- Design
- Double-blind, placebo-controlled randomised trial, 5 Dutch sites
- Population
- 92 adults with xerostomia and a life-limiting condition or frailty
- Primary outcome
- Change in xerostomia severity (NRS 0-10) at 4 weeks
- Effect
- Adjusted β -0.37 (95% CI -1.31 to 0.58), not significant
This double-blind randomised trial at two Dutch hospitals and three nursing homes enrolled 92 adults with a life-limiting condition or frailty and xerostomia rated 5 or more out of 10, allocating them to four weeks of topical pilocarpine drops or placebo.
There was no significant difference in xerostomia severity at two weeks (adjusted β 0.35, 95% CI -0.44 to 1.15) or four weeks (β -0.37, -1.31 to 0.58). Both groups improved by about 1.5 points in the first two weeks; only the pilocarpine group continued to improve to week four. Oral health quality of life was better with pilocarpine at two weeks. Side effects were limited.
Dry mouth is a common and neglected symptom in frail and dying patients, with few treatment options. The trial recruited 92 of the 120 needed, so it could have missed a real effect.
Pilocarpine drops remain a reasonable trial for a distressed patient, but not one backed by evidence of benefit.
- Review anticholinergic and other drying medications first.
- Use simple measures: sips of water, saliva substitutes, mouth care.
- Pilocarpine drops can be tried, with realistic expectations.
- Watch for sweating and bradycardia with any pilocarpine use.
Why it matters
A symptom that affects comfort at the end of life still lacks a proven drug treatment.
Don't overread it
The trial enrolled 92 of 120 planned participants, so a lack of significant difference does not prove pilocarpine is ineffective.
The statistics, in plain English
An underpowered trial is too small to detect the effect it was designed to find. The intervals for the primary outcome include both small benefit and small harm, and the late improvement seen only with pilocarpine is a within-group finding, weaker than a between-group comparison.
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