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A Systematic Review of Observational Studies on Treatment of Opioid Dependence

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A Systematic Review of Observational Studies on Treatment of Opioid Dependence A Systematic Review of Observational Studies on Treatment of Opioid Dependence Anna Maria Bargagli, Marina Davoli, Silvia Minozzi, Simona Vecchi, and Carlo A Perucci Department of Epidemiology, ASL RM E, Rome BACKGROUND DOCUMENT PREPARED FOR THIRD MEETING OF TECHNICAL DEVELOPMENT GROUP (TDG) FOR THE WHO "G UIDELINES FOR PSYCHOSOCIALLY ASSISTED PHARMACOTHERAPY OF OPIOID DEPENDENCE " 17-21 SEPTEMBER 2007 GENEVA , SWITZERLAND A STYSTEMATIC REVIEW OF OBSERVATIONAL STUDIES ON TREATMENT OF OPIOID DEPENDENCE Anna Maria Bargagli, Marina Davoli, Silvia Minozzi, Simona Vecchi, and Carlo A Perucci Department of Epidemiology, ASL RM E, Rome SUMMARY Background Evidence of effectiveness of substitution treatment with or without psychological treatment is derived mainly from systematic reviews of randomised controlled trials. Long term outcomes or rare events are not easily suitable for being evaluated within experimental studies and ancillary evidence can be drawn from observational studies. Aim To conduct a systematic reviews of observational studies to evaluate effectiveness of treatment for opioid dependence on overall mortality, fatal or non fatal overdose occurrence. Methods Medline (1966 to May 2006), Embase (1988 to May 2006), and CINAHL (1982 to May 2006) were searched to identify cohort and case-control studies evaluating the relationship between treatments for opioid dependence and overall or overdose mortality. The Newcastle-Ottawa Scale (NOS scale; NOS ) for assessing quality of non-randomized studies in meta-analysis was used. Quality assessment was not used as exclusion criteria. Results We screened a total number of 1040 studies, and included 18 studies; four studies have been conducted in the USA, three in Australia, two in Sweden, two in Spain, two in Italy, three in The Netherlands and two in England. All the included studies were cohort studies but one case-control study. Fourteen studies analysed the occurrence of overdose mortality and four non fatal overdose episodes. A total of 80,919 opioid addicts were enrolled in the included studies (range: 102-23,529). Median of mean age was 29.3 years (range of mean 23- 45). Median of proportion of male was 76,5% (range 50%- 99%). The studies were conducted in the period 1966 to 2002, most of them after the 80’s. Fourteen studies were conducted after the spread of the HIV epidemic, but only 5 of these reported information on HIV status, the proportion of infected patients ranging from 8% to 68% . Median length of follow up was 6.5 years (range 6 months, for the study evaluating occurrence of serious adverse events, to 21 years). Most studies analysing the effect of treatment on mortality compared patients in methadone maintenance treatment (MMT) with patients out of treatment (discharged voluntarily, involuntarily or not in treatment): they all, but one, show significant excess risk of mortality for patients not in treatment as compared with those in treatment, both for overall and overdose mortality. The two studies comparing different interventions do not show conclusive evidence of differences across different treatments. Overall, being in methadone treatment showed a strong significant protective effect (5 studies, 43035 participants): RR=0.37; 95%CI: 0.29-0.48 towards mortality for any cause as compared to being out of treatment (either discharged or not in treatment). Pooling of results was not possible for overdose mortality because of strong heterogeneity, however all studies but one (RR=0.95; 95%CI: 0.58, 1.54) reported significant protective effect ranging from 0.36 (95% CI 0.13-0.97) to 0.02 (95%CI: 0.01-0.09). Studies analysing non fatal overdose use different comparisons. Three studies compare occurrence of non fatal overdose episodes before and after the start of treatment, NTX or MMT, all showing reduction in the number of overdose episodes. However, the study analysing the effect of NTX implant shows significant increase in the occurrence of sedative overdose after the start of treatment. One study compares occurrence of non fatal overdose and other serious adverse events out NTX and agonist treatment compared with occurrence in treatment showing higher occurrence out of NTX treatment as compared with out of agonist treatment. Conclusions This systematic review provides additional evidence on the effectiveness of methadone maintenance treatment in reducing overall and overdose mortality; results are derived from studies conducted in different countries and contexts; the protective effect of treatment on mortality from any cause can range from 2 to five time less mortality among patients in methadone maintenance treatment as compared to patients out of treatment, while the magnitude of the protective effect of treatment on overdose mortality can range from virtually no effect (one study) to 3-50 time reduction in overdose mortality in the remaining studies. The evidence on reducing non fatal overdose is less striking, mainly due to the limited number of studies and problems related to the methodological quality of the studies. In particular the effectiveness of naltrexone appears to be controversial. Unfortunately we did not find data on the effectiveness of different durations of treatment, different intensities of treatment or different models of treatment. The studies on mortality show consistently that the major risk factor is cessation of treatment, which is associated with high risk of overdose death particularly in the first period after drop out. Limited evidence suggests higher risk of death in the first two weeks of methadone treatment. A STYSTEMATIC REVIEW OF OBSERVATIONAL STUDIES ON TREATMENT OF OPIOID DEPENDENCE Anna Maria Bargagli, Marina Davoli, Silvia Minozzi, Simona Vecchi, and Carlo A Perucci BACKGROUND It is well documented that heroin users are at substantially greater risk of premature mortality than their general population peers (Bargagli AM, 2001; Frischer M, 1997). Longitudinal studies indicate yearly mortality rates of between 1% and 3% among heroin users (Hulse GK, 1999). The excess mortality risk among heroin users have been estimated to be between 6 and 20 times higher than in the general population of the same age and gender (Hulse GK, 1999). Deaths attributed to overdose remain a major cause of mortality for heroin users, and in many countries is the leading cause of death (Sporer KA, 1999; Darke S, 2003). Treatment for heroin dependence is a highly effective public health response. The efficacy of different pharmacological and psychosocial treatment modalities have been evaluated in randomised clinical trials (RCT) and results from these studies have been synthesised in systematic reviews. Main outcome measures considered in RCT include retention in treatment, illegal drug use and criminal activity. The reduction of mortality rate is an important outcome in the evaluation of treatment effectiveness. Despite the fact that death represents the more relevant effect of abuse and the more reliable outcome measurable in population studies, mortality is rarely reported in RCTs of treatment of opioid dependence and is seldom taken into account to assess the efficacy of treatments. Although randomised controlled trials are considered the reference study design to evaluate treatment effectiveness, the relationship between drug treatment and mortality can reasonably be considered an exception (Black N, 1996) because of the very low death rates, demanding extremely large sample sizes, and long follow- ups to be tested by RCTs. Most of evidence on the effectiveness of treatments for opiate addiction in reducing mortality rates, comes from observational studies and is mainly concerning methadone maintenance. Very few studies have compared the effectiveness of different treatment types in preventing mortality from overdose, and only other pharmacological treatments have been considered (Digiusto E, 2004; Ritter AJ, 2002). Since evidence is lacking on reduction of mortality from randomised controlled trials a systematic review of non-experimental studies can provide useful information about the effectiveness of treatments when implemented in uncontrolled, or real-world, conditions. Observational studies are susceptible to biases mainly arising from selection of study participants and uncontrolled confounding factor. A careful evaluation of the study quality is needed to judge the reliability of evidence provided by observational studies. OBJECTIVES To evaluate the effects of treatment for opioid dependence on overall and overdose mortality and on non fatal overdose occurrence. CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW Types of studies Literature was reviewed for all cohort and case-control studies evaluating the relationship between treatments for opioid dependence and overall and overdose mortality. Types of participants Opioid dependents. Studies including a low proportion of dependents from other substances (<=20%) were also included. Studies focused on pregnancy status were excluded from the review. No other restriction were imposed in terms of inclusion or exclusion criteria. Types of intervention Any pharmacological intervention with or without psychosocial treatments compared with others pharmacological interventions with or without psychosocial treatments or no-treatment for opioid dependence. Psychosocial treatments without pharmacological treatment were not considered in this review. Types of outcome measures 1. Overall mortality assessed by record linkage with Local or National Mortality Registers, Forensic Institutes, Coroners’
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