Department of Internal Medicine, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand.
King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
BMJ Evid Based Med. 2023 Nov 22;28(6):399-406. doi: 10.1136/bmjebm-2022-112231.
To compare the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
Randomised, double blind controlled trial, with central randomisation.
Thai traditional medicine hospital, district hospital, and university hospitals in Thailand.
Participants with a diagnosis of functional dyspepsia.
The interventions were curcumin alone (C), omeprazole alone (O), or curcumin plus omeprazole (C+O). Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Functional dyspepsia symptoms on days 28 and 56 were assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (-4.83, -5.46 and -6.22), non-pain (-2.22, -2.32 and -2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (-7.19, -8.07 and -8.85), non-pain (-4.09, -4.12 and -3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
Curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
TCTR20221208003.
比较姜黄素与奥美拉唑改善功能性消化不良患者报告结局的疗效。
随机、双盲对照试验，中央随机分组。
泰国传统医学医院、地区医院和大学医院。
功能性消化不良的患者。
干预措施为姜黄素单药（C）、奥美拉唑单药（O）或姜黄素加奥美拉唑（C+O）。联合组患者每日服用 2 粒 250mg 姜黄素，每日 4 次，每日服用 1 粒 20mg 奥美拉唑，共 28 天。
第 28 天和第 56 天使用消化不良严重程度评估（SODA）评分评估功能性消化不良症状。次要结局为不良事件和严重不良事件的发生情况。
共纳入 206 例患者，随机分为三组，其中 151 例完成研究。三组的人口统计学数据（年龄 49.7±11.9 岁；女性 73.4%）、临床特征和基线消化不良评分均相似。第 28 天，C+O、C 和 O 组疼痛（-4.83、-5.46 和-6.22）、非疼痛（-2.22、-2.32 和-2.31）和满意度（0.39、0.79 和 0.60）评分均有显著改善，第 56 天，C+O、C 和 O 组疼痛（-7.19、-8.07 和-8.85）、非疼痛（-4.09、-4.12 和-3.71）和满意度（0.78、1.07 和 0.81）评分均有显著改善。三组间无显著差异，无严重不良事件发生。
姜黄素和奥美拉唑治疗功能性消化不良的疗效相当，无明显协同作用。
TCTR20221208003。
