Showing papers on "Placebo-controlled study published in 1984"

L-Thyroxine Therapy in Subclinical Hypothyroidism: A Double-Blind, Placebo-Controlled Trial

Abstract: The indications for treating patients with subclinical hypothyroidism (normal serum thyroxine and free thyroxine levels, but elevated serum thyrotrophin levels) are poorly defined. In this study, 33 patients with subclinical hypothyroidism were randomly assigned in a double-blind manner to receive placebo or L-thyroxine therapy and were followed for 1 year with thyroid function tests, serum lipid measurements, basal metabolic rate and systolic time interval determinations, and a questionnaire on hypothyroid symptoms. The placebo group showed no changes in thyroid function or peripheral indices of thyroid hormone action. In the thyroxine-treated group, serum lipids and the mean systolic time interval did not change, but the systolic time intervals became normal in the 5 patients with the most abnormal baseline values. Symptoms improved in 8 of 14 patients receiving thyroxine and in 3 of 12 patients receiving placebo (p less than 0.05). L-Thyroxine therapy may be useful for patients with subclinical hypothyroidism with abnormal myocardial contractility or symptoms consistent with mild hypothyroidism, or both.

Randomized, Double‐Blind, Placebo Controlled Trial of Low‐Dose Pulse Methotrexate in Psoriatic Arthritis

Abstract: Thirty-seven patients with psoriatic arthritis were entered into a 12-week prospective, controlled, double-blind multicenter trial comparing placebo and oral pulse methotrexate therapy. Methotrexate was given in a dose of 2.5-5.0 mg every 12 hours in 3 consecutive doses per week. A stable background medication program with nonsteroidal antiinflammatory drugs was allowed. Methotrexate was superior to placebo only in physician assessment of arthritis activity and in improvement of the amount of skin surface area with psoriasis. A small but statistically significant rise of serum total bilirubin occurred in the methotrexate-treated patients. No patients were withdrawn from the study for adverse drug effects.

A controlled two-centre trial of parenteral methotrexate therapy for refractory rheumatoid arthritis.

Abstract: Forty-eight patients with rheumatoid arthritis refractory to other treatments were studied in a placebo controlled trial of methotrexate (MTX) in 2 institutions. Once weekly for 6 weeks, the patients were injected with placebo (Group 1), MTX 10 mg (Group 2), or MTX 25 mg (Group 3). Then, for the next 6 weeks, Group 1 received MTX, either 10 or 25 mg/wk, and Groups 2 and 3 continued their same dose. Adverse reactions necessitated change from 25 mg to 10 mg in some patients, but no major side effects of MTX were noted. At 6 weeks, the effect of the 2 MTX doses did not differ significantly but patients on MTX had fared significantly better (p less than 0.005 - less than 0.001) than those given placebo. At 12 weeks, all indices showed significant improvement in Group 1 and maintenance or enhancement of the improvement in Groups 2 and 3. We conclude that weekly low dose MTX therapy is efficacious for refractory rheumatoid arthritis.

Treatment of the restless legs syndrome with carbamazepine: a double blind study.

Abstract: One hundred and seventy four patients suffering from the restless legs syndrome were examined in a double blind, between patient, placebo controlled study in general practice for five weeks to investigate the effects of carbamazepine and placebo on the syndrome. The syndrome was more common among middle aged women with relatively low systolic blood pressure. The median haemoglobin concentration was about average for the population, but the severity of the symptoms seemed to increase with decreasing concentrations of haemoglobin. Both placebo and carbamazepine showed a significant therapeutic effect (p less than 0.01). Carbamazepine was significantly more effective than placebo (p less than or equal to 0.03). The significant therapeutic effect of placebo in restless legs showed that only double blind controlled trials can confirm the efficacy of suggested treatments.

A controlled trial of hyposensitization with adsorbed tyrosine Dermatophagoides pteronyssinus antigen in childhood asthma: in vivo aspects

Abstract: Continuing study for a second year and further analysis of a double-blind placebo controlled trial, already briefly reported, of injections of tyrosine-adsorbed, glutaraldehyde-modified Dermatophagoides pteronyssinus antigen in fifty-one children with perennial asthma and positive bronchial challenge to the antigen, confirms that the patients receiving the treatment reduced their symptomatic medication more than controls, without deterioration of symptoms. Some became symptom-free, when off all treatment. A double-blind placebo controlled trial of continuing treatment for a second year gave evidence of deterioration when the treatment was stopped. Within the treatment group, the improvement was associated with loss of late (6 hr) reaction to bronchial provocation with the antigen, but was not associated with change of immediate (20 min) reaction in lungs or skin. Those who improved in the placebo group did not lose their late reaction. There was a trend for similar benefit from active treatment in the control group, during the second year, though less than in the original active group, and only one lost his late reaction. Only one of the six children with very severe early onset asthma improved. Local reactions to either active or placebo (tyrosine) were seen in half the patients; these were mild and did not influence the treatment. Systemic symptoms occurred shortly after four active injections and after two placebo injections; only one patient stopped the treatment.

A double-blind, placebo-controlled study of ketanserin in patients with Prinzmetal's angina. Evidence against a role for serotonin in the genesis of coronary vasospasm.

Abstract: This study was designed to test the hypothesis of a possible role of serotonin in the pathogenesis of myocardial ischemia in patients with pure vasospastic angina, since serotonin is known to cause contraction in isolated coronary arteries. This effect, as well as serotonin-induced platelet aggregation, is reversed by ketanserin, a specific S2-receptor blocker. Five male patients (49 to 68 years old) with more than six episodes/day of myocardial ischemia at rest as characterized by ST segment elevation on the electrocardiogram (ECG) were selected for the study after a 2 day run-in period of continuous ECG Holter monitoring in the absence of any therapy except that with sublingual nitrates. In a double-blind crossover protocol they received consecutive infusions of 6 hr each of ketanserin (2 mg/hr iv, preceded by a 10 mg bolus in three patients) and placebo in the following sequence: ketanserin-placebo-ketanserin-placebo in the first and placebo-ketanserin-placebo-ketanserin in the second 24 hr period. The efficacy of the infused drug was tested by exposing platelet-rich plasma, obtained from the study patients at a fixed morning time before and during ketanserin infusions, to a series of serotonin concentrations from 10(-5) to 10(-8)M in a conventional aggregometer. A complete suppression of aggregation curves in the range of serotonin concentrations tested resulted during administration of ketanserin. The efficacy of the drug in preventing ischemic episodes was assessed by computing the ischemic episodes (recorded by Holter monitoring) and nitroglycerin consumption in each 6 hr ketanserin period and in the corresponding placebo period. A total of 171 ischemic episodes were recorded, 33 of which (19%) were symptomatic.(ABSTRACT TRUNCATED AT 250 WORDS)

Oral acyclovir prophylaxis against herpes simplex virus in non-Hodgkin lymphoma and acute lymphoblastic leukaemia patients receiving remission induction chemotherapy. A randomised double blind, placebo controlled trial

Abstract: Forty-one patients receiving remission induction chemotherapy with vincristine, adriamycin and prednisolone (VAP) for high grade lymphoma or acute lymphoblastic leukaemia were entered into a double blind, placebo controlled trial of oral acyclovir prophylaxis against herpes simplex virus (HSV) infection. The dose of acyclovir was 200 mg four times daily for the duration of chemotherapy (six weeks). Of the 40 evaluable patients, 20 were randomised to each arm. Prophylactic oral acyclovir significantly reduced the incidence of clinical HSV infection from 60% on placebo to 5% acyclovir (P less than 0.001), and the incidence of viral isolates from 70% on placebo to 5% on acyclovir (P less than 0.001).

A placebo-controlled study of the antidepressant activity of moclobemide, a new MAO-A inhibitor.

Abstract: Preliminary open trials performed by the authors and others with Moclobemide, a new MAO-A inhibitor, indicated that the drug has a satisfactory antidepressant activity. In the present double-blind study Moclobemide has been compared to placebo in a group of 34 unipolar psychotic or neurotic depressed patients. The mean daily dose of Moclobemide was 297 mg and treatment lasted from two to four weeks. Drug effectiveness was measured by improvements in the Hamilton Rating Scale for Depression (HRSD), Clinical Global Impression (CGI) and 100 mm Visual Analogue Scale (VAS). The results have shown that the active drug was markedly superior to placebo. The mean total score of HRSD was reduced from 41.7 to 16.5 in 18 pts. treated with Moclobemide and from 36.3 to 29.1 in 16 pts. who received placebo. Self-assessment with VAS showed a mean reduction from 82.7 mm to 42.2 mm and from 84.3 to 70.6 mm respectively. Moderate to marked improvement was observed by the CGI in 15 cases treated with Moclobemide and mild to moderate in 5 cases who received placebo. The treatment was well tolerated.

Placebo effect in surgery for Meniere's disease: a three-year follow-up study of patients in a double blind placebo controlled study on endolymphatic sac shunt surgery.

Abstract: In a previously published double blind, placebo controlled study, the efficacy of an endolymphatic sac-mastoid shunt was compared with a purely placebo operation (mastoidectomy) in controlling the symptoms in 30 patients with typical Meniere's disease. Minor differences could be demonstrated after one year between patients with the shunt versus the sham operation, but the greatest difference was between the pre- and postoperative scores, and both groups improved significantly. It was concluded that the impact of the various endolymphatic sac shunts upon the symptoms in patients with Meniere's disease is highly unspecific, and that the 70% improvement in both our groups was most likely caused by a placebo effect. The patients have now been regularly followed for a minimum of 3 years and the symptoms registered whenever present. The results of hearing tests, the patients' own evaluation, and the investigator's evaluation (while still unaware of the type of operation in each patient) show that the 3-year results are the same as our results from the first year: no significant difference could be found between the two groups.

Double-blind placebo-controlled trial of erythromycin in the treatment of clinical campylobacter infection

Abstract: In a double-blind placebo-controlled trial in patients hospitalized with campylobacter infection, erythromycin lessened pain and curtailed the carriage state but otherwise did not alter the natural course of the illness, which proved to be a short-lived, self-limiting one, even in this selected group of hospitalized patients; the majority had become asymptomatic by the time of the bacteriological diagnosis. The rarity of bacteraemia is highlighted by the study.

Efficacy and Tolerability of Oral Acetylcysteine (Fabrol®) in Chronic Bronchitis: A Double-Blind Placebo Controlled Study

Abstract: This multicentre, double-blind, placebo controlled, between-patient study in general practice in the United Kingdom examined the effect of oral N-acetylcysteine (Fabrol) on the symptomatology of patients with chronic bronchitis over a 3-month period. Although improvement in subjective symptoms (sputum viscosity and character, difficulty in expectoration and cough severity) occurred in both treatment groups over the trial period, improvements in difficulty in expectoration and cough severity were greater in patients receiving N-acetylcysteine compared to matching placebo. Trial medication was well tolerated, with a greater number of side-effects attributed to therapy occurring in patients receiving placebo.

A double blind, placebo controlled study of piroxicam in the management of acute musculoskeletal disorders.

Abstract: General Practitioners from the United Kingdom produced data on 1,282 patients with acute soft tissue injury treated with either piroxicam (Feldene) or matching placebo for a period of up to two weeks. The dosage of piroxicam was 40 mg for the first 2 days and 20 mg daily thereafter. Clinical assessment included pain, swelling, limitation of active and passive movement and overall assessment of efficacy and toleration. Piroxicam was significantly better than placebo in improving patient signs and symptoms, and in its overall efficacy (P less than 0.001); 87% of piroxicam treated patients had excellent or good responses, compared to 53% of placebo treated patients. On analysis of four of the most commonly occurring diagnoses (injuries of ankle, knee, shoulder, back) patients with moderate or severe pain showed a significant improvement on treatment with piroxicam. Physicians' overall assessment of toleration showed no evidence of differences between treatments. Over 90% of patients in both treatment groups had good or excellent toleration. Withdrawals due to side effects were 3% and 2.5% respectively for piroxicam and placebo treated patients.

A double blind placebo controlled trial of mixed gangliosides in diabetic peripheral and autonomic neuropathy.

Abstract: Diabetic neuropathy is a common complication of diabetes that is incurable at present. The likelihood of clinical manifestations increases with the duration and severity of the hyperglycemia.1–7Apart from the beneficial effects of insulin by continuous infusion8,9 or the alcohol myoinositol, 10–13 the only other drugs tried with questionable benefit in clinical diabetic neuropathy are isaxonine and sorbinil. 15–18

Low-dose acetylsalicylic acid (100 mg/day) after aortocoronary bypass surgery: a placebo-controlled trial.

Abstract: The effect of low-dose acetylsalicylic acid (100 mg/day) upon bypass patency-rate and clinical course after aortocoronary bypass surgery was investigated in a randomized, placebo-controlled clinical trial. Sixty patients with 143 distal anastomoses of bypasses were randomized, 46 underwent repeat angiography after 4 months. Using the intention to treat-strategy, treatment was superior to placebo as judged by bypass patency rate and occurrence of cardiovascular complications or death. Counting the six drop-outs as failures, only nine of the 31 patients of the placebo group, but 16 of the 29 patients of the treatment group were considered successes (P less than 0.04). Eighteen patients in the placebo group and eight patients of the treatment group received beta-adrenoceptor blockers postoperatively, suggesting again a favourable effect of the treatment. Adverse drug reactions were very rare and minor. Supported by pathophysiological insights and positive trends in similar trials, the positive result justifies the recommendation of prescribing 100 mg of acetylsalicylic acid once daily to all patients without contraindications after aortocoronary bypass surgery. The positive result of this trial warrants further clinical trials of low-dose acetylsalicylic acid for other indications in arterial diseases.

Nomifensine in geriatric inpatients: a placebo-controlled study.

Abstract: In a double-blind randomized group design, nomifensine (100 mg single daily dose) was compared to placebo in 100 geriatric inpatients (average age = 75 years). Patients in each group were categorized as depressed (Feighner criteria for primary depressive disorder and Hamilton Depression Rating Scale scores greater than or equal to 18) or non-depressed (no psychopathologic disorders and HDRS scores less than or equal to 7). Outcome measures included the HDRS and various tests of cognitive function. The nomifensine-treated depressed patients showed significant improvement over the placebo depressed patients early in and throughout treatment. Depressed patients also showed significant improvement on several cognitive tests with nomifensine treatment. Nomifensine was well tolerated in both depressed and nondepressed patients.

An assessment of the novel antihistamine BW 825C in the treatment of chronic idiopathic urticaria. A placebo-controlled study.

Abstract: 20 patients with a diagnosis of chronic idiopathic urticaria were entered into a double-blind placebo-controlled cross-over study. All patients completed the trial and during the assessment period they were treated with placebo, BW 825C (4 mg) and BW 825C (8 mg) according to a fully randomised and balanced treatment plan. Both doses of BW 825C were found to be highly effective and significantly better than placebo in controlling signs and symptoms of urticaria. Few adverse reactions were reported and in this small group of patients there was no significant difference from placebo in reports of drowsiness or any other side-effects.

Prophylaxis of fever and infection in adult cancer patients. A placebo-controlled trial of oral trimethoprim-sulfamethoxazole plus erythromycin.

Abstract: Oral trimethoprim-sulfamethoxazole (Bactrim) plus erythromycin (TMZ-E) was tested versus placebo (P) as prophylaxis for bacterial infection in a randomized, double-blind trial in adult cancer patients receiving cytotoxic chemotherapy expected to result in significant neutropenia. The incidence of adverse reactions attributable to TMZ and/or E was higher in drug-treated episodes (18 of 28 vs 3 of 29 for P, P less than 0.0005) resulting in poorer compliance. The incidence of fever was not significantly different between episodes treated with TMZ-E (18/27) and those treated with P (17/29), nor was there a significant difference in the median interval between the onset of neutropenia and the onset of fever. However, 14 of 18 fevers in TMZ-E recipients were without a documented infectious source compared with only 6 of 17 in P recipients (P less than 0.05). The same patterns were apparent even when episodes in which compliance with the regimen was either excellent or good were considered separately. There was no significant difference in the number of deaths from infection between TMZ-E and P recipients (3/27 vs 1/29). It is concluded that TMZ-E prophylaxis is of no practical benefit, may mask the cause of infection in febrile neutropenic cancer patients, and is associated with substantial toxicity.

Oxatomide in the treatment of pruritus senilis. A double-blind placebo-controlled trial.

Abstract: The antiallergic drug oxatomide was evaluated in a double-blind placebo-controlled study in 35 patients with pruritus senilis. The trial was run in the wintertime, and the patients were orally given either 30 mg oxatomide b.i.d. (n = 19) or a placebo (n = 16) for 2 months. Complete suppression or marked improvement of the complaints was experienced by 79% of the patients given oxatomide and by 31% of the control patients. Oxatomide was superior to the placebo in reducing both the duration and the severity of itching. The need of additional topical medication was higher in the placebo group. Somnolence and cramps were each reported by 1 oxatomide-treated patient.

Fluphenazine/nortriptyline in the irritable bladder syndrome. A double-blind placebo controlled study.

Abstract: A double-blind, placebo controlled, randomised order crossover study was carried out on the effect of Motival (0.5 mg fluphenazine with 10 mg nortriptyline) 3 times daily on the bladder function and psychiatric morbidity of 13 women without evidence of infection, complaining of recurrent dysuria and frequency. Bladder function was assessed symptomatically and by ambulatory urodynamics, and patients completed the General Health Questionnaire, a validated instrument for the detection of psychiatric disturbance. Correction of the urodynamic abnormalities was associated with Motival treatment in 5 of the 8 patients with unstable bladders, compared with none of 7 patients receiving placebo (P less than 0.02). Motival was also associated with a greater frequency of symptomatic improvement. Only 2 patients were classified as psychiatrically disturbed, suggesting that the therapeutic effect of Motival is not related to its psychotropic properties.

Cholecystokinin-octapeptide in chronic schizophrenia: a double-blind placebo-controlled study.

Abstract: 1. Antipsychotic properties of cholecystokinin have been suggested both in laboratory studies and in some open clinical trials, mainly in patients suffering from chronic schizophrenia. 2. Eighteen patients (14 males, 4 females) meeting Research Diagnostic Criteria for schizophrenia had been receiving neuroleptics at a dosage that had not changed for 3 months, and to which the patients were at best only partially responsive. 3. The patients were randomized into groups that received weekly intravenous injections of 10 μg of CCK-8 or normal saline over 8 weeks. Neuroleptic medication was unchanged for the study. Baseline and weekly assessments were carried out using the Brief Psychiatric Rating Scale (BPRS) and the Schizophrenia Subscale of the Present State Examination (SS-PSE). 4. Analysis of covariance revealed significant differences between CCK-8 and placebo over the study period on the Thought Disturbance Factor and Total Score of the BPRS, and on the Nuclear Syndrome, Total Delusion Factor, and Total Score of the SS-PSE. 5. No important side effects were noted. 6. It is concluded that CCK-8 has definite antipsychotic properties in patients with chronic schizophrenia. Clinical trials in neurolept ic-free patients are warranted.

Iron and infection in infancy—Report on field studies in Papua New Guinea: II. Protocol and description of study cohort

Abstract: The protocol for a prospective, randomized, double-blind, placebo controlled trial of iron prophylaxis in infants is described. Specific design points discussed include (i) control and "blind", (ii) dose, preparation and age of administration of iron, (iii) standardization of morbidity recording, (iv) data analysis and (v) ethics. The study cohort at birth is described and rationale for exclusions and reasons for withdrawals are discussed. An initial descriptive comparison is made of treatment and control groups entering the trial at two months of age.

Management of middle-ear effusions in children

Abstract: A double-blind placebo controlled trial of Mucodyne (carbocisteine, Berk Pharmaceuticals), Actifed (triprolidine HC1 and pseudoephedrine HC1, Wellcome) and combined Mucodyne and Actifed in the treatment of middle-ear effusions is reported. The trial was undertaken to assess whether either preparation, alone or in combination, would reduce the number of children requiring surgical treatment for this condition. No statistical difference between the various groups in avoiding surgical treatment was detected. In those patients undergoing surgery, pre-operative treatment with Mucodyne was associated with a significantly greater number of ears restored to a normal appearance and middle ear function as measured by tympanometry. All patients relapsing after surgery belonged to the groups receiving placebo, Actifed or the combination of Mucodyne and Actifed prior to the operation.

Oxypertine in tardive dyskinesia: an 8-week controlled study.

Abstract: In a double-blind placebo controlled trial of oxypertine in the treatment of tardive dyskinesia, 33 patients with chronic schizophrenia received either oxypertine or placebo. At the end of eight weeks, the results showed that oxypertine was superior to placebo at a statistically significant level.

Clinical experiences with the radiation sensitizer MTDQ (Sensorad) in advanced malignancies of the head and neck region and in uterine cancer

Abstract: 33 patients with malignancies of the head and neck and 9 patients with carcinoma uteri received Sensorad combined with megavolt-therapy in a placebo controlled trial. 35% of the Sensorad treated patients with head and neck cancer showed an early radiomucositis. A full regression was achieved in 15 patients and a partial regression in 18 patients thus the drug helped in 79% of the patients treated. No regression was noted in 6 patients and a progression in 3, that means in 21% of patients no benefit was detected. In the placebo control group a benefit was proved for 35% of the patients whereas 65% of the patients showed no benefit. The proportion of benefit to no benefit was 3.66 in the Sensorad group compared to 0.54 in the placebo group. The patients with carcinoma uteri all showed a benefit from the treatment with Sensorad. The number of adverse reactions was small. 4 patients had nausea and gastrointestinal symptoms, 2 allergic reactions and 3 elevated SGOT (21.4%).