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Biomedical subjects

P Albertazzi

Publications and source records attributed to P Albertazzi.

At least 19 recordsLinked to original sources

Effect of intermittent compression therapy on bone mineral density in women with low bone mass.

Intermittent pneumatic compression has been shown to increase blood flow in the leg which, in turn, may improve BMD. We performed a pilot study to assess whether intermittent compression of the leg could improve BMD at the femoral neck. 37 postmenopausal women with low bone density T score < -1 at either hip or spine were recruited into the study of whom 24 completed. Women applied intermittent compression for 2 h a day for 6 months to each leg in turn. The study lasted 1 year. Women were also given daily 1 g of Calcium and 800 IU of vitamin D (Calcichew D 3 forte Shire, UK). Lumbar spine BMD decreased by 0.5% at 12 months compared with baseline (mean difference 0.005 g/cm(2), 95% C.I -0.2287 to 0.03459, P = 0.28). At 12 months the right femoral neck BMD increased by 3% compared with baseline (mean 0.811 +/- 0.08, P = 0.22), while the left increased 2% (0.783 +/- 0.06, P = 0.16). There was no change in BMD at the distal tibia or heels and no site effect of the compression. The fat mass decreased by 4.6% in the right leg and 5% in the left leg (P = 0.005 and 0.003, respectively). Tissue thickness did not change. The analysis of the interaction between the degree of exercise and change in BMD showed a statistically significant increase in right femoral neck BMD following 6 months of right leg intermittent compression, but only in women whose exercise was minimal (P = 0.029). This effect was not seen in the left femur possibly due to the reduced number of patients who completed the study in this group. These preliminary results indicate that intermittent pneumatic leg compression may have a role in osteoporosis prevention. It may provide a mean of inhibiting decline in femoral neck BMD, particularly in sedentary women.

Aged↗

Urogenital effects of selective estrogen receptor modulators: a systematic review.

OBJECTIVE: Selective estrogen receptor modulators (SERMs) include a relatively large number of compounds, each with different profiles of estrogenic/antiestrogenic actions on the genital tract. The aim of this review was to systematically evaluate all the available data from randomized, controlled studies on the effects of these compounds on pelvic organ prolapse and urinary incontinence. METHODS: Literature searches were performed using three computerized databases to identify the result of all randomized, controlled trials performed with SERMs having any effects on pelvic floor as an outcome. A manual search was performed on all related articles. RESULTS: We have identified only one randomized, placebo-controlled trial specifically designed to assess the effect of raloxifene and tamoxifen on the urogenital tract. Most of the data on genitourinary effects of various compounds derive from either questionnaires or adverse events reported during phase III clinical trials. Both tamoxifen and raloxifene appear to increase the incidence of pelvic floor prolapse in one trial, although this was not apparent from the licensing studies data for either of the drugs. Raloxifene does not appear to increase the incidence of urinary incontinence. Levormeloxifene and idoxifene, on the contrary, were noted to increase uterine prolapse and incontinence during phase III trials that prematurely terminated. No data are available on the genitourinary effect of toremifene and on the newer SERMs currently undergoing phase III trials: basedoxifene, lasofoxifene, and arzoxifene. CONCLUSION: Contrary to their effects in bone, SERMs do not have a class-specific effect on the genitourinary tract. In fact, compounds that are more estrogenic on the uterus such as levormeloxifene and idoxifene also increase the risk of prolapse and incontinence. SERMs can adversely affect the pelvic floor and incontinence but data from urodynamic studies are not yet available. Data on prolapse are contradictory. Given the increased incidence of prolapse and incontinence observed in several licensing trials, more focused research on the effect of these molecules on pelvic floor function is needed.

Clinical Trials as Topic↗

Effect of pure genistein on bone markers and hot flushes.

OBJECTIVE: To evaluate the effect of 90 mg of daily genistein on markers of bone turnover and menopausal symptoms. DESIGN: This was a cross-over, placebo-controlled study involving 100 postmenopausal women. Subjects were randomly assigned to daily genistein or placebo for 6 weeks and crossed over to the alternative preparation for the following 6 weeks. Pure genistein was processed and encapsulated in accordance with British Pharmacopoeia standards. Each capsule contained 90 mg of pure genistein while the placebo contained just the recipients. RESULTS: In women with significant hot flushes (score (intensity x number) > or = 9), genistein reduced symptoms by 30% compared to baseline and the difference compared to placebo was statistically significant. No effect was observed on biochemical markers of bone turnover, possibly due to the short duration of each arm of the study. Genistein reduced osteocalcin, a marker of bone formation, by 3.6% compared to baseline and 0.31% compared to placebo (p = 0.81 and 0.40, respectively). Genistein increased cross-link telopeptide, a marker of bone resorption, by 1.8% compared to baseline and 0.29% compared to placebo; both differences were not statistically significant (p = 0.078 and 0.88, respectively). CONCLUSION: Pure genistein at a dose of 90 mg per day appears to reduce the number of hot flushes in postmenopausal women but the effect is mild.

Biomarkers↗

Comparison of the effects of two different types of calcium supplementation on markers of bone metabolism in a postmenopausal osteopenic population with low calcium intake: a double-blind placebo-controlled trial.

OBJECTIVE: To investigate calcium supplements in postmenopausal women. Calcium supplements in postmenopausal women with a low calcium intake have been shown to prevent osteoporotic vertebral fracture, but calcium is variably absorbed and often poorly tolerated, which may limit effectiveness. METHODS: The study compared the efficacy and tolerability of 500 mg/day of calcium in the form of ossein-hydroxyapatite (OHC) versus 500 mg/day of tricalcium phosphate (TCP) and placebo in the prevention of postmenopausal bone loss. This was a prospective randomized study enrolling 153 postmenopausal osteopenic women. Serum and urine markers of bone turnover were collected at 3 and 6 months. Bone density measurement was performed at baseline and 6 months in all participants, and at 12 months in women taking OHC. RESULTS: At 3 and 6 months, both TCP and OHC decreased serum markers of bone formation significantly, compared with placebo. At 6 months, TCP and OHC decreased osteocalcin by 9.9% and 12.3%, respectively; the aminoterminal propeptide of type I procollagen (PINP) was decreased by 5.3% and 6.3%, respectively; bone-specific alkaline phosphatase was decreased by 4.3% and 6.7%, respectively, compared with baseline. The effects on bone resorption markers or on bone mineral density did not reach statistical significance, although OHC increased bone density by 0.8% at the spine at 12 months. Both forms of calcium were well tolerated and did not differ from placebo in terms of side-effects. CONCLUSIONS: While both OHC and TCP were well tolerated and significantly reduced bone turnover markers, the effect of ossein-hydroxyapatite seems slightly superior to that of tricalcium phosphate.

Aged↗

Factors affecting long-term adherence to hormone replacement therapy after screening for osteoporosis.

OBJECTIVE: To investigate factors likely to influence adherence to hormone replacement therapy (HRT) in women known to have low bone mass. STUDY DESIGN: This was a prospective study of bone mineral density screening in 6282 women aged 50-54 years. RESULTS: Low bone mass at either the hip or spine was found in 1462 women. The principal route of HRT delivery, transdermal or oral, as well as the presence of climacteric symptoms before starting treatment, did not influence adherence. However, adherence to HRT type was significantly superior in hysterectomized women taking unopposed estradiol (median 32 months) compared with those on sequential HRT (median 28 months; p = 0.011). Overall, a 5-year adherence to HRT of 61% was achieved. CONCLUSION: Approximately 34% of women starting HRT are likely to stop in the first 2 years of use. Following this, the discontinuation rate is low. The combination of knowledge of risk for osteoporosis and regular follow-up positively influences long-term adherence to HRT.

Absorptiometry, Photon↗

Purified phytoestrogens in postmenopausal bone health: is there a role for genistein?

OBJECTIVE: Genistein is the main isoflavone present in soy and the one to which biological action is most often ascribed. There are suggestions that genistein could have a role as an osteoprotective agent. Hence, a review of the evidence has been undertaken. METHODS: MEDLINE (1966-August 2001), Allied Complementary Medicine (1985-2001), the Cochrane Library and the Database of Systematic Reviews (2nd Quarter 2001) were searched using the key words: genistein, osteoporosis, bone, isoflavones. RESULTS: Genistein appears to bind to the estrogen receptor (ER), with greatest affinity to ER beta. In vitro it stimulates protein synthesis in osteoblast cell lines, and in animal studies it appears to be effective in preventing bone loss caused by estrogen deficiency. There are no published human studies using pure genistein. CONCLUSION: Genistein appears to have a stimulatory effect on osteoblasts and, in some animal studies, it has been shown to exert an anabolic effect on bone. If these effects were to be demonstrated in humans, genistein would be a potentially useful oral anabolic agent for the treatment of osteoporosis.

Administration, Oral↗

Attitudes towards and use of dietary supplementation in a sample of postmenopausal women.

OBJECTIVES: To assess the reason why people take food supplements in addition to or in place of medication, as well as the perceived efficacy and risk of these supplements. METHODS: A 20-item, computer-assisted telephone questionnaire was administered to 442 women over 60 years of age in Hull, to assess the prevalence of use and perception of efficacy and safety of food supplements. RESULTS: Data were available for 411 women, of whom 269 (65.4%) were currently taking food supplements, 76 (18.5%) were previous users and 66 (16%) were never-users. There was no difference in terms of age, smoking, consumption of fruit and vegetables, life-style and attitude towards conventional medicine between current or past users of supplements and never-users. The majority of users (n = 229, 66%) thought that food supplements help maintain good health (p < 0.001). Overall long-term (5 years) adherence was achieved in 244 cases of supplement uses (36%). Among users, 150 (43%) thought that supplements were very effective, and 171 (49.5%) women had noticed an improvement of various symptoms. Although the majority of users (n = 176, 51%) believed that supplements might have adverse effects, over 66% would not associate side-effects with the food supplement. Information regarding supplements was obtained primarily from the media, particularly magazine and newspaper articles (27%), with health professionals rarely being consulted (16%). CONCLUSIONS: Users believed supplements to be effective, although possibly with associated side-effects. However, they would not attribute adverse effects experienced to this form of treatment. Medical practitioners and health professionals are rarely informed or consulted, leaving potentially dangerous side-effects of food supplements to go unreported.

Aged↗

Oestrogen and selective oestrogen receptor modulators (SERMs): current roles in the prevention and treatment of osteoporosis.

Post-menopausal oestrogen replacement therapy (HRT) is the agent of choice for restraint of post-menopausal bone loss. In numerous observational, and in a few intervention studies, it has been shown to reduce osteoporotic fractures. However, in order to be effective treatment has to be carried on long term. This is a task not easily achieved due to poor patient adherence. The majority of patients stop treatment after a few months. Fear of breast cancer and refusal to tolerate resumption of cyclic withdrawal bleeding are the principal objections. Newer and more user-friendly forms of treatment are needed. Ideally, these should have an efficacy similar to oestrogen on the central nervous system, cardiovascular system and bone, without adverse effects on the breast and uterus. With this in mind, Selective oestrogen Receptor Modulators (SERMs) have been developed. In this chapter we review how effective modern pharmacology has been in achieving an improved design of hormonal replacement for the post-menopausal women, and the place that it has obtained today alongside both older and newer forms of treatment.

Estrogen Replacement Therapy↗

Exploration of cyclical changes in memory and mood in postmenopausal women taking sequential combined oestrogen and progestogen preparations.

OBJECTIVE: To investigate the effect of progesterone on cognitive function, mood, sleep quality and libido when added to oestrogen in sequential combined hormonal replacement therapy regimens. DESIGN: Observational study over three hormonal replacement therapy cycles. SETTING: Menopause Centre of Ospedale Maternità, Bologna, Italy. POPULATION: Twenty-three postmenopausal women with an average of 70 months of amenorrhoea (range 12 to 234 months) on different sequential combined hormonal replacement therapy regimen for an average of 15 months (range 3-48) months. METHODS: Psychological testing for memory, mood, sleep quality and libido during the oestrogen only part of the cycle compared with the oestrogen-progestogen part of the cycle. RESULTS: Twenty women completed the six visits of the trial. The addition of progestogens to oestrogen appeared to benefit memory (P < 0.01) but worsened mood (P < 0.005). There was no evidence of change in other parameters such as sleep quality or libido. CONCLUSION: The addition of progestogens improved memory above what was obtained with oestrogen alone. This effect did not depend on an improvement of mood since the latter worsened during the progestogenic phase of an hormonal replacement therapy cycle. Progestogen added to oestrogen did not significantly influence sleep or libido.

Affect↗

The life and times of the estrogen receptors: an interim report.

The estrogens profoundly influence the growth, differentiation and function of the organs of the reproductive system such as the breast, uterus and ovary, but also have an effect on the non-reproductive tissues of the skeletal, cardiovascular and central nervous systems. Formerly, only one estrogen receptor (ER) was thought to mediate all functions. Now termed ER alpha, this agent was known to reside in the nucleus, to be activated by ligand and to direct the expression of target genes. A second oestrogen receptor (ER beta) has been identified, and estrogen influence has been further clarified through demonstration of actions which operate via membrane receptors and non-genomic pathways. This review summarizes our growing understanding of receptor structure, mechanism of action and tissue distribution, together with the implication of these data for the development and clinical delivery of estrogen replacement regimens.

Drug Delivery Systems↗

The effect of tibolone versus continuous combined norethisterone acetate and oestradiol on memory, libido and mood of postmenopausal women: a pilot study.

OBJECTIVE: Several studies have shown a positive effect of oestrogen on memory, mood and well-being but these data are controversial and focus particularly on the effect of oestrogen alone. In this pilot study we have investigated the effect of a continuous combination of norethisterone acetate 1 mg and oestradiol valerate 2 mg (Kliogest) versus tibolone (Livial) on memory, sexuality and mood. METHODS: Twenty-two postmenopausal women, age range 51-57, were randomised to a 6 months single blind interventional study treatment with either continuous combined oestradiol plus norethisterone acetate, or tibolone. Computerised psychological test of memory, mood and libido were administered both before and at the end of the 6 months treatment. RESULTS: Fourteen patients completed the study; eight on Livial and six on Kliogest. Recognition memory was improved by Kliogest but not by Livial (P<0.05) while either drug equally improved both the reaction time (P<0.01) and accuracy of performance (P<0.001) of categorical semantic memory. Both the treatments improved libido significantly (P<0.05), while the mood did not change with either. CONCLUSION: The results suggest that both these forms of hormonal replacement therapy improve the efficiency of memory performance and libido. However, a combination of oestradiol and norethisterone acetate seems to be marginally more effective on improving cognitive processes.

Affect↗

Pyoderma gangrenosum of the cervix.

BACKGROUND: Ulcerated cervical lesions are common findings in gynecology, but pyoderma gangrenosum presenting solely as a cervical ulcer is unusual. CASE: A 33-year-old nulligravida presented with postcoital bleeding and an extensive ulcerated lesion of the cervix that showed nonspecific inflammation on biopsy. After 6 months of topical steroid treatment, the lesion resolved completely. CONCLUSION: Pyoderma gangrenosum should be suspected in nonspecific cervical ulcers, especially those that worsen after surgical resection or ablation and then respond to steroid treatment.

Adult↗

Plasma lipoproteins in soy-treated postmenopausal women: a double-blind, placebo-controlled trial.

BACKGROUND AND AIM: Postmenopausal modification of the lipid profile plays a major role in the risk of ischemic heart disease. Lifestyle counseling and estrogen replacement therapy have all been proposed as first-line measures, but there is no agreement on the best way to treat climacteric dyslipidemia. Soybean-based diet seems particularly attractive in this context, given its cholesterol lowering potential, its hypothetical anticancerous effects and possible modification of climacteric symptoms. METHODS AND RESULTS: We evaluated the effect of 60 g isolated soy protein (ISP) daily on the lipid profile of 104 postmenopausal women (53.3 +/- 3.3 years) in a double-blind, parallel, placebo-controlled (caseinate) trial, as part of a broader assessment of the effect of ISP on climacteric symptomatology. Serum total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apo A-I, apo B and lipoprotein (a) were determined before and after a 12-week diet modification. Seventy-seven women completed the trial. Both soy and placebo determined a significant reduction in total cholesterol (-0.42 +/- 0.79 and -0.40 +/- 0.57 mmol/L) and LDL-cholesterol (-0.35 +/- 0.72 and -0.31 +/- 0.54 mmol/L), but only soy had a significant lowering effect on apo B and the LDL-cholesterol/HDL-cholesterol ratio (-6% and -8% from baseline respectively); lipoprotein (a) plasma levels were not significantly changed by either treatment. Forty-four women were dyslipidemic at baseline; those with increased LDL concentrations showed a somewhat greater improvement in their lipoprotein profile (LDL-cholesterol and apo B reduction) with soy rather than placebo. No further information emerged when the subjects were divided into three apo E phenotypes. CONCLUSIONS: We conclude that diet supplementation with 60 g ISP is slightly better than caseinate in favorably modifying the lipoprotein metabolism of postmenopausal women; this effect is more evident in hypercholesterolemic subjects.

Caseins↗

Dietary soy supplementation and phytoestrogen levels.

OBJECTIVE: To investigate the relationship between levels of phytoestrogens in blood and urine and symptom control in postmenopausal women whose diets were supplemented with soy containing high levels of phytoestrogen. METHODS: Phytoestrogen levels in blood and urine were correlated with the number of hot flushes and vaginal maturation indices in 104 postmenopausal women whose diets were supplemented with 60 g of soy powder daily for 3 months in a double-masked, parallel, placebo-controlled trial. The effect of soy supplementation on menopausal symptoms in this study population was reported previously. RESULTS: Serum levels of genistin, daidzin, and equol were significantly higher in women after soy diet supplementation (+756%, +593%, +1008%, and 57% respectively). The concentration of enterolactone in the soy group was increased by 57% compared with baseline, but the difference with placebo was not statistically significant. The increase in phytoestrogen levels in the soy group in blood or urine did not correlate with fewer hot flushes. Vaginal maturation indices did not change in the soy group. CONCLUSION: Phytoestrogen levels increased in women who consumed soy supplement, but that does not fully explain climacteric symptom reduction. It is possible that other types of yet unknown phytoestrogens or components in soy other than phytoestrogen influence hot flushes.

Climacteric↗

Tibolone: a review.

Tibolone appears to be at least as efficacious as other forms of hormonal replacement therapy (HRT) on climacteric symptoms. It does not cause withdrawal bleeding when used in women with at least 1 year of amenorrhea. It is, therefore, not indicated in perimenopause because it may cause irregular bleeding. The androgenic action of tibolone may have a two-fold benefit: on the one hand, it may help depression and libido more than other forms of HRT, while, on the other hand, it may improve some lipid parameters such as Lp(a), and triglycerides. However, this androgenic action, may also be responsible for the reduction of HDL cholesterol, that may thus reduce the beneficial effect of tibolone on lipids. It is estimated that only 30% of cardiovascular risk protection of HRT is due to improvement of classical lipids parameters while a great role is played by the direct effect of estrogen on vessels. Tibolone, as well as estrogen, has been shown to induce peripheral vasodilatation and also has a direct effect on vascular reactivity thus increasing peripheral blood flow with no changes in blood pressure or cardiac output. Tibolone seems to exert a similar effect as other forms of HRT on markers of bone metabolism and bone mass, but no data is yet available on fracture prevention.

Anabolic Agents↗

The effect of dietary soy supplementation on hot flushes.

OBJECTIVE: To assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in postmenopausal women. METHODS: We carried out a double-blind, parallel, multicenter, randomized placebo-controlled trial of 104 postmenopausal women. Fifty-one patients (age range 48-61 years) took 60 g of products containing 40 g of isolated soy protein [corrected] daily and 53 patients (age range 45-62 years) took 60 g of placebo (casein) daily. The study lasted 12 weeks. Using analysis of covariance, we analyzed changes from baseline in mean number of moderate to severe hot flushes (including night sweats) during treatment. RESULTS: Soy was significantly superior to placebo (P < .01 in reducing the mean number of hot flushes per 24 hours after 4, 8, and 12 weeks of treatment. In particular, women taking soy had a 26% reduction in the mean number of hot flushes by week 3 and a 33% reduction by week 4 (P < .001 by the Wilcoxon exact test). By the end of the 12th week, patients taking soy had a 45% reduction in their daily hot flushes versus a 30% reduction obtained with the placebo (P < .01). The overall rates of adverse effects were similar for soy and casein-placebo. Twenty-five patients dropped out of the study: 11 in the soy group and 14 in the placebo group. Gastrointestinal side effects were the most common cause of premature withdrawal from the study (seven patients in each group). CONCLUSION: Soy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women.

Cohort Studies↗