猴姑米稀对脾气虚型非器质性胃肠疾病有效性与安全性的多中心随机双盲对照试验:一年随访结果

The efficiency and safety of Hou Gu Mi Xi for patients with spleen qi deficiency nonorganic gastrointestinal disorders:1-year follow-up results in a multicenter,randomized,double blind,controlled trial

目的评价猴姑米稀对非器质性胃肠疾病(nonorganic gastrointestinal disorders,NOGD)脾气虚证(spleen qi deficiency,SQD)患者的有效性和安全性。方法采用随机、盲法、平行、安慰剂对照试验设计,纳入NOGD患者并随机分为猴姑米稀组与安慰剂组,每天食用30g猴姑米稀或安慰剂,于第0、2、4、8、26、52周随访观察,比较两组的不同NOGD类型和不同幽门螺旋杆菌(helicobacter pylori,Hp)类型亚组间SQD症状评估量表得分、体重、体质指数(body mass index,BMI)、胃泌素17及不良事件发生情况。结果共纳入200例患者,其中猴姑米稀组100例,安慰剂组100例。在第4、8、26、52周随访点,猴姑米稀组SQD量表得分(临床症状)显著低于安慰剂组[MD=-9.40,95%CI(-18.53,-0.27),P=0.044]、[MD=-10.07,95%CI(-19.66,-0.48),P=0.04]、[MD=-12.45,95%CI(-22.31,-2.59),P=0.014]和[MD=-17.25,95%CI(-28.53,-5.97),P=0.003]。亚组分析显示,在第8、26、52周3个随访点,猴姑米稀可显著降低Hp阴性患者的SQD量表得分[MD=-15.20,95%CI(-28.16,-2.24),P=0.022]、[MD=-17.91,95%CI(-31.22,-4.59),P=0.009]和[MD=-20.38,95%CI(-35.43,-5.32),P=0.008];但对Hp阳性患者,两组得分差异无统计学意义。在第2、26、52周,猴姑米稀可显著降低慢性非萎缩性胃炎患者的SQD量表得分[MD=-13.02,95%CI(-24.75,-1.29),P=0.03]、[MD=-12.43,95%CI(-24.36,-0.5),P=0.041]和[MD=-15.90,95%CI(-30.72,-1.08),P=0.036],并在第52周时降低功能性胃肠病患者的SQD量表得分[MD=-18.22,95%CI(-35.75,-0.69),P=0.042]。研究和随访期间猴姑米稀组均未发生不良事件。两组患者在体重、BMI、胃泌素17水平方面的差异均无统计学意义。结论猴姑米稀可有效改善非器质性胃肠疾病,特别是Hp阴性患者的脾气虚证症状,且安全性良好。

Objectives To investigate the efficacy and safety of Hou Gu Mi Xi(HGMX) in patients with nonorganic gastrointestinal disorders(NOGD) from the aspect of dietary therapy. Methods A randomized, doubleblind, parallel, placebo-controlled trial was performed. Patients with NOGD and spleen qi deficiency(SQD) syndrome were randomly assigned into HGMX or placebo group. Each received 30 g/day HGMX or placebo for one year. The outcomes included SQD scores, body weight, body mass index(BMI), gastrin-17, and adverse events(AEs) between HGMX and placebo groups, or subgroups divided by NOGD type or helicobacter pylori(Hp) infection, at the 0th, 2nd, 4th,8th, 26th, or 52nd weeks’ follow-up. Results The reduction of SQD scale score was found in the HGMX group compared with the placebo group at 4th week(MD=-9.40, 95%CI-18.53 to-0.27, P=0.044), 8th week(MD=-10.07, 95%CI-19.66 to-0.48, P=0.04), 26th week(MD=-12.45, 95%CI-22.31 to-2.59, P=0.014) and 52th week(MD=-17.25, 95%CI-28.53 to-5.97, P=0.003), respectively. In the subgroup analyses, HGMX showed significant efficacy in Hp-negative patients with the detailed reduction of SQD scale score being(MD=-15.20, 95%CI-28.16 to-2.24, P=0.022),(MD=-17.91, 95%CI-31.22 to-4.59, P=0.009) and(MD=-20.38, 95%CI-35.43 to-5.32, P=0.008) at the 8th, 26th and 52nd week, respectively,and in patients with chronic nonatrophic gastritis with the detailed reduction being(MD=-13.02, 95%CI-24.75 to-1.29,P=0.03),(MD=-12.43, 95%CI-24.36 to-0.5, P=0.041) and(MD=-15.90, 95%CI-30.72 to-1.08, P=0.036) at the 2nd, 26th and 52nd week, respectively, and in patients with functional gastrointestinal disease with the reduction being(MD=-18.22,95%CI-35.75 to-0.69, P=0.042) at the 52nd week. However, no significant efficacy was found in Hp-positive patient at any time. HGMX was not associated with changes in weight, BMI, or gastrin-17. No AEs were reported in the HGMX group. Conclusions HGMX improves SQD symptoms in patients with NOGD, especially Hp-negative patients, and has a good safety profile.