Hormonal contraceptives for contraception in overweight or obese women

Background Obesity has reached epidemic proportions around the world. Effectiveness of hormonal contraceptives may be related to metabolic changes in obesity or greater body mass or body fat. Hormonal contraceptives mainly include oral contraceptives, injectables and implants, the transdermal patch, and the vaginal ring. We systematically reviewed the evidence on the effectiveness of hormonal contraceptives among overweight and obese women. Objectives To examine the effectiveness of hormonal contraceptives in preventing unplanned pregnancies among women who are overweight or obese versus women of lower weight or body mass index (BMI). Search methods Through January 2013, we searched MEDLINE, CENTRAL, POPLINE, ClinicalTrials.gov, and ICTRP. The previous search also included EMBASE. We contacted investigators to identify other trials. Selection criteria All study designs were eligible. Any type of hormonal contraceptive could have been examined. Reports had to contain information on the specific contraceptive method(s). The primary outcome was pregnancy. Overweight or obese women must have been identified by an analysis cutoff for weight or BMI (kg/m(2)). Data collection and analysis Data were abstracted by two authors. Life-table rates were included where available. For dichotomous variables, we computed an odds ratio with 95% confidence interval (CI). We used reported pregnancy rates or relative risk (RR) when those were the only results provided. The main comparisons were between overweight or obese women and women of lower weight or BMI. We assessed the quality of evidence for this review. Main results We found nine reports with data from 13 trials that included a total of 49,712 women. Five reports from 2002 to 2012 compared BMI groups; of those, one reported a higher pregnancy risk for overweight or obese women. In that trial, women assigned to an oral contraceptive containing norethindrone acetate 1.0 mg plus EE 20 mu g and having a BMI at least 25 had greater pregnancy risk compared to those with BMI less than 25 (reported RR 2.49; 95% CI 1.01 to 6.13). The comparisons reported in the other four studies were not significantly different for pregnancy. These included studies of a combined oral contraceptive (COC), a transdermal patch, an implant, and an injectable. The COC study showed no trend by BMI or weight. With the transdermal patch, body weight was associated with pregnancy (reported P < 0.001) but BMI was not. The implant study had one pregnancy and the injectable study reported no pregnancies. Four studies from the 1990s used weight alone rather than BMI. Results were mixed. Studies of a vaginal ring (never marketed) and a six-rod implant showed higher pregnancy rates for women weighing at least 70 kg versus those weighing less than 70 kg (reported P values: 0.0013 and <0.05, respectively). However, two implant studies showed no trend by body weight. Authors' conclusions The evidence did not generally show an association of BMI with effectiveness of hormonal contraceptives. However, the evidence was limited for any individual contraceptive method. Studies using BMI (rather than weight alone) can provide more information about whether body composition is related to contraceptive effectiveness. The efficacy of subdermal implants and injectable contraceptives may be unaffected by body mass. The contraceptive methods examined here are among the most effective when the recommended regimen is followed. The overall quality of evidence was low for this review. More recent reports provided moderate quality evidence, while the older studies provided evidence of low or very low quality for our purposes. Investigators should consider adjusting for potential confounding related to BMI. Trials should be designed to include sufficient numbers of overweight or obese women to adequately examine effectiveness and side effects of hormonal contraceptives within those groups.