Subject: GEN: Heroin maintenance for chronic heroin-dependent individuals.
Cochrane Database of Systematic Reviews: 2010, Issue 8.
Art. No.: CD003410. DOI: 10.1002/14651858.CD003410.pub3.
22 September 2010
Heroin maintenance for chronic heroin-dependent individuals.
Ferri M., Davoli M., Perucci C.A.
For the first time an authoritative review has combined results from all the trials to date of long-term heroin prescribing for the management of heroin addiction. Its analyses reveal several significant or probably significant advantages for patients previously failed by methadone.
Abstract
Prescribing heroin for the treatment of heroin addiction is today generally seen as a 'rescue' option for patients who have not benefited sufficiently from methadone maintenance. This updated review and meta-analysis A study which uses recognised procedures to summarise quantitative results from several studies of the same or similar interventions to arrive at composite outcome scores. Usually undertaken to allow the intervention's effectiveness to be assessed with greater confidence than on the basis of the studies taken individually. from the respected Cochrane collaboration adds new studies of the treatment from England, Spain and Canada, supplementing the earlier British, German, Swiss and pair of Dutch studies. The aim was to integrate findings on injectable (or in one case, smokable) 'heroin maintenance' as compared to more conventional oral methadone treatment, but also to any other comparators available in the literature, without limiting the selection to trials which allocated patients at random. In the event, seven of the eight relevant studies did explicitly compare heroin maintenance Often supplemented by oral methadone to help bridge time gaps (heroin has a much shorter duration of action) and to ease the burden of having to attend the clinic three times a day to inject heroin under medical supervision. to oral methadone; the remaining study also effectively did so, since all but a few of the control group A group of people, households, organisations, communities or other units who do not participate in the intervention(s) being evaluated. Instead, they receive no intervention or none relevant to the outcomes being assessed, carry on as usual, or receive an alternative intervention (for the latter the term comparison group may be preferable). Outcome measures taken from the controls form the benchmark against which changes in the intervention group(s) are compared to determine whether the intervention had an impact and whether this is statistically significant.
Comparability between control and intervention groups is essential.
Normally this is best achieved by randomly allocating research participants to the different groups. Alternatives include sequentially selecting participants for one then the other group(s), or deliberately selecting similar set of participants for each group. patients who had to find other sources of help in fact enrolled in methadone programmes.
The review assumed that all patients were chronic heroin addicts since only these patients would qualify for such treatments. Studies typically recruited local addicts who had regularly used illicit heroin for several years and who had not done well in previous non-heroin based treatments.
Main findings
Over the periods of the eight studies, for every 100 patients retained in treatment on methadone, another 23 were retained on heroin, almost a statistically significant advantage (ie, unlikely to have happened by chance). In the Dutch studies heroin patients faced stricter disciplinary discharge rules than methadone patients, biasing the retention rates. Leaving these studies out, heroin's advantage rises to another 43 patients and becomes statistically significant. Similar results are found if the analysis is restricted to the more recent (and more tightly controlled) studies.
Across the five studies to report this, for every 100 patients prescribed methadone who relapsed to use of illicit heroin, just 70 did so when prescribed heroin, very nearly a statistically significant advantage. Three studies also documented use of other substances; here there was a statistically significant advantage for prescribed heroin, the ratio being 100 on methadone to just 63 on heroin.
Across the six studies which reported on patient deaths, there were so few that the relative safety of heroin- and methadone-based treatments could not be assessed. Slightly fewer (0.9 in every 100 patients versus
1.2) heroin patients died, but on the other hand, significantly more adverse medical events short of death were recorded among the same patients - an extra 61%.
A 20% reduction in self-reported criminal activity among heroin compared to methadone patients just failed to reach statistical significance.
However, a significant extra reduction in average days involved in crime per month recorded in the Spanish study could not be incorporated in the calculations because this measure was incompatible with those of the other studies. Just two studies reported on imprisonment, of which the German trial was the only one to have tested modern-day treatments. In this study the numbers imprisoned were significantly and substantially fewer (a near halving) on heroin compared to methadone. Convictions too were fewer in the first 12 months of the study; 50% of heroin patients were convicted compared to 66% of methadone patients. In the studies reporting these outcomes, employment rates and improvements in family relationships did not significantly differ between heroin and non-heroin patients; possibly the need to attend the clinic to take prescribed heroin two or three times a day counteracted the expected gains.
The reviewers' conclusions
The available results demonstrate limited statistically significant positive effects of heroin (plus flexible dosing with methadone) with regard to most of the outcomes considered. Results are consistent across studies except (as explained above) for the Dutch studies which recorded better retention in the control group. All the authors of the studies highlighted the risks of adverse events. This risk warrants the provision of heroin only to patients who have clearly been failed by methadone treatment and only in centres equipped to respond to emergencies. What counts as 'failure' in this context remains to be clearly delineated. Certain disadvantages including poverty, lack of family support, and psychiatric problems are associated with poor compliance and response to many kinds of medical treatments. Since everywhere resources are limited, the open question is whether it is advisable to allocate patients to more expensive medications like heroin, rather than trying to address more effectively the identified health and social predictors of non-compliance and relapse which prevent methadone treatment working as well as it might. Given the higher rate of serious adverse events, the risk-benefit balance of heroin prescription should carefully be evaluated before the treatment is implemented in clinical practice. Heroin prescription should remain a treatment of last resort for people failed by conventional maintenance treatment. The capacity of addiction services and whether the treatment can be afforded in the long term should carefully be assessed beforehand.
Findings
The very cautious conclusion reached by the reviewers might easily have been more positive with some justifiable adjustments to the pool of studies included in the analyses or if the included outcomes had been only a fraction different. In particular, the early British trial could justifiably have been considered a trial of such a different kind There was no supervised consumption of heroin at the clinic, doses were low, and there was no requirement that patients had to have been failed by prior methadone treatment. of heroin-based treatment that it could have been analysed separately. Give such adjustments, In this case omitting the Dutch trials which had stricter disciplinary discharge rules for heroin patients. the advantage in retention became statistically significant and quite substantial - important because substitute prescribing treatments tend to be like an on-off switch; while patients remain in treatment they quickly improve and most do relatively well, but a rapid reversion to regular illicit heroin use with all its consequences is common if they drop out or are forced out of treatment.
Similarly, omitting the early English trial might have led the nearly significant heroin relapse comparison to have become statistically significant. Results for other substances were significant without adjustment. The death toll could not have been expected to be significantly different but still favoured heroin and would have done so more clearly had the early English trial been separated out. The higher incidence of adverse effects recorded among heroin patients may largely have been due to the fact their injecting - and any resultant immediate complications - were observed by the clinics, while any injecting by methadone patients would not have been. Had results from the Spanish trial been able to be included in the analysis, then the near significant extra reduction in crime among heroin patients may also have crossed the threshold to statistical significance.
For Britain the RIOTT trial conducted at clinics in London, Darlington, and Brighton between 2005 and 2008 is the vital study. The questions posed by the study were whether patients who remained wedded to street heroin despite extensive treatment were simply beyond available treatments, whether it was just that their current oral treatment programmes were sub-optimal, or whether they would only do well if prescribed injectable medications. Each of these three propositions was true for some of the patients. A third did seem beyond current treatments even as extended and optimised by the study. For a fifth, 'all' it took was to individualise and optimise dosing and perhaps also psychosocial support and treatment planning in a continuing oral methadone programme. But despite pulling out many stops to make the most of oral methadone, nearly half the patients only did well if prescribed injectable medications, with heroin by far the better option than methadone at suppressing illegal heroin use. The upshot was that the most reliable option in terms of securing a divorce from regular illegal heroin injecting was to prescribe the same drug to be taken in the same way, but legally and under medical supervision. As defined by the study, two-thirds of these seemingly intractable patients responded well to this option. However, from a conference presentation it seems injectable medications and heroin in particular had a far less clear-cut advantage in respect of crime, health, and quality of life.
Conclusions similar to those reached by the featured review have been reflected in UK national clinical guidelines and in guidance issued by England's National Treatment Agency for Substance Misuse. In particular the latter is clear that injectable prescribing should be considered only for the minority of patients with persistently poor outcomes despite optimised oral programmes, and that the priority should be improving the effectiveness of oral maintenance treatment for the majority.
Apart from the obvious and serious issue of cost, there is in any event a major logistical problem in extending heroin prescribing programmes based as recommended on supervised consumption at the clinic. Studies in continental Europe and Britain have shown that requiring on-site injecting or smoking of heroin several times a day is feasible. However, this can only work for patients who can easily and quickly get to the clinic. Unless the network of heroin prescribing centres is greatly expanded, on-site consumption will leave large parts of Britain unserved, especially rural areas. The inconvenience of on-site consumption can be tempered by allowing patients to skip visits and take oral medication instead, an opportunity most took advantage of in Swiss trials. Insisting instead on the return of used ampoules - a tactic used with seeming success in a study in London - may be a less intrusive and less expensive way to prevent diversion.
For more on substitute prescribing for heroin addiction see this Findings hot topic. For heroin prescribing studies in particular run this search on the Findings site, and especially see this Findings review and a later review which paid careful attention to the context of the studies and the details of the treatments.
This draft entry is currently subject to consultation and correction by the study authors and other experts.
Last revised 22 September 2010
http://dx.doi.org/10.1002/14651858.CD003410.pub3
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