Complementary and Alternative Medicine (CAM):  A heart to heart discussion about Acupuncture and IVF

Paul C. Magarelli, (PCM) M.D., Ph.D. Board Certified RE&I
Diane K. Cridennda, (DKC) L.Ac.  NCCAOM

An imaginary debate follows... the goal is to highlight the pros and cons of CAM (Complementary and Alternative Medicine) in the treatment of infertile couples.

PCM: “First, do no harm.”  (Latin: rimum nil nocere)  It is one of the principal precepts all medical students are taught in medical school.  This western ideal of medicine leads many physicians to question the utility of acupuncture in the treatment of infertile couples undergoing IVF.  They reason that there have not been Randomized Controlled Trials (RCT’s) that “prove” the efficacy of acupuncture as an adjunct to the pharmacologic therapy that defines contemporary infertility treatments. 

DKC: Traditional Chinese Medicine (TCM) has been used for thousands of years to treat infertility.  Acupuncture and herbs are used to build blood and regulate hormones needed for a normal healthy cycle.  In Traditional Chinese Medicine (TCM), the follicular phase (Yin) and the luteal phase (Yang) have to be in harmony for pregnancy to take place.  TCM looks at the whole body as being “organ systems.”  The organs are related and dependant on each other and one cannot work without the cooperation of the others.  This is called dynamic balance. TCM has been time tested as it is 5,000 years old.  Long before RCT’s were invented, TCM was used for the treatment of infertility. The basic theory was that a healthy, balanced body would carry out its normal human functions, including reproducing.

PCM: “Not many IVF programs utilize CAM.”  Most IVF programs “tolerate” CAM, but don’t promote it.  I certainly can understand their points of view.

DKC: "I disagree."  In 1996, when I presented the idea of treating IVF patients with acupuncture, Dr. Magarelli scoffed.  He did what any red-blooded western trained MD., Ph.D. would do and told me that he would not subject his patients to acupuncture unless I could “show him the data,” meaning an RCT that demonstrated acupuncture’s effectiveness.  Dr. Magarelli was concerned that his patients would be taken advantage of, since most were desperate to have a child and would do anything to get pregnant. 

In most acupuncture clinics, the motivation to prove that acupuncture works is neither that compelling nor necessary.  A patient comes in with back pain, we put needles in, and the pain goes away.  This is what we call “clinical experience.” The acupuncturist doesn’t need an RCT study to prove its efficacy. TCM has been used to treat infertility for thousands of years and it has a pretty good track record. 

There have been some excellent studies showing that acupuncture can enhance IVF outcomes.  In 1996, Stener-Victorin (SV) did a randomized controlled trial of IVF patients treated with e-Stim acupuncture and found a significant improvement (P < 0.05) in IVF outcomes in those patients that were demonstrated to have poor perfusion of the uterine arteries as measured by pulsatility index (PI).  This study was followed by research conducted by Paulus et al. in 2002 that demonstrated improved pregnancy rates in IVF patients treated with acupuncture just before embryo transfer and again after embryo transfer.  This was not only an RCT, but it was conducted using “fake” acupuncture in the control group to minimize bias in the interpretation of the outcomes. 

I persisted with my attempts to convince Dr. Magarelli to combine IVF treatment with acupuncture, but he said there was not enough data.  I then presented some less rigorous studies that demonstrated improvements in IVF outcomes and he finally relented.  He agreed to send patients to me for acupuncture who were defined as "poor prognosis," i.e., elevated FSH, poor sperm parameters, AMA (Advanced Maternal Age), elevated pulsatility indices (PI).  He gave the referrals passively; his nurses would mention acupuncture to the patients and if they wanted to do acupuncture, they would be referred to me.

Dr. Magarelli did not know who was getting acupuncture, therefore the treatments and results were blinded to him.  He felt it was necessary to be blinded to the acupuncture treatments because he had his pre-conceived bias that the acupuncture would not help.  The data was collected and was not shared with Dr. Magarelli for over 3 years.  As time went by, more and more patients self-referred themselves to acupuncture and his nurses would also offer acupuncture options to the patients.  During this time, Dr. Magarelli did not see any decline in pregnancy rates; in actuality, they seemed to be rising in all his patients.  There did not appear to be any harm from acupuncture and he related to me that he began to notice a lessening of anxiety in the patients during their IVF treatments. 

PCM: “I was not convinced!”  There were no statistically significant improvements in pregnancy rates, however, the miscarriage rates were half those of the cohort (the group not receiving acupuncture).  This translated to more couples taking home babies if the woman had an acupuncture treatment.  I doubted the results, but felt compelled to see if acupuncture would help all IVF patients.  I wanted to understand the mechanisms of action.  I was intrigued!

DKC: Acupuncture improves results!  In 2003, Dr. Magarelli asked me to put together a list of patients who received acupuncture and the type they received.  By then Paulus had published his protocol, so in 2002 we added the pre/post embryo transfer option for patients.  Dr. Magarelli knew about the treatment of these patients since it had to be coordinated during the embryo transfer.  We analyzed the data and in 2004 we presented our abstract entitled, Acupuncture in Poor Prognosis IVF Patients:  A Cure?  We won the Physicians in Private Practice Award at the Pacific Coast Reproductive Society meeting. Our studies showed a significant increase in “take home babies” (THB) in “poor prognosis” patients treated with acupuncture, with an 11% improvement!

TCM was making headway!  We followed up on this study by investigating if “good prognosis” patients were similarly helped.  At ASRM 2004, we made a presentation that indeed demonstrated a similar finding, more “take home babies,” at an 8% improvement!

Now Dr. Magarelli was intrigued and he was beginning to see the data!  At first, he did not believe it could help.  Later, he was confused that we did not have improved pregnancy rates (something seen in other studies), but did have more “take home babies” for couples.  As a non-TCM practitioner, this did not make sense to him, but it made all the sense to me! The acupuncture points that were chosen could also help with “holding” the pregnancy.  Dr. Magarelli thought it had to do with better blood flow to the uterus and therefore enhanced implantation.  I think this was just a small part of the much larger picture.

Our next endeavor was to determine overall pregnancy rates in IVF patients regardless of their diagnosis (good vs. poor).  We presented this data at the 12th Congress on Human Reproduction in Venice Italy in March 2005.  Our data demonstrated a significant improvement in pregnancy rates (P < 0.05), an overall 25% improvement! 

We looked for changes in SAB and ectopic rates and though improved, the results were not statistically significantly better.

Since 2003, Dr. Paul C. Magarelli, M.D., Ph.D. and I have studied the impact of combining both protocols on IVF outcomes in over 350 patients.  We have presented our data at ASRM (American Society of Reproductive Medicine,) PCRS (Pacific Coast Reproductive Society), the 12th Congress on Human Reproduction in Venice, Italy, SAR (Society for Acupuncture Research), ARRC (Acupuncture Research Resource Center), Nature Child Conference at the College of Royal Physicians, London, England as well as the AAMA (American Association of Medical Acupuncturists).  Our data is not an RCT study, rather it’s a cohort (prospective) study and these studies should be viewed as stimulants for greater research at American universities.

Our East and West Future:  We feel we have the information to create a RCT to “prove” acupuncture helps IVF patients.  We are currently looking for a funding agency to help us conduct this study. 

Why do we think this study needs to be done?  We believe that acupuncture will improve rates at any IVF practice.  We believe that pregnancy rates could be increased by a conservative 10% and the “take home baby” rate could be increased by that same 10%.  This minimal improvement could save over $150,000,000 in health care dollars in the USA each year.  This figure is based on the fact that in the USA, IVF centers conduct 150,000 IVF cycles/year.  If 10% of the patients do not have to repeat an IVF cycle, then $150,000,000 {15,000 patients X $10,000/cycle} could be saved each year!