抽象的

Safety and efficacy of the honghuaruyi pill for relieving chronic pelvic pain: A multiple center and randomized controlled study.

Yanxia Liu, Xin Xu, Jimaocairang, Zhongming Zhou, Bei Lv, Min Xia, Baoli Cao, Xinpei Zhang, Shuyan Ma, Zhe Jin

Honghuaruyi (HHRY) pill is considered as an effective treatment for Chronic pelvic pain (CPP) with the efficacy of promoting qi and blood circulation but lack of high-quality clinical evidence. This study is to evaluate the efficacy and safeties of HHRY pill.280 patients were randomly divided into two groups to receive HHRY pill or placebo. Pain relief rate, curative effect of disease as well as qi stagnation and blood stasis symptom in TCM, clinical signs of CPP, adnexal masses size and amount of fluid and EQ-5D instruments were evaluated. After treatment, pain relief rate was significantly higher (P<0.05). There was also significant difference (P<0.0001) of curative effect in both disease and symptom. The score of low abdominal pain, etc. were significantly lower (P<0.05). The score of tenderness caused by limited uterine activity and thickening or with adnexal masses of attachments were significantly different (P<0.05). The increased size of adnexal mass in HHRY pill group was 0.53 ± 8.19 and was 0.80 ± 4.28 in placebo group. The decreasing amount of fluid in HHRY pill group was 0.53 ± 2.63 and was 1.10 ± 3.40 in placebo group. Pain, anxiety and EQ-VAS score were significantly improved (P<0.05). No serious adverse reactions occurred. This study indicated HHRY pill would reduce patients’ chronic pelvic pain, improve corresponding clinical signs, symptoms in TCM and enhance the quality of life. However, more biochemical indicators are needed to assess the effect.