Perneger 1998.
Methods | Allocation: randomised controlled trial; Randomization Blindness of patients in respect to treatment: non described. Duration of treatment within the study: 6 months |
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Participants | Diagnosis: Heroin addicts; N=51 age >20; use >2yrs (12 years on average); more previous attempt of drug treatments (average 8 range 2‐21) and had experienced four drug overdoses (range 0‐30); high prevalence of mental disorders and health status scores 1‐2 SD below population norms. | |
Interventions | Heroin injected by the patients themselves + oral methadone if the patient travels or want to reduce the attendance of the clinic; mean daily dosages of intravenous heroin was 509 mg/day in one to three injections; in addition to heroin all the patients occasionally received oral opiates and 16 patients received clorazepate substitution therapy (median dose 60 mg/day)
psychological support (N=27) Any other conventional drug treatment (N=24) control: waiting list (control patients were encouraged to select any drug treatment program available in Geneva and were enrolled immediately whenever possible). Psychosocial treatment: all patients received psychological counselling, HIV prevention counselling, social and legal support services, and somatic primary care. |
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Outcomes | Consumption of street heroin; frequency of overdoses; risk behaviour for HIV; number of days ill in the past months; use of health services, health status, work status, living arrangements, quality of social relationships, monthly living and drug related expenditures, sources of income, and criminal behaviour, retention in treatment. | |
Notes | Country: Switzerland 1995‐1996 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer generated list of numbers placed in sealed envelopes". |
Allocation concealment (selection bias) | Low risk | Patients are allocated by the psychiatrist during the first visit through the sealed envelopes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All experimental group patients and 22 in the control group were reassessed 196 days on average after enrolment (range 168248); one person from the control group filled only the SF36 questionnaire. The two remaining patients in the control group were alive at follow up but refused to cooperate. |
Selective reporting (reporting bias) | Unclear risk | Protocol not identified probably due to the date of the study. |
Blinding (objective outcomes: drop out, use of substances measured by urine analysis) | High risk | no objective measures adopted: all outcome measures were self reported, which raises the issue of information bias. |
Blinding (subjective outcomes: use of substances as measured by self report, side effects) | High risk | no actions to reduce the risks reported |