A Phase III Clinical Trial Evaluating the Efficacy of Yinghua Tablet in the Treatment of Sequelae of Pelvic Inflammatory Disease.

OBJECTIVE

To evaluate the efficacy and safety of the Yinghua tablet in treating sequelae of pelvic inflammatory diseases (PID) that manifest as the syndrome of dampness-heat stasis.

METHODS

The experimental group enrolled 360 cases, while the control group enrolled 120 cases. The experimental group took Yinghua tablets three times a day, three tablets each time, and the control group took Fuyankang tablets three times a day, three tablets each time. The treatment course was six weeks. Before treatment, at three weeks and six weeks of treatment, the patients were scored for TCM syndrome, clinical symptoms and, signs, and adverse events during treatment were recorded.

RESULTS

The experimental group included 340 cases, and the control group finally included 114 cases. After six weeks of treatment, statistically significant differences were observed between the two groups in the treatment effect, recovery rate, markedly effective rate, and total effective rate (P < .05). The two groups had no significant difference in the effective rate of local signs (P > .05). However, the two groups had a significant difference in the total effective rate (P < .05). Before and after treatment, traditional Chinese medicine (TCM) symptoms score, symptom sign score, and local sign score were statistically significant (P < .05). The incidence of adverse events (AEs) after taking Yinghua Tablets was 3.61% (13 times), of which the incidence of adverse events related to study drugs was 0.28% (1 case). The AEs of Fuyankang Tablets were 1.67% (2 times), of which the incidence of adverse events related to study drugs was 1.67% (2 cases). There was no significant difference in the incidence of AEs between the two groups as compared to Fisher (P = .3767), indicating that no serious AEs occurred in either group.

CONCLUSIONS

Yinghua tablet was effective and safe in treating sequelae of pelvic inflammatory diseases.