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Showing papers on "Placebo published in 1984"


Journal ArticleDOI
TL;DR: L-Thyroxine therapy may be useful for patients with subclinical hypothyroidism with abnormal myocardial contractility or symptoms consistent with mild hypothy thyroid hormone action, or both.
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.

414 citations


Journal ArticleDOI
TL;DR: It is concluded that oral acyclovir given for four months markedly reduces but does not completely prevent recurrences of genital herpes and does not influence the long-term natural history of the disease.
Abstract: Patients with frequently recurring genital herpes were enrolled in a double-blind placebo-controlled trial comparing 200-mg acyclovir capsules, given five or two times daily, with placebo. Of 47 placebo recipients, 44 (94 per cent) had recurrences during the 120-day treatment period, compared with 13 (29 per cent) of 45 patients treated with acyclovir five times daily and 18 of 51 (35 per cent) treated with acyclovir twice daily (P less than 0.001 for each regimen compared with placebo). The median time to the first clinical recurrence was 18 days in placebo recipients, compared with over 120 days in both acyclovir-treated groups (P less than 0.001 for both groups compared with placebo). The mean monthly recurrence rate during the medication period was 0.86 in placebo recipients, compared with 0.13 in patients treated with acyclovir five times daily and 0.14 in patients treated with acyclovir twice daily (P less than 0.001 for both groups compared with placebo). While receiving therapy, 86 of 96 acyclovir-treated patients had over a 50 per cent reduction in their pretreatment recurrence rate. Breakthrough recurrences in acyclovir recipients were of shorter duration and associated with a lower frequency of viral shedding than recurrences in placebo recipients. After medication was discontinued, the subsequent recurrence rate returned to pretreatment frequencies. Daily oral acyclovir was well tolerated. We conclude that oral acyclovir given for four months markedly reduces but does not completely prevent recurrences of genital herpes and does not influence the long-term natural history of the disease.

324 citations


Journal ArticleDOI
TL;DR: Vaccine prepared from RIT 4237 strain of attenuated bovine rotavirus thus seems to protect children against heterologous subgroup 2 rotav virus diarrhoea.

323 citations


Journal ArticleDOI
01 Jan 1984-Nature
TL;DR: This study underscores the power of the placebo and emphasizes that even the most subtle cues can elicit a placebo response.
Abstract: The appropriate control group in studies of placebo-induced analgesia has not been established. A traditional control has been a 'no treatment' or natural-history group. In some studies, the natural-history group receives a hidden infusion of vehicle, a physiologically inactive substance such as saline solution, to eliminate differences in expectation of the outcome on the part of the experimenter. To evaluate whether 'hidden' as well as open infusion of vehicle can elicit a placebo response, we have now tested a different natural-history group, one which received an infusion of vehicle from a syringe pump controlled by a programmable timer. A comparison of these two control groups provides evidence that hidden infusion of vehicle can elicit a placebo response. Use of this new control group also permitted a clear distinction between a naloxone-antagonizable component of placebo analgesia and naloxone antagonism of endorphin-mediated analgesia induced by surgical stress. Our study underscores the power of the placebo and emphasizes that even the most subtle cues can elicit a placebo response.

301 citations


Journal ArticleDOI
TL;DR: It is concluded that oral acyclovir suppresses genital herpes in patients with frequent recurrences, but the potential for problems with drug resistance and the long-term safety need to be more fully explored.
Abstract: We studied 35 otherwise healthy adults with frequently recurring genital herpes (≥1 episode per month), in a double-blind trial comparing oral acyclovir with placebo capsules for suppression of recurrent infection. The patients were treated for 125 days unless herpes recurred. Among 32 evaluable patients, there were significantly fewer recurrences during acyclovir treatment (4 of 16) than during placebo treatment (16 of 16, P<0.001). The mean duration of therapy was significantly longer for patients receiving acyclovir than for those receiving placebo (114.9 vs. 24.8 days, P<0.001). Of 19 patients who had recurrences in the blind trial, only 2 had recurrences when given acyclovir in a second, open-study phase. All patients had recurrences after completing acyclovir treatment. The therapy was well tolerated, with minimal gastrointestinal upset and one hypersensitivity reaction. Studies of the viral isolates demonstrated that lesions developing in patients receiving acyclovir contained drug-resista...

300 citations


Journal ArticleDOI
TL;DR: The purpose of the present study is to determine whether prolonged administration of propranolol enhances the efficacy of this therapy.

281 citations


Journal ArticleDOI
TL;DR: Methotrexate was superior to placebo only in physician assessment of arthritis activity and in improvement of the amount of skin surface area with psoriasis.
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.

280 citations


Journal ArticleDOI
TL;DR: Preliminary clinical and laboratory observations suggest that nifedipine might prevent progression of threatened myocardial infarction by reversing coronary spasm or might limit necrosis during the course of acuteMyocardial Infarction.
Abstract: Preliminary clinical and laboratory observations suggest that nifedipine might prevent progression of threatened myocardial infarction by reversing coronary spasm or might limit necrosis during the course of acute myocardial infarction. We screened 3143 patients with ischemic pain of greater than 45 min duration and randomly assigned 105 eligible patients with threatened myocardial infarction and 66 with acute myocardial infarction to receive nifedipine (20 mg orally every 4 hr for 14 days) or placebo plus standard care. Treatment was started 4.6 +/- 0.1 hr after the onset of pain. Infarct size index was calculated by the MB-creatine kinase (CK) method and expressed as CK-geq/m2 +/- SE. The incidence of progression to infarction among patients with threatened myocardial infarction was not significantly altered by nifedipine (36 of 48 [75%] for placebo-treated and 43 of 57 [75%] for nifedipine-treated patients). Furthermore, infarct size index was similar among placebo- and nifedipine-treated patients (16.9 +/- 1.5 MB-CK-geq/m2, n = 65, and 17.0 +/- 1.5 MB-CK-geq/m2, n = 68, respectively) with threatened myocardial infarction who exhibited infarction and for those with acute myocardial infarction. Among the 171 eligible patients randomly assigned to drug or placebo, 6 month mortality did not differ significantly (8.5% for placebo vs 10.1% for nifedipine, NS), but mortality in the 2 weeks after randomization was significantly higher for nifedipine-treated patients (0% for placebo compared with 7.9% for nifedipine, p = .018).(ABSTRACT TRUNCATED AT 250 WORDS)

276 citations


Journal ArticleDOI
TL;DR: Enalapril was evaluated in 36 patients with New York Heart Association functional class II to III heart failure who were clinically stable on digoxin and diuretic therapy and showed a significant improvement as judged by subjective patient impression, functional class, and exercise duration.
Abstract: A number of studies have shown short-term hemodynamic and symptomatic improvement in patients with congestive heart failure treated with angiotensin converting-enzyme inhibitors. The long-term efficacy of the oral long-acting converting-enzyme inhibitor enalapril remains to be established in controlled studies. We evaluated this drug in 36 patients with New York Heart Association functional class II to III heart failure who were clinically stable on digoxin and diuretic therapy. After baseline assessment of symptoms, exercise capacity, and results of echocardiographic examination and right heart catheterization, patients were randomly assigned to treatment with 5 mg enalapril twice daily (n = 18) or placebo (n = 18) in a double-blind fashion. The two groups had similar clinical, echocardiographic, and hemodynamic characteristics before treatment. After 3 months of treatment, the enalapril group showed a significant improvement as judged by subjective patient impression, functional class, and exercise duration (9.3 +/- 5.7 vs 17.6 +/- 5.6 min; p less than .001). Diuretic dosage was reduced in six patients and increased in one patient, one patient had died and another had been withdrawn from the study. In the placebo group there was no significant change with respect to patient impression, functional class, or exercise duration; diuretic dosage was increased in seven patients and four patients had died. Echocardiographic left ventricular dimensions were significantly reduced and left ventricular shortening fraction significantly increased in the enalapril group but were unchanged in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

261 citations


Journal ArticleDOI
TL;DR: Improvement in diarrhea was not associated with any change in stool weight but was associated with reductions in stool frequency, and incidence of urgency, which was the only symptom that was significantly more common in the success group, compared with the group who did not feel better on loperamide.
Abstract: Symptom scores, stool data, and the transit of a standard, solid meal were measured in 28 patients with irritable bowel syndrome (IBS) during baseline conditions and after five weeks of treatment with placebo and loperamide, given as a flexible dosage regime in the form of a double-blind, cross-over trial. All patients had undergone a comprehensive series of diagnostic investigations and had failed to respond to dietary supplementation with coarse wheat bran (10–30 g daily). Loperamide treatment accelerated gastric emptying, compared with placebo (1.2±0.1 vs 1.5±0.1 hr; P<0.001) and delayed both small bowel (6.2±0.3 vs 4.3±0.3 hr P<0.001) and whole gut transit (56±5 vs 42±4 hr; P<0.01). Eighteen patients said they felt better taking loperamide compared with placebo and, at follow up, 15 of these patients remained satisfied with the effects of the drug. Most symptoms improved significantly on placebo compared with the baseline period, but three of these [diarrhea (P<0.01), urgency (P<0.01) and borborygmi (P<0.05)] showed a further significant improvement on loperamide. Improvement in diarrhea was not associated with any change in stool weight but was associated with reductions in stool frequency (P<0.001), passage of unformed stools (P<0.01), and incidence of urgency (P<0.001). Urgency was the only symptom that was significantly more common in the success group, compared with the group who did not feel better on loperamide.

239 citations


Journal ArticleDOI
TL;DR: Oral acyclovir provides effective prophylaxis against reactivation of herpes simplex virus among severely immunosuppressed patients able to take orally administered drugs and was associated with significantly more rapid marrow engraftment in patients receiving methotrexate.
Abstract: Oral acyclovir was found to be safe and effective for the prevention of herpes simplex virus reactivation after marrow transplantation in a double-blind, placebo-controlled trial. Acyclovir or placebo was administered to 49 patients for 5 weeks beginning 1 week before transplantation: 5 of 24 patients receiving acyclovir developed herpes simplex virus infection during prophylaxis, compared to 17 of 25 patients receiving placebo (p less than 0.01). The median time to first virus reactivation was significantly longer among patients receiving acyclovir (78 days versus 9 days after transplant, p = 0.006). The effect was even more pronounced when the analysis was adjusted for drug compliance: Among patients taking a minimum of 40% of their prescribed drug, acyclovir was 96% virologically effective and 100% clinically effective during the period of administration. Acyclovir use was also associated with significantly more rapid marrow engraftment in patients receiving methotrexate. No virus resistant to acyclovir was isolated. Oral acyclovir provides effective prophylaxis against reactivation of herpes simplex virus among severely immunosuppressed patients able to take orally administered drugs.

Journal ArticleDOI
TL;DR: Although neither steroid improved short-term survival, oxandrolone therapy was associated with a beneficial effect on long- term survival, especially true in patients with moderate disease.
Abstract: A cooperative study was conducted to determine the efficacy of 30 days of treatment with either a glucocorticosteroid (prednisolone) or an anabolic steroid (oxandrolone) in moderate or severe alcoholic hepatitis. One hundred thirty-two patients with moderate disease and 131 with severe disease were randomly assigned to one of three treatments: prednisolone, oxandrolone, or placebo. During the 30 days, mortality in the groups receiving steroid therapy was not significantly different from mortality in the placebo group. Thirteen per cent of the moderately ill patients and 29 per cent of the severely ill patients died. Although neither steroid improved short-term survival, oxandrolone therapy was associated with a beneficial effect on long-term survival. This was especially true in patients with moderate disease: among those who survived for one or two months after the start of treatment the conditional six-month death rate was 3.5 per cent after oxandrolone and 19 to 20 per cent after placebo (P = 0.02). No consistent long-term effect was associated with prednisolone therapy.

Journal ArticleDOI
TL;DR: Phenelzine was superior to placebo on many measures, while the superiority of imipramine to placebo was confined to several variables, and trends toward superiority on several other measures.
Abstract: • Sixty patients meeting specific criteria for atypical depression completed six weeks of double-blind, randomly assigned treatment with phenelzine sulfate, imipramine hydrochloride, or placebo. The overall response rates were 67% with phenelzine, 43% with imipramine, and 29% with placebo. At week 6, phenelzine was superior to placebo on many measures, while the superiority of imipramine to placebo was confined to several variables. Phenelzine was superior to imipramine on the interpersonal sensitivity and paranola factors of the 90-Item Hopkins Symptom Checklist, with trends toward superiority on several other measures, while imipramine was not differentially superior on any measure. Atypical depressive patients with a history of spontaneous panic attacks and hysteroid dysphoric patients both showed extremely low rates of response to placebo and high rates of response to phenelzine. Conversely, those without panic or hysteroid dysphoric features responded equally to all three treatments. Responders to phenelzine also had greater platelet monoamine oxidase inhibition while receiving drug therapy than did nonresponders. Completion of the 120-patient sample will allow more detailed analyses.

Journal ArticleDOI
TL;DR: It was predicted, and found, that a significant proportion of patients who showed no clear-cut response at four weeks would show much improvement at six weeks in drug but not placebo conditions, and that this would be the case for patients receiving drug and patients receiving placebo.
Abstract: • Data from three six-week placebo-controlled randomized antidepressant trials were pooled to test the hypothesis that a four-week trial is insufficient to reach a determination of drug failure in depressed patients. We compared global clinical ratings at weekly intervals for patients receiving drug and patients receiving placebo and calculated the proportion of patients whose clinical status changed over time. We predicted, and found, that a significant proportion of patients who showed no clear-cut response at four weeks would show much improvement at six weeks in drug but not placebo conditions. Baseline Research Diagnostic Criteria diagnosis, baseline illness severity, and drug dose adjustments after four weeks did not predict either late clinical improvement or relapse between four and six weeks. Additional placebo-controlled studies are needed to replicate our findings concerning the advantage of extending trials to five or six weeks in samples of patients of various depressive subtypes.

Journal ArticleDOI
11 Feb 1984-BMJ
TL;DR: Clear evidence of the efficacy of dothiepin in psychogenic facial pain, though the drug may be needed for up to a year is shown, though an adverse life event before development of pain, minimal previous surgical treatment, and freedom from pain at nine weeks were strong prognostic indicators for success.
Abstract: Ninety three patients took part in a two centre double blind controlled clinical trial designed to assess the efficacy of dothiepin (Prothiaden) as compared with placebo and a soft biteguard in the treatment of psychogenic facial pain. The results showed the superiority of dothiepin over placebo in achieving pain relief; 71% of patients were pain free in the dothiepin group at nine weeks compared with 47% in the placebo group. The biteguard conferred no benefit and compliance in its use was poor. Out of 84 patients followed up for 12 months, 68 (81%) became pain free. An adverse life event before development of pain, minimal previous surgical treatment, and freedom from pain at nine weeks were strong prognostic indicators for successful treatment. These results are clear evidence of the efficacy of dothiepin in psychogenic facial pain, though the drug may be needed for up to a year.

Journal Article
TL;DR: It is concluded that weekly low dose MTX therapy is efficacious 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.

Journal ArticleDOI
TL;DR: Patients undergoing coronary artery bypass grafting were randomly assigned to receive prophylactic timolol or placebo, given in a double-blind fashion, and both groups were comparable for frequency of preoperative supraventricular arrhythmias, left ventricular ejection fraction, duration of cardiopulmonary bypass, aortic cross-clamp time, number of bypass grafts, and total duration of monitoring.
Abstract: Forty-one patients undergoing coronary artery bypass grafting were randomly assigned to receive prophylactic timolol or placebo, given in a double-blind fashion. beta-Adrenoceptor-blocking therapy was stopped at least one half-life before surgery. Three to 7 hr after surgery (304 +/- 56 min), 0.5 mg of timolol or placebo was given intravenously twice daily in a double-blind manner. When oral medications were resumed postoperatively, 10 mg of timolol twice daily or placebo was continued orally. Continuous electrocardiograms were recorded for 24 hr before and for 7 days after surgery with a standard cassette recorder. No patient received digoxin. Both groups were comparable for frequency of preoperative supraventricular arrhythmias, left ventricular ejection fraction, duration of cardiopulmonary bypass, aortic cross-clamp time, number of bypass grafts, and total duration of monitoring. Analysis of arrhythmias was done by hand counts, and supraventricular arrhythmias were divided into supraventricular tachycardia and atrial fibrillation and/or flutter. Timolol decreased the frequency of supraventricular tachycardia (581 episodes placebo vs 84 timolol; p less than .05) and of atrial fibrillation and/or flutter (291 episodes placebo vs five timolol; p less than .05). Timolol decreased the number of patients with severe (heart rate greater than 200 beats/min, duration greater than 50 beats) episodes of supraventricular tachycardia (four placebo vs 0 timolol; p less than .05) and also decreased the number of episodes of severe (heart rate greater than 200 beats/min, duration greater than 5 min) atrial fibrillation and/or flutter (16 placebo vs one timolol; p less than .005). There were differences in the durations of supraventricular arrhythmias.(ABSTRACT TRUNCATED AT 250 WORDS)

Journal ArticleDOI
TL;DR: The results suggest that the efficacy of DSCG in bronchial asthma might be related to its ability to suppress the local accumulation of eosinophils and specific-IgE antibodies.
Abstract: In a double-blind, placebo-controlled study, we measured the effect of disodium cromoglycate (DSCG) on leukocyte counts, total IgE, IgG, IgA, IgM, house dust mite-specific IgE, C3, and C4 in bronchoalveolar lavage (BAL) fluid and peripheral blood in 36 atopic, perennial asthmatic subjects (DSCG 19; placebo 17). Differential cell counts on bronchial mucus were also performed. The percentage of eosinophils in bronchial mucus and BAL fluid was significantly less after DSCG. There was also a significant decrease in the concentration of total IgA (expressed as an IgA/albumin ratio) in BAL fluid after a 28-day treatment with DSCG. When the DSCG-treated patients were divided into responders and nonresponders on the basis of average daily symptom scores, the responders had significantly less bronchial mucus eosinophils, BAL eosinophils, and house dust mite-specific IgE (but not IgA) after DSCG. No significant differences in any of the measurements were observed in the nonresponders or the placebo group similarly subdivided on the basis of symptom scores. These results suggest that the efficacy of DSCG in bronchial asthma might be related to its ability to suppress the local accumulation of eosinophils and specific-IgE antibodies.

Journal ArticleDOI
11 Feb 1984-BMJ
TL;DR: The significant therapeutic effect of placebo in restless legs showed that only double blind controlled trials can confirm the efficacy of suggested treatments.
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.

Journal ArticleDOI
TL;DR: Adverse reactions were related to dosage and generally could be managed by careful titration of dosage and use of antiparkinson drugs, except for an abnormal ECG in one patient.
Abstract: This double-blind, crossover, prospective study compared the efficacy and safety of pimozide to placebo in 20 patients with Tourette's syndrome (TS). The study included a 2–week drug-free period, random assignment to pimozide or placebo for 6 weeks and crossover to the alternate medication for a second 6–week period. Multiple dependent measures of efficacy at endpoint by the clinician, patient and judges were all highly significant (most p values = 0.0001). Adverse reactions, commonly encountered with antipsychotic drugs, were related to dosage and generally could be managed by careful titration of dosage and use of antiparkinson drugs, except for an abnormal ECG in one patient. This study confirms previous reports in the literature that pimozide is an effective drug for the treatment of TS. Future controlled studies should be conducted to evaluate whether pimozide is more effective and has less adverse effects than haloperidol and other drugs.

Journal ArticleDOI
01 Feb 1984-Gut
TL;DR: Coarse wheat bran was no better than placebo for most symptoms in irritable bowel syndrome, although its efficacy in constipation was confirmed, and it predicted a successful outcome with bran.
Abstract: The effect of open treatment with coarse wheat bran was compared with response to placebo, given in the form of a double blind, cross over drug trial, in patients with irritable bowel syndrome. Both bran and placebo significantly reduced the severity of most of the symptoms. Constipation was the only symptom that improved significantly with bran, but not with placebo, and was the only symptom that predicted a successful outcome with bran. Diarrhoea did not improve with bran. In fact, stools became less formed in patients presenting with this symptom. The incidence of pain and urgency was significantly more frequent on bran compared with placebo. Compared with a baseline period, bran treatment resulted in an acceleration of whole gut transit time (p less than 0.05) increases in daily stool weight (p less than 0.01) and the proportion of unformed stools (p less than 0.01) but no change in stool frequency. Coarse wheat bran was no better than placebo for most symptoms in irritable bowel syndrome, although its efficacy in constipation was confirmed.

Journal ArticleDOI
TL;DR: The thiazide effect seemed to be independent of urinary calcium, but was less beneficial in patients with hyperuricosuria, and the placebo group showed a substantial decrease in the expected number of new stones, emphasizing the importance of an adequate control group.
Abstract: Fifty recurrent stone formers were included in a double-blind randomized study (median 3 years) performed in a Norwegian general practice to compare twice daily administration of 25 mg hydrochlorothiazide versus placebo. The number of patients with new stones was significantly higher in the placebo group than in the thiazide group (p=0.05, one-tailed test). If a new stone was formed, thiazide, but not placebo, had the effect of prolonging the stone-free interval (p≤0.01). The probability of not forming a new stone during the treatment period was 45% for the placebo group and 75% for the thiazide group. The thiazide effect seemed to be independent of urinary calcium, but was less beneficial in patients with hyperuricosuria. The placebo group also showed a substantial decrease in the expected number of new stones (p≤0.01), emphasizing the importance of an adequate control group.

Journal ArticleDOI
TL;DR: The results of this study indicated that ami-triptyline hydrochloride at a dosage of 150 mg at bedtime had significant antidepressant activity in this group of patients and demonstrated considerable improvement in eating behavior.
Abstract: Bulimia is an eating disorder characterized by a pattern of episodic binge-eating. Patients with this eating disorder frequently demonstrate depressive symptoms when seen for evaluation. A familial association between bulimia and affective disorders has also been suggested. The authors report a placebo-controlled, double-blind trial of amitriptyline hydrochloride in a series of 32 female outpatients who satisfied DSM-III criteria for bulimia. The results of this study indicated that amitriptyline hydrochloride at a dosage of 150 mg at bedtime had significant antidepressant activity in this group of patients. Patients in both the placebo and active drug group also received a minimal behavioral treatment program in addition to drug therapy. Both groups demonstrated considerable improvement in eating behavior. The magnitude of this improvement was dramatic and not anticipated. The drug was well tolerated and was not associated with weight gain or increased carbohydrate craving.

Journal ArticleDOI
TL;DR: It is suggested that interferon might reduce exacerbations in certain patients and indicate guidelines for future trials of interferons in MS.
Abstract: A randomized, double-blind, placebo-controlled crossover study tested the efficacy of natural alpha interferon in altering exacerbating-remitting MS. Twenty-four patients with frequent exacerbations were treated for 6-month periods, beginning with either 5 × l06 IU of interferon daily or placebo. A 6-month washout period followed each treatment. Exacerbation rates were reduced during interferon and placebo phases compared with pre-study rates; a greater reduction occurred on interferon, particularly following placebo, possibly reflecting a learning phenomenon. Fifteen patients with a strictly exacerbating-remitting course had fewer and milder exacerbations on interferon compared with those on placebo, whereas 9 patients with a progressive component continued to have active disease. These results suggest that interferon might reduce exacerbations in certain patients and indicate guidelines for future trials of interferon in MS.

Journal ArticleDOI
TL;DR: It is concluded that timolol and propranolol are equally effective in the used doses (1:8) for common migraine prophylaxis.
Abstract: Common migraine sufferers (25 males, 71 females) with a history of 2-6 attacks per month participated in a 4-centre trial comparing the prophylactic effect of timolol (10 mg b.i.d.) and propranolol (80 mg b.i.d.) to placebo. After a pretreatment period of 4 weeks they entered a double-blind 3-way cross-over trial with 3 treatment periods of 12 weeks each. 83 patients received all 3 treatments. The mean frequency of attacks per 28 days was 3.35 on timolol, 3.69 on propranolol and 4.83 on placebo. Mean severity of attacks (0-3) was 1.75 on timolol, 1.83 on propranolol, and 1.93 on placebo. Mean duration of attacks was 7.41 h on timolol, 7.38 on propranolol and 7.95 on placebo. The headache index (frequency times severity) was 5.71 on timolol, 6.66 on propranolol and 9.03 on placebo (P less than 0.05, P less than 0.01 compared to placebo). The difference between propranolol and timolol was non-significant: frequency of attacks 0.34 (95% confidence limits - 0.26; 0.89). Headache index 0.95 propranolol and 23 patients on placebo experienced side effects (P less than 0.05). It is concluded that timolol and propranolol are equally effective in the used doses (1:8) for common migraine prophylaxis.

Journal ArticleDOI
TL;DR: It is demonstrated that phenelzine is significantly more effective than placebo in the treatment of bulimic patients capable of maintaining a tyramine-free diet and a place for MAOIs is suggested in the treated patients.
Abstract: Twenty bulimic women of normal weight participated in a double-blind trial studying the effects of a monoamine oxidase inhibitor (MAOI). Nine women received phenelzine sulfate and 11 received placebo. Although phenelzine's side effects were a problem, the phenelzine-treated patients reported significantly fewer binges per week and had a lower Eating Attitudes Test score. Five of the nine phenelzine-treated patients ceased binging entirely and the other four reduced their binge frequency by at least 50%; none of the 11 placebo-treated patients stopped binging and only two reduced their binge frequency by 50% or more. These data demonstrate that phenelzine is significantly more effective than placebo in the treatment of bulimic women of normal weight and suggest a place for MAOIs in the treatment of bulimic patients capable of maintaining a tyramine-free diet.

Journal ArticleDOI
TL;DR: A detailed analysis of the results of a multi-centre clinical trial shows that, while the relapse rate following recovery from an operationally defined depressive illness was smaller among patients subsequently treated with either amitryptiline or lithium than with a placebo, there was no clinically significant difference between the prophylactic efficacy of the 2 antidepressants.
Abstract: A detailed analysis of the results of a multi-centre clinical trial shows that, while the relapse rate following recovery from an operationally defined depressive illness was smaller among patients subsequently treated with either amitryptiline or lithium than with a placebo, there was no clinically significant difference between the prophylactic efficacy of the 2 antidepressants. An account is given of the relative adverse effects of the treatments, and the implications of the findings are discussed.

Journal ArticleDOI
TL;DR: The results do not support the use of propranolol administered four or more hours after the onset of symptoms to limit infarct size and no significant difference was observed in the change in left ventricular ejection fraction, extent of area involved in pyrophosphate uptake, R-wave loss on electrocardiograms, or mortality.
Abstract: A multicenter randomized single-blind study was performed to evaluate the effects of propranolol administered during the evolution of myocardial Infarction. Five centers enrolled a total of 269 patients, with 134 receiving propranolol and 135 placebo. Propranolol or placebo was given intravenously upon randomization (0.1 mg per kilogram of body weight) and then orally for nine days to keep the heart rate between 45 and 60 beats per minute. Less than 2 per cent of patients were treated within 4 hours after the onset of symptoms, but 50 per cent received therapy within 8 hours of onset of chest pain, and the remainder between 8 and 18 hours. The heart rates in the propranolol-treated group were significantly lower than those in the placebo group (P<0.001). Base-line characteristics, including the mean heart rate (79.6 vs. 81.3) and the left ventricular ejection fraction (49.0 vs. 49.5), were similar in the two groups. The primary end point evaluated — infarct size as estimated from plasma MB creati...

Journal ArticleDOI
TL;DR: Prophylactic oral acyclovir seems to be an effective treatment for patients with frequently recurring genital herpes.

Journal ArticleDOI
01 Apr 1984-Pain
TL;DR: New information is provided concerning the possible mechanism of cluster headache attacks and a new therapeutic approach is suggested that is comparable to ergotamine tartrate treatment.
Abstract: The pain relieving effect of somatostatin treatment during 72 attacks of cluster headache in 8 male patients was compared to treatment with ergotamine or placebo in a double-blind study. Infusion of somatostatin (25 μg/min for 20 min i.v.) reduced the maximal pain intensity and the duration of pain significantly compared to placebo treatment, and to a degree comparable to ergotamine tartrate treatment (250 μg i.m.). The results obtained provide new information concerning the possible mechanism of cluster headache attacks and suggest a new therapeutic approach.