Gerra 2002.

Methods	Study design: Randomised controlled trial Study grouping: Parallel group Blinding: Single Duration: 8 days Single‐centre
Participants	Baseline characteristics Flumazenil IV Male, N (%): 9 (45) Age, mean (SD): 35.9 Oxazepam tapering Male, N (%): 11 (55) Age, mean (SD): 38.2 Placebo Male, N (%): 6 (60) Age, mean (SD): 35.4 Inclusion criteria: History of benzodiazepine dependence according to DSM‐IV criteria. Exclusion criteria: Severe chronic liver or renal diseases or other chronic physical disorders, recent onset of significant weight loss or gain, endocrinopathies, neurological disorders, immunopathy, in particular HIV disease, a positive family history of cardiovascular disease and hypertension, current abuse of illicit drugs and alcohol Pretreatment: None in reported parameters
Interventions	Intervention characteristics All participants received high doses of oxazepam (120 mg/day) during the last week before detoxification (pretreatment week). Benzodiazepine cessation + flumazenil 1.0 mg x 2 IV (N = 20) Oxazepam tapering + placebo (saline solution IV)(N = 20) Placebo + placebo(N = 10)
Outcomes	Benzodiazepine withdrawal symptoms: self reported withdrawal scores Relapse to benzodiazepine use
Identification	Sponsorship source: Not mentioned Country: Italy Setting: Inpatients Declarations of interest: Not mentioned Author's name: Gilberto Gerra Institution: Addiction Research Center, Ser.T., AUSL, Parma, Italy Email: gerra@polaris.it Address: Gilberto Gerra, Centro Studi Farmacotossicodipendenze, Ser.T., A.U.S.L., Via Spalato 2,43100 Parma, Italy
Notes	Only the comparison between flumazenil and placebo was considered relevant and included in the meta‐analysis, cf. Cochrane Handbook on multiple comparisons. Rate of relapse NOT reported for the placebo group because: (quote) Long‐term outcome of group C (placebo) patients was not evaluated in comparison with A and B patients because they received low‐dose benzodiazepine treatment for 2 weeks, immediately after the detoxification procedure, for ethical reasons.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Not described Quote: "The study was single‐blind, randomised and placebo‐controlled."
Allocation concealment (selection bias)	Unclear risk	Comment: Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "the trial was single‐blind, permitting direct clinical interventions in the case of dramatic withdrawal symptoms"
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Not done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Though not clearly described, judging from the text it appears that no participants withdrew during the 8‐day intervention trial.
Selective reporting (reporting bias)	Low risk	Comment: No reason to suspect selective outcome reporting
Other bias	Unclear risk	Comment: Funding not described.