Abstract
BackgroundPediatric 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.MethodsEighty-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.ResultsPediatric 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.ConclusionsIn 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.Trial registrationClinicaltrials.gov, Identifier: NCT03005821, Data of registration: 2016-12-29.
Highlights
Pediatric Tuina has beenwidely used in children with acute diarrhea in China
In total, 2031 children with acute diarrhea were screened at Dongguan Kanghua Hospital from January 8, 2017, through October 2019, of which 1689 were ineligible and 256 were eligible but could not be enrolled for a variety of reasons (Fig. 2)
A total of 84 children were included in the ITT analyses, whereas 68 patients were included in the PP analyses (33 in the pediatric Tuina group and 35 in the sham Tuina group) (Fig. 2)
Summary
Pediatric Tuina has beenwidely used in children with acute diarrhea in China. 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. Pediatric acute diarrhea is the most common cause of morbidity, mortality and presentation at health services in low- and middle-income countries [1, 2]. 25 years, diarrhea remains one of the leading causes of death among children younger than 5 years old and has become an important global health problem as well as a heavy burden of disease [1, 3, 4]. If children with diarrhea are not treated in a timely and appropriate manner, dehydration, electrolyte imbalance, or even death may occur
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