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Double-blind Pilot Study (double-blind + pilot_study)
Selected AbstractsA Comparison of Two Botulinum Type A Toxin Preparations for the Treatment of Glabellar Lines: Double-Blind, Randomized, Pilot StudyDERMATOLOGIC SURGERY, Issue 12 2005Philippa L. Lowe MB ChB Background. Botulinum toxins have been proven effective for reducing facial lines. There are two commercial types of botulinum toxin type A available in many countries but no published comparison studies. Objective. To compare the efficacy and tolerability of Botox Cosmetic and Dysport 50 U in the treatment of glabellar lines (using 20 U of Botox Cosmetic, which is the dose approved by the US Food and Drug Administration for the treatment of glabellar lines, and 50 U of Dysport, which has been reported to be the optimal dose for this formulation). Study Design. Parallel-group double-blind pilot study. Evaluation by observing physician, photographic, and patient evaluations. Conclusion. Botox 20 U provided better and more prolonged efficacy than Dysport 50 U in the treatment of glabellar lines. NICHOLAS LOWE, MD, FRCP, AND RICKIE PATNAIK, MD, HAVE RECEIVED RESEARCH GRANTS FROM ALLERGAN INC. NICHOLAS LOWE OWNS STOCK IN ALLERGAN INC AND HAS RECEIVED CONSULTING PAYMENTS AND EDUCATIONAL GRANTS FROM ALLERGAN INC. THIS STUDY WAS FUNDED BY A GRANT FROM ALLERGAN INC. [source] Cluster headache: the challenge of clinical trials.HEADACHE, Issue 3 2003K Moore Curr Pain Headache. Rep 2002 Feb;6(1):52-56 The design and execution of clinical trials poses special problems for cluster headache. Although there is less inter-individual and intra-individual variability of attacks than seen with migraine, the brevity of attacks, spontaneous remissions unrelated to treatment, and the relative rarity of cluster headaches challenge investigators. The International Headache Society has developed guidelines that represent a compromise between scientific rigor and practicality. Only injectable sumatriptan for acute attacks and verapamil for prophylaxis have demonstrated a robust therapeutic effect in controlled clinical trials. Comment: Kenneth Moore raises important methodological considerations. It is possible to undertake crossover trials comparing different active treatments? He is correct in his assertion that few agents show robust efficacy. A major issue relates to the proportion of patients with episodic versus chronic cluster headache where efficacy of active treatments can vary. For example, oral zolmitriptan was effective against placebo only in those patients with episodic disease (Bahra A, Gawel MJ, Hardebo JE, Millson DS, Breen SA, Goadsby PJ. Oral zolmitriptan is effective in the acute treatment of cluster headache. Neurology. 2000;54:1832-1839). And a set of small studies on melatonin and cluster demonstrate the problems Dr. Moore describes. In one study (Leone M, D'Amico D, Moschiano F, Fraschini F, Busonne G. Metalonin versus placebo in the prophylaxis of cluster headache: a double-blind pilot study with parallel groups. Cephalalgia. 1996;16:494-496), the melatonin worked only in episodic, not chronic cluster patients. In the second study (Prinsheim T, Magnoux E, Dobson CF, Hamel E, Aube M. Melatonin as adjuctive therapy in the prophylaxis of cluster headache: a pilot study. Headache. 2002;42:787-792), melatonin did not work better than placebo in either episodic or chronic cluster patients. Furthermore, the paper abstracted above by Torelli and Manzoni suggests that episodic cluster may progress to chronic cluster as a result of extrinsic factors such as smoking. Finally, there are ethical issues in placebo-controlled cluster studies, given the severity of the pain and the availability of effective acute and chronic treatments. As noted above, Dr. Peter Goadsby points out the need to persevere with these studies to find nonvasoactive treatments for patients with cluster headache. DSM and SJT [source] A Pilot Trial of the Alpha-1 Adrenergic Antagonist, Prazosin, for Alcohol DependenceALCOHOLISM, Issue 2 2009Tracy L. Simpson Background:, Current medications for alcohol dependence (AD) show only modest efficacy. None target brain noradrenergic pathways. Theory and preclinical evidence suggest that noradrenergic circuits may be involved in alcohol reinforcement and relapse. We therefore tested the ,-1 adrenergic receptor antagonist, prazosin, as a pharmacotherapy for AD. Methods:, We randomized 24 participants with AD but without posttraumatic stress disorder to receive either prazosin or placebo in a 6-week, double-blind pilot study. Medication was titrated to a target dose of 4 mg QAM, 4 mg QPM, and 8 mg QHS by the end of week 2. Participants received 5 medical management treatment sessions. Participants were reminded 3 times each day via a text pager to take medications and to call a telephone monitoring system once daily to provide self-reports of alcohol consumption and craving, the primary outcome measures. Results were analyzed using mixed linear regression adjusted for drinking days per week at baseline and week number. Results:, Twenty of the 24 (83%) subjects completed. Among the completers, the prazosin group reported fewer drinking days per week than the placebo group during the final 3 weeks of the study. Since only 1 woman was randomized to placebo and only three women completed the trial, the following results focus on the 17 male completers. The prazosin group reported fewer drinking days per week and fewer drinks per week during the final 3 weeks of the study; average total number of drinking days for the placebo group 5.7 (SEM 1.9) versus 0.9 (SEM 0.5) for the prazosin group, and average total number of drinks 20.8 (SEM 6.5) for the placebo group versus 2.6 (SEM 1.3) for the prazosin group. Rates of adverse events were equivalent across conditions. Conclusions:, Prazosin holds promise as a pharmacologic treatment for AD and deserves further evaluation in a larger controlled trial. [source] Evaluation of acupuncture in the treatment of Parkinson's disease: A double-blind pilot studyMOVEMENT DISORDERS, Issue 9 2005Adrian Cristian MD Abstract As many as 40% of patients with Parkinson's disease (PD) use some form of complementary medicine during the course of their illness, and many try acupuncture. One nonblinded study of the effects of acupuncture in PD suggested that it might be helpful for some aspects of PD. We performed a double-blind, randomized, pilot study comparing acupuncture to a control nonacupuncture procedure to determine the effects of acupuncture upon a variety of PD-associated symptoms. Fourteen patients with Stage II or III PD received acupuncture or a control nonacupuncture protocol. Before and after treatment, patients were evaluated using the Motor subscale of the Unified Parkinson's Disease Rating Scale (UPDRS), the Parkinson's Disease Questionnaire (PDQ-39), and the Geriatric Depression Scale. There were no statistically significant changes for the outcomes measured. In the patients who received acupuncture, nonsignificant trends toward improvement were noted in the Activities of Daily Living score of the PDQ-39, the PDQ-39 Summary Index, and the Motor subscale of the UPDRS. © 2005 Movement Disorder Society [source] | ||||||||||