Showing papers on "Placebo published in 1991"
TL;DR: There was an excess of deathsDue to arrhythmia and deaths due to shock after acute recurrent myocardial infarction in patients treated with encainide or flecainide.
Abstract: Background and Methods. In the Cardiac Arrhythmia Suppression Trial, designed to test the hypothesis that suppression of ventricular ectopy after a myocardial infarction reduces the incidence of sudden death, patients in whom ventricular ectopy could be suppressed with encainide, flecainide, or moricizine were randomly assigned to receive either active drug or placebo. The use of encainide and flecainide was discontinued because of excess mortality. We examined the mortality and morbidity after randomization to encainide or flecainide or their respective placebo. Results. Of 1498 patients, 857 were assigned to receive encainide or its placebo (432 to active drug and 425 to placebo) and 641 were assigned to receive flecainide or its placebo (323 to active drug and 318 to placebo). After a mean follow-up of 10 months, 89 patients had died: 59 of arrhythmia (43 receiving drug vs. 16 receiving placebo; P = 0.0004), 22 of nonarrhythmic cardiac causes (17 receiving drug vs. 5 receiving placebo; P = 0.0...
2,896 citations
TL;DR: The findings indicate that despite its beneficial hemodynamic actions, long-term therapy with oral milrinone increases the morbidity and mortality of patients with severe chronic heart failure.
Abstract: Background. Milrinone, a phosphodiesterase inhibitor, enhances cardiac contractility by increasing intracellular levels of cyclic AMP, but the long-term effect of this type of positive inotropic agent on the survival of patients with chronic heart failure has not been determined. Methods. We randomly assigned 1088 patients with severe chronic heart failure (New York Heart Association class III or IV) and advanced left ventricular dysfunction to double-blind treatment with 40 mg of oral milrinone daily (561 patients) or placebo (527 patients). In addition, all patients received conventional therapy with digoxin, diuretics, and a converting-enzyme inhibitor throughout the trial. The median period of follow-up was 6.1 months (range, 1 day to 20 months). Results. As compared with placebo, milrinone therapy was associated with a 28 percent increase in mortality from all causes (95 percent confidence interval, 1 to 61 percent; P = 0.038) and a 34 percent increase in cardiovascular mortality (95 percent...
2,108 citations
TL;DR: It is concluded that antihypertensive treatment in hypertensive men and women aged 70-84 confers highly significant and clinically relevant reductions in cardiovascular morbidity and mortality as well as in total mortality.
1,721 citations
TL;DR: A randomized, double-blind trial in patients with sepsis and a presumed diagnosis of gram-negative infection was conducted in this article, where the patients received either a single 100mg intravenous dose of HA-1A or placebo.
Abstract: Background HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with gram-negative bacteremia and endotoxemia Methods To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of gram-negative infection The patients received either a single 100-mg intravenous dose of HA-1A(in 35 g of albumin) or placebo (35 g of albumin) Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol Results Of 543 patients with sepsis who were treated, 200 (37 percent) had gram-negative bacteremia as proved by blood culture For the patients with gram-negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0014) For the patients with gram-negative bacteremia and sho
1,512 citations
TL;DR: The odds of suffering a major stroke, myocardial infarction or vascular death were 15% less in the combined aspirin groups compared with the placebo group which is compatible with the continuing overview of all the similar trials of antiplatelet drugs.
Abstract: From 1979-85, 2435 patients with a transient ischaemic attack or minor ischaemic stroke were randomly allocated to receive long term "blind" treatment with aspirin 600 mg twice daily (n = 815), aspirin 300 mg once daily (n = 806) or placebo (n = 814). No patient was lost to follow up. The "intention to treat" comparison included all the serious vascular events and deaths which occurred before the end of the follow up period on 30 September 1986. There was no difference in efficacy between the 300 mg and 1200 mg daily doses of aspirin, but the lower dose was undoubtedly less gastrotoxic. Also, there was no definite difference in the response of males and females to aspirin. The odds of suffering a major stroke, myocardial infarction or vascular death were 15% less in the combined aspirin groups compared with the placebo group (95% confidence interval 29% reduction to 3% increase in odds) which is compatible with the continuing overview of all the similar trials of antiplatelet drugs where the relative reduction in odds was 25%. There was no statistically significant reduction in the likelihood of either disabling major stroke and vascular death or vascular death occurring.
1,078 citations
TL;DR: It is concluded that sustained administration of desferrioxamine may slow the clinical progression of the dementia associated with AD.
666 citations
TL;DR: Evidence is provided that GM-1 enhances the recovery of neurologic function after one year in patients with spinal-cord injuries and that the increased recovery was attributable to initially paralyzed muscles that regained useful motor strength rather than to strengthening of paretic muscles.
Abstract: Background. Spinal-cord injury is devastating; until recently, there was no medical treatment to improve recovery of the initial neurologic deficit. Studies in animals have shown that monosialotetrahexosylganglioside (GM-1) ganglioside enhances the functional recovery of damaged neurons. Methods. A prospective, randomized, placebo-controlled, double-blind trial of GM-1 ganglioside was conducted in patients with spinal-cord injuries. Of 37 patients entered into the study, 34 (23 with cervical injuries and 11 with thoracic injuries) completed the test-drug protocol (100 mg of GM-1 sodium salt or placebo intravenously per day for 18 to 32 doses, with the first dose taken within 72 hours of the injury) and a one-year follow-up period. Neurologic recovery was assessed with the Frankel scale (comprising five categories) and the American Spinal Injury Association (ASIA) motor score (a scale of scores from 0 to 100, derived from strength tests of 20 specific muscles, each scored from 0 to 5). Results. Th...
521 citations
TL;DR: Preliminary analysis suggests that metronidazole was more effective in patients with disease confined to the large intestine or affecting both small and large bowel than in those with small bowel disease only.
Abstract: A double blind study compared the efficacy of metronidazole in two doses (20 mg/kg, 10 mg/kg) with placebo in patients with Crohn's disease One hundred and five patients participated but only 56 completed the 16 week study -21 were withdrawn for deterioration of symptoms, 17 for adverse experiences, and 11 for protocol violation Significant improvement in disease activity as measured by the Crohn's disease activity index (metronidazole 20 mg/kg, 97 units; metronidazole 10 mg/kg, 67 units; placebo -1 unit, p = 0002) and serum orosomucoid (metronidazole 20 mg/kg/day, 49; 10 mg/kg/day, 38; placebo, -9, p = 0001)) were detected Changes in C reactive protein concentrations did not achieve significance when all three groups were considered but were significant when all metronidazole treated patients were grouped and compared with the placebo treated patients (08 v -09, p less than 005) Although patients receiving metronidazole 20 mg/kg/day had a greater improvement in disease activity than those receiving 10 mg/kg/day (difference 30 units (95% confidence intervals -27-87), the small sample size may have precluded the detection of statistical significance Preliminary analysis suggests that metronidazole was more effective in patients with disease confined to the large intestine or affecting both small and large bowel than in those with small bowel disease only There were no differences in remission rates between metronidazole and placebo treated patients We conclude that metronidazole warrants further assessment in the treatment of patients with active Crohn's disease
488 citations
TL;DR: Melatonin may act as a phase-setter for sleep-wake cycles in subjects with a delayed sleep phase syndrome and is investigated by means of a randomised, double-blind, placebo-controlled trial.
412 citations
TL;DR: It is concluded that valproatets a useful new drug for the treatment of manic patients with acute manic episodes who had previously failed to respond to or to tolerate lithium carbonate.
Abstract: • We onducted a placeplacebo-controlled, double-blind valproate, iginally developed as an antiepileptic, patients with acute manic episodes who had previously failed to respond to or to tolerate lithium carbonate. Treatment duration was 7 to 21 days, with no other psychotropic medications permittedcept lorazepammg/d during the first 10 days of treatment. Serum valproateations were measured three times weekly; an unblindedator then adjusted dosage to produce serum concentrations between 50 and 100 mValproated superior to placebo in alleviating manic symptoms. The 17 patients randomized to active drug demonstrated a median 54% decrease in scores on the Young Mania Rating Scale as compared with a median 5.0%rease among the 19patients receiving placebo. On the 100-point Global Assessment Scale of overall psychiatric functioning, patients receiving vim-te proved by a median of 20 points as compared with a zero-point change with placebo. Significant differences also emerged on the Brief Psychiatric Rating Scale and in the number of supplemental doses of lorazepam by the patients in each group. Substantial antimanicappeared within 1 to 4 days of achieving therapeutic serum valproateations. Adverse effects were infrequent, with no adverse effect appearing significantly more frequently with valproateh placebo. We conclude that valproatets a useful new drug for the treatment of manic patients.
390 citations
TL;DR: It is confirmed that cyclosporin is a safe and effective short-term treatment for severe, refractory atopic dermatitis.
TL;DR: Ribavirin therapy resulted in a significant reduction in the risk of entering the oliguric phase and experiencing hemorrhage, and the only ribavirin-related side effect was a well-recognized, fully reversible anemia after completion of therapy.
Abstract: A prospective, randomized, double-blind, concurrent, placebo-controlled clinical trial of intravenous ribavirin (loading dose of 33 mg/kg, 16 mg/kg every 6 h for 4 days, and 8 mg/kg every 8 h for 3 days) was conducted in 242 patients with serologically confirmed hemorrhagic fever with renal syndrome (HFRS) in the People's Republic of China. Mortality was significantly reduced (sevenfold decrease in risk) among ribavirin-treated patients, when comparisons were adjusted for baseline risk estimators of mortality (P = .01; two-tailed). HFRS typically consists of five consecutive but frequently overlapping clinical phases. Only occurrence of oliguric phase and hemorrhage was associated with severity of clinical disease in the placebo group. Ribavirin therapy also resulted in a significant reduction in the risk of entering the oliguric phase and experiencing hemorrhage. The only ribavirin-related side effect was a well-recognized, fully reversible anemia after completion of therapy.
TL;DR: It is concluded that measures of HR variability are stable over short periods of time, and certain time and frequency domain variables are highly correlated and may serve as surrogates for each other, and no placebo effect on these variables is evident.
Abstract: Both time and frequency domain measures of heart rate (HR) variability have been used to assess autonomic tone in a variety of clinical conditions. Few studies in normal subjects have been performed to determine the stability of HR variability over time, or the correlation between and within time and frequency domain measures of HR variability. Fourteen normal subjects aged 20 to 55 years were studied with baseline and placebo 24-hour ambulatory electrocardiograms performed 3 to 65 days apart to assess the reproducibility of the following time domain measures of cycle length variability: the standard deviation of all normal cycle intervals; mean normal cycle interval; mean day normal cycle interval; night/day difference in mean normal cycle interval; root-mean-square successive cycle interval difference; percentage of differences between adjacent normal cycle length intervals that are >50 ms computed over the entire 24-hour electrocardiographic recording (proportion of adjacent intervals >50 ms); and the frequency domain measures of high (0.15 to 40 Hz), low (0.003 to 0.15) and total (0.003 to 0.40) power. The mean and standard deviations of these measures were virtually identical between placebo and baseline measurements and within the studied time range. Variables strongly dependent on vagal tone (high-frequency, low-frequency and total power, root-mean-square successive difference, and percentage of differences between adjacent normal cycle intervals >50 ms computed over the entire 24-hour electrocardiographic recording) were highly correlated (r > 0.8). It is concluded that measures of HR variability are stable over short periods of time. Certain time and frequency domain variables are highly correlated and may serve as surrogates for each other, and no placebo effect on these variables is evident.
TL;DR: The present study examined whether a high caffeine dose improved running and cycling performance and altered substrate metabolism in well-trained runners and found that it had no effect on respiratory exchange ratio or plasma free fatty acid data at rest or during exercise.
Abstract: The present study examined whether a high caffeine dose improved running and cycling performance and altered substrate metabolism in well-trained runners. Seven trained competitive runners [maximal O2 uptake (VO2max) 72.6 +/- 1.5 ml.kg-1.min-1] completed four randomized and double-blind exercise trials at approximately 85% VO2max; two trials running to exhaustion and two trials cycling to exhaustion. Subjects ingested either placebo (PL, 9 mg/kg dextrose) or caffeine (CAF, 9 mg/kg) 1 h before exercise. Endurance times were increased (P less than 0.05) after CAF ingestion during running (PL 49.2 +/- 7.2 min, CAF 71.0 +/- 11.0 min) and cycling (PL 39.2 +/- 6.5 min, CAF 59.3 +/- 9.9 min). Plasma epinephrine concentration [EPI] was increased (P less than 0.05) with CAF before running (0.22 +/- 0.02 vs. 0.44 +/- 0.08 nM) and cycling (0.31 +/- 0.06 vs. 0.45 +/- 0.06 nM). CAF ingestion also increased [EPI] (P less than 0.05) during exercise; PL and CAF values at 15 min were 1.23 +/- 0.13 and 2.51 +/- 0.33 nM for...
TL;DR: Data from these trials do not show that fluoxetine is associated with an increased risk of suicidal acts or emergence of substantial suicidal thoughts among depressed patients.
Abstract: OBJECTIVE--A comprehensive meta-analysis of clinical trial data was performed to assess the possible association of fluoxetine and suicidality (suicidal acts and ideation). DESIGN--Retrospective analysis of pooled data from 17 double blind clinical trials in patients with major depressive disorder comparing fluoxetine (n = 1765) with a tricyclic antidepressant (n = 731) or placebo (n = 569), or both. MAIN OUTCOME MEASURES--Multiple data sources were searched to identify patients with suicidal acts. Suicidal ideation was assessed with item 3 of the Hamilton depression rating scale, which systematically rates suicidality. Emergence of substantial suicidal ideation was defined as a change in the rating of this item from 0 or 1 at baseline to 3 or 4 during double blind treatment; worsening was defined as any increase from baseline; improvement was defined as a decrease from baseline at the last visit during the treatment. RESULTS--Suicidal acts did not differ significantly in comparisons of fluoxetine with placebo (0.2% v 0.2%, p = 0.494, Mantel-Haenszel adjusted incidence difference) and with tricyclic antidepressants (0.7% v 0.4%, p = 0.419). The pooled incidence of suicidal acts was 0.3% for fluoxetine, 0.2% for placebo, and 0.4% for tricyclic antidepressants, and fluoxetine did not differ significantly from either placebo (p = 0.533, Pearson's chi 2) or tricyclic antidepressants (p = 0.789). Suicidal ideation emerged marginally significantly less often with fluoxetine than with placebo (0.9% v 2.6%, p = 0.094) and numerically less often than with tricyclic antidepressants (1.7% v 3.6%, p = 0.102). The pooled incidence of emergence of substantial suicidal ideation was 1.2% for fluoxetine, 2.6% for placebo, and 3.6% for tricyclic antidepressants. The incidence was significantly lower with fluoxetine than with placebo (p = 0.042) and tricyclic antidepressants (p = 0.001). Any degree of worsening of suicidal ideation was similar with fluoxetine and placebo (15.4% v 17.9%, p = 0.196) and with fluoxetine and tricyclic antidepressants (15.6% v 16.3%, p = 0.793). The pooled incidence of worsening of suicidal ideation was 15.3% for fluoxetine, 17.9% for placebo, and 16.3% for tricyclic antidepressants. The incidence did not differ significantly with fluoxetine and placebo (p = 0.141) or tricyclic antidepressants (p = 0.542). Suicidal ideation improved significantly more with fluoxetine than with placebo (72.0% v 54.8%, p less than 0.001) and was similar to the improvement with tricyclic antidepressants (72.5% v 69.8%, p = 0.294). The pooled incidence of improvement of suicidal ideation was 72.2% for fluoxetine, 54.8% for placebo, and 69.8% for tricyclic antidepressants. The incidence with fluoxetine was significantly greater than with placebo (p less than 0.001) and did not differ from that with tricyclic antidepressants (p = 0.296). CONCLUSIONS--Data from these trials do not show that fluoxetine is associated with an increased risk of suicidal acts or emergence of substantial suicidal thoughts among depressed patients.
TL;DR: Sumatriptan is effective and well tolerated in patients with acute migraine and reduced nausea and photophobia significantly better than placebo.
Abstract: Sumatriptan succinate, a 5-HT 1D receptor agonist, constricts human cranial arteries. Two parallel-group trials for treatment of acute migraines were conducted in the United States. Adult patients were randomized and given either 6 mg of sumatriptan succinate subcutaneously (n = 734) or placebo (n = 370). At 1 hour, sumatriptan was significantly more effective than placebo in reducing moderate or severe headache pain to mild or no pain (70% vs 22%), in completely relieving headaches (49% vs 9%), and in improving clinical disability (76% vs 34%). Sumatriptan also reduced nausea and photophobia significantly better than placebo. Patients with residual migraines received another injection; those who had originally received sumatriptan received either a second active injection (n = 187) or placebo (n = 178), while those who had received placebo received a second placebo injection (n = 335). Statistical evidence for benefit of second sumatriptan injection is absent. Adverse events associated with sumatriptan were tingling, dizziness, warm-hot sensations, and injection-site reactions. Sumatriptan is effective and well tolerated in patients with acute migraine. ( JAMA . 1991;265:2831-2835)
TL;DR: Analysis for the 65 patients who completed the trial showed a significant beneficial effect of tacrine over placebo in the MMSE score, and the main outcome measures were the mini mental state examination (MMSE), the abbreviated mental test score (AMTS), and the carer's rating of the activities of daily living scale.
TL;DR: The efficacy of epidural injections of 80 mg triamcinolone acetonide plus 0.5% procaine hydrochloride in saline, administered via the caudal route in a double-blind, placebo controlled trial with 1 year follow-up is assessed.
Abstract: The management of sciatica due to lumbar nerve root compromise remains controversial, probably because few well-controlled studies of conservative management have been performed. This preliminary study assesses the efficacy of epidural injections of 80 mg triamcinolone acetonide plus 0.5% procaine hydrochloride in saline, administered via the caudal route, in a double-blind, placebo controlled trial with 1 year follow-up. Twenty-three patients were entered into the study: 12 received treatment and 11 placebo. The active group showed significant pain relief (P = 0.02) and a significant increase in mobility (P = 0.01) at 4 weeks, which resulted in improved quality of life (P = 0.02). At 1 year, subjective and objective measures improved in both groups. The improvement was greater in the actively treated group, but only the objective assessment (straight leg raise) was statistically significant.
TL;DR: All transdermal nicotine doses significantly decreased the severity of nicotine withdrawal symptoms and significantly reduced cigarette use by patients who did not stop smoking.
Abstract: Objective. —To evaluate the efficacy of a new transdermal nicotine system for smoking cessation. Design. —Two 6-week, randomized, double-blind, placebo-controlled, parallel group trials were conducted. Successful abstainers from both trials enrolled in a third trial for blinded downtitration from medications (6 weeks) and subsequent off-drug follow-up (12 weeks). Setting. —Nine outpatient clinics specializing in the treatment of smoking cessation. Patients. —Healthy volunteers who smoked one or more packs of cigarettes daily and wanted to participate in a smoking cessation program. Intervention. —Patients were randomly assigned to a transdermal nicotine system delivering nicotine at rates of 21,14, or 7 mg (in trial 1 only) over 24 hours or to placebo. Group counseling sessions were provided to all participants. Main Outcome Measure. —Rates of continuous smoking abstinence were determined during 6 weeks of full-dose treatment, a 6-week weaning period (through week 12), and a 3-month follow-up receiving no therapy (through week 24). Abstinence was defined by patient diary reports of no smoking during the designated periods, confirmed by expired-breath carbon monoxide levels of 8 ppm or lower. Results. —The centers enrolled 935 patients. Cessation rates during the last 4 weeks of the two 6-week trials (pooled data) were 61%, 48%, and 27% for 21-and 14-mg transdermal nicotine and placebo, respectively ( P ≤.001 for each active treatment vs placebo). Six-month abstinence rates for 21-mg transdermal nicotine and placebo were 26% and 12%, respectively ( P ≤.001). All transdermal nicotine doses significantly decreased the severity of nicotine withdrawal symptoms and significantly reduced cigarette use by patients who did not stop smoking. Compliance was excellent, and no serious systemic adverse effects were reported. Conclusions. —Transdermal nicotine systems show considerable promise as an aid to smoking cessation. ( JAMA . 1991;266:3133-3138)
TL;DR: The nicotine skin patch proved to be safe and effective, as demonstrated by a higher rate of abstinence than with placebo, which is lower than the rate in studies that have combined the use of nicotine chewing gum with behavioral therapy.
Abstract: Background. The use of nicotine chewing gum combined with psychological support improves the success rate in quitting smoking. We studied the safety and efficacy of a transdermal nicotine patch in smoking cessation. Methods. We conducted a double-blind randomized study comparing the effects of a 16-hour nicotine patch (15±3.5 mg of nicotine in 16 hours) with those of a placebo patch. Of the 289 smokers (207 women and 82 men) enrolled in the study, 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks. Results. Rates of sustained abstinence were significantly better with active treatment than with placebo: 53, 41, 24, and 17 percent of those in the nicotine-patch group were abstinent after 6,12, 26, and 52 weeks, respectively, as compared with 17, 10, 5, and 4 percent of those in the placebo-patch group (P<0.0001). Only two subjects with the nicotine patch and one with the placebo patch had to withdraw from the study because of side effects. Conclusions. The nicotine ski...
Journal Article•
TL;DR: It is concluded that capsaicin cream is a safe and effective treatment for arthritis and means reductions in pain were statistically significant compared with those reported with placebo.
TL;DR: Desipramine relieves pain in many patients with painful diabetic neuropathy, offering an alternative for patients unable to tolerate amitriptyline, and blockade of norepinephrine reuptake may mediate this analgesic effect.
Abstract: Although amitriptyline relieves pain in many patients with painful diabetic neuropathy, side effects often preclude effective treatment. Desipramine has the least anticholinergic and sedative effects of the first generation tricyclic antidepressants. We compared a 6 week course of desipramine (mean dose, 201 mg/day) to active placebo in 20 patients with painful diabetic neuropathy in a double-blind crossover trial. Pain relief with desipramine was statistically significant in weeks 5 and 6. Eleven patients reported at least moderate relief with desipramine, compared to 2 with placebo. Pain relief tended to be greater in depressed patients, but relief was also observed in patients who did not show an antidepressant effect. We conclude that desipramine relieves pain in many patients with painful diabetic neuropathy, offering an alternative for patients unable to tolerate amitriptyline. Blockade of norepinephrine reuptake, an action shared by desipramine, amitriptyline, and other antidepressants proven effective in neuropathic pain, may mediate this analgesic effect.
TL;DR: CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with Huntington's Disease.
Abstract: Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.
TL;DR: Significant perceived symptom 'costs' of tamoxifen therapy in postmenopausal women, of a magnitude likely to compromise long-term compliance, are suggested.
Abstract: Adjuvant breast cancer therapy with tamoxifen is associated with greater disease-free survival and possibly overall survival. Long-term treatment, possibly of indefinite duration, is being evaluated. Compliance with long-term therapy will depend largely on the nature and severity of tamoxifen's side effects. We evaluated the symptoms associated with tamoxifen therapy in 140 postmenopausal women with axillary node negative breast cancer in remission (mean years since menopause, 9.3) enrolled in a placebo-controlled, randomized toxicity study. Tamoxifen recipients reported moderate or severe vasomotor symptoms up to 17%, and gynecologic symptoms up to 4% more frequently than placebo subjects. Persistent vasomotor, gynecologic, or other major side effects were reported by 48% of tamoxifen recipients, and by 21% of placebo subjects. These carefully collected data suggest significant perceived symptom 'costs' of tamoxifen therapy in postmenopausal women, of a magnitude likely to compromise long-term compliance. ( Arch Intern Med. 1991;151:1842-1847)
TL;DR: Clear evidence of a therapeutic response to strontium-89 compared with only a limited placebo effect was found in a prospective double-blind crossover study comparing it with stablestrontium as placebo in 32 patients with prostate cancer metastatic to bone.
TL;DR: In patients with AIDS, silent persistent infection is common after clinically successful treatment for cryptococcal meningitis, and maintenance therapy with fluconazole is highly effective in preventing recurrent cryptococ CAL infection.
Abstract: Background and Methods. In patients with the acquired immunodeficiency syndrome (AIDS), the rate of relapse after primary treatment for cryptococcal meningitis remains high. We conducted a controlled, doubleblind trial to evaluate the efficacy of maintenance therapy with fluconazole. At entry into the study, all participants had sterile cultures of cerebrospinal fluid, blood, and urine after following a standardized course of therapy for culture-proved cryptococcal meningitis. The patients were randomly assigned to take either fluconazole or placebo as maintenance therapy. The dose of fluconazole was 100 mg daily in the first phase of the study and 200 mg daily in the second phase. Results. Of 84 patients initially enrolled, 16 (19 percent) were found to have silent, persistent infection on the basis of cultures that became positive after entry into the study; 7 other patients were lost to follow-up shortly after entry. Of the remaining 61 patients, 10 of 27 assigned to placebo (37 percent) and 1...
TL;DR: Oxybutynin has statistically significant effects on subjective symptoms and objective urodynamic parameters in patients with detrusor hyperactivity compared to propantheline.
TL;DR: Obstructive and irritative symptoms, assessed according to the Boyarsky scale, significantly improved in the alfuzosin group compared with the placebo group, and mean urinary flow rates had increased.
TL;DR: The clinical efficacy of a herbomineral formulation containing roots of Withania somnifera, the stem of Boswellia serrata, rhizomes of Curcuma longa and a zinc complex, was evaluated in patients with osteoarthritis.
TL;DR: It is concluded that gastroesophageal reflux can play a significant role in some patients with nonallergic pulmonary disease and that its treatment can improve pulmonary symptoms and objective measurements of pulmonary function.