Sangthawan 2001.
| Methods | Location: Thailand Number of centres: 1 Date of recruitment: January 1998 to January 1999 |
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| Participants | Inclusion criteria: histologically documented squamous cell carcinoma of head and neck who would receive definite or postoperative radiation Exclusion criteria: significant uncontrolled cardiac, pulmonary, renal or occular disease or required tricyclic antidepressants or antihistamine with anticholinergic effects, betablocker, pilocarpine for ophthalmic indications or chemotherapy Age: pilocarpine: 57 years; placebo: 58 years Gender (M:F): 49:11 Cancer type: oropharynx (n = 27); nasopharynx (n = 14); others (n = 19) Radiotherapy: Cobalt‐60 or 6 MV photon machine. Standard arrangement ‐ opposing lateral portals, loaded 1:1 and/or anterior low neck field. Both parotids treated to a dose of at least 50 Gy with an equal daily dose of 1.8‐2.0 Gy Chemotherapy: none Number randomised: 60 (30 per group) Number evaluated: 47 (25 pilocarpine; 22 placebo) |
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| Interventions |
Pilocarpine versus placebo Pilocarpine jelly: self administered 5 mg 3 times daily at meal times for duration of RT (7 weeks) Placebo: self administered 3 times daily at meal times for duration of RT (7 weeks) Follow‐up: 6 months after RT |
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| Outcomes | Xerostomia: subjective evaluation scores for xerostomia questionnaire (100 mm VAS for each of 5 questions) Salivary flow rates: not reported Adverse effects: reported ("non‐specific symptoms such as nausea, vomiting, dizziness, urinary frequency, palpitation, sweating and tearing") Survival data: not reported Other oral symptoms: not reported Other oral signs: disability to oral intake, amount of meals, use of analgesics Quality of life: not reported Patient satisfaction: not reported Cost data: not reported Timing of assessment: 6 months after RT |
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| Funding | Faculty of Medicine, Prince of Songkla University | |
| 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 | Information provided by author: "random number table" |
| Allocation concealment (selection bias) | Low risk | Information provided by author: "clinician not participating in study generated allocation sequence. Treatment codes concealed in sealed envelopes. Treatment coding not disclosed to investigator or patient" |
| Blinding (performance bias and detection bias) patients/carers | Low risk | Quote: "identically appearing placebo... patients and investigators were unaware of which treatment was administered" |
| Blinding (performance bias and detection bias) outcome assessment | Low risk | Information provided by author: "treatment code was disclosed to the investigator only after completion of the analysis of the results of the study" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 22% dropout rate |
| Selective reporting (reporting bias) | High risk | Poor reporting of xerostomia without SD |
| Other bias | Low risk | No other sources of bias are apparent |