Prospective double-blind

A clinical trial to evaluate misoprostol as a protector of normal tissue during a course of XRT in cancer patients suggests a reduction in acute normal tissue injury (215). A randomized, prospective, double-blind study indicates that topical misoprostol, administered as an oral rinse 15-20 min before irradiation using conventional 2-Gy (200 rad) fractions, five days a week over 6—7 weeks, significantly protects the oral mucosa from radiomucositis, a frequently observed normal tissue complication during XRT for head and neck cancer (215). 

Turunen UM, Farkkila MA, Hakala K, Seppala K, Sivonen A, Ogren M, Vuoristo M, Valtonen VV, Miettinen TA Long-term treatment of ulcerative colitis with ciprofloxacin A prospective, double-blind, placebo-controlled study. Gastroenterology 1998 115 1072-1078. 

Morag, M. et al., Psychological variables as predictors of rubella antibody titers and fatigue—a prospective, double blind study, J. Psychiat. Res., 33, 389, 1999. 

Marshall, B. J., Goodwin, C. S., Warren, J. R., et al. (1988) Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori. Lancet. 2, 1437-1442. 

Catassi, C., Fabiani, E., Iacono, G., D Agate, C., Francavilla, R., Biagi, F., Volta, U., Accomando, S., Picarelli, A., De, V. I., Pianelli, G., Gesuita, R., et al. (2007a). A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am. J. Clin. Nutr. 85,160-166. 

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. 

Eric L A prospective double-blind comparative multicentre study of paroxetine and placebo in preventing recurrent major depressive episodes. Biol Psychiatry 29 25-45, 1991... 

Several reports have described a series of symptoms after discontinuation or dose reduction of serotonergic antidepressant medications. The most common symptoms include dizziness, headache, paresthesia, nausea, diarrhea, insomnia, and irritability. Of note, these symptoms may also be seen when a patient misses doses. A prospective, double-blind, placebo-substitution study confirmed that discontinuation symptoms are most common with short half-life antidepressants, such as paroxetine (Rosenbaum et al. 1998). 

Comaty et al. (452) conducted a prospective double-blind, placebo-controlled trial of low-dose benztropine (i.e., 2 mg/day) maintenance therapy. After an acute EPS had been stabilized with 2 days of active antiparkinsonian medication, the recurrence of EPS did not differ significantly between those maintained on active drug or those switched to placebo over the next 8 days. While there was a trend favoring the active drug group, low-dose maintenance benztropine (i.e., 2 mg/day) afforded little benefit in comparison with placebo. 

Tesar GE, Rosenbaum JE, Pollack MH, et al. Clonazepam versus alprazolam in the treatment of panic disorder interim analysis of data from a prospective, double-blind, placebo-controlled trial. J Clin Psychiatry 1987 48[Suppl] 16-19. 

Lyritis GP, Ioannidis GV, Karachalios T, Roidis N, Kataxaki E, Papaioannou N, Kaloudis J, Galanos A. Analgesic effect of salmon calcitonin suppositories in patients with acute pain due to recent osteoporotic vertebral crush fractures a prospective double-blind, randomized, placebo-controlled clinical study. Clin J Pain... 

There are two protein replacement products available for A1AD, both pooled human plasma donor-derived products. Approval of these products was based upon replacement of serum AAT to the above-mentioned levels. Neither has been proven to prevent lung disease in a prospective, double-blinded placebo-controlled fashion, but retrospective registry data suggest a beneficial effect. However, protein replacement therapy has been very safe. Particularly remarkable has been the lack of an adaptive immune response by patients on therapy, which may relate to the genetic homogeneity of this A1AD population, in which approximately 95% have one particular missense mutant allele (PI Z). 

One randomized control trial involving the use of abciximab during PPI demonstrated no long-term benefit in stent patency for complex superficial femoral lesions (35), However, a larger prospective, double-blind, placebo-controlled designed study that involved 98 patients showed that adjunctive administration of abciximab had a favorable effect on patency and clinical outcome in patients undergoing complex femoropopliteal catheter interventions not hampered by serious bleeding (36). 

J5 Study Group. (1992). Treatment of severe infectious purpura in children with human plasma from donors immunized with Escherichia coli]b A prospective double-blind study./ Infect. Dis. 165, 695-701. 

Kunz, B., Ring, J., and Braun-Falco, O., Eicosapentaenoic acid (EPA) treatment in atopic eczema a prospective double-blind trial, J. Allergy Clin. Immunol., 83, 196, 1987. 

Calandra, T., Glauser, M.P., Schellekens, J., Verhoef, J. Swiss Dutch, J5 Immunoglobulin Study Group, Treatment of Gram-negative septic shock with human IgG antibody to Escherichia coli J5 A prospective, double-blind, randomized trial, JInfectDis 158 (1988) 312-319. 

In a prospective, double-blind, randomized, placebo-controlled study in 119 healthy volunteers (mean age 35 years), who took either atovaquone 250 mg/day + chlor-oguanide 100 mg/day or mefloquine 250 mg/week, depression, anger, and fatigue occurred during the use of mefloquine but not atovaquone + chloroguanide (510). Mefloquine can also cause psychosis. 

Bolt B, Benz B, Korner F, et al.A mydriatic eyedrop combination without systemic effects for prernamre infants a prospective double-blind smdy. J Pediatr Ophthalmol Strabismus 1992 29 157-162. 

Sokol WN Jr, SuUivan JG, Acampora MD, Busman TA, Notario GF. A prospective, double-blind, multicenter study comparing clarithromycin extended-release with... 

Bryson YJ, Monahan C, Pollack M, Shields WD. A prospective double-blind study of side effects associated with the administration of amantadine for influenza A virus prophylaxis. J Infect Dis 1980 141(5) 543-7. 

In a prospective double-blind study of more than 600 patients, 0.6 mg/kg of DAMB was compared with 3.0 mg/kg of L-Amb, a dose relation at the lower limit of equivalent doses determined in an animal model (117). At these dosages, in a large prospective double-blind study, there was a doubling of serum creatinine concentration in 19% of neutropenic patients receiving empirical therapy with L-AmB and 34% receiving conventional amphotericin (47). 

In a prospective, double-blind study, the use of either vancomycin -I- heparin -I- ciprofloxacin or vancomycin - -heparin flush solution, compared with heparin alone, significantly reduced the infective comphcations associated with tunnelled central venous lines in immunocompromised children. Neither antibiotic could be detected after flushing and there were no adverse events (30). 

In a prospective, double-blind, parallel-group study for 18 months in 817 children with atopic dermatitis aged 12-24 months, cetirizine 0.25 mg/kg bd had no effect on the QTc interval (4). 

The effects of cetirizine 0.25 mg/kg bd for 18 months have been investigated in a prospective, double-blind, parallel-group study in 817 children with atopic dermatitis aged 12-24 months (4). Dropouts and serious events, including hospitalization, were infrequent and were less common in the children who took cetirizine, although the differences were not statistically significant. Most of the adverse events were mild and were not related to medication. 

Dawson DL, Cutler BS, Meissner MH, Strandness DE Jr. Cilostazol has beneficial effects in treatment of intermittent claudication results from a multicenter, randomized, prospective, double-blind trial. Circulation 1998 98(7) 678-86. 

There have been another two studies of the analgesic effect of intrathecal morphine in children (34,35). In a prospective, double-blind study, 30 children (aged 9-19 years) scheduled for spinal fusion were randomly allocated to a single dose of saline or intrathecal morphine 2 or 5 pg/kg after surgery, a PCA device provided access to additional intravenous morphine (34). The doses of 2 and 5 pg/kg had similar analgesic effectiveness and adverse effects profiles (nausea, vomiting, pruritus). There were no episodes of severe respiratory depression. Low-dose intrathecal morphine supplemented with PCA morphine provides better analgesia than PCA morphine alone. 

Hamann GO. Severe, primary dysmenorrhea treated with naproxen. A prospective, double-blind, crossover investigation. Prostaglandins 1980 19(5) 651-7. 

Selegiline is a relatively selective and irreversible inhibitor of monoamine oxidase type B, which has been used in the treatment of Parkinson s disease. It was originally suggested that selegiline may be neuroprotective. However, in a prospective double-blind study no such action was seen (1). On the other hand, selegiline does delay the start of disability, determined by the need for levodopa and progression of parkinsonian signs and symptoms (2). 

Panagou P, Siafakas NM. Intrapleural streptokinase versus urokinase in the treatment of comphcated parapneumonic effusions a prospective, double-blind study. Am J Respir Crit Care Med 1997 155(l) 291-5. 

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