Good trial design is particularly important for acupuncture due to the nature of the therapy. The gold standard for drugs trials is double blinding. However, acupuncture is a procedure, not a pill. The Institute of Medicine considers the problems of designing acupuncture trials to be very similar to those of designing surgery trials. Sham acupuncture is a particularly thorny issue. A sham control should be physiologically inert.
There are different types of 'sham' or 'placebo' acupuncture. Some styles involve pressing on acupuncture points, essentially acupressure. Others involve superficial needle insertion, either on the same acupuncture points used in the trial, or on points considered to be non-acupuncture points. Another 'sham' technique is to provide acupuncture stimulation to points considered irrelevant to the aims of the intervention. However, since acupuncture modulates physiological activity, how would the authors know that those points would not affect the patient?
The fact is that stimulation of the skin and modulation of acupuncture points, even superficially, also modulates physiological activity. Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Thus, sham acupuncture may not be inert, as So and colleagues (1) believe.
Three out of the four meta analyses published in 2008 found patients benefit from acupuncture when acupuncture is performed around embryo transfer (2). At the London Bridge Fertility, Gynaecology and Genetics Centre we demonstrated that acupuncture does improve pregnancy rates, as previously demonstrated by the review by Manheimer and colleagues (2008) (3).
Acupuncture is among the most popular complementary therapies and its use is both supported and encouraged by WHO as a simple, inexpensive and effective therapeutic option for certain conditions. There are several different forms of acupuncture in use worldwide. The use of acupuncture is claimed to be effective in treating or ameliorating the symptoms in a wide range of medical conditions. Traditional Chinese Acupuncture (TCA) has long been used to modulate the autonomic nervous system to increase relaxation and, more recently, to influence uterine receptivity in IVF patients. Several studies describe the use of various forms of acupuncture as an adjunct therapy in IVF treatment with some promising results. As a result of patient requests, Bridge has made acupuncture available to patients undergoing embryo transfer since 2006.
We conducted a retrospective review of the effect of acupuncture intervention, both before and after embryo transfer, on IVF treatment outcome in terms of chemical and clinical pregnancy rates per embryo transfer for treatments performed between Nov 2006 and Aug 2008.
Patients received TCA over a 40-minute period before and after embryo transfer to several acupoints. Pre-embryo Transfer Acupuncture (ETA) was delivered not more than one hour before embryo transfer, and post-ETA delivered not more than 20 minutes after embryo transfer. In both pre- and post-ETA treatments, ear acupuncture was applied to points to calm the mind and nervous system. During the pre-ETA treatment, body TCA was applied to acupoints to stimulate the channels of the spleen, stomach, liver, pericardium and governing vessel. Post-ETA treatment, body acupuncture was applied to the spleen, stomach and large intestine channels. All body acupoints were stimulated five times at five-minute intervals.
65 patients underwent 70 cycles of IVF involving acupuncture before and after embryo transfer. Outcomes were compared with 70 cycles of IVF involving randomly selected age-matched controls. Overall, after ETA, positive pregnancy rates (PPR) and clinical pregnancy rates (CPR) per embryo transfer compared well with a randomly-selected age-matched control group.
Acupuncture is a safe, adjunct therapy in IVF and results suggest that it may increase positive pregnancy rates when used before and after embryo transfer in agreement with a number of recent studies. Pregnancy rates for women aged between 35 and 39 yrs and those over 40 years were more than 10 per cent better than control groups of the same ages, indicating the treatment may have more benefits for older women undergoing IVF. No side effects or complications were experienced by women who received acupuncture, suggesting its application in IVF is safe and may be beneficial, particularly in older patients.
These preliminary data are encouraging, although a placebo effect cannot yet be ruled out. However, further trials involving older women to include additional objective measurements of the effect of acupuncture (such as ultrasound assessment of increased blood flow and changes in hormone levels) may help to distinguish a real effect from placebo and identify those patient groups most likely to benefit from acupuncture treatment.