Evidence map›Paper›PMID 24176001›Full record

ArticleBMC palliative care2013

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

Jane Nikles, Geoffrey K Mitchell, Janet Hardy, Meera Agar, Hugh Senior, Sue-Ann Carmont, Philip J Schluter, Phillip Good, Rohan Vora, David Currow

Registry-linked trialAbstract read
In one paragraph

Article in BMC palliative care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02982577 (Effect of Pilocarpine in Patients With Xerostomia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02982577 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Effect of Pilocarpine in Patients With Xerostomia

TypeinterventionalSponsorUniversity of Sao PauloRan2016 to 2017Enrolled80ConditionsXerostomiaArmsPilocarpine, Spray without Pilocarpine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Diagnostic accuracy of patient-reported dry mouth as a predictor for oral dryness in terminally ill cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Jane NiklesSchool of Medicine, The University of Queensland, Brisbane, Australia. uqjnikle@uq.edu.au.
Geoffrey K Mitchell
Janet Hardy
Meera Agar
Hugh Senior
Sue-Ann Carmont
Philip J Schluter
Phillip Good
Rohan Vora
David Currow

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. 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 registrationAustralia and New Zealand Clinical Trial Registry Number: 12610000840088.

Identifiers

PMID24176001
PMCPMC3827871

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.