We searched the following databases to January 2013: Cochrane Drugs and Alcohol Review Group Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Current Contents, PsycLIT, CORK, Alcohol and
Drug Council of Australia, Australian
Drug Foundation, Centre for Education and Information on Drugs and Alcohol, Library of Congress, reference lists of identified studies and reviews. We sought published/unpublished randomised controlled trials (RCTs) from authors.
SELECTION CRITERIA: We used Cochrane Collaboration methodology.
MAIN RESULTS: We include 31 trials (5430 participants), the quality of evidence varied from high to moderate quality.There is high quality of evidence that
buprenorphine was superior to placebo medication in retention of participants in treatment at all doses examined. Specifically,
buprenorphine retained participants better than placebo: at low doses (2 - 6 mg), 5 studies, 1131 participants, risk ratio (RR) 1.50; 95% confidence interval (CI) 1.19 to 1.88; at medium doses (7 - 15 mg), 4 studies, 887 participants, RR 1.74; 95% CI 1.06 to 2.87; and at high doses (≥ 16 mg), 5 studies, 1001 participants, RR 1.82; 95% CI 1.15 to 2.90. However, there is moderate quality of evidence that only high-dose
buprenorphine (≥ 16 mg) was more effective than placebo in suppressing illicit
opioid use measured by urinanalysis in the trials, 3 studies, 729 participants, standardised mean difference (SMD) -1.17; 95% CI -1.85 to -0.49, Notably, low-dose, (2 studies, 487 participants, SMD 0.10; 95% CI -0.80 to 1.01), and medium-dose, (2 studies, 463 participants, SMD -0.08; 95% CI -0.78 to 0.62)
buprenorphine did not suppress illicit
opioid use measured by urinanalysis better than placebo.There is high quality of evidence that
buprenorphine in flexible doses adjusted to participant need,was less effective than
methadone in retaining participants, 5 studies, 788 participants, RR 0.83; 95% CI 0.72 to 0.95. For those retained in treatment, no difference was observed in suppression of
opioid use as measured by urinalysis, 8 studies, 1027 participants, SMD -0.11; 95% CI -0.23 to 0.02 or self report, 4 studies, 501 participants, SMD -0.11; 95% CI -0.28 to 0.07, with moderate quality of evidence.Consistent with the results in the flexible-dose studies, in low fixed-dose studies,
methadone (≤ 40 mg) was more likely to retain participants than low-dose
buprenorphine (2 - 6 mg), (3 studies, 253 participants, RR 0.67; 95% CI: 0.52 to 0.87). However, we found contrary results at medium dose and high dose: there was no difference between medium-dose
buprenorphine (7 - 15 mg) and medium-dose
methadone (40 - 85 mg) in retention, (7 studies, 780 participants, RR 0.87; 95% CI 0.69 to 1.10) or in suppression of illicit
opioid use as measured by urines, (4 studies, 476 participants, SMD 0.25; 95% CI -0.08 to 0.58) or self report of illicit
opioid use, (2 studies, 174 participants, SMD -0.82; 95% CI -1.83 to 0.19). Similarly, there was no difference between high-dose
buprenorphine (≥ 16 mg) and high-dose
methadone (≥ 85 mg) in retention (RR 0.79; 95% CI 0.20 to 3.16) or suppression of self-reported
heroin use (SMD -0.73; 95% CI -1.08 to -0.37) (1 study, 134 participants).Few studies reported adverse events ; two studies compared adverse events statistically, finding no difference between
methadone and
buprenorphine, except for a single result indicating more sedation among those using
methadone.
AUTHORS' CONCLUSIONS:
Buprenorphine is an effective medication in the maintenance treatment of
heroin dependence, retaining people in treatment at any dose above 2 mg, and suppressing illicit
opioid use (at doses 16 mg or greater) based on placebo-controlled trials.However, compared to
methadone,
buprenorphine retains fewer people when doses are flexibly delivered and at low fixed doses. If fixed medium or high doses are used,
buprenorphine and
methadone appear no different in effectiveness (retention in treatment and suppression of illicit
opioid use); however, fixed doses are rarely used in clinical practice so the flexible dose results are more relevant to patient care.
Methadone is superior to
buprenorphine in retaining people in treatment, and
methadone equally suppresses illicit
opioid use.