Behar J, Brand D L, Brown F C, Castell D O, Cohen S, Crossley R J, Pope C E, Winans C S
Gastroenterology. 1978 Feb;74(2 Pt 2):441-8.
The effectiveness of cimetidine for symptomatic relief in patients with chronic gastroesophageal reflux was studied in a multicenter, double blind clinical trial. Patients were entered into the study for a total of 8 weeks, receiving either cimetidine, 300 mg four times daily, or identical placebo tablets. Throughout the trial, frequent assessments were made of symptom severity and frequency, combined with careful measurement of antacid use. Esophagoscopy, esophageal acid sensitivity, and lower esophageal pressures were performed before and at the completion of the treatment period. Significant (P less than 0.05) decreases in symptom frequency and severity were noted throughout the study in the cimetidine-treated patients, as compared with the placebo group. This subjective improvement was corroborated by a concomitant decrease in antacid use, which was significantly (P less than 0.05) reduced in the cimetidine-treated group. In addition, significant improvement in esophageal acid sensitivity resulted from cimetidine therapy. No objective improvement in esophageal endoscopic appearance or sphincter pressures was noted. The results of this double blind trial indicate that cimetidine is more effective than the placebo for the relief of symptoms of gastroesophageal reflux.
在一项多中心、双盲临床试验中，研究了西咪替丁对慢性胃食管反流患者症状缓解的有效性。患者进入研究共8周，分别接受每日4次、每次300毫克的西咪替丁或相同的安慰剂片。在整个试验过程中，频繁评估症状的严重程度和频率，并仔细测量抗酸剂的使用情况。在治疗期开始前和结束时进行食管镜检查、食管酸敏感性和食管下段压力测量。与安慰剂组相比，在整个研究中，西咪替丁治疗的患者症状频率和严重程度显著降低（P<0.05）。这种主观改善得到了抗酸剂使用量同时减少的证实，西咪替丁治疗组的抗酸剂使用量显著减少（P<0.05）。此外，西咪替丁治疗使食管酸敏感性有显著改善。食管内镜外观或括约肌压力未见客观改善。这项双盲试验的结果表明，西咪替丁在缓解胃食管反流症状方面比安慰剂更有效。
