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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.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Homoeopathy for induction of labour (Review) i


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Homoeopathy for induction of labour

Caroline A Smith1
1 Centre 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. caroline.smith@uws.edu.au.

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 induction of labour. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD003399.
DOI: 10.1002/14651858.CD003399.

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

ABSTRACT
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.
Homoeopathy for induction of labour (Review) 1
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
PLAIN LANGUAGE SUMMARY

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 the
body 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.

BACKGROUND The resulting homoeopathic medicine may contain very few or


no single molecules of the original solute. For this reason many
Sometimes it is necessary to bring on labour artificially because
scientists have suggested the clinical effects resulting from ho-
of safety concerns for the mother or baby. This review is one of a
moeopathic remedies are due to the placebo effect (Vandenbrouke
series of reviews of methods of labour induction using a standard-
1997). However, data from two meta-analyses of placebo con-
ised protocol. For more detailed information on the rationale for
trolled clinical trials have found a greater therapeutic effect from
this methodological approach, please refer to the currently pub-
homoeopathy compared with the placebo (Boissel 1996; Linde
lished ’generic’ protocol (Hofmeyr 2009). The generic protocol
1997). The precise biophysical mechanism underlying homoeopa-
describes how a number of standardised reviews will be combined
thy remains undefined.
to compare various methods of preparing the cervix of the uterus
and inducing labour.
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
Homoeopathy is used around the world and is most widely used the patient’s general constitution. This involves consideration of
in Europe and India. Homoeopathy is a form of pharmacological the individual’s current illness, medical history, personality and be-
therapy based on the concept that a substance which gives rise haviour. Other practitioners prescribe a combination of homoeo-
to specific symptoms, when given in pharmacological doses to pathic therapies, ’complex homoeopathy’, on the basis of a con-
healthy individuals, can be used to treat patients presenting with ventional diagnosis. Clinical homoeopathy uses the same remedy
the same symptoms. This is described as the Law of Similars. in patients presenting with a homogenous pathology or constella-
Homoeopathy seeks to strengthen the body’s immune system, the tion of symptoms. There is no evidence that describes the benefits
principle of the treatment being that the homoeopathic substance of one approach compared with another approach. Homoeopathy
will stimulate the body and healing functions so that a state of is practiced on different levels. Many homoeopathic therapies are
balance is attained and the symptoms are relieved. Homoeopathic available over the counter in pharmacies and health food shops.
remedies are all natural medicines, with some remedies derived However, homoeopaths require several years of study to achieve
from herbs, minerals or other natural substances. their qualification. The trained homoeopath will treat an individ-
ual based on a detailed case history and the homoeopathic treat-
Homeopathic remedies are applied as potencies as a result of tiny ment will be tailored to the individual’s constitution.
and highly diluted amounts of the substances from which they are
derived. They are prepared by a process of step by step repeated In recent years the use of alternative and complementary medicine
dilution and vigorous shaking, which is thought to make them ca- has become popular in many Western countries (MacLennan
pable of stimulating the body’s own defence system. The resulting 2002). Unconventional therapies are more common among
potency is labelled on the basis of the ratio of dilutent and diluted women of reproductive age, with almost half of all women (49%)
agent (D = decimal dilution = 1/10 diluted agent/dilutent; C = reporting that they have used them (Eisenberg 1998). It is possible
centesimal dilution = 1/100 diluted agent/dilutent) and the num- that a significant proportion of women are using these therapies
ber of dilution steps (e.g. C5 indicates 5 dilution steps 1/100). The during pregnancy. The use of homoeopathy has been applied at the
repetitive dilutions are thought to produce results more quickly, time of conception, pregnancy and labour to treat some of the dis-
act on symptoms more effectively and are less likely to lead to side comforts and imbalances that can arise during pregnancy such as
effects than the original substances. backache, constipation, morning sickness and heartburn. A recent
Homoeopathy for induction of labour (Review) 2
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
survey described the prevalence and use of complementary thera- Types of participants
pies among 82 nurse-midwives in North Carolina (Allaire 2000).
Pregnant women due for third trimester induction of labour, car-
Over 30% of nurse-midwives reported recommending homoeopa-
rying a viable fetus.
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 Types of interventions


labour may be perceived to intervene in the natural process of
pregnancy and may drastically change their expected plan of care Homoeopathy compared with placebo/no treatment or any other
during pregnancy. The reasons why pregnant women are inter- method on a predefined list of methods of labour induction.
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 Types of outcome measures
effects from homoeopathy are rare, and remedies recommended
for use in pregnancy are not thought to cause any problems in Clinically relevant outcomes for trials of methods of cervical ripen-
pregnancy. ing/labour induction have been prespecified by two authors of
labour induction reviews (Justus Hofmeyr and Zarko Alfirevic).
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 Primary outcomes
few days before labour starts, or alternatively to dissolve a tablet Five primary outcomes were chosen as being most representative
in a glass of water and sip from the glass from time to time, or of the clinically important measures of effectiveness and compli-
whenever a contraction is imminent. A non-randomised clinical cations:
trial was carried out to examine the efficacy of caulophyllum before (1) vaginal delivery not achieved within 24 hours;
birth for the treatment of uterine inertia and reducing the risk (2) uterine hyperstimulation with fetal heart rate (FHR) changes;
of postpartum haemorrhage (Ventoskovskiy 1990). The authors (3) caesarean section;
concluded this remedy has a role in preventing poor contraction (4) serious neonatal morbidity or perinatal death (e.g. seizures,
patterns. 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).
OBJECTIVES Perinatal and maternal morbidity and mortality are composite
To determine, from the best available evidence, the effectiveness outcomes. This is not an ideal solution because some components
and safety of homoeopathy for third trimester cervical ripening are clearly less severe than others. It is possible for one intervention
and induction of labour. to cause more deaths but less severe morbidity. However, in the
context of labour induction at term this is unlikely. All these events
will be rare, and a modest change in their incidence will be easier
to detect if composite outcomes are presented. Where possible, the
METHODS incidence of individual components were explored as secondary
outcomes (see below).

Criteria for considering studies for this review


Secondary outcomes

Secondary outcomes relate to measures of effectiveness, complica-


tions and satisfaction.
Types of studies
Clinical trials comparing homoeopathy for cervical ripening or
labour induction, with placebo/no treatment or other methods
Measures of effectiveness
listed on a predefined list of methods of labour induction (see
Methods); the trials included random allocation to either group; (6) Cervix unfavourable/unchanged after 12 to 24 hours;
and they reported one or more of the prestated outcomes. (7) oxytocin augmentation.

Homoeopathy for induction of labour (Review) 3


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Complications 1. quarterly searches of the Cochrane Central Register of
(8) Uterine hyperstimulation without FHR changes; Controlled Trials (CENTRAL);
(9) uterine rupture; 2. weekly searches of MEDLINE;
(10) epidural analgesia; 3. handsearches of 30 journals and the proceedings of major
(11) instrumental vaginal delivery; conferences;
(12) meconium-stained liquor; 4. weekly current awareness alerts for a further 44 journals
(13) Apgar score less than seven at five minutes; plus monthly BioMed Central email alerts.
(14) neonatal intensive care unit admission; Details of the search strategies for CENTRAL and MEDLINE,
(15) neonatal encephalopathy; the list of handsearched journals and conference proceedings, and
(16) perinatal death; the list of journals reviewed via the current awareness service can
(17) disability in childhood; be found in the ‘Specialized Register’ section within the edito-
(18) maternal side effects (all); rial information about the Cochrane Pregnancy and Childbirth
(19) maternal nausea; Group.
(20) maternal vomiting; Trials identified through the searching activities described above
(21) maternal diarrhoea; are each assigned to a review topic (or topics). The Trials Search
(22) other maternal side-effects; Co-ordinator searches the register for each review using the topic
(23) postpartum haemorrhage (as defined by the trial authors); list rather than keywords.
(24) serious maternal complications (e.g. intensive care unit ad-
mission, septicaemia but excluding uterine rupture);
Searching other resources
(25) maternal death.
We searched the reference lists of identified papers.
We did not apply any language restrictions.
Measures of satisfaction
(26) Woman not satisfied;
(27) caregiver not satisfied. Data collection and analysis
While all the above outcomes were sought, only those with data
A strategy was developed to deal with the large volume and com-
appear in the analysis tables.
plexity of trial data relating to labour induction. Many methods
The terminology of uterine hyperstimulation is problematic
have been studied, in many different categories of women under-
(Curtis 1987). In the reviews we use the term ’uterine hyperstimu-
going labour induction. Most trials are intervention-driven, com-
lation without FHR changes’ to include uterine tachysystole (more
paring two or more methods in various categories of women. Clin-
than five contractions per 10 minutes for at least 20 minutes) and
icians and parents need the data arranged by category of woman,
uterine hypersystole/hypertonus (a contraction lasting at least two
to be able to choose which method is best for a particular clinical
minutes) and ’uterine hyperstimulation with FHR changes’ to de-
scenario. To extract these data from several hundred trial reports
note uterine hyperstimulation syndrome (tachysystole or hyper-
in a single step would be very difficult. We, therefore, developed
systole with fetal heart rate changes such as persistent decelera-
a two-stage method of data extraction. The initial data extraction
tions, tachycardia or decreased short-term variability).
is done in a series of reviews arranged by methods of induction of
Outcomes were included in the analysis if reasonable measures
labour, following a standardised methodology.
were taken to minimise observer bias; and data were available for
To avoid duplication of data in the primary reviews, the labour
analysis according to original allocation.
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
Search methods for identification of studies 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
Electronic searches will be added to the end of the list. The current list is as follows:
We searched the Cochrane Pregnancy and Childbirth Group’s Tri- 1. placebo/no treatment;
als Register by contacting the Trials Search Co-ordinator (1 De- 2. vaginal prostaglandins (Kelly 2003);
cember 2009). 3. intracervical prostaglandins (Boulvain 2008);
The Cochrane Pregnancy and Childbirth Group’s Trials Register 4. intravenous oxytocin (Kelly 2001c);
is maintained by the Trials Search Co-ordinator and contains trials 5. amniotomy (Bricker 2000);
identified from: 6. intravenous oxytocin with amniotomy (Howarth 2001);
7. vaginal misoprostol (Hofmeyr 2003);

Homoeopathy for induction of labour (Review) 4


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
8. oral misoprostol (Alfirevic 2006); all levels were sought.
9. mechanical methods including extra-amniotic Foley Predefined subgroup analyses are: previous caesarean section or
catheter (Boulvain 2001); not; nulliparity or multiparity; membranes intact or ruptured, and
10. membrane sweeping (Boulvain 2005); cervix unfavourable, favourable or undefined. Only those out-
11. extra-amniotic prostaglandins (Hutton 2001); comes with data will appear in the analysis tables.
12. intravenous prostaglandins (Luckas 2000); Individual outcome data were included in the analysis if they met
13. oral prostaglandins (French 2001); the pre stated criteria in Types of outcome measures. Included
14. mifepristone (Neilson 2000); trial data were processed as described in the Cochrane Reviewers’
15. oestrogens with/without amniotomy (Thomas 2001); Handbook (Clarke 2002). Data extracted from the trials were
16. corticosteroids (Kavanagh 2006a); analysed on an intention-to-treat basis (when this was not done in
17. relaxin (Kelly 2001a); the original report, re-analysis is performed if possible). Where data
18. hyaluronidase (Kavanagh 2006b); were missing, clarification was sought from the original authors. If
19. castor oil, bath, and/or enema (Kelly 2001b); the attrition was such that it might significantly affect the results,
20. acupuncture (Smith 2004); these data are excluded from the analysis. This decision rests with
21. breast stimulation (Kavanagh 2005); the review authors of primary reviews and is clearly documented.
22. sexual intercourse (Kavanagh 2001); Once missing data become available, they will be included in the
23. homoeopathic methods; analyses.
24. nitric oxide (Kelly 2008); Data were extracted from all eligible trials to examine how issues
25. buccal or sublingual misoprostol (Muzonzini 2004) of quality influence effect size in a sensitivity analysis. In trials
26. hypnosis where reporting was poor, methodological issues were reported as
27. other methods for induction of labour. unclear or clarification sought.
The reviews are analysed by the following subgroups: Due to the large number of trials, double data extraction was
1. previous caesarean section or not; not feasible and agreement between the three data extractors was
2. nulliparity or multiparity; therefore assessed on a random sample of trials.
3. membranes intact or ruptured; Once the data had been extracted, they were distributed to indi-
4. cervix favourable, unfavourable or undefined. vidual review authors for entry onto the Review Manager com-
The trials included in the reviews were extracted from an initial set puter software (RevMan 2003), checked for accuracy, and anal-
of trials covering all interventions used in induction of labour (see ysed as above using the RevMan software. For dichotomous data,
above for details of search strategy). The data extraction process risk ratios and 95% confidence intervals were calculated, and in
was conducted centrally. This was co-ordinated from the Clini- the absence of heterogeneity, results were pooled using a fixed-
cal Effectiveness Support Unit (CESU) at the Royal College of effect model.
Obstetricians and Gynaecologists, UK, in co-operation with the The predefined criteria for sensitivity analysis included all aspects
Pregnancy and Childbirth Group of The Cochrane Collaboration. of quality assessment as mentioned above, including aspects of se-
This process allowed the data extraction process to be standardised lection, performance and attrition bias. Letters are used to indi-
across all the reviews. cate the quality of the included trials as described by Clarke 2002.
The trials were initially reviewed on eligibility criteria, using a stan- The sensitivity analysis explores the influence of high-quality trials
dardised form and the basic selection criteria specified above. Fol- (defined as “A”), versus moderate quality trials (defined as “B”),
lowing this, data were extracted to a standardised data extraction and high-quality trials (defined as “A”) versus low-quality trials
form which was piloted for consistency and completeness. The (defined as “C”), as well as the effects of analysing by intention to
pilot process involved the researchers at the CESU and previous treat on the effect size.
review authors in the area of induction of labour. Primary analysis was limited to the prespecified outcomes and
Information was extracted regarding the methodological quality subgroup analyses. In the event of differences in unspecified out-
of trials on a number of levels. This process was completed without comes or sub-groups being found, these were analysed post hoc,
consideration of trial results. Assessment of selection bias examined but clearly identified as such to avoid drawing unjustified conclu-
the process involved in the generation of the random sequence sions.
and 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 RESULTS
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 Description of studies

Homoeopathy for induction of labour (Review) 5


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
See: Characteristics of included studies; Characteristics of excluded sample size was small in both trials and there was no description
studies. of the sample size calculation or if a calculation was undertaken.
Four studies were identified. Two were included and two were ex- The information on any side effects arising from caulophyllum
cluded. The search strategy identified two randomised controlled was unclear and it was unclear as to how women assessed the tol-
trials for inclusion in this review (Beer 1999; Dorfman 1987). erability of caulophyllum. No data were provided on side effects
The study by Beer et al (Beer 1999) compared caulophyllum in a from the Dorfman 1987 trial.
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
Effects of interventions
at term with prelabour rupture of membranes (PROM) at term
and not in labour. The trial examined the effect of caulophyllum Two trials involving 133 women were included in the review.
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 Caulophyllum versus placebo
rate of maternal and neonatal infection. Women were adminis- Forty women with a singleton pregnancy and prelabour rupture
tered caulophyllum or a placebo hourly for seven hours. Each ac- of membranes were randomised to caulophyllum or placebo (Beer
tive tablet consisted of 250 mg caulophyllum trituration D4, a 1999).
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. Primary outcomes
The trial presented information on the baseline characteristics be- Vaginal delivery not achieved within 24 hours was reported for
tween the two randomised groups. No differences in age, weight, one woman in the control group (1/20) and no women in the
height, cervical score at trial entry and time since PROM were treatment group (risk ratio (RR) 0.33, 95% confidence interval
found between study groups. (CI) 0.01 to 7.72). Data on uterine hyperstimulation were not
The study by Dorfman et al (Dorfman 1987) was undertaken recorded. Two women in the group given caulophyllum had cae-
in France. The trial compared five homoeopathic therapies with sarean sections compared with no women in the placebo group
placebo in 93 women from 36 weeks’ pregnant; 53 women were (RR 5.0, 95% CI 0.26 to 98.00). No data were presented on fetal
randomised to the treatment group and 40 to the placebo group. heart rate changes although the author describes that slight but not
The trial examined the effect of the homoeopathic therapy on significant differences were noted. No data were reported on se-
length of labour and the proportion of women experiencing a rious maternal or neonatal morbidity such as; meconium-stained
difficult labour. No details were provided on the placebo. The liquor; Apgar score less than seven at five minutes; neonatal in-
groups were comparable with respect to parity. tensive care unit admission; postpartum haemorrhage; or serious
maternal complications (e.g. intensive care unit admission, septi-
caemia).
Excluded studies
The use of caulophyllum for the preparation of labour (Arnal-
Laserre 1986) and for use in false labour and dystocia (Coudert- Secondary outcomes
Deguillaume 1981) have been examined in two research theses.
No data were presented on cervical change, however the author
Extensive efforts have been made to contact the authors and we
reported minor differences between groups. Oxytocin augmenta-
do not have enough information to make a decision whether the
tion was administered to nine women (45%) in each group, no
trial meets the inclusion criteria.
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
Risk of bias in included studies in Apgar scores between groups. Women’s and midwives’ views on
The method of randomisation in both trials was not described and this method were sought and all described the method as tolerable.
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. Additional data
There were no withdrawals from the trials. The authors of the tri- The difference in the interval between administration of the in-
als did not state they performed an intention-to-treat analysis, al- tervention and regular uterine contractions was 13 hours in the
though the studies did analyse outcome data from the same num- treatment group and 13.4 hours in the control group (mean dif-
ber of women who were reported as having been randomised. The ference -0.40, 95% CI -7.21 to 6.41).

Homoeopathy for induction of labour (Review) 6


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
In the Dorfman 1987 trial only two outcomes were reported. The AUTHORS’ CONCLUSIONS
mean length of labour for women receiving the homoeopathic
therapy was 5.1 hours compared with 8.48 hours in the placebo Implications for practice
group (P less than 0.001). Data could not be entered into the
meta-analysis due to the absence of data on standard deviation. There is insufficient evidence to recommend the use of any ho-
A difficult labour was reported for six women (11.3%) in the moeopathic therapies as a method of induction of labour.
treatment 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 Implications for research
group. 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-
DISCUSSION stimulation as well as indicators of maternal and neonatal morbid-
ity. Further research using classical homoeopathy might be more
This review included two trials. There were no differences seen
relevant to assessing both the effectiveness and safety of homoeopa-
in any of the primary outcome measures described in this review.
thy.
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
stimulating the onset of labour. The lack of data in this area is com- ACKNOWLEDGEMENTS
pounded by a lack of relevant clinical outcome data which could
be included into this review. The use of caulophyllum may not The author would like to thank Bettina Hinger for the German
represent common homoeopathic practice, where the prescribing to English translation (Beer 1999) and Alison Ledward for the
of a therapy would be more individualised. French to English translation (Dorfman 1987).

REFERENCES

References to studies included in this review Additional references

Beer 1999 {published data only} Alfirevic 2006


Beer AM, Heiliger F. Randomized, double blind trial Alfirevic Z, Weeks A. Oral misoprostol for induction of
of Caulophyllum D4 for induction of labour after labour. Cochrane Database of Systematic Reviews 2006, Issue
premature rupture of membranes at term. Gerburtshilfe und 2. [DOI: 10.1002/14651858.CD001338.pub2]
Frauenheilkunde 1999;59:431–5. Allaire 2000
Allaire AD, Moos M, Wells SR. Complementary and
Dorfman 1987 {published data only}
alternative medicine in pregnancy: a survey of North
Dorfman P, Lasserre M, Tetau M. Homoeopathic
Carolina nurse-midwives. Obstetrics & Gynecology 2000;95
preparation for labour: two fold experiment comparing
(1):19–23.
a less widely known therapy with a placebo. Cahiers de
Biotherapie 1987;94:77–81. Boissel 1996
Boissel JP, Cucherat M, Haugh M, Gauthier E. Critical
References to studies excluded from this review literature on the effectiveness of homoeopathy: overview of
data from homoeopathic medicine trials.. Homoeopathic
Arnal-Laserre 1986 {published data only} Medicine Research Group, editors. Report. Brussels:
Arnal-Laserre MN. Preparation a l’accouchement par Commission of the European Communities 1996:195-210.
homeopathie: experimentation en double insu versus placebo Boulvain 2001
(Dissertation). Paris: Academie de Paris, Universite Rene Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical
Descartes, 1986. methods for induction of labour. Cochrane Database
Coudert-Deguillaume 1981 {published data only} of Systematic Reviews 2001, Issue 4. [DOI: 10.1002/
Coudert-Deguillaume M. Etude l’accouchement par 14651858.CD001233]
homeopthie: experimentation en double insu versus placebo Boulvain 2005
[Dissertation]. Limoges: Faculte de Medecine et de Boulvain M, Stan C, Irion O. Membrane sweeping
Pharmacie, Universite de Limoges, 1981. for induction of labour. Cochrane Database of
Homoeopathy for induction of labour (Review) 7
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Systematic Reviews 2005, Issue 1. [DOI: 10.1002/ Kavanagh 2005
14651858.CD000451.pub2] Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for
Boulvain 2008 cervical ripening and induction of labour. Cochrane
Boulvain M, Kelly AJ, Irion O. Intracervical prostaglandins Database of Systematic Reviews 2005, Issue 3. [DOI:
for induction of labour. Cochrane Database of 10.1002/14651858.CD003392.pub2]
Systematic Reviews 2008, Issue 1. [DOI: 10.1002/ Kavanagh 2006a
14651858.CD006971] Kavanagh J, Kelly AJ, Thomas J. Corticosteroids
Bricker 2000 for induction of labour. Cochrane Database of
Bricker L, Luckas M. Amniotomy alone for induction of Systematic Reviews 2006, Issue 2. [DOI: 10.1002/
labour. Cochrane Database of Systematic Reviews 2000, Issue 14651858.CD003100.pub2]
4. [DOI: 10.1002/14651858.CD002862] Kavanagh 2006b
Clarke 2002 Kavanagh J, Kelly AJ, Thomas J. Hyaluronidase for cervical
Clarke M, Oxman AD, editors. Cochrane Reviewers’ priming and induction of labour. Cochrane Database
Handbook 4.2.0 [updated March 2003]. In: The Cochrane of Systematic Reviews 2006, Issue 2. [DOI: 10.1002/
Library, Issue 2, 2003. Oxford: Update Software. Updated 14651858.CD003097.pub2]
quarterly.
Kelly 2001a
Curtis 1987 Kelly AJ, Kavanagh J, Thomas J. Relaxin for cervical
Curtis P, Evans S, Resnick J. Uterine hyperstimulation. ripening and induction of labour. Cochrane Database
The need for standard terminology. Journal of Reproductive of Systematic Reviews 2001, Issue 2. [DOI: 10.1002/
Medicine 1987;32:91–5. 14651858.CD003103]
Eisenberg 1998 Kelly 2001b
Eisenberg DA, Davis RB, Ettner SL, Appel S, Wilky S, Kelly AJ, Kavanagh J, Thomas J. Castor oil, bath and/
Van Rompay M. Trends in alternative medicine use in the or enema for cervical priming and induction of labour.
United States, 1990-1997: results of a follow up national Cochrane Database of Systematic Reviews 2001, Issue 2.
survey. JAMA 1998;280:1569–75. [DOI: 10.1002/14651858.CD003099]
French 2001
Kelly 2001c
French L. Oral prostaglandin E2 for induction of labour.
Kelly AJ, Tan BP. Intravenous oxytocin alone for cervical
Cochrane Database of Systematic Reviews 2001, Issue 2.
ripening and induction of labour. Cochrane Database
[DOI: 10.1002/14651858.CD003098]
of Systematic Reviews 2001, Issue 3. [DOI: 10.1002/
Hofmeyr 2003 14651858.CD003246]
Hofmeyr GJ, Gülmezoglu AM. Vaginal misoprostol for
Kelly 2003
cervical ripening and induction of labour. Cochrane
Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin
Database of Systematic Reviews 2003, Issue 1. [DOI:
(PGE2 and PGF2a) for induction of labour at term.
10.1002/14651858.CD000941]
Cochrane Database of Systematic Reviews 2003, Issue 4.
Hofmeyr 2009 [DOI: 10.1002/14651858.CD003101]
Hofmeyr GJ, Alfirevic Z, Kelly AJ, Kavanagh J, Thomas
J, Neilson JP, Dowswell T. Methods for cervical ripening Kelly 2008
and labour induction in late pregnancy: generic protocol. Kelly AJ, Kavanagh J. Nitric oxide donors for cervical
Cochrane Database of Systematic Reviews 2009, Issue 3. ripening and induction of labour. Cochrane Database
[DOI: 10.1002/14651858.CD002074.pub2] of Systematic Reviews 2008, Issue 1. [DOI: 10.1002/
14651858.CD006901]
Howarth 2001
Howarth GR, Botha DJ. Amniotomy plus intravenous Linde 1997
oxytocin for induction of labour. Cochrane Database Linde K, Clausius N, Ramirez G, Melchart D, Eitel F,
of Systematic Reviews 2001, Issue 3. [DOI: 10.1002/ Hedges LV, et al.Are the clinical effects of homoeopathy
14651858.CD003250] placebo effects? A meta analysis of placebo controlled trials.
Lancet 1997;350:834–3.
Hutton 2001
Hutton E, Mozurkewich E. Extra-amniotic prostaglandin for Luckas 2000
induction of labour. Cochrane Database of Systematic Reviews Luckas M, Bricker L. Intravenous prostaglandin for
2001, Issue 2. [DOI: 10.1002/14651858.CD003092] induction of labour. Cochrane Database of Systematic Reviews
2000, Issue 4. [DOI: 10.1002/14651858.CD002864]
Kavanagh 2001
Kavanagh J, Kelly AJ, Thomas J. Sexual intercourse for MacLennan 2002
cervical ripening and induction of labour. Cochrane MacLennan AH, Wilson DH, Taylor AW. The escalating
Database of Systematic Reviews 2001, Issue 2. [DOI: cost of alternative medicine. Preventive Medicine 2002;35:
10.1002/14651858.CD003093] 166–73.

Homoeopathy for induction of labour (Review) 8


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Muzonzini 2004 1. [DOI: 10.1002/14651858.CD002962.pub2]
Muzonzini G, Hofmeyr GJ. Buccal or sublingual Thomas 2001
misoprostol for cervical ripening and induction of labour. Thomas J, Kelly AJ, Kavanagh J. Oestrogens alone or with
Cochrane Database of Systematic Reviews 2004, Issue 4. amniotomy for cervical ripening or induction of labour.
[DOI: 10.1002/14651858.CD004221.pub2] Cochrane Database of Systematic Reviews 2001, Issue 4.
Neilson 2000 [DOI: 10.1002/14651858.CD003393]
Neilson JP. Mifepristone for induction of labour. Cochrane Vandenbrouke 1997
Database of Systematic Reviews 2000, Issue 4. [DOI: Vandenbroucke JP. Homoeopathy trials: going nowhere.
10.1002/14651858.CD002865] Lancet 1997;350:824.
Priestman 1988 Ventoskovskiy 1990
Priestman KG. A few useful remedies in pregnancy, labour Ventoskovskiy BM, Popov AV. Homeopathy as a practical
and the first few days of the babies’ life. British Homeopathy alternative to traditional obstetric methods. British
Journal 1988;77:172–3. Homeopathy Journal 1990;79(4):201–5.
RevMan 2003
References to other published versions of this review
The Cochrane Collaboration. Review Manager (RevMan).
4.2 for Windows. Oxford, England: The Cochrane Smith 2003
Collaboration, 2003. Smith CA. Homoeopathy for induction of labour (Cochrane
Smith 2004 Review). Cochrane Database of Systematic Reviews 2003,
Smith CA, Crowther CA. Acupuncture for induction of Issue 4. [DOI: 10.1002/14651858.CD003399]
labour. Cochrane Database of Systematic Reviews 2004, Issue ∗
Indicates the major publication for the study

Homoeopathy for induction of labour (Review) 9


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

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

Homoeopathy for induction of labour (Review) 10


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

Homoeopathy for induction of labour (Review) 11


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

Comparison 1. Homoeopathy versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

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

Comparison 2. Homoeopathy versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Vaginal delivery not achieved 1 40 Risk Ratio (M-H, Fixed, 95% CI) 0.33 [0.01, 7.72]
within 24 hours

Comparison 3. Homoeopathy versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

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

Comparison 4. Homoeopathy versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

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

Homoeopathy for induction of labour (Review) 12


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Comparison 5. Homoeopathy versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

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

Comparison 6. Homoeopathy versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

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

WHAT’S NEW
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

HISTORY
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 and will be included in a future up-
date when they have been translated. The Implications
for research section has also been updated.

Homoeopathy for induction of labour (Review) 13


Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CONTRIBUTIONS OF AUTHORS
The review author prepared the review, selected studies for inclusion, extracted the data and prepared the text of the review.

DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT

Internal sources
• University of Adelaide, Adelaide, Australia.
• University of South Australia, Adelaide, Australia.

External sources
• No sources of support supplied

INDEX TERMS

Medical Subject Headings (MeSH)



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

MeSH check words


Female; Humans; Pregnancy

Homoeopathy for induction of labour (Review) 14


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