Randomized clinical trial Randomized clinical trial examining psychosocial and quality of life benefits of bilateral breast reduction surgery O. C. Iwuagwu 1 , L. G. Walker 3 , P. W. Stanley 2 , N. B. Hart 2 , A. J. Platt 2 and P. J. Drew 1 1 Academic Surgical Unit and 2 Plastic and Reconstructive Surgery Unit, University of Hull, Castle Hill Hospital, Cottingham, and 3 Institute of Rehabilitation, University of Hull, Hull Royal Infirmary, Hull, UK Correspondence to: Professor P. J. Drew, Academic Surgical Unit, University of Hull, Castle Hill Hospital, Castle Road, Cottingham HU16 5JQ, UK (e-mail: P.J.Drew@hull.ac.uk) Background: The aim was to determine the effects of bilateral reduction mammaplasty on quality of life and psychosocial functioning in women with mammary hypertrophy. Methods: Seventy-three women who were referred to either the Hull Breast Unit or Hull Plastic and Reconstructive Surgery Unit were randomized to early or delayed surgery. Both groups had quality of life and psychosocial assessment. Each group underwent two sets of tests. Women who had early bilateral breast reduction were tested before and at 4 months after surgery, whereas those in the control group were tested at the time of randomization and 4 months later, before undergoing surgery. Results: All 73 women completed the study. Mean age was 39 years, and the two groups were well matched for age, body mass index and breast dimension. There were highly significant differences between groups in scores measured on the Functional Assessment of Non-Life Threatening Conditions version 4, EuroQoL, and both mental and physical scales of Short Form 36 (P < 0·001). The Eysenck Personality Questionnaire – Revised demonstrated a statistically significant increase in extroversion and emotional stability in the early treatment group. Conclusion: Reduction mammaplasty significantly improved quality of life, and increased extroversion and emotional stability. Presented to the 27th San Antonio Breast Meeting, San Antonio, Texas, USA, December 2004 and to a scientific meeting of the British Association of Plastic Surgery, Dublin, Ireland, July 2004 Paper accepted 4 October 2005 Published online 19 December 2005 in Wiley InterScience (www.bjs.co.uk). DOI: 10.1002/bjs.5234 Introduction Bilateral breast reduction (BBR) is one of the commonest reconstructive surgical procedures for benign conditions performed on the breast, but it has become increas- ingly restricted by health authority purchasers in the UK 1 . There is a paucity of adequately designed studies examining quality of life (QoL) after reduction mamma- plasty and most published data are retrospective 2–5 . The few prospective studies have inherent design limitations, mostly related to the difficulty in con- ducting a randomized trial in these women 6,7 . The aim of this randomized study was to examine the value and impact of BBR in women with mammary hypertrophy. Patients and methods Seventy-three consecutive women were recruited into the study from outpatient department referrals to the Hull Breast Unit and Hull Plastic and Reconstructive Surgery Unit. The women were either on the waiting list for surgery (40 women) or had been referred by the general practitioner (37) to be considered for BBR. A consultant plastic surgeon or consultant breast surgeon saw each patient initially to confirm suitability for BBR and to obtain informed consent. Women who requested breast reduction for symptoms of mammary hypertrophy and were fit for surgery were included. Symptoms included headache, neck pain, back pain, shoulder pain, bra strap groove pain, submammary dermatitis and difficulty with clothing, in association Copyright 2005 British Journal of Surgery Society Ltd British Journal of Surgery 2006; 93: 291–294 Published by John Wiley & Sons Ltd