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Biomedical subjects

M J Godley

Publications and source records attributed to M J Godley.

6 recordsLinked to original sources

Rationale and statistical methodology for the VISA studies.

After examination of the epanolol ('Visacor') clinical package it became clear that, although efficacy and safety of epanolol were equivalent to efficacy and safety with other antianginal therapies, tolerability was improved. It was decided to initiate 2 studies with 500 patients in each to quantify the improved tolerability and examine patient preference for antianginal treatments. One study was a comparison of epanolol 200mg daily with metoprolol 100mg twice a day and the other compared epanolol 200mg daily with nifedipine retard 20mg twice a day. The rationale, design and statistical methodology are presented, together with a summary of the geographical spread of the study.

Adrenergic beta-Antagonists

Cryotherapy compared with trichloroacetic acid in treating genital warts.

In an observer blind comparative study, 130 men with penile warts were randomly allocated to treatment with either cryotherapy or trichloroacetic acid (TCAA). There was no significant difference in response to treatment, side effects, or recurrence rates between the two treatments. Warts resolved in 81% of patients treated with TCAA compared with 88% of those treated with cryotherapy. Early recurrence occurred in 36% of patients treated with TCAA and in 39% of those treated with cryotherapy.

Adolescent

Quantitation of vaginal discharge in healthy volunteers.

The mean quantity of vaginal discharge measured on four occasions during one menstrual cycle in 22 asymptomatic volunteers was 1.55 g/8 h although the amount varied significantly between different days of the cycle. The maximum occurred at mid-cycle (1.96 g/8 h) and low mean values were seen on day 7 (1.38 g/8 h) and day 26 (1.37 g/8 h), contrasting with the widely held view that the discharge increases premenstrually. This cyclical variation was statistically significant (P less than 0.02) in celibate women using no contraception but was less marked in sexually active women taking the combined oral contraceptive pill.

Adult

An international collaborative study of 'genetic drift' in Salmonella typhimurium strains used in the Ames test.

An international collaborative study of the response of 5 Salmonella typhimurium strains (TA1535, TA1537, TA1538, TA98 and TA100) to 4-nitroquinoline-N-oxide was performed. A laboratory's 'in-house' stock of these strains was compared with a set of reference strains, using a standardized protocol. The prime objective of this study was to investigate whether the ability of these strains to produce spontaneous or induced mutants had changed during their prolonged cultivation in different laboratories, i.e. to investigate their 'genetic drift'. Any observed change in mutability might contribute to the variations between laboratories in the results of the Ames test. A second objective was to obtain information on the extent of intra- and inter-laboratory variation when a standardized protocol was used. 38 laboratories participated in this study. The data were analysed statistically by 3 groups using different models and the same conclusion was reached: genetic drift is found in some strains in some laboratories, but does not contribute significantly to inter-laboratory variation in the Ames test. When the inter-laboratory variation was analysed there was considerable correlation between results for the 'in-house' and the reference strain, and between results for different strains in the same laboratory (Margolin et al., accompanying paper).

4-Nitroquinoline-1-oxide