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

• Published in: BJOG : an international journal of obstetrics and gynaecology Vol. 109; no. 8; pp. 874 - 885
• Main Authors: Voss, Simon, Quail, Deborah, Dawson, Alison, Bäckström, Tjorbörn, Aguas, Fernanda, Erenus, Mithat, The, Hok Sien, Bonnar, John, De Geyter, Christian, Hunter, Myra, Nickelsen, Thomas
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.08.2002; Blackwell
• Subjects: Aged; Biological and medical sciences; Breast Diseases - chemically induced; Double-Blind Method; Female; Genital system. Reproduction; Hormone Replacement Therapy - methods; Humans; Medical sciences; Middle Aged; Pain - chemically induced; Patient Compliance; Patient Satisfaction; Pharmacology. Drug treatments; Postmenopause; Quality of Life; Raloxifene Hydrochloride - therapeutic use; Selective Estrogen Receptor Modulators - therapeutic use; Surveys and Questionnaires; Treatment Refusal; Vasodilation - drug effects; Human; Replacement therapy; Treatment efficiency; Antiestrogen; Antihormone; Quality of life; Drug compliance; Chemotherapy; Estroprogestagen; Double blind study; Postmenopause; Adult; Female; Raloxifene; Non steroid compound
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1016/S1470-0328(02)01510-0

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. Double-blind, randomised controlled trial of six-month duration. One hundred and twenty-nine gynaecology hospital departments, clinics or practices specialised in women's healthcare, located in Europe, South Africa and Israel. Healthy postmenopausal women ( n = 1008). 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). 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). 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.