Acupuncture and Moxibustion May Increase Pregnancy Rates in IVF after Embryo Implantation Failure
Women's Health
Abstract and Commentary
By Natawadee Young, MD
Associate Professor of Family Medicine, AnMed Health Family Medicine Residency Program, Anderson, South Carolina
Dr. Young reports no financial relationships relevant to this field of study.
Synopsis: This prospective trial performed at an infertility clinic in Brazil randomized 84 women who had at least two prior failed in vitro fertilization (IVF) attempts to three groups. The first group had acupuncture plus moxibustion in addition to IVF, the second had sham acupuncture and IVF, and the third group only underwent IVF. Results showed a significant increase in clinical pregnancy rates in the true acupuncture plus moxibustion group compared to the sham acupuncture and the IVF only groups (35.7% vs 10.7% and 7.1%, respectively).
Source:Villahermosa DI, et al. Influence of acupuncture on the outcomes of in vitro fertilization when embryo implantation has failed: A prospective randomized controlled clinical trial. Acupunct Med 2013;31:157-161 doi: 10.1136./acupmed-2012-010269.
Summary Points
- A small randomized, controlled trial showed that acupuncture and moxibustion in addition to in vitro fertilization significantly improved clinical pregnancy rates in women who had embryo implantation failure. However, there should be larger and more robust trials to see if this result can be replicated.
- Future research on acupuncture would benefit from adhering to more fidelity in reporting according to STRICTA and CONSORT protocols.
This prospective, randomized trial was conducted at the Clinic for Human Reproduction, Faculty of Medicine of ABC, Santo Andre SP, Brazil. Women aged ≤ 38 years with infertility who had at least two prior unsuccessful IVF attempts (defined as embryo implantation failure) were asked to participate. The study excluded transfer of frozen or poor-quality embryos, prior use of acupuncture by participants, use of other adjunctive infertility treatments, severe oligospermia in the partner (< 2 million/mL), and age of male partner > 50 years.
Randomization was done with sealed envelopes using computer-generated numbers to create three groups: true acupuncture with moxibustion (n = 28), sham acupuncture (n = 28), and control (n = 28). Blinding of participants, treating providers, and investigators was not discussed. All participants underwent IVF treatment using the same clinic protocol. The women in the true acupuncture arm received moxibustion at nine acupuncture points (Bl18, Bl22, Bl23, Bl52, CV3, CV4, CV5, CV7, GV4) typically used for infertility for 5 minutes, followed by traditional acupuncture needling at 12 points (PC6, Ki3, Ki6, Ki7, Ki10, Lr3, Sp4, Sp6, Sp10, St10, St40, Lu7, unilaterally and Zigong bilaterally). All sessions were performed by the same acupuncturist with more than 5 years of practice. Needles were manually inserted and stimulated to obtain de qi sensation and left in place for 20 minutes. The de qi sensation is described as an aching discomfort at the site of the acupuncture needle felt by the patient when the acupuncture needle is gently twisted by the acupuncturist. The acupuncturist feels de qi as a "grasping" sensation by the patient's tissues as the needle is gently twisted and manipulated. Traditional Chinese medicine (TCM) methods of acupuncture advocate that the de qi sensation is a sign that qi is being moved by the acupuncture treatment — the goal of acupuncture in restoring balance.1
Women in the sham acupuncture group had eight needles inserted in non-acupuncture point locations bilaterally in the arm and thigh. Needles were inserted superficially, in points unrelated to the meridian, and without eliciting de qi. Needles were left in for 20 minutes. No moxibustion was performed on the sham acupuncture group. Women in the control group underwent IVF only per clinic protocol.
Investigators measured demographic data, number of oocytes retrieved, endometrial thickness, and number of transferred embryos from all groups. Primary outcomes measured were chemical pregnancy rates (defined as fraction of βhCG on 12th day after embryo transfer) and clinical pregnancy rates (defined as presence of an intrauterine gestational sac seen on transvaginal ultrasound after the fourth or fifth week of gestation).
All three groups of women had no baseline differences in demographic data including age, duration of infertility, fraction with primary infertility, and number of previous IVF cycles. There were no dropouts or incomplete data. All three groups had the same number of embryos transferred (mean = 2.2, P = 0.5238). There was a trend toward higher number of oocytes retrieved (8.4 ± 3.1 [true] vs 6.5 ± 3.1 [sham] vs 6.5 ± 3.5 [control], P = 0.0427) but no statistical significance. However, women in the true acupuncture and moxibustion group had thicker endometrial measurements (10.3 ± 1.6 mm vs 8.5 ± 1.6 mm [sham] vs 8.7 ± 1.6 mm [control], P = 0.0002).
For the primary outcome of biochemical pregnancy rates, there was a statistically significant trend toward higher rates in the true acupuncture group (39.3% vs 10.7% [sham] vs 10.7% [control], P = 0.0327; 95% confidence interval [CI], 1.08-9.91). There was a statistically significant increase in clinical pregnancy rate in the true acupuncture group compared to the other two groups (35.7% [true acupuncture] vs. 10.7% [sham] vs. 7.1% [control], P = 0.0169; 95% CI, 1.25-14.09).
Commentary
Up to 17% of couples will experience difficulty in conceiving at some period in their lives. Despite many gains, current pregnancy rates with IVF range around 30%. These authors are studying a subset of women undergoing IVF who have failed two or more IVF cycles, defined as embryo implantation failure (EIF). They state that in women with EIF, pregnancy rates in subsequent IVF cycles fall to less than 10%.2 The treatment arm compared using acupuncture and moxibustion to a sham acupuncture group vs IVF alone.
Moxibustion is a TCM method of heating acupuncture points on the skin, traditionally by placing moxa, a dried plant mugwort (Artemisia vulgaris) on skin points and burning it or heating the skin with it. According to TCM concepts, this heating of skin along acupuncture points facilitates normal movement and flow of Qi. TCM concepts of infertility often ascribe the imbalance to a deficiency of heat in the lower warmer.3 As such, moxibustion is often an essential component in TCM treatments for infertility.
Although this was a small study (n = 84), the authors did plan to enroll at least 66 patients to have enough power to detect a statistical difference, accounting for an estimated clinical pregnancy rate of 10%. Demographics did not show any significant differences between the women in the three groups. Results showed a slightly lower than normal clinical pregnancy rate in the IVF only group of 7.1%, as well as an expected rate of pregnancy in the sham acupuncture group of 10%. However the true acupuncture + moxibustion arm showed a statistically significant increase in clinical pregnancy rate of 35.7%. This would mean an absolute risk reduction of 28.6% between the IVF only and the true acupuncture and moxibustion group and a number needed to treat (NNT) of 3.5.
It would have been difficult to blind the acupuncturist, since only one acupuncturist performed all treatments: moxibustion, true, and sham acupuncture. There was also no discussion about concealing allocation or blinding of either patients or IVF providers/ researchers. All research was conducted at one site in Brazil over a 2-year time period. All these factors would contribute to a bias that would favor the treatment outcome. It is unclear how study authors chose the specific moxibustion and acupuncture points used for the study arm of this trial, although many of these acupoints are commonly used in the TCM treatment of infertility. This standardization of points makes the study more replicable; however, according to TCM precepts, different acupuncturists may have chosen different points or tailored them to the individual patient.
In this particular study, given the lack of allocation concealment and the lack of blinding of acupuncturist and study, can the increase in clinical pregnancy rate be truly attributed to acupuncture and moxibustion itself? There are other potential confounders that were not accounted for in study design. Since there was no sham moxibustion in the sham acupuncture arm, did the longer treatment time in the true acupuncture and moxibustion group make the difference? In addition, the sham acupuncture protocol of inserting needles superficially in non-acupuncture points may not have been an inert treatment and may have contributed to some treatment effect.
There was no mention of adverse effects or harms. There were apparently no dropouts. However, inclusion criteria were very stringent, and generalization of this acupuncture and moxibustion protocol to other groups would be difficult without a clearer reporting of the actual methods.
There has been considerable research into how acupuncture may improve assisted reproductive techniques, especially IVF. Several studies have measured biochemical responses to acupuncture.4 Others have looked at pregnancy rates if acupuncture is performed on different days of IVF treatment, in particular, around days before and after embryo transfer.5 Yet other studies have looked at acupuncture's influence on perceived stress in the women undergoing infertility treatment and whether that corresponds to IVF success rates.6 Recent systematic reviews and meta-analyses of RCTs of acupuncture's effects on infertility and IVF have commented on the heterogeneity of studies along with methodological flaws in study design.7
Nevertheless, many acupuncture studies do suggest the plausibility of acupuncture influencing fertility. Studies have shown that acupuncture can affect stress levels in couples going through infertility treatments.5 Acupuncture can influence reproductive hormones levels and increase ovarian blood flow.3,8 However, little has been studied about combining moxibustion and acupuncture as an adjunct to IVF.
The revised STRICTA (STandards in Reporting Interventions in Clinical Trials of Acupuncture) protocol, developed by expert consensus in 2010, calls for fidelity in reporting acupuncture trials methodology according to a six-item checklist. The checklist asks authors to clearly state: 1) acupuncture rationale, 2) details of needling, 3) treatment regimen, 4) other components of treatment, 5) practitioner background, and 6) control or comparator interventions. STRICTA protocol was designed to be used in conjunction with the 25-item checklist developed by the CONSORT working group that provides an evidence-based reporting protocol for reporting all parallel, randomized, control trials.9 The aim of both STRICTA and CONSORT protocols is to ensure that all trials have clear and transparent reporting standards so that replication, generalization, and critical appraisal of studies are possible. Future acupuncture studies would greatly benefit from conforming to these reporting protocols.
In conclusion, this small, randomized, controlled trial on a specific subset of women with infertility who have failed earlier IVF treatments suggests that combining acupuncture with moxibustion significantly increased clinical pregnancy rate compared with sham acupuncture and IVF alone. Further research is needed to reproduce these findings and stricter reporting of methods is needed to further the study of acupuncture's influence on infertility.
References
- Xinnong C. Chinese Acupuncture and Moxibustion.Beijing: Foreign Languages Press; 1999.
- Simon A, Laufer N. Repeated implantation failure: Clinical approach. Fertil Steril 2012;97:1039-1043.
- Matsumoto K, Euler D. Kiiko Matsumoto's Clinical Strategies: In the Spirit of Master Nagano. Vol. 2. 2012: 287.
- Stener-Victorin E, et al. Effects of electro-acupuncture on anovulation in women with polycystic ovary syndrome. Acta Obstet et Gyn Scand 2000;79,3:180-188.
- Westergaard LG, et al. 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.
- Isoyama D, et al. Effect of acupuncture on symptoms of anxiety in women undergoing in vitro fertilization: A prospective randomized controlled study. Acupunct Med 2012;30:85-88.
- Cheong YC, et al. Acupuncture and assisted reproductive technology. Cochrane Database Syst Rev 2013;7:CD006920. DOI: 10.1002/14651858.CD006920.pub3.
- Stener-Victorin E, Humaidan P. Use of acupuncture in female infertility and a summary of recent acupuncture studies related to embryo transfer. Acupunct Med 2006;2:157-163.
- MacPherson H, et al; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med 2010;3:140-155. doi: 10.1111/j.1756-5391.2010.01086.x.
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