BACKGROUND: While dyspeptic patients in primary care often receive empirical treatment with antisecretory drugs, a substantial number suffer from motility disturbances which may be associated with their complaints. We aimed to compare the effectiveness of treatment with antisecretory treatment with a prokinetic agent in uninvestigated dyspepsia. METHODS:563 patients presenting dyspeptic complaints to the general practitioner with a low likelihood of organic (ulcer, reflux or malignant) disease, i.e. absence of alarm symptoms or a history of peptic ulcer disease or gastro-oesophageal reflux disease were included. They entered a randomized, double-blind trial of 4 weeks of ranitidine 150 mg bid compared with 4 weeks of cisapride 10 mg bid, with 3 months follow-up. Treatment failure was defined as no response to treatment or a relapse of symptoms within the follow-up period. Also studied were the effect on dyspepsia severity, response to treatment after 4 weeks, and time to relapse. RESULTS: For all randomized patients, the incidence of overall treatment success after 3 months follow-up with antisecretory treatment was 107/271 (39.5%) and with a prokinetic agent 122/282 (43.3%); the risk difference was 3.8% (95% CI -4.4% to 12.0%); the difference in symptom severity score after 4 weeks of treatment was 0.3; 95% CI -0.4% to 1.0%. For patients responding to 4 weeks of treatment, relapse-free time was 86 days in the prokinetic group and 79 days in the acid suppression group (P = 0.005). CONCLUSIONS:Antisecretory and prokinetic therapies are equally effective in primary care patients with uninvestigated dyspeptic complaints, though relapse rates are lower in patients treated with prokinetic treatment.
RCT Entities:
BACKGROUND: While dyspeptic patients in primary care often receive empirical treatment with antisecretory drugs, a substantial number suffer from motility disturbances which may be associated with their complaints. We aimed to compare the effectiveness of treatment with antisecretory treatment with a prokinetic agent in uninvestigated dyspepsia. METHODS: 563 patients presenting dyspeptic complaints to the general practitioner with a low likelihood of organic (ulcer, reflux or malignant) disease, i.e. absence of alarm symptoms or a history of peptic ulcer disease or gastro-oesophageal reflux disease were included. They entered a randomized, double-blind trial of 4 weeks of ranitidine 150 mg bid compared with 4 weeks of cisapride 10 mg bid, with 3 months follow-up. Treatment failure was defined as no response to treatment or a relapse of symptoms within the follow-up period. Also studied were the effect on dyspepsia severity, response to treatment after 4 weeks, and time to relapse. RESULTS: For all randomized patients, the incidence of overall treatment success after 3 months follow-up with antisecretory treatment was 107/271 (39.5%) and with a prokinetic agent 122/282 (43.3%); the risk difference was 3.8% (95% CI -4.4% to 12.0%); the difference in symptom severity score after 4 weeks of treatment was 0.3; 95% CI -0.4% to 1.0%. For patients responding to 4 weeks of treatment, relapse-free time was 86 days in the prokinetic group and 79 days in the acid suppression group (P = 0.005). CONCLUSIONS: Antisecretory and prokinetic therapies are equally effective in primary care patients with uninvestigated dyspeptic complaints, though relapse rates are lower in patients treated with prokinetic treatment.