Objective: To estimate the minimal clinically important difference (MCID) of the frequency of bowel movement for the patients with chronic severe functional constipation treated with acupuncture so as to provide the evidence for the clinical decision.
Methods: In this study, 813 patients with chronic severe functional constipation treated with acupuncture in two previous randomized controlled trials were included. Through the anchor-based method (anchored by the item 28 "satisfaction with previous treatment" of the patient assessment of constipation-quality of life [PAC-QOL]) and the distribution-based method, the MCID of the weekly frequency of complete spontaneous bowel movement (CSBM) and spontaneous bowel movement (SBM) was analyzed statistically in the patients.
Results: The MCID of the mean weekly frequency of CSBM and SBM was 1.3 times and 1.6 times in patients with chronic severe functional constipation treated with acupuncture, respectively.
Conclusion: The mean increase of the weekly CSMB is ≥ 1.3 times and that of SBM is ≥ 1.6 times after treatment when compared with the baseline respectively, suggesting the clinical significance.
目的：评估针刺治疗慢性严重功能性便秘患者排便次数的最小临床意义变化值（MCID），为临床决策提供依据。方法：纳入既往两项随机对照试验中813例接受针刺治疗的慢性严重功能性便秘患者，通过校标法[以便秘患者生活质量量表（PAC-QOL）第28条“对以往治疗满意度”为校标]和分布法，对患者平均每周完全自主排便（CSBM）次数和自主排便（SBM）次数的MCID进行统计分析。结果：针刺治疗慢性严重功能性便秘患者平均每周CSBM和SBM次数的MCID分别为1.3次和1.6次（校标法）。结论：慢性严重功能性便秘患者在治疗后平均每周CSBM较治疗前增加≥1.3次、SBM增加≥1.6次具有临床意义。.
Keywords: acupuncture; chronic severe functional constipation; frequency of complete spontaneous bowel movement; frequency of spontaneous bowel movements; minimal clinically important difference (MCID).