Margaret A. Cramer

Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial

BACKGROUND Isoflavones are naturally occurring plant estrogens that are abundant in soy. Although purported to protect against bone loss, the efficacy of soy isoflavone supplementation in the prevention of osteoporosis in postmenopausal women remains controversial. OBJECTIVE Our aim was to test the effect of soy isoflavone supplementation on bone health. DESIGN A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg of soy hypocotyl aglycone isoflavones plus calcium and vitamin D on bone changes in 403 postmenopausal women. Study subjects were tested annually and changes in whole-body and regional bone mineral density (BMD), bone mineral content (BMC), and T scores were assessed. Changes in serum biochemical markers of bone metabolism were also assessed. RESULTS After study site, soy intake, and pretreatment values were controlled for, subjects receiving a daily supplement with 120 mg soy isoflavones had a statistically significant smaller reduction in whole-body BMD than did the placebo group both at 1 y (P < 0.03) and at 2 y (P < 0.05) of treatment. Smaller decreases in whole-body BMD T score were observed among this group of women at 1 y (P < 0.03) but not at 2 y of treatment. When compared with the placebo, soy isoflavone supplementation had no effect on changes in regional BMD, BMC, T scores, or biochemical markers of bone metabolism. CONCLUSION Daily supplementation with 120 mg soy hypocotyl isoflavones reduces whole-body bone loss but does not slow bone loss at common fracture sites in healthy postmenopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.

Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women

BACKGROUND Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety. OBJECTIVE Our aim was to evaluate the clinical outcomes of soy hypocotyl isoflavone supplementation in healthy menopausal women as a secondary outcome of a trial on bone health. DESIGN A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health of 403 postmenopausal women. At baseline and after 1 and 2 y, clinical blood chemistry values were measured and a well-woman examination was conducted, which included a mammogram and a Papanicolaou test. A cohort also underwent transvaginal ultrasound measurements to assess endometrial thickness and fibroids. RESULTS The baseline characteristics of the groups were similar. After 2 y of daily isoflavone exposure, all clinical chemistry values remained within the normal range. The only variable that changed significantly was blood urea nitrogen, which increased significantly after 2 y (P = 0.048) but not after 1 y (P = 0.343) in the supplementation groups. Isoflavone supplementation did not affect blood lymphocyte or serum free thyroxine concentrations. No significant differences in endometrial thickness or fibroids were observed between the groups. Two serious adverse events were detected (one case of breast cancer and one case of estrogen receptor-negative endometrial cancer), which was less than the expected population rate for these cancers. CONCLUSION Daily supplementation for 2 y with 80-120 mg soy hypocotyl isoflavones has minimal risk in healthy menopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.

Effect of soy isoflavone supplementation on menopausal quality of life.

ObjectiveThe purpose of this study was to assess the effect of soy isoflavone supplementation on quality of life in postmenopausal women. MethodsA multicenter, randomized, double-blind, placebo-controlled 24-month trial was conducted to assess the effect of 80 or 120 mg of daily aglycone hypocotyl soy isoflavone supplementation on quality of life in 403 postmenopausal women using a validated Menopause-Specific Quality of Life questionnaire. ResultsMenopause-Specific Quality of Life domain scores at 1 year and 2 years were similar to baseline. There were no differences in domain scores among treatment groups. ConclusionsSoy isoflavone supplementation offers no benefit to quality of life in postmenopausal women.

Re-enactments in their developmental context

The power of the repetition compulsion is felt in an especially keen way during re-enactments within psychodynamic psychotherapy. In this paper, the authors recommend greater attention to the developmental aspects of re-enactments as providing valuable information about the affective character of the crisis being brought to life in the treatment. Specifically, the authors suggest that the current developmental stage of the patient influences the experience and expression of the core developmental conflict that lies at the heart of the re-enactment in the treatment dyad. Re-enactments in childhood, adolescence and young adulthood, as well as at midlife and in the later years, each have different signatures. Thus, increased knowledge and awareness of both developmental stage and developmental core conflict is important for the following reasons: It provides a firmer theoretical foundation for understanding what is, by definition, a formidable moment in treatment; it adds another dimension and thus enhanced flexibility to the clinician’s clinical stance during a time of greater countertransference potential; and it adds to the theoretical perspective that the compulsion to repeat functions, at least in part, as an attempt to master an intrapsychic, affectively charged, previous experience of defeat. Clarifying the developmental nature of re-enactments for both patient and therapist can serve an orienting function during what is often a confusing and destabilizing time in the treatment relationship, and it can help differentiate developmentally appropriate behaviour from re-enacted conflict.