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The object of this study was to evaluate the effect of different doses of a compound containing isoflavones 60 mg, primrose oil 440 mg and vitamin E 10 mg. (IOVE) on menopausal complaints. This was an open, multicentre, randomised, group comparative, efficacy and safety trial. A total of 1,080 postmenopausal women, with climacteric symptoms, were allocated into one of two treatment groups to receive one (Group 1; n = 562) or two IOVE capsules (Group 2; n = 518) per day. The Blatt - Kupperman scale and safety parameters including weight, body mass index, blood pressure and adverse effects were assessed at the first visit before initiating the treatment, and 3 - 6 months thereafter. In addition, cholesterol, high density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride levels were measured at baseline and at the 6th month visit. Finally, at the end of follow-up, the patient's satisfaction was assessed. No differences between groups at the beginning of the study and during the follow-up were observed. A significant reduction in Blatt - Kupperman scores were observed in the two groups. In addition, the reduction of the symptoms was more intense in the first 3 months. Increasing doses of IOVE add no beneficial effects since both studied doses were equally effective in the reduction of climacteric complaints.

Serum tartrate-resistant acid phosphatase (TRAP) is considered a biological marker of bone resorption as it is synthesised by osteoclasts. Oestrogens inhibit bone resorption, and this may justify the influence of this hormone on osteoclastic activity. Thus, we have quantified serum TRAP levels in women to define their biological profile and observe any changes in relation to their hormone status.The TRAP level of 18 girls under 5 years of age was 8.1 f 1.7 u/l. This value decreased ( P < 0.001) in girls aged 5 to 12 years ( n = 20, mean 6.3 k 1.3u/l). Following the menarche, another decrease was observed in 12 to 15 year old girls ( n = 25, mean 5.5 5 0.6u/l, P < 0.01). The mean TRAP value continued to decrease during the childbearing years, 16 to 48 ( n = 40,3.8 f 0.3 u/l, P < 0.001). Finally, the mean level increased again at the menopause ( n = 26, 4.5 f 0.4u/l, P < 0@01). In women, serum TRAP changes reflect the dependence of bone modelling and turnover on hormone status.

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