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

BMC Palliative Care

Study Protocol

Meera Agar¹  Rohan Vora²  Janet Hardy³  David Currow⁴  Philip J Schluter⁵  Sue-Ann Carmont⁶  Jane Nikles⁶  Geoffrey K Mitchell⁶  Hugh Senior⁶  Phillip Good⁷ 

[1] Department of Palliative Care, Braeside Hospital, Fairfield, Australia;Department of Palliative Care, Gold Coast Health Service District, Gold Coast, Australia;Department of Palliative and Supportive Care, Mater Health Services, Brisbane, Australia;Discipline Palliative and Supportive Services, Bedford Park, Australia;School of Health Sciences, University of Canterbury, Christchurch, New Zealand;School of Nursing and Midwifery, The University of Queensland, Brisbane, Australia;School of Medicine, The University of Queensland, Brisbane, Australia;St Vincents’ Private Hospital, Brisbane, Australia;

关键词: Pilocarpine;    n-of-1 trial;    Palliative care;    Xerostomia;    Advanced cancer;   

DOI  :  10.1186/1472-684X-12-39

 received in 2013-08-15, accepted in 2013-10-24,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundIt 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/DesignAggregated 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.DiscussionManaging 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 registrationAustralia and New Zealand Clinical Trial Registry Number: 12610000840088.

【 授权许可】

CC BY   
© Nikles et al.; licensee BioMed Central Ltd. 2013