Department of Respiratory, Baoshan Hospital of Shanghai University of Traditional Chinese Medicine, No. 181 , Youyi Road, Baoshan District, Shanghai, 201900, China.
Department of Digestive System, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 , Ganhe Road, Shanghai, 200437, China.
Eur J Med Res. 2024 Sep 19;29(1):466. doi: 10.1186/s40001-024-02030-z.
To assess the efficacy of the Chinese herbal medication Shugan Hewei formula (SHF) combined with rabeprazole in patients with refractory gastroesophageal reflux disease (rGERD).
A total of 264 participants were randomly assigned to the treatment group (n = 132) receiving SHF granules (20 mg) combined with rabeprazole (10 mg) and the control group (n = 132) receiving placebo SHF granules (20 mg) combined with rabeprazole (20 mg). Both groups undergo 8 weeks of treatment and 2 weeks of follow-up.
The treatment group showed higher total clinical symptom efficacy and lower total symptom scores compared to the control group. The treatment group was superior to the control group in reducing rGERD major symptom scores, including heartburn, retrosternal pain, regurgitation and belching, and acid regurgitation. Additionally, treatment group (Z = 8.169, P < 0.001) and control group (Z = 9.800, P < 0.001) treatments were all significantly attenuated esophageal inflammation, demonstrating comparable efficacy. Patients with esophagitis grade A decreased from 40.34% to 17.23%, and those with grade B decreased from 11.76% to 3.78% in the treatment group. The results of the SF-36 scale showed that combination therapy was more effective in improving role limitations due to physical health, vitality, general health, total somato-physical health, and psychiatric mental health.
Our study reveals that the combined treatment of SHF with rabeprazole is more efficacious in managing patients with rGERD when contrasted with sole rabeprazole treatment.
评估疏肝和胃方（SHF）联合雷贝拉唑治疗难治性胃食管反流病（rGERD）的疗效。
共 264 名患者被随机分为治疗组（n=132），给予 SHF 颗粒（20mg）联合雷贝拉唑（10mg）；对照组（n=132）给予安慰剂 SHF 颗粒（20mg）联合雷贝拉唑（20mg）。两组均接受 8 周的治疗和 2 周的随访。
治疗组总临床症状疗效优于对照组，总症状评分低于对照组。治疗组在降低 rGERD 主要症状评分方面优于对照组，包括烧心、胸骨后疼痛、反流和呃逆、酸反流。此外，治疗组（Z=8.169，P<0.001）和对照组（Z=9.800，P<0.001）的治疗均显著减轻食管炎症，疗效相当。食管炎 A 级患者从 40.34%降至 17.23%，B 级患者从 11.76%降至 3.78%。SF-36 量表的结果表明，联合治疗在改善因身体健康导致的角色受限、活力、一般健康、躯体总体健康和心理精神健康方面更有效。
与单独使用雷贝拉唑相比，SHF 联合雷贝拉唑治疗 rGERD 患者更有效。
