Efficacy and tolerability of artichoke dry extract (drug/extract ratio 25-35:1, aquous extract, CY450) as coated tablets containing 450 mg extract (tradename: Valverde Artischocke bei Verdauungsbeschwerden) was investigated in the treatment of hyperlipoproteinemia and compared with placebo. 143 adult patients with initial total cholesterol of > 7.3 mmol/l (> 280 mg/dl) were included in a double blind, randomized, placebo controlled, multi-center clinical trial. Patients received 1,800 mg artichoke dry extract per day or placebo over 6 weeks. Changes of total cholesterol and LDL-cholesterol from baseline to the end of treatment showed a statistically significant superiority (p = 0.0001) of artichoke dry extract over placebo. The decrease of total cholesterol in the CY450 group was 18.5% compared to 8.6% in the placebo group. LDL-cholesterol decrease in the CY450 group was 22.9% and 6.3% for placebo. LDL/HDL ratio showed a decrease of 20.2% in the CY450 group and 7.2% in the placebo group. There were no drug related adverse events during this study indicating an excellent tolerability of artichoke dry extract. This prospective study could contribute clear evidence to recommend artichoke dry extract CY450 for treating hyperlipoproteinemia and, thus, prevention of atherosclerosis and coronary heart disease.
The aim of this study was to investigate the efficacy and tolerability of a 0.1% dimetindene maleate spray (Fenistil Nasal Dosierspray) compared to placebo when applied intranasally. Dimetindene (dimetindene maleate, CAS 3614-69-5, DMM) is a very potent and well established H1-receptor antagonist. A total of 36 asymptomatic patients (17 female, 19 male), suffering from seasonal allergic rhinitis from grass pollen, were randomly assigned to treatment with matching topicalnasal sprays with either dimetindene maleate 0.1% or placebo as control in a double-blind, randomised, cross-over-design, with 2 weeks wash-out periods between. The trial period was chosen in a pollen-free time from 20th October to 5th November 1998 to guarantee asymptomatic patients. The patients being allergic to grass pollen, verified by positive case history, positive skin prick test and positive nasal provocation test, were challenged under controlled conditions with purified airborne grass pollen in the Vienna Challenge Chamber. The nasal spray were applied as single doses (1 puff = 0.14 ml of the respective solution with or without 0.14 mg dimetindene maleate) in the evening before at 7.30 p.m. and in the morning at 7.30 a.m. to each nostril exactly 15 min before the onset of allergen provocation. The dosage scheme relates to a daily dose of 0.56 mg DMM in the active treatment group. Subjective nasal and ocular symptoms were measured on-line in time intervals of 30 min during the 4 h allergen provocation. The statistical analysis was a priori sequentially ordered to account for multiple testing and keep the 5% level of significance. All measured primary criteria, Total Nasal Symptom Score (p < 0.0001) calculated from the three single symptoms running of the nose (p = 0.0032) sneezing stimulus (p < 0.0001) and nasal itching (p < 0.0001), as well nasal secretion (p = 0.0031), resulted consistently in a statistically significant and clinically relevant superiority of 0.1% DMM compared to placebo. The same superior treatment effect was observed for all the other criteria, despite the nasal flow, but including the ocular variables. This can be interpreted as a positive efficacy also in secondary allergic conjunctivitis. No systemic or topical adverse events were reported. The results of the study demonstrate that 0.1% DMM as nasal spray is an efficient and safe application form for patients suffering from seasonal allergic rhinitis.
The aim of this study was to investigate the efficacy and tolerability of intranasally applied dimetindene (CAS 3614-69-5) 0.1% spray in children suffering from seasonal allergic rhinitis. A total of 100 children under 14 years with acute seasonal allergic rhinitis participated in this randomised, single-blind, reference-controlled, multi-center, parallel group study with two treatment groups. The study took place between 2nd April and 16th September 1996 during the pollen season. Patients were examined at enrollment (day 1), day 8 and day 15. Patients kept diary throughout the 2-week treatment phase. Patients were randomised to receive either dimetindene 0.1% (Fenistil Nasal Spray) or a levocabastine (CAS 79516-68-0) 0.05% solution as reference medication. Both medications were supplied in similar outer packages. A single-blind approach was chosen, because the reference medication levocabastine requires two spray puffs per nostril as a single dose, whereas for dimetindene maleate solution a single spray puff per nostril is sufficient. Dimetindene 0.1% was applied with 1 spray puff (= 0.14 mg dimetindene) in each nostril and levocabastine with 2 spray puff (= 0.10 mg levocabastine) in each nostril every day in the morning before leaving the house and in the evening before going to bed. Additional administration of the spray was allowed up to 4 times a day if needed. Efficacy was assessed as change in severity of characteristic symptoms associated with pollen rhinitis: nasal rhinorrhea, nasal itching, nasal sneezing and nasal congestion. In addition, changes in ocular symptoms, lacrimation, ocular itching and red eyes, global physician's assessment of efficacy at the end of treatment were assessed. The primary criterion change of total nasal symptom severity score between day 1 and day 3 resulted in a statistically equivalent and therapeutically relevant symptom reduction for the two treatments. All secondary criteria showed a similar reduction in symptoms, thus underlining the consistency of the findings. Both nasal sprays were well tolerated. It is concluded from these results that dimetindene 0.1% nasal spray solution is a safe and efficient treatment option for children under 14 years suffering from seasonal allergic rhinitis.
The efficacy of topical dimethindene maleate (DMM, CAS 31614-69-5, Fenistil Gel) in the treatment of sunburn was evaluated in a placebo-controlled, 1-period crossover trial in 24 healthy volunteers. An UV-erythema (sunburn) of a well-defined intensity and extent was experimentally induced on three different skin test-areas by means of UV-A/B irradiation with three times the minimal erythema dose (MED). About 24 h after irradiation, one skin test-area was subjected to a 1-h occlusive treatment with DMM gel, the second test area was subjected to treatment with a placebo gel and the third one remained untreated. As objective-quantitative indicators of tenderness, a key symptom of sunburn, sensory and pain thresholds to CO2-Laser stimulation and laser somatosensory evoked potentials (SEPs) in Vertex-EEG were assessed about 1.5 h postdose. The reaction times (RTs) to painless and painful CO2-laser stimulation (sensory and pain threshold level, respectively) on the DMM-treated area were significantly longer than RTs to stimulation on the placebo-treated area. Thresholds in terms of laser energy showed no differences between the treatments. The SEP N1-amplitude on the DMM-area was markedly decreased in comparison to placebo. With regard to subjective sensations of pain, itching and tenderness assessed by means of visual analogue scales (VAS), no clinically relevant differences between treatments were observed after sole UV-irradiation. After additional laser stimulation tenderness was--objectively but not subjectively--decreased on the DMM-area versus placebo. Both gel preparations were well tolerated.
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