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Clinical Efficacy (clinical + efficacy)
Kinds of Clinical Efficacy Selected AbstractsA Review of the Biologic Effects, Clinical Efficacy, and Safety of Silicone Elastomer Sheeting for Hypertrophic and Keloid Scar Treatment and ManagementDERMATOLOGIC SURGERY, Issue 11 2007BRIAN BERMAN MD Silicone elastomer sheeting is a medical device used to prevent the development of and improve the appearance and feel of hypertrophic and keloid scars. The precise mechanism of action of silicone elastomer sheeting has not been defined, but clinical trials report that this device is safe and effective for the treatment and prevention of hypertrophic and keloid scars if worn over the scar for 12 to 24 hours per day for at least 2 to 3 months. Some of the silicone elastomer sheeting products currently on the market are durable and adhere well to the skin. These products are an attractive treatment option because of their ease of use and low risk of adverse effects compared to other treatments, such as surgical excision, intralesional corticosteroid injections, pressure therapy, radiation, laser treatment, and cryotherapy. Additional controlled clinical trials with large patient populations may provide further evidence for the efficacy of silicone elastomer sheeting in the treatment and prevention of hypertrophic and keloid scars. The purpose of this article is to review the literature on silicone elastomer sheeting products and to discuss their clinical application in the treatment and prevention of hypertrophic and keloid scars. [source] Zolmitriptan Intranasal: A Review of the Pharmacokinetics and Clinical EfficacyHEADACHE, Issue 1 2006Peter J. Goadsby MD Migraine is a common disabling neurological disorder, associated with headache, nausea, and on occasions vomiting. Zolmitriptan is a widely available serotonin 5HT1B/1D receptor agonist with a long track record in clinical studies and in the treatment of acute migraine. A nasal formulation has been developed that has clear evidence for local absorption, resulting in plasma drug concentrations within 2 minutes of dosing, central nervous system penetration 3 minutes later, and a significant efficacy benefit versus placebo 10 to 15 minutes after dosing. Intranasal zolmitriptan offers advantages to migraineurs, particularly those seeking a more rapid onset of effect without wishing to self-inject, or those with gastrointestinal upset. The comparison of pharmacokinetic and clinical data available from different formulations of zolmitriptan contributes both to the understanding of its mode of action and the characteristics required of an acute migraine treatment if it is to meet patient needs. [source] Clinical Efficacy of Frovatriptan: Placebo-Controlled StudiesHEADACHE, Issue 2002R. Ryan MD Objective.,To confirm the clinical efficacy of frovatriptan 2.5 mg. Background.,Frovatriptan is a new 5-hydroxytryptamine (5-HT)1B/1D receptor agonist being developed for the acute treatment of migraine with or without aura. Results from preclinical and clinical pharmacology studies showed frovatriptan to be a potent 5-HT1B receptor agonist with a long terminal elimination half-life (26 hours) and a broad therapeutic index. Design.,Three randomized, placebo-controlled, double-blind, parallel-group trials, in a total of 2676 patients, were performed to confirm the clinical efficacy of frovatriptan 2.5 mg for the acute treatment of migraine. Results.,In all three studies, headache response 2 hours after frovatriptan dosing was significantly greater than that seen with placebo (P.001) with approximately a two-fold measure of effect over placebo for headache response at 2 and 4 hours postdosing. Time to headache response occurred within 1.5 hours in a substantial proportion of patients. The incidence of 24-hour headache recurrence with frovatriptan was low (10% to 25%). Frovatriptan therapy also was associated with a high degree of patient satisfaction. Conclusions.,Frovatriptan represents a consistently effective acute treatment for migraine and accompanying symptoms. [source] Lack of Clinical Efficacy of a Phosphodiesterase-4 Inhibitor for Treatment of Heaves in HorsesJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2006Jean-Pierre Lavoie Phosphodiesterase-4 (PDE 4) enzyme inhibitors have been shown to have anti-inflammatory properties in various animal disease processes and therefore could be effective drugs for the treatment of equine airway diseases. The purpose of this study was to evaluate the efficacy and adverse effects of the PDE 4 inhibitor L-826,141 in horses with heaves. In a blinded parallel design, horses with heaves exposed daily to moldy hay were given a placebo for 14 days and then administered either L-826,141 (n = 6; loading dose of 1 mg/kg IV followed by 0.5 mg/kg IV q48h) or dexamethasone (n = 6; 0.04 mg/kg IV q24h) from days 15 to 29 (study 1). Pulmonary function and bronchoalveolar (BAL) cytology were evaluated weekly from baseline (day 0) to 29 days. In study 2, horses were treated with L-826,141 (1.0 mg/kg IV q24h) for 8 days. Although ex vivo lipopolysaccharide-induced tumor necrosis factor (TNF)-, and LTB4 production by fresh blood were inhibited up to 90% after repeated administrations of L-826,141, this treatment failed to improve lung function. In contrast, dexamethasone (positive control) treatment resulted in significant improvement in lung mechanics and airway function in all horses. Neither drug had a significant effect on BAL total cell counts and differential cytology. Administration of the PDE 4 inhibitor L-826,141 for up to 14 days to horses with heaves was not associated with an improvement in airway function or inflammation. These findings suggest that the PDE 4 enzyme is not a key mediator of lung inflammation in heaves. [source] Clinical Efficacy and Safety of Recombinant Canine Erythropoietin in Dogs with Anemia of Chronic Renal Failure and Dogs with Recombinant Human Erythropoietin-Induced Red Cell AplasiaJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2004John F. Randolph The efficacy and safety of recombinant canine erythropoietin (rcEPO) therapy was evaluated in 19 dogs with anemia of chronic renal failure (group 1) and 6 dogs with chronic renal failure and recombinant human erythropoietin (rhEPO)-induced red cell aplasia (group 2). Hematocrit (Hct) and absolute reticulocyte count (ARC) were monitored weekly for the first 8 weeks, CBC (including ARC) and serum iron profiles were evaluated monthly, and serum biochemical analyses were performed every 2 months for 6 (group 2) to 12 (group 1) months. For group 1 dogs, median Hct and ARC increased significantly during the 1st week of rcEPO treatment, and median Hct was sustained at >35% after week 5. In contrast, median Hct and ARC for group 2 did not change significantly with rcEPO treatment, even with doses greater than those used in group 1. Nevertheless, 2 (33%) of the 6 dogs in group 2 developed erythroid hyperplasia, reticulocytosis, and increases in Hct with rcEPO treatment. Although median systolic blood pressure did not change significantly in either group, 5 dogs developed systolic blood pressures a 180 mm Hg during the study. Appetite and energy level improved in most group 1 dogs with increases in Hct. Recombinant cEPO stimulated erythrocyte production in dogs with nonregenerative anemia secondary to chronic renal failure without causing the profound erythroid hypoplasia that can occur in rhEPO-treated dogs. Unfortunately, rcEPO was not as effective in restoring erythrocyte production in dogs that had previously developed rhEPO-induced red cell aplasia. [source] A Review of the Clinical Efficacy and Safety of Cruciferous Vegetable PhytochemicalsNUTRITION REVIEWS, Issue 6 2007Deanna M. Minich PhD Supplementation with the crucifer-derived phytochemicals indole-3-carbinol (I3C) and 3,3, -diindolylmethane (DIM) has been an area of active interest due to their role in estrogen metabolism. This review addresses the debate about which cruciferous compound to use clinically by evaluating their efficacy and safety. Significantly more clinical trials are available for I3C than for DIM. I3C leads to beneficial shifts in hormone markers, and limited evidence suggests that DIM may result in a similar effect. More research in humans is needed to further address whether DIM poses any safety risk. Current data do not suggest that DIM provides enhanced clinical benefits over I3C. [source] Comparative Study of Clinical Efficacy and Tolerance in Seasonal Allergic Conjunctivitis Management with 0.1% Olopatadine Hydrochloride versus 0.05% Ketotifen FumarateACTA OPHTHALMOLOGICA, Issue 2000Alejandro J. Aguilar ABSTRACT. Objective: To compare the clinical efficacy and tolerance of 0.1% olopatadine hydrochloride (OHC) versus 0.05% ketotifen fumarate (KF) in the management of allergic conjunctivitis. Materials and Methods: Eighty adult patients with a history of allergy (allergic conjunctivitis, hay fever, asthmatic bronchitis and dermatitis) that were showing allergic conjunctivitis signs and symptoms (itching, hyperemia, mucous discharge and tearing) at the time of inclusion in this study were evaluated. Patients were divided in two groups, A and B. Group A patients were treated with OHC and group B patients were treated with KF. Both groups received one drop in the affected eye every 12 hrs. The start time of this study was the first patient visit, in which the medication was instilled for the first time. Both groups of patients were evaluated 30 min, 48 hr., 7 days and 14 days later. Local tolerance of each medication was evaluated. Results: Clinical improvement of the signs and symptoms of allergic conjunctivitis occurred in 42.5% to 62.5% of the patients in Group A when assessed 30 min following the first topical ocular dose of olopatadine. However, mucous discharge was not affected. Forty-eight (48) hrs. after the first instillation, improvements in 57.5% to 75% of the patients were shown in every evaluated parameter. After 7 days of treatment, positive clinical results were observed in 80% to 87.5% of the treated patients. Except for the patients that were dismissed from the study before the seventh day of treatment due to the absence of therapeutic response (4/40), all patients satisfactorily completed the therapeutic plan by the seventh day. No intolerance reactions were observed in patients of this group. In Group B patients (KF), clinical improvement of the signs and symptoms measured in the study was shown in 20.0% to 47.5% 30 min after instillation. As observed with olopatadine, no improvement in the number of patients showing mucous discharge was noted at the 30-min time point. At 48 hr. after the first instillation, 27.5% to 48% of patients showed improvement in every evaluated parameter. After 7 days of treatment, improvement was observed in 60% to 75% of patients. On Day 14, positive responses were observed in 67.5% to 75% of patients. Seventeen and one-half percent of the patients were dismissed from the study before the seventh day of treatment due to the absence of a therapeutic response. Approximately 23% of the patients had mild reactions of intolerance (stinging) which was not a cause to discontinue the treatment. Conclusion: Olopatadine hydrochloride controlled allergic conjunctivitis symptoms and signs more rapidly and to a greater extent than ketotifen fumarate. Fewer cases of treatment failure were noted with OHC, and no local intolerance reactions were observed, while KF triggered mild reactions (stinging) in 23% of patients. [source] Clinical efficacy comparison of anti-wrinkle cosmetics containing herbal flavonoidsINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 2 2010P. Chuarienthong Synopsis Herbal anti-wrinkle cosmetics were formulated from ginkgo (Ginkgo biloba), a mixture of tea and rooibos (Camellia sinensis and Aspalathus linearis) and soybean (Glycine soja). These extracts were incorporated into the preliminary developed stable gel base with good preference. The gingko formulation was found to be more stable than the formula containing a mixture of tea and rooibos and the soybean formula. Clinical efficacies of the ginkgo formula and the formula containing a mixture of tea and rooibos were compared following 28 days of application. The ginkgo preparation increased skin moisturization (27.88%) and smoothness (4.32%) and reduced roughness (0.4%) and wrinkles (4.63%), whereas the formula containing tea and rooibos showed the best efficacy on wrinkle reduction (9.9%). In comparison to the tea and rooibos formula, gingko significantly improved skin moisturization (P = 0.05). Résumé Comparaison de l'efficacité clinique de cosmétiques antiride contenant des flavonoïdes d'origine végétale Des cosmétiques antiride d'origine végétale ont été formulés à partir de ginkgo (Ginkgo biloba), d'un mélange de thé et de rooibos (Camélia sinensis et Aspalathus linearis) et de soja (Glycine soja). Ces extraits ont été incorporés dans une base de gel stable préalablement développée. La formulation de gingko s'est révélée plus stable que les formules contenant le mélange de thé et rooibos et le soja. Les efficacités cliniques de la formule ginkgo et de la formule contenant le mélange de thé et rooibos ont été comparées après 28 jours d'application. La préparation ginkgo a augmenté l'hydratation cutanée (27.88%) et la douceur de la peau (4.32%), la rugosité a été réduite (0.4%) ainsi que les rides (4.63%). La formule contenant le mélange thé et rooibos a montré la meilleure efficacité sur la réduction de ride (9.9%). En comparaison la formule ginkgo a augmenté de façon significative (P = 0.05) l'hydratation cutanée face à la formule contenant le mélange thé et rooibos. [source] Clinical efficacies of topical agents for the treatment of seborrheic dermatitis of the scalp: A comparative studyTHE JOURNAL OF DERMATOLOGY, Issue 3 2009Hyoseung SHIN ABSTRACT Previous studies have shown that topical steroid and shampoo containing zinc pyrithione provide clinical benefits for treatment of scalp seborrheic dermatitis. But the clinical efficacy of topical tacrolimus, a newly developed calcineurin inhibitor on seborrheic dermatitis, is not well investigated yet. We wanted to compare the clinical efficacy of topical tacrolimus with that of conventional treatment (zinc pyrithione shampoo and topical betamethasone) for treatment of seborrheic dermatitis of the scalp. Patients with seborrheic dermatitis of the scalp were randomly allocated to receive topical betamethasone, topical tacrolimus or zinc pyrithione shampoo. Some patients were instructed to continue the treatments for 8 weeks and the others to discontinue the treatments at week 4. We evaluated the efficacy using a clinical severity score, dandruff score and sebum secretion at baseline, week 4 and week 8. All treatment groups showed significant improvements in clinical assessment after 4 weeks. While the patients treated by zinc pyrithione improved continuously even after cessation of the treatment, the patients treated by betamethasone lotion or tacrolimus ointment were aggravated clinically. Topical tacrolimus was as effective as topical betamethasone, and showed more prolonged remission than topical betamethasone. To treat seborrheic dermatitis of the scalp, we think that the combination therapy of topical steroid or topical tacrolimus, and zinc pyrithione is recommended. [source] Clinical efficacy and safety of oral terbinafine in fungal mycetomaINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 2 2006Bassirou N'Diaye MD Objectives, An open-label study was performed to assess the efficacy and safety of terbinafine in the treatment of eumycetoma. Methods, Single-center, open-label study, including 27 patients with signs and symptoms of eumycetoma which had developed within 5 years and was confirmed by mycological examination. The intention-to-treat population (n = 23) received 500 mg of terbinafine bid for 24,48 weeks. Efficacy evaluations included clinical signs and symptoms (e.g. sinuses open or closed, degree of tumefaction, and emission of grains either present or absent); mycological examinations from Week 24 onwards; and investigators' overall assessment of efficacy (cure, improved since baseline, unchanged since baseline, or deterioration since baseline). Safety evaluations included monitoring of adverse events, laboratory assessments, vital signs and physical examinations. Results, Good clinical improvement was seen in patients who completed the study (n = 20). Tumefaction was absent or improved in 80% of patients; sinuses were closed in 50% of patients, and grain emissions were absent in 65% of patients. Of the 16 patients who had repeat mycological assessment, four (25%) were mycologically cured. In the investigators' overall opinion at the end of the study, five (25%) were cured and 11 (55%) were clinically improved. The majority of adverse events reported were mild to moderate, and consistent with the known tolerability profile of terbinafine. Conclusion, High-dose terbinafine (1000 mg/day) is well tolerated and clinically effective in patients with eumycetoma, a difficult-to-treat subcutaneous mycoses. [source] A multi center study of granulocyte and monocyte adsorption apheresis therapy for ulcerative colitis,Clinical efficacy and production of interleukin-1 receptor antagonistJOURNAL OF CLINICAL APHERESIS, Issue 3 2008Hiroaki Takeda Abstract Granulocyte and monocyte adsorption apheresis (GCAP) is a useful strategy for intractable ulcerative colitis, but its mechanisms of therapy is not fully explained. Previously, depleting activated granulocytes and monocytes (GMs) and modifying product of proinflammatory cytokines had been proposed. In addition, activated GMs are releasing anti-inflammatory cytokines, interleukin-1 receptor antagonist (IL-1ra) that may contribute to the clinical efficacy of GCAP therapy. Hence, to investigate contribution of IL-1ra as well as to confirm clinical efficacy of this therapy based on clinical activity index (CAI), we performed a multicenter study. Twenty-five of 38 (65.8%) patients achieved remission state (CAI , 4) and two of 38 (5.3%) revealed clinical improvement. Almost effective cases significantly decreased CAI even at 3rd session of GCAP. Plasma level of IL-1ra from outflow of the GCAP column at 30 min was significantly increased rather than inflow. Median exact elevated level of IL-1ra was 221 pg/ml and median of increasing ratio was 1.6 times. Furthermore, the responsive patients, who well released the IL-1ra at outflow more than 100 pg/ml compared with inflow, tended to show clinical effectiveness. While, the increased ratio of IL-1ra in effective cases did not differ from ineffective cases, and there were no significant relationship with improvement of CAI score. These conflict results suggest that the increase of IL-1ra at outflow is not a direct factor to the clinical improvement, but the induction of clinical improvement is accompanied by the release of IL-1ra. The IL-1ra may be involved in the multiple steps for the improvement induced by GCAP. J. Clin. Apheresis, 2008. © 2008 Wiley-Liss, Inc. [source] Clinical efficacy of prostate cancer detection using power doppler imaging in American and Japanese menJOURNAL OF CLINICAL ULTRASOUND, Issue 4 2002Koji Okihara MD Abstract Purpose The aim of this study was to compare the detection rates of tumor vascular flow as measured by power Doppler imaging (PDI) in 2 populations and to determine whether PDI can reduce the number of unnecessary prostate biopsies in men with serum prostate-specific antigen (PSA) concentrations less than 10.1 ng/ml. Methods The patient populations were Japanese (group 1) and American (group 2) men with either serum PSA concentrations of 4.1,10.0 ng/ml or abnormal findings on digital rectal examination (DRE) plus PSA concentrations less than 4.1 ng/ml. We compared the overall diagnostic accuracy of DRE, gray-scale transrectal sonography (TRUS), and PDI between the 2 groups. Results In total, 275 men were studied, 154 in group 1 and 121 in group 2. Cancer was identified in 27% of men in group 1 and in 60% of group 2. Men with cancer in both groups differed significantly in age, peripheral zone volume, and mean number of positive biopsy cores. The sensitivity and specificity of PDI in group 2 were significantly inferior to those in group 1. The negative predictive value (NPV) of PDI was significantly higher for group 1 than for group 2. The NPV of PDI in group 1 was equivalent to that for the combination of DRE and TRUS, whereas the NPV for PDI in group 2 was significantly inferior to that of DRE and TRUS. Conclusions Tumor vascularity could be detected by PDI more effectively in Japanese men with cancer than in American men with cancer. We hypothesize that this difference was a result of larger cancer volumes and smaller prostates in the Japanese men. PDI did not provide any performance advantage over DRE and TRUS in avoiding unnecessary biopsies. © 2002 Wiley Periodicals, Inc. J Clin Ultrasound 30:213,221, 2002; Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jcu.10054 [source] Clinical efficacy of Kampo medicine (Japanese traditional herbal medicine) in the treatment of primary dysmenorrheaJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 5 2008Atsuko Oya Abstract Objective:, We intended to evaluate the clinical efficacy of Kampo medicine, a Japanese traditional herbal medicine, for primary dysmenorrhea which was prescribed according to the Kampo diagnosis, with classification of its severity. Method:, A retrospective evaluation of Kampo treatment in 176 subjects with dysmenorrhea during the previous 12 years was performed. In order to minimize the subjective discretion of the severity of symptoms, classification of the severity level of abdominal pain during menstruation was applied by considering the requirement for non-steroidal anti-inflammatory drugs (NSAIDs) and disturbance of daily activities. The following severity levels were used: no abdominal pain (level 0), abdominal pain with no requirement of NSAIDs (level 1), abdominal pain with no daily activity disturbances with use of NSAIDs (level 2), and painful menstruation which required absenteeism even with use of NSAIDs (level 3). Results:, Severity levels before and after Kampo treatment were defined in 108 subjects. Distribution of the severity levels in 108 subjects was significantly changed by Kampo treatment; the numbers of cases in levels 0, 1, 2, and 3 changed from 0 (0%), 0 (0%), 47 (43.5%), and 61 (56.5%) to 5 (4.6%), 42 (38.9%), 51 (47.2%), and 10 (9.3%), respectively. (P < 0.0001) There were 25 kinds of Kampo formulae prescribed in effective cases. Conclusion:, Kampo medicine prescribed according to Kampo diagnosis reduced the severity of primary dysmenorrhea and is therefore suggested to be beneficial in improving quality of life. [source] Clinical efficacy and safety of a once-daily formulation of carbimazole in cats with hyperthyroidismJOURNAL OF SMALL ANIMAL PRACTICE, Issue 10 2009R. Frénais Objective:Evaluation of efficacy and safety of a novel controlled-release formulation of carbimazole in feline hyperthyroidism. Methods:A multicentre, self-controlled study in 44 client-owned cats with history and clinical signs of hyperthyroidism, and total thyroxine concentration greater than or equal to 50 nmol/l. Treatment was started at 15 mg once daily, response assessed after 10 days, and 3, 5, 8, 26 and 53 weeks and dose adjusted as required. Results:The median dose of carbimazole was 10 mg (range 10 to 15 mg) and 15 mg (5 to 25 mg) once daily after 3 and 53 weeks, respectively. Median total thyroxine concentration dropped significantly from 118 nmol/l (50 to 320 nmol/l) at presentation to 33 nmol/l (n=40) after 10 days, 31 nmol/l (n=34) at 3 weeks and 21 nmol/l (n=18) at 53 weeks. Clinical signs improved or resolved in almost all cats within three weeks after starting treatment. Twenty-one adverse reactions possibly (20) or probably (1) related to treatment were reported. During treatment, increased blood urea nitrogen concentration was observed in 25 per cent of the cats, eosinophilia in 20 per cent and lymphopenia in 16 per cent, while liver enzymes tended to improve. Clinical Significance:Once daily administration of controlled-release carbimazole tablets was effective and had expected tolerance in hyperthyroid cats during short- and long-term treatment. [source] Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trialJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 10 2006Antonella Tosti Abstract Background, Clinical efficacy of topical corticosteroids in alopecia areata (AA) is still controversial. Positive clinical results have been obtained using ointments with occlusive dressing but this approach has a low patient compliance. Recently, a new topical formulation (thermophobic foam: Versafoam®) of clobetasol propionate 0.05% has been introduced on the market (Olux®, Mipharm, Milan, Italy) (CF). This formulation is easy to apply. After application to the skin the foam quickly evaporates without residues and it has a good patient compliance. In vitro studies have also shown that this formulation enhances the delivery of the active compound through the skin. Aim, To evaluate the efficacy, safety and tolerability of CF in the treatment of moderate to severe AA. Subjects and methods, Thirty-four patients with moderate to severe AA (eight men, mean age 40 ± 13 years) were enrolled in a randomized, double-blind, right-to-left, placebo-controlled, 24-week trial. Alopecia grading score (AGS) was calculated at baseline and after 12 and 24 weeks of treatment using a 0,5 score (0 = no alopecia; 5 = alopecia totalis). Clobetasol foam and the corresponding placebo foam (PF) were applied twice a day for 5 days/week for 12 weeks (phase 1) using an intrapatient design (right vs. left). From weeks 13 to 24 each enrolled patient continued only with the treatment (both on the right and left site) that was judged to have a greater efficacy than that on the contralateral side (phase 2). The primary outcome of the trial, evaluated on an intention-to-treat basis, was the hair regrowth rate, which was evaluated using a semiquantitative score (RGS) (from 0: no regrowth, to 4: regrowth of 75%). Results, At baseline the AGS was 4.1 (range: 2,5). Nine (26%) patients prematurely concluded the trial. At the end of phase 1, a greater hair regrowth was observed in 89% of the head sites treated with CF vs. 11% in the sites treated with PF. The RGS was 1.2 ± 1.6 in the CF-treated sites and 0.4 ± 0.8 in the PF-treated sites (P = 0.001). A RGS of 2 (hair regrowth of more than 25%) was observed in 42% CF-treated sites and in 13% of PF-treated sites (P = 0.027). In seven subjects (20%) a RGS of 3 to 4 (hair regrowth of 50%) was observed in CF-treated sites. In three subjects (9%) a RGS of 4 (hair regrowth of 75%) was observed in CF-treated sites. In one patient only, in a PF-treated region, a RGS of 3 was observed. The AS was reduced to 3.8 by CF treatment at the end of phase 1 and to 3.3 at the end of phase 2 (P = 0.01). From weeks 12 to 24 the treatment with CF induced a further increase in the RGS (from 1.2 to 1.5 ± 1.4). Forty-seven per cent of CF-treated patients had a RGS of 2 at the end of the trial. A total of eight patients (25%) at the end of the treatment with CF showed a RGS of 3. Folliculitis occurred in two patients. No significant modifications in cortisol and ACTH blood levels were observed during the trial. Conclusion, This new formulation of clobetasol propionate foam is an effective, safe and well-tolerated topical treatment for AA. This formulation has a good cosmetic acceptance and patient compliance profile. [source] Methylnaltrexone bromide for the treatment of opioid-induced constipation in patients with advanced illness , a cost-effectiveness analysisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2010S. R. EARNSHAW Aliment Pharmacol Ther,31, 911,921 Summary Background, Opioid-induced constipation is a common adverse event in patients with advanced illness and has a significant negative impact on patients' quality of life and costs. Aim, To examine the cost-effectiveness of treating opioid-induced constipation with methylnaltrexone bromide (MNTX) plus standard care compared with standard care alone in patients with advanced illness who receive long-term opioid therapy from a third-party payer perspective in the Netherlands. Methods, A decision-analytical model was created in which advanced-illness patients with constipation were treated with MNTX plus standard care or standard care alone. Clinical efficacy in terms of percentage of patients with rescue-free laxation and time to rescue-free laxation were obtained from a randomized, controlled clinical study. Resource use, costs, utilities and mortality were obtained from published literature and supplemented with data from clinical experts. Results, Treatment with MNTX plus standard care results in more days without constipation symptoms. Cost of MNTX was mostly offset by reduction in other constipation-related costs. Thus, treating with MNTX plus standard care is cost-effective, with an incremental cost per QALY of ,40 865. Results were robust to changes in all parameters. Conclusions, Although using MNTX may increase total costs, MNTX plus standard care is cost-effective in treating advanced-illness patients with opioid-induced constipation. [source] Clinical efficacy of intravenous administration of marbofloxacin in a Staphylococcus aureus infection in tissue cages in poniesJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2006M. VOERMANS Tissue cages (TC), implanted subcutaneously in the neck in eight ponies, were inoculated with Staphylococcus aureus (S. aureus) to determine the clinical efficacy of marbofloxacin in the treatment of this infection. From 21 h after inoculation, marbofloxacin (6 mg/kg) was administered intravenously (i.v.) once daily for 7 days. Samples of the tissue cage fluid (TCF) were taken to determine marbofloxacin concentrations (days 1, 3 and 7), using high-pressure liquid chromatography, and numbers of viable bacteria [colony forming units (CFU)] (days 1, 3, 7, 14 and 21). Statistical analysis was used to compare CFU before and after treatment. Clinical signs and CFU were used to evaluate the efficacy of treatment. Although, there was a slight decrease in CFU in all TC initially, the infection was not eliminated by marbofloxacin treatment in any of the ponies and abscesses formed. As the MIC (0.25 ,g/mL) did not change during treatment and the concentration of marbofloxacin during treatment (mean concentration in TCF was 0.89 ,g/mL on day 1, 0.80 ,g/mL on day 3 and 2.77 ,g/mL on day 7) was above MIC, we consider that the treatment failure might be attributable to the formation of a biofilm by S. aureus. Based on the present results, i.v. administration of marbofloxacin alone is not suitable for the elimination of S. aureus infections from secluded sites. [source] Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy studyALLERGY, Issue 1 2004M. S. Khinchi Background:, Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed. Objective:, To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side-effects. Methods:, A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age. Results:, Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one-half and SCIT to one-third of placebo treatment. No statistical significant difference between the two groups was observed. Both for symptoms and medication scores actively treated patients showed statistically significant and clinical relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects. Conclusion:, Based on the limited number of patients the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile SLIT may be favored. [source] Reduced intensity conditioning regimen with fludarabine, busulfan, and low-dose TBI (Flu-BU2-TBI): Clinical efficacy in high-risk patients,AMERICAN JOURNAL OF HEMATOLOGY, Issue 4 2010Mutsumi Takahata Reduced intensity conditioning (RIC) regimens are widely used in allogeneic stem cell transplantation (SCT). In this study, we retrospectively investigated the clinical outcomes of RIC with fludarabine (Flu; 180 mg/m2), intravenous busulfan (BU; 6.4 mg/kg) or oral BU (8 mg/kg), and low-dose total body irradiation (TBI; 4 Gy) (Flu-BU2-TBI) in 66 patients (median age: 54.5 years) with various hematological malignancies. Thirty-eight patients (58%) were high-risk patients (median age: 56 years). The overall survival rate at 2 years of the high-risk patients was 64.5%, which was comparable to the survival rate of 70.9% in standard-risk patients (P = 0.68). The relapse rates at 2 years in the standard-risk and high-risk patients were 16 and 28%, respectively, and day 100 treatment-related mortality rates were 0 and 6%, respectively. The Flu-BU2-TBI regimen for high-risk patients showed therapeutic effects equivalent to those for standard-risk patients and favorable outcomes compared with those of other previous RIC regimens. Am. J. Hematol., 2010. © 2010 Wiley-Liss, Inc. [source] LETTER TO THE EDITOR: Clinical efficacy of reserpine as "add-on therapy" to antihistamines in patients with recalcitrant chronic idiopathic urticaria and urticarial vasculitisTHE JOURNAL OF DERMATOLOGY, Issue 9 2010Toshio DEMITSU No abstract is available for this article. [source] Clinical efficacy of diclofenac sodium and flunixin meglumine as adjuncts to antibacterial treatment of respiratory disease of calvesAUSTRALIAN VETERINARY JOURNAL, Issue 6 2010M Guzel Objective To compare the efficacy of the non-steroidal antiinflammatory drugs, diclofenac sodium and flunixin meglumine as adjuncts to the antibiotic treatment of bovine respiratory disease (BRD). Procedure We randomly allocated 80 Holstein calves with BRD to three groups. All the calves received a dose of 2.5 mg/kg tulathromycin by single subcutaneous injection and two of the groups received, in addition, either 2.5 mg/kg diclofenac sodium as a single intramuscular injection (diclofenac group, n = 30) or 2.2 mg/kg flunixin meglumine as an intravenous injection on the first three consecutive days after tulathromycin administration (flunixin group, n = 30). All calves were given a clinical score prior to initial treatment (day 0) and after treatment (days 1, 2, 3, 7 and 14) by observing appetite, demeanour, rectal temperature, the rate and type of respiration, presence or absence of coughing, and nasal discharge. Results During the first 48 h, improvement of adverse signs of respiratory disease, such as pyrexia and elevated respiratory rate, and of a high clinical index score was significant in the two adjunct groups compared with the calves receiving antibiotic alone. The reduction in pyrexia was greatest in the diclofenac group. There were no statically significant differences between treatment groups with regard to eventual perceived recovery from respiratory disease in 14 days. Conclusion In this trial, a single intramuscular dose of diclofenac sodium was equally effective as three intravenous injections of flunixin meglumine given on consecutive days as adjunctive therapy for BRD. [source] Teriparatide (Biosynthetic Human Parathyroid Hormone 1,34): A New Paradigm in the Treatment of OsteoporosisBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 6 2004Kim T. Brixen Biosynthetic human parathyroid hormone 1,34 (teriparatide) was recently approved in the EU and the USA as the first anabolic treatment of osteoporosis. The effects of teriparatide are mediated by the G-protein-dependent, parathyroid hormone receptor-1 in the cell membrane. The binding of the ligand to the receptor activates adenylate cyclase and a number of phospholipases (A, C, and D) and increases intracellular levels of cAMP and calcium. Intermittent teriparatide increases the number of osteoblasts and bone formation by activation of pre-existing osteoblasts, increased differentiation of lining cells, and reduced osteoblast apoptosis. Anabolic effects of teriparatide on bone have been demonstrated in several species. It increases bone mass, structural integrity, bone diameter, and bone strength. Clinical efficacy was demonstrated in a randomized study comprising 1637 post-menopausal women with osteoporosis showing a 65% and 35% reduction of the relative risk of vertebral and appendicular fractures, respectively, during 18 months of treatment. Moreover, bone mineral density in the lumbar spine and hip increased by 9.7% and 2.6%, respectively. Similar effects on bone mineral density have been reported in men with osteoporosis and in glucocorticoid-induced osteoporosis, however, fracture data are limited in these groups. Direct comparison with alendronate revealed that teriparatide has a more pronounced effect on bone mineral density. Teriparatide should be used in combination with calcium plus vitamin D, and may be combined with hormonal replacement therapy. In contrast, alendronate attenuates the effect of teriparatide. The efficacy of other combinations remains uncertain. After termination of teriparatide, bone mineral density of the lumbar spine is reduced by approximately 2,3% after 2 1/2 years. This decrease is prevented by treatment with bisphosphonates. The most frequent adverse effects with teriparatide are nausea, headache, dizziness, and leg cramps, however, only the latter two differed significantly between the groups receiving teriparatide 20 ,g/day and placebo. In the pivotal clinical study, reduced dosage or termination of therapy due to hypercalcaemia was necessary in 3% and 0.2%, respectively. In a rat toxicology study, in which teriparatide was administered in high dosages for an extended period of time, osteosarcoma was seen in a significant number of animals. However, none of the approximately 2800 patients in clinical trials has developed osteosarcoma. Teriparatide constitutes a break-through in the treatment of severe osteoporosis, although a number of issues about the optimal use of teriparatide remains unsettled. The published data provide proof of concept on anabolic therapy which changes several paradigms of bone physiology. Other parathyroid hormone analogues are being investigated in clinical trials and the development of non-peptide, small molecules targeted at the parathyroid hormone receptor may be envisaged. [source] Oral retinoic acid metabolism blocking agent RambazoleTM for plaque psoriasis: an immunohistochemical studyBRITISH JOURNAL OF DERMATOLOGY, Issue 2 2007H.J. Bovenschen Summary Background, The novel systemic all- trans retinoic acid metabolism blocking agent (RAMBA) R115866 (RambazoleTM; Barrier Therapeutics, Geel, Belgium; further referred to as rambazole) increases intracellular levels of endogenous all- trans retinoic acid (RA). Well-known effects of RA are normalization of aberrant epithelial growth and differentiation. Hence, rambazole might be beneficial in the treatment of plaque psoriasis. Objectives, The dynamics of epidermal proliferation, keratinization, lesional T-cell subsets and cells expressing natural killer (NK)-receptors in plaque psoriasis were assessed during treatment with rambazole, as part of a phase IIa open-label clinical trial. Methods, Six patients were treated with rambazole, 1 mg, once daily, for 8 weeks. At weeks 0, 2 and 8, psoriatic plaque severity scores (SUM) and biopsies from a target lesion were assessed. Epidermal proliferation (Ki67), keratinization markers (K10, K13, K19), T-cell subsets (CD3, CD4+, CD8+, CD45RO+, CD45RA+, CD2+, CD25+, GITR+) and cells expressing NK-receptors (CD94, CD161) were immunohistochemically stained and quantified with image analysis. Results, At week 2 the mean SUM-score was virtually equal to baseline, which was accompanied immunohistochemically by equal epidermal hyperproliferation, a nonsignificant decrease in K10 positive epidermis and, overall, a nonsignificant increase in immunocyte subsets. At week 8, in contrast, plaque severity was reduced by 34% from baseline (P < 0·05). Improvements were also detected for epidermal proliferation (,63%; P < 0·01) and K10 expression (+29%; P < 0·01), compared with baseline. No induction of retinoid-specific keratinization (K13, K19) was observed. A nonsignificant reduction of all pathogenic T-cell subsets and cells expressing NK-receptors was observed at week 8 of treatment (P > 0·05). Conclusions, Clinical efficacy of rambazole is primarily the result of restoring proliferation (Ki67) and differentiation (K10) of epidermal keratinocytes. Secondly, relevant T-cell subsets and cells expressing NK-receptors showed nonsignificant reductions after 8 weeks of treatment with rambazole. [source] Clinical efficacy of prophylactic strategy of long-term low-dose acyclovir for Varicella-Zoster virus infection after allogeneic peripheral blood stem cell transplantation,CLINICAL TRANSPLANTATION, Issue 6 2008Dong Hwan Kim Abstract:, Varicella-Zoster virus infection (VZV) has a high incidence post-allogeneic peripheral blood stem cell transplant (PBSCT). However, data regarding long-term acyclovir prophylaxis for VZV prevention are limited. We evaluated the clinical efficacy of long-term low-dose acyclovir prophylaxis for VZV infection after allogeneic PBSCT at the Princess Margaret Hospital (PMH), Canada and the Kyungpook National University Hospital (KNUH), Korea. The acyclovir prophylaxis regimen at PMH was acyclovir 400 mg/d orally until engraftment, and at KNUH was acyclovir 800 mg/d orally until immunosuppression discontinuation. Long-term acyclovir prophylaxis was given to 26/193 (14%) patients in the PMH group and 73/79 (92%) patients in the KNUH group. In the PMH group, 42 cases (22%) developed VZV infection, while six cases (8%) had VZV infection in the KNUH group (p = 0.005). With a median of 26.5 months of follow-up, the incidences of VZV infection at one and two yr were 15.8% and 20.7% in the PMH group, and 2.5% and 5.8% in the KNUH group, respectively (p = 0.001). By controlling the other potential risk factors for VZV infection in multivariate analysis, the use of long-term acyclovir was the only protective factor for VZV infection after allogeneic PBSCT (p = 0.04, hazard ratio = 0.296). Long-term use of acyclovir appears to be protective for VZV infection after allogeneic PBSCT, especially during the period of immunosuppressive therapy. [source] Moisturizer effect on Irritant Dermatitis: an overviewCONTACT DERMATITIS, Issue 2 2006Miki Yokota Moisturizers are empirically used as prevention and treatment of surfactant and irritant dermatitis. Some products state they not only improve barrier function by providing moisturization but also create an environment optimal for healing. Yet, moisturizer clinical efficacy remains a topic of controversy. We reviewed publication from 1992 to 2006 that quantitatively examines moisturizer effectiveness, as an update of our prior overview, Zhai and Maibach in 1998 (2). We intuitively (in a testimonial sense) believe that moisturizers are sometimes effective for preventing and treating irritant dermatitis. However, moisturizer may not be broadly effective (8, 12) and may be relatively specific against certain acids, bases, hydrophilics, and lipophilics. We need to develop principles of what is formulated in moisturizers to improve efficacy; for this purpose, there is a need for experimental moisturizer models for comparative studies. [source] Low-Fluence Q-Switched Neodymium-Doped Yttrium Aluminum Garnet Laser for Melasma with Pre- or Post-Treatment Triple Combination CreamDERMATOLOGIC SURGERY, Issue 6 2010SE-YEONG JEONG MD BACKGROUND Topical triple combination (TC) treatment is considered the primary approach to melasma. Recently, collimated low-fluence 1,064-nm Q-switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser treatment has attracted attention as an alternative approach. OBJECTIVES To compare the clinical efficacy and adverse effects of low-fluence Q-switched Nd:YAG laser when performed before and after treatment with topical TC using a split-face crossover design. METHODS Thirteen patients with melasma received topical treatment with TC cream or 1,064-nm Q-switched Nd:YAG laser treatment on opposite sides of the face for 8 weeks, and then treatments were reversed for 8 weeks. Responses were evaluated using the Melasma Area and Severity Index scoring system, spectrophotometry measurements, and a subjective self-assessment method. RESULTS After 16 weeks, better results were seen in subjective assessments when laser treatment was used after 8 weeks of topical TC treatment than before usage of TC. There were no significant adverse effects with the laser treatments. CONCLUSIONS Laser treatment after topical TC cream was found to be safer and more effective than the post-treatment use of topical agents. The authors have indicated no significant interest with commercial supporters. [source] Histometric and Histochemical Analysis of the Effect of Trichloroacetic Acid Concentration in the Chemical Reconstruction of Skin Scars MethodDERMATOLOGIC SURGERY, Issue 10 2006SUNG BIN CHO MD BACKGROUND Atrophic scars can be induced by various causes, including severely inflamed acne, chicken pox, and trauma. Many treatment modalities are used for reconstructing and improving the appearance of scars with various treatment results. OBJECTIVE A recent report shows the clinical efficacy of the chemical reconstruction of skin scars (CROSS) method, which consists of the focal application of trichloroacetic acid (TCA) in a higher concentration. Histometric analysis of the CROSS method, however, has not yet been established. METHODS In this study, five hairless mice were used to evaluate the effect of the CROSS method and to analyze the difference between the CROSS method and simple TCA application. RESULTS Similar histologic changes were observed in the two methods, including epidermal and dermal rejuvenation with new collagen deposition. These changes, however, were more prominent in the CROSS method,treated areas, particularly when 100% TCA was used. CONCLUSION The results of this study suggest that treatment of atrophic scars using the CROSS method is more effective than simple application of TCA in activating fibroblasts in the dermis and increasing the amount of collagen. [source] Mesotherapy and Phosphatidylcholine Injections: Historical Clarification and ReviewDERMATOLOGIC SURGERY, Issue 4 2006ADAM M. ROTUNDA MD BACKGROUND Mesotherapy was originally conceived in Europe as a method of utilizing cutaneous injections containing a mixture of compounds for the treatment of local medical and cosmetic conditions. Although mesotherapy was traditionally employed for pain relief, its cosmetic applications, particularly fat and cellulite removal, have recently received attention in the United States. Another treatment for localized fat reduction, which was popularized in Brazil and uses injections of phosphatidylcholine, has been erroneously considered synonymous with mesotherapy. Despite their attraction as purported "fat-dissolving" injections, the safety and efficacy of these novel cosmetic treatments remain ambiguous to most patients and physicians. OBJECTIVE To distinguish mesotherapy from phosphatidylcholine injections by reviewing their history and the relevant experimental or clinical findings. METHODS A comprehensive search of Medline indexed literature and conference proceedings. RESULTS All the published studies evaluating the clinical efficacy of traditional mesotherapy currently originate from Europe. These reports focus primarily on musculoskeletal pain and vascular disease, rather than cosmetic applications. Although experimental data suggest that a number of traditional mesotherapy ingredients may theoretically reduce fat, these effects have not been supported in peer-reviewed studies. An increasing number of reports demonstrate that subcutaneous injections of a formula containing phosphatidylcholine combined with its emulsifier, deoxycholate, are effective in removing small collections of adipose tissue. Cell lysis, resulting from the detergent action of deoxycholate, may account for this clinical effect. CONCLUSIONS Mesotherapy is distinct from a method of treating adipose tissue with subcutaneous injections of deoxycholate alone or in combination with phosphatidylcholine. Additional clinical and experimental studies are necessary to more definitively establish the safety and efficacy of these treatments. [source] The pharmacology of cilostazolDIABETES OBESITY & METABOLISM, Issue 2002Karsten Schrör Cilostazol (6-[4-(1-cyclohexyl- 1H -tetrazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone; OPC-13013) is a 2-oxo-quinoline derivative with antithrombotic, vasodilator, antimitogenic and cardiotonic properties. The compound is a potent inhibitor of phosphodiesterase (PDE) 3A, the isoform of PDE 3 in the cardiovascular system (IC50: 0.2 µm). In addition, there is inhibition of adenosine uptake, eventually resulting in changes in cAMP levels, dependent on the type of adenosine receptors (A1 or A2). Cilostazol inhibits platelet aggregation and has considerable antithrombotic effects in vivo. The compound relaxes vascular smooth muscle and inhibits mitogenesis and migration of vascular smooth muscle cells. In the heart, cilostazol causes positive inotropic and chronotropic effects. Most, if not all, of these actions are cAMP-mediated, including the modification of cAMP-controlled gene expression. Cilostazol decreases levels of serum triglycerides and causes some increase in HDL-cholesterol levels. The compound has a number of additional effects which might contribute to its overall clinical efficacy. Cilostazol undergoes intensive and finally complete hepatic metabolism via the cytochrome P450 systems. This might result in some drug interaction, i.e. with erythromycin and omeprazole. The half-life is approximately 10 h, resulting in about 2-fold accumulation of the drug during repeated administration. [source] Temporary self-expanding metallic stents and pneumatic dilation for the treatment of achalasia: a prospective study with a long-term follow-upDISEASES OF THE ESOPHAGUS, Issue 5 2010Y.-D. Li SUMMARY The present study compares the efficacy of a self-expanding metallic stent (SEMS, diameter of 30 mm) and pneumatic dilation for the long-term clinical treatment of achalasia. A total of 155 patients diagnosed with achalasia were allocated for pneumatic dilation (n= 80, group A) or a temporary, 30-mm diameter SEMS (n= 75, group B). The SEMSs were placed under fluoroscopic guidance and removed by gastroscopy 4,5 days after placement. Data on clinical symptoms, complications, and long-term clinical outcomes were collected, and follow-up observations were performed at 6 months and at 1, 3,5, 5,8, 8,10, and >10 years, postoperatively. Pneumatic dilation and stent placement were technically successful in all of the patients. There were no significant differences in technique success, 30-day mortality, or complications between the two groups. The clinical remission rate in group A was significantly lower than that in group B at 1, 1,3, 3,5, 5,8 and, >10 years (P < 0.05), while the cumulative clinical failure rate in group A (66%, 53/80) was higher than that in group B (92%, 6/75). The mean primary patency in group B was significantly longer than that in group A (4.2 vs 2.1 years, respectively; P < 0.001). A temporary, 30-mm diameter SEMS was associated with a better long-term clinical efficacy in the treatment of patients with achalasia as compared with treatment with pneumatic dilation. 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