International Journal of Clinical Pharmacology Research 

About: International Journal of Clinical Pharmacology Research is an academic journal. The journal publishes majorly in the area(s): Pharmacokinetics & Blood pressure. It has an ISSN identifier of 0251-1649. Over the lifetime, 835 publications have been published receiving 9554 citations.

Effects of a standardized ginseng extract on quality of life and physiological parameters in symptomatic postmenopausal women: a double-blind, placebo-controlled trial. Swedish Alternative Medicine Group.

Abstract: A randomized, multicenter, double-blind, parallel group study was performed to assess the effects of a standardized ginseng extract compared with those of a placebo on quality of life (QoL) and on physiological parameters in symptomatic postmenopausal women Validated questionnaires [Psychological General Well-Being (PGWB) index, Women's Health Questionnaire (WHQ)] and Visual Analogue (VA) scales were used to assess the effects of the extract on QoL at baseline and after 16 weeks' treatment with either the ginseng extract or placebo To assess the efficacy of ginseng on postmenopausal symptoms, physiological parameters [follicle-stimulating hormone (FSH) and estradiol levels, endometrial thickness, maturity index and vaginal pH] were recorded at the same time points Of the 384 randomized patients (mean age 535 +/- 40 years), the questionnaires were completed by 193 women treated with ginseng and 191 treated with placebo With regard to the primary endpoint (total score of the PGWB index) the extract showed only a tendency for a slightly better overall symptomatic relief (p < 01) Exploratory analysis of PGWB subsets, however, reported p-values < 005 for depression, well-being and health subscales in favor of ginseng compared with placebo No statistically significant effects were seen for the WHQ and the VA scales or the physiological parameters, including vasomotor symptoms (hot flushes) The positive effects of ginseng on health-related QoL in menopausal women should be further investigated This study shows, however, that the beneficial effects of ginseng are most likely not mediated by hormone replacement-like effects, as physiological parameters such as FSH and estradiol levels, endometrial thickness, maturity index and vaginal pH were not affected by the treatment

Telmisartan has the strongest binding affinity to angiotensin II type 1 receptor: comparison with other angiotensin II type 1 receptor blockers.

Abstract: There is a growing body of evidence that the renin-angiotensin system (RAS) plays a pivotal role in the pathogenesis of cardiovascular diseases. Indeed, large clinical trials have demonstrated a substantial benefit of the blockade of this system for cardiovascular-organ protection. Although several types of angiotensin II type 1 (AT1) receptor blockers (ARBs) are commercially available for the treatment of patients with hypertension, comparisons of the binding affinity to AT1 receptor among them remain to be elucidated. In this study, we examined the dissociation rate of several ARBs from AT1 receptor in vitro. Angiotensin II time-dependently dissociated telmisartan, olmesartan, candesartan, valsartan, losartan and an active metabolite of losartan, EXP3174, from membrane components containing human AT1 receptor The dissociation rate constant of each ARB was 0.003248, 0.004171, 0.005203, 0.009946, 0.01027 and 0.008561 min(-1), with corresponding half-lives of 213, 166, 133, 70, 67 and 81 min, respectively. These results demonstrate that telmisartan has the strongest binding affinity to AT1 receptor among various ARBs examined herein. The rank order of affinity was telmisartan > olmesartan > candesartan > EXP3174 > or = valsartan > or = losartan. The present findings suggest that telmisartan (Micardis) may have long-lasting blood pressure-lowering effects and superior cardioprotective properties in patients with hypertension due to its strongest AT1 receptor antagonistic ability.

Pharmacokinetic study of rifaximin after oral administration in healthy volunteers

Abstract: Eighteen healthy male volunteers, with a mean age of 24 yrs (range 18-40), underwent an open pharmacokinetics study, aimed at detecting rifaximin concentration in blood and urine after a single oral administration of 400 mg of the antibiotic. Administration took place after a 9 hours' fast and was followed by a breakfast after 2 hours and a lunch after 5 hours. Blood samples were collected before rifaximin administration and 1, 2, 4, 8, 12, 24 and 48 hours after dosing. Urine samples were collected immediately before dosing (reference sample) and then at the end of the following intervals of time: 0-6 h, 6-12 h, 12-24 h, 24-48 h. During the whole study period, the local and general tolerance to rifaximin administration was checked. Rifaximin concentration was assessed by reversed phase high performance liquid chromatography with electrochemical detection. In almost every plasma sample, rifaximin concentration was undetectable (lower than the detection limit of the analytical method, i.e. 2 ng/ml). In urine, very small amounts of the unchanged molecule (< 0.01% of the administered dose) were found in the period 0-48 hours. These results confirm the negligible absorption by the intestinal tract of a single oral dose of rifaximin (400 mg). Local and general tolerance of the administered drug was very good.

Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo

Abstract: This study assessed the analgesic action of tramadol compared with placebo in patients suffering from fibromyalgia syndrome. Twelve patients (11 females, one male) were treated according to a double-blind crossover experimental design. Each patient, after signing informed consent, was randomly allocated to either tramadol (100 mg ampul in 100 ml given intravenously in 15 min doses) or placebo for a single dose treatment. At the second visit, patients crossed over to the other drug for a further single dose treatment. There was a wash-out period of 1 week. Nine patients completed the study, while in three cases (two tramadol, one placebo) the study was discontinued due to the onset of side effects. The assessment of efficacy, carried out at the baseline and 15 min and 2 hours after administration of each dose, involved the use of a visual analog scale (VAS 100 mm) for spontaneous pain and pressure dolorimetry (kg/cm2) at 12 "symptomatic" tender points and nine "control" tender points for fibromyalgic pain. During the first treatment cycle effective control of spontaneous pain was achieved with tramadol, which determined a reduction of 20.6% while with the placebo spontaneous pain increased by 19.8%. With pressure dolorimetry there were no clinically important differences observed after either active treatment or placebo. The contrasting results found in the present study could be a stimulus for the organization of new projects, which may lead to the identification of an optimal therapeutic approach for fibromyalgic patients, also using tramadol for long periods.

Evaluation of metronidazole toxicity: a prospective study.

Abstract: Metronidazole is an antimicrobial, antiprotozoal agent that has been widely used in the treatment of a variety of infections. Some therapeutic indications necessitate prolonged treatment with metronidazole. Peripheral neuropathy is a potential metronidazole-induced toxicity, which has been reported in only a few isolated retrospective studies. This prospective study was designed to determine the toxic profile of metronidazole in patients undergoing long-term treatment with this drug. In the present study, 17 patients of both sexes, aged between 20 and 50 years, with body weights ranging from 46 to 62 kg and who were suffering from various medical ailments were recruited. The patients received 400 mg t.i.d. oral metronidazole in a total dose of 16.8-39.6 g for 2-4 weeks. It was found that patients usually suffered from some of the toxic symptoms of metallic taste, headache and dry mouth and to a lesser extent nausea, glossitis, urticaria, pruritus, urethral burning and dark colored urine. Symptoms were irrespective of sex and directly proportional to duration of therapy. Deep tendon ankle jerks were maximally reduced in four patients and sense of vibration at the level of olecranon and patella was affected in two patients. Distal latency and velocity of the sural and posterior tibial nerves were significantly affected (p < 0.01) compared with control values. These results indicate possible motor-sensory neurotoxicity involving the lower limbs due to long-term metronidazole therapy.