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Double-blind Comparison (double-blind + comparison)
Selected AbstractsA Randomized, Double-Blind Comparison of Two Topical Anesthesic Formulations Prior to Electrodesiccation of Dermatosis Papulosa NigraDERMATOLOGIC SURGERY, Issue 1 2006ERIC L. CARTER MD BACKGROUND Liposomal lidocaine 4% (L.M.X.4 cream, Ferndale Laboratories Inc., Ferndale, MI, USA) has been proposed as a more rapidly acting topical anesthetic than the eutectic mixture of lidocaine 2.5% and prilocaine 2.5% (EMLA cream, AstraZeneca LP, Wilmington, DE, USA) for venipuncture and laser procedures. However, their anesthetic efficacy has not been previously compared for electrosurgical destruction of superficial skin lesions. OBJECTIVE To test the hypothesis that L.M.X.4 and EMLA differ in anesthetic efficacy when applied under occlusion for 30 minutes prior to electrodesiccation of papules of dermatosis papulosa nigra. METHODS Forty adults were randomly assigned to treatment with either agent for 30 minutes under Tegaderm. The study drug was administered for an additional 30 minutes if the electrodesiccation of the first few papules was too painful. RESULTS One subject treated with EMLA versus none treated with L.M.X.4 experienced complete anesthesia after a single 30-minute application. Nineteen of 20 (95%) subjects treated with EMLA versus 18 of 20 (90%) subjects treated with L.M.X.4 required only a single application (p=.49). Pain scores after the initial 30-minute application (scale: 0=none to 10=very severe) were EMLA 3.3±2.2 (mean±SD) versus L.M.X. 4 2.9±2.0 (p=.46). CONCLUSION EMLA and L.M.X.4 provide comparable levels of anesthesia after a single 30-minute application under occlusion prior to electrodesiccation of superficial skin lesions. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Double-blind comparison of ropivacaine 7.5 mg mL,1 for sciatic nerve block. (Ninewells Hospital and Medical School, Dundee, United Kingdom) British J Anesh.PAIN PRACTICE, Issue 4 20012001;26:20 Two groups of 12 patients had a sciatic nerve block performed with 20 mL of either ropivacaine 7.5 mg mL,1 or bupivacaine 5 mg mL,1. There was no statistically significant difference in the mean time to onset of complete anesthesia of the foot or to the first request for postoperative analgesia. The quality of the block was the same in each group. Although there is no statistically significant difference in the mean time to peak plasma concentrations the mean peak concentration of ropivacaine was significantly higher than that of bupivacaine. There were no signs of systemic local anesthetic toxicity in any patient in either group. [source] Maintenance of Crohn's disease over 12 months: fixed versus flexible dosing regimen using budesonide controlled ileal release capsulesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2001J. R. B. Green Background: It may be possible to achieve more effective management of Crohn's Disease by introducing a flexible dosage regimen sensitive to patients' needs. Aim: Comparison of the efficacy and tolerability of a fixed vs. flexible budesonide controlled ileal release treatment regimen for the prevention and management of relapse in Crohn's disease patients. Budesonide controlled ileal release is an oral formulation which delivers drug directly to disease sites in the ileum and ascending colon, by preventing more proximal release and absorption. Methods: A randomized, double-blind comparison of a fixed dose of budesonide controlled ileal release (6 mg o.m.) and a flexible dose of budesonide controlled ileal release (3, 6 or 9 mg o.m.) for 12 months, in 143 patients in remission from ileal or ileo,caecal Crohn's Disease. Results: Very low rates of clinical relapse in Crohn's disease were achieved with budesonide controlled ileal release 6 mg o.m. There was no significant difference between the treatment groups with respect to the survival estimate of percentage of treatment failures (flexible group 15%, fixed group 19%; P=0.61). The average consumed dose of budesonide was comparable in both groups (5.8 mg flexible, 6.0 mg fixed). Similar proportions of patients reported adverse events (flexible 100%, fixed 97%). There were 33 serious adverse events (flexible 19, fixed 14) and 13 withdrawals due to significant adverse events (flexible 9, fixed 4). Conclusion: Maintenance treatment with budesonide controlled ileal release 6 mg o.m. is well-tolerated and is associated with low rates of clinical relapse in stable Crohn's disease over 12 months. Flexible dosing remains an option for individual patients, but this study has shown no advantage over a standard fixed dosing regimen. [source] Tramadol for prevention of postanaesthetic shivering: a randomised double-blind comparison with pethidineANAESTHESIA, Issue 2 2009M. Mohta Summary The present study was conducted with the aims of comparing intravenous tramadol 1, 2 and 3 mg.kg,1 with pethidine 0.5 mg.kg,1 for prophylaxis of postanaesthetic shivering and to find a dose of tramadol that could provide the dual advantage of antishivering and analgesic effect in the postoperative period. The study included 165 patients, randomly allocated to five groups of 33 each. Tramadol in doses of 1, 2 and 3 mg.kg,1, pethidine 0.5 mg.kg,1 or normal saline were administered at the time of wound closure. All three doses of tramadol were effective and comparable to pethidine in preventing postanaesthetic shivering. Tramadol 2 mg.kg,1 had the best combination of antishivering and analgesic efficacy without excessive sedation and thus appeared to be a good choice to be administered at the time of wound closure to provide antishivering effect and analgesia without significant side effects in the postoperative period. [source] Itch and scratching as predictors of time to clearance of psoriasis with narrow-band ultraviolet B therapyBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2009A.W.M. Evers Summary Background, Narrow-band ultraviolet (UV) B phototherapy is an effective treatment for psoriasis. However, there is considerable variability in the number of treatment sessions needed to achieve psoriasis clearance. While several clinical and treatment-related factors predict time to clearance, the effect of itching and scratching on the number of irradiation sessions is insufficiently understood. Objective, Predictors of the time to clearance were assessed in patients with psoriasis who were referred for UVB treatment in a randomized double-blind comparison of irradiation regimens for UVB phototherapy. Methods, After randomization to either UVB irradiation with a suberythematogenic or an erythematogenic regimen, patients were irradiated with 20% and 40% incremental doses, respectively, three times weekly. The Psoriasis Area and Severity Index (PASI) score was measured at baseline and every 4 weeks, and itching and habitual scratching were measured at baseline. Results, Among the 77 patients who achieved psoriasis clearance (90% reduction of PASI), itching and scratching were correlated with the number of irradiation sessions needed to achieve clearance, with higher levels of itch and scratching predicting more sessions. These effects remained significant after controlling for the initial PASI score, irradiation schemes, minimal erythema dose (MED), skin type, cumulative dose, protocol adjustments and lifestyle factors (smoking habits and alcohol consumption). Conclusions, Patients with higher levels of itch and scratching need more irradiation sessions to achieve clearance of psoriasis with UVB phototherapy. Systematic assessment of the severity of itch and scratching, followed by short-term itch-coping programmes for patients at risk, might be a cost-effective, adjunct to UVB therapy. [source] Neuroprotection trials in Parkinson's disease: Systematic review,,MOVEMENT DISORDERS, Issue 5 2009Robert G. Hart MD Abstract Treatments to slow the progression are a major unmet need in Parkinson's disease. Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double-blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO-B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow-up averaged <16 months in all but two trials. Detailed randomization methods and success of double-blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. Future trials should include participants with wider ranges of disease stages and assess broader neurological outcomes. © 2008 Movement Disorder Society [source] | |||||||||||||||||||