Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials (2013)

Type of Content
Journal ArticlePublisher
University of Canterbury. School of Health SciencesCollections
- Health: Journal Articles [153]
Authors
Abstract
Background: It is estimated that 39,000 Australians die from malignant disease yearly. Of these, 60% to 88% of advanced cancer patients suffer xerostomia, the subjective feeling of mouth dryness. Xerostomia has significant physical, social and psychological consequences which compromise function and quality of life. Pilocarpine is one treatment for xerostomia. Most studies have shown some variation in individual response to pilocarpine, in terms of dose used, and timing and extent of response. We will determine a population estimate of the efficacy of pilocarpine drops (6 mg) three times daily compared to placebo in relieving dry mouth in palliative care (PC) patients. A secondary aim is to assess individual patients’ response to pilocarpine and provide reports detailing individual response to patients and their treating clinician.
Methods/Design: Aggregated n-of-1 trials (3 cycle, double blind, placebo-controlled crossover trials using standardized measures of effect). Individual trials will identify which patients respond to the medication. To produce a population estimate of a treatment effect, the results of all cycles will be aggregated.
Discussion: Managing dry mouth with treatment supported by the best possible evidence will improve functional status of patients, and improve quality of life for patients and carers. Using n-of-1 trials will accelerate the rate of accumulation of high-grade evidence to support clinical therapies used in PC.
Citation
Nikles, J., Mitchell, G.K., Hardy, J., Agar, M., Senior, H., Carmont, S.-A., Schluter, P.J., Good, P., Vora, R., Currow, D. (2013) Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials. BMC Palliative Care, 12, pp. 39 (7pp).This citation is automatically generated and may be unreliable. Use as a guide only.
Keywords
Pilocarpine; n-of-1 trial; Palliative care; Xerostomia; Advanced cancerANZSRC Fields of Research
11 - Medical and Health Sciences::1103 - Clinical Sciences11 - Medical and Health Sciences::1115 - Pharmacology and Pharmaceutical Sciences
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