OBJECTIVETo assess the efficacy and safety of Dan'e-fukang soft extract for dysmenorrhea by meta-analysis.

METHODSCochrane Controlled Trials Register, PubMed, EMBASE, CBM, VIP, Wanfang Data, and CNKI databases were searched. Results of randomized controlled trials were also harvested from pharmaceutical companies by manual search. Meta-analysis was carried out according to the method provided by the Cochrane Collaboration with RevMan5.0 software.

RESULTSTwelve Chinese papers were selected, and 1213 patients were included. Significant difference in recovery rate was found between Dan'e-fukang soft extract group and other drugs group (RR=1.33, 95%CI: 1.02-1.75, P<0.05), but the difference no longer existed when studies with pseudo ginseng and marvelon were removed from other drug groups (RR=1.08, 95%CI: 0.91-1.29, P>0.05). No statistical difference was noticed in total effective rate between two groups (RR=1.04, 95%CI: 1.00-1.08, P>0.05). A statistical difference in improvement of dysmenorrhea symptoms was found before and after treatment in both Dan'e-fukang soft extract group and other drugs group (MD=5.79, 95%CI: 5.01-6.56, P<0.001; MD=4.62, 95%CI: 3.71-5.53, P<0.001), while no significant difference was seen between two groups before treatment (MD=0.20, 95%CI: -0.11-0.50, P>0.05) and after treatment (MD=-0.94, 95%CI: -2.11-0.23, P>0.05). Oral administration of Dan'e-fukang soft extract caused only mild gastrointestinal discomfort, but other drugs had more adverse effects including serious gastrointestinal reaction, severe liver dysfunction, vaginal bleeding, and female masculinity.

CONCLUSIONThe existing evidence shows that Dan'e-fukang soft extract has the same efficacy as other drugs in treatment of dysmenorrheal. Because of the quality of the included studies was limited, the evidence of the efficacy and safety of Dan'e-fukang soft extract was not strong, and high-quality randomized trials with large samples are needed.