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

Nikles, J; Mitchell, GK; Hardy, J; Agar, M; Senior, H; Carmont, SA; Schluter, PJ; Good, P; Vora, R; Currow, D

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

Nikles, J Mitchell, GK Hardy, J Agar, M

Senior, H Carmont, SA Schluter, PJ Good, P

Vora, R Currow, D

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Publication Type:: Journal Article
Citation:: BMC Palliative Care, 2013, 12 (1)
Issue Date:: 2013-11-18

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Field	Value	Language
dc.contributor.author	Nikles, J	en_US
dc.contributor.author	Mitchell, GK	en_US
dc.contributor.author	Hardy, J	en_US
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119	en_US
dc.contributor.author	Senior, H	en_US
dc.contributor.author	Carmont, SA	en_US
dc.contributor.author	Schluter, PJ	en_US
dc.contributor.author	Good, P https://orcid.org/0000-0002-8198-0375	en_US
dc.contributor.author	Vora, R	en_US
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250	en_US
dc.date.available	2013-10-24	en_US
dc.date.issued	2013-11-18	en_US
dc.identifier.citation	BMC Palliative Care, 2013, 12 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/115777
dc.description.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. Trial registration. Australia and New Zealand Clinical Trial Registry Number: 12610000840088. © 2013 Nikles et al.; licensee BioMed Central Ltd.	en_US
dc.relation.ispartof	BMC Palliative Care	en_US
dc.relation.isbasedon	10.1186/1472-684X-12-39	en_US
dc.subject.classification	Gerontology	en_US
dc.title	Do pilocarpine drops help dry mouth in palliative care patients: A protocol for an aggregated series of n-of-1 trials	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	12	en_US
utslib.for	1117 Public Health and Health Services	en_US
utslib.for	1110 Nursing	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	open_access
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	12	en_US

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. Trial registration. Australia and New Zealand Clinical Trial Registry Number: 12610000840088. © 2013 Nikles et al.; licensee BioMed Central Ltd.

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http://hdl.handle.net/10453/115777