Serial multilevel urine pregnancy testing to assess medical abortion outcome: a meta-analysis.
I read with interest the systematic review onmedical abortion by Chen and Creinin and was concerned by their conclusion that “more data are needed to evaluate clinical outcomes.beyond 63 days of gestation.” In fact, more data have been published since this review, but additional data should not be a prerequisite for offering the safe and effective regimen of mifepristone plus misoprostol between 64 and 70 days of gestational age. To be sure, mifepristone is not a new drug with unknown properties: using it beyond 63 days of gestation is an addition to an established, proven procedure. The review authors indicate that the data from 332 patients identified between 64 and 70 days of gestation offer insufficient evidence to recommend clinical use, yet this sample provides a confidence interval (CI) of 89.6–95.5 in which even the lower limit represents a highly efficacious procedure that women should be allowed to choose. Doctors Chen and Creinin even note that the reviewdemonstrates a higher efficacy through 63 days of gestation than the pivotal trial for U.S. Food and Drug Administration (FDA) approval. This statement is also true through 70 days of gestation. Indeed the CIs are almost precisely the same (FDA approval to 49 days of gestation: 92% CI 90–94; 10th week review data: 93% CI 90–96%). Two substantial clinical trials have directly compared efficacy in the 9th and 10th weeks of gestation and find no statistically significant differences, and a new summary of the literature in the 10th week (more than 900 women) reaches the same conclusion. The caution advocated by Chen and Creinin in the 10th week of gestation should simply take the form of counseling. Women seeking medical abortion in the 10th week of gestation should know efficacy rates and then make their decisions accordingly. Indeed, how much data do the authors feel would be enough to recommend this regimen in the 10th week of gestation?With what width of a CI? Let’s not allow excessive caution to distort our understanding of the evidence or inhibit us from providing the care our patients deserve.