Placebo controls

A third study (85) enrolled 7825 hypertensive patients (55% males and 45% females) having diastoHc blood pressures (DBP) of 99—104 mm Hg (13—14 Pa) there were no placebo controls. Forty-six percent of the patients were assigned to SC antihypertensive dmg therapy, ie, step 1, chlorthaUdone step 2, reserpine [50-55-5] or methyldopa [555-30-6], and step 3, hydralazine [86-54-4]. Fifty-four percent of the patients were assigned to the usual care (UC) sources in the community. Significant reductions in DBP and in cardiovascular and noncardiovascular deaths were noted in both groups. In the SC group, deaths from ischemic heart disease increased 9%, and deaths from coronary heart disease (CHD) and acute myocardial infarctions were reduced 20 and 46%, respectively. 

In low doses, inhaled NO may have a beneficial therapeutic effect, since NO in the inspired air leads to pulmonary vasodilation. In persistent pulmonary hypertension of the newborn, NO inhalation has already been used with some success. NO inhalation as the treatment for acute respiratory distress syndrome, however, has been disappointing. Only transient improvements of oxygenation were detected and the outcome of placebo-controlled trials did not show any improvement... 

It has been proposed that the development of the complications of diabetes mellitus may be linked to oxidative stress and therefore might be attenuated by antioxidants such as vitamin E. Furthermore, it is discussed that glucose-induced vascular dysfunction in diabetes can be reduced by vitamin E treatment due to the inactivation of PKC. Cardiovascular complications are among the leading causes of death in diabetics. In addition, a postulated protective effect of vitamin E (antioxidants) on fasting plasma glucose in type 2 diabetic patients is also mentioned but could not be confirmed in a recently published triple-blind, placebo-controlled clinical trial [3]. To our knowledge, up to now no clinical intervention trials have tested directly whether vitamin E can ameliorate the complication of diabetes. 

Appropriate study design should be selected to achieve the desired outcome. A description of the type/design of frial to be conducted (e.g., double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design. 

Sec. 4.2, between regions placebo-controlled multiple dose. 12 placebo) primary Interim... 

Using a primary-care model of treatment, O Malley et al. (2003) initially treated alcohol-dependent patients with open-label naltrexone for 10 weeks, in combination with either CBT or primary care management (PCM), a less intensive, supportive approach. They found no effect of psychosocial treatment on response to treatment, although CBT was associated with a lower risk of drinking. Treatment responders from this study were then randomly assigned to one of two placebo-controlled 24-week continuation studies in... 

Dorus and colleagues (1989) conducted a multicenter, double-blind, placebo-controlled trial in depressed and nondepressed alcoholic veterans. A total of 457 male alcoholic patients, of whom approximately one-third were depressed, were randomly assigned to receive either 600-1,200 mg/day of lithium or a comparable number of placebo capsules. No significant differ-... 

Fawcett J, Clark DC, Aagesen CA, et al A double-blind, placebo-controlled trial of lithium carbonate therapy for alcoholism. Arch Gen Psychiatry 44 248-2 56,1987... 

Kranzler HR, Del Boca F, Korner P, et ah Adverse effects limit the usefulness of flu-voxamine for the treatment of alcoholism.] Subst Abuse Treat 10 283-287, 1993 Kranzler HR, Burleson JA, Del Boca FK, et ah Buspirone treatment of anxious alcoholics a placebo-controlled trial. Arch Gen Psychiatry 31 720—731, 1994 Kranzler HR, Burleson JA, Korner P, et ah Placebo-controlled trial of fluoxetine as an adjunct to relapse prevention in alcoholics. Am] Psychiatry 152 391-397, 1995 Kranzler HR, Burleson JA, Brown J, et al Fluoxetine treatment seems to reduce the beneficial effects of cognitive-behavioral therapy in type B alcoholics. Alcohol Clin Exp Res 20 1534-1341, 1996... 

Kranzler HR, Wesson DR, Billot L Naltrexone depot for treatment of alcohol dependence a multicenter, randomized, placebo-controlled clinical trial. Alcohol Clin... 

Malcolm R, Anton RF, Randall CL, et al A placebo-controlled trial of Buspirone in anxious inpatient alcoholics. Alcohol Clin Exp Res 16 1007—1013, 1992... 

Mason BJ, RitvoEC, Morgan RO, etal A double-blind, placebo-controlled pilot study to evaluate the efficacy and safety of oral nalmefene HCL for alcohol dependence. Alcohol Clin Exp Res 18 1162-1167, 1994... 

Meyer RE How to understand the relationship between psychopathology and addictive disorders another example of the chicken and the egg, in Psychopathology and Addictive Disorders. Edited by Meyer RE. New York, Guilford, 1986, pp 3-16 Monteiro MG, Klein ]L, Schuckit MA High levels of sensitivity to alcohol in young adult]ewlsh men a pilot study. ] Stud Alcohol 32 464 69, 1991 Mueller TI, Stout RL, Rudden S, et al A double-blind, placebo-controlled pilot study of carbamazepine for the treatment of alcohol dependence. Alcohol Clin Exp Res... 

Tiihonen J, Ryynanen O-P, KauhanenJ, etal Citalopramin the treatment of alcoholism a double-blind placebo-controlled study. Pharmacopsychiatry 29 27-29, 1996... 

McRae AL, Sonne SC, Brady KT, et al A randomized, placebo-controlled trial of buspirone for the treatment of anxiety in opioid-dependent individuals. Am J Addict 13 53-63, 2004... 

Nestler EJ, Hyman SE, Malenka RC Molecular Neuropharmacology A Foundation for Clinical Neuroscience. New York, McGraw Hill, 2001 Novick DM, Pascarelli EE, Joseph H, et al Methadone maintenance patients in general medical practice a preliminary report. JAMA 259 3299—3302, 1988 Nunes EV, Quitkin EM, Donovan SJ, et al. Imipramine treatment of opiate-dependent patients with depressive disorders a placebo-controlled trial. Arch Gen Psychiatry 55 153-160, 1998... 

Wikler A Opioid Dependence Mechanisms and Treatment. New York, Plenum, 1980 Williams JT, Christie MJ, Manzoni O Cellular and synaptic adaptations mediating opioid dependence. Physiol Rev 81 299—343, 2001 Woody GE, O Brien CR, Rickels K Depression and anxiety in heroin addicts a placebo-controlled study of doxepin in combination with methadone. Am J Psychiatry 132 447--i50, 1975... 

Gerra G, Zaimovic A, Giusti F, et al Intravenous flumazenil versus oxazepam tapering in the treatment of benzodiazepine withdrawal a randomized, placebo-controlled... 

Schweizer E, Patterson W, Rickels K, et al Double-blind, placebo-controlled study of a once-a-day, sustained-release preparation of alprazolam for the treatment of panic disorder. Am J Psychiatry 150 1210-1215, 1993 Seivewright N Benzodiazepine misuse by illicit drug misusers. Addiction 96 333—334, 2001... 

Voderholzer U, Riemann D, Hornyak M, et al A double-blind, randomized and placebo-controlled study on the polysomnographic withdrawal effects of zopiclone, zolpidem and triazolam in healthy subjects. Eur Arch Psychiatry Clin Neurosci 251 117-123, 2001... 

Using a within-subject, placebo-controlled design, Haney et al. (2003) recently reported that nefazodone, an antidepressant that also has some sedative properties, decreased reports of anxiety and muscle pain during closely mon-... 

Cornelius JR, Salloum IM, EhlerJG, et al Fluoxetine in depressed alcoholics a doubleblind, placebo-controlled trial. Arch Gen Psychiatry 54 700—705, 1997 Cornelius JR, Salloum IM, Haskett RF, et al Fluoxetine versus placebo for the marijuana use of depressed alcoholics. Addict Behav 24 111—114, 1999 Cui S-S, Bowen RC, Gu G-B, et al Prevention of cannabinoid withdrawal syndrome by lithium involvement of oxytocinergic neuronal activation. J Neurosci 21 9867— 9876, 2001... 

Catecholamine Reserpine, propranolol, and other p blockers Placebo-controlled trial of reserpine had negative... 

A meta-analysis of placebo-controlled studies by Levin and Lehman (1991) showed that desipramine produced greater cocaine abstinence than placebo. Although a more recent review did not concur (Lima et al. 2001), secondary analyses of studies with imipramine, desipramine, and bupropion suggested that depressed cocaine abusers are more likely to show significant reductions in cocaine abuse than nondepressed cocaine abusers (Margolin et al. 1995 Nunes et al. 1991 Ziedonis and Kosten 1991). Furthermore, recent work with desipramine supported its efficacy in opioid-dependent patients, particularly in combination with contingency management therapies (Kosten et al. 2004 Oliveto et al. 1999). 

Grabowski J, Rhoades H, Elk R, et al Fluoxetine is ineffective for treatment of cocaine dependence or concurrent opiare and cocaine dependence two placebo-controlled double-blind rrials. J Clin Psychopharmacol 15 163—174, 1995... 

Kranzler HR, Bauer LO, Hersh D, et al Carbamazepine treatment of cocaine dependence a placebo-controlled trial. Drug Alcohol Depend 38 203-211, 1995 Levin FR, Lehman AF Meta-analysis of desipramine an adjunct in the treatment of cocaine addiction. J Clin Pharmacol 11 374-378, 1991 Lima MS, Reisser AA, Soares BG, et al Antidepressants for cocaine dependence. Cochrane Database Syst Rev 4 CD002950, 2001 Ling W, Shoptaw S, Majewska D Baclofen as a cocaine anti-craving medication a preliminary clinical study 0etter). Neuropsychopharmacology 18 403 04, 1998... 

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