Taoying Lu1,2,3, Lingjia Yin2,4, Ruoqing Chen5, Huiyan Zhang6, Jianxiong Cai2, Meiling Li7, Lin Dai8, Conghao Zhu9, Yongping Zhang9, Feng Xiang9, Li Wang9, Lu Li9, Lixin Wang10, Darong Wu11,12,13. 1. State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, PO Box 510120, 111 Dade Road, Guangzhou, China. 2. Program for Outcome Assessment in TCM, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, PO Box 510120, 111 Dade Road, Guangzhou, China. 3. Health Construction Administration Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. 4. Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. 5. Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 6. TCM-Integrated Hospital of Southern Medical University, Guangzhou, China. 7. Gastroenterology Department, Guangzhou Hospital of TCM, Guangzhou, China. 8. Acupuncture and Tuina Department, Wenzhou Hospital of Chinese Medicine, Wenzhou, China. 9. Pediatric Department, Dongguan Kanghua Hospital, Dongguan, China. 10. Department of Tuina, Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China. 11. State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, PO Box 510120, 111 Dade Road, Guangzhou, China. darongwu@gzucm.edu.cn. 12. Program for Outcome Assessment in TCM, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, PO Box 510120, 111 Dade Road, Guangzhou, China. darongwu@gzucm.edu.cn. 13. Health Construction Administration Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. darongwu@gzucm.edu.cn.
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. TRIAL REGISTRATION: Clinicaltrials.gov, Identifier: NCT03005821 , Data of registration: 2016-12-29.
RCT Entities:
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. TRIAL REGISTRATION: Clinicaltrials.gov, Identifier: NCT03005821 , Data of registration: 2016-12-29.
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