Effects Of One-year Treatment Research Articles

Reply to Editorial Comment, Re: Engelhardt PF and Riedl CR, Effects of one-year treatment with isoflavone extract from red clover on prostate, liver function, sexual function, and quality of life in men with elevated PSA levels and negative prostate biopsy findings. Urology 71: 190, 2008

Reply to Editorial Comment, Re: Engelhardt PF and Riedl CR, Effects of one-year treatment with isoflavone extract from red clover on prostate, liver function, sexual function, and quality of life in men with elevated PSA levels and negative prostate biopsy findings. Urology 71: 190, 2008

Effects of One-Year Treatment with Isoflavone Extract from Red Clover on Prostate, Liver Function, Sexual Function, and Quality of Life in Men with Elevated PSA Levels and Negative Prostate Biopsy Findings

To asses the effect of an isoflavonoid extract from red clover on the prostate, liver function, quality of life, and sexual function in men with an initial elevated prostate-specific antigen (PSA) level and negative prostate biopsy findings during a 1-year treatment period. A total of 20 men (mean age 65 years) were treated with a daily 60-mg dose of an isoflavone extract for 1 year. Liver function, sexual hormone levels (total testosterone, estrogen, luteotropic hormone, follicle-stimulating hormone, and dehydroepiandrosterone sulfate), transrectal ultrasonography volumetry of the prostate, PSA level, International Prostate Symptom Score, and International Index of Erectile Function score were recorded at the beginning of the study and every 3 months for 1 year. The average PSA level was 10.16 ng/mL at baseline versus 7.15 ng/mL after 12 months, for a statistically significant reduction of 33% (P <0.019). The mean prostate volume had decreased slightly from 49.3 cm3 to 44.3 cm3 after 12 months (P <0.097). The sexual hormone levels did not change throughout the study. We registered a significant increase in all three liver transaminases after 3 months (P <0.001). The International Prostate Symptom Score showed a mean value of 7.9 at baseline and 6.68 after 12 months (P <0.421). Sexual function was not influenced by the treatment. Daily oral administration of 60 mg of an isoflavone extract was well tolerated and caused no side effects. The significant increase in liver transaminases and the significant decrease in total PSA levels by >30% indicates that patients, general practitioners, and urologists should be informed about these potential effects of red clover extracts and possibly other phytoestrogens, on liver transaminases and elevated total PSA levels.

No Effect of One-Year Treatment with Indomethacin on Alzheimer's Disease Progression: A Randomized Controlled Trial

BackgroundThe objective of this study was to determine whether treatment with the nonselective nonsteroidal anti-inflammatory drug (NSAID) indomethacin slows cognitive decline in patients with Alzheimer's disease (AD).Methodology/Principal FindingsThis double-blind, randomized, placebo-controlled trial was conducted between May 2000 and September 2005 in two hospitals in the Netherlands. 51 patients with mild to moderate AD were enrolled into the study. Patients received 100 mg indomethacin or placebo daily for 12 months. Additionally, all patients received omeprazole. The primary outcome measure was the change from baseline after one year of treatment on the cognitive subscale of the AD Assessment Scale (ADAS-cog). Secondary outcome measures included the Mini-Mental State Examination, the Clinician's Interview Based Impression of Change with caregiver input, the noncognitive subscale of the ADAS, the Neuropsychiatric Inventory, and the Interview for Deterioration in Daily life in Dementia. Considerable recruitment problems of participants were encountered, leading to an underpowered study. In the placebo group, 19 out of 25 patients completed the study, and 19 out of 26 patients in the indomethacin group. The deterioration on the ADAS-cog was less in the indomethacin group (7.8±7.6), than in the placebo group (9.3±10.0). This difference (1.5 points; CI −4.5–7.5) was not statistically significant, and neither were any of the secondary outcome measures.Conclusions/SignificanceThe results of this study are inconclusive with respect to the hypothesis that indomethacin slows the progression of AD.Trial RegistrationClinicalTrials.gov NCT00432081

PD-02.01: The effects of one-year treatment with an isoflavone extract from red clover on prostate, liver, sexual function and quality of life in men

PD-02.01: The effects of one-year treatment with an isoflavone extract from red clover on prostate, liver, sexual function and quality of life in men

Effects of one-year treatment with rilmenidine on systemic hypertension-induced left ventricular hypertrophy in hypertensive patients

In patients with essential hypertension, left ventricular hypertrophy (LVH) increases the risk for cardiovascular morbidity and mortality. Thus its reversal represents one of the principal endpoints of antihypertensive treatment. We assessed the cardiovascular effects of 1-year antihypertensive treatment with rilmenidine (1 or 2 mg/day orally), a new oxazoline with a potent antihypertensive action that acts selectively through imidazoline-preferring receptors. In 11 hypertensive patients (mean age, 49 ± 2 years) with LVH, we measured systemic hemodynamics, large artery compliance, cardiac anatomy, and endocrine function. Patients underwent M-mode and 2-dimensional echocardiography as well as Doppler and peripheral pulsed Doppler flowmetry, determination of plasma atrial natriuretic factor (ANF) levels and renin activity (PRA), and of 24-hour urinary electrolyte and creatinine excretion in control conditions (systolic/diastolic blood pressure, 148 ± 3 102 ± 1 mm Hg ), 4 weeks after blood pressure normalization ( 131 ± 2 84 ± 2 mm Hg ; p < 0.01), after 1 year of satisfactory antihypertensive treatment ( 142 ± 3 90 ± 1 mm Hg ; p <0.01) and, finally, 1 month after therapy withdrawal ( 155 ± 3 106 ± 2 mm Hg ; difference not significant [NS]). One-year of rilmenidine treatment induced an improvement in brachial artery compliance (from 0.92 ± 0.06 to 1.16 ± 0.08 cm 4/dyne; p <0.05), which persisted after withdrawal of treatment (1.17 ± 0.06 cm 4/ dyne; p <0.05). LVH was reversed after 1 year of rilmenidine treatment (from 152 ± 5 to 131 ± 4 g/m 2 body surface area; p <0.05). Finally, PRA and urinary electrolyte excretion did not change throughout the study, and ANF remained unchanged after blood pressure normalization (48.4 ± 6.2 vs 44.7 ± 2.9 pg/mL; difference not significant) but fell after reversal of LVH (28.6 ± 3.4 pg/mL; p <0.05) and remained significantly lower than in control conditions after therapy withdrawal (27.5 ± 2.9 pg/mL; p <0.05). Our results demonstrate that long-term antihypertensive treatment with rilmenidine is able to induce a reversal of LVH and of the vascular structural changes associated with essential hypertension. In addition, they indicate that rilmenidine-induced regression of LVH is associated with significant and persistent reduction of ANF levels, which may suggest a favorable influence of the drug with the biosynthetic properties of ventricular myocardium.

Effects of one-year treatment with estrogens on bone mass, intestinal calcium absorption, and 25-hydroxyvitamin D-1alpha-hydroxylase reserve in postmenopausal osteoporosis

Effects of one-year treatment with estrogens on bone mass, intestinal calcium absorption, and 25-hydroxyvitamin D-1alpha-hydroxylase reserve in postmenopausal osteoporosis