PubMed · 15813090
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Kenzo Uchida, Shigeru Nakano, Toshikazu Kigoshi. 2005. [Randomized Aldactone Evaluation Study (RALES)].. https://pubmed.ncbi.nlm.nih.gov/15813090/
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OBJECTIVES: To examine the efficacy of a hop extract enriched in 8-prenylnaringenin (8-PN, the phytoestrogen in hops, Humulus lupulus L.) on relief of menopausal discomforts. METHODS: A prospective, randomized, double-blind, placebo-controlled study over 12 weeks with 67 menopausal women, who were administered a hop extract standardized on 8-PN (100 or 250 microg). The responses were determined by means of a modified Kupperman index (KI) and a patients' questionnaire. RESULTS: All groups, including placebo, showed a significant reduction of the KI both after 6 weeks and after 12 weeks. The hop extract at 100 microg 8-PN was significantly superior to placebo after 6 weeks (P=0.023) but not after 12 weeks (P=0.086). No dose-response relationship could be established, as the higher dose (250 microg) was less active than the lower dose both after 6 weeks and after 12 weeks. Still, a trend for a more rapid decrease of KI was noticed for both active groups as compared to placebo. In particular, the decrease in hot flush score (isolated from the KI) was found significant for both treatment groups after 6 weeks (P<0.01) with respect to placebo. Results of the patients' questionnaire were consistent with those of the KI, with the most pronounced effects being observed for the 100-microg treatment. CONCLUSIONS: Daily intake of a hop extract, standardized on 8-PN as a potent phytoestrogen, exerted favorable effects on vasomotor symptoms and other menopausal discomforts. Hop-derived prenylated flavonoids may provide an attractive addition to the alternative treatments available for relief of hot flushes and other menopausal discomforts.
BACKGROUND/AIMS: A new lipid emulsion based on soybean oil, medium chain triglycerides, olive oil and fish oil (SMOFlipid) was tested for safety, tolerance, metabolic and clinical efficacy in surgical patients. METHODS: In a prospective, double-blind European multicenter study, postoperative patients (elective abdominal or thoracic surgery) were randomized to receive isonitrogenous, isoenergetic (30-35 kcal/kg) total parenteral nutrition over 5 postoperative days including either SMOFlipid 20% or standard soybean oil emulsion (Lipovenoes 20%) as lipid source (1.5 g kg(-1) day(-1)). Metabolic efficacy measurements included serum levels of triglycerides (AUC), phospholipids, and total cholesterol. Safety/tolerance parameters were: hematology; clinical chemistry; coagulation profile; clinical course (arterial blood pressure, heart rate, body temperature), and documentation of adverse events. Clinical efficacy was monitored by length of hospital stay and mortality. RESULTS: The 2 groups (per-protocol population: SMOFlipid n = 99, and Lipovenoes n = 100) were similar with respect to demographic characteristics and types of surgical intervention. Concentrations of serum triglycerides, phospholipids, and total cholesterol were comparable in both groups and within the expected ranges. Laboratory and clinical parameters were not different. A trend towards a reduced length of hospital stay was observed with SMOFlipid (15.7 +/- 6.3 vs. 17.8 +/- 13.2 days). CONCLUSIONS: SMOFlipid is clinically safe and well tolerated in postoperative patients. There are indications that SMOFlipid may be associated with a better liver tolerance and a shorter length of hospitalization.
STUDY DESIGN: Double-blinded randomized controlled trial. OBJECTIVE: To test the short-term efficacy of a single intravenous (IV) pulse of glucocorticoids on the symptoms of acute discogenic sciatica. SUMMARY OF BACKGROUND DATA: The use of glucocorticoids in the treatment of acute discogenic sciatica is controversial. A potential advantage of the IV pulse therapy is the ability to distribute high glucocorticoid concentrations to the area surrounding the prolapsed disc without the risks and inconveniences of an epidural injection. METHODS: Patients with acute sciatica (<6-week duration) of radiologically confirmed discogenic origin were randomized to receive either a single IV bolus of 500 mg of methylprednisolone or placebo. Clinical evaluation was performed in a double-blind manner on days 0, 1, 2, 3, 10, and 30. The primary outcome was reduction in sciatic leg pain during the first 3 days following the infusion; secondary outcomes were reduction in low back pain, global pain, functional disability, and signs of radicular irritation. The analysis was performed on an intent-to-treat basis using a longitudinal regression model for repeated measures. RESULTS: A total of 65 patients were randomized, and 60 completed the treatment and the follow-up assessments. A single IV bolus of glucocorticoids provided significant improvement in sciatic leg pain (P = 0.04) within the first 3 days. However, the effect size was small, and the improvement did not persist. IV glucocorticoids had no effect on functional disability or clinical signs of radicular irritation. CONCLUSIONS: Although an IV bolus of glucocorticoids provides a short-term improvement in leg pain in patients with acute discogenic sciatica, its effects are transient and have small magnitude.