Yi-Sing Shih1, Chang-Hai Tsai2, Tsai-Chung Li3, Cheng-Ju Yu4, Jen-Wei Chou4, Chun-Lung Feng4, Kun-Teng Wang5, Hsueh-Chou Lai6, Ching-Liang Hsieh7. 1. Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, 91 Hsueh-Shih Road, Taichung 40402, Taiwan; Division of Hepato-Gastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung 40447, Taiwan. 2. School of Medicine, College of Medicine, China Medical University, Taichung 40402, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, China Medical University Hospital, Taichung 40447, Taiwan. 3. Department of Public Health, College of Public Health, China Medical University, Taichung, 40402, Taiwan; Department of Healthcare Administration, College of Health Science, Asia University, Taichung 413, Taiwan. 4. Division of Hepato-Gastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung 40447, Taiwan. 5. Brion Research Institute of Taiwan, Taipei City 231, Taiwan. 6. Division of Hepato-Gastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung 40447, Taiwan; School of Chinese Medicine, College of Chinese Medicine, China Medical Univeristy, Taichung 40402, Taiwan. 7. Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, 91 Hsueh-Shih Road, Taichung 40402, Taiwan; Graduate Institute of Acupuncture Science, College of Chinese Medicine, China Medical University, Taichung 40402, Taiwan; Chinese Medicine Research Center, China Medical University, Taichung 40402, Taiwan; Department of Chinese Medicine, China Medical University Hospital, Taichung 40447, Taiwan. Electronic address: clhsieh@mail.cmuh.org.tw.
Abstract
BACKGROUND: The main symptoms of gastroesophageal reflux disease GERD are heartburn and acid regurgitation. Proton-pump inhibitors (PPI) are considered to be safe and effective for the treatment of GERD. In traditional Chinese medicine, wu chu yu tang (WCYT) is used to treat nausea after eating, vomiting, and diarrhea. PURPOSE: We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the therapeutic effect of WCYT on GERD using omeprazole as a PPI for the positive control. METHODS:Ninety patients with GERD were randomly assigned to the 1) control group (CG), who received an oral administration of omeprazole (20 mg) once per day and given WCYT placebo (3.0 g) three times per day for 4 weeks continuously; or the 2) treatment group (TG), who received oral administration of omeprazole (20 mg) placebo once per day and WCYT (3.0 g) three times per day for 4 weeks continuously. RESULTS:Seventy-seven patients (37 in CG, 40 in TG) completed the trial. Both Reflux Disease Questionnaire (RDQ) and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores was less in the second assessment (V2) and in the third assessment (V3) than those in V1 (first assessment; baseline) in the CG and TG groups (all p < 0.001); the score difference of both RDQ and GERDQ between V2 and V1 was similar between CG and TG (p = 1.00, p = 0.54, respectively). The score difference of both RDQ and GERD between V3 and V1 was less in the CG group than those of the TG group (both p = 0.004). CONCLUSION: WCYT has an effect similar to omeprazole for GERD treatment. Furthermore, this effect resulting from WCYT appeared to be maintained for a longer period of time than did that of omeprazole. A study with a larger sample size and longer study period is needed to corroborate our findings.
RCT Entities:
BACKGROUND: The main symptoms of gastroesophageal reflux diseaseGERD are heartburn and acid regurgitation. Proton-pump inhibitors (PPI) are considered to be safe and effective for the treatment of GERD. In traditional Chinese medicine, wu chu yu tang (WCYT) is used to treat nausea after eating, vomiting, and diarrhea. PURPOSE: We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the therapeutic effect of WCYT on GERD using omeprazole as a PPI for the positive control. METHODS: Ninety patients with GERD were randomly assigned to the 1) control group (CG), who received an oral administration of omeprazole (20 mg) once per day and given WCYT placebo (3.0 g) three times per day for 4 weeks continuously; or the 2) treatment group (TG), who received oral administration of omeprazole (20 mg) placebo once per day and WCYT (3.0 g) three times per day for 4 weeks continuously. RESULTS: Seventy-seven patients (37 in CG, 40 in TG) completed the trial. Both Reflux Disease Questionnaire (RDQ) and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores was less in the second assessment (V2) and in the third assessment (V3) than those in V1 (first assessment; baseline) in the CG and TG groups (all p < 0.001); the score difference of both RDQ and GERDQ between V2 and V1 was similar between CG and TG (p = 1.00, p = 0.54, respectively). The score difference of both RDQ and GERD between V3 and V1 was less in the CG group than those of the TG group (both p = 0.004). CONCLUSION: WCYT has an effect similar to omeprazole for GERD treatment. Furthermore, this effect resulting from WCYT appeared to be maintained for a longer period of time than did that of omeprazole. A study with a larger sample size and longer study period is needed to corroborate our findings.
Authors: Nuria Eguaras; Elena Sonsoles Rodríguez-López; Olga Lopez-Dicastillo; M Ángeles Franco-Sierra; François Ricard; Ángel Oliva-Pascual-Vaca Journal: J Clin Med Date: 2019-10-19 Impact factor: 4.241