Büntzel 1998.

Methods	Location: Germany Number of centres: 1 Date of recruitment: not stated
Participants	Inclusion criteria: stage III or IV carcinoma of the head and neck, aged 16 to 80 and no evidence of systemic infection or liver or renal impairment. Tumour resected or excised before adjuvant RT Exclusion criteria: not reported Age: amifostine: median 61 (range 40‐77); control: median 58 (range 38‐75) Gender: amifostine 13 M, 1 F; control 12 M, 2 F Cancer type: tumour location (amifostine/control): larynx = 3/1, hypopharynx = 4/3, mesopharynx = 3/7, nose = 2/1, mouth = 2/2 Radiotherapy: 2 Gy fractions, 5 days a week for 6 weeks; maximum dose of 60 Gy (encompassing 75% of the major salivary glands) Chemotherapy: 20 min IV infusion of carboplatin (70 mg/m² days 1 to 5 and 21 to 25 of treatment) Number randomised: 28 (14 amifostine, 14 control) Number evaluated: 28
Interventions	Amifostine versus no intervention Amifostine: (500 mg) 15 min IV before carboplatin (days 1 to 5 and days 21 to 25). Followed by antiemetic regimen to control nausea/vomiting Control: nothing Use of supportive drugs reported: (amifostine/control): G‐CSF: 2/7; GM‐CSF: 0/7; antibiotics: 4/10
Outcomes	Xerostomia: incidence and severity using WHO grading (0 to 4 scale ‐ we report grade 2 and above) Salivary flow rates: not reported Adverse effects: hypotension Survival data: not reported Other oral symptoms: dysgeusia (taste disturbance), dysphagia (difficulty in swallowing), mucositis (WHO) Other oral signs: not reported Quality of life: not reported Patient satisfaction: not reported Cost data: economic evaluation (Bennett 2001) Timing of assessment: xerostomia at end of RT and 1 year; other oral symptoms at end of RT
Funding	US Bioscience who produce Ethyol‐amifostine
Trial registration	Not registered
Sample size calculation presented	Not reported
Notes	Additional data presented but included extra 11 patients in amifostine group who were not entered in the study (not included in analyses)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Blinding (performance bias and detection bias) patients/carers	High risk	Amifostine versus no intervention
Blinding (performance bias and detection bias) outcome assessment	High risk	Not blinded and xerostomia is a subjective outcome
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants included in analysis
Selective reporting (reporting bias)	Low risk	Xerostomia and adverse events reported
Other bias	Low risk	No other sources of bias are apparent