Monday, August 1, 2011
New 2011 Study Questions Routine Metformin Use In All PCO Patients
A recent study published in the medical journal "Clinical Endocrinology" Frans S., Clinical Endocrinology. [Oxf], 2011; 74:148-151, brings into question the routine use of Metformin in PCO (polycystic ovary) patients. The study showed a small improvement for ovulation but not clearly better than weight loss. It also showed no improvement in pregnancy outcomes, except in patients with diabetes. It showed no benefit or improvement in hirsuitism, acne or hair loss resulting from PCO (polycystic ovary). Alone, it showed no improvement in pregnancy rates but did show some improvement in combination with Clomiphene (Clomid), yet there was no increase in the live birth rate. The authors therefore concluded that there was no real evidence to draw any conclusions regarding Metformin’s treatment in PCO, and that its only benefits may be in patients with diabetes or impaired glucose tolerance.
As you have seen through reading my blog, PCO (polycystic ovaries) is a very common problem among infertility patients. I have participated in numerous posts, have had several on-line, television and radio discussions regarding this problem, and I have given my opinion regarding the diagnosis, management and treatment options associated with this problem. One of the main problems that I face, almost on a daily basis within the medical community, is the mistreatment of PCO patients with Metformin. I see this commonly done by second tier providers such as Nurse practitioners and Physician Assistants, as well as, Physician providers such as Family Medicine practitioners and general Ob/Gyns. Many of these providers have mistakenly latched onto Metformin as the ultimate drug for the treatment of PCO, much the same as they have latched unto Clomid is the ultimate treatment for infertility. As a result, they automatically treat all suspected PCO patients with Metformin. This practice is unfounded and this recent study shows that treating all PCO patients with Metformin may be misguided. In fact, it brings into question whether there is any benefit at all.
I would not say or conclude that there is no benefit, but there is selective benefit. There are certainly studies that show benefit in a sub-population of PCO patients, just as this study shows benefit in patients with impaired glucose tolerance. These are patients that have been found to have an elevated insulin level or diabetes from insulin resistance. Not diabetics who do not produce insulin. Decreasing this level, either through weight loss or Metformin, will often return the ovary to normal function in these patients, or make their ovaries more responsive to fertility medications.
But clearly, it does not benefit all PCO patients and therefore should be selectively used, not, as many of these aforementioned providers do, used for all PCO patients. There is not a good way to know exactly which patients will respond or not respond to this medication, but here are three requirements that I abide by.\:
*First, a fasting insulin level should be taken to see if it is elevated. If not, then skip the Metformin.
*Secondly, if Metformin is going to work, it can take several months, some authors state 6-8 months, to see if there is any effect. The effect should be noticed by resumption of normal ovarian function i.e. regular menstrual cycles or decrease of the fasting insulin levels.
*Thirdly, a minimum dosage of 1500 mg per day is required. I have seen some patients taking only 500 mg. That is a total waste. If you are going to use this medication then you have to use it in the clinically effective dose.
The exact cause of PCOS is not understood. Some thought it was elevated insulin, but that clearly is not the case in all patients. Some thought it was increased weight, but that also is not the cause. It is clearly some inherent pathway within the ovary that is dyfunctioning, and it is clear that there are many forms of this disorder. It may be a multi-factorial condition where there is not one presentation or one treatment. In is imperative that patients and Physicians understand this and not latch onto one treatment modality for all. Treatments have to be specific to the patient.
Which brings me to my final point regarding the patient-doctor relationship:
This is exactly why Medicine can never be dictated by a cookbook method. People are all different, present differently and must be treated differently. We call that the art of medicine, and this is what makes some doctors better or worse than others, makes some doctors decide to specialize, an option which, unfortunately, is quickly disappearing from medicine as we look to less trained and less costly practitioners.
Edward J. Ramirez, MD, FACOG
The Fertility & Gynecology Center
Monterey Bay IVF