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. 2019 Jan 20;2019(1):CD001324. doi: 10.1002/14651858.CD001324.pub6
Dr. Schenk comments Author / FRG responses
With interest but also with concern I read the updated Cochrane review “Interventions for emergency contraception”, published in Issue 8, 2017. Without presenting any new data you changed your conclusion about the effectiveness of ulipristal acetate (UPA) from “UPA may be more effective than LNG” (= levonorgestrel) in the former version (published 2012) to “UPA was more effective than levonorgestrel” in the actual review. I suppose that this is based on a mistake in the results section of the new version: We edited the conclusion to say “UPA may be more effective than LNG” in the Authors’ conclusions in the abstract and main text
On page 23 in the full pdf of the updated review under item 2.15.1 you state that “UPA was associated with fewer pregnancies than levonorgestrel ‘within 72 hours after unprotected intercourse’ (RR 0.59, 95% CI 0.35 to 0.99, 2 RCTs, n = 3448…)” referring to Analysis 16.1. In the abstract you present this result even without mentioning the time elapsed since intercourse. In Analysis 16.1, however, all the five‐day data (i.e. within 120 hours) from the Glasier 2010 trial were combined with the three‐day data from the Creinin 2006 trial. We edited section 2.15.1 to say ‘within 120 hours after unprotected intercourse’
The correct analysis for the comparison UPA versus LNG within 72 hours after unprotected intercourse is Analysis 16.4 which reveals a statistically non‐significant difference (RR 0.63, 95% CI 0.37 to 1.07). This was the first comparison described in the results section of the former review (published 2012) and the only one mentioned in the former abstract and there are good reasons preferring it: The risk of pregnancy is significantly lower if LNG is administered within 72 hours of unprotected intercourse than if it is given later than this (RR 0.51, 95% CI 0.31 to 0.84, Analysis 28.4). In Europe as well as in the USA LNG is approved for use within 72 hours of unprotected intercourse only. In the discussion of the former review you also stated that “since the Creinin 2006 trial did not recruit participants who had unprotected intercourse after 72 hours, the rationale of combining all five‐day data from the Glasier 2010 trial in the analysis is debatable” (page 19 in the full pdf of the version from 2012). The current review lacks such critical considerations – the thought that “we may need more trials conducted by independent investigators to make a firm conclusion” (page 19, version from 2012) has disappeared as well. No changes were made, the abstract will remain as:
Ulipristal acetate (UPA) was associated with fewer pregnancies than levonorgestrel (RR 0.59; 95% CI 0.35 to 0.99, 2 RCTs, n = 3448, I2 = 0%, high‐quality evidence).