纾肠方治疗肝郁脾虚证腹泻型肠易激综合征多中心随机双盲安慰剂对照研究

Shuchang Decoction for Treatment of Diarrhea Predominant Irritable Bowel Syndrome with Gan Depression and Pi Deficiency:A Multicenter,Randomized,Double-Blind,Placebo Controlled Trial

目的观察纾肠方治疗肝郁脾虚证腹泻型肠易激综合征(IBS-D)的临床疗效和安全性。方法采用多中心、随机、双盲、安慰剂平行对照、优效性检验临床试验设计,收集12家上海市脾胃病专科联盟加盟单位就诊的IBS-D患者179例,最终入组受试者120例,采用中心分层区组化随机方法分为试验组(42例,给予纾肠方)、对照组(43例,给予疏肝饮)和安慰剂组(35例,给予十分之一剂量药物)。3组同时给予低可发酵的低聚糖、二糖、单糖和多元醇(FODMAP)饮食指导。治疗周期为8周。采用符合方案集(PPS)为主要数据集进行疗效评价,依据意向性分析原则进行安全性分析。主要疗效评价指标为肠道严重程度评分(IBS-SSS)及中医证候评分;次要疗效指标为腹痛/腹部不适视觉模拟(VAS)评分、腹泻评分、临床症状痊愈率和肠易激综合征生活质量量表(IBS-QOL)。结果PPS集纳入110例,其中试验组39例,对照组39例,安慰剂组32例。与本组治疗前比较,试验组与对照组治疗14~56天时IBS-SSS评分均降低(P<0.05),56天时多梦易醒、急躁易怒、善思多虑症状评分及脾虚次症均降低(P<0.05),治疗后IBS-QOL评分亦降低(P<0.05)。与安慰剂组比较,试验组与对照组IBS-SSS、腹痛、腹泻总有效率及临床痊愈率升高,中医证候总有效率及显效率亦升高(P<0.05),试验组中医证候痊愈率及临床痊愈率升高(P<0.05);试验组与对照组治疗后IBS-SSS评分、多梦易醒、急躁易怒、善思多虑、食欲不振、精神疲乏、四肢无力次症评分及IBS-QOL评分均降低(P<0.05)。与对照组比较,试验组IBS-SSS总有效率、痊愈率,中医证候评分显效率,腹痛痊愈率,腹泻痊愈率和总有效率,临床症状痊愈率均升高(P<0.05);试验组治疗42~56天时IBS-SSS评分、56天时善思多虑、精神疲乏、四肢无力评分均降低(P<0.05)。治疗前后未发现试验组安全性指标异常。结论纾肠方可改善肝郁脾虚证IBS-D患者腹痛腹泻症状和中医证候,疗效优于疏肝饮,短期应用安全性好。

Objective To observe the clinical efficacy and safety of Shuchang Decoction(SCD)in the treatment of diarrhea-predominant irritable bowel syndrome(IBS-D)with Gan depression and Pi deficiency syndrome.Methods This was a multicenter,randomized,double-blind,placebo-controlled,superiority testing clinical trial.A total of 179 patients with IBS-D were recruited from 12 hospitals of Shanghai TCM Gastroenterology Federation.Finally 120 patients who met the inclusion criteria were randomly assigned to the test group(42 cases),the control group(43 cases),and the placebo group(35 cases).Patients in the test group took SCD,patients in the control group took Shugan Decoction(SGD),while those in the placebo group took 1/10 dose of SCD.The treatment period was 8 weeks.All subjects accepted low-FODMAP food instruction.The efficacy was evaluated with Per Protocol set(PPS)and the safety evaluation was analyzed according to the principle of intention-to-treat analysis.The main efficacy indexes were irritable bowel syndrome intestinal severity score(IBS-SSS)and Chinese medicine(CM)symptom score.The secondary efficacy indexes were abdominal pain/discomfort Visual Analogue Scale(VAS)score,diarrhea score,clinical cure rate and IBS-QOL.Results Totally 110 patients were included in PPS set,39 cases in the test group,39 cases in the control group,and 32 cases in the placebo group.Compared with the baseline,IBS-SSS scores of the test group and the control group decreased at 14-56 days(P<0.05),and CM symptom scores of dreaminess,irritability,anxiety and all CM symptom scores of Pi deficiency decreased at 56 days(P<0.05),IBS-QOL scores of the test group and the control group decreased after the treatment(P<0.05).Compared with the placebo group,IBSSSS total effective rate,the cure rate and the total effective rate of abdominal pain and diarrhea,CM symptom total effective rate and the remarkable effective rate increased in the test and the control group(P<0.05),CM symptom cure rate and clinical cure rate increased in the test group(P<0.05).Compared with the placebo group,IBS-SSS score,dreaminess score,irritability score,anxiety score,poor appetite score,fatigue score,limb weakness score and IBS-QOL score decreased in both groups after treatment(P<0.05).Compared with the control group,IBS-SSS total effective rate and the cure rate,CM symptom remarkable effective rate,abdominal pain cure rate,diarrhea cure rate and total effective rate,as well as clinical cure rate increased in the test group(P<0.05).Compared with the control group,IBS-SSS score decreased at 42-56 days,the scores of anxiety,fatigue and limb weakness score decreased at 56 days after treatment in the test group(P<0.05).There were no abnormal safety indexes in the test group.Conclusions SCD can relieved the symptoms of abdominal pain,diarrhea and CM syndrome in IBS-D patients with Gan depression and Pi deficiency syndrome.Short-term application is safe.