Dyspepsia in primary care: acid suppression as effective as prokinetic therapy. A randomized clinical trial.
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.
Quartero
A O
AO
University Medical Centre Utrecht, Julius Center for General Practice and Patient-Oriented Research, The Netherlands. a.o.quartero@med.uu.nl
Numans
M E
ME
de Melker
R A
RA
Hoes
A W
AW
de Wit
N J
NJ
D000328:Adult; D020117:Cisapride / Q000627:therapeutic use*; D015331:Cohort Studies; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D011899:Ranitidine / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D006635:Histamine H2 Antagonists; D011899:Ranitidine; D020117:Cisapride