Pilocarpine drops for dry mouth in frailty: no clear benefit in an underpowered trial

Design

Randomised, double-blind, placebo-controlled trial

Population

92 adults with xerostomia and a life-limiting condition or frailty

Primary outcome

Change in xerostomia severity at 4 weeks

Effect

Adjusted difference −0.37 (95% CI −1.31 to 0.58)

A double-blind trial in two Dutch hospitals and three nursing homes randomised 92 adults with a life-limiting condition or frailty and xerostomia of 5 or more out of 10 to four weeks of topical pilocarpine or placebo drops. It needed 120 participants.

At four weeks, xerostomia severity did not differ (adjusted difference −0.37, −1.31 to 0.58). Both groups improved by about 1.5 points in the first two weeks, but only the pilocarpine group continued to improve between weeks two and four. Oral health-related quality of life was better with pilocarpine at two weeks. Adverse effects were limited.

Dry mouth is common and distressing near the end of life and has few treatments. This trial neither proves nor rules out a benefit.

• Review anticholinergic and other drying medicines first.
• Offer frequent sips, saliva substitutes and mouth care.
• Pilocarpine drops are a reasonable trial where other measures fail, given good tolerability.
• Stop if no benefit after about four weeks.

Why it matters

It gives the first controlled data on a cheap option for a common, distressing symptom.

Don't overread it

The trial recruited 92 of 120 needed, so it could have missed a real effect.

The statistics, in plain English

The interval from −1.31 to 0.58 on a 10-point scale includes a benefit of about one point, which patients may notice. Within-group trends after week two are secondary and not a fair comparison.

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