7A.3.1 Improvement and deterioration as components of treatment outcome

In the present trial, patients were considered as responders if they showed at least 40% improvement after twelve months of treatment, compared to their situation at baseline, in at least one of the areas in which they functioned poorly at the start of the study (i.e. on the basis of which they were included at baseline), and these improvements should not have gone at the expense of similar deterioration in functioning in any of the other outcome domains (see paragraph 2.9.3). Hence, non-responders in the trial could consist of (1) subjects who had improved 40% or more on at least one of the outcome domains, but had concurrently deteriorated on at least one of the other outcome domains, (2) subjects who had neither improved, nor deteriorated according to the criteria, and (3) subjects who had not shown improvement (of 40% or more) on any of the outcome domains, but who had deteriorated on at least one of the outcome domains. Table 10 provides an overview of the percentage of patients in the treatment groups A and B in each of these categories.

Table 10. Types of non-responders in terms of improvement and deterioration (n = 174)

As indicated by Table 10, the observed effect in terms of percentage responders in the co-prescribed heroin group (56.6% versus 31.6% in the methadone alone group) did not go at the expense of an increased percentage of non-responders who did not improve and deteriorated (14.5% versus 30.6% in the methadone alone group).