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Abstract：
BACKGROUND: Pediatric Tuina has been widely used in children with acute diarrhea in China. However, due to the lack of high-quality clinical evidence, the benefit of Tuina as a therapy is not clear. We aimed to assess the effect of pediatric Tuina compared with sham Tuina as an add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea.
METHODS: Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive pediatric Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.
RESULTS: Pediatric Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT (crude RR, 0.73 [95% CI, 0.59-0.91]) and PP analyses (crude RR, 0.66 [95% CI, 0.53-0.83]). However, the results were not significant when we adjusted for social demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.
CONCLUSIONS: In children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.
BACKGROUND: Clinicaltrials.gov, Identifier: NCT03005821 , Data of registration: 2016-12-29.
METHODS: Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive pediatric Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.
RESULTS: Pediatric Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT (crude RR, 0.73 [95% CI, 0.59-0.91]) and PP analyses (crude RR, 0.66 [95% CI, 0.53-0.83]). However, the results were not significant when we adjusted for social demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.
CONCLUSIONS: In children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.
BACKGROUND: Clinicaltrials.gov, Identifier: NCT03005821 , Data of registration: 2016-12-29.
摘要：
背景：小儿推拿已广泛应用于中国急性腹泻患儿。然而,由于缺乏高质量的临床证据，推拿作为治疗的益处尚不清楚。我们旨在评估小儿推拿与假推拿作为0-6岁急性腹泻患儿常规治疗之外的附加疗法的效果。
方法：86名0-6岁急性腹泻患者随机接受小儿推拿加常规护理（n=43）或假推拿加常规护理（n=43）。主要结果为从基线开始的腹泻天数和第3天的腹泻次数。次要结果包括全球变化评级（GCR）和粪便特征恢复正常的天数。评估不良事件。
结果：在两种ITT中，与假推拿相比，小儿推拿与第3天腹泻次数减少有关（粗RR，0.73[95%CI，0.59-0.91])和PP分析(粗RR，0.66[95%CI，0.53-0.83]）。然而,当我们校正社会人口统计学和临床特征时,结果并不显著.两组间腹泻天数无显著差异,全球变化评级，或粪便特征恢复正常的天数。
结论：在0-6岁急性腹泻的儿童中，与假推拿相比，小儿推拿在减少腹泻次数方面显示出显着效果。有必要进行更大样本量和调整试验设计的研究，以进一步评估小儿推拿疗法的效果。
背景：Clinicaltrials.gov，标识符:NCT03005821,注册数据：2016-12-29。
方法：86名0-6岁急性腹泻患者随机接受小儿推拿加常规护理（n=43）或假推拿加常规护理（n=43）。主要结果为从基线开始的腹泻天数和第3天的腹泻次数。次要结果包括全球变化评级（GCR）和粪便特征恢复正常的天数。评估不良事件。
结果：在两种ITT中，与假推拿相比，小儿推拿与第3天腹泻次数减少有关（粗RR，0.73[95%CI，0.59-0.91])和PP分析(粗RR，0.66[95%CI，0.53-0.83]）。然而,当我们校正社会人口统计学和临床特征时,结果并不显著.两组间腹泻天数无显著差异,全球变化评级，或粪便特征恢复正常的天数。
结论：在0-6岁急性腹泻的儿童中，与假推拿相比，小儿推拿在减少腹泻次数方面显示出显着效果。有必要进行更大样本量和调整试验设计的研究，以进一步评估小儿推拿疗法的效果。
背景：Clinicaltrials.gov，标识符:NCT03005821,注册数据：2016-12-29。
