Showing papers on "Randomized controlled trial published in 1992"
TL;DR: Finding and analyzing all therapeutic trials in a given field has become such a difficult and specialized task that the clinical experts called on to summarize the evidence in a timely fashion need access to better databases and new statistical techniques to assist them.
Abstract: Objective —To examine the temporal relationship between accumulating data from randomized control trials of treatments for myocardial infarction and the recommendations of clinical experts writing review articles and textbook chapters Data Sources —(1) MEDLINE search from 1966 to present; search terms used were myocardial infarction, clinical trials, multicenter studies, double-blind method, meta-analysis , and the text word "random:"; (2) references from pertinent articles and books; and (3) all editions of English-language general medical texts and manuals and review articles on treatment of myocardial infarction Study Selection —Randomized control trials of therapies for reducing the risk of total mortality in myocardial infarction (acute and secondary prevention) Review articles and textbook chapters dealing with the general clinical management of patients with myocardial infarction Data Extraction —Two authors read the material and recorded the results; disagreements were resolved by conference Data Synthesis —We used the technique of cumulative meta-analysis (performing a new meta-analysis when the results of a new clinical trial are published) and compared the results with the recommendations of the experts for various treatments for myocardial infarction Discrepancies were detected between the meta-analytic patterns of effectiveness in the randomized trials and the recommendations of reviewers Review articles often failed to mention important advances or exhibited delays in recommending effective preventive measures In some cases, treatments that have no effect on mortality or are potentially harmful continued to be recommended by several clinical experts Conclusions —Finding and analyzing all therapeutic trials in a given field has become such a difficult and specialized task that the clinical experts called on to summarize the evidence in a timely fashion need access to better databases and new statistical techniques to assist them in this important task ( JAMA 1992;268:240-248)
1,405 citations
Journal Article•
TL;DR: The Danish Breast Cancer Cooperative Group (DBCG) conducted a randomized trial comparing breast conservation with mastectomy in patients with invasive mammary carcinoma from January 1983 to March 1989 as mentioned in this paper.
Abstract: The Danish Breast Cancer Cooperative Group (DBCG) conducted a randomized trial comparing breast conservation with mastectomy in patients with invasive mammary carcinoma. From January 1983 to March 1989, the trial accrued a total of 1153 women. Of this number, 905 patients (79%) were randomly assigned to one of the two treatment options, whereas 248 patients (21%) did not accept randomization. Of the randomly assigned patients, 90% received the surgical option to which they had been originally assigned. In the breast conservation arm the tumor was excised with the intention of obtaining free margins determined at gross examination, and radiotherapy was subsequently administered to residual breast tissue. The axilla was dissected in all instances. Patient and tumor characteristics were similar in the two randomization arms. The median follow-up time was 40 months. At 6 years of life-table analysis the probability of recurrence-free survival was 70% in the breast conservation arm against 66% in the mastectomy arm. Survival figures were 79% against 82%, respectively.
578 citations
TL;DR: In men with complicated gastroesophageal reflux disease, surgery is significantly more effective than medical therapy in improving the symptoms and endoscopic signs of esophagitis for up to two years, although medical treatment is also effective.
Abstract: Background. Conventional medical treatment for gastroesophageal reflux disease involves lifestyle modifications and combination drug therapy, but few studies have included these features in their protocols. Antireflux surgery has seldom been studied prospectively, and there have been no trials comparing modern medical and surgical treatments for reflux disease. Methods. We conducted a long-term, randomized trial of medical therapy (lifestyle modifications and up to four medications) and surgical therapy (Nissen fundoplication) in 247 patients (243 men and 4 women) with peptic esophageal ulcer, stricture, erosive esophagitis, or Barrett's esophagus. They received by random assignment either continuous medical therapy, medical therapy for symptoms only, or surgical therapy. Symptoms were assessed quarterly with a disease-activity index; esophagoscopy was performed at base line and each year for two years. The outcomes evaluated at one and two years included the activity index and the endoscopic gra...
540 citations
TL;DR: The graded activity program made the patients occupationally functional again, as measured by return to work and significantly reduced long-term sick leave.
Abstract: The aim of this study was to determine whether graded activity restored occupational function in industrial blue-collar workers who were sick-listed for 8 weeks because of subacute, nonspecific, mechanical low back pain (LBP). Patients with LBP, who had been examined by an orthopedic surgeon and a social worker, were randomly assigned to either an activity group (n = 51) or a control group (n = 52). Patients with defined orthopedic, medical, or psychiatric diagnoses were excluded before randomization. The graded activity program consisted of four parts: (1) measurements of functional capacity; (2) a work-place visit; (3) back school education; and (4) an individual, submaximal, gradually increased exercise program, with an operant-conditioning behavioral approach, based on the results of the tests and the demands of the patient's work. Records of the amount of sick leave taken over a 3-year period (ie, the 1-year periods before, during, and after intervention) were obtained from each patient's Social Insurance Office. The patients in the activity group returned to work significantly earlier than did the patients in the control group. The median number of physical therapist appointments before return to work was 5, and the average number of appointments was 10.7 (SD = 12.3). The average duration of sick leave attributable to LBP during the second follow-up year was 12.1 weeks (SD = 18.4) in the activity group and 19.6 weeks (SD = 20.7) in the control group. Four patients in the control group and 1 patient in the activity group received permanent disability pensions. The graded activity program made the patients occupationally functional again, as measured by return to work and significantly reduced long-term sick leave.
529 citations
TL;DR: Low-dose heparin should be preferred to prednisone when treatment is indicated for high-risk pregnant women with antiphospholipid antibodies, and these results could be generalized to the other groups of women ascertained during the course of the study.
522 citations
TL;DR: Methotrexate given weekly in low doses is an effective treatment for children with resistant juvenile rheumatoid arthritis, and at least in the short term this regimen is safe.
Abstract: Background. The antimetabolite methotrexate has been shown in placebo-controlled trials to be effective in adults with rheumatoid arthritis. Methotrexate may also be effective in children with resistant juvenile rheumatoid arthritis, but the supporting data are from uncontrolled trials. Methods. Centers in the United States and the Soviet Union participated in this randomized, controlled, double-blind trial designed to evaluate the effectiveness and safety of orally administered methotrexate. Patients received one of the following treatments each week for six months: 10 mg of methotrexate per square meter of body-surface area (low dose), 5 mg of methotrexate per square meter (very low dose), or placebo. The use of prednisone (≤10 mg per day) and two nonsteroidal antiinflammatory drugs was also allowed. Results. The 127 children (mean age, 10.1 years) had a mean duration of disease of 5.1 years; 114 qualified for the analysis of efficacy. According to a composite index of several response variable...
522 citations
TL;DR: To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women, a systematic search of the English-language literature was conducted.
Abstract: Objective —To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women Data Sources —We conducted a systematic search of the English-language literature from January 1960 through September 1991 to identify all relevant studies of specific pharmacotherapies employed in the treatment of acute myocardial infarction To accomplish this, we searched MEDLINE, major cardiology textbooks, meta-analyses, reviews, editorials, and the bibliographies of all identified articles Study Selection —Only trials in which patients were randomly allocated to receive a specific therapeutic regimen or a placebo or nonplacebo control regimen were included for review Data Extraction —Studies were abstracted for year of publication, source of support, performance location, drug therapies to which patients were randomized, use of invasive diagnostic tests or therapeutic procedures, exclusion criteria, size and demographic characteristics of the randomized study population, and principal outcome measures Data Synthesis —A total of 214 trials met inclusion criteria, involving 150920 study subjects Over 60% of trials excluded persons over the age of 75 years Studies published after 1980 were more likely to have age-based exclusions compared with studies published before 1980 (adjusted odds ratio, 492; 95% confidence interval, 233 to 1054) Trials of thrombolytic therapy involving an invasive procedure were more likely to exclude elderly patients compared with other studies (adjusted odds ratio, 245; 95% confidence interval, 110 to 547) Studies with age-based exclusions had a smaller percentage of women compared with those without such exclusions (18% vs 23%; P =0002), with the mean age of the study population significantly associated with the proportion of women participants ( P =0001, R 2 =29) Conclusions —Age-based exclusions are frequently used in clinical trials of medications used in the treatment of acute myocardial infarction Such exclusions limit the ability to generalize study findings to the patient population that experiences the most morbidity and mortality from acute myocardial infarction ( JAMA 1992;268:1417-1422)
517 citations
TL;DR: A program of supervised fitness walking and patient education can improve functional status without worsening pain or exacerbating arthritis-related symptoms in patients with osteoarthritis of the knee.
Abstract: Objective To assess the effect of a program of supervised fitness walking and patient education on functional status, pain, and use of medication in patients with osteoarthritis of the knee. Design An 8-week randomized, controlled trial. Setting Inpatient and outpatient services of an orthopedic hospital in an academic medical center. Patients A total of 102 patients with a documented diagnosis of primary osteoarthritis of one or both knees participated in the study. Data were obtained on 47 of 51 intervention patients and 45 of 51 control patients. Interventions An 8-week program of supervised fitness walking and patient education or standard routine medical care. Measurements Patients were evaluated and outcomes assessed before and after the intervention using a 6-minute test of walking distance and scores on the physical activity, arthritis impact, pain, and medication subscales of the Arthritis Impact Measurement Scale (AIMS). Results Patients randomly assigned to the walking program had a 70-meter increase in walking distance relative to their baseline assessment, which represents an improvement of 18.4% (95% Cl, 9.8% to 27.0%). In contrast, controls showed a 17-meter decrease in walking distance relative to their baseline assessment (P less than 0.001). Improvements in functional status as measured by the AIMS physical activity subscale were also observed in the walking group but not in the control group (P less than 0.001); patients assigned to the walking program improved 39% (Cl, 15.6% to 60.4%). Although changes in scores on the arthritis impact subscale were similar in the two groups (P = 0.093), the walking group experienced a decrease in arthritis pain of 27% (Cl, 9.6% to 41.4%) (P = 0.003). Medication use was less frequent in the walking group than in the control group at the post-test (P = 0.08). Conclusions A program of supervised fitness walking and patient education can improve functional status without worsening pain or exacerbating arthritis-related symptoms in patients with osteoarthritis of the knee.
496 citations
TL;DR: A novel design for intervention studies is presented, the so called PROBE study (Prospective Randomized Open, Blinded End-point), which is compared to the classical double-blind design.
Abstract: A novel design for intervention studies is presented, the so called PROBE study (Prospective Randomized Open, Blinded End-point). This design is compared to the classical double-blind design. Among the advantages of the PROBE design are lower cost and greater similarity to standard clinical practice, which should make the results more easily applicable in routine medical care. Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard.
487 citations
TL;DR: It is suggested that composition of dietary PUFA may influence CVD and cancer rates and support reports that n-3 fatty acids are protective against CVD.
Abstract: This evaluation of the Multiple Risk Factor Intervention Trial database investigated the effects of dietary PUFA on disease outcomes that may relate to polyunsaturated fatty acid (PUFA) biochemistry. The Multiple Risk Factor Intervention Trial was a randomized clinical trial in coronary heart disease (CHD) primary prevention involving 12,866 middle-aged men determined to be at high risk of CHD. They were assigned to either a special intervention group or a usual care group and returned to clinics on an annual basis for assessment of risk factor status. Only data on the usual care men (n = 6,250) are presented, since the multi-intervention effects on the special intervention group introduce considerable analytic complexities. Mean PUFA intake estimates were calculated from four dietary recall interviews at baseline and follow-up Years 1, 2, and 3 and estimates for PUFA were established using absolute grams, percentage of total kilocalories, and ratios. Proportional hazards regression analysis controlling for age, race and baseline diastolic blood pressure, smoking, high and low density lipoprotein cholesterol levels, and alcohol was used to analyze dietary PUFA intakes on 10.5-year mortality rates. Results were more significant when PUFA were expressed as percentage of total kilocalories. No significant associations with mortality were detected for linoleic acid (18:2n-6), the predominant dietary PUFA.(ABSTRACT TRUNCATED AT 250 WORDS)
450 citations
TL;DR: Treatment with plasmapheresis plus a standard regimen of prednisone and cyclophosphamide therapy does not improve the clinical outcome in patients with systemic lupus erythematosus and severe nephritis, as compared with the standard regimen alone.
Abstract: Background. The prognosis of patients with systemic lupus erythematosus who have glomerulonephritis is poor, despite treatment with immunosuppressive therapy. Plasmapheresis therapy has been used, but there have been few controlled clinical observations of its efficacy. Methods We carried out a randomized, controlled trial comparing a standard-therapy regimen of prednisone and cyclophosphamide (standard therapy) with a regimen of standard therapy plus plasmapheresis in 86 patients with severe lupus nephritis in 14 medical centers. The patients underwent plasmapheresis three times weekly for four weeks. Drug therapy was standardized, with strict adherence to nine detailed medical-management protocols. Results Forty-six patients received standard therapy, and 40 patients received standard therapy plus plasmapheresis. The mean follow-up was 136 weeks. Six patients (13 percent) in the standard-therapy group and eight patients (20 percent) in the plasmapheresis group died. Renal failure developed in 8...
Journal Article•
TL;DR: Tumor size was found in univariate analysis to be a significant risk factor for local recurrence in the breast-conserving therapy group but not in the mastectomy group, and Measurements of quality of life and cosmesis show a clear benefit for the Breast-conserve therapy group.
Abstract: In a prospective randomized clinical trial conducted by the European Organization for Research and Treatment of Cancer (EORTC), mastectomy was compared with breast-conserving therapy in 903 stage I and stage II breast cancer patients entering the study between 1980 and 1986. The main participating centers were: Guy's Hospital, London; The Netherlands Cancer Institute, Amsterdam; University Hospital, Leuven; Radiotherapy Institute, Rotterdam; Breast Unit, Tijgerberg, S.A. The data were collected in the EORTC Data Center, Brussels. Treatment in the study arm consisted of lumpectomy, axillary clearance, and radiotherapy to the breast (50 Gy external irradiation in 5 weeks followed by boost with iridium implant of 25 Gy). Important in this study is the large number of TNM stage II patients (755). Most patients were stage II because of the size of the tumor (2-5 cm). The patient and tumor characteristics in the study and control groups were well balanced. So far the survival curves and local recurrence rates are not statistically different for the two study arms. Tumor size was found in univariate analysis to be a significant risk factor for local recurrence in the breast-conserving therapy group but not in the mastectomy group. Results of salvage treatment for local recurrence were not better for the breast-conserving therapy group compared with the mastectomy group. Measurements of quality of life and cosmesis show a clear benefit for the breast-conserving therapy group.
TL;DR: The early treatment diabetic retinopathy study (ETDRS) as mentioned in this paper was a randomized clinical trial of aspirin vs placebo, which was sponsored by the National Eye Institute (NIEI).
Abstract: Objectives. —This report presents information on the effects of aspirin on mortality, the occurrence of cardiovascular events, and the incidence of kidney disease in the patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS). Study Design. —This multicenter, randomized clinical trial of aspirin vs placebo was sponsored by the National Eye Institute. Patients. —Patients (N=3711) were enrolled in 22 clinical centers between April 1980 and July 1985. Men and women between the ages of 18 and 70 years with a clinical diagnosis of diabetes mellitus were eligible. Approximately 30% of all patients were considered to have type I diabetes mellitus, 31% type II, and in 39% type I or II could not be determined definitely. Intervention. —Patients were randomly assigned to aspirin or placebo (two 325-mg tablets once per day). Main Outcome Measures. —Mortality from all causes was specified as the primary outcome measure for assessing the systemic effects of aspirin. Other outcome variables included cause-specific mortality and cardiovascular events. Results. —The estimate of relative risk for total mortality for aspirin-treated patients compared with placebo-treated patients for the entire study period was 0.91 (99% confidence interval, 0.75 to 1.11). Larger differences were noted for the occurrence of fatal and nonfatal myocardial infarction; the estimate of relative risk was 0.83 for the entire follow-up period (99% confidence interval, 0.66 to 1.04). Conclusions. —The effects of aspirin on any of the cardiovascular events considered in the ETDRS were not substantially different from the effects observed in other studies that included mainly nondiabetic persons. Furthermore, there was no evidence of harmful effects of aspirin. Aspirin has been recommended previously for persons at risk for cardiovascular disease. The ETDRS results support application of this recommendation to those persons with diabetes at increased risk of cardiovascular disease. (JAMA. 1992;268:1292-1300)
Journal Article•
TL;DR: The Danish Breast Cancer Cooperative Group (DBCG) conducted a randomized trial comparing breast conservation with mastectomy in patients with invasive mammary carcinoma, where the probability of recurrence-free survival was 70% in the breast conservation arm against 66%" in the mastectomy arm.
Abstract: The Danish Breast Cancer Cooperative Group (DBCG) conducted a randomized trial comparing breast conservation with mastectomy in patients with invasive mammary carcinoma. From January 1983 to March 1989, the trial accrued a total of 1153 women. Of this number, 905 patients (79%) were randomly assigned to one of the two treatment options, whereas 248 patients (21%) did not accept randomization. Of the randomly assigned patients, 90% received the surgical option to which they had been originally assigned. In the breast conservation arm the tumor was excised with the intention of obtaining free margins determined at gross examination, and radiotherapy was subsequently administered to residual breast tissue. The axilla was dissected in all instances. Patient and tumor characteristics were similar in the two randomization arms. The median follow-up time was 40 months. At 6 years of life-table analysis the probability of recurrence-free survival was 70% in the breast conservation arm against 66% in the mastectomy arm. Survival figures were 79% against 82%, respectively.
TL;DR: Clinicians' views of drug therapies are affected by the common use of relative risk reductions in both trial reports and advertisements, by end-point emphasis, and, above all, by underuse of summary measures that relate treatment burden to therapeutic yields in a clinically relevant manner.
Abstract: ▪Objective:To compare clinicians' ratings of therapeutic effectiveness when different trial end points were presented as percent reductions in relative compared with absolute risk and as n
TL;DR: A detailed study was carried out of recovery of arm function after acute stroke, and compares orthodox physiotherapy with an enhanced therapy regime which increased the amount of treatment as well as using behavioural methods to encourage motor learning.
Abstract: Previous research on stroke rehabilitation has not established whether increase in physical therapy lead to better intrinsic recovery from hemiplegia. A detailed study was carried out of recovery of arm function after acute stroke, and compares orthodox physiotherapy with an enhanced therapy regime which increased the amount of treatment as well as using behavioural methods to encourage motor learning. In a single-blind randomised trial, 132 consecutive stroke patients were assigned to orthodox or enhanced therapy groups. At six months after stroke the enhanced therapy group showed a small but statistically significant advantage in recovery of strength, range and speed of movement. This effect seemed concentrated amongst those who had a milder initial impairment. More work is needed to discover the reasons for this improved recovery, and whether further development of this therapeutic approach might offer clinically significant gains for some patients.
TL;DR: Treatment with prednisolone improves the short-term survival of patients with severe biopsy-proved alcoholic hepatitis and persisted after stratification according to center and the presence of encephalopathy, and after adjustment for prognostic factors in a proportional-hazards model.
Abstract: Background. Controlled trials have yielded inconsistent results with regard to the efficacy of corticosteroids in the treatment of alcoholic hepatitis. Three meta-analyses suggest that they may be effective in patients with encephalopathy who have severe liver disease. Methods. We conducted a randomized, double-blind trial comparing 28 days of prednisolone treatment (40 mg per day) with placebo in 61 patients with biopsy-proved alcoholic hepatitis and either spontaneous hepatic encephalopathy (n = 19) or a discriminant-function value higher than 32. The discriminant function used was as follows: 4.6 (prothrombin time — control time [in seconds]) + serum bilirubin (in micromoles per liter)/17. Fifty-seven of the patients had evidence of cirrhosis on biopsy. The primary end point was death within two months. Results. One patient was lost to follow-up after 56 days. Treatment was discontinued in two patients because of drug toxicity. By the 66th day after randomization, 16 of 29 placebo recipients h...
TL;DR: PC appears to be an acceptable alternative in patients unable to tolerate PS, and the results of several end points of efficacy suggest that the relative efficacy of PC approximately equals that of PS.
Abstract: Objective To compare pyrimethamine plus clindamycin (PC) to pyrimethamine plus sulfadiazine (PS) as a treatment for toxoplasmic encephalitis (TE) in patients with the acquired immunodeficiency syndrome (AIDS). Design Randomized, unblinded phase II, multicenter trial with provision for crossover for failure or intolerance of the assigned regimen. Setting University hospitals. Patients Eighty-four patients with presumptive TE were entered. Thirteen were excluded when they were found to have another diagnosis, and 12 were excluded because they did not meet entry criteria. The baseline characteristics in the remaining 26 patients randomized to PC and 33 randomized to PS were comparable. Interventions Patients were treated for 6 weeks with pyrimethamine and folinic acid plus either sulfadiazine or clindamycin. Clindamycin was given intravenously during the first 3 weeks. Measurements and main results There was a trend toward greater survival in patients randomized to PS (hazard ratio, 3.25; 95% CI, 0.63 to 16.8; P = 0.13), but most study deaths were not directly related to TE. In contrast, patients randomized to PC appeared more likely to achieve complete clinical (odds ratio, 0.67; CI, 0.2 to 1.97; P greater than 0.2) and radiologic responses (odds ratio, 0.28; CI, 0.08 to 0.96; P = 0.02). Multivariate analysis revealed drug effects to be largely independent of other variables. Similar efficacy of the treatments was also suggested by a hazard analysis of resolution of abnormal mental status, fever, and headache. Skin rash was the most common adverse event in both treatment arms. Because of toxicity, six patients randomized to PC and 11 patients randomized to PS had to switch to the alternate treatment, but only three were unable to complete therapy after crossover. Conclusions The results of several end points of efficacy, taken together, suggest that the relative efficacy of PC approximately equals that of PS. PC appears to be an acceptable alternative in patients unable to tolerate PS.
TL;DR: Beta-blockers may be recommended for prevention of first bleeding in cirrhotic patients with varices who have a high risk for bleeding and the effectiveness of sclerotherapy remains undetermined.
Abstract: OBJECTIVE To assess the effectiveness of beta-blockers and endoscopic sclerotherapy in the prevention of first bleeding and reduction of mortality in patients with cirrhosis and esophagogastric varices. DATA SOURCES Pertinent studies were selected using MEDLINE (1980 to 1990), reference lists from published articles or reviews, and congress abstract lists. STUDY SELECTION Randomized trials comparing beta-blockers or sclerotherapy with a nonactive treatment. Nine randomized clinical trials of beta-blockers and 19 trials of sclerotherapy were reviewed. Seven trials of beta-blockers and 15 of sclerotherapy were published as full papers. DATA EXTRACTION Crude rates of bleeding and death in treated and control groups were extracted from each trial by three independent observers according to the intention-to-treat principle. The quality of published papers was systematically assessed and scored. DATA SYNTHESIS The Mantel-Haenszel-Peto method was used for statistical evaluation of heterogeneity and for pooling of the results. No substantial heterogeneity was found, and the incidence of bleeding in trials of beta-blockers was significantly reduced (pooled odds ratio, 0.54; 95% CI, 0.39 to 0.74), particularly in patients with large or medium-sized varices or in those with varices and a hepatic vein pressure gradient above 12 mm Hg; however, only a trend toward reduced mortality was obtained. Sclerotherapy trials were highly heterogeneous in the direction of the treatment effects on both bleeding (pooled odds ratio, 0.6; CI, 0.49 to 0.74) and mortality (pooled odds ratio, 0.76; CI, 0.61 to 0.94). The quality of the trials and the rate of bleeding in the untreated groups were the major sources of heterogeneity. The favorable results of sclerotherapy were obtained in trials with high bleeding rates among controls; several of these trials had a low quality score. CONCLUSIONS Beta-blockers may be recommended for prevention of first bleeding in cirrhotic patients with varices who have a high risk for bleeding. The effectiveness of sclerotherapy remains undetermined. Further trials in high-risk patients may prove useful if improved criteria to predict bleeding risk become available.
TL;DR: Reviewed studies focused on rape victims, combat veterans, the tragically bereaved, torture victims, accident victims, of physical assault, and child abuse victims, finding that cognitive therapy, psychodynamic therapy, and hypnosis suggest that these approaches may also hold promise.
Abstract: OBJECTIVE--The purpose of this article is to review the empirical evidence for the efficacy of a range of treatments for posttraumatic stress disorder (PTSD). Reviewed studies focused on rape victims, combat veterans, the tragically bereaved, torture victims, accident victims, of physical assault, and child abuse victims. DATA SOURCES--Peer-reviewed journals (Psych-Info, MEDLINE), book chapters (PILOTS database), active investigators, abstracts from the 1990 and 1991 International Society for Traumatic Stress Studies. STUDY SELECTION--We identified 255 English-language reports of treatment for PTSD. We restricted our focus to randomized, clinical trials that included a systematic assessment of PTSD using DSM-III or DSM-III-R criteria (N = 11). DATA EXTRACTION--Studies were assessed according to methodological strength: random assignment to the treatment of interest, and either an alternative treatment or control group; sample selection; and inclusion of statistical tests of significance. DATA SYNTHESIS--Drug studies show a modest but clinically meaningful effect on PTSD. Stronger effects were found for behavioral techniques involving direct therapeutic exposure, particularly in terms of reducing PTSD intrusive symptoms. However, severe complications have also been reported from the use of these techniques in patients suffering from other psychiatric disorders. Studies of cognitive therapy, psychodynamic therapy, and hypnosis suggest that these approaches may also hold promise. However, further research is needed before any of these approaches can be pronounced effective as lasting treatment of PTSD. CONCLUSIONS--Further studies should specifically address combined treatment approaches, optimal treatment length and timing, effects of comorbidity, and unstudied traumatized populations.
TL;DR: The intervention of an experienced physiotherapist late after stroke specifically improves mobility, albeit by a small amount, but the effects do not seem to be maintained, perhaps because there is an underlying decline in mobility in these patients as discussed by the authors.
Abstract: OBJECTIVE--To determine whether the intervention of a physiotherapist improved mobility in patients seen more than one year after stroke. DESIGN--Randomised crossover trial comparing two groups offered intervention by a physiotherapist, one immediately after entry into the trial and the other after a delay of three months. The intervention consisted of identifying problems and offering advice and help to solve the problems. SETTING--Patients' homes in Oxfordshire. SUBJECTS--Patients who had reduced mobility due to a stroke more than one year before entry; 60 were recruited from a community stroke register and 34 in other ways. MAIN OUTCOME MEASURES--Standard measures of mobility including gait speed, functional ambulation categories, the Nottingham extended activities of daily living index, and individual items from the Barthel activities of daily living index and the Frenchay activities index. Measures of manual dexterity, depression, and anxiety were used as controls. RESULTS--94 patients entered the trial and 49 were randomised to immediate and 45 to delayed physiotherapy; 89 were compared at the crossover point. At randomisation the two groups were comparable. At three months the group given early therapy showed an improvement in gait speed whereas the untreated group had declined (differences of -3.9 v 6.4 s to walk 10 m; p less than 0.01); between three and six months the group given delayed therapy showed improvement and the previously treated group declined (differences of 6.5 v -3.9 s to walk 10 m; p less than 0.01). A 9% (95% confidence interval 0% to 18%) decrease in time taken to walk 10 m was associated with treatment and a 12% (2% to 19%) increase when patients were untreated. Other measures did not change significantly. CONCLUSION--Intervention of an experienced physiotherapist late after stroke specifically improves mobility, albeit by a small amount, but the effects do not seem to be maintained, perhaps because there is an underlying decline in mobility in these patients. Gait speed offers a simple and sensitive measure of outcome.
TL;DR: The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.
Abstract: Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% ( N = 7, p = .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease ( N = 6, p = .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD ( p = .01) but not by the CY-BOCS ( p = .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.
TL;DR: There was insufficient scientific evidence to support any of the current methods of treatment for lateral epicondylitis of the elbow, and the importance of the natural evolution of the syndrome and of the placebo effect of all treatments was established.
Abstract: We have reviewed 185 articles published since 1966 to assess the scientific evidence for methods of treatment for lateral epicondylitis of the elbow. Of the 185 articles, 78 discussed treatment, but since the natural history of the syndrome is uncertain we considered only those series with concurrent control groups. Only 18 of these were randomised and controlled studies. We then graded these papers for scientific validity, using the methods of Chalmers et al (1981). The mean score of the 18 articles was only 33%, with a range from 6% to 73%. A minimum of 70% is required for a valid clinical trial, and we therefore concluded that there was insufficient scientific evidence to support any of the current methods of treatment. There were too many methodological differences to allow a quantitative meta-analysis, but our qualitative review established the importance of the natural evolution of the syndrome and of the placebo effect of all treatments. Properly designed, controlled trials are needed.
TL;DR: Electroacupuncture is effective in relieving symptoms of fibromyalgia and its potential in long term management should now be studied.
Abstract: OBJECTIVE--To determine the efficacy of electroacupuncture in patients with fibromyalgia, a syndrome of unknown origin causing diffuse musculoskeletal pain. DESIGN--Three weeks' randomised study with blinded patients and evaluating physician. SETTING--University divisions of physical medicine and rehabilitation and rheumatology, Geneva. PATIENTS--70 patients (54 women) referred to the division for fibromyalgia as defined by the American College of Rheumatology. INTERVENTIONS--Patients were randomised to electroacupuncture (n = 36) or a sham procedure (n = 34) by means of an electronic numbers generator. MAIN OUTCOME MEASURES--Pain threshold, number of analgesic tablets used, regional pain score, pain recorded on visual analogue scale, sleep quality, morning stiffness, and patient's and evaluating physician's appreciation. RESULTS--Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group. Differences between the groups were significant for five of the eight outcome measures after treatment. CONCLUSIONS--Electroacupuncture is effective in relieving symptoms of fibromyalgia. Its potential in long term management should now be studied.
TL;DR: For patients with systemic sclerosis of recent onset, extracorporeal photochemotherapy is a well-tolerated treatment that may partially reverse the process that results in cutaneous sclerosis.
Abstract: • Background and Design.— In a pilot study of extracorporeal photochemotherapy, two patients with systemic sclerosis who received this therapy experienced significant clinical improvement. These results prompted the development of a multicenter trial to examine the benefit of extracorporeal photochemotherapy in the treatment of systemic sclerosis. Seventy-nine patients with systemic sclerosis of recent onset (mean symptom duration, 1.83 years) and progressive skin involvement during the preceding 6 months entered a randomized, parallel-group, single-blinded clinical trial comparing extracorporeal photochemotherapy treatments given on 2 consecutive days monthly with treatment with D-penicillamine at a maximum dose of 750 mg/d. Blinded clinical examiners evaluated skin severity score (thickness), percent surface area involvement, oral aperture, and hand closure. Serial skin biopsies and pulmonary function studies were also performed. Results.— Following 6 months of treatment, significant improvement in skin severity score occurred in 21 (68%) of 31 patients receiving photochemotherapy and in eight (32%) of 25 receiving D-penicillamine treatment, while significant worsening occurred in three (10%) of 31 receiving photochemotherapy and in eight (32%) of 25 receiving penicillamine treatment, thus indicating a significantly higher response rate for individuals who received photochemotherapy (P.02). At both the 6- and 10-month evaluation points, the mean skin severity score, mean percent skin involvement, and mean oral aperture measurements were significantly improved from baseline among those who received photochemotherapy. Mean right and left hand closure measurements had also improved significantly by 10 months of therapy. By comparison, among the patients treated with D-penicillamine, none of the parameters of cutaneous disease had improved significantly after 6 months of therapy, although for those individuals in whom treatment was continued, the mean skin severity score and mean percent skin involvement had improved by 10 months. Skin biopsy studies revealed a correlation between clinical improvement and decreased thickness of the dermal layer. Adverse effects of extracorporeal photochemotherapy were minimal and did not require discontinuation of treatment in any of the patients receiving this therapy; six patients permanently discontinued the use of D-pencillamine treatment due to adverse effects. Conclusions.— For patients with systemic sclerosis of recent onset, extracorporeal photochemotherapy is a well-tolerated treatment that may partially reverse the process that results in cutaneous sclerosis. (Arch Dermatol.1992;128:337-346)
TL;DR: For patients who have achieved clinical remission, adjustment of steroid treatment duration on the basis of endoscopy results is of no benefit, and the endoscopic aspect has no prognostic value; thus, it appears unnecessary to repeat colonoscopy in such patients before steroid tapering is begun.
TL;DR: Nortriptyline was clearly superior to placebo for treatment of depression and was accompanied by marked improvements in anxiety, certain respiratory symptoms, overall physical comfort, and day-to-day function; placebo effects were negligible.
TL;DR: Comparison of the effects of an ACE inhibitor and a calcium antagonist on both hypertension and the progression of non-diabetic renal insufficiency in a long-term study found blood pressure control was significantly better after randomization.
TL;DR: The authors show that each of these questions had different sample size requirements, and illustrate their point with a discussion of an ancillary study of large bowel epithelial proliferation in the National Cancer Institute's Polyp Prevention Trial.
Abstract: An intermediate endpoint is a biologic event or marker that is a precursor to a given health outcome. Examples of potential intermediate endpoints include serum cholesterol for coronary heart disease, endogenous steroid hormones for breast cancer, and CD4 count for acquired immunodeficiency syndrome. When one is studying a potential intermediate endpoint in the context of an intervention trial, five types of questions may be investigated: 1) Does the intervention affect the intermediate endpoint? 2) Is the intermediate endpoint associated with prognostic or risk factors? 3) Is the intermediate endpoint associated with the main outcome? 4) Is the intervention effect on the main outcome mediated by the intermediate endpoint? 5) Are the prognostic or risk factor effects mediated by the intermediate endpoint? In this paper, the authors show that each of these questions had different sample size requirements, and they illustrate their point with a discussion of an ancillary study of large bowel epithelial proliferation in the National Cancer Institute's Polyp Prevention Trial. The same methods may be used in an observational study, in which case questions 2, 3, and 5 are relevant. However, much larger numbers than those used in the Polyp Prevention Trial example will be required when the main outcome is rare.
TL;DR: It is indicated that hypnosis was effective in reducing reported oral pain for patients undergoing marrow transplantation and risk, SIP, and BSI pre‐transplant were found to be effective predictors of inpatient physical symptoms.
Abstract: Few controlled clinical trials have tested the efficacy of psychological techniques for reducing cancer pain or post-chemotherapy nausea and emesis. In this study, 67 bone marrow transplant patients with hematological malignancies were randomly assigned to one of four groups prior to beginning transplantation conditioning: (1) hypnosis training (HYP); (2) cognitive behavioral coping skills training (CB); (3) therapist contact control (TC); or (4) treatment as usual (TAU; no treatment control). Patients completed measures of physical functioning (Sickness Impact Profile; SIP) and psychological functioning (Brief Symptom Inventory; BSI), which were used as covariates in the analyses. Biodemographic variables included gender, age and a risk variable based on diagnosis and number of remissions or relapses. Patients in the HYP, CB and TC groups met with a clinical psychologist for two pre-transplant training sessions and ten in-hospital "booster" sessions during the course of transplantation. Forty-five patients completed the study and provided all covariate data, and 80% of the time series outcome data. Analyses of the principal study variables indicated that hypnosis was effective in reducing reported oral pain for patients undergoing marrow transplantation. Risk, SIP, and BSI pre-transplant were found to be effective predictors of inpatient physical symptoms. Nausea, emesis and opioid use did not differ significantly between the treatment groups. The cognitive behavioral intervention, as applied in this study, was not effective in reducing the symptoms measured.