clinical trial

Breech births are difficult.  Instead of the baby’s head at the bottom, ready to charge through at the proper time, it is the feet which are “presented” to the doctor.  A viewing of the movie “Red Cliff” showed Zhuge Liang (played by Takeshi Kaneshiro) successfully solve the problem of breech birth in a horse.  However, traditionally the use of moxibustion on acupoint Zhiyin (BL-67, or the 67th point of the Bladder channel).  However, a recent article <http://www.reuters.com/article/healthNews/idUSTRE59S41C20091029?pageNumber=1&virtualBrandChannel=10522> says that the “Chinese Medicine Tactic doesn’t turn breech babies”

Before I examine the article in depth, I’d like to point out how this “tactic” is supposed to work.

Using a Moxibustion "cigar"

Peter Deadman describes the procedure as such:

The principal application of Zhiyin BL-67 is the treatment of malposition of the foetus, for which it is renowned.  For this purpose it is treated by stick moxibustion for fifteen to twenty minutes bilaterally, or by moxa cones (five to ten cones at each point) once or twice a day.  the woman should loosen her clothes and sit in a comfortable semi-reclining position.  It is common practice in China to demonstrate this method to the pregnant woman who is then supplied with moxa sticks for self-treatment at home.  Best results are achieved if this treatment is started in the 34th week.

That’s what Peter Deadman says in his encyclopedic work, A Manual of Acupuncture which is actually more huge textbook than manual.  Other texts describe the procedure differently:

Chinese Therapeutic Methods of Acupoints published by Hunan Science and Technology Press elaborates:

Let the patient loosen her clothing and evacuate the urine from her bladder.  She should lie supine in bed.  then, hold two moxa sticks respectively 2-3 cm bilaterally to Zhiyin (BL-47).  Ignite them for moxibustion for 15-20 minutes causing local congestion.  The treatment is given once a day.

What strikes me in this description is the need to perform moxibustion on both sides (two points, both BL-67) simultaneously.

So how did the study do it?  You know the drill by know, folks: we quote the study and critique it.

NEW YORK (Reuters Health) – A traditional Chinese therapy used for turning babies out of the breech position before birth may not be effective, a new study finds.

The study, reported in the journal Obstetrics & Gynecology, tested a tactic known as moxibustion, which uses heat to stimulate a particular acupuncture point in an effort to turn a breech fetus to the head-down position before birth.

Moxibustion is MORE than just heat.  It is also exposing the acupoint to the essential oils released when the mugwort plant (mogusa in Japanese, hence the name “moxa”) is burned.

Some research has suggested moxibustion might be effective; a trial in China, for example, found that the method increased the chances of the fetus turning to the head-down position.

However, some other studies have been unable to replicate that success, and moxibustion remains “controversial” outside of Chinese medicine, according to the researchers on the new study, led by Marie-Julia Guittier of the Geneva University Hospitals in Switzerland.

Uh… I love it when people seem to imply that only Chinese studies prove efficacy.  What about the following:

Acupuncture plus moxibustion to resolve breech presentation: a randomized controlled study.  – Neri I – J Matern Fetal Neonatal Med – 01-APR-2004; 15(4): 247-52

OBJECTIVE: In many Western countries breech presentation is an indication for elective Cesarean section. In order to correct fetal presentation, the stimulation of the acupoint BL67 by moxibustion, acupuncture or both has been proposed. Since no studies had previously been carried out on Western populations, pregnant Italian women at 33-35 weeks gestational age carrying a fetus in breech presentation were enrolled in a randomized, controlled trial involving an active BL67 point stimulation and an observation group. METHODS: A total of 240 women at 33-35 weeks of gestation carrying a fetus in breech presentation were randomized to receive active treatment (acupuncture plus moxibustion) or to be assigned to the observation group. Bilateral acupuncture plus moxibustion was applied at the BL67 acupoint (Zhiyin). The primary outcome of the study was fetal presentation at delivery. RESULTS: Fourteen cases dropped out. The final analysis was thus made on 226 cases, 114 randomized to observation and 112 to acupuncture plus moxibustion. At delivery, the proportion of cephalic version was lower in the observation group (36.7%) than in the active-treatment group (53.6 %) (p = 0.01). Hence, the proportion of Cesarean sections indicated for breech presentation was significantly lower in the treatment group than in the observation group (52.3% vs. 66.7%, p = 0.03). CONCLUSIONS: Acupuncture plus moxibustion is more effective than observation in revolving fetuses in breech presentation. Such a method appears to be a valid option for women willing to experience a natural birth.

That was not just moxibustion however: it was acupuncture AND moxibustion.

Effectiveness of acupuncture-type interventions versus expectant management to correct breech presentation: A systematic review – van der Berg et al, Complementary Therapies in Medicine Volume 16, Issue 2, April 2008, Pages 92-100 Online March 18, 2008 Accessed 30 october 2009 (http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WCS-4S0356K-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=c619612fbda948f84d4d532350dfd306>

Objective

A systematic review of studies assessing the effectiveness of acupuncture-type interventions (moxibustion, acupuncture, or electro-acupuncture) on acupuncture point BL 67 to correct breech presentation compared to expectant management, based on controlled trials.

Data sources

Articles published from 1980 to May 2007 in databases of Medline, EMBASE, the Cochrane Central Register of Controlled Trials, AMED, NCCAM, Midirs and reference lists.

Study selection

Studies included were original articles; randomised controlled trials (RCT) or controlled cohort studies; acupuncture-type intervention on BL 67 compared with expectant management; ultrasound confirmed breech presentation and position of the fetus after treatment confirmed with ultrasound, position at delivery, and/or the proportion of caesarean sections reported.

Data extraction

Three reviewers independently extracted data. Disagreements were resolved by consensus.

Data synthesis

Of 65 retrieved citations, six RCT’s and three cohort studies fulfilled the inclusion criteria. Data were pooled using random-effects models. In the RCT’s the pooled proportion of breech presentations was 34% (95% CI: 20–49%) following treatment versus 66% (95% CI: 55–77%) in the control group (OR 0.25 95% CI: 0.11–0.58). The pooled proportion in the cohort studies was 15% (95% CI: 1–28%) versus 36% (95% CI: 14–58%), (OR 0.29, 95% CI: 0.19–0.43). Including all studies the pooled proportion was 28% (95% CI: 16–40%) versus 56% (95% CI: 43–70%) (OR 0.27, 95% CI: 0.15–0.46).

Conclusions

Our results suggest that acupuncture-type interventions on BL 67 are effective in correcting breech presentation compared to expectant management. Some studies were of inferior quality to others and further RCT’s of improved quality are necessary to adequately answer the research question.

Breech Pregnancies - treated by moxibustion?

Habek D, Habek J and Jagust. “Acupuncture Conversion of Fetal Breech Presentation” Fetal Diagn Ther 2003;18:418-421 (DOI: 10.1159/000073135)  Accessed 30 October 2009<http://content.karger.com/ProdukteDB/produkte.asp?Doi=73135>

Abstract

Aim: The aim of this study was to assess the value of acupuncture (AP) in the conversion of fetal breech presentation into vertex presentation. Patients and Methods: A randomized prospective controlled clinical study included 67 pregnant women with fetal breech presentation: 34 women with singleton pregnancies treated with manual AP (urinary bladder 67, Zhiyin) and a control group which included 33 women with singleton pregnancies without AP treatment. The AP treatment lasted 30 min a day, and was conducted during and after 34 weeks of pregnancy with simultaneous cardiotocography. Results: The success rate of the AP correction of fetal breech presentation is 76.4% (26 women), and spontaneous conversion without AP in vertex presentation is observed in 15 women (45.4%; p < 0.001). Conclusions: We believe that AP correction of fetal malpresentation is a relatively simple, efficacious and inexpensive method associated with a lower percentage of operatively completed deliveries, which definitely reflects in improved parameters of vital and perinatal statistics.

So… a study in Croatia suggests that not only is it effective, but that it improves fetal health as well.

But anyway back to our article of the day:

For their study, the researchers followed 212 women who had a fetus in the breech position between the 34th and 36th week of pregnancy.

Half of the women were randomly assigned to have moxibustion therapy; a midwife trained in acupuncture performed it three times weekly in the hospital, and the women were encouraged to do it at home on all other days. The rest of the women received no therapy and served as control group.

All study participants, however, had the option of undergoing an ECV at the 37th week of pregnancy.

In the end, Guittier’s team found, 18 percent of fetuses in the moxibustion group had turned to the head-down position by the time of delivery or a scheduled ECV. In the control group, 16 percent of fetuses had spontaneously turned — a difference that was not statistically significant.

I am very much looking forward to obtaining a copy of this study because I want to see the following answered:

a) what BRAND of moxibustion was used? (some brands are great, some suck big time… like comparing cheap china watches to rolexes)

b) how COMPLIANT were the mothers-to-be in terms of using the moxa at home?

c) what MANIPULATION was used? You don’t just wave the stick at the toe, there are various techniques to it.

Also, the study was done with MIDWIVES TRAINED IN ACUPUNCTURE.  Note, MIDWIVES TRAINED IN ACUPUNCTURE.  Not fully trained acupuncturists.  Maybe they think this is simple enough, waving weed on a toe.

“To say the least, moxibustion was not as effective as suggested in (the) earlier trial that was conducted in China,” co-researcher Dr. Michel Boulvain, also with the Geneva University Hospitals, told Reuters Health in an email. The reasons for the differences in the trials, he added, are unclear.

Yes, the study says it was not as effective as the earlier trial conducted in China AND the one in Italy AND the one in Croatia AND the one… etc.

It’s also unclear whether moxibustion has any physiological effects that would help turn a breech fetus.

Boulvain said that some researchers have reported increases in fetal movement during moxibustion sessions, which in theory could be beneficial. But he added that there are no known reasons, based on “traditional physiology,” for why moxibustion would work in this context.

Based on the existing evidence, Boulvain said, “the decision in our hospital is to not implement or recommend moxibustion for these women.

I agree, conventional physiology cannot explain acupuncture 100%, which is why I cringe when some MDs try to force acupuncture to fit into western concepts.  Acupuncture and Moxibustion developed using CHINESE philosophy, CHINESE experience and CHINESE vocabulary.

And he has the guts to say “based on the existing evidence…” Well based on YOUR evidence maybe, not based on the kaboodles of others, “…the decision in our hospital is not to implement or recommend moxibustion for these women.” I agree, especially if the treatment is not done by professionals.