Abstract：
OBJECTIVE: To confirm the efficacy and safety of Ganyushu Granule (GYSG) in treating premenstrual syndrome (PMS) in patients with Gan (Liver) depression and qi stagnation syndrome (GDQSS) and determine its effective dosage.
METHODS: From June 2018 to March 2021, a total of 240 PMS women with GDQSS were included and randomly divided into 3 groups in a 1:1:1 ratio using central block randomization: high-dose GYSG group (n=78, GYSG 2 packs/time), low-dose GYSG group (n=82, GYSG and its simulant 1 pack/time), and placebo group (n=80, GYSG simulant 2 packs/time). Treatment with GYSG or placebo was given thrice daily and for up to 3 menstrual cycles. Primary outcomes were PMS diary (PMSD) score and premenstrual tension syndrome self-rating scale (PMTS). Secondary outcomes were Chinese medicine (CM) syndrome efficacy. PMSD, PMTS, and efficacy of CM were evaluated with menstrual cycles during the treatment period. Outcome indicators were analyzed after each menstrual cycle. All analyses were performed using an intention-to-treat method, and clinical safety was assessed.
RESULTS: Of the 216 patients included in the effectiveness analysis, 70, 75, and 71 patients were in the high-, low-dose GYSG, and placebo groups, respectively. From the 2nd treatment cycle, the change in PMSD scores in the high- and low-dose groups was lower than that in the placebo group (P<0.05). PMTS scores in the high-dose GYSG group after the 1st treatment cycle was lower than that in the placebo group (P<0.05), while after the 3rd treatment cycle, that in the low-dose group was lower than that in the placebo group (P<0.05). After the 2nd treatment cycle, the high-dose GYSG group had the best CM syndrome efficacy (P<0.05). No serious adverse reactions were reported.
CONCLUSIONS: GYSG was safe and well-tolerated at both doses for treating PMS patients with GDQSS. High-dose GYSG might be the optimal dose for a phase III trial. (Registration No. ChiCTR1800016595).
METHODS: From June 2018 to March 2021, a total of 240 PMS women with GDQSS were included and randomly divided into 3 groups in a 1:1:1 ratio using central block randomization: high-dose GYSG group (n=78, GYSG 2 packs/time), low-dose GYSG group (n=82, GYSG and its simulant 1 pack/time), and placebo group (n=80, GYSG simulant 2 packs/time). Treatment with GYSG or placebo was given thrice daily and for up to 3 menstrual cycles. Primary outcomes were PMS diary (PMSD) score and premenstrual tension syndrome self-rating scale (PMTS). Secondary outcomes were Chinese medicine (CM) syndrome efficacy. PMSD, PMTS, and efficacy of CM were evaluated with menstrual cycles during the treatment period. Outcome indicators were analyzed after each menstrual cycle. All analyses were performed using an intention-to-treat method, and clinical safety was assessed.
RESULTS: Of the 216 patients included in the effectiveness analysis, 70, 75, and 71 patients were in the high-, low-dose GYSG, and placebo groups, respectively. From the 2nd treatment cycle, the change in PMSD scores in the high- and low-dose groups was lower than that in the placebo group (P<0.05). PMTS scores in the high-dose GYSG group after the 1st treatment cycle was lower than that in the placebo group (P<0.05), while after the 3rd treatment cycle, that in the low-dose group was lower than that in the placebo group (P<0.05). After the 2nd treatment cycle, the high-dose GYSG group had the best CM syndrome efficacy (P<0.05). No serious adverse reactions were reported.
CONCLUSIONS: GYSG was safe and well-tolerated at both doses for treating PMS patients with GDQSS. High-dose GYSG might be the optimal dose for a phase III trial. (Registration No. ChiCTR1800016595).
摘要：
目的：证实肝郁气滞证(GDQSS)患者经前期综合征(PMS)的疗效和安全性,并确定其有效剂量。
方法：从2018年6月至2021年3月，共纳入240名患有GDQSS的PMS女性，并使用中央阻滞随机化以1：1：1的比例随机分为3组：高剂量GYSG组（n=78，GYSG2包/次），低剂量GYSG组（n=82，GYSG及其模拟1包/次），和安慰剂组（n=80，GYSG模拟2包/次）。每天三次给予GYSG或安慰剂治疗，最多3个月经周期。主要结果是PMS日记（PMSD）评分和经前期紧张综合征自评量表（PMTS）。次要结果为中医(CM)证候疗效。PMSD,PMTS,治疗期间以月经周期评价CM的疗效。每个月经周期后分析结果指标。所有分析均使用意向治疗方法进行，并对临床安全性进行了评估.
结果：在纳入有效性分析的216例患者中，70、75和71名患者处于高，低剂量GYSG,和安慰剂组，分别。从第二个治疗周期开始，高、低剂量组PMSD评分变化低于安慰剂组(P<0.05)。大剂量GYSG组在第1个治疗周期后的PMTS评分低于安慰剂组(P<0.05),而在第三个治疗周期后，低剂量组低于安慰剂组(P<0.05)。第二个治疗周期后，高剂量GYSG组CM综合征疗效最好(P<0.05)。无严重不良反应报告。
结论：GYSG在两种剂量下治疗PMS患者的GDQSS均安全且耐受性良好。高剂量GYSG可能是III期试验的最佳剂量。(登记号ChiCTR1800016595)。
方法：从2018年6月至2021年3月，共纳入240名患有GDQSS的PMS女性，并使用中央阻滞随机化以1：1：1的比例随机分为3组：高剂量GYSG组（n=78，GYSG2包/次），低剂量GYSG组（n=82，GYSG及其模拟1包/次），和安慰剂组（n=80，GYSG模拟2包/次）。每天三次给予GYSG或安慰剂治疗，最多3个月经周期。主要结果是PMS日记（PMSD）评分和经前期紧张综合征自评量表（PMTS）。次要结果为中医(CM)证候疗效。PMSD,PMTS,治疗期间以月经周期评价CM的疗效。每个月经周期后分析结果指标。所有分析均使用意向治疗方法进行，并对临床安全性进行了评估.
结果：在纳入有效性分析的216例患者中，70、75和71名患者处于高，低剂量GYSG,和安慰剂组，分别。从第二个治疗周期开始，高、低剂量组PMSD评分变化低于安慰剂组(P<0.05)。大剂量GYSG组在第1个治疗周期后的PMTS评分低于安慰剂组(P<0.05),而在第三个治疗周期后，低剂量组低于安慰剂组(P<0.05)。第二个治疗周期后，高剂量GYSG组CM综合征疗效最好(P<0.05)。无严重不良反应报告。
结论：GYSG在两种剂量下治疗PMS患者的GDQSS均安全且耐受性良好。高剂量GYSG可能是III期试验的最佳剂量。(登记号ChiCTR1800016595)。
