Onset of action during on-demand treatment with Maalox suspension or low-dose ranitidine for heartburn

Aim: To compare the onset of action of the local antacid Maalox and the sys temic H-2-antagonist ranitidine, during 'on demand' ambulant treatment of a single heartburn episode, using a randomized, parallel group, double-blind , double-dummy design. Methods: Subjects with self-perceived heartburn without known gastrointesti nal disease or interfering treatments were selected with questionnaires. Th e study was performed unsupervised, whenever heartburn required medication. An electronic patient diary gave instructions when to take study medicatio n, and provided visual analogue scales and five-item relief ratings for hea rtburn, at frequent time intervals activated by an alarm-clock. Results: After a study of the natural history of heartburn and the feasibil ity of the study procedures in 23 patients, 49 subjects took Maalox and 45 ranitidine. Half of these experienced meaningful heartburn relief within 19 min after Maalox, and within 70 min after ranitidine. One hour after intak e, the average heartburn relief score was 3.43 in the Maalox group and 3.04 in the ranitidine group (3 means 'slight improvement' and 4 'strong improv ement'). Heartburn was similar in both groups after 3 h. Conclusions: Maalox provides faster relief of heartburn than ranitidine. He artburn can be assessed frequently and reliably under ambulant conditions u sing an electronic patient diary.