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eLetters: Electronic letters published:
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Inadequate and Unsubstantiated Evidence
- Aviv Messinger, Prof. Daniel S. Seidman (5 November 2009)
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Response to Boivin & Schmidt
- Jon L Wardle (15 April 2009)
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Aviv Messinger, Chinese Medicine Practitioner The Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel Aviv, Israel, Prof. Daniel S. Seidman
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aviv{at}aviv-clinic.co.il Aviv Messinger, et al.
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Dear Sir, 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 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) 85:13411346. 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) 336:545549 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) 115:12031213 Conflict of Interest:None declared |
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Jon L Wardle, Research Scholar School of Population Health, University of Queensland, Herston Q 4006, Australia
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j.wardle{at}sph.uq.edu.au Jon L Wardle
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Sir, I congratulate Boivin and Schmidt on their fascinating insights into complementary and alternative medicine (CAM) use in assisted reproduction and on bringing this important issue to light (Boivin and Schmidt 2009). However, I would urge those reading the article to recognise the complexity of CAM and refrain from making broad assumptions suggested by the data. The high association of CAM use with poor pregnancy outcomes does not automatically imply causation. As the authors noted, it is already known that CAM users generally have poorer health than non-CAM users and have often turned to CAM for this very reason (Sirois 2008; Sibbritt et al 2004). However, whilst Boivin and Schmidt analysed their own data for previous treatment failure we remain unaware of differences in previous medical history of their respondents. The quality or appropriateness of CAM used by patients could also affect these results and the issue at play could be one of variable product quality, uninformed self-prescription or the inappropriate prescription by inadequately trained therapists rather than broad use of CAM per se, particularly considering the generally lax regulation surrounding CAM (Wardle 2008). Boivin and Schmidt have themselves suggested several further possible reasons for the association, including lack of commitment to any one procedure amongst CAM users and lack of communication exchange between CAM and conventional providers, rather than a direct causal link. Moreover CAM is a plethoric field and the validity of their results can be somewhat obscured by this heterogeneity. Herbal medicine and aromatherapy which were grouped together in the study are enormously different CAM interventions with vast differences in risk profile (Mills and Bone 2004). This is in addition to the marked difference in pharmacology or therapeutic actions of individual herbs or essential oils. Yet not only were efforts not undertaken to isolate specific herbal medicines, they were also not undertaken to isolate specific CAM modalities more broadly. The authors have proffered this latter limitation themselves. Some specific CAMs show promise when used in conjunction with assisted reproduction techniques (Cheong et al 2008), yet others offer suggestion that they most certainly should not be used (Cahill et al 1994). However in reality there exists a dearth of usable or valid data on neither the potential positive nor negative causal effects of specific CAMs when used in conjunction with assisted reproduction techniques. I applaud the authors for highlighting this important gap in research. I concur that the issue is one that merits far more evaluation, particularly considering the enormous popularity of and sometimes dubious marketing practices of both conventional and complementary therapists in relation to CAM provision in fertility treatment. However, I strongly suggest that the complexity and heterogeneity of CAM needs to be appropriately acknowledged during its evaluation. Jon Wardle School of Population REFERENCES: Boivin, J. and 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 (2009) doi:10.1093/humrep/dep077. Sirois, F. Provider-based complementary and alternative medicine use among three chronic illness groups: associations with psychosocial factors and concurrent use of conventional health-care services. Complement Ther Med (2008) 16:74-81. Sibbritt, D., Adams, J. and Young, A. A longitudinal analysis of mid-age women's use of complementary and alternative medicine (CAM) in Australia. Women Health (2004) 40: 41-56. Wardle, J. Regulation of complementary medicines: A brief report on the regulation and potential role of complementary medicines in Australia (2008) Brisbane: Network of Researchers in Public Health and Complementary and Alternative Medicine (NORPHCAM). Available at: http://www.norphcam.org/cmregreport/cmregreport.pdf [cited 11 Apr 2009] Mills, S. and Bone, K. The Essential Guide to Herbal Safety (2004) Edinburgh: Churchill Livingstone. Cheong, Y., Hung Yu Ng, E. and Ledger, W. Acupuncture and assisted conception. Cochrane Database Syst (2008) Rev 8: CD006920. Cahill, D., Fox, R., Wardle, P. and Harlow, C. Multiple follicular development associated with herbal medicine. Hum Reprod (1994) 9:1469-1470. Conflict of Interest:None declared |
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