Pimentel 2014.

Methods	Location: Brazil Number of centres: 1 Date of conduct: not reported
Participants	Inclusion criteria: newly diagnosed head and neck cancer beginning treatment with RT Exclusion criteria: previous RT, concomitant chemotherapy, cardiopathy, hypertension, diabetes, allergy to pilocarpine, Sjögren syndrome, salivary gland tumours, chronic lung disease, glaucoma, peptic ulcer, taking betablockers or drugs that could alter salivary flow Age: mean 60 years (not given by group) Gender (M:F): 8:3 Cancer type: oral (n = 1); oropharynx (n = 3); mouth floor and tongue (n = 2); larynx (n = 4); pharynx (n = 1) Radiotherapy: 35 to 50 Gy, with daily doses about 2 Gy Chemotherapy: none Number randomised: unclear whether 29 or 11 (see attrition bias) Number evaluated: 11 (pilocarpine 5, placebo 6)
Interventions	Pilocarpine versus placebo Pilocarpine: 5 mg 3 times daily for duration of RT Placebo: saline solution 3 times daily for duration of RT
Outcomes	Xerostomia: patient‐reported feeling of dry mouth Salivary flow rates: unstimulated (USF) and stimulated saliva (SSF) (ml/min) Adverse effects: reported narratively Survival data: locoregional control: not reported Other oral symptoms: oral mucositis, ulcers Other oral signs: difficulty in eating Quality of life: only eating Patient satisfaction: not reported Cost data: not reported Timing of assessment: weekly during RT (4 weeks)
Funding	The National Research Council (CNPq)
Trial registration	Not registered
Sample size calculation presented	No
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...dispensing pharmacy held custody of the samples, separating those from the group who took pilocarpine solution from those which took the placebo. All patients were assigned a number corresponding to the medicine bottle. Researchers were not granted access to that information prior to the end of the survey"
Allocation concealment (selection bias)	Low risk	Quote: "...dispensing pharmacy held custody of the samples, separating those from the group who took pilocarpine solution from those which took the placebo. All patients were assigned a number corresponding to the medicine bottle. Researchers were not granted access to that information prior to the end of the survey"
Blinding (performance bias and detection bias) patients/carers	Low risk	Double‐blind ‐ see above
Blinding (performance bias and detection bias) outcome assessment	Low risk	Double‐blind ‐ see above
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "We pre‐selected 29 patients; however, the careful selection of the population was directly reflected in the number of enrolled patients and in the end, only 11 were included in the survey. We consider that this low number is a result not only of the exclusion stemming from previously established eligibility criteria but also from the breach of protocol"
Selective reporting (reporting bias)	High risk	Poorly reported data for xerostomia and no adverse events
Other bias	Low risk	No other sources of bias are apparent