目的:thumbtack刺法(TN)已用于治疗功能性便秘(FC),尽管支持其有效性的现有证据有限。本研究旨在评估TN改善FC的功效。
方法:共招募482名符合条件的患者,并随机分配到TN组或枸橼酸莫沙必利(MC)组。TN被埋了三天,在连续两次埋葬后休息一天,随后进行为期4周的随访。主要结果指标是完全和自发排便评分(CSBM)。次要结果指标包括布里斯托尔凳子形式量表(BSFS),克利夫兰诊所评分(CCS),便秘患者生活质量评估问卷(PAC-QOL)。
结果:在随机分组的482例患者中,241个被分配到每个组。其中,两组共216例(89.6%)患者完成干预和随访。与基线相比,在第4周时,TN组[1.76(95%CI,1.61~1.91)]和MC组[1.35(95%CI,1.20~1.50)]的CSBMs差异达到最小临床重要差异(MCID)的阈值.然而,两组在第2周和第8周与基线无临床差异.在第4周,TN组为3.35±0.99,MC组为3±1.03(组间调整后的差异,0.37点[95%CI,0.18至0.55];P<0.001),尽管两组之间的差异未达到MCID阈值.
结论:与柠檬酸莫沙必利相比,图钉针刺在CSBM中产生了更大的改进,尽管与对照组的差异无临床意义。
结果:
■ChiCTR2100043684。
OBJECTIVE: Thumbtack Needling (TN) has been employed in the treatment of functional constipation (FC), although the existing evidence supporting its effectiveness is limited. This study is to evaluate the efficacy of TN in ameliorating FC.
METHODS: A total of 482 eligible patients were recruited and randomly assigned to the TN group or the Mosapride Citrate (MC) group. The TN was buried once for three days, rest for one day after two consecutive burials, followed by a 4-week follow-up. The primary outcome measure was the score for Complete and spontaneous bowel movement score (CSBMs). Secondary outcome measures included the Bristol Stool Form Scale (BSFS), Cleveland Clinic Score (CCS), and the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).
RESULTS: Out of the 482 patients randomized, 241 were allocated to each group. Of these, 216 patients (89.6 %) in both groups completed the intervention and follow-up. Compared with the baseline, the differences of CSBMs in TN group [1.76(95 % CI, 1.61 to 1.91)] and MC group [1.35(95 % CI, 1.20 to 1.50)] at week 4 meet the threshold for minimal clinically important difference (MCID). However, there were no clinical difference from baseline at week 2 and week 8 in both groups. Mean CSBMs at week 4 was 3.35 ± 0.99 in the TN group and 3 ± 1.03 in the MC group (adjusted difference between groups, 0.37 points [95 % CI, 0.18 to 0.55]; P < 0.001), although differences between the two groups did not meet the MCID threshold.
CONCLUSIONS: Compared with mosapride citrate, thumbtack needling produced a greater improvement in CSBMs, although the difference from control was not clinically significant.
RESULTS: UNASSIGNED: ChiCTR2100043684.