BACKGROUND: Therapeutic benefits of nonsteroidal anti-inflammatory drugs (NSAIDs) are offset by their gastrointestinal side effects. We evaluated whether oral ketotifen, which prevents experimental NSAID-induced gastric mucosal injury, is superior to placebo in preventing NSAID-induced gastropathy. DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. SETTING:Rheumatology clinic in a tertiary care hospital. PARTICIPANTS: A majority of the 53 subjects had rheumatoid arthritis (n = 36) or osteoarthritis (12). Those with comorbidity, gastrointestinal (GI) symptoms or abnormal endoscopic findings at entry were excluded. Persons on steroids or NSAIDs in the previous month were also excluded. The subjects were started on indomethacin 25 mg thrice daily. INTERVENTION: Subjects were randomly allocated to receive 2 mg ketotifen or placebo tablets. Compliance was measured by tablet count. OUTCOME MEASURE: At the end of every week a questionnaire was administered to elicit GI symptoms or adverse effects. Every patient underwent endoscopy after four weeks. RESULTS: Of 53 patients recruited (27 drug, 26placebo), three (2 drug, 1 placebo) dropped out. The age, sex, NSAID use and clinical conditions were similar in the two groups. Eight in the drug group and 16 in the placebo group developed GI symptoms and/or endoscopic lesions (relative risk 0.51, 95% CI 0.27-0.95). The difference was significant on intention-to-treat analysis. CONCLUSIONS:Ketotifen significantly reduced the risk of GI side effects in patients on indomethacin.
RCT Entities:
BACKGROUND: Therapeutic benefits of nonsteroidal anti-inflammatory drugs (NSAIDs) are offset by their gastrointestinal side effects. We evaluated whether oral ketotifen, which prevents experimental NSAID-induced gastric mucosal injury, is superior to placebo in preventing NSAID-induced gastropathy. DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. SETTING: Rheumatology clinic in a tertiary care hospital. PARTICIPANTS: A majority of the 53 subjects had rheumatoid arthritis (n = 36) or osteoarthritis (12). Those with comorbidity, gastrointestinal (GI) symptoms or abnormal endoscopic findings at entry were excluded. Persons on steroids or NSAIDs in the previous month were also excluded. The subjects were started on indomethacin 25 mg thrice daily. INTERVENTION: Subjects were randomly allocated to receive 2 mg ketotifen or placebo tablets. Compliance was measured by tablet count. OUTCOME MEASURE: At the end of every week a questionnaire was administered to elicit GI symptoms or adverse effects. Every patient underwent endoscopy after four weeks. RESULTS: Of 53 patients recruited (27 drug, 26 placebo), three (2 drug, 1 placebo) dropped out. The age, sex, NSAID use and clinical conditions were similar in the two groups. Eight in the drug group and 16 in the placebo group developed GI symptoms and/or endoscopic lesions (relative risk 0.51, 95% CI 0.27-0.95). The difference was significant on intention-to-treat analysis. CONCLUSIONS:Ketotifen significantly reduced the risk of GI side effects in patients on indomethacin.