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Pediatric Tuina for functional constipation in children: study protocol for a randomized controlled trail.

Xinghe Zhang^1,2, Luan Hu³, Li Li⁴

¹School of Second Clinical Medicine, Yunnan University of Chinese Medicine, Kunming, China.

|September 5, 2022

Summary

Pediatric Tuina may be a safe and effective treatment for functional constipation (FC) in children. This study compares pediatric Tuina to probiotics, hypothesizing Tuina is superior for improving bowel movements and related symptoms.

Keywords:

Functional constipation Pediatric Tuina Randomized controlled trial

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Area of Science:

Pediatric Gastroenterology
Complementary and Alternative Medicine

Background:

Functional constipation (FC) significantly impacts children's quality of life.
Pediatric Tuina is a potential therapy for FC, but high-quality evidence is lacking.
This study addresses the need for robust data on pediatric Tuina's efficacy and safety.

Purpose of the Study:

To evaluate the efficacy and safety of pediatric Tuina for treating functional constipation in children.
To compare pediatric Tuina with Medilac-Vita (probiotics) in managing pediatric FC.
To provide reliable evidence for the clinical application of pediatric Tuina.

Main Methods:

A randomized, controlled, multicenter clinical trial involving 176 children with FC.
Participants assigned to either pediatric Tuina or Medilac-Vita group.
Weekly assessments of spontaneous bowel movements, complete spontaneous bowel movements, stool form, distress, and enema rates over a treatment and follow-up period.

Main Results:

Primary outcomes include weekly spontaneous and complete spontaneous bowel movements.
Secondary outcomes encompass effective rate, stool form, distress sensation, and glycerine enema rate.
Adverse events will be monitored throughout the study.

Conclusions:

The study hypothesizes that pediatric Tuina is more effective than probiotics for pediatric FC.
Results will offer crucial evidence supporting pediatric Tuina as a treatment for childhood functional constipation.
This research aims to enhance the management of FC in pediatric populations.