Department of Medicine, University of Hong Kong, Queen Marry Hospital, Hong Kong, China.
World J Gastroenterol. 2012 Nov 14;18(42):6127-33. doi: 10.3748/wjg.v18.i42.6127.
To evaluate sertraline, a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia.
Consecutive tertiary hospital patients with a clinical diagnosis of functional dyspepsia (FD) according to the Rome II criteria with a Hong Kong dyspepsia index (HKDI) of greater than 16 were recruited. Patients commenced enrolment prior to the inception of the Rome III criteria for functional dyspepsia. All patients were ethnic Chinese, had a normal upper endoscopy and were Helicobacter pylori negative prior to enrolment. Study patients were randomized to receive sertraline 50 mg or placebo daily for 8 wk. HKDI symptom scores, quality of life, hospital anxiety and depression (HAD) scale and global symptom relief were evaluated before, during and after treatment. Adverse effects were monitored during and after treatment.
A total of 193 patients were randomized in the intention to treat (ITT), and 150 patients were included in the per protocol (PP) analysis. In both the ITT and PP, there was no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups at week 8. In the ITT analysis, 98 and 95 patients were randomized to the sertraline and placebo groups respectively. A total of 43 patients withdrew from the study (22.3%) by week 8, with 23 of the 24 drop-outs in the sertraline group occurring prior to week 4 (95.8%). In contrast, in the placebo arm, 11 of 19 patients dropped out by week 4 (57.9%). Utilizing the last response carried forward to account for the drop-outs, there were no differences between the sertraline and placebo groups at baseline in terms of the HKDI, HKDI 26.08 ± 6.19 vs 26.70 ± 5.89, P = 0.433; and at week 8, HKDI 22.41 ± 6.36 vs 23.25 ± 7.30, P = 0.352 respectively. In the PP analysis, 74 and 76 patients were randomized to the sertraline and placebo groups respectively. At baseline, there were no statistically significant differences between the sertraline and placebo groups, HKDI 25.83 ± 6.313 vs 27.19 ± 5.929 respectively, P = 0.233; however by week 8, patients in the sertraline group demonstrated a statistically significant difference in their Hong Kong Dyspepsia Index compared to placebo, HKDI 20.53 ± 6.917 vs 23.34 ± 7.199, P = 0.02, respectively). There was also no statistically significant difference in overall quality of life measures or the HAD scale related to treatment in either the ITT or PP analysis at week 8.
This pilot study, the first to examine sertraline, a selective serotonin reuptake inhibitor, for the management of FD, did not find that it was superior to placebo.
评估选择性 5-羟色胺再摄取抑制剂（SSRIs）舍曲林治疗功能性消化不良（FD）患者的疗效。
连续入选符合罗马 II 标准的临床诊断为 FD 的三级医院患者，且香港消化不良指数（HKDI）>16。患者在功能性消化不良罗马 III 标准之前开始入组。所有患者均为华裔，在上消化道内镜检查正常且 Hp 阴性。研究患者随机接受舍曲林 50mg 或安慰剂，每日一次，疗程 8 周。治疗前后分别评估 HKDI 症状评分、生活质量、医院焦虑抑郁量表（HAD）和整体症状缓解情况。治疗期间和治疗后监测不良反应。
共有 193 例患者被纳入意向治疗（ITT）分析，150 例患者被纳入符合方案（PP）分析。在 ITT 和 PP 分析中，8 周时舍曲林组和安慰剂组的整体消化不良症状主要结局均无差异。在 ITT 分析中，98 例和 95 例患者分别随机分配至舍曲林组和安慰剂组。共有 43 例患者（22.3%）在 8 周时退出研究，其中舍曲林组 24 例脱失患者中有 23 例（95.8%）发生在第 4 周前。相比之下，安慰剂组中，19 例患者中有 11 例在第 4 周前脱失（57.9%）。采用最后一次响应结转来处理脱失患者，舍曲林组和安慰剂组在基线时 HKDI 无差异，分别为 26.08±6.19 和 26.70±5.89，P=0.433；第 8 周时 HKDI 也无差异，分别为 22.41±6.36 和 23.25±7.30，P=0.352。在 PP 分析中，74 例和 76 例患者分别被随机分配至舍曲林组和安慰剂组。基线时，舍曲林组和安慰剂组之间无统计学显著差异，HKDI 分别为 25.83±6.313 和 27.19±5.929，P=0.233；但第 8 周时，舍曲林组的香港消化不良指数与安慰剂组相比有统计学显著差异，分别为 20.53±6.917 和 23.34±7.199，P=0.02。第 8 周时，ITT 和 PP 分析中整体生活质量测量或与治疗相关的 HAD 量表也无统计学显著差异。
本研究为首次评估选择性 5-羟色胺再摄取抑制剂（SSRIs）舍曲林治疗 FD 的试验，未发现其优于安慰剂。
