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.
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.
Phytomedicine. 2019 Mar 15;56:118-125. doi: 10.1016/j.phymed.2018.09.185. Epub 2018 Sep 18.
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.
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.
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.
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).
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.
胃食管反流病（GERD）的主要症状是烧心和反酸。质子泵抑制剂（PPI）被认为是治疗 GERD 的安全有效药物。在中医中，吴茱萸汤（WCYT）用于治疗食后恶心、呕吐和腹泻。
我们设计了一项随机、双盲、安慰剂对照的临床试验，以评估 WCYT 对 GERD 的治疗效果，采用奥美拉唑作为 PPI 的阳性对照。
90 例 GERD 患者被随机分为 1）对照组（CG），给予口服奥美拉唑（20mg），每日 1 次，并连续 4 周给予 WCYT 安慰剂（3.0g），每日 3 次；或 2）治疗组（TG），给予口服奥美拉唑（20mg）安慰剂，每日 1 次，连续 4 周给予 WCYT（3.0g），每日 3 次。
77 例患者（CG 组 37 例，TG 组 40 例）完成了试验。CG 组和 TG 组的反流疾病问卷（RDQ）和胃食管反流病问卷（GERDQ）评分在第二次评估（V2）和第三次评估（V3）时均低于第一次评估（V1，基线）（均 p<0.001）；CG 组和 TG 组 V2 与 V1 时 RDQ 和 GERDQ 评分的差异均无统计学意义（p=1.00，p=0.54）。CG 组 V3 与 V1 时 RDQ 和 GERD 评分的差异小于 TG 组（均 p=0.004）。
WCYT 对 GERD 的治疗作用与奥美拉唑相似。此外，WCYT 的作用似乎比奥美拉唑维持的时间更长。需要更大样本量和更长研究时间的研究来证实我们的发现。
