Guo 2001.
Methods | randomised placebo controlled trial; used the table of random number. ratio of patients receiving naltrexone to those receiving placebo: 2:1 double blind. Multicenter study. | |
Participants | 49 Chinese patients who completed detoxification without using opiates for at least 5‐7 days before naltrexone treatment. Mean age: 24,96 (naltrexone) 26,76 (placebo). Male: 88,57% (naltrexone),92,86% (placebo). Educational level below junior high school: 68% (naltrexone) 78,57% (placebo); unemployed : 57,14% (naltrexone) 35,71% (placebo) | |
Interventions | naltrexone 50 mg/day(35) vs placebo (14). Outpatients setting duration: 6 month study | |
Outcomes | use of substance of abuse: n. of patients abstinent every month and at the end of the study. adverse effects | |
Notes | withdrawn from the study: data not given. Results on use of substances presented for 34 patients on naltrexone and 12 participants on placebo | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | quote: " the randomisation was performed according to the tables of random permutation" |
Allocation concealment? | Unclear risk | method for allocation concealment not reported |
Blinding? objective outcomes | Low risk | the study is labelled as double blind, but is also reported that " to investigate the optimal dose for Chinese patients, naltrexone was titrated according to the patients response COMMENT:The lack of blinding is unlikely to bias objective outcomes |
Blinding? subjective outcomes | Unclear risk | the study is labelled as double blind, but is also reported that " to investigate the optimal dose for Chinese patients, naltrexone was titrated according to the patients response |
Incomplete outcome data addressed? All outcomes | High risk | not reported how many patients dropped out form the studies and the different outcomes are measured on different numbers of patients |