Treatment of symptomatic polyneuropathy with actovegin in type 2 diabetic patients.

OBJECTIVE To evaluate the efficacy and safety of actovegin in patients with diabetic polyneuropathy. RESEARCH DESIGN AND METHODS In this multicenter, randomized, double-blind trial, 567 patients with type 2 diabetes received 20 intravenous infusions of actovegin (2,000 mg/day) (n = 281) or placebo (n = 286) once daily followed by three tablets of actovegin (1,800 mg/day) or placebo three times daily for 140 days. Total symptom score (TSS) of the lower limbs and vibration perception threshold (VPT) were used as coprimary outcome measures, computed as the area under the curve (AUC) from repeated scores and divided by duration of exposure. Secondary end points included individual TSS symptoms, neuropathy impairment score of the lower limbs (NIS-LL), and quality of life (short form [SF]-36). RESULTS TSS was significantly improved during actovegin treatment compared with placebo, as assessed by AUC (-0.56 points [95% CI -0.85 to -0.27]; P = 0.0003), and from baseline to 160 days (-0.86 points [-1.22 to -0.50]; P < 0.0001). VPT (five sites per foot) decreased by 3% (95% CI 0-6; P = 0.084) with actovegin than placebo, as assessed by AUC, and by 5% (1-9; P = 0.017) after 160 days. NIS-LL sensory function, as assessed by AUC, was significantly improved with actovegin versus placebo (-0.25 [95% CI -0.46 to -0.04]; P = 0.021), as was the SF-36 mental health domain. There were no differences in the incidence of adverse events between the groups. CONCLUSIONS Sequential intravenous and oral actovegin treatment over 160 days improved neuropathic symptoms, VPT, sensory function, and quality of life in type 2 diabetic patients with symptomatic polyneuropathy.

Variations in percentage of body fat within different BMI groups in young, middle-aged and old women.

OBJECTIVES: The objective of the present study was to characterize age-dependent variations in percentage of body fat within different body mass index (BMI) classes in healthy Danish women. DESIGN: Cross-sectional analysis. SETTINGS: The study was done at the Center for Clinical and Basic Research, Ballerup, Denmark. SUBJECTS: Four hundred and four healthy women aged 18-75 years were included in the present study. MEASUREMENTS: Fat tissue mass was estimated using dual-energy X-ray absorptiometry. Menopausal status and physical characteristics were also registered. RESULTS: Mean values of percentage of body fat calculated in the normal and overweight BMI groups were higher in middle-aged and old women compared with young women. No significant differences were seen in the underweight and obese BMI groups. The cut-off levels between normal and overweight and between overweight and obesity were 35-43% and 40-50%, respectively. CONCLUSION: The percentage of body fat is dependent on both age and menopausal status within each of the following BMI classes: from 20 to 25 and from 25 to 30, further emphasizing that BMI has limitations when used generally as an indicator of body fatness, and argues for defining BMI cut-off values age-specifically.

The effect of hormone replacement therapy on appendicular lean tissue mass in early postmenopausal women.

OBJECTIVE: The impact of hormone replacement therapy (HRT) on skeletal muscle mass is still a controversial issue in women's health. Some authors hypothesize anabolic effects, others catabolic. These hypotheses, however, await confirmation by longitudinal observations based on more direct measurements of muscle mass. The aim of the present preliminary study was to evaluate the effect of a 3-year HRT program on appendicular lean tissue mass (LTM(A)) in early postmenopausal women aged 45-54 years. DESIGN: This was a randomized, double-blind and placebo-controlled trial. Women received HRT with 2 mg estradiol valerate combined either continuously with 1 mg cyproterone acetate (days 1-28; n = 15) or sequentially with 75 mug levonorgestrel (days 17-28; n = 15), or placebo (n = 18). Serum estradiol was measured by radioimmunoassay. LTM(A) was measured by dual photon absorptiometry (baseline) and dual energy X-ray absorptiometry (years 2 and 3). RESULTS: Baseline serum estradiol did not show significant correlation with the respective LTM(A) (r = 0.018, p = 0.88, n = 75). Cross-sectional analysis found no significant differences between the intervention groups at any time points. The longitudinal changes between years 2 and 3 showed a trend toward decreasing LTM(A) in those receiving HRT (-0.08 +/- 0.12 kg, n = 30) compared to those receiving placebo (0.12 +/- 0.25 kg, n = 18, p = 0.44). CONCLUSIONS: The present preliminary study did not find significant effects on LTM(A) caused by HRT. The trends toward decreasing LTM(A) in the HRT groups might suggest catabolic rather than anabolic effects. These trends, however, await confirmation by larger clinical trials.

Appendicular lean tissue mass and the prevalence of sarcopenia among healthy women.

Studies indicate that deficient skeletal muscle mass or sarcopenia is a major cause of disability and morbidity among the elderly. In part, due to the lack of generally applicable normal values, there is still insufficient epidemiologic data available on the frequency and severity of sarcopenia in health and under various disease-related conditions. The objectives of the present study were to (1) characterize the age- and menopause-related variations in appendicular lean tissue mass (LTM(A)), (2) provide young-normal means and estimate the age-specific prevalence of sarcopenia among healthy women. A total of 754 healthy women were included in the study of cross-sectional design. LTM(A) was estimated by dual-energy x-ray absorptiometry (DEXA). Physical characteristics and menopausal status were also registered. LTM(A) as well as height showed significant negative correlation with age with Pearson's r values of -0.43 and -0.06, respectively (P <.05). Trend of finding lower mean values with advancing age remained even when LTM(A) was adjusted for height(2) (ht(2)). Menopause did not seem to have any influence on LTM(A). Young-normal means were obtained from 216 premenopausal women aged 18 to 39 years. Prevalence rates of sarcopenia in healthy women were determined with reference to a cut-off line corresponding to LTM(A) or LTM(A)/ht(2) less than young-normal mean 2 SD and were found to be 40.2% and 12.3%, respectively, among the healthy elderly (>70 years of age). Results of the present study provide further evidence that sarcopenia exists even among otherwise healthy women with increasing age-specific prevalence. Further studies are needed (1) to estimate the prevalence of sarcopenia under various health and disease-related conditions with reference to the hereby given cut-off values and (2) to find therapeutic strategies with beneficial effects in conserving skeletal muscle mass.