Bauer 1985.

Methods	Design: Randomised, parallel group trial Year: Not reported Country: Germany
Participants	Patients: 40 patients were randomised to one of the following groups: Buprenorphine: N = 20 females, mean age = 60.3 years. Tilidin‐HCI + naloxon‐HCI: N = 20 females, mean age = 54 years. Inclusion criteria: "40 female patients were treated for severe cancer pain at the women's clinic at Heidelberg University." Exclusion criteria: Patients with severe liver or kidney damage, restriction of breathing or respiratory regulation, increased intracranial pressure, or allergy to tilidin‐HCI with naloxone‐HCl or buprenorphine.
Interventions	Buprenorphine arm: Drug: Buprenorphine hydrochloride. Dose/dosing: Single daily dose consisting of two tablets each giving a dose of 0.216 mg buprenorphine hydrochloride (= 0.2 mg buprenorphine). The abstract reports that it is a single daily dose, the methods section does not report any further details on dosing, however the results suggest that it is not a single daily dose, but rather a fixed dose given as needed. Formulation: SL. Route of administration: Oral. Length of treatment: 28 days. Titration schedule: No information reported. Rescue medication: No information reported. Other medication: No information reported. Comparison arm: Drug: Tilidin‐HCI + naloxon‐HCI. Dose/dosing: Single daily dose consisting of two capsules each giving a dose of 50 mg tilidin‐HCI and 4 mg naloxon‐HCI. The abstract reports that it is a single daily dose, the methods section does not report any further details on dosing. However the results suggest that it is not a single daily dose, but rather a fixed dose given as needed. Formulation: Oral. Route of administration: Oral. Length of treatment: 28 days. Titration schedule: No information reported. Rescue medication: No information reported. Other medication: No information reported.
Outcomes	Pain intensity: Assessed by patients in the morning, at midday and in the evening on days 0 (= before treatment), 1, 7, 14, 21 and 28 on a visual analogue scale. Side effects: No further details reported. Subjective evaluation of the drug: No further details reported.
Notes	Study free of commercial funding? No information reported. Groups comparable at baseline? The groups were comparable in terms of weight, height and baseline pain intensity. Unclear if they were balanced for age. ITT analyses undertaken? No information specifically reported, but the analyses appear to be conducted as ITT. Study published in German and lay‐translated by MSH.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study states it is randomised, but gives no further details.
Allocation concealment (selection bias)	Unclear risk	See cell above.
Blinding of participants and personnel (performance bias) Pain	Unclear risk	No details reported.
Blinding of participants and personnel (performance bias) Adverse events	Unclear risk	No details reported.
Blinding of outcome assessment (detection bias) Pain	Unclear risk	No details reported.
Blinding of outcome assessment (detection bias) Adverse events	Unclear risk	No details reported.
Incomplete outcome data (attrition bias) Pain	Low risk	Data from all 40 patients appear to be included.
Incomplete outcome data (attrition bias) Adverse events	Unclear risk	Data not reported in a manner where this can be ascertained.
Selective reporting (reporting bias)	Unclear risk	The outcomes are not well‐reported.
Other bias	Unclear risk	It is unclear due to limited reporting whether the study is subject to other bias(es).
Were the patients adequately titrated?	Unclear risk	No details reported.
For cross‐over trials: Are data available for both time periods?	Unclear risk	NA.