A randomised, double-blind trial comparing raloxifene HCl and continuous combined hormone replacement therapy in postmenopausal women: effects on compliance and quality of life

Authors: Voss, Simon¹; Quail, Deborah¹; Dawson, Alison¹; Bäckström, Tjorbörn²; Aguas, Fernanda³; Erenus, Mithat⁴; The, Hok Sien⁵; Bonnar, John⁶; Geyter, Christian⁷; Hunter, Myra⁸; Nickelsen, Thomas¹

Source: BJOG: An International Journal of Obstetrics & Gynaecology, Volume 109, Number 8, August 2002 , pp. 874-885(12)

Publisher: Blackwell Publishing

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Abstract:

Objective

To compare continuous combined hormone replacement therapy (ccHRT) and raloxifene with respect to compliance and quality of life, which were predefined secondary endpoints of a large, prospective study designed to investigate the uterine effects of both treatments. Design

Double-blind, randomised controlled trial of six-month duration. Setting

One hundred and twenty-nine gynaecology hospital departments, clinics or practices specialised in women's healthcare, located in Europe, South Africa and Israel. Population

Healthy postmenopausal women ( n= 1008 ). Main outcome measures

Changes in quality of life using the Women's Health Questionnaire (WHQ) and compliance using a compliance questionnaire and pill count. Adverse event and early discontinuation rates and satisfaction with treatment using a visual analogue scale (VAS). Results

Women taking raloxifene reported greater satisfaction with their treatment as assessed on the VAS ( P= 0.004 ),and a lower proportion, as compared with ccHRT, reported being worried by the treatment ( 9.6%vs 20.2%, P < 0.01 ). Women taking ccHRT reported greater deterioration in scores from the WHQ for depressed mood and menstrual symptoms than those taking raloxifene ( P < 0.01 ). For memory, vasomotor symptoms and sexual behaviour, the ccHRT group reported significantly greater mean improvements ( P < 0.05 ). Over half (58.8%) of those taking raloxifene noticed no effect, 37.7% felt better and 3.4% felt worse as measured using the compliance questionnaire. Fifty percent of the women taking ccHRT felt better, 37.8% noticed no effect but over 10% felt worse. More women on raloxifene (94.6%) than on ccHRT (85.9%) reported that they were taking their double-blinded medication regularly ( P < 0.01 ). Conclusions

A lower rate of adverse event-related discontinuations, the lack of negative effects on quality of life and a smaller proportion of women being worried by the drug treatment were associated with higher treatment satisfaction and better compliance in postmenopausal women taking ccHRT or raloxifene.

Document Type: Research article

DOI: 10.1111/j.1471-0528.2002.01510.x

Affiliations: 1: Eli Lilly & Company Limited, Surrey, UK 2: Department of Obstetrics and Gynaecology, Umea University, Umea, Sweden 3: Department of Obstetrics and Gynaecology, Maternidade Bissaya Barreto, Coimbra, Portugal 4: Department of Obstetrics and Gynaecology, Marmara University, Istanbul, Turkey 5: Department of Obstetrics and Gynaecology, St Antonius Teaching Hospital, Nieuwegein, The Netherlands 6: Department of Obstetrics and Gynaecology, Trinity Centre for Health Sciences, St James' Hospital, Dublin, Ireland 7: Department of Obstetrics and Gynaecology, Kantonsspital Basel, Basel, Switzerland 8: Department of Clinical Psychology, St Thomas' Hospital, London, UK

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