compared with another approach. Homoeopathy

is practiced on different levels. Many homoeopathic therapies are

available over the counter in pharmacies and health food shops.

However, homoeopaths require several years of study to achieve

their qualification. The trained homoeopath will treat an individ-

ual based on a detailed case history and the homoeopathic treat-

ment will be tailored to the individual’s constitution.

In recent years the use of alternative and complementary medicine

has become popular in many Western countries (MacLennan2002). Unconventional therapies are more common among

women of reproductive age, with almost half of all women (49%)

reporting that theyhave used them(Eisenberg 1998). It is possible

that a significant proportion of women are using these therapies

duringpregnancy. Theuse of homoeopathy hasbeen applied at the

time of conception, pregnancy and labour to treat some of the dis-

comforts and imbalances that can arise during pregnancy such as

backache, constipation, morning sickness and heartburn. A recent





survey described the prevalence and use of complementary thera-

pies among 82 nurse-midwives in North Carolina ( Allaire 2000).

Over30% of nurse-midwivesreported recommendinghomoeopa-

thy for use in pregnancy. Homoeopathy was recommended for use

to ripen the cervix, induce labour and to augment labour.

For some women with a prolonged pregnancy, an induction of labour may be perceived to intervene in the natural process of

pregnancy and may drastically change their expected plan of care

during pregnancy. The reasons why pregnant women are inter-

ested in using complementary therapies to ripen the cervix or in-

duce labour, or both, is an important question and needs to be

answered when evaluating new options of care. Serious adverse

effects from homoeopathy are rare, and remedies recommended

for use in pregnancy are not thought to cause any problems in

pregnancy.

Caulophyllum thalictroides is proposed to be extremely useful

with establishing labour, or when uterine contractions are short

and irregular or when uterine contractions stop (Priestman 1988).Some homoeopaths suggest taking one tablet daily for the last

few days before labour starts, or alternatively to dissolve a tablet

in a glass of water and sip from the glass from time to time, or

whenever a contraction is imminent. A non-randomised clinical

trial wascarriedout to examine theefficacy of caulophyllum before

birth for the treatment of uterine inertia and reducing the risk

of postpartum haemorrhage (Ventoskovskiy 1990). The authors

concluded this remedy has a role in preventing poor contraction

patterns.

O B J E C T I V E S

To determine, from the best available evidence, the effectiveness

and safety of homoeopathy for third trimester cervical ripening

and induction of labour.

M E T H O D S

Criteria for considering studies for this review

Types of studies

Clinical trials comparing homoeopathy for cervical ripening or

labour induction, with placebo/no treatment or other methods

listed on a predefined list of methods of labour induction (see Methods); the trials included random allocation to either group;

and they reported one or more of the prestated outcomes.

Types of participants

Pregnant women due for third trimester induction of labour, car-

rying a viable fetus.

Types of interventions

Homoeopathy compared with placebo/no treatment or any other

method on a predefined list of methods of labour induction.

Types of outcome measures

Clinicallyrelevantoutcomesfor trials of methods of cervical ripen-

ing/labour induction have been prespecified by two authors of

labour induction reviews (Justus Hofmeyr and Zarko Alfirevic).

Primary outcomes

Five primary outcomes were chosen as being most representative

of the clinically important measures of effectiveness and compli-

cations:

(1) vaginal delivery not achieved within 24 hours;

(2) uterine hyperstimulation with fetal heart rate (FHR) changes;

(3) caesarean section;

(4) serious neonatal morbidity or perinatal death (e.g. seizures,

birth asphyxia defined by trialists, neonatal encephalopathy, dis-

ability in childhood);

(5) serious maternal morbidity or death (e.g. uterine rupture, ad-

mission to intensive care unit, septicemia).

Perinatal and maternal morbidity and mortality are compositeoutcomes. This is not an ideal solution because some components

are clearly lesssevere than others. It is possible for one intervention

to cause more deaths but less severe morbidity. However, in the

context of labourinduction at term this is unlikely. All these events

will be rare, and a modest change in their incidence will be easier

to detectif composite outcomes are presented. Where possible, the

incidence of individual components were explored as secondary

outcomes (see below).

Secondary outcomes

Secondary outcomes relate to measures of effectiveness, complica-

tions and satisfaction.

Measures of effectiveness

(6) Cervix unfavourable/unchanged after 12 to 24 hours;

(7) oxytocin augmentation.





Complications

(8) Uterine hyperstimulation without FHR changes;

(9) uterine rupture;

(10) epidural analgesia;

(11) instrumental vaginal delivery;

(12) meconium-stained liquor;(13) Apgar score less than seven at five minutes;

(14) neonatal intensive care unit admission;

(15) neonatal encephalopathy;

(16) perinatal death;

(17) disability in childhood;

(18) maternal side effects (all);

(19) maternal nausea;

(20) maternal vomiting;

(21) maternal diarrhoea;

(22) other maternal side-effects;

(23) postpartum haemorrhage (as defined by the trial authors);

(24) serious maternal complications (e.g. intensive care unit ad-

mission, septicaemia but excluding uterine rupture);(25) maternal death.

Measures of satisfaction

(26) Woman not satisfied;

(27) caregiver not satisfied.

While all the above outcomes were sought, only those with data

appear in the analysis tables.

The terminology of uterine hyperstimulation is problematic

(Curtis 1987). In the reviews we use the term ’uterine hyperstimu-

lation without FHRchanges’ to include uterine tachysystole (more

than five contractions per 10 minutes for at least 20 minutes) and

uterine hypersystole/hypertonus (a contraction lasting at least twominutes) and ’uterine hyperstimulation with FHR changes’ to de-

note uterine hyperstimulation syndrome (tachysystole or hyper-

systole with fetal heart rate changes such as persistent decelera-

tions, tachycardia or decreased short-term variability).

Outcomes were included in the analysis if reasonable measures

were taken to minimise observer bias; and data were available for

analysis according to original allocation.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group’s Tri-

als Register by contacting the Trials Search Co-ordinator (1 De-

cember 2009).

The Cochrane Pregnancy and Childbirth Group’s Trials Register

is maintained by the Trials Search Co-ordinator and contains trials

identified from:

1. quarterly searches of the Cochrane Central Register of

Controlled Trials (CENTRAL);

2. weekly searches of MEDLINE;

3. handsearches of 30 journals and the proceedings of major

conferences;

4. weekly current awareness alerts for a further 44 journalsplus monthly BioMed Central email alerts.

Details of the search strategies for CENTRAL and MEDLINE,

the list of handsearched journals and conference proceedings, and

the list of journals reviewed via the current awareness service can

be found in the ‘Specialized Register’ section within the edito-

rial information about the Cochrane Pregnancy and Childbirth

Group.

Trials identified through the searching activities described above

are each assigned to a review topic (or topics). The Trials Search

Co-ordinator searches the register for each review using the topic

list rather than keywords.

Searching other resources

We searched the reference lists of identified papers.

We did not apply any language restrictions.

Data collection and analysis

A strategy was developed to deal with the large volume and com-

plexity of trial data relating to labour induction. Many methods

have been studied, in many different categories of women under-

going labour induction. Most trials are intervention-driven, com-

paringtwo or more methods in various categories of women. Clin-

icians and parents need the data arranged by category of woman,

to be able to choose which method is best for a particular clinicalscenario. To extract these data from several hundred trial reports

in a single step would be very difficult. We, therefore, developed

a two-stage method of data extraction. The initial data extraction

is done in a series of reviews arranged by methods of induction of

labour, following a standardised methodology.

To avoid duplication of data in the primary reviews, the labour

induction methods have been listed in a specific order, from one

to 25. Each review includes comparisons between one of the

methods (from two to 25) with only those methods above it on

the list. Thus, the review of intravenous oxytocin (4) includes

only comparisons with intra cervical prostaglandins (3), vaginal

prostaglandins (2) or placebo (1). Methods identified in the future

will be added to the end of the list. The current list is as follows:

1. placebo/no treatment;

2. vaginal prostaglandins (Kelly 2003);

3. intracervical prostaglandins (Boulvain 2008);

4. intravenous oxytocin (Kelly 2001c);

5. amniotomy (Bricker 2000);

6. intravenous oxytocin with amniotomy (Howarth 2001);

7. vaginal misoprostol (Hofmeyr 2003);



http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/PREG/frame.html









8. oral misoprostol ( Alfirevic 2006);

9. mechanical methods including extra-amniotic Foley

catheter (Boulvain 2001);

10. membrane sweeping (Boulvain 2005);

11. extra-amniotic prostaglandins (Hutton 2001);

12. intravenous prostaglandins (Luckas 2000);13. oral prostaglandins (French 2001);

14. mifepristone (Neilson 2000);

15. oestrogens with/without amniotomy (Thomas 2001);

16. corticosteroids (Kavanagh 2006a );

17. relaxin (Kelly 2001a );

18. hyaluronidase (Kavanagh 2006b);

19. castor oil, bath, and/or enema (Kelly 2001b);

20. acupuncture (Smith 2004);

21. breast stimulation (Kavanagh 2005);

22. sexual intercourse (Kavanagh 2001);

23. homoeopathic methods;

24. nitric oxide (Kelly 2008);

25. buccal or sublingual misoprostol (Muzonzini 2004)26. hypnosis

27. other methods for induction of labour.

The reviews are analysed by the following subgroups:

1. previous caesarean section or not;

2. nulliparity or multiparity;

3. membranes intact or ruptured;

4. cervix favourable, unfavourable or undefined.

The trials included in the reviews were extracted from an initial set

of trials covering all interventions used in induction of labour (see above for details of search strategy). The data extraction process

was conducted centrally. This was co-ordinated from the Clini-

cal Effectiveness Support Unit (CESU) at the Royal College of

Obstetricians and Gynaecologists, UK, in co-operation with thePregnancy and ChildbirthGroup of The Cochrane Collaboration.

This process allowed the data extraction process to be standardised

across all the reviews.

The trials were initiallyreviewedon eligibility criteria,using a stan-

dardised form and the basic selection criteria specified above. Fol-

lowing this, data were extracted to a standardised data extraction

form which was piloted for consistency and completeness. The

pilot process involved the researchers at the CESU and previous

review authors in the area of induction of labour.

Information was extracted regarding the methodological quality

of trialson a number of levels. This process wascompletedwithout

considerationof trial results. Assessmentof selectionbias examined

the process involved in the generation of the random sequenceand the method of allocation concealment separately. These were

then judged as adequate or inadequate using the criteria described

in Appendix 1 for the purpose of the reviews.

Performance bias was examined with regards to whom was blinded

in the trials, i.e. patient, caregiver, outcome assessor or analyst.

In many trials the caregiver, assessor and analyst were the same

party. Details of the feasibility and appropriateness of blinding at

all levels were sought.

Predefined subgroup analyses are: previous caesarean section or

not; nulliparity or multiparity; membranes intact or ruptured, and

cervix unfavourable, favourable or undefined. Only those out-

comes with data will appear in the analysis tables.

Individual outcome data were included in the analysis if they metthe pre stated criteria in Types of outcome measures. Included

trial data were processed as described in the Cochrane Reviewers’

Handbook (Clarke 2002). Data extracted from the trials were

analysed on an intention-to-treat basis (when this was not done in

the originalreport, re-analysis is performed if possible). Wheredata

were missing, clarification was sought from the original authors. If

the attrition was such that it might significantly affect the results,

these data are excluded from the analysis. This decision rests with

the review authors of primary reviews and is clearly documented.

Once missing data become available, they will be included in the

analyses.

Data were extracted from all eligible trials to examine how issues

of quality influence effect size in a sensitivity analysis. In trials where reporting was poor, methodological issues were reported as

unclear or clarification sought.

Due to the large number of trials, double data extraction was

not feasible and agreement between the three data extractors was

therefore assessed on a random sample of trials.

Once the data had been extracted, they were distributed to indi-

vidual review authors for entry onto the Review Manager com-

puter software (RevMan 2003), checked for accuracy, and anal-

ysed as above using the RevMan software. For dichotomous data,

risk ratios and 95% confidence intervals were calculated, and in

the absence of heterogeneity, results were pooled using a fixed-

effect model.

The predefined criteria for sensitivity analysis included all aspectsof quality assessment as mentioned above, including aspects of se-

lection, performance and attrition bias. Letters are used to indi-

cate the quality of the included trials as described by Clarke 2002.

The sensitivity analysis explores the influence of high-quality trials

(defined as “A”), versus moderate quality trials (defined as “B”),

and high-quality trials (defined as “A”) versus low-quality trials

(defined as “C”), as well as the effects of analysing by intention to

treat on the effect size.

Primary analysis was limited to the prespecified outcomes and

subgroup analyses. In the event of differences in unspecified out-

comes or sub-groups being found, these were analysed post hoc,

but clearly identified as such to avoid drawing unjustified conclu-

sions.

R E S U L T S

Description of studies





See: Characteristics of includedstudies; Characteristics of excluded

studies.

Four studies were identified. Two were included and two were ex-

cluded. The search strategy identified two randomised controlled

trials for inclusion in this review (Beer 1999; Dorfman 1987).

The study by Beer et al (Beer 1999) compared caulophyllum in a placebo double blind controlled trial and was undertaken in Ger-

many. The authors of this trial examined the efficacy and tolerabil-

ity of the homoeopathic remedy caulophyllum D4 in 40 women

at term with prelabour rupture of membranes (PROM) at term

and not in labour. The trial examined the effect of caulophyllum

on the time interval from entry to the onset of regular uterine

contractions. Other outcomes examined the effect on the dura-

tion of labour, oxytocin requirements, mode of delivery and the

rate of maternal and neonatal infection. Women were adminis-

tered caulophyllum or a placebo hourly for seven hours. Each ac-

tive tablet consisted of 250 mg caulophyllum trituration D4, a

mixture of magnesium stearate and a wheat starch mixture. The

placebo contained no active ingredients but contained the mag-nesium stearate and a wheat starch mixture.

The trial presented information on the baseline characteristics be-

tween the two randomised groups. No differences in age, weight,

height, cervical score at trial entry and time since PROM were

found between study groups.

The study by Dorfman et al (Dorfman 1987) was undertaken

in France. The trial compared five homoeopathic therapies with

placebo in 93 women from 36 weeks’ pregnant; 53 women were

randomised to the treatment group and 40 to the placebo group.

The trial examined the effect of the homoeopathic therapy on

length of labour and the proportion of women experiencing a

difficult labour. No details were provided on the placebo. The

groups were comparable with respect to parity.

Excluded studies

The use of caulophyllum for the preparation of labour ( Arnal-

Laserre 1986) and for use in false labour and dystocia (Coudert-

Deguillaume 1981) have been examined in two research theses.

Extensive efforts have been made to contact the authors and we

do not have enough information to make a decision whether the

trial meets the inclusion criteria.

Risk of bias in included studies

The methodof randomisation in both trials wasnot described and

was therefore unclear. Both trials were reported as double blind

although there was no information as to whether caregivers and

the outcome assessors were blind to the women’s group allocation.

There were no withdrawals from the trials. The authors of the tri-

als did not state they performed an intention-to-treat analysis, al-

though the studies did analyse outcome data from the same num-

ber of women who were reported as having been randomised. The

sample size was small in both trials and there was no description

of the sample size calculation or if a calculation was undertaken.

The information on any side effects arising from caulophyllum

was unclear and it was unclear as to how women assessed the tol-

erability of caulophyllum. No data were provided on side effects

from the Dorfman 1987 trial.

Effects of interventions

Two trials involving 133 women were included in the review.

Caulophyllum versus placebo

Forty women with a singleton pregnancy and prelabour rupture

of membranes were randomised to caulophyllum or placebo (Beer

1999).

Primary outcomes

Vaginal delivery not achieved within 24 hours was reported for

one woman in the control group (1/20) and no women in the

treatment group (risk ratio (RR) 0.33, 95% confidence interval

(CI) 0.01 to 7.72). Data on uterine hyperstimulation were not

recorded. Two women in the group given caulophyllum had cae-

sarean sections compared with no women in the placebo group

(RR 5.0, 95% CI 0.26 to 98.00). No data were presented on fetal

heart rate changes although theauthor describesthat slightbut not

significant differences were noted. No data were reported on se-

rious maternal or neonatal morbidity such as; meconium-stained

liquor; Apgar score less than seven at five minutes; neonatal in-

tensive care unit admission; postpartum haemorrhage; or seriousmaternal complications (e.g. intensive care unit admission, septi-

caemia).

Secondary outcomes

No data were presented on cervical change, however the author

reported minor differences between groups. Oxytocin augmenta-

tion was administered to nine women (45%) in each group, no

differences were found (RR 1.0, 95% CI 0.50 to 1.98). There was

no difference in the rate of instrumental delivery between the two

groups (RR 1.0 95%CI 0.54 to 1.86). No differences were found

in Apgar scores between groups. Women’s and midwives’ views on

this method were sought andall described themethodas tolerable.

Additional data

The difference in the interval between administration of the in-

tervention and regular uterine contractions was 13 hours in the

treatment group and 13.4 hours in the control group (mean dif-

ference -0.40, 95% CI -7.21 to 6.41).





In the Dorfman 1987 trial only two outcomes were reported. The

mean length of labour for women receiving the homoeopathic

therapy was 5.1 hours compared with 8.48 hours in the placebo

group (P less than 0.001). Data could not be entered into the

meta-analysis due to the absence of data on standard deviation.

A difficult labour was reported for six women (11.3%) in thetreatment group and 16 (40%) in the placebo group (RR 0.28,

95% CI 0.12 to 0.66). Mode of delivery was not reported by study

group.

D I S C U S S I O N

This review included two trials. There were no differences seen

in any of the primary outcome measures described in this review.

Unfortunately, the quality of the trials was difficult to assess be-

cause of insufficient detail in the research papers, and the small

sample sizes provide inadequate power.

There is little research to assess the effectiveness of remedies in

stimulatingthe onset of labour. Thelack of data in this area is com-

pounded by a lack of relevant clinical outcome data which could

be included into this review. The use of caulophyllum may not

represent common homoeopathic practice, where the prescribing

of a therapy would be more individualised.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

There is insufficient evidence to recommend the use of any ho-

moeopathic therapies as a method of induction of labour.

Implications for research

Given that some women are likely to continue to seek homoeo-

pathic therapies for induction of labour, there is a need for rig-

orous, adequately powered trials that assess clinically meaningful

outcomes. Such trials should include assessment of uterine hyper-

stimulation as well as indicators of maternal and neonatal morbid-

ity. Further research using classical homoeopathy might be more

relevant to assessingboth the effectiveness andsafety of homoeopa-

thy.

A C K N O W L E D G E M E N T S

The author would like to thank Bettina Hinger for the German

to English translation (Beer 1999) and Alison Ledward for the

French to English translation (Dorfman 1987).

R E F E R E N C E S

References to studies included in this review

Beer 1999 {published data only}Beer AM, Heiliger F. Randomized, double blind trial

of Caulophyllum D4 for induction of labour after

premature rupture of membranes at term. Gerburtshilfe und

Frauenheilkunde 1999;59:431–5.

Dorfman 1987 {published data only}

Dorfman P, Lasserre M, Tetau M. Homoeopathic

preparation for labour: two fold experiment comparing

a less widely known therapy with a placebo. Cahiers de

Biotherapie 1987;94:77–81.

References to studies excluded from this review

Arnal-Laserre 1986 {published data only}

Arnal-Laserre MN. Preparation a l’accouchement par homeopathie: experimentation en double insu versus placebo

(Dissertation). Paris: Academie de Paris, Universite Rene

Descartes, 1986.

Coudert-Deguillaume 1981 {published data only}

Coudert-Deguillaume M. Etude l’accouchement par

homeopthie: experimentation en double insu versus placebo

[Dissertation] . Limoges: Faculte de Medecine et de

Pharmacie, Universite de Limoges, 1981.

Additional references

Alfirevic 2006 Alfirevic Z, Weeks A. Oral misoprostol for induction of

labour. Cochrane Database of Systematic Reviews 2006, Issue

2. [DOI: 10.1002/14651858.CD001338.pub2]

Allaire 2000

Allaire AD, Moos M, Wells SR. Complementary and

alternative medicine in pregnancy: a survey of North

Carolina nurse-midwives. Obstetrics & Gynecology 2000;95

(1):19–23.

Boissel 1996

Boissel JP, Cucherat M, Haugh M, Gauthier E. Critical

literature on the effectiveness of homoeopathy: overview of

data from homoeopathic medicine trials.. Homoeopathic

Medicine Research Group, editors. Report. Brussels:

Commission of the European Communities 1996:195-210.

Boulvain 2001

Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical

methods for induction of labour. Cochrane Database

of Systematic Reviews 2001, Issue 4. [DOI: 10.1002/

14651858.CD001233]

Boulvain 2005

Boulvain M, Stan C, Irion O. Membrane sweeping

for induction of labour. Cochrane Database of





Systematic Reviews 2005, Issue 1. [DOI: 10.1002/

14651858.CD000451.pub2]

Boulvain 2008

Boulvain M, Kelly AJ, Irion O. Intracervical prostaglandins



14651858.CD006971]

Bricker 2000

Bricker L, Luckas M. Amniotomy alone for induction of


4. [DOI: 10.1002/14651858.CD002862]

Clarke 2002

Clarke M, Oxman AD, editors. Cochrane Reviewers’

Handbook 4.2.0 [updated March 2003]. In: The Cochrane

Library, Issue 2, 2003. Oxford: Update Software. Updated

quarterly.

Curtis 1987

Curtis P, Evans S, Resnick J. Uterine hyperstimulation.

The need for standard terminology. Journal of Reproductive

Medicine 1987;32:91–5.

Eisenberg 1998

Eisenberg DA, Davis RB, Ettner SL, Appel S, Wilky S,

Van Rompay M. Trends in alternative medicine use in the

United States, 1990-1997: results of a follow up national

survey. JAMA 1998;280:1569–75.

French 2001

French L. Oral prostaglandin E2 for induction of labour.

Cochrane Database of Systematic Reviews 2001, Issue 2.

[DOI: 10.1002/14651858.CD003098]

Hofmeyr 2003

Hofmeyr GJ, Gülmezoglu AM. Vaginal misoprostol for

cervical ripening and induction of labour. Cochrane

Database of Systematic Reviews 2003, Issue 1. [DOI:10.1002/14651858.CD000941]

Hofmeyr 2009

Hofmeyr GJ, Alfirevic Z, Kelly AJ, Kavanagh J, Thomas

J, Neilson JP, Dowswell T. Methods for cervical ripening

and labour induction in late pregnancy: generic protocol.


[DOI: 10.1002/14651858.CD002074.pub2]

Howarth 2001

Howarth GR, Botha DJ. Amniotomy plus intravenous

oxytocin for induction of labour. Cochrane Database


14651858.CD003250]

Hutton 2001Hutton E, Mozurkewich E. Extra-amniotic prostaglandin for

induction of labour. Cochrane Database of Systematic Reviews

2001, Issue 2. [DOI: 10.1002/14651858.CD003092]

Kavanagh 2001

Kavanagh J, Kelly AJ, Thomas J. Sexual intercourse for


Database of Systematic Reviews 2001, Issue 2. [DOI:

10.1002/14651858.CD003093]

Kavanagh 2005

Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for



10.1002/14651858.CD003392.pub2]

Kavanagh 2006a Kavanagh J, Kelly AJ, Thomas J. Corticosteroids



14651858.CD003100.pub2]

Kavanagh 2006b

Kavanagh J, Kelly AJ, Thomas J. Hyaluronidase for cervical

priming and induction of labour. Cochrane Database


14651858.CD003097.pub2]

Kelly 2001a

Kelly AJ, Kavanagh J, Thomas J. Relaxin for cervical

ripening and induction of labour. Cochrane Database


14651858.CD003103]

Kelly 2001b

Kelly AJ, Kavanagh J, Thomas J. Castor oil, bath and/

or enema for cervical priming and induction of labour.


[DOI: 10.1002/14651858.CD003099]

Kelly 2001c

Kelly AJ, Tan BP. Intravenous oxytocin alone for cervical



14651858.CD003246]

Kelly 2003

Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin(PGE2 and PGF2a) for induction of labour at term.


[DOI: 10.1002/14651858.CD003101]

Kelly 2008

Kelly AJ, Kavanagh J. Nitric oxide donors for cervical



14651858.CD006901]

Linde 1997

Linde K, Clausius N, Ramirez G, Melchart D, Eitel F,

Hedges LV, et al.Are the clinical effects of homoeopathy

placebo effects? A meta analysis of placebo controlled trials.

Lancet 1997;350:834–3.

Luckas 2000

Luckas M, Bricker L. Intravenous prostaglandin for

induction of labour. Cochrane Database of Systematic Reviews

2000, Issue 4. [DOI: 10.1002/14651858.CD002864]

MacLennan 2002

MacLennan AH, Wilson DH, Taylor AW. The escalating

cost of alternative medicine. Preventive Medicine 2002;35:

166–73.





Muzonzini 2004

Muzonzini G, Hofmeyr GJ. Buccal or sublingual

misoprostol for cervical ripening and induction of labour.


[DOI: 10.1002/14651858.CD004221.pub2]

Neilson 2000

Neilson JP. Mifepristone for induction of labour. Cochrane


10.1002/14651858.CD002865]

Priestman 1988

Priestman KG. A few useful remedies in pregnancy, labour

and the first few days of the babies’ life. British Homeopathy

Journal 1988;77:172–3.

RevMan 2003

The Cochrane Collaboration. Review Manager (RevMan).

4.2 for Windows. Oxford, England: The Cochrane

Collaboration, 2003.

Smith 2004

Smith CA, Crowther CA. Acupuncture for induction of


1. [DOI: 10.1002/14651858.CD002962.pub2]

Thomas 2001

Thomas J, Kelly AJ, Kavanagh J. Oestrogens alone or with

amniotomy for cervical ripening or induction of labour.


[DOI: 10.1002/14651858.CD003393]

Vandenbrouke 1997

Vandenbroucke JP. Homoeopathy trials: going nowhere.

Lancet 1997;350:824.

Ventoskovskiy 1990

Ventoskovskiy BM, Popov AV. Homeopathy as a practical

alternative to traditional obstetric methods. British

Homeopathy Journal 1990;79(4):201–5.

References to other published versions of this review

Smith 2003

Smith CA. Homoeopathy for induction of labour (Cochrane

Review). Cochrane Database of Systematic Reviews 2003,

Issue 4. [DOI: 10.1002/14651858.CD003399]∗ Indicates the major publication for the study





C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Beer 1999

Methods Double-blind placebo controlled trial. The method of allocation concealment was unclear

Participants 40 women 38-42 weeks’ gestation with PROM. The study was undertaken in Germany

Interventions Caulophyllum D4 or a placebo tablet. Doses were repeated hourly for 7 hours or until labour started

Outcomes Time to the onset of regular uterine contractions, labour and delivery outcomes. Maternal and neonatal

infection

Notes No sample size calculation. No losses to follow up.

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Unclear B - Unclear.

Dorfman 1987

Methods Double-blind placebo controlled trial. The method of concealment was not described

Participants 93 women were recruited to the study at 36 weeks’ gestation. The study was undertaken in France. Women were excluded from the study if they had a history of a poor obstetric history, a current history

of hypertension, diabetes, previous caesarean section or cephalo-pelvic disproportion

Interventions The treatment group received 5 homoeopathic therapies: caulophyllum, arnica, actea racemosa, pulsatilla

and gerenium, with three granules administered morning and evening from 36 weeks’ gestation. When

labour commenced, the same dosage was given every 15 minutes and stopped after 2 hours or sooner if

the woman was comfortable. Not details were provided on the placebo or the precise dosage

Outcomes Average length of labour and difficult labour.

Notes No sample size calculation. No losses to follow up.

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Unclear B - Unclear.

PROM: prelabour rupture of membranes





Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Arnal-Laserre 1986 We have been unable to contact the authors, and do not have enough information to make a decision

whether the trial meets the inclusion criteria

Coudert-Deguillaume 1981 We have been unable to contact the authors, and do not have enough information to make a decision

whether the trial meets the inclusion criteria





D A T A A N D A N A L Y S E S

Comparison 1. Homoeopathy versus placebo

Outcome or subgroup titleNo. of

studies

No. of

participants Statistical method Effect size

3 Caesarean section 1 40 Risk Ratio (M-H, Fixed, 95% CI) 5.0 [0.26, 98.00]



studies

No. of


1 Vaginal delivery not achieved

within 24 hours

1 40 Risk Ratio (M-H, Fixed, 95% CI) 0.33 [0.01, 7.72]



studies

No. of


1 Augmentation with oxytocin 1 40 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.50, 1.98]



studies

No. of


1 Instrumental delivery 1 40 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.54, 1.86]







studies

No. of


2 Length of labour 1 40 Mean Difference (IV, Fixed, 95% CI) -0.40 [-7.21, 6.41]



studies

No. of


1 Difficult labour 1 93 Risk Ratio (M-H, Fixed, 95% CI) 0.28 [0.12, 0.66]

Analysis 1.3. Comparison 1 Homoeopathy versus placebo, Outcome 3 Caesarean section.

Review: Homoeopathy for induction of labour

Comparison: 1 Homoeopathy versus placebo

Outcome: 3 Caesarean section

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

Beer 1999 2/20 0/20 100.0 % 5.00 [ 0.26, 98.00 ]

Total (95% CI) 20 20 100.0 % 5.00 [ 0.26, 98.00 ]

Total events: 2 (Treatment), 0 (Control)

Heterogeneity: not applicable

Test for overall effect: Z = 1.06 (P = 0.29)

0.1 0.2 0.5 1 2 5 10

Favours treatment Favours control





Analysis 2.1. Comparison 2 Homoeopathy versus placebo, Outcome 1 Vaginal delivery not achieved within

24 hours.



Outcome: 1 Vaginal delivery not achieved within 24 hours



Beer 1999 0/20 1/20 100.0 % 0.33 [ 0.01, 7.72 ]

Total (95% CI) 20 20 100.0 % 0.33 [ 0.01, 7.72 ]




0.1 0.2 0.5 1 2 5 10


Analysis 3.1. Comparison 3 Homoeopathy versus placebo, Outcome 1 Augmentation with oxytocin.



Outcome: 1 Augmentation with oxytocin



Beer 1999 9/20 9/20 100.0 % 1.00 [ 0.50, 1.98 ]

Total (95% CI) 20 20 100.0 % 1.00 [ 0.50, 1.98 ]




0.1 0.2 0.5 1 2 5 10






Analysis 4.1. Comparison 4 Homoeopathy versus placebo, Outcome 1 Instrumental delivery.



Outcome: 1 Instrumental delivery



Beer 1999 10/20 10/20 100.0 % 1.00 [ 0.54, 1.86 ]

Total (95% CI) 20 20 100.0 % 1.00 [ 0.54, 1.86 ]




0.1 0.2 0.5 1 2 5 10


Analysis 5.2. Comparison 5 Homoeopathy versus placebo, Outcome 2 Length of labour.



Outcome: 2 Length of labour

Study or subgroup Treatment ControlMean

Difference WeightMean

Difference

N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

Beer 1999 20 13 (11.81) 20 13.4 (10.1) 100.0 % -0.40 [ -7.21, 6.41 ]

Total (95% CI) 20 20 100.0 % -0.40 [ -7.21, 6.41 ]



Test for subgroup differences: Not applicable

-10 -5 0 5 10

Favours control Favours treatment





Analysis 6.1. Comparison 6 Homoeopathy versus placebo, Outcome 1 Difficult labour.



Outcome: 1 Difficult labour



Dorfman 1987 6/53 16/40 100.0 % 0.28 [ 0.12, 0.66 ]

Total (95% CI) 53 40 100.0 % 0.28 [ 0.12, 0.66 ]




0.1 0.2 0.5 1 2 5 10

Favours control Favours treatment

A P P E N D I C E S

Appendix 1. Methodological quality of trials

Methodological item Adequate Inadequate

Generation of random sequence Computer-generated sequence, random num-

ber tables, lot drawing, coin tossing, shuffling

cards, throwing dice

Case number, date of birth, date of admission,

alternation.

Concealment of allocation Central randomisation, coded drug boxes, se-

quentially sealed opaque envelopes

Open allocation sequence, any procedure based

on inadequate generation





W H A T ’ S N E W

Last assessed as up-to-date: 13 January 2010.

Date Event Description

12 January 2010 New search has been performed Search updated. No new trials identified. Two trials, previously identified, have

been translated and are now excluded

H I S T O R Y

Protocol first published: Issue 2, 2000

Review first published: Issue 4, 2001

Date Event Description

3 September 2008 Amended Converted to new review format.

29 July 2003 New citation required and conclusions have changed Substantive amendment.

13 May 2003 New search has been performed This update includes one new trial. Two further trials

have been identified andwill be included in a future up-

date when they have been translated. The Implications

for research section has also been updated.

C O N T R I B U T I O N S O F A U T H O R S

The review author prepared the review, selected studies for inclusion, extracted the data and prepared the text of the review.

D E C L A R A T I O N S O F I N T E R E S T

None known.

S O U R C E S O F S U P P O R T



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Internal sources

• University of Adelaide, Adelaide, Australia.

• University of South Australia, Adelaide, Australia.

External sources

• No sources of support supplied

I N D E X T E R M S

Medical Subject Headings (MeSH)

∗Caulophyllum; ∗Cervical Ripening; ∗Homeopathy; ∗Labor, Induced; Randomized Controlled Trials as Topic

MeSH check words

Female; Humans; Pregnancy



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