Control blind

Avoid the use of instrumentation that may have low first cost, but is very expensive to operate or maintain. Blind controllers, for example, are completely unsatisfactory for most applications. The author has seen examples of temperature controllers set at the factory, but with no method of readout or calibration. These almost always require retrofitting of additional instrumentation later. Internal level floats on process vessels that require plant... 

Malcolm R, Ballenger JC, Sturgis ET, et ah Double-blind controlled trial comparing carbamazepine to oxazepam treatment of alcohol withdrawal. Am J Psychiatry 146 617-621, 1989... 

Nimmerrichter AA, Walter H, Gutierrez-Lobos KE, et al Double-blind controlled trial of gamma-hydroxybutyrate and clomethiazole in the treatment of alcohol withdrawal. Alcohol 37 67—73, 2002... 

Zhang, H. Y., Shu, L., Li, H. F. et al. (2006). Risperidone versus haloperidol in treatment of acute manic episodes of bipolar 1 disorder a randomized double-blind controlled multicenter study. Journal of Chinese Psychiatry, 39(1), 33-7. 

YT Bryson, M Dillon, G Acuna, S Taylor, JD Cherry, BL Johnson, E Wiesmeier, W Growden, T Greagh-Kirk, R Keeney. Treatment of first episodes of genital herpes simplex virus infection with oral acyclovir. A randomized double-blind controlled trial in normal subjects. N Engl J Med 308 916-921, 1983. 

Olie, P. Emsley, R. (2005). Confirmed clinical efficacy of agomelatine (25-50 mg) in major depression two randomized, double-blind controlled studies. Eur. Neuropsychopharmacol. 15, (Suppl. 3) S416. 

Conn HO, Leevy CM, Vlahcevic ZR, Rodgers JB, Maddrey WC, Seeff L, Levy LL Comparison of lactulose and neomycin in the treatment of chronic portal-systemic encephalopathy. A double blind controlled trial. Gastroenterology 1977 72 573-583. 

Dickinson et al. [27], in 1985, published a double-blind controlled trial on the use of oral vancomycin as an adjunctive therapy in acute exacerbations of idiopathic colitis. No significant difference was found between the two treatment groups with only a trend in favor of a superior efficacy of vancomycin. It is important to underline that 7 of the 40 patients enrolled had colonic CD and that none of them had C. difficile infection that could explain the action of vancomycin. Subsequently, intravenous metronidazole, in addition to steroids, was effective similar to placebo in inducing remission [28],... 

Dickinson RJ, O Connor HJ, Pinder I, Hamilton I, Johnston D, Axon AT Double-blind controlled trial of oral vancomycin as adjunctive treatment in acute exacerbations of idiopathic colitis. Gut 1985 26 1380-1384. 

In the above trial [70] rifaximin was dissolved in chloroform and applied by repeated painting. After the solvent had dried a red sludge persisted over the dental structures allowing a continuous antimicrobial effect. Better delivery systems, such as subgingival controlled release preparations [12], are, however, needed to fully exploit the rifaximin potential in periodontal disease. In this connection, a gum-like device [71] has been developed that allows a controlled and continuous release of the antibiotic within the oral cavity. Large double-blind controlled trials using this and other formulations are now needed to establish the best therapeutic regimen for this indication. 

Palatnik, A., Frolov, K., Fux, M., Benjamin, J. Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder./. Clin. Psychopharmacol. 21 335-339, 2001. 

Sutton CJ, Ewen SP, Whitelaw N (1994) Prospective, randomized double-blind controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild and moderate endometriosis. Fertil Steril 62 696-700... 

Podoleanu C, Maggi R, Brignole M et al. (2006) Lower limb and abdominal compression bandages prevent progressive orthostatic hypotension in elderly persons a randomized single-blind controlled study. J Am Coll Cardiol 48(7) 1425-1432... 

A double-blind control is also an essential element of drug studies. Double-blind means that neither experimenter nor subject knows who is receiving the active treatment or the placebo. Again, this is to eliminate potential bias from both parties. Otherwise, experimenters could unwittingly influence the outcome of the study by subtly treating subjects differently. 

Durga J, van Boxtel MR Schouten EG Kok FJ, Jolles J, Katan MB, Verhoef R (2007) Effect of 3-year fohc acid supplementation on cognitive function in older adults in the FACfr trial A randomised, double blind, controlled trial. Lancet 369 208-216. 

All were double-blind controlled evaluations and established iprindole as at least as effective as imipramine, and one study [195] included an examination of the doctor-patient interaction as a factor in such work (a similar discussion was felt necessary, as noted above [179] in the evaluation of oxpertine). In only two [192, 194] of the above reports is it possible to estimate the frequency and severity of anticholinergic side effects, thou in the one case [192] the care taken in the experimental design and the number of patients observed leaves little doubt that the dry mouth, constipation, etc. characteristic of imipramine therapy is either greatly reduced or even absent during iprindole treatment. This point is confirmed in an extension of this team s work to include a 12 month toxicity study [197] which, in addition, failed to produce evidence of haemopoitic, hepatic, cardiac, ocular or renal damage. Similar results followed other work. 

Daneshmend TK, Hawkey Q, Langman MJS, et al. Omeprazole versus placebo for acute upper gastrointestinal bleeding randomised double blind controlled trial. BMJ 1992 304 143-7. 

Bates D, Cartlidge NE, French JM, Jackson MJ, Nightingale S, Shaw DA, A double-blind controlled trial of long chain -3 polyunsaturated fatty acids in the treatment ofmultiple sclerosis,/NeurolNeurosurgPsychiatry 52 18—22, 1989. 

Prospective observational studies with SBC-5-IMNs in 3 international centers indicated over 80-90% remission in early as well as late RA. These findings need to be supported by prospective double blind controlled trials. The RworalDs and RwD achieved can be maintained by immediate suppression of early flare. Even grade >2 erosions of joints can be healed when treated adequately. 

Enkelmann R (1991) Alprazolam versus buspirone in the treatment of outpatients with generalized anxiety disorder. Psychopharmacology (Berl) 105 428-432 Faravelli C, Rosi S, Truglia E (2003) Treatments benzodiazepines. In Nutt DJ, BaUenger JC (eds) Anxiety disorders. Blackwell Science, Oxford, pp 315-338 Fawcett J, Barkin RL (1998) A meta-analysis of eight randomized, double-blind, controlled clinical trials of mirtazapine for the treatment of patients with major depression and symptoms of anxiety. J Clin Psychiatry 59 123-127 Febbraro GA, Clum GA (1998) Meta-analytic investigation of the effectiveness of self-regulatory components in the treatment of adult problem behaviors. Clin Psychol Rev 18 143-161... 

Persson B, Ronquist G, Ekblom M Ameliorative effect of allopurinol on nonbacterial prostatitis a parallel double-blind controlled study. 1 Urol 1996 155 961-964. 

Flament, M.F, Rapoport, J.L., Berg, C.J., Sceery, W., Kilts, C., Mells-trom, B., and Linnoila, M. (1985) Clomipramine treatment of childhood obsessive-compulsive disorder. A double-blind controlled study. Arch Gen Psychiatry 42 977—983. 

Some (Campbell et ah, 1995 Malone, et ah, 2000) but not all (Rifkin et ah, 1997), controlled studies of lithium among children with conduct disorder (CD) appear to support lithium s efficacy in the treatment of aggression in this population. Both aggression and irritability are symptoms that cut across diverse disorders and are important confounders in studies of impulse dyscontrol. Double-blind controlled studies are needed to further validate the choice of lithium for patients with BD presenting with excessive irritability and anger outbursts (Fava, 1997). 

Klein, E., Kreinin, L, Christyakov, A., Koren, D., Mecz, L., Marmur, S., Ben-Shachar, D., and Feinsod, M. (1999) Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression a double blind controlled study. Arch Gen Psychiatry 56 315-320. 

Spencer, T. (1997) A double-blind, controlled study of desipramine in children with ADHD and tic disorders. In Scientific Proceedings of the Annual Meeting American Academy of Child and Adolescent Psychiatry, Toronto. Washington, DC American Academy of Child and Adolescent Psychiatry. 

Sallee, F.R., Vrindavanam, N.S., Deas-Nesmith, D., Carson, S.W., and Sethuraman, G. (1997) Pulse intravenous clomipramine for depressed adolescents a double-blind, controlled trial. Am J Psychiatry 154 668-673. 

There are no randomized, double-blind, controlled studies of hospitalized children and adolescents with acute mania. Two systematic, albeit open, studies of lithium in hospitalized, acutely manic adolescents had response rates of 67%-80% in classic manic adolescents, and 33%-40% in manic adolescents with prior ADHD (Strober et al., 1988 1998). In a discontinuation study in which manic adolescents stabilized on lithium were subsequently assigned double-blind to placebo or continuation treatment, the response rate was 53.5%, and the presence of prior ADHD made no difference in outcome (Kafantaris et al., 1998). However, the presence of psychosis decreased the likelihood of lithium response and antipsychotic medication was necessary for stabilization. Naturalistic discontinuation of lithium (because of noncompliance) after stabilization resulted in relapse rates of 90% vs. 37.5% for those remaining on lithium (Strober et al., 1990). A NIMH multisite study is currently examining this issue more systematically. 

Marras, C., Andrews, D., Sime, E., and Lang, A.E. (2001) Botulinum toxin for simple motor tics a randomized, double-blind, controlled clinical trial. Neurology 56 605-610. 

EPS, extrapyramidal side effects HPD, haloperidol MLD, molindone N, total number of subjects in study , number of preschool-age children in study RCT, randomized, double-blind, controlled trial RISP, risperidone SE, side effect TFP, trifluperidol THX, thiothixene. 

Valproate, a simple branched-chain fatty acid, was first reported as a successful treatment for acute mania by Lambert and colleagues in 1966. Following this report, at least 16 uncontrolled trials consistently supported the observation that valproate has acute and long-term mood-stabilizing effects in patients with bipolar disorder (reviewed by Keck et al. 1992a). Recently, five double-blind controlled studies of valproate have been completed that provide definitive evidence of its efficacy in acute mania. 

Inositol is a simple component of diet that is an important precursor in the PI cycle. Li" lowers tissue inositol levels. An open study of low-dose inositol in Li -induced polyuria-polydipsia showed marked attenuation of these side effects. A double-blind controlled trial of 12 g of inositol daily for 4 weeks in... 

Some questions have been raised about the relative efficacy of the SSRls, particularly in severe depression. The pooled analyses of the data from blinded, controlled trials have tended to find similar levels of efficacy between the SSRls and the comparator TCA, imipramine. Paroxetine and fluvoxamine were both found in subanalyses of patients with severe depression included in large placebo- and imipramine-controlled studies to be more effective than imipramine in severe depression (S. A. Montgomery 1992a Ottevanger 1991 Tignol et al. 1992 Wakelin 1988]. However, imipramine may not be the TCA that is most effective in severe depression or may not have been used in the trials at an adequate dose. 

Fluoxetine has been the subject of four reports in the treatment of social phobia. However, no double-blind, control studies have been reported. Preliminary results suggest that fluoxetine is effective in social phobia. Doses ranged from 10 to 100 mg/day. The onset of symptom resolution was variable among subjects. A justifiable approach to treatment with fluoxetine would be to implement an approach similar to that in the treatment of depression. One would start with a dose of 10-20 mg/day and titrate slowly upward over a period of several weeks. A duration of at least 6 weeks would be recommended as a minimum trial of this agent, with 12 weeks perhaps affording a better opportunity to assess the full measure of improvement. 

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