Approximately 3% of fetuses are in breech presentation at delivery. Since the randomized trial published by Hannah et al in 2000,1 the cesarean delivery rate for this category of fetuses has increased in many regions of the world,2,3 including in France.4
Performed from 36 weeks of gestation onward, external cephalic version reduces the risks of both breech presentation and cesarean delivery.5 Nonetheless, because women fear it for the pain it frequently causes6 and its association, although rare, with fetal complications,7 alternative safer methods of fetal version should be sought.
Since 1998, several randomized trials have examined fetal version by moxibustion at acupoint BL 67, either alone8–12 or with acupuncture13; the results have been discordant. One trial studying this combination concluded that their effect was beneficial.13 Meta-analyses indicate that moxibustion, with or without acupuncture, may be associated with a reduced risk of breech presentation at delivery.14,15 Their authors have nonetheless underlined the heterogeneous nature of the studies, their quality,14 and their protocols14,15 and pointed to the need for large randomized trials and rigorous methodology.14,15
This randomized placebo-controlled trial sought to assess the efficacy of moxibustion with acupuncture for version of breech presentations after 33+4 weeks of gestation to reduce their rate at 37 weeks of gestation and at delivery.
MATERIALS AND METHODS
This single-center single-blind prospective placebo-controlled randomized trial compared the combination of moxibustion with acupuncture with a placebo treatment that sham-stimulated the same acupuncture point (inactivated laser).
During the third trimester of pregnancy, at their ultrasound consultation or during a routine prenatal appointment, women were recruited by the ultrasonographer, the midwife, or the obstetrician. They were eligible for inclusion if the ultrasound examination showed breech presentation and gestational age was from 33+4 to 35+4 weeks of gestation. The exclusion criteria were multiple pregnancy, uterine malformation, premature rupture of the membranes, placenta previa, third-trimester vaginal bleeding, fetal malformation, admission for threatened preterm delivery, contraindication to vaginal delivery, and patient's inability to come for acupuncture sessions every 48 hours.
All patients received oral and written information about the study and about external cephalic version (recommended if breech presentation persisted at 37+2 weeks of gestation). To participate, women also had to be at least 18 years old, speak and understand French, and consent in writing. The regional ethics committee approved the protocol (Comité consultatif pour la protection des personnes dans la recherche biomédicale de Lille). Our protocol was approved by our institutional review board, direction à la recherche clinique.
The randomization allocation sequence was generated by the study statistician from tables of random numbers for two equal arms (one-to-one), in blocks of eight, stratified by parity (primiparous or multiparous). Women were allocated to a group during the inclusion visit by a midwife with a degree in acupuncture from our university, when she opened the opaque, white, sealed, and consecutively numbered envelopes prepared in advance, which announced the woman's allocated to either the moxibustion with acupuncture or the laser placebo group. Six sessions (moxibustion with acupuncture or laser) were then scheduled at one every 48 hours. In each session, the midwife provided the treatment—real or placebo—during 10 minutes on each foot. The 19 graduate midwives who participated in the study were previously trained by a certified acupuncture practitioner from our university. All of these midwives had 60 hours of theoretical teaching and 44 hours of practical training for their certification in acupuncture, which is required for acupuncture's practice in France. Fetal presentation was checked by clinical examination at the beginning of each session. Ultrasound examination was performed in case of doubt. If the presentation had become cephalic, no further study treatment was given.
During each session, the woman was placed in a half-seated or lying position. In the moxibustion with acupuncture group, point BL 67 was punctured at the external angle of each fifth toenail, a millimeter behind this angle. The acupuncture needles were sterile, stainless steel with a copper handle measuring 0.20×13 mm. This point was heated by moxibustion, at 3 or 4 mm from the skin, with a part of the moxibustion stick placed on the needle. Each foot was heated in turn and changed when the patient began to perceive the heat as too strong; the procedure lasted for a duration of 20 minutes. To avoid smoke and odor, the moxibustion was performed with a pure charcoal stick measuring 9.4×1 cm.
For the women in the placebo (laser) group—because laser stimulation is an alternative to needles in acupuncture treatments—we used an inactivated laser probe placed on point BL 67 for 20 minutes, without any pressure, with, again, each foot treated in turn. So, the trial was placebo-controlled but not blinded to all women, because the inactivated laser did not cause any pain. Specifically, we used the probe of detection or stimulation laser inactivated by the supplier. The stimulation characteristics were verified by the laser research study center of the University of Lille 1 (CERLA—atom, molecule and laser physics laboratory, UMR University–CNRS 8523, Villeneuve d'Ascq, France). Accordingly, the probe emitted a single wave length in the red zone at 652 nm. The power measured at the diode exit was 1.25 mW but only 150 microwatts after inactivation by removal of the collimating lens.
Patients were queried about adverse effects at the end of each session. No concomitant drug treatment was contraindicated during the study. If version had not occurred by the end of six sessions, external cephalic version was offered between 37+2 and 37+5 weeks of gestation. If breech presentation persisted at delivery, the mode of delivery was discussed with the patient in accordance with the department's protocol.16
The study's outcome measures and endpoints were prespecified. The principal endpoint was the rate of breech presentations at 37+2 weeks of gestation, which eliminated any confounding by the effect of the external cephalic version performed between 37+2 and 37+5 weeks of gestation. If the neonate was born before 37+2 weeks of gestation, the presentation considered was that of the fetus at birth regardless of gestational age. The secondary outcome measures were: the percentage of successful external cephalic version, the rate of breech presentations at delivery, and the cesarean delivery rate at delivery. We prospectively recorded maternal, neonatal, and related data, including type of breech at inclusion (complete compared with not complete, ie, frank, kneeling, or single footling), number of sessions, presentation at each session and rate of preterm delivery, premature rupture of membranes, and mode of labor onset.
The sample size was determined in advance. The proportion of breech presentations at 34 weeks of gestation that spontaneously convert to cephalic presentation at 37+2 weeks of gestation has been estimated at 40%.9,13,17 Based on the study by Neri et al,13 the only one that has studied the effect of moxibustion associated with acupuncture, we considered that treatment by moxibustion with acupuncture might increase this proportion by 16% after treatment and thus raise it to 56%. We accordingly calculated that inclusion of at least 160 patients in each group would allow us to show a statistically significant difference with a type I (α) risk of 0.05 and a type II (β) risk of 0.20 (two-tailed test). The protocol called for an intention-to-treat analysis. Recruitment began in October 2006 and ended at the end of planned recruitment on May 2010.
The data entry and analysis were performed with Epi-Data 3.1. The statistical comparisons used the χ2 or Fisher’s exact test for the qualitative variables and Student’s t test for the quantitative variables. The means are reported with standard deviations. Percentages are reported with their 95% confidence intervals (CIs). All the tests were two tailed and the significance level was set at P<.05.
The study was conducted between October 6, 2006, and May 28, 2010, in the obstetric department of our university hospital. During this 43-month period, there were 18,181 deliveries, including 1,087 (6.0%) in breech presentation at or beyond 22 weeks of gestation, excluding terminations of pregnancy for fetal anomalies; 486 singleton breech fetuses were born at term (2.7%). The randomized trial included 328 women (Fig. 1). Two women in the moxibustion with acupuncture group and five of the placebo (laser) group were included, although they turned out to not have met an inclusion criterion or to have met an exclusion criterion (2.1%). Moreover, 11 women, six in the treatment arm and five in the placebo arm (3.3%), did not receive treatment after randomization. All patients were analyzed in their initial allocation group.
The groups did not differ meaningfully in either the mothers' characteristics or the type of breech at inclusion (Table 1). More than half the women were primiparous, and in more than half the breech presentations were not complete. The mean number of sessions per patient was 4.5±2.1. Overall, the trial included 187 primiparous women (57.0%) and 141 multiparous women (43.0%).
Table 2 presents the endpoints, adverse effects, and pregnancy outcome. For the principal endpoint, the percentage of breech presentations at 37+2 weeks of gestation was higher, although not significantly, in the moxibustion with acupuncture group than in the placebo group (72.0% compared with 63.4%, relative risk [RR] 1.13, 95% CI 0.98–1.32, P=.10) both among primiparous (83.2% compared with 79.3%, RR 1.05, 95% CI 0.91–1.20, P=.50) and multiparous women (56.5% compared with 43.1%, RR 1.31, 95% CI 0.94–1.84, P=.11). The success rate of external cephalic version did not differ significantly according to the treatment (30.0% compared with 21.1%, RR 0.70, 95% CI 0.40–1.23, P=.21) either for primiparous (23.6% compared with 9.6%, RR 0.41, 95% CI 0.16–1.1, P=.05) or multiparous women (40.0% compared with 52.6%, RR 1.20, 95% CI 0.7–2.2, P=.57).
The percentage of fetuses in breech presentation was also similar in both groups at delivery (56.7% compared with 54.3%, RR 1.04, 95% CI 0.86–1.27, P=.66) both for primiparous (69.6% compared with 73.9%, RR 0.94, 95% CI 0.78–1.13, P=.50) and multiparous women (23.2% compared with 16.7%, RR 1.39, 95% CI 0.71–2.72, P=.33). Nor did the percentage of cesarean deliveries differ significantly according to treatment (34.8% compared with 31.7%, RR 1.10, 95% CI 0.81–1.49, P=.56) either among primiparous (43.2% compared with 43.5%, RR 0.99, 95% CI 0.72–1.38, P=.96) or multiparous women (23.2% compared with 16.7%, RR 1.39, 95% CI 0.71–2.72, P=.33).
The percentage of premature births before 37 weeks of gestation did not differ significantly between the two groups. Nor was there any difference for mode of delivery or neonatal condition. One in utero fetal death occurred at 35+4 weeks of gestation in the moxibustion with acupuncture group as a result of recurrence of massive histiocytic intervillositis. Fourteen women (8.5%) in the moxibustion with acupuncture group reported adverse effects after treatment—a painful burning sensation (n=7), blisters or other burn lesions (n=4), vasovagal syncope (n=1), and nausea and vomiting (n=2); there were no adverse events after treatment in the placebo group (P<.001).
Our randomized study did not show that the combination of moxibustion with acupuncture provided any benefits over placebo for version of fetuses in breech presentation between 33+4 weeks and 35+4 weeks of gestation. Of the various published trials assessing moxibustion alone or with acupuncture in version of breech presentations after 32 weeks of gestation, only six randomized controlled trials used a methodology comparable to ours.8–13 The sample sizes in these trials have ranged from 68 to 406, and patients in the control group were most often not treated at all,8–11,13 except in a recent trial12 in which the women in one of the control arms received moxibustion at acupuncture point SP1, putatively inactive according to traditional Chinese medicine.
Our results are very different from those obtained by the first two randomized but not placebo-controlled trials, both published before 2005; their results strongly favored use of moxibustion.9,13 The first, conducted in China, included 260 patients; Cardini and Weixin found a significant reduction in the percentage of breech presentations at delivery in the group treated daily by moxibustion from 32 weeks of gestation (24.6% compared with 37.7%, RR 0.82 [0.70–0.98]).9 The second trial took place in Italy and included 240 patients after 33 weeks of gestation13; the combination of moxibustion with acupuncture was associated with a significant reduction in breech presentations at delivery (45.5% compared with 62.3%, RR 0.70 [0.53–0.93]).13
Our results, on the other hand, are similar to those of the three trials published since 2005, by Cardini et al,8 Millereau et al,11 and Guittier et al.10 The first included 123 Italian women and was stopped when only 46% of the expected number of women had been recruited because of their poor adhesion to moxibustion treatment.8 The rate of breech presentation at delivery was essentially the same in both groups (47.7% compared with 49.2%, RR 1.06 [0.62–1.82]). The second was a small French trial of 68 women, which compared the effect of moxibustion with no treatment beginning at 34 weeks of gestation.11 The rate of breech presentation at delivery was similar in both groups (51.5% compared with 54.3%, RR 1.06 [0.51–2.22]). Finally, the third trial, in Switzerland, studied the use of moxibustion in 212 women between 34 and 36 weeks of gestation.10 The rate of breech presentation at delivery was similar in both groups (63.2% compared with 59.4%, RR 1.08 [0.77–1.52]).
Very recently, a randomized controlled trial including 406 women recruited in 58 Spanish health centers showed a reduction in the risk of breech presentation at delivery in patients receiving moxibustion by a moxa stick (herbal preparation with Artemisia vulgaris) at point BL67 between 33 and 35 weeks of gestation (41.9% compared with 55.2%, RR 0.78 [0.59–0.95]).12
The initial meta-analyses about the effect of moxibustion alone, published in 200818 and then 2009,15,19 found that moxibustion had a positive effect, but neither took into account the results of the last two negative trials, both published in 2009.10,11 In particular, the results were significantly heterogeneous.15 This heterogeneity is probably related to the variable quality of the studies, the differences in their treatment methods (duration and frequency of sessions), the variation in gestational age at inclusion, and differences between the populations. Very recently, the meta-analysis by Coyle et al14 added the trials in which moxibustion alone—without acupuncture—was associated with postural techniques to correct breech presentation. Whether these trials were considered or not, moxibustion alone no longer appears to be associated with a reduction in the rate of breech presentation at delivery (RR 0.90 [0.67–1.19]). Finally, only when moxibustion was combined with acupuncture was it significantly associated with a reduced rate of breech presentations at delivery in this meta-analysis.14 Only one such trial showed a significant reduction in the percentage of breech presentations at delivery.13 In that trial of 226 patients, moxibustion combined with acupuncture was associated with a significant reduction in the risk of breech presentation at delivery (RR 0.73 [0.57–0.94]). Our study is therefore the second to study specifically the combination of moxibustion with acupuncture. Our results do not show any beneficial effect of this combination and call for reconsideration of the results of Neri et al13 and of the conclusions of the meta-analysis by Coyle et al.14
We are aware that our study has several limitations. First, because we considered that a placebo was necessary to avoid unexpected differences between the two arms, the choice of our placebo can be criticized. Several types of placebos have already been evaluated and used in clinical trials assessing acupuncture.20 We did not use stimulation of another acupuncture point or an inactive area because of concern that such stimulation might cause an unexpected effect. Our choice of the inactivated laser had the twofold advantage of a low cost and of previous validation as a placebo for acupuncture, because it has previously been used in some randomized controlled trials.21 Moreover, laser stimulation is an alternative to needles in acupuncture treatment in children or for some difficult points.22 In particular, this technique mimics stimulation of the same acupuncture point as that stimulated in the treated group.
We did not choose to have the patients or family members perform moxibustion with acupuncture at home, as most other trials have done.8–12 In our study, the treatment sessions were always performed by trained professional acupuncturists, like in the studies by Neri et al13,23 and Guittier et al.10 Nonetheless, the large number of participants performing this treatment in our study might have introduced heterogeneity into its application.
We observed an 8.5% frequency of adverse effects in the moxibustion with acupuncture group but none in the placebo group. Most of these were directly related to the moxibustion itself (blisters, burns, or burning sensations). No complication of this type was reported in the previous trials,8–11,13 and this frequency may therefore appear high. Nonetheless, burn injuries and blisters have already been reported with the treatment by moxibustion,24 including at point BL 67.12,25
Choosing the best gestational age for fetal version is difficult. It is possible that the gestational age at which we performed the moxibustion with acupuncture treatment was too late to be effective, because the quantity of amniotic fluid is highest around 32 weeks of gestation.26 We chose to include patients at 34 weeks of gestation in our study because only 6% of women have a fetus in breech presentation at this gestational age,27 whereas this rate is approximately 24% at 28 weeks of gestation and 13% at 32 weeks of gestation.28 This difference enabled us to limit the number and cost of the interventions.29
Our study showed that moxibustion with acupuncture may play a role in facilitating external cephalic version in the subgroup of primiparous women. Compared with data from the literature, the success rate of version is nonetheless low in our placebo group (9.6%)30 compared with the success rate in the moxibustion with acupuncture group (23.6%), which is close to the usual success rate for version in primiparas in our department, usually close to 22% (data not shown). It is possible that the late nature of the attempted external cephalic version (37 weeks of gestation) might partially explain this low success rate in all the women. The apparent, nonsignificant benefit of moxibustion with acupuncture on this secondary outcome measure may also be the result of chance. We note that no study, to our knowledge, has assessed the role of moxibustion with acupuncture as a preliminary treatment for external cephalic version in primiparous women. Guittier et al reported a similar success rate for external cephalic version between the moxibustion and control groups at 37 weeks of gestation but did not analyze their data according to parity.10 We suggest that this point be explored in subsequent studies with parity taken into account.
Finally, treatment by moxibustion with acupuncture did not improve version rates for fetuses in breech presentation between 33 and 35 weeks of gestation. We do not think that this negative result is related to any lack of compliance by the women, any methodologic defect, or a lack of statistical power.
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