Context.— Traditional Chinese medicine uses moxibustion (burning herbs to stimulate
acupuncture points) of acupoint BL 67 (Zhiyin, located beside the outer corner
of the fifth toenail), to promote version of fetuses in breech presentation.
Its effect may be through increasing fetal activity. However, no randomized
controlled trial has evaluated the efficacy of this therapy.
Objective.— To evaluate the efficacy and safety of moxibustion on acupoint BL 67
to increase fetal activity and correct breech presentation.
Design.— Randomized, controlled, open clinical trial.
Setting.— Outpatient departments of the Women's Hospital of Jiangxi Province,
Nanchang, and Jiujiang Women's and Children's Hospital in the People's Republic
Patients.— Primigravidas in the 33rd week of gestation with normal pregnancy and
an ultrasound diagnosis of breech presentation.
Interventions.— The 130 subjects randomized to the intervention group received stimulation
of acupoint BL 67 by moxa (Japanese term for Artemisia vulgaris) rolls for 7 days, with treatment for
an additional 7 days if the fetus persisted in the breech presentation. The
130 subjects randomized to the control group received routine care but no
interventions for breech presentation. Subjects with persistent breech presentation
after 2 weeks of treatment could undergo external cephalic version anytime
between 35 weeks' gestation and delivery.
Main Outcome Measures.— Fetal movements counted by the mother during 1 hour each day for 1 week;
number of cephalic presentations during the 35th week and at delivery.
Results.— The intervention group experienced a mean of 48.45 fetal movements vs
35.35 in the control group (P<.001; 95% confidence
interval [CI] for difference, 10.56-15.60). During the 35th week of gestation,
98 (75.4%) of 130 fetuses in the intervention group were cephalic vs 62 (47.7%)
of 130 fetuses in the control group (P<.001; relative
risk [RR], 1.58; 95% CI, 1.29-1.94). Despite the fact that 24 subjects in
the control group and 1 subject in the intervention group underwent external
cephalic version, 98 (75.4%) of the 130 fetuses in the intervention group
were cephalic at birth vs 81 (62.3%) of the 130 fetuses in the control group
(P=.02; RR, 1.21; 95% CI, 1.02-1.43).
Conclusion.— Among primigravidas with breech presentation during the 33rd week of
gestation, moxibustion for 1 to 2 weeks increased fetal activity during the
treatment period and cephalic presentation after the treatment period and
IN CASES OF BREECH presentation at the onset of labor, delivery is associated
with additional risks: for the mother, cesarean delivery and for the neonate,
physical injury. Breech presentation is common in the midtrimester pregnancy
and the incidence decreases as the pregnancy approaches term because of spontaneous
It is reasonable to assume (although not firmly established) that fetal activity
plays an important role in spontaneous version.5-9
The incidence of breech presentation at delivery can be reduced, but not eliminated,
by the use of external cephalic version (ECV).10
Since ancient times, traditional Chinese medicine has proposed moxibustion
of acupoint BL 67 (Zhiyin) to promote version of fetuses in breech presentation.
Moxibustion is a traditional Chinese method that uses the heat generated by
burning herbal preparations containing Artemisia vulgaris (mugwort) (the Japanese name is moxa) to
stimulate acupuncture points. Acupoint BL 67 is beside the outer corner of
the fifth toenail.
At present, there are no randomized, controlled clinical trials to evaluate
the efficacy of this therapy. The 2 published Chinese studies11,12
are not randomized and are based on a mixed population of primipara and multipara
subjects stimulated at varying times between the 28th and 38th weeks of pregnancy.
Although both studies give encouraging results and stimulate reflection regarding
possible mechanisms of action, they do not allow definitive conclusions regarding
efficacy because they are not randomized, little information is provided about
the population sample, and the times at which stimulation is applied are wide
Cardini et al13 identified the stage
of pregnancy at which stimulation should commence and the parity status of
the groups studied as primary factors to ensure the reliability of a clinical
trial concerning spontaneous or induced correction of breech presentation.
Data in the literature concerning the probability of spontaneous correction
indicate that correcting breech presentation before the 32nd week is useless.14-16 There is also a sharp
differentiation between multigravidas (high likelihood of spontaneous correction
of breech presentation, even between the 32nd and 35th weeks) and primigravidas
or multigravidas with a previous breech presentation at term (low probability
of spontaneous version after the 32nd week).15-17
Gottlicher and Madjaric,15,16
by ultrasound examination of 4066 pregnant women, defined the likelihood of
spontaneous correction of breech presentation from the 33rd week of pregnancy
as 15.5% (95% confidence interval [CI], 2.8%-28.2%) for primigravidas and
57.5% (95% CI, 36.3%-78.7%) for multigravidas.
Westgren et al,17 by ultrasound screening
of 4600 women in the 32nd week of pregnancy, identified 310 cases (6.7%) of
breech presentation, which were prospectively studied until birth. Rates of
spontaneous cephalic version varied, according to whether subjects were primigravida
(46%), multigravida with a previous breech presentation (32%), or multigravida
with no previous breech presentation (78%). All the studies available report
data relating to Western populations and we have been unable to retrieve any
information regarding the spontaneous version rate from the 33rd week to term
among Chinese pregnant women.
Given this background, Cardini and Marcolongo,18
in a retrospectively controlled clinical trial, compared 23 primigravidas
treated for breech presentation by moxibustion in the 32nd and 33rd week with
a retrospective, untreated group at the same stage of pregnancy. The difference
in prevalence of breech presentation showed borderline statistical significance
(P=.05). Thus, the subgroup of primigravidas with
breech presentation at the 33rd week of pregnancy seemed to be the ideal population
for a randomized, controlled clinical trial.
We undertook this study to evaluate the efficacy and safety of moxibustion
on acupoint BL 67 in correcting breech presentation in a population of primigravidas
treated since the 33rd week of pregnancy and to evaluate the efficacy of this
technique in increasing active fetal movements (AFMs).
These 2 main objectives are consistent with the hypothesis that the
use of moxibustion in women whose fetuses are breech in the 33rd week of pregnancy
will (1) increase fetal activity; (2) reduce the proportion of fetuses that
remain in a nonvertex presentation and, hence, decrease the need for ECV;
and (3) decrease the incidence of breech presentation at birth. A secondary
aim of the study was to assess the efficacy of 2 different dosages of moxibustion.
This was a randomized, controlled, open clinical trial of subjects treated
by moxibustion since the 33rd week of pregnancy (intervention group) vs untreated
subjects (control group). Subjects with persistent breech presentation after
2 weeks' treatment (intervention group) or observation (control group) could
undergo ECV. Moxibustion in the early third trimester and ECV in late pregnancy
are the standard care for breech presentation in both the centers involved
in the trial. Thus (and also for ethical reasons), the availability of ECV
was maintained for all subjects recruited.
Subjects were included if they were primigravidas, in the 33rd week
of gestation (from 32 weeks + 1 day to 33 complete weeks, based on the last
menstruation date and ultrasound data), with breech presentation diagnosed
by ultrasound within 24 hours of randomization, and with normal fetal biometry
(biparietal diameter and abdominal circumference between the 10th and 90th
percentiles). Subjects were excluded if they had pelvic defects, previous
uterine surgery, uterine malformation or fibromyoma of diameter greater than
4 cm, fetal malformation, twin gestation, tocolytic therapy during pregnancy,
risk of premature birth (uterine hypercontractility and/or initial shortening
or dilatation of the neck, with a Bishop score ≥4), or pathological pregnancy
(eg, intrauterine growth retardation, gestosis, serious infections, placenta
previa, polyhydramnios, oligohydramnios) judged by the investigator to contraindicate
inclusion in the study. Subjects refusing to undergo treatment were also excluded.
The trial was conducted from April 1995 through August 1996 in the Women's
Hospital of Jiangxi Province, Nanchang, People's Republic of China. A few
subjects (23) were recruited in the nearby Jiujiang Women's and Children's
Hospital, also in Jiangxi Province. The subjects were recruited during the
routine management of normal pregnancies in the outpatient department. All
procedures were executed by midwives (with the supervision of physicians)
except ultrasound examinations and ECVs. The protocol followed the ethical
standards of the Declaration of Helsinki.
Pregnant women fulfilling all criteria of the study were asked to participate.
Interested subjects gave oral informed consent. Subjects had an ultrasound
scan at the 33rd week. On the day of the ultrasound scan by which breech presentation
was confirmed, the selected subject was randomly assigned to 1 of the 2 groups.
The sample was randomly allocated by numbered envelopes (randomized in groups
of 10 by the computer program PACT, Version 2.0 [Glaxo-Wellcome, London, England],
in Italy). Once randomized, subjects and investigators were aware of group
assignment. All subjects recruited were advised to avoid or, at least, to
ask the investigators about other interventions or therapies that could contaminate
the results of the trial.
All subjects were asked to return after 2 weeks for an ultrasound check
on presentation. If breech presentation persisted at this time, the subject
(after giving informed consent) could undergo ECV in the following weeks.
All subjects were also asked to complete 2 record forms for AFMs, 1
for each of the 2 weeks subsequent to recruitment. These 2 forms were returned
at the time of the ultrasound examination. Each record form had to be completed
once daily for 7 days, reporting the number of AFMs counted in 1 hour (if
possible, between 5 and 8 PM) and times of starting and finishing the count.
Finally, each subject was asked to report all significant details of
her pregnancy and delivery during a personal or telephone appointment after
she had given birth. The following specific information was collected: date
of birth, place of birth, name and address of the obstetrician normally consulted,
and name and address of the obstetrician present at birth. In this way, it
was possible to consult other sources of information (obstetrician normally
consulted, obstetrician present at birth, patient record forms) if the subject
provided incomplete or unreliable information. Because almost all the enrolled
subjects gave birth in the same hospital where they had been studied, information
about delivery was reliable and easy to check.
If the subject belonged to the intervention group, she was admitted
to the hospital to attend an instruction session within 24 hours of randomization,
alone or with her partner or the person who was actually going to help administer
the treatment. Teaching the technique for applying moxibustion at home included
presenting the moxibustion material (cigar-shaped rolls containing Artemisia), locating of acupoint BL 67, and explaining the technique
for stimulation of acupoint BL 67. During the therapy the subject relaxed
in the sitting or semisupine position, with the partner sitting comfortably.
The therapy was executed for 30 minutes (15 minutes per side) daily for 7
days in the first 87 subjects, and twice daily in the last 43 subjects. The
subjects were allowed to choose the time, ensuring no interruptions in the
therapy (if possible, between 5 and 8 PM). The intensity of moxibustion was
just below the individual tolerability threshold, causing hyperemia from local
vasodilatation but not burn blisters.
Reasons for discontinuing stimulation and consulting the investigator
(abdominal pain, other suspected adverse effects, sensation that version had
occurred before completion of 7 days' treatment) were explained to the subject,
together with symptoms suggesting that version had occurred (decreased pressure
in the epigastrium or hypochondrium, increased pressure in the hypogastrium,
pollakiuria, a "different feeling" in the abdomen). The first stimulation
session was executed in the hospital and the necessary materials for the following
6 days' stimulation were dispensed, together with the AFM record forms.
Last, an examination after 1 week's treatment (visit 2) was scheduled.
Visit 2 included a check on presentation and collection of the AFM record
form. The presentation check was by localization of fetal heartbeats and abdominal
palpation (Leopold maneuvers). Ultrasound examination was performed only in
the event that the techniques described herein failed or yielded uncertain
findings.19 This was to avoid an excess of
ultrasound examinations, given that an ultrasound examination was scheduled
for the 35th week in all subjects. If cephalic version had not occurred, another
week's treatment was advised if there were no adverse effects and the subject
agreed to continue. Further moxa rolls were therefore
dispensed to the subject with a second AFM record form. The frequency of the
treatment was the same as in the first week. Visit 3 was scheduled and executed
after a further week; the procedure was the same for all treated and untreated
subjects as described herein (Figure 1).
The primary outcomes were number of cephalic presentations at the 35th
week and at birth and fetal motor activity. Secondary outcomes were compliance
with treatment, observation of possible adverse effects in the intervention
group and adverse events in both groups, number of cephalic versions after
1 and 2 weeks of treatment (ie, 34th and 35th weeks' gestation), number of
cephalic versions with 2 different dosages of moxibustion (once or twice daily),
number and causes of cesarean deliveries, spontaneous and induced vaginal
deliveries, and Apgar score at 5 minutes.
On the basis of the study by Cardini and Marcolongo,18
for primigravidas it seemed possible to identify a 30% difference in the number
of cephalic presentations at the 35th week and at term between the intervention
and control groups, with an α significance level of .05 and greater
than 90% power if 60 subjects per group completed the study. Given that the
reliability of the preliminary study was limited because it was based on retrospective
data and that we decided to assess the efficacy of 2 different dosages of
moxibustion, the number of enrolled subjects was increased to 130 per group.
Even if not attributable to 1 of the causes specified in the research
protocol, discontinuation of treatment did not entail the subject's exclusion
from the study. Outcomes of all subjects recruited were analyzed on the basis
of intention to treat. Every possible effort was made to ascertain the reason
The statistical processing was performed using Epi Info, Version 6.04
(Centers for Disease Control and Prevention, Atlanta, Ga). The χ2 test (supplemented, where necessary, by the Fisher exact test) and
the t test were used for comparing qualitative and
continuous variables, respectively. The measurement of effects was also described
in terms of relative risk (RR) with 95% confidence intervals (CIs).
The total number of subjects was 260 (130 subjects per group), recruited,
randomized, observed, or treated and followed up to delivery. No significant
differences emerged between the intervention group and the control group
(Table 1). Neither the placental
localization and grading nor the amount of amniotic fluid at the 33rd week
showed significant differences between the 2 groups.
The main results of the trial are summarized in Table 2. At the ultrasound check at the 35th week of gestation
(2 weeks after the first visit), 98 (75.4%) of 130 fetuses in the intervention
group were cephalic compared with 62 (47.7%) of 130 in the control group
(P<.001; RR, 1.58; 95% CI, 1.29-1.94).
After 35 weeks of pregnancy, only 1 subject in the intervention group
agreed to undergo ECV, but version was not obtained. Twenty-four subjects
in the control group agreed to undergo ECV and in 19 subjects cephalic version
was obtained. Despite this, the number of cephalic presentations at birth
was still significantly different in the 2 groups: 98 (75.4%) of 130 in the
intervention group compared with 81 (62.3%) of 130 in the control group (P=.02; RR, 1.21; 95% CI, 1.02-1.43). The results obtained
excluding subjects treated with ECV are shown in Table 2.
Of the 98 cephalic versions obtained in the intervention group, 82 occurred
during the first week and 16 during the second week of treatment. The cephalic
or breech presentations observed at the second visit (35th week of pregnancy)
remained unchanged up to term in all subjects treated and observed, except
for those successfully treated with ECV.
Compliance and Adverse Effects and Events
The only intervention allowed for the subjects in the control group
was ECV during the last 5 weeks of pregnancy. They were specifically questioned
at the 35th week and after delivery and none reported having been treated
with moxibustion or other therapies.
Among the intervention group only 1 subject failed to comply with the
treatment schedule prescribed and discontinued the therapy. At the end of
the first week of treatment 8 subjects withdrew from therapy, 3 on the advice
of the obstetrician (for Braxton Hicks contractions, breech engagement, and
maternal tachycardia and atrial sinus arrhythmia, respectively) and 5 subjects
for unspecified reasons. All 9 subjects maintained the breech presentations
of their fetuses to term and none of them were excluded from the statistical
The form of discomfort most frequently reported by both groups was a
sense of tenderness and pressure in the epigastric region or in one of the
hypochondria (epigastric crushing) attributable to the head of the breech
fetus pressing against the maternal organs.
No adverse events occurred in the intervention group during treatment.
After treatment, 2 premature births occurred (both at 37 weeks), 1 of which
was preceded by premature rupture of the membranes (PROM). There were 4 PROMs
in the intervention group.
Adverse events occurring in the control group included 3 premature births
at 34, 35, and 37 weeks (the third was preceded by placental detachment with
fetal distress) and 1 intrauterine fetal death (intrauterine growth retardation
and oligohydramnios, spontaneous delivery at 38 weeks; growth was within normal
limits at ultrasound examination at 35 weeks). The total number of PROMs in
the control group was 12.
Regarding the efficacy of the moxibustion treatment in producing an
increase in fetal motility, comparison between the 2 groups proved possible
for only the first week of treatment (or observation) because all the subjects
in the intervention group who achieved cephalic version in the first week
of treatment filled in only the first of the 2 record forms used for the weekly
AFM counts. The mean value for fetal movements recorded during a 1-hour observation
period for 7 days was 48.45 for the subjects in the intervention group and
35.35 for the subjects in the control group (difference, 13.08; 95% CI, 10.56-15.60; t test, 10.215; P<.001).
Effects of 1 or 2 Moxibustion Sessions per Day
In the intervention group, the first 87 subjects received 1 stimulation
per day, lasting 30 minutes, for 7 or 14 days (QD [quaque
die] group). The last 47 subjects received 2 30-minute stimulations
per day for 7 or 14 days (BID [bis in die] group).
The 2 subgroups showed no significant differences in amount of amniotic fluid
during the 33rd week, frequency of straight or bent leg position during the
33rd week, placental localization, neonatal sex, treatment compliance, or
adverse effects attributable to the treatment.
At the end of the first week of treatment in the BID group, 34 (79.1%)
of 43 cephalic versions were obtained compared with 48 (55.2%) of 87 in the
QD group (P=.007; RR, 1.43; 95% CI, 1.12-1.83).
During the second week of treatment, 15 additional cephalic versions
were obtained in the QD group and only 1 additional version in the BID group.
Thus, the following cephalic presentation results were observed on ultrasound
examination at the end of the second week of treatment: 63 (72.4%) of 87 in
the QD group and 35 (81.4%) of 43 in the BID group (nonsignificant difference).
The same percentages were maintained to term.
Cesarean and Vaginal Deliveries
No statistically significant differences were found in the number of
cesarean deliveries performed. In the intervention group, 46 cesarean deliveries
(35.4% of births) were performed, 20 of which were with cephalic presentations
and 26 of which were with breech presentations. The 20 cesarean deliveries
in the cephalic presentations were performed for fetopelvic disproportion
(14 cases), postterm pregnancy (3 cases), or fetal distress (3 cases). The
26 cesarean deliveries in the breech presentations were performed for PROM
after week 37 (10 cases), large fetus (2 cases), fetal distress (1 case),
oligohydramnios (2 cases), and unspecified causes (11 cases).
In the control group, 47 cesarean deliveries (36.2%) were performed,
21 of which were with cephalic presentations and 26 of which were with breech
presentations. Indications for cesarean delivery in the subjects with cephalic
fetuses included fetopelvic disproportion (11 cases, 1 of which was with oligohydramnios),
fetal distress (4 cases, 1 of which was in a subject with toxemia of pregnancy),
sacral rotation of the occiput (2 cases), placental insufficiency (1 case),
toxemia of pregnancy (1 case), PROM (1 case), and deep transverse arrest (1
case). Cesarean deliveries in the breech presentations were performed for
PROM after 37 weeks (8 cases, 1 of which was with prolapse of the cord), oligohydramnios
(3 cases), fetal distress (2 cases), large fetus (1 case), and unspecified
causes (12 cases).
In both the intervention and control groups, cesarean delivery revealed
1 case of previously undiagnosed bicornuate uterus. In both cases, the presentation
at birth was breech. Because they had been randomized, both cases were included
in the statistical analysis of the data despite uterine malformations being
In regard to vaginal deliveries, the only significant difference between
the 2 groups relates to the use of oxytocin, given to 7 (8.6%) of 81 subjects
in the intervention group vs 25 (31.3%) of 80 in the control group (RR, 1.33
[95% CI, 1.13-1.56]; P <.001) before or during
labor. In the intervention group, 2 vacuum-extractor and 1 forceps deliveries
were performed and in the control group, 2 vacuum-extractor and 3 forceps
deliveries were performed.
No neonates in the intervention group, but 7 in the control group, had
Apgar scores of less than 7 at 5 minutes (Fisher exact test, P =.006). On grouping Apgar scores in the traditional manner, in the
intervention group no neonates had Apgar scores less than 4 and 4 had scores
4 to 7; in the control group, 2 neonates had Apgar scores less than 4 and
12 had scores 4 to 7.
Moxibustion is a popular and much appreciated therapy for breech presentation
in the People's Republic of China; thus, it would have been impossible to
propose a "sham moxibustion" as a placebo for the control group.
Furthermore, moxibustion is a typical cheap, self-administered home
therapy. This made blinding practically impossible. It was very difficult
for investigators to persuade subjects to accept randomization and the consequent
risk of having to do without the therapy. Consent was often obtained because
of the availability of ECV later in pregnancy, but this is a much less popular
and somewhat feared therapy; thus, only a few subjects, mostly belonging to
the control group, opted for this solution.
Because the main results of the trial are of a qualitative type and
were measured objectively (ultrasound), we believe that the lack of blinding
and a placebo does not undermine the validity of the results. This is not
entirely the case when considering fetal movement count, which was subjectively
The choice of sample (primigravidas at the 33rd week of gestation) appears
to have been appropriate because the presentation did not change after the
35th week in any of the subjects (except for those undergoing ECV). This confirms
the rarity of spontaneous fetal version (to either breech or cephalic presentation)
among primigravidas after the 35th week.16
Two half-hour stimulations per day proved more effective in producing
cephalic version than a single stimulation. On prolonging the therapy by 1
week in those cases in which cephalic version was not achieved, this difference
in efficacy was partly, although not entirely, annulled. Of the 2 dosages,
then, twice-daily stimulation is recommended because it did not reduce treatment
compliance and had no adverse effects. Compliance with the treatment was by
and large good.
In 2 cases, disorders serious enough to prompt discontinuation were
observed during treatment. It was not clear whether these were adverse effects
of the treatment.
No severe adverse events attributable to the treatment were observed
and, in particular, there were no cases of intrauterine death or placental
detachment. No cases of severe fetal anemia attributable to fetomaternal transfusion20 were reported. The number of PROMs was similar in
both groups and the number of premature births was lower in the intervention
Moxibustion treatment did not reduce the rate of cesarean deliveries
in a population in which elective cesarean delivery is not envisaged for breech
presentations. On the other hand, it is possible that the significantly higher
number of breech presentations at birth in the control group may have been
a factor in bringing about worse Apgar scores.
The mechanism of action of moxibustion appears to be through increased
AFMs, which proved significantly stronger in the treated subjects. Although
a number of studies in China11,12,21
have investigated the neurologic path of stimulation by moxibustion and have
shown evidence of its effect on maternal plasma cortisol and prostaglandins,
we think that the mechanism of action of moxibustion is not entirely clear
and warrants further research.
Further studies22 are needed to establish
the efficacy and safety of moxibustion at more advanced gestational ages than
those considered in this trial, as well as in second pregnancies or multigravidas
and populations other than Chinese. Moreover, it is not clear whether moxibustion
is more or less efficacious than ECV at term for obtaining cephalic presentation
given the small number of subjects (nearly all belonging to the control group)
who underwent ECV. Furthermore, since moxibustion and ECV must be performed
at different gestational ages, we may regard them as complementary therapies
to be used in succession. As we see it, if the results of this trial are confirmed,
moxibustion should be extensively used on account of its noninvasiveness,
low cost, and ease of execution. In fact, it is easy to train expectant mothers
(either alone or with their partners) to administer the therapy at home. Further
studies are also necessary to establish whether moxibustion treatment can
reduce the rate of cesarean deliveries where these are used electively for
breech presentation at birth.
Additional results regarding the effects of family history, fetal sex,
cranial circumference, and leg position on the likelihood of cephalic version
will be presented in a subsequent article.
On the basis of the results of the trial, moxibustion, when performed
in primigravidas for 1 or 2 weeks starting in the 33rd week of pregnancy,
has proved to be an effective therapy for inducing a significant increase
in cephalic versions within 2 weeks of the start of therapy and in cephalic
presentations at birth.
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