Onset of action during on-demand treatment with maalox suspension or low-dose ranitidine for heartburn.
OBJECTIVE
To compare the onset of action of the local antacid Maalox and the systemic H2-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 gastrointestinal disease or interfering treatments were selected with questionnaires. The study was performed unsupervised, whenever heartburn required medication. An electronic patient diary gave instructions when to take study medication, and provided visual analogue scales and five-item relief ratings for heartburn, at frequent time intervals activated by an alarm-clock.


RESULTS
After a study of the natural history of heartburn and the feasibility 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 intake, 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 improvement'). Heartburn was similar in both groups after 3 h.


CONCLUSIONS
Maalox provides faster relief of heartburn than ranitidine. Heartburn can be assessed frequently and reliably under ambulant conditions using an electronic patient diary.
Faaij
R A
RA
Centre for Human Drug Research (CHDR), Leiden, The Netherlands. rf@chdr.nl
Van Gerven
J M
JM
Jolivet-Landreau
I
I
Masclee
A A
AA
Vendrig
E M
EM
Schoemaker
R C
RC
Jacobs
L D
LD
Cohen
A F
AF
D000328:Adult; D000536:Aluminum Hydroxide / Q000627:therapeutic use*; D000863:Antacids / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006356:Heartburn / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008276:Magnesium Hydroxide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000627:therapeutic use*; D013997:Time Factors
D000863:Antacids; D004338:Drug Combinations; D006635:Histamine H2 Antagonists; C013591:aluminum hydroxide, magnesium hydroxide, drug combination; D000536:Aluminum Hydroxide; D011899:Ranitidine; D008276:Magnesium Hydroxide