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At least 19 recordsLinked to original sources

High-dose intravenous immunoglobulin in inflammatory myopathies: experience based on controlled clinical trials.

Controlled clinical trials with high-dose intravenous immunoglobulin (IVIg) have been conducted in patients with DM and IBM, but not PM. A double-blind placebo-controlled study in DM patients, resistant or partially responsive to conventional therapies, showed that IVIg is very effective in improving both the muscle strength and the skin rash. The clinical benefit, which was impressive in patients with early disease, was associated with improvement in the muscle cytoarchitecture. Quantitative histological studies in repeated muscle biopsies showed a statistically significant increased in the size of muscle fibers and the number of capillaries with normalization of the capillary diameter. Resolution of the aberrant immunopathological parameters including interception of complement activation products and downregulation of T cells, ICAM-I, VCAM, TGF-beta and MHC-I molecules was also noted. In IBM, IVIg showed marginal, and non statistically significant, improvements in muscle strength. Up to 20% of patients however, demonstrated clinical improvement with increased activities of daily living while certain muscle groups, such as the muscles of swallowing, showed significant improvements compared to placebo implying mild regional benefits. In PM, small uncontrolled series have shown improvements in muscle strength in up to 70% of the IVIg-treated patients. Because PM, as a stand-alone clinical entity, is a very rare disease, completion of controlled trials will be very difficult.

Dermatomyositis↗

[Evidence-based medicine. Input of controlled clinical trials].

Controlled clinical trials are the support of Evidence-Based Medicine. In most instances, only them can indeed provide the demonstration of both the efficacy and safety of a pharmacological treatment, based upon rigorous scientific experimental observations avoiding potential bias due to subjective interpretation. In order to be able to extrapolate conclusions of drug trials to clinical practice and to positively influence physician's attitudes, "explanatory" trials, which aim at proving the intrinsic activity of the molecule, should be completed by "pragmatic" trials, which aim at demonstrating the clinical utility of the drug.

Attitude of Health Personnel↗

Bias in treatment assignment in controlled clinical trials.

Controlled clinical trials of the treatment of acute myocardial infarction offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment. A group of 145 papers was divided into those in which the randomization process was blinded (57 papers), those in which it may have been unblinded (45 papers), and those in which the controls were selected by a nonrandom process (43 papers). At least one prognostic variable was maldistributed (P less than 0.05) in 14.0 per cent of the blinded-randomization studies, in 26.7 per cent of the unblinded-randomization studies, and in 58.1 per cent of the nonrandomized studies. Differences in case-fatality rates between treatment and control groups (P less than 0.05) were found in 8.8 per cent of the blinded-randomization studies, 24.4 per cent of the unblinded-randomization studies, and 58.1 per cent of the nonrandomized studies. These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration.

Clinical Trials as Topic↗

Moore hemi-arthroplasty with and without bone cement in femoral neck fractures. A clinical controlled trial.

In a clinical, controlled trial 112 patients with fresh femoral neck fractures were allocated to two groups of treatment: 55 patients had a Moore hemi-arthroplasty cemented with methyl methacrylate and 57 patients a non-cemented prosthesis. 75 patients attended the follow-up study. At 6 weeks, 3 months, 6 months and 12 months after the operation the function of the hip was assessed according to Merle d'Aubigné. At 6 weeks, 3 months and 6 months after the operation the clinical results were significantly better among patients with cemented prosthesis, especially in relation to pain relief and gait function. It is concluded that fixation of the prosthesis with cement improves the clinical results, at least during the first 6 months following the operation.

Aged↗

Surgical treatment for the thumb-in-palm deformity in patients with cerebral palsy.

BACKGROUND: Thumb-in-palm deformity in patients with spastic cerebral palsy is a deformity that impairs the ability to use the thumb and thus severely limits hand function. From the variety of operative procedures that have been described, it may be clear that there is no consensus on the surgical treatment of thumb-in-palm deformity. OBJECTIVES: To review the efficacy of surgical interventions for the thumb-in-palm deformity in patients with spastic cerebral palsy; to review the selection criteria to surgically treat thumb-in-palm deformity in these patients; and to review the outcome assessment used in these studies. SEARCH STRATEGY: We identified studies for inclusion from searches of several electronic databases: the Cochrane Central Register of Controlled Trials (Issue 4, 2003), MEDLINE (1966 to December 2004), EMBASE (1980 to December 2004) and CINAHL (1982 to December 2004). We also cross-checked the reference lists of these studies to identify additional studies. SELECTION CRITERIA: We considered a trial eligible for inclusion when it met the following criteria. 1) It was described as a randomized clinical trial, clinical controlled trial or prospective study that compared pre-operative- with post-operative outcome assessment. 2) It concerned patients with thumb-in-palm deformity affected by spastic cerebral palsy. There was no restriction in age. 3) It compared or described any surgical intervention to the thumb. 4) It followed subjects for at least six months. 5) Outcomes described included one or more of the following items: rate of success; functional improvement; active and passive range of motion of the thumb; grasp and release; pinch grip; complications and side effects; and quality of life. DATA COLLECTION AND ANALYSIS: Two authors assessed each study using a scoring system. Meta-analysis was not possible because the selected studies were poorly designed, and the results were presented in an incompatible form. Therefore, we compiled a descriptive summary of the results of the individual studies. We did not attempt to acquire the raw data for re-analysis. MAIN RESULTS: We identified 14 prospective studies that compared preoperative and postoperative outcomes as eligible for inclusion in this review. We found no randomized clinical trials or controlled clinical trials. The studies with the best available evidence were prospective studies that compared pre- with post-operative assessment. After assessment, we ultimately included nine studies. Participants In all the included studies the participants were more or less homogeneous regarding the most important prognostic indications. The nine included studies treated 234 patients. Age at operation ranged from 4-48 years (Median approximately 11 years). Interventions Twenty-four different specific interventions were performed, or combined, aiming to 1) stabilize the first metacarpophalangeal joint, 2) weaken the spastic thumb adductors, and 3) augment thumb abduction and extension. Outcome measures All of the included studies assessed whether the thumb had stayed out of the palm at follow-up. Additional outcome measures varied among studies. Selection criteria There was no consensus on the selection criteria for eligibility for surgical treatment. There was also considerable variety in the use of methods of assessment among the studies. There is no standardized method to evaluate the pre- and post-operative data, and most of the assessment methods were not validated. It was impossible to compare the outcomes among studies. Judgement about the effectiveness of one particular surgical intervention was not possible, because different surgical interventions and co-interventions were used within most studies. Nonetheless, generally, the outcome of surgical treatment of thumb-in-palm deformity was considered satisfactory to both patients and to surgeons in all studies. AUTHORS' CONCLUSIONS: Because the methodological quality of the studies is poor, it is impossible to provide a reliable judgement of the role of surgery for thumb-in-palm deformity. This review has demonstrated the need for randomized clinical trials or controlled clinical trials on the surgical treatment of thumb-in-palm deformity. Surgical reconstruction appears to improve hand function, to facilitate hygiene, and to improve the appearance and quality of life. For patient selection, a validated classification system should be developed to determine the type and extent of the cerebral palsied hand. The influence of age, intelligence, and voluntary muscle control still needs to be investigated. Investigators should focus on one particular surgical intervention or a specific group of interventions to find out which procedures produce the best functional improvement.

Cerebral Palsy↗

[Clinical controlled trial for secondary caries preventive effect of Duraphat on cavity walls].

On a base of a clinical controlled trial the secondary caries preventive effect of a topical application of fluoride varnish (Duraphat) was verified. 255 pairs of amalgam restorations were placed in 191 patients, 152 (79.6%) of whom returned for assessment after a 24 month follow-up period. This group of 152 patients received 188 (73.7%) pairs of restorations. The cavity walls of one restoration of each pair were covered with an thin layer of a fluoride containing varnish. The secondary caries rate of the untreated restorations in such manner was four time greater than the treated ones. The results suggest that the topical application of a fluoride varnish on the cavity walls can be an effective measure for secondary caries prevention.

Adolescent↗

Medical ethics and controlled clinical trials.

The controlled clinical trial is a relatively new phenomenon; the first large clinical trial on evaluation of streptomycin in therapy of pulmonary tuberculosis occurred in 1946. In such a study, two or more groups of patients with similar characteristics are chosen by random allocation to receive one or more therapies. The essential ethical dilemma is based on the risk-benefit ratio of the new therapy. Ethical factors that must be considered in the design of controlled clinical trials include provision for informed consent, nature of alternate therapy, confidentiality of data, source of funding and potential conflict of interest, remuneration of subjects, criteria for ending participation of the subject, criteria for concluding the trial, compensation of injured subjects, compliance with institutional, municipal, state and federal regulations and provisions for special groups such as the fetus and pregnant woman, infants and young children, institutional patients and prisoners. Federal guidelines for research in specific areas are now available through the reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. To date, commission reports include recommendations for research in fetuses and pregnant women and in children. Protection of the subject is best provided by the the quality of the protocol, integrity of the investigator, valid informed consent, and review of the research program by an independent committee composed of scientists and consumers.

Child↗

Lessons learned from prematurely terminated clinical trials.

Controlled clinical trials in cardiovascular disease are the cornerstone for therapeutic advances in this field of medicine. Since the introduction of the concept of controlled clinical trials, there has been substantial progress in the design, conduct, and analysis of such studies. A growing awareness of ethical issues emerging from such trials has led to increased public and investigator scrutiny, and the routine requirement for interim data analysis. A benefit of such interim analysis is that either an entire clinical trial or a specific treatment limb can be stopped if the observed findings warrant premature termination. For example, highly positive findings, as were noted in the Heart Outcomes Prevention Evaluation (HOPE) study, led to its closure about 1 year early after 4.5 years of treatment. Alternatively, the doxazosin treatment limb of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) and the amlodipine treatment limb of the African-American Study of Kidney Disease and Hypertension (AASK) were stopped early because of negative findings. Finally, economic considerations can enter into the decision to close a study early as was the case in the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) trial. Most such decisions rely heavily on information obtained from independent data and safety monitoring boards. Such boards ensure patient safety by providing an unbiased ongoing review of data, which would otherwise be unavailable until a study's completion. Early termination of a clinical trial can have important clinical implications and, in particular, can redirect patterns of clinical practice.

Cardiovascular Diseases↗

Chlorambucil dosage in frequently relapsing nephrotic syndrome: a controlled clinical trial.

A controlled clinical trial was performed using two dosage regimens of chlorambucil to treat children with frequently relapsing nephrotic syndrome. All children concurrently received prednisone (60 mg/m2 on alternate days). Ten children (Group I) were given chlorambucil as a stable dose (0.2 mg/kg/day) for 56 to 60 days, and 11 children (Group II) received increasing doses (0.2 to 0.63 mg/kg/day) for 42 to 77 days. Two children in each group subsequently relapsed. Follow-up averaged 28.6 and 27.2 months in Groups I and II, respectively. Three children in Group II developed infectious complications. The data indicate that a stable dosage regimen for chlorambucil is as effective as an increasing dose regimen in achieving long-term remission of frequently relapsing nephrotic syndrome.

Adolescent↗

Hypnosis or cognitive behavioral training for the reduction of pain and nausea during cancer treatment: a controlled clinical trial.

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.

Adult↗

Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial.

Few controlled clinical trials of psychological interventions for cancer pain relief exist in spite of frequent support for their importance as adjuncts to medical treatment. This study compared oral mucositis pain levels in 4 groups of cancer patients receiving bone marrow transplants (BMT): (1) treatment as usual control, (2) therapist support, (3) relaxation and imagery training, and (4) training in a package of cognitive-behavioral coping skills which included relaxation and imagery. A total of 94 patients completed the study which involved two training sessions prior to treatment and twice a week 'booster' sessions during the first 5 weeks of treatment. Results confirmed our hypothesis that patients who received either relaxation and imagery alone or patients who received the package of cognitive-behavioral coping skills would report less pain than patients in the other 2 groups. The hypothesis that the cognitive-behavioral skills package would have an additive effect beyond relaxation and imagery alone was not confirmed. Average visual analogue scale (VAS) report of pain within the therapist support group was not significantly lower than the control group (P = 0.103) nor significantly higher than the training groups. Patient reports of relative helpfulness of the interventions for managing pain and nausea matched the results of VAS reports. From these results, we conclude that relaxation and imagery training reduces cancer treatment-related pain; adding cognitive-behavioral skills to the relaxation with imagery does not, on average, further improve pain relief.

Adaptation, Psychological↗

No detrimental effect of fibrin glue on the regeneration of intrabony defects. A controlled clinical trial.

This controlled clinical trial evaluated the potential of fibrin glue as a biological carrier to locally deliver guided tissue regeneration (GTR) modulators, 2 controlateral, morphologically similar defects were selected in each of 11 patients and randomly assigned to the test (teflon membrane and fibrin glue) and the control treatment (teflon membrane alone). Outcomes were assessed at membrane removal as newly formed granulation tissue and at the 1-year follow-up in terms of changes in probing attachment level, probing pocket depth, recession of the gingival margin, probing bone levels and percentage of fill of the intrabony defects. Data confirmed that GTR treatment of deep intrabony defects results in clinically and statistically significant improvements of the clinical parameters. No significant differences, however, were evidenced between the test and the control treatments. It is suggested that, since fibrin glue did not show detrimental effects on GTR, it could be applied as a biological carrier for the delivery of GTR enhancers into the surgical wound.

Adult↗

Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.

In controlled clinical trials there are usually several prognostic factors known or thought to influence the patient's ability to respond to treatment. Therefore, the method of sequential treatment assignment needs to be designed so that treatment balance is simultaneously achieved across all such patients factor. Traditional methods of restricted randomization such as "permuted blocks within strata" prove inadequate once the number of strata, or combinations of factor levels, approaches the sample size. A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor. The improved treatment balance obtained by this approach is explored using simulation for a simple model of a clinical trial. Further discussion centers on the selection, predictability and practicability of such a procedure.

Carmustine↗

Vasectomy techniques for male sterilization: systematic Cochrane review of randomized controlled trials and controlled clinical trials.

BACKGROUND: The review aimed to compare the effectiveness, safety and acceptability of vasectomy techniques for male sterilization. METHODS: We searched five computerized databases and reference lists of relevant articles and book chapters for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing vasectomy techniques. Two reviewers independently extracted data from eligible articles. RESULTS: Two poor-quality trials compared vas occlusion with clips versus a conventional technique, and four poor-quality trials examined vas irrigation with water versus no irrigation or irrigation with euflavine. No significant differences regarding the primary outcome of time to azoospermia were found. However, one trial reported fewer median number of ejaculations to azoospermia with euflavine rather than water irrigation. An interim report of a high-quality trial comparing vasectomy with and without fascial interposition found more azoospermia with fascial interposition but also more surgical difficulties. CONCLUSIONS: No conclusions can be reached regarding the effectiveness, safety and acceptability of vas occlusion techniques or vas irrigation since only low-quality, underpowered studies were available. Fascial interposition had improved vasectomy success but also increased surgical difficulty. High-quality, adequately reported RCTs are required. More work is also needed in the standardization of follow-up protocols, evaluation of vasectomy success and failure, recanalization and analytical methods.

Controlled Clinical Trials as Topic↗

Changes in sagittal lumbar configuration with a new method of extension traction: nonrandomized clinical controlled trial.

OBJECTIVE: To determine if a new method of lumbar extension traction can increase lordosis in chronic low back pain (LBP) subjects with decreased lordosis. DESIGN: Nonrandomized controlled trial with follow-up at 3 months and 1(1/2) years. SETTING: Primary care spine clinic in Nevada. PATIENTS: Beginning in mid-1998, the first 48 consecutive patients, who met the inclusion criteria of chronic LBP with decreased lordosis and who completed the treatment program were matched for sex, age, height, weight, and pain scores to 30 control subjects with chronic LBP, who received no treatment. INTERVENTIONS: A new form of 3-point bending lumbar extension traction was provided in-office 3 to 4 times a week for 12+/-4 weeks. Per session, traction duration was started at 3 minutes and was increased to a maximum of 20 minutes. For short-term pain relief, torsion lumbar spinal manipulation was provided in the initial 3 weeks. MAIN OUTCOME MEASURES: Pain as measured on a visual analog scale (VAS) and standing lateral lumbar radiographic measurements. RESULTS: Pain scales and radiographic measurements did not change in the control subjects. In the traction group, VAS ratings decreased from mean +/- standard deviation of 4.4+/-1.9 pretreatment to 0.6+/-0.9 posttreatment (P<.001), and radiographic angles (except at T12-L1) showed statistically significant changes. Mean changes were 5.7 degrees at L4-5 (P<.001), 11.3 degrees between posterior tangents on L1 and L5 (P<.001), 9.1 degrees in Cobb angle at T12-S1 (P<.001), 4.6 degrees in pelvic tilt (P<.001), and 4.7 degrees in Ferguson's sacral base angle (P<.001). At long-term follow-up (17(1/2)mo), 34 of the 48 (71%) subjects returned. Improvements in lordosis were maintained in all 34. CONCLUSIONS: This new method of lumbar extension traction is the first nonsurgical rehabilitative procedure to show increases in lumbar lordosis in chronic LBP subjects with hypolordosis. The fact that there was no change in control subjects' lumbar lordosis indicates the stability of the lumbar lordosis and the repeatability of x-ray procedures. Because, on average, chronic LBP patients have hypolordosis, additional randomized trials should be performed to evaluate the clinical significance of restoration of the lumbar lordosis in chronic LBP subjects.

Adult↗

Acute and chronic changes in atrial natriuretic factor induced by ventricular pacing: a self controlled clinical trial.

A self controlled clinical trial was carried out to study the acute and chronic effects of ventricular pacing (VVI) on the atrial natriuretic factor (ANF). Eleven people were selected from a pool of 20 DDD paced patients. Pacemakers were programmed to the VVI mode for 1 month and their effectiveness tested by ECG at rest and after an effort test. AnF was measured by radioimmunoassay at baseline, after 15 minutes, and again 1 month after programming. The reliability of the radioimmunoassay was confirmed using the coefficients of variation between (12.5%) and within assay (9.7%). Data analysis was done using Wilcoxon's test. Our results showed that the onset of VVI pacing led to a sudden sharp rise in ANF in all patients (P < 0.0001). During VVI pacing, three patients were dropped from the study (2 were withdrawn because of symptoms and 1 voluntarily withdrew). After 1 month of VVI pacing, a significant increase of ANF above the baseline was observed (P < 0.05). The results showed that ventricular pacing led to an immediate rise in ANF and, that with long-term VVI pacing, there was an increase in ANF levels as well. The role of these findings in the pathophysiology of the pacemaker syndrome calls for further research.

Adult↗