Pediatric Tui Na for acute diarrhea in children under 5 years old: A systematic review and meta-analysis of randomized clinical trials

Highlights

• 26 randomized trials testing traditional Chinese Pediatric Tui Na for children under five years of age with acute diarrhea were identified.

• Pediatric Tui Na therapy appears to be effective in relieving symptoms of acute diarrhea in children under five years old.

• Considering moderate to low quality of evidence and insufficient reporting, further large, rigorous and adequately reported trials are needed.

Abstract

Objective

To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age.

Design

Systematic review and meta-analysis of randomized clinical trials.

Methods

We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. ‘Clinical cure’ is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane’s Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table.

Results

Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29–1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49–2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34–1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD −0.40 h, 95% CI −15.31 to −5.48 h, n = 410, 6 trials) and daily stool frequency (MD −1.71times, 95% CI −2.37 to −1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants.

Conclusions

This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings.

Introduction

Acute diarrhea is the second highest prevalence of childhood illness among children less than five years of age.^1,2 It is one of the most important causes for hospital attendance of children, and the acute diarrhea induced by rotavirus infection is responsible for more than 50% of hospitalizations.³ Acute diarrhea can lead to threatening dehydration and electrolytes disorder, and it is an important cause of malnutrition in children.⁴

Montmorillonite (Diosmectite or Smectite), as the mucosal protective agent, is one of the well-defined conventional treatment for acute diarrhea.⁵ It is a naturally-multilayered aluminum magnesium clay of silicate, consisting of a double aluminum and magnesium silicate. Other treatment modalities of probiotics are nonpathogenic living microorganisms, some of which live in a symbiotic relationship with human body.⁶ Current evidence from meta-analysis showed that montmorillonite and probiotics can significantly reduce the duration of childhood acute diarrhea, and montmorillonite can also increase the clinical cure rate.^7,8 However, the effect of montmorillonite on stool output remains uncertain and safety is under investigating, the relationship between the therapeutic effect and dose of probiotics has not yet been clearly explored, and the tolerance and safety of probiotics was inconclusive. To date, there is still no direct evidence showing the dose-response effect of probiotics.9, 10, 11 Indeed, children under 5 years old are often less likely to be compliant to drugs than non-pharmaceutical treatment such as Tui Na therapy.¹² Additionally, the immune system is relatively immature at birth, and has to evolve during a life of exposure to multiple foreign challenges through childhood, if with a low immune system or a weak stomach, they may not tolerate the drugs. Therefore, non-pharmaceutical therapy is urgently expected to treat acute diarrhea in children.

Pediatric Tui Na, as one of the traditional Chinese medicine (TCM) therapies, is a therapeutic massage for children. When give pediatric Tui Na, the practitioner may stimulate specific acupoints in the fingers, palms, arms or other areas of children’s body, as well as Tui Na manipulations in Du meridian (Governor vessel) or the abdomen.^13,14 The frequently used acupoints and treating areas are shown in Appendix Fig. A1. Pediatric Tui Na has been used for a long time in infants and children in China, especially when oral or intravenous administration of medication is not well-tolerated.¹⁵ One 2012 and 2016 systematic reviews^16,17 involving 15 trials and 16 trails separately demonstrated that pediatric Tui Na on childhood diarrhea had beneficial effect on total effect rate in children with diarrhea. However, the two systematic reviews did not specify the course of diarrhea, age of the children, details of control treatment, which increase the difficulty of interpreting the findings. In addition, the outcome assessment is only total effect rate, which is not internationally recognized outcome. Therefore, this systematic review aims to evaluate the effects and safety of pediatric Tui Na for the treatment of acute diarrhea in children less than 5 years of age.