Phytoestrogen and multiple vitamin/mineral effects on bone mineral density in early postmenopausal women: a pilot study.

The purpose of the study was to assess the effect of a combination regimen of herbs, vitamins, and minerals on bone mineral density (BMD) in early postmenopausal women via a 2-year, single-blind, uncontrolled, prospective trial. BMD was measured by dual energy x-ray absorptiometry (DEXA) at baseline and at 6, 12, and 24 months. Results of lumbar spine, hip, and forearm densities did not differ significantly from historical controls derived from other recent trials using a similar patient population. Bone mineral losses are reported on an annualized basis over the 2 years for the 12 women who completed the trial: spine (-1.42% per year), hip (-0.43% per year), forearm (-1.42% per year). Six women were withdrawn from the trial by the investigators because of excessive losses of bone mineral, and 1 of these women was diagnosed with hyperparathyroidism. There were no metabolic diseases to explain the losses in the remaining 5 withdrawn subjects. Four of 21 subjects experienced adverse side effects, necessitating dropping out by 3 of these women. In conclusion, the combined treatment regimen of a menopause symptom-oriented herbal blend plus a high potency vitamin/mineral was unsuccessful in protecting women against the predictable acceleration of bone mineral losses associated with early postmenopause.