Showing papers on "Placebo-controlled study published in 1992"

Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group.

Abstract: Background. The antimetabolite methotrexate has been shown in placebo-controlled trials to be effective in adults with rheumatoid arthritis. Methotrexate may also be effective in children with resistant juvenile rheumatoid arthritis, but the supporting data are from uncontrolled trials. Methods. Centers in the United States and the Soviet Union participated in this randomized, controlled, double-blind trial designed to evaluate the effectiveness and safety of orally administered methotrexate. Patients received one of the following treatments each week for six months: 10 mg of methotrexate per square meter of body-surface area (low dose), 5 mg of methotrexate per square meter (very low dose), or placebo. The use of prednisone (≤10 mg per day) and two nonsteroidal antiinflammatory drugs was also allowed. Results. The 127 children (mean age, 10.1 years) had a mean duration of disease of 5.1 years; 114 qualified for the analysis of efficacy. According to a composite index of several response variable...

Antioxidant treatment with N-acetylcysteine during adult respiratory distress syndrome: a prospective, randomized, placebo-controlled study.

Abstract: Objective To examine whether the antioxidant N-acetylcysteine could ameliorate the course of the adult respiratory distress syndrome (ARDS) in man. Design Randomized, double-blind, placebo-controlled study. Setting Medical and surgical ICU in a regional hospital. Patients Sixty-six ICU patients with ARDS. Interventions Patients with ARDS (PaO2/FiO2 ratio less than 250 torr) were treated with either the antioxidant N-acetylcysteine 150 mg/kg as a loading dose and then 20 mg/kg/hr, or with placebo for 6 days. Measurements and main results No improvement could be demonstrated in the PaO2/FiO2 ratio in the study group as compared with the control group on any day. Pulmonary compliance was higher in the N-acetylcysteine group than in the placebo group on all days, but this difference did not reach the chosen 5% level of significance. No difference between the two groups could be demonstrated on chest radiograph or on survival rate. We documented that N-acetylcysteine acts as an anticoagulant and perhaps decreases pulmonary fibrin uptake during ARDS. Conclusions N-acetylcysteine might be of benefit in ARDS. Before further clinical studies are started, problems with N-acetylcysteine and coagulation have to be elucidated in order to find out whether N-acetylcysteine could have a beneficial effect in the treatment of ARDS.

A double-blind, placebo-controlled study of the efficacy of transdermal clonidine in autism

Abstract: Background Autistic individuals often exhibit hyperarousal behaviors (eg, stereotyped body movements, self-stimulation, hypervigilance, and hyperactivity) Clonidine, an alpha 2-adrenergic receptor agonist, has been shown to be effective in reducing impulsivity, inattention, and hyperactivity associated with attention deficit disorder with hyperactivity This study investigated the efficacy and safety of transdermal clonidine in reducing hyperarousal behaviors associated with autism Method A double-blind, placebo-crossover study with transdermal clonidine was performed in nine autistic males (aged 5 to 33 years) Subjects received either clonidine (approximately 0005 mg/kg/day) or placebo by a weekly transdermal patch Each trial lasted 4 weeks with a 2-week washout period between treatment phases Subjects were evaluated every 2 weeks by clinician raters and weekly by parents Results The clonidine treatment showed a significant difference from placebo treatment on three subscales of the Ritvo-Freeman Real Life Rating Scale (ie, social relationship to people, affectual responses, and sensory responses) The Clinical Global Impressions scale indicated that clonidine produced a significant improvement on severity of illness, global improvement, and efficacy index for therapeutic effect of the drug A patient global rating scale showed clonidine treatment resulted in significant improvement in comparison with placebo Adverse effects included sedation and fatigue during the first 2 weeks of clonidine treatment Conclusion Results from this preliminary study show that clonidine was effective in reducing several hyperarousal behaviors and improved social relationships in some autistic subjects Further studies are needed in a larger autistic population to determine the dose-response relationship of clonidine

A placebo-controlled trial of buspirone in anxious inpatient alcoholics.

Abstract: The present study is a double-blind control trial of buspirone versus placebo in highly anxious alcoholics who recently completed inpatient detoxification for alcoholism. Subjects met DSM-III-R criteria for generalized anxiety syndrome and/or other nonpanic forms of anxiety disorders and alcohol dependence. Male veterans aged 21 to 65 were randomized to 45 to 60 mg/day of buspirone (n = 33) or placebo (n = 34). Anxiety scores, as measured by the Hamilton Anxiety Scale and other anxiety measures, declined significantly for both groups, but there were no differential group differences throughout the 6-month treatment period. Survival analysis measuring time to study drop out, time to first drink, time to 5 consecutive drinking days, and time to first intoxication indicated no significant differences between groups. The number of standard drinks per drinking day for nonabstainers also did not differ between groups. In the present study anxious alcoholics taking buspirone did not receive any benefit over placebo on a number of anxiety and alcohol use measures.

Clomipramine effectively reduces premenstrual irritability and dysphoria: a placebo-controlled trial.

Abstract: Forty nondepressed women displaying severe premenstrual irritability and/or dysphoria and fulfilling the DSM-III-R criteria of late luteal phase dysphoric disorder were treated daily for 3 menstrual cycles with either the potent serotonin reuptake inhibitor clomipramine (25-75 mg; flexible dosage) (n = 20) or placebo (n = 20). In both treatment groups premenstrual irritability and dysphoria (as rated daily by the patients using a visual analogue scale) were significantly reduced as compared with the rating during 2 pretreatment reference cycles; however, in the placebo group this reduction was only about 40% whereas, in the clomipramine group, the symptom decrease was greater than 80%. At all 3 treatment cycles, patients on clomipramine displayed significantly lower symptom rating than controls. Also with respect to the rating of global improvement, the results obtained with clomipramine were considerably and significantly better than those obtained with placebo. It is concluded that low doses of clomipramine effectively reduce premenstrual irritability and dysphoria with a response rate close to 100%. The possible role of serotonin in the pathophysiology of the premenstrual syndrome is discussed.

Pharmacokinetically designed double-blind placebo-controlled study of nortriptyline in 6- to 12-year-olds with major depressive disorder.

Abstract: A random assignment, double-blind, placebo-controlled study of nortriptyline in 50 prepubertal 6- to 12-year-olds with Research Diagnostic Criteria and DSM-III major depressive disorder was performed. The protocol included a 2-week placebo wash-out phase and an 8-week double-blind, placebo-controlled phase with weekly plasma level monitoring. Active subjects had their plasma level pharmacokinetically placed at 80 +/- 20 ng/ml by using previously developed tables to determine the starting dose from a plasma level 24 hours after a single dose administered at baseline. The mean plasma level was 89.9 ng/ml. The study population was severely depressed, had a chronic, unremitting course of long duration before the study, had a high percentage of family histories with affective disorder, alcoholism and suicidality, and had a high rate of comorbidity. None of the subjects had ever received tricyclic antidepressants before this study. There was a poor rate of response in both treatment groups (30.8% active, 16.7% placebo). Active subjects did not evidence the anticholinergic side effects reported in adult samples. The implications of these findings for future pharmacotherapy studies of depressed children are discussed.

Empiric treatment of acute diarrheal disease with norfloxacin. A randomized, placebo-controlled study. Swedish Study Group.

Abstract: Objective To evaluate the clinical and microbiologic efficacy and safety of norfloxacin for acute diarrhea Design Double-blind, placebo-controlled, randomized clinical multicenter trial Setting Six departments of infectious disease Participants Patients 12 years of age or older with a history of acute diarrhea lasting 5 or fewer days Eighty-five percent of patients (511/598) were evaluable for efficacy Of these evaluable patients, 70% had traveled abroad within the previous 6 weeks Interventions Patients received either norfloxacin, 400 mg, or placebo twice daily for 5 days Measurements Enteric pathogens were isolated in 51% of the evaluable patients: Campylobacter species in 29%, Salmonella species in 16%, Shigella species in 35%, and other pathogens in 26% Results Norfloxacin had a favorable overall effect compared with placebo (cure rate, 63% compared with 51%; P = 0003) There were statistically favorable effects in culture-positive patients, patients with salmonellosis, and severely ill patients but not in culture-negative patients or patients with campylobacteriosis or shigellosis A significant difference was noted between norfloxacin and placebo in median time to cure among all evaluable patients (3 compared with 4 days, P = 002) and in patients with campylobacteriosis (3 compared with 5 days, P = 005) but not in patients Culture-positive, but not culture-negative patients, in the norfloxacin group had significantly fewer loose stools per day compared with patients in the placebo group from day 2 onward (P less than or equal to 001) Norfloxacin was significantly less effective than placebo in eliminating Salmonella species on days 12 to 17 (18% compared with 49%, P = 0006), whereas the opposite was true for Campylobacter species (70% compared with 50%, P = 003) In six of nine patients tested, norfloxacin-resistant Campylobacter species (MIC, greater than or equal to 32 micrograms/mL) appeared after norfloxacin treatment Conclusion Empiric treatment reduced the intensity and, to some extent, the duration of symptoms of acute diarrhea The effect was restricted to patients who had bacterial enteropathogens or who were severely ill The clinical usefulness of this treatment is limited by the fact that norfloxacin seems to delay the elimination of salmonella and to induce resistance in campylobacter

Fluoxetine prophylaxis of migraine.

Abstract: Many patients with severe migraine remain refractory to the current treatment regimens or cannot tolerate the side effects. Since current research implicates serotonin dysregulation in migraine pathogenesis, we investigated in a double blind, placebo controlled study the prophylactic effect of the serotonergic drug fluoxetine. Sixteen subjects were randomly assigned to 8 week fluoxetine treatment and 16 to the placebo group; nine subjects in each group completed the study. Migraine headache scores were obtained for two weeks prior to commencement of treatment, and then for each successive two week period. Zung depression scores were obtained before and after completion of the study. Fluoxetine caused significant reduction in headache scores starting with weeks 3-4 of treatment; there was no significant change with placebo. Depression scores did not differ between groups before treatment, and did not significantly change with either treatment. Fluoxetine appears to be a safe and effective drug for migraine prophylaxis, and deserves further therapeutic trials with larger groups for longer periods of time.

A Randomized, Double-blind, Placebo-controlled Study of Dextran/Pentoxifylline Medication in Acute Acoustic Trauma and Sudden Hearing Loss

Abstract: The effectiveness of any therapy in acute acoustic trauma or sudden hearing loss of unknown origin has not been demonstrated convincingly. The assessment is difficult because of a relatively high rate of spontaneous recovery. Nevertheless, many different forms of treatment are recommended. We tested one form, treatment with rheoactive substances, in a prospective, randomized, double-blind trial and compared treatment with (a) infusions of dextran-40 with pentoxifylline, (b) saline infusions with pentoxifylline, and (c) saline infusions with placebo medication. Pure-tone hearing thresholds served as control parameters and were taken before treatment and at 1 and 4 weeks after the onset of therapy. Three hundred eighty-two patients were included in the trial, 331 (87%) could be analyzed, 184 patients were treated because of sudden hearing loss, 147 because of acute acoustic trauma. The three treatment groups were comparable in their basic characteristics including the amount of initial hearing loss. In pati...

Superiority of clomipramine over imipramine in the treatment of panic disorder: a placebo-controlled trial.

Abstract: A double-blind, placebo-controlled trial was undertaken to compare the effects of imipramine and clomipramine in the treatment of panic disorder with or without agoraphobia. The number of dropouts in the placebo-treated group was 7; in the imipramine-treated group, 4; and in the clomipramine treated group, 0. Ten subjects fulfilled the 12 weeks of treatment in the placebo group, 25 in the imipramine group, and 22 in the clomipramine group. To minimize dropouts because of side effects, a flexible dose regimen with a careful escalation of doses was applied. The maximal dose allowed was 250 mg/day. The mean (+/- SEM) daily doses reached were 124 +/- 9 mg (range, 50-250 mg) of imipramine and 109 +/- 8 mg (range, 25-200 mg) of clomipramine. At the end of the trial, the number of panic attacks as well as the anxiety between attacks (measured using the Hamilton Rating Scale for Anxiety) were markedly reduced in patients treated with either of the two antidepressant drugs, but only slightly decreased in patients on placebo. With respect to all major outcome parameters, i.e., full panic attacks, total number of anxiety attacks (full plus mild), and anxiety between attacks, the effect of clomipramine was clearly and significantly superior to that of imipramine (p less than 0.001, p less than 0.002, and p less than 0.002, respectively). Moderate intake of diazepam was allowed; in the clomipramine group (p less than 0.006), but neither in the imipramine group nor in the placebo group, a significant decrement in diazepam intake was observed during the course of the trial. The finding that clomipramine may have a higher potency and/or efficacy than imipramine in the treatment of panic disorder supports the concept that the antipanic effect of antidepressant drugs is due to the influence of these compounds on serotonergic rather than noradrenergic neurotransmission.

A randomised, double-blind, placebo-controlled trial of dermatan sulphate for prevention of deep vein thrombosis in hip fracture.

Abstract: Dermatan sulphate (MF 701) is a natural glycosaminoglycan that catalyses thrombin inhibition by heparin cofactor II. The aim of the study was to evaluate the efficacy and safety of MF 701 for prevention of deep vein thrombosis (DVT) in patients with hip fracture. A randomised, double-blind, placebo-controlled design was used to assess two dose regimens of MF 701 in two consecutive study phases. Treatment was started within 48 h from the trauma and continued for 14 days for non-operated patients or until the 10th postoperative day. Bilateral mandatory venography was used to assess the end-point. Eighty patients were included in the first phase (40 MF 701, 40 placebo). MF 701, 100 mg IM b.i.d., did not reduce incidence of DVT from that on placebo and did not induce any bleeding. In the second phase 126 patients were included, with a randomisation ratio of 2:1 (84 MF 701, 300 mg IM b.i.d., 42 placebo). Bilateral venography was obtained for 110 patients. The incidence of DVT was 64% (23/36) in the placebo group and 38% (28/74) in the MF 701 group (p = 0.01; odds ratio [OR] = 0.34, 95% confidence limits [CL] = 0.15-0.80p; proximal DVTs were 42% (15/36) and 20% (15/74), respectively (p = 0.02; OR = 0.36, CL = 0.15-0.89). No significant differences were found in haemorrhagic complications (2.4% in each group), blood loss from drains, blood transfusions, haemoglobin and haematocrit values. This study is the first demonstration that dermatan sulphate is a clinically effective antithrombotic agent without bleeding effects. It also provides evidence of the biological role of heparin cofactor II.

Vitamin E in the treatment of tardive dyskinesia: a double-blind placebo-controlled study.

Abstract: The authors compared vitamin E with placebo in a double-blind randomized crossover study of 27 patients with tardive dyskinesia. Each treatment period lasted for 6 weeks. Vitamin E showed no differences from placebo in the treatment of tardive dyskinesia.

Placebo-controlled trial of oral 5-ASA in relapse prevention of Crohn's disease.

Abstract: Treatment of Crohn's disease (CD) in clinical remission is still a debated issue. Previous studies have shown a high risk of relapse for patients with CD in clinical remission (CDAI<150) but with some abnormally high laboratory parameters as well as a possible beneficial role of low-dosage steroid treatment in this group of patients. Furthermore, good results have been reported on the efficacy of 5-aminosalicylic acid (5-ASA) in moderately active CD. In our study we verified the efficacy of a slow-release oral 5-ASA preparation in preventing relapses in a group of patients in clinical remission but with raised laboratory parameters. Forty-four patients were randomized in a double-blind manner to receive either 5-ASA (2 g/day) or placebo for four months. Location of disease and previous steroid treatment were similar in both groups. One patient in the 5-ASA group discontinued the drug because of uterine bleeding. During the study period, 13 of 22 placebo-treated patients and 11 of 21 5-ASA-treated patients relapsed (corrected chi square=NS). Considering the location of disease, three of 10 patients in the 5-ASA group and six of nine patients in the placebo group with ileal CD relapsed (therapeutic gain with 5-ASA: 36.6%; 95% allowance for error from −6% to 79.2%). Moreover, in seven patients with ileal CD who remained in remission, we found a statistically significant decrease in α1 acid glycoprotein and C-reactive protein from the second month of the study. In conclusion, although results with 5-ASA in CD seem disappointing, the possible benefit of higher dosages of 5-ASA in selected subgroups of CD patients is discussed.

Nadolol to treat aggression and psychiatric symptomatology in chronic psychiatric inpatients: a double-blind, placebo-controlled study.

Abstract: BACKGROUND: Considerable evidence indicates that the lipophilic beta-blocker propranolol is useful in treating organically based aggression. This study looked at the efficacy of a more hydrophilic beta-blocker, nadolol, to treat aggression in chronic psychiatric inpatients. METHOD: Forty-one chronic psychiatric inpatients with an average of one aggressive outburst per week (defined by the Overt Aggression Scale [OAS]) were entered into a double-blind, placebo-controlled study lasting 17 weeks. The OAS was used to track aggression on a per-incident basis, while the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions scale (CGI) were used to track clinical status. RESULTS: Nadolol subjects showed a significant decline in frequency of aggression compared with controls (p =.026) and a significant decline in the BPRS total score (p =.007) and in the subfactors "hostility and suspicion," "negative symptoms," and "signs of hyperarousal/tension." There was no significant change in CGI "severity of illness" ratings between groups, although the nadolol group was significantly improved from baseline at every subsequent time period while the placebo group was unchanged throughout the study. CONCLUSION: Nadolol is of significant benefit in the treatment of aggression in chronic psychiatric inpatients. This drug does penetrate the brain over time, but the success of a drug whose primary locus of action is peripheral may implicate a bimodal mechanism of action, i.e., a role for the CNS and the soma in the maintenance of aggression. Language: en

The efficacy of perioperative antibiotic therapy on recovery following tonsillectomy in adults: randomized double-blind placebo-controlled trial.

Abstract: One hundred and one adult patients undergoing tonsillectomy for chronic/recurrent tonsillitis completed a prospective, randomized, double-blind, placebo-controlled study in which ticarcillin disodium and clavulanate potassium (Timentin) or placebo was administered intravenously at the time of surgery and for 12 hours postoperatively. The patients than received oral amoxicillin and clavulanate potassium (Augmentin) therapy or placebo for an additional seven days. Each patient kept a daily log to assess the incidence and severity of postoperative symptoms. Tonsillar core tissue at the time of surgery, as well as tonsillar fossa cultures after 7 days of treatment, were obtained. Those patients who received antibiotics fared consistently better in the immediate postoperative period compared with the placebo group. Specifically, patients in the antibiotic group experienced significantly less mouth odor, were able to tolerate a regular diet sooner, and resumed their normal activities earlier than did patients who received placebo. Patients who received antibiotics experienced fewer days with mouth odor (p = 0.004). In addition, on postoperative days 3 to 5, the antibiotic group was eating a regular diet (p = 0.05) and had returned to their routine activities earlier (p = 0.045) when compared with the placebo group. Perioperative antibiotic therapy was well tolerated and was effective in minimizing symptoms after tonsillectomy.

The clinical effects of electrostimulation on salivary function of Sjögren's syndrome patients. A placebo controlled study.

Abstract: A multi-center double-blind study of an electro-stimulator device was conducted to evaluate its ability to increase the production of saliva and reduce clinical symptomatology A total of 77 Sjogren's syndrome patients at three centers were assigned to active devices (n = 40) or to placebo devices (n = 37) There were 2 male and 32 female patients assigned to active devices, and 1 male and 36 female patients assigned to placebo devices The age range with the greatest number of patients was 60-69 years making up more than 31% of the study population The selection criteria required the patients to have no greater than 02 g/min of whole salivary production (approximately 19% of normal salivary production) At the start of the study, the patients assigned the active device had a mean salivary production of 006 ml per min (6% of normal) and patients assigned placebo devices had a mean salivary production of 007 ml per min (7% of normal) There were three scheduled visits, 2 weeks apart, over a treatment period of 4 weeks At all visits, the patients using active devices showed a statistically greater (P = 0005 to 002) increase in the production of saliva than placebo patients The study also evaluated the reduction of patients symptoms associated with xerostomia Patients showed significant improvement in (1) difficulty in swallowing and (2) burning tongue (P = 0008) Some patients on their initial visit had no response to the active device and did not show a significant response at subsequent visits(ABSTRACT TRUNCATED AT 250 WORDS)

A dietary fibre supplement in the treatment of mild hypertension. A randomized, double-blind, placebo-controlled trial.

Abstract: Objective:To study the effects of a dietary fibre supplement given as monotherapy upon blood pressure in mildly hypertensive patients.Design:The investigation was performed as a prospective randomized, double-blind, placebo-controlled trial for 3 months.Setting:Patients attending an outpatient hyper

Recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for malignant lymphoma: a British National Lymphoma Investigation double-blind, placebo-controlled trial.

Abstract: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is active in enhancing the production of mature myeloid cells in vitro and several phase 1/11 clinical trials have suggested that its administration may accelerate neutrophil recovery after autologous bone marrow transplantation (ABMT). We have conducted a multicentre randomized double-blind placebo controlled trial in patients with poor prognosis malignant lymphoma receiving an identical high-dose combination chemotherapy regimen with ABMT. 61 patients were entered and 29 in each arm of the trial were evaluated. Treatment with GM-CSF did not affect the period of severe neutropenia (absolute neutrophil count (ANC) of 37.5-degrees-C (median 8 v 6) or days on parenteral antibiotics (11 v 10). Patients receiving GM-CSF had a median period of hospitalization following BMT of 24 d (control 25). No significant major toxicity attributable to GM-CSF administration was detected. We have confirmed in a randomized trial that GM-CSF accelerates neutrophil but not platelet recovery following ABMT. We were unable to demonstrate any accompanying changes in clinical outcome and believe that further trials are necessary to assess the clinical value of GM-CSF in BMT.

Efficacy of cod liver oil as an adjunct to non-steroidal anti-inflammatory drug treatment in the management of osteoarthritis in general practice.

Abstract: A double blind, placebo controlled trial was carried out to assess the efficacy of cod liver oil as an adjunct treatment to non-steroidal anti-inflammatory drugs (NSAIDs) in the management of osteoarthritis in general practice. Eighty six patients were given 10 ml of either cod liver oil or olive oil placebo daily as a supplement to their regular NSAID treatment for 24 weeks. Patients were assessed by their general practitioner at four week intervals for joint pain/inflammation, overall interference with activities, and unwanted effects of treatment. Patients recorded on visual analogue scales their daily pain and the extent to which arthritis interfered with everyday activities. There was no significant benefit for the patients taking cod liver oil compared with those taking placebo.

Randomised trial of inhaled steroids in preterm infants with respiratory symptoms at follow up.

Abstract: BACKGROUND: Preterm infants often suffer from recurrent respiratory symptoms at follow up. Although these infants are responsive to treatment with bronchodilators some continue to wheeze or cough despite treatment. In a randomised double blind placebo controlled trial, the ability of inhaled steroids to reduce recurrent respiratory symptoms and the requirement for bronchodilator treatment in preterm infants less than two years of age has been assessed. METHODS: Eighteen premature infants with mean gestational age 28 weeks and postnatal age 10.5 months were recruited. The study consisted of two six week treatment periods separated by a two week washout period. The infants received either 200 micrograms of beclomethasone dipropionate or placebo as one puff twice daily from an inhaler, through a spacer and a face mask. Parents kept a daily record of their infants' respiratory tract symptoms (wheeze and cough) and use of bronchodilators. Functional residual capacity (FRC) was measured at the beginning and end of each six week period. RESULTS: The symptom score was reduced by 37% in the active compared with the placebo period. During the active period the infants had a mean of 28 bronchodilator free days, compared with 22 days in the placebo period. The FRC improved significantly in the active but not the placebo period. CONCLUSION: Regular dosage with beclomethasone by inhalation is a useful treatment for preterm infants with respiratory symptoms.