In Brief OBJECTIVE: Several clinical studies suggest that black cohosh may be effective in climacteric complaints. However, evidence of its efficacy based on current quality standards has been limited. METHODS: This randomized, multicenter, double-blind trial compared the and tolerability isopropanolic extract treatment complaints with placebo. A total 304 patients were randomly allocated to receive tablets corresponding 40 mg drug or matching placebo daily for 12 weeks. The primary measure...

Objective: This study sought to confirm the efficacy and safety of currently recognized dose Cimicifugae racemosae rhizoma (40 mg/day) evaluate a higher its associated physiological effects. Methods: We conducted controlled, randomized, double-blinded parallel group perimenopausal postmenopausal women treated with two different doses (39 mg 127.3 mg) unique C. racemosa preparation over 24-week period. Efficacy tolerability were determined by Kupperman Menopause Index, Self-Rating Depression...

Tanacetum parthenium (feverfew), is a well-known herb for the prophylactic treatment of migraine. The primary objective was to show dose-response new stable extract (MIG-99) reproducibly manufactured with supercritical CO 2 from feverfew ( T. parthenium). Furthermore, study should provide data on safety and tolerability MIG-99. In randomized, double-blind, multicentre, controlled trial an adaptive design, clinical efficacy three dosages MIG-99 (2.08 mg; 6.25 18.75 mg t.i.d.) were compared...

The efficacy and tolerability of a CO 2 -extract feverfew (MIG-99, 6.25 mg t.i.d.) for migraine prevention were investigated in randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients ( N = 170 intention-to-treat; MIG-99, 89; placebo, 81) suffering from according to International Headache Society criteria treated 16 weeks after 4-week baseline period. primary endpoint was the average number attacks per 28 days during treatment months 3 compared with...

We evaluated the pharmacokinetic interaction between a low-hyperforin St John's wort (SJW) extract and alprazolam, caffeine, tolbutamide, digoxin. Previous reports on other SJW products had shown remarkably decreased plasma concentrations of certain co-medicated drugs, which was attributed to an inducing effect cytochrome P-450 (CYP) p-glycoprotein (p-gp) activity. Two randomised, placebo-controlled studies were performed with 28 healthy volunteers (age 18 - 55 years) in each study. In study...

To investigate the influence of an isopropanolic Cimicifuga racemosa extract (iCR) on recurrence-free survival after breast cancer, including estrogen-dependent tumors.This pharmacoepidemiologic observational retrospective cohort study examined cancer patients treated at general, gynecological and internal facilities linked to a medical database in Germany. The main endpoint was disease-free following diagnosis cancer. impact treatment with iCR analyzed by Cox-proportional hazards models,...

The common cold (acute viral respiratory tract infection) is one of the most frequent diseases in man, world-wide. Clinically relevant efficacy should include early improvement all symptoms. Results a clinical trial commercially available fixed combination herbal remedy (Radix echinaceae, Radix baptisiae, Herba thujae) are reported here. aim this study was to verify shown recent studies under (i) good practice (GCP) quality assurance and (ii) situations at family doctors.Patients attending...

Background: The objective was to evaluate the oedema-protective effect of a vasoactive drug (coumarin/ troxerutin [SB-LOT]) plus compression stockings in patients suffering from chronic venous insufficiency after decongestion legs as recommended by new guidelines. Patients and methods: 231 were randomly assigned medical SB-LOT (90 mg coumarin 540 per day) or placebo for first 4 weeks second 12 study. primary efficacy endpoint lower leg volume measured well-established water plethysmometry....

Journal Article Highly purified omega‐3‐polyunsaturated fatty acids for topical treatment of psoriasis. Results a double‐blind, placebo‐controlled multicentre study Get access H.‐H. HENNEICKE‐VON ZEPELIN, ZEPELIN Department Dermatology, University Kicl, Germany Correspodence: H.H. Henneicke‐von Zepelin, Kiel, Schittenhelmstrasse 7, D‐24105 Germany. Search other works by this author on: Oxford Academic Google Scholar U. MROWIETZ, MROWIETZ L. FARBER, FARBER Clinical Research Department, Sandoz...

Coumarin is reported to elevate liver function tests (LFT) values. In a prospective, placebo-controlled, clinical trial, efficacy and safety of coumarin-containing combination (SB-LOT) were evaluated in the treatment chronic venous insufficiency. Here, we report on drug coumarin with special respect reaction.114 patients treated SB-LOT (30 mg 180 troxerutin t.i.d.) 117 placebo during period 16 weeks. LFT values (ALT, AST, AP gamma-GT) monitored at baseline, 4, 6, 8, 12 weeks therapy. Adverse...

Objective. Effect of isopropanolic Cimicifuga racemosa extract (iCR) on uterine fibroid size compared with tibolone. Method. The randomized, double-blind, controlled study in China enrolled 244 patients aged 40-60 years menopausal symptoms (Kupperman Menopause Index ≥ 15). participants were treated either iCR 40 mg crude drug/day (N = 122) or tibolone 2.5 mg/day orally for 3 months 2004. Now, we investigated the subset all women 62) at least one onset treatment effect 34) 28) by transvaginal...

Coumarin, used in the treatment of chronic venous diseases, is mainly metabolized to non-toxic 7-hydroxy-coumarin by CYP2A6. At least, 3 variant alleles, CYP2A6*2, CYP2A6*3 and CYP2A6*4A, have been shown encode catalytically defective proteins. Sporadic elevation liver enzymes has reported on administration ofcoumarin. We sought determine if susceptibility coumarin-associated dysfunction genetically determined polymorphism CYP2A6 impairment 7-hydroxylation Additionally, we were interested...

53 patients with planned antibiotic therapy for the treatment of acute exacerbation chronic bronchitis as an example a severe bacterial infection requiring antibiotics were included in prospective, multicentre, double-blind, placebo-controlled study. The was staged by forced expiratory volume 1st second (FEV<sub>1</sub>) measured infection-free interval prior to current episode and had be between 35 75% predicted value. Patients randomly assigned receive newer macrolide plus...

The purpose of this report was to evaluate specific depressive symptoms that are most suitable for a therapy with the Ze 117 St. John's wort extract. We examined antidepressant efficacy and drug safety fluoxetine in multicentric prospective randomized double-blind parallel group comparison according generally accepted guidelines such as Declaration Helsinki GCP. treated outpatients (n = 240; 117: 126; fluoxetine: 114) mild moderate episodes (ICD-10: F 32.0, 32.1; HAMD range: 16-24) either...