[Evaluation on Efficacy and Safety of Jinying Capsule in Treatment of Pelvic Inflammatory Disease Patients with Accumulated Damp-heat Syndrome].

Objective: To evaluate the efficacy and safety of Jinying Capsule (JC) in treating pelvic inflammatory disease patients with accumulated damp-heat syndrome (ADHS).

Methods: Totally 328 patients were recruited in a prospective, positive drug parallel controlled, and multi-center clinical trial. Of them 213 patients in the treatment group took JC (0.5 g per capsule), 4 capsules each time, 3 times per day, while 115 patients in the control group took Kangfuyan Capsule (KC, 0.4 g per capsule), 3 capsules each time, twice per day. The course of treatment was 4 weeks for all. Scores of Chinese medical syndromes, visual analogue scale (VAS) of the lower abdominal pain, and European quality of life-five dimension scale (EQ-5D) were observed before treatment and after 4 weeks of treatment.

Results: There were 204 patients in the treatment group and 109 in the control group who completed this trial. The total effective rate of Chinese medical syndrome was 89.71% (183/204 cases) in the treatment group and 76.15% (83/109 cases) in the control group (P < 0.01). Compared with before treatment in the same group, EQ-5D scores increased, and VAS scores of the lower abdominal pain decreased in the two groups after treatment. EQ-5D scores was 0.857 ± 0.157 in the treatment group, obviously higher than that in the control group (0.753 ± 0.126, P < 0.05). VAS scores of the lower abdominal pain was 2.14 ± 1.23 in the treatment group, lower than that in the control group (2.33 ± 1.24), but with no statistical difference between the two groups (P > 0.05). No adverse reaction occurred in the two groups.

Conclusion: JC was superior to KC in improving Chinese medical syndrome and quality of life of pelvic inflammatory disease patients with accumulated damp-heat syndrome.