Efficacy of decoction for regulating thoroughfare vessel and resolving stasis on ovarian endometriosis cyst:a randomized double-blind placebo-controlled trial
Objective It is to evaluate the efficacy and safety of decoction for regulating thoroughfare vessel and resol-ving stasis in the treatment of ovarian endometriosis cyst of type of Qi stagnation and blood stasis.Methods Sixty-four eligi-ble subjects were selected from the patients with ovarian endometriosis cyst of type of Qi stagnation and blood stasis treated in the Second Affiliated Hospital of Jiangxi University of Chinese Medicine from September 2020 to August 2023,and were randomly assigned to either the treatment group or the control group in a 1∶1 ratio.The treatment group was treated with granules of decoction for regulating thoroughfare vessel and resolving stasis,and the control group was treated with granules of placebo,both groups were treated for 3 months.The cyst size,pain VAS score,serum level of CA125,and quality of life[assessed by Endometriosis Health Profile-30(EHP-30)]after 3 months of treatment were compared between the two groups,and the adverse events in both groups were counted.Results Thirty cases in the control group and 31 cases in the treatment group completed the study.Compared with before treatment,the cyst size was decreased(P<0.05),the pain VAS score and all scores of items of EHP-30 were significantly decreased(all P<0.05),but there was no significant change in the serum level of CA125 in the treatment group after 3 months of treatment(P>0.05),and there was no signif-icant change in the above indexes in the control groupafter 3 months of treatment(all P>0.05).After treatment,the pain VAS score and the scores of 3 dimensions of pain,control and powerlessness and emotional health in the EHP-30 scale in the treatment group were significantly lower than those in the control group(all P<0.05),but the differences in cyst size,serum CA125 level,and scores of dimensions of social support and self-image in the EHP-30 scale were not statistically sig-nificant between the two groups(all P>0.05).No significant adverse events occurred in the two groups during treatment.Conclusion Decoction for regulating thoroughfare vessel and resolving stasis can relieve pain and improve quality of life without obvious side effect in women with ovarian endometriosis cyst of type of Qi stagnation and blood stasis.
ovarian endometriosis cystendometriosisdecoction for regulating thoroughfare vessel and resolving sta-sispainquality of life