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    Testing the effectiveness of pilocarpine drops for dry mouth in advanced cancer using aggregated n-of-1 trials: a pilot study (2015)

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    12658308_2014 03 28 Pilocarpine results paper v33SCC.docx (49.12Kb)
    Type of Content
    Journal Article
    UC Permalink
    http://hdl.handle.net/10092/11793
    
    Publisher's DOI/URI
    https://doi.org/10.1177/0269216315585473
    
    Publisher
    University of Canterbury. School of Health Sciences
    Collections
    • Health: Journal Articles [151]
    Authors
    Nikles, J.
    Mitchell, G.K.
    Hardy, J.
    Agar, M.
    Senior, H.
    Carmont, S.A.
    Schluter, P.J.
    Good, P.
    Vora, R.
    Currow, D.
    show all
    Abstract

    Purpose : Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. We aimed to test the effectiveness of pilocarpine drops compared to placebo, for participants with advanced cancer, who experienced dry mouth.

    Method : Aggregated n-of-1 trials for patients of specialist palliative care services with advanced cancer assessed as having a dry mouth. Each participant was offered three cycles of pilocarpine drops 4%, 6 mg tds (3 days) and placebo drops (3 days) in random order. Patients self-completed a diary using validated symptom and quality of life scores. The randomisation order was unmasked at the end of each person’s trial by a clinician independent of the trial to allow a treatment decision for individual patients to be made.

    Results : Twenty people were recruited to this pilot study, of whom five completed the planned three cycles; 36 cycles of data were completed in total. 438 doses of pilocarpine were administered. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Overall, no clinical difference in relief of dry mouth was noted on two measures of dry mouth, and an oral health related quality of life scale.

    Conclusion : The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate dose and method of delivery, then a retest of pilocarpine drops for this symptom.

    Citation
    Nikles, J., Mitchell, G.K., Hardy, J., Agar, M., Senior, H., Carmont, S.A., Schluter, P.J., Good, P., Vora, R., Currow, D. (2015) Testing the effectiveness of pilocarpine drops for dry mouth in advanced cancer using aggregated n-of-1 trials: a pilot study. Palliative Medicine, 29(10), pp. 967-974.
    This citation is automatically generated and may be unreliable. Use as a guide only.
    Keywords
    palliative care; xerostomia; pilocarpine; n-of-1 trial; advanced cancer
    ANZSRC Fields of Research
    32 - Biomedical and clinical sciences::3211 - Oncology and carcinogenesis::321104 - Cancer therapy (excl. chemotherapy and radiation therapy)
    32 - Biomedical and clinical sciences::3214 - Pharmacology and pharmaceutical sciences::321402 - Clinical pharmacology and therapeutics
    Rights
    https://hdl.handle.net/10092/17651

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