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

Nikles, Jane, Mitchell, Geoffrey K., Hardy, Janet, Agar, Meera, Senior, Hugh, Carmont, Sue-Ann, Schluter, Philip J., Good, Phillip, Vora, Rohan and Currow, David (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 (Provisional PDF) 39: 1-15. doi:10.1186/1472-684X-12-39

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Nikles, Jane
Mitchell, Geoffrey K.
Hardy, Janet
Agar, Meera
Senior, Hugh
Carmont, Sue-Ann
Schluter, Philip J.
Good, Phillip
Vora, Rohan
Currow, David
Title Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials
Journal name BMC Palliative Care   Check publisher's open access policy
ISSN 1472-684X
Publication date 2013-10-31
Sub-type Article (original research)
DOI 10.1186/1472-684X-12-39
Open Access Status DOI
Volume 12 (Provisional PDF)
Issue 39
Start page 1
End page 15
Total pages 15
Place of publication London, United Kingdom
Publisher BioMed Central
Language eng
Formatted 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 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.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
School of Nursing, Midwifery and Social Work Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 3 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 2 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Thu, 14 Nov 2013, 21:09:18 EST by Vicki Percival on behalf of School of Medicine