- Design
- Double-blind placebo-controlled randomised trial
- Population
- 92 adults with a life-limiting condition or frailty and xerostomia
- Primary outcome
- Change in xerostomia severity at 4 weeks
- Effect
- Adjusted β −0.37 (−1.31 to 0.58)
This double-blind trial at two hospitals and three nursing homes in the Netherlands randomised 92 adults with a life-limiting condition or frailty and moderate-to-severe dry mouth to topical pilocarpine drops or placebo for four weeks. It was published in August 2026.
The primary outcome, change in xerostomia severity at four weeks, did not differ (adjusted β −0.37, 95% CI −1.31 to 0.58). Both groups improved by about 1.5 points in the first two weeks; only the pilocarpine group improved further between weeks two and four (−0.86, −1.56 to −0.15). Oral health-related quality of life was better with pilocarpine at two weeks. Side effects were few.
The trial needed 120 patients and enrolled 92, so it could miss a real benefit. The large placebo response is itself useful: attention to mouth care and regular review help. Pilocarpine drops remain a reasonable, well-tolerated option to try, but this trial does not show they work.
- Review drugs that cause dry mouth, such as anticholinergics, before adding a treatment.
- Provide regular mouth care and saliva substitutes as first steps.
- Consider a trial of pilocarpine drops if dry mouth persists, reviewing after four weeks.
- Expect improvement with attention alone; reassess before concluding a drug has worked.
Why it matters
Dry mouth is common and distressing at the end of life, and the evidence for drug treatment remains thin.
Don't overread it
An underpowered trial that missed its endpoint neither proves nor disproves that pilocarpine helps.
The statistics, in plain English
The main result's interval crosses zero, so no difference was shown. The further fall with pilocarpine between weeks two and four is a within-group secondary finding, which is weaker evidence than a between-group difference on the primary outcome.
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