Testing pilocarpine drops for @entity2133 in XXXX using n-of-1 trials: A feasibility study.

@entity1 @entity2133 @entity137 @entity5
BACKGROUND: @entity2133 is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. AIM: This study aimed to test the feasibility of using n-of-1 trials to test pilocarpine drops compared to placebo, for @entity1 of palliative care units with @entity5 , who experienced @entity2133 . DESIGN: This was an N-of-1 study, in which each @entity1 was offered three cycles of pilocarpine drops 4% (6 mg tds) (3 days) and placebo drops (3 days) in random order. SETTING/ @entity1 : @entity1 were @entity1 of specialist palliative care services with @entity5 assessed as having a @entity2133 , defined as having a score of    3 on an 11-point self-rated xerostomia numerical rating scale, from any cause. @entity1 self-completed a diary using validated symptom and quality-of-life scores. The randomisation order was unmasked at the end of each @entity1 's trial by a clinician independent of the trial to allow a treatment decisions for individual @entity1 to be made. RESULTS: Nine @entity1 completed at least 1 cycle; 33 cycles of data were completed in total, comprising 438 doses of pilocarpine. Four @entity1 completed the trial: two responded and two did not. Most withdrawals related to deteriorating condition, unacceptable @entity137 , non-compliance with study procedures or withdrawal of consent. Many issues contributed to slow recruitment and high withdrawal rate. CONCLUSION: The formulation of pilocarpine drops proved unacceptable to most @entity1 . More work is required to determine an appropriate formulation, dose and method of delivery and then a retest of pilocarpine drops for this symptom.
