Ketotifen for IBS: Four 2010 Trial Checks

Who participated?

An eight-week trial randomized 60 adults with IBS, 43 women, to oral ketotifen or placebo. Its main outcome was rectal balloon tolerance in participants with heightened sensitivity: 15 per treatment arm.¹

Did symptoms improve?

In the full trial, overall relief was 20% versus 10%, not statistically significant. Individual symptom differences also lost significance after correction for multiple comparisons. In the hypersensitive subgroup, balloon tolerance improved within the ketotifen group; the between-group percentage-change comparison was nonsignificant (P=.08). Two participants declined repeat balloon testing. Selected quality-of-life domains improved. Funding included Johnson & Johnson.¹

What were the risks?

Seven ketotifen recipients versus one placebo recipient reported gaining 2–5 kg.¹

Irish Zaditen tablet information contraindicates use with epilepsy, oral diabetes medicines or breastfeeding. Sedation can impair driving; alcohol and other sedating medicines can intensify effects. Pregnancy needs a prescriber’s assessment.²

What would a prescription treat?

The Irish information lists allergic conditions, including rhinitis and conjunctivitis, rather than IBS. Its adult regimen can increase to 2 mg twice daily.²

The trial reached 6 mg twice daily.¹

Do not copy the study dose. NIDDK³ describes different medicine options for diarrhea, constipation and pain. Ask which symptom a proposed prescription would target, how improvement would be measured and what to do about side effects. Follow your clinician’s instructions.³

Bloated by Dinner includes “The Visit Script”: bring your symptom pattern, medicine and supplement list, and dietary changes. Ask what has been ruled out and what comes next. Those notes can keep an appointment focused on the symptoms you need help with.