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Andrew Al-Adwani, Consultant Psychiatrist Great Oaks, Ashby High Street, Ashby, Scunthorpe, North Lincolnshire, DN16 2JX, Ravi Nahata, Psychiatrist
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al-adwani{at}ntlworld.com Andrew Al-Adwani, et al.
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Haasen et al (2007) report highly significant findings in their trial of heroin plus methadone maintenance. A small problem is that the heroin plus methadone group were, to a large extent, self-selected with only 2.3% failing to initiate treatment in this group versus 28.8% in the methadone only arms. They state that this “limiting effect is minimised” by randomisation and intention to treat (ITT) analysis. ITT makes their already significant findings even more impressive but randomisation is limited by the unavoidable self-selection in a necessarily unblinded trial. The paper goes on to say “retention was higher in the heroin group, with 67.2% completing the 12 month treatment compared with 40% of the methadone group”, but later this is given as 56.3% for the methadone only group when the 28.8% who did not initiate treatment were excluded. The retention rate would rise again if the dropout (“discontinued”) rate was calculated using the same reduced denominator and therefore retention rates would possibly differ insignificantly. Taking this into consideration would also explain the almost equal numbers of discontinued subjects in the two main arms of the trial. The findings of this aspect of the trial are not surprising and without doubt it would be difficult to devise a control with the reinforcing power of heroin. Injectable methadone, financial incentives or pleasurable activities might approximate a substitute and produce more accurate retention figures. With the high cost of freeze-dried heroin, as used in the UK, adding these incentives might attract funding for a suitably modified study conducted here. Given that high retention rates are today’s centrally defined most desirable outcome in the UK, this sort of study might be even more attractive within these shores. Christian Haasen, Uwe Verthein, Peter Degkwitz, Juergen Berger, Michael Krausz, and Dieter Naber (2007) Heroin-assisted treatment for opioid dependence: Randomised controlled trial. British Journal of Psychiatry, 191, 55-62. |
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Christian Haasen, psychiatrist Dept. of Psychiatry, University Medical Center Eppendorf, Hamburg Germany
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haasen{at}uke.uni-hamburg.de Christian Haasen
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Dr. Al-Adwani raises an important issue in evaluating the outcome of maintenance treatment, namely how to evaluate the retention rate in an unblinded trial. The special incentive for patients randomised into methadone treatment was the option to switch into the heroin group after completing one year of treatment. Considering the fact that retention is considered one of the main outcome measures for maintenance treatment, our trial shows that heroin-assisted treatment (HAT) has two advantages, namely that it reaches a higher number of potential patients (% initiating treatment) and that the retention rate of those initiating treatment also is significantly higher for HAT (68.3 vs. 56.3%; LogRank=14.1, p<0.001). Therefore, it is incorrect to say that “retention rates would possibly differ insignificantly”: the difference is certainly less, but still significant. |
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