Chinese Medicine Notes

Inadequate and Unsubstantiated Evidence

Posted on December 3, 2009 by Yael

Earlier this year, an article was published by Boivin and Schmidt in the journal Human Reproduction.
The article presented a research, which concluded that CAM therapies might cause a decrease in pregnancies in women who were using CAM therapies during their IVF treatments. The article stated a decrease of 30%.

I was made aware of this misleading article by a colleague from Israel, Aviv Messinger, who along with Daniel Seidman wrote a response to the article. whic the journal chose to publish.
Here is the full comment.

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I read with great interest the article of Boivin and Schmidt published in the July 2009 issue of your journal.
Although I agree that there is an urgent need to improve our understanding of the role of complementary and alternative medicine (CAM) therapies in the management of infertility, it appears that the present report provides limited evidence to support its seemingly one-sided conclusions.

The weakness of this study stems from several sources. First, there was no enquiry as to why and when the patients requested the assistance of CAM therapies, nor what the duration of the CAM treatment was. Using this poor methodology, a patient could have begun her CAM therapy a day before T2 evaluation, and still be considered as a CAM patient. Although the authors state that failure to conceive may have preceded the use of CAM rather than followed it, this limitation is critical when evaluating the results, and cannot be overlooked.

The assumption that CAM therapy can be considered as a uniform form of treatment is groundless. The CAM therapies considered in this study vary widely in their proposed mechanisms of action, as well as in their known effects and side-effects. For instance, herbal therapy is a vast field that includes an enormous variety of different herbs and ways of administration. In this article there was no attempt to classify the CAM therapies that were used.

The authors suggest that the use of CAM therapy can lead to an increased incidence of congenital malformations. This conclusion, however, cannot be made from the article of Zhu et al. (2006) to which the authors refer.
Zhu et al.(2006) concluded that although babies born following infertility treatment have a higher incidence of malformations, this was a result of the primary infertility condition, and not a result of the treatment.

Moreover, comparing six categories of fertility treatments, CAM users had the lowest incidence of congenital malformations.

In addition, the paper claims that applying acupuncture on the 2nd day after embryo transfer leads to a two-fold increase in abortions - based on the paper by Westergaard et al. (2006), ignoring the fact that these results were found not to be of statistical significance.

The authors’ claims regarding safety concerns are in stark contrast to the conclusions of three recent meta-analyses (Cheong et al., 2008, Manheimer et al., 2008, El-Toukhy et al., 2008) that examined the efficacy of acupuncture in IVF treatment. These comprehensive studies noted that acupuncture should be considered a safe practice, with no serious adverse effects. The authors admit that they were unable “to isolate the effects of specific CAMs”, but claim that it may be important to publish “contentious associations in reproductive health” and that their finding “are important because they show that CAM use ’can’ be associated with poorer outcomes.” However, despite the admitted poor methodology the title and conclusions strongly emphasize a presumed strong negative association between CAM and the outcome of fertility treatments, which we believe not only has low plausibility, but is also poorly supported by the actual evidence presented.

Aviv Messinger, Daniel S. Seidman, MD, MMSc
Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, and the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
Address for Correspondence: Daniel S. Seidman, M.D.
Department of Obstetrics and Gynecology
Chaim Sheba Medical Center
Tel-Hashomer 52621, Israel
Tel: +972 3 604 6596
FAX: +972 3 535 2081
E-Mail: dseidman@tau.ac.il

Reference
1. Boivin J, Schmidt L. Use of complementary and alternative medicines associated with a 30% lower ongoing pregnancy/live birth rate during 12 months of fertility treatment Hum Reprod. 200924:1626-31.
2. Zhu JL, Basso O, Obel C, Bille C, Olsen J. Infertility, infertility treatment, and congenital malformations: Danish national birth cohort. BMJ (2006) 333(7570):679.
3. Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertil Steril (2006) 85:1341–1346.
4. Cheong YC, Hung Yu Ng E, Ledger WL. Acupuncture and assisted conception, Cochrane Database of Systematic Reviews, 4 (2008).
5. Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilization rates of pregnancy and live birth meta-analysis. BMJ (2008) 336:545–549
6. El-Toukhy T, Sunkara S, Khairy M, Dyer R, Khalaf Y, Coomarasamy A. A systematic review and meta-analysis of acupuncture on in vitro fertilisation. BJOG (2008) 115:1203–1213