BMJ 1996;313:75-78 (13 July)

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Randomised placebo controlled trial of effect on mood of lowering cholesterol concentration

J Wardle, reader in health psychology,a J Armitage, senior registrar in public health medicine,b R Collins, senior research fellow,b K Wallendszus, research officer,b A Keech, honorary senior registrar in cardiology,b A Lawson, research nurse,b  for the Oxford Cholesterol Study Group

a Imperial Cancer Research Fund, Health Behaviour Unit, University College London, London WC1E 6BT, b British Heart Foundation/ Medical Research Council/ Imperial Cancer Research Fund Clinical Trial Service Unit, Nuffield Department of Clinical Medicine, University of Oxford, Radcliffe Infirmary, Oxford OX2 6HE

Correspondence to: Dr Wardle.

Abstract

Objective: To evaluate the effects on mood of a substantial and prolonged reduction in total cholesterol concentration.
Design: Randomised placebo controlled comparison of patients who had been allocated to receive simvastatin 20 mg or 40 mg daily versus those allocated matching placebo in a ratio of 2:1. Follow up at an average of 152 weeks after randomisation.
Subjects: Men and women aged between 40 and 75 years at entry with blood total cholesterol of 3.5 mmol/l or greater, who were considered to be at higher than average risk of coronary heart disease based on medical history.
Main outcome measures: The shortened profile of mood states questionnaire, reported use of psychotropic medication, and symptoms possibly related to mood.
Results: Simvastatin reduced total cholesterol by 1.9 mmol/l (26.7%) at the time of follow up. Among all 621 patients randomised to simvastatin (414 patients) or placebo (207 patients) there were no significant differences in the use of psychotropic medication or in reports of symptoms possibly related to mood. Of these patients, 491 (334 simvastatin, 157 placebo) completed the mood questionnaire, and there were no significant differences between the treatment groups in total or subscale scores, even when patients with low baseline cholesterol concentrations or elderly subjects were considered separately.
Conclusion: These results do not support the hypothesis that treatment to lower cholesterol concentration causes mood disturbance.

Key messages

  • A randomised placebo controlled trial of simvas- tatin (a drug that lowers cholesterol concentration substantially) showed no associated mood distur- bance over a period of nearly three years in subjects with cardiovascular disease and no pre-existing psychiatric conditions

  • No effects on mood were seen in individuals with low baseline cholesterol concentrations or in older individuals, and there were no differences in use of psychotropic drugs between the treatment groups

  • These results give little support to the idea that reducing cholesterol concentration has adverse effects on mood


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