Research Triangle Park, NC, USA — In part in an effort to improve safety, drug manufacturers have been decreasing the dose of estrogen in combined oral contraceptives since they were first introduced more than 30 years ago. Some have claimed that the amount of estrogen in the pills can be lowered to 20 micrograms or less without compromising menstrual cycle control. However, a systematic review from Family Health International (FHI), conducted with partial funding from the U.S. Agency for International Development suggests otherwise. The review of 18 randomized controlled trials comparing pills containing 20 micrograms or less of estrogen with those containing more than 20 micrograms of the hormone found that women taking some of the very low-dose pills had an increased risk of bleeding disturbances and higher rates of early discontinuation from the trials. The trials were too small to adequately compare the pills in terms of contraceptive effectiveness.
"Basically, consumers and clinicians should be skeptical of claims of superiority with new products. 'New' is not always a synonym for 'improved' when it comes to drugs," says Dr. David Grimes, a co-author of the review and vice president for biomedical affairs at FHI.
Health care providers — many who today routinely prescribe pills containing 20 micrograms of estrogen — need to balance any theoretical benefit of these pills with the evidence that they cause more bleeding problems and thus may cause more women to quit using them. To read the abstract for this review, published in Contraception, click here.
Family Health International (FHI) is dedicated to improving lives, knowledge, and understanding worldwide through a highly diversified program of research, education, and services in family health and HIV/AIDS prevention and care. FHI conducts research and programs in accordance with international ethical principles, provides technical assistance to partners in the conduct of ethical research (medical and behavioral), and develops materials that provide guidance in establishing, monitoring, and maintaining high ethical standards in conducting projects or research involving people.