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Author's reply

Published online by Cambridge University Press:  02 January 2018

J. Leff
Affiliation:
Institute of Psychiatry, King's College London, Denmark Hill, London SE5 8AF
B. Everitt
Affiliation:
Institute of Psychiatry, King's College London, Denmark Hill, London SE5 8AF
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Abstract

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Copyright © 2001 The Royal College of Psychiatrists 

Dr Ogundipe is, of course, quite right in pointing out that our conclusion about the greater acceptability of couple therapy compared with antidepressant drugs can only apply to the particular regime used in our trial. However, it is worth noting that similarly high drop-out rates have been recorded in other well-regarded trials of antidepressant treatment. For example, in the National Institute of Mental Health trial, the drop-out rate from imipramine treatment was 33% over 18 months (Reference Jacobson and HollonJacobson & Hollon, 1996).

Dr Ogundipe's view about intention-to-treat analysis is contrary to current statistical opinion and the recommendations of the British Medical Journal for the reporting of clinical trials (Reference AltmanAltman, 1996; Reference SchulzSchulz, 1996). The comment about baselines is not relevant here, since subjects who comply may fare differently and in an unpredictable way from those who do not comply. Thus, any observed differences between groups constructed in this manner may be due not to treatment but to factors associated with compliance. In this study, patients who dropped out were younger and had higher depression scores than those who completed the trial. The method of analysis should be consistent with the experimental design of a study. For randomised trials, such consistency requires the preservation of the random treatment assignment. Because methods that violate the principles of randomisation are susceptible to bias, they should not be used.

An analysis of the number needed to treat may be a sensible suggestion in general, although for a number of technical reasons it is not popular among statisticians (see Reference HuttonHutton, 2000). In any case, in this trial the high drop-out rate from the medication group would make the results of such an analysis suspect.

Marital discord was assessed using the Dyadic Adjustment Scale. As shown in Table 1 in the paper, the two treatment groups did not differ on this score, making it unlikely that this variable confounded the results.

References

Altman, D. G. (1996) Better reporting of randomised controlled trials: the CONSORT statement. British Medical Journal, 313, 570571.Google Scholar
Hutton, J. L. (2000) Number needed to treat: properties and problems. Journal of the Royal Statistical Society, Series A, 163, 403419.CrossRefGoogle Scholar
Jacobson, N. S. & Hollon, S. D. (1996) Cognitive–behavior therapy versus pharmacotherapy: now that the jury's returned its verdict, it's time to present the rest of the evidence. Journal of Consulting and Clinical Psychology, 64, 7480.Google Scholar
Schulz, K. F. (1996) Randomised trials, human nature, and reporting guidelines. Lancet, 348, 596598.Google Scholar
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