The Pharmaceutical Journal
Vol 269 No 7214 p319-323
7 September 2002

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  Emergency hormonal contraception (EHC)
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Letters to the Editor

Olanzapine

Questions need answering

From Mr J. A. Tweed, MRPharmS

I read the paper (PDF 70K) by Anne Gilchrist et al (PJ, 17 August, pp222–225) but found that there were many questions needing answers.

There is no mention of the study being approved by an ethics committee, which would be especially important in view of the patient group recruited in the secure unit. Also, no mention is made of whether the patients, or their legal representatives, gave informed consent to enter the study. Are there references for the scales used for the measurements of the positive and negative symptoms? It would be interesting to know the names of the other antipsychotic drugs that were being prescribed along with the test drug.

The statistical analysis was said to be performed using the "intention to treat" basis, yet some 50 per cent of the patients have not been included in the tables nor in the results from the Lothian Primary Care NHS Trust. What were the results from these patients?

The results that are published appear to show that 24 per cent of the 116 patients who reached six months of treatment, had a "good response" (a reduction in positive symptoms of 40 per cent or more). Thus only 28 patients in the LPCT group, out of 116 recruited, had a "good response". This casts doubt on the conclusion that the test drug is clinically effective in the general adult psychiatric setting.

It would also have been useful if the 95 per cent confidence intervals had been stated.

Was the study funded or supported by the pharmaceutical company who manufacture the test drug?

J A Tweed
Burton Joyce, Nottingham

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