Double-blinded clinical trials

Yamaguchi T, Sano K, Takakura K, Saito I, Shinohara Y, Asano T, Yasuhara H. Ebselen in acute ischemic stroke a placebo-controlled, double-blind clinical trial. Ebselen study group. Stroke 1998 29 12-17. 

KLIPPEL K F, HiLTL D M, scHipp B (1997) A multicentric placebo controlled double-blind clinical trial of beta-sitosterol for the treatment of benign prostate hyperplacia. British J Urology, 80(3) 427-32. 

DuPont HL, Jiang ZD, Ericsson CD, Adachi JA, Mathewson JJ, DuPont MW, Palazzini E, Riopel LM, Ashley D, Martinez-Sandoval F Rifaximin versus ciprofloxacin for the treatment of traveler s diarrhea A randomized, double-blind clinical trial. Clin Infect Dis 2001 33 1807-1815. 

Vinci M, Gatto A, Giaglio A, Raciti T, D Avola G, Di Stefano B, Salanitri G, Di Stefano F Double-blind clinical trial on infectious diarrhea therapy Rifaximin versus placebo. Curr TherRes Clin Exp 1984 36 92-99. 

Double blind clinical trial on infectious diarrhoea therapy Rifaximin versus placebo. Curr Ther Res 1984 36 92-99. 

All of the more recent compounds have been tested in randomized double-blind clinical trials using the Unified Parkinson s Disease Rating Scale (UPDRS). We do not however have studies comparing the different drugs nor different treatment durations. In addition, the length of these trials is totally different from that of the natural disease course (20 years). It is paradoxical that levodopa, developed in the sixties, remains today the mainstay treatment for Parkinson s disease (levodopa is always associated with a peripheral decarboxylase inhibitor, either car-bidopa or benzerazide). 

Gallbladder effect. Seeds, administered orally to 20 adult males with mild hypercholesterolemia at a dose of 5.1 g/day for 40 days, reduced postprandial residual volume and increased volume of bile emptied b Gallstone prevention. Psyllium was investigated in a double-blind clinical trial to compare the effect of rational diet plus ursodeoxycholic acid vs a rational diet... 

Ernst AA, Weiss SI, Park S, et al. Prochlorperazine versus promethazine for uncomplicated nausea and vomiting in the emergency department a randomized, double-blind clinical trial. Ann EmergMed 2000 36 89-94. 

Goldstein, D.J., Mallickrodt, C., Lu, Y., Demitrack, MA Duloxetine in the treatment of major depressive disorder, a double blind clinical trial. J. Clin Psychiatry 63,225— 231.2002. 

Lingjaerde O, Engstrand E, Ellingsen P, et al. Antipsychotic effect of diazepam when given in addition to neuroleptics in chronic psychotic patients a double blind clinical trial. Curr TherRes 1979 26 505-514. 

Schou et al. (159) also compared the relapse rate of patients in their double-blind clinical trial with those in their naturalistic open study and found a similar rate. 

Biton V, Levisohn P, Hoyler S, Vuong A, Hammer AE. Lamotrigine versus valproate monotherapy-associated weight change in adolescents with epilepsy results from a post hoc analysis of a randomized, double-blind clinical trial. J Child Neurol 2003 18 133-9. 

The specific immunosensitizing therapy for the treatment of allergic diseases is the main etiological therapeutic tool, as demonstrated by many doubleblind placebo-controlled clinical studies, recently reviewed by Abramson et al. [5] in a meta-analysis study. The efficacy of the treatment requires certain patient selection criteria, preparation and administration of hyposensitizing extracts. Its efficacy has been confirmed by double-blind clinical trials, reported in a World Health Organization Position Paper [6]. 

Shafran SD, Tyring SK, Ashton R, et al. Once, twice, or three times daily famciclovir compared with aciclovir for the oral treatment of herpes zoster in immunocompetent adults a randomized, multicenter, double-blind clinical trial. J Clin Virol. 2004 29 248-253. 

Because it is necessary for the stroke patient to receive prompt treatment before brain cell death occurs, any useful drug must be effective even when there is considerable time lapse (often several hours) between the occurrence of the stroke and the onset of treatment. The term "therapeutic window" refers to the critical time of intervention between the onset of the ischaemia and occurrence of brain infarction. Some of the drugs that have been developed and shown to be effective in the treatment of various animal models of stroke are listed in Table 14.5. It should be emphasized that none of these drugs is currently marketed for the treatment of stroke. All have been developed on animal models and recent positron emission tomography and magnetic resonance imaging studies have shown that the therapeutic window may be much more variable and prolonged in man than in such models. Only extensive double-blind clinical trials (estimated... 

Mechanism of action that provides symptom relief with pentoxifylline is poorly understood but is thought to involve red blood cell deformability as well as a reduction in fibrinogen concentration, platelet adhesiveness and whole blood viscosity (75). The recommended dose of pentoxifylline is 400 mg three times daily with meals. Pentoxifylline causes a marginal but statistically significant improvement in pain-free and maximal walking distance (a net benefit of 44 m in the maximal distance walked on a treadmill (95% Cl, 0 14 to 0 74) based on meta-analyses of randomized, placebo-controlled, double-blind clinical trials (76). At the same time pentoxifylline does not increase the ABI at rest or after exercise (56). Pentoxifylline may be used to treat patients with intermittent claudication however, it is likely to be of marginal clinical importance (56,77). Medical therapies... 

Weintraub M, Hasday JD, Mushlin Al, Lockwood DH. A double-blind clinical trial in weight control. Use of fenfluramine and phentermine alone and in combination. Arch Intern Med 1984 144 1143-1148. 

In addition to demonstrating safety, shock advocates would also have to prove efficacy through double-blind clinical trials comparing ECT to sham or placebo in which the subject is put to sleep without the actually administering the shock. Thus far, placebo-controlled trials have failed to show any significant superiority of ECT over sham ECT. 

A multicenter, randomized, double-blind clinical trial showed no significant difference in duration of viral shedding, duration of pain, or time to loss of all symptoms in immimocompetent adults with an initial episode of genital HSV treated with oral valacyclovir or oral acyclovir (Valaciclovir International Study Group). 

Chosidow O, Drouault Y, Leconte-Vavriac F, et al. Famciclovir vs. aciclovir in immunocompetent patients with recurrent genital herpes infections a parallel-groups, randomized, double-blind clinical trial. BrJ Dermatol 2001 144(4) 818-824. 

Mfiler J, Wolf EM. Antazoline phosphate and naphazoUne hydrochloride, singly and in combination for the treatment of allergic conjunctivitis. A controlled double-blind clinical trial. Ann Allergy 1975 35 81-86. 

Kleijnen J et al 1994 Placebo effect in double-blind clinical trials. Lancet 344 1347-1349 Mead T (ed) 1998 Science-based complementary medicine. Royal College of Physicians of London London... 

Weismann, K., Christensen, E., Dreyer, V Zinc supplementation in alcoholic cirrhosis. A double-blind clinical trial. Acta Med. Scand. 1979 205 361-366... 

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