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PubMed1992

A randomized controlled trial of early surgery in Duchenne muscular dystrophy.

We performed a randomized controlled trial of early surgical treatment of contractures in 20 boys with Duchenne muscular dystrophy, age 4-6 yr. Surgery consisted of release of hip flexors, removal of iliotibial bands, and lengthening of tendo Achilles bilaterally. All patients were monitored for at least 12 months post-randomization, and assessed quantitatively for muscle strength and function. Surgery corrected the deformities, but had no beneficial effect on strength or function. Indeed, data in the second year showed more rapid deterioration of function in some of the operated boys. There appeared to be continued evolution of pathology following surgery, as assessed by sequential muscle ultrasound and muscle biopsy. We cannot recommend this type of surgery as a routine treatment.

Biopsy↗
PubMed2004

Does it matter which exercise? A randomized control trial of exercise for low back pain.

STUDY DESIGN: Multicentered randomized controlled trial. OBJECTIVES: To determine if previously validated low back pain (LBP) subgroups respond differently to contrasting exercise prescriptions. SUMMARY OF BACKGROUND DATA: The role of "patient-specific" exercises in managing LBP is controversial. METHODS: A total of 312 acute, subacute, and chronic patients, including LBP-only and sciatica, underwent a standardized mechanical assessment classifying them by their pain response, specifically eliciting either a "directional preference" (DP) (i.e., an immediate, lasting improvement in pain from performing either repeated lumbar flexion, extension, or sideglide/rotation tests), or no DP. Only DP subjects were randomized to: 1) directional exercises "matching" their preferred direction (DP), 2) exercises directionally "opposite" their DP, or 3) "nondirectional" exercises. Outcome measures included pain intensity, location, disability, medication use, degree of recovery, depression, and work interference. RESULTS: A DP was elicited in 74% (230) of subjects. One third of both the opposite and non-directionally treated subjects withdrew within 2 weeks because of no improvement or worsening (no matched subject withdrew). Significantly greater improvements occurred in matched subjects compared with both other treatment groups in every outcome (P values <0.001), including a threefold decrease in medication use. CONCLUSIONS: Consistent with prior evidence, a standardized mechanical assessment identified a large subgroup of LBP patients with a DP. Regardless of subjects' direction of preference, the response to contrasting exercise prescriptions was significantly different: exercises matching subjects' DP significantly and rapidly decreased pain and medication use and improved in all other outcomes. If repeatable, such subgroup validation has important implications for LBP management.

Exercise Therapy↗
PubMed2003

Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up.

STUDY DESIGN: A multicenter, randomized, controlled trial with 1-year follow-up. OBJECTIVES: To compare the effect of manual therapy to exercise therapy in sick-listed patients with chronic low back pain (>8 wks). SUMMARY AND BACKGROUND DATA: The effect of exercise therapy and manual therapy on chronic low back pain with respect to pain, function, and sick leave have been investigated in a number of studies. The results are, however, conflicting. METHODS: Patients with chronic low back pain or radicular pain sick-listed for more than 8 weeks and less than 6 months were included. A total of 49 patients were randomized to either manual therapy (n = 27) or to exercise therapy (n = 22). Sixteen treatments were given over the course of 2 months. Pain intensity, functional disability (Oswestry disability index), general health (Dartmouth COOP function charts), and return to work were recorded before, immediately after, at 4 weeks, 6 months, and 12 months after the treatment period. Spinal range of motion (Schober test) was measured before and immediately after the treatment period only. RESULTS: Although significant improvements were observed in both groups, the manual therapy group showed significantly larger improvements than the exercise therapy group on all outcome variables throughout the entire experimental period. Immediately after the 2-month treatment period, 67% in the manual therapy and 27% in the exercise therapy group had returned to work (P < 0.01), a relative difference that was maintained throughout the follow-up period. CONCLUSIONS: Improvements were found in both intervention groups, but manual therapy showed significantly greater improvement than exercise therapy in patients with chronic low back pain. The effects were reflected on all outcome measures, both on short and long-term follow-up.

Adult↗
PubMed2004

Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors.

OBJECTIVE: To examine predictors of adherence in a randomized controlled trial of resistance exercise training (RET) in prostate cancer survivors receiving androgen deprivation therapy. STUDY DESIGN AND SETTING: A randomized controlled trial conducted at fitness centers in Ottawa and Edmonton, Canada. Prostate cancer survivors (n=155) completed measures of social cognitive variables, quality of life (QOL), behavior, and fitness before being randomized to either an exercise (n=82) or control (n=73) group. The exercise group was asked to perform supervised RET three times per week for 12 weeks. RESULTS: The exercise group attended 28.2 of the 36 (78.3%) RET sessions. Univariate analyses revealed eight different significant (Ps <.05) predictors of exercise adherence including exercise stage of change, intention, age, QOL, fatigue, subjective norm, leg-press test, and perceived behavioral control. A multivariate analysis indicated that there were three independent predictors of adherence that explained 20.4% of the variance: exercise stage of change (beta=0.26; P=.013), age (beta=-0.22; P=.037), and intention (beta=0.19; P=.073). CONCLUSION: Exercise adherence in the trial was very good but not optimal. Adherence was predicted by variables from many different categories including social cognitive, QOL, behavioral, fitness, and demographic. These findings may have important implications for maximizing adherence during clinical trials of exercise in prostate cancer survivors.

Age Factors↗
PubMed1988

Effects of transdermal clonidine treatment on withdrawal symptoms associated with smoking cessation. A randomized, controlled trial.

In a double-blind, randomized, placebo-controlled trial, we studied 40 cigarette smokers to determine the effects of one week of transdermal clonidine hydrochloride (Catapres-TTS No. 2) treatment on the withdrawal symptoms associated with smoking cessation. Subjects were instructed to maintain their usual cigarette intake during days 1 through 3 and cease smoking for days 4 through 6. All of the withdrawal symptoms measured (craving, irritability, anxiety, restlessness, difficulty concentrating, and hunger) significantly increased during the three days of smoking cessation in the placebo group. There was a 4.3-fold increase in craving, a 3.8-fold increase in irritability, a 3.7-fold increase in anxiety, and a 3.3-fold increase in restlessness in the placebo group compared with the transdermal clonidine group during the three days of smoking cessation. Impairment of concentration and hunger were not significantly diminished by transdermal clonidine treatment during smoking cessation. In addition, a trend was present in the transdermal clonidine group to spontaneously decrease the number of cigarettes smoked per day during the smoking period. Side effects were generally mild. We conclude that transdermal clonidine treatment ameliorates some of the short-term withdrawal symptoms, especially craving, associated with smoking cessation.

Acute Disease↗
PubMed2005

Medical students' and tutors' experiences of directed and self-directed learning programs in evidence-based medicine: a qualitative evaluation accompanying a randomized controlled trial.

This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In the trial, no statistically significant differences between the study groups were shown for any outcomes considered (EBM knowledge, skills, and attitudes). Further analysis suggests that main reason for the negative trial results was that the majority of students learned equally effectively, whichever program they received, although implementation of the educational programs was not complete because of varying attendance. This study illustrates a stepwise evaluation model that might be useful in evaluating other socially complex interventions.

Education, Medical, Undergraduate↗
PubMed2002

The effects of side-posture positioning and spinal adjusting on the lumbar Z joints: a randomized controlled trial with sixty-four subjects.

STUDY DESIGN: A blinded, randomized controlled trial was conducted. OBJECTIVE: To test the hypothesis that chiropractic side-posture manipulation (adjusting) of the lumbar spine separates (gaps) the zygapophysial (Z) joints. SUMMARY OF BACKGROUND DATA: Spinal adjusting is thought to gap the Z joints, yet no studies have conclusively validated this hypothesis, and some investigators have reported that the lumbar Z joints do not gap during rotation. METHODS: For this study, 64 healthy student volunteers (32 men and 32 women) ages 22 to 30 years with no history of significant low back pain were randomized into four groups of 8 men and 8 women each. Interventions included lumbar side-posture spinal adjusting (manipulation) and side-posture positioning. Anterior to posterior measurements of the Z joints from MRI scans taken before and after side-posture spinal adjusting and before and after side-posture positioning were compared. RESULTS: Observers performing the measurements were blinded as to group and first and second scans. Reliability of the measurements was established. Differences were found between the groups (F = 24.15; P < 0.000, analysis of variance). Side-posture positioning showed greater gapping than the control condition (mean difference, 1.18; P < 0.000); side-posture adjusting showed greater gapping than the control condition (mean difference, 1.89; P < 0.000), and side-posture adjusting showed greater gapping than side-posture positioning (mean difference, 0.71; P = 0.047). CONCLUSIONS: Spinal adjusting produced increased separation (gapping) of the Z joints. Side-posture positioning also produced gapping, but less than that seen with lumbar side-posture adjusting. This study helps to increase understanding about the mechanism of action for spinal manipulation.

Adult↗
PubMed2006

5-hydroxytryptamine-3 receptor antagonist with or without short-course dexamethasone in the prophylaxis of radiation induced emesis: a placebo-controlled randomized trial of the National Cancer Institute of Canada Clinical Trials Group (SC19).

PURPOSE: To evaluate the effectiveness of prophylactic dexamethasone for the control of radiation induced emesis (RIE) when added to ondansetron during days 1 to 5 of fractionated radiotherapy. The study had two hypotheses: ondansetron and dexamethasone could provide superior control of RIE over ondansetron alone during the prophylactic period and; the combination could provide sustained control of RIE during subsequent fractions of radiotherapy. PATIENTS AND METHODS: Between May 2001 to Jan 2004, 211 patients receiving radiotherapy (> or = 15 fractions) to the upper abdomen were randomly assigned to receive ondansetron 8 mg bid with either dexamethasone 4 mg daily or placebo during fractions 1 to 5. Rescue antiemetics were provided. RESULTS: During the prophylactic period there was a trend for improved complete control of nausea in the dexamethasone arm (50% v 38%; P = .06) while complete and partial control of emesis, average nausea score, and use of rescue medications were similar in the two groups. During the overall study period patients receiving dexamethasone had better complete control of emesis (23% v 12%; P = .02) and a lower average nausea score (0.28 v 0.39; P = .03); there was a trend towards less use of rescue medications with dexamethasone (70% v 80%; P = .09); other outcomes were similar on the two arms. Quality of life analysis showed a significant difference in appetite. CONCLUSION: The addition of dexamethasone to ondansetron as prophylaxis provides a modest improvement in protection against RIE during moderately emetogenic fractionated radiotherapy. It is a potentially useful addition to 5-hydroxytryptamine-3 receptor antagonists in this setting.

Antiemetics↗
PubMed2004

Home breastfeeding support by health professionals: findings of a randomized controlled trial in a population of Italian women.

AIM: We conducted a randomized controlled trial to assess the effectiveness of a support intervention delivered by health professionals to increase the rate and duration of breastfeeding. METHODS: A randomized controlled intervention study was conducted in the period 2000-2001 among 605 mothers who had given birth in a public maternity ward located in the city of Rome, Italy. The intervention consisted of a home visit by a midwife from the maternity ward of the hospital. The outcome of the study was the infant's feeding habits, assessed by a 24-h recall. The effect of the intervention on the duration of breastfeeding was estimated by the Kaplan-Meier method and by the Cox multivariate regression model. RESULTS: According to intention-to-treat analysis, there was no significant difference between the intervention and the control group, after controlling for confounding factors (hazard ratio (HR) 1.04; 95% confidence interval (95% CI): 0.85-1.26). The duration of breastfeeding was shorter (HR 1.61; 95% CI: 1.13-2.31) for women in the intervention group who refused the obstetric visit. CONCLUSION: Our study shows that an early home support programme delivered by health professionals was not effective in increasing breastfeeding initiation and duration.

Adolescent↗
PubMed2006

Textured surface breast implants in the prevention of capsular contracture among breast augmentation patients: a meta-analysis of randomized controlled trials.

BACKGROUND: Capsular contracture is a common complication associated with the use of breast implants. Numerous randomized controlled trials addressing the efficacy of textured surface breast implants in reducing capsular contracture have yielded nonuniform results. This meta-analysis addresses the use of textured breast implants in the prevention of capsular contracture. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were searched to identify all randomized controlled trials involving the use of textured versus smooth breast implants. The results of these trials were meta-analyzed to obtain a pooled odds ratio of the effect of textured surfacing on capsular contracture rates. In addition, subgroup analyses were performed based on implant type (saline or silicone gel), type of surface texturing (Siltex or Biocell), placement (subglandular or submuscular), and length of follow-up. RESULTS: Eleven trials were reviewed. Four were excluded because they failed to meet a priori inclusion criteria. The remaining seven trials were meta-analyzed. Only three of these studies found significantly lower rates of capsular contracture with the use of textured implants. However, when all seven studies were pooled, the odds ratio was found to be 0.19 (95 percent confidence interval, 0.07 to 0.52), indicating a protective effect for surface texturing on the rate of capsular contracture. Submuscular placement was the only subgroup in which significance was not achieved. However, this subgroup consisted of a single study, which was dramatically underpowered. CONCLUSION: The results of this meta-analysis demonstrate the superiority of textured over smooth breast implants in decreasing the rate of capsular contracture.

Breast↗
PubMed2006

[Effectiveness of lifestyle modification programs for control of blood pressure: a non-randomized controlled trial in Komatsu, Japan].

PURPOSE: A non-randomized controlled trial was conducted to evaluate the effectiveness of three lifestyle modification programs to reduce blood pressure: individual counseling only; counseling using group dynamics; and individual support using mail. METHODS: We enrolled men and women ages 20-69 with a systolic blood pressure (SBP) of 130-159 mmHg and/or a diastolic blood pressure of 85-99 mmHg (high-normal or mild hypertension). Participants were assigned to one of 4 groups: individual counseling (n = 134); group counseling (n = 79); mailing support (n = 127); and controls (with usual care) (n = 178). The three intervention programs included behavioral support for each person's lifestyle problems once a month for 6 months. Sex and age adjusted net blood pressure change (and 95% confidence intervals [CIs]) compared with the control group was calculated for each of the intervention groups. RESULTS: Net SBP change was the largest for the group counseling group: sex and age adjusted net SBP change was -6.5 mmHg (95% CI: -10.0, -3.0). Net SBP change for the mailing support group was also significant (-4.3 mmHg [95% CI: -7.3, -1.3]). Net SBP change for the individual counseling group was -2.5 mmHg (95% CI: -5.5, 0.5). Looking at the results separately by sex, net SBP reduction was also largest in women of the group counseling group, whereas improvement in men was similar among 3 groups (approximately 4 mmHg). Body weights were reduced by about 1 kg in all 3 groups. CONCLUSIONS: Lifestyle modification programs using group dynamics or using individual support by mail, in addition to individual behavioral support, appear to be effective for blood pressure reduction. Group counseling may be more effective in women.

Adult↗
PubMed1985

A randomized controlled trial of prophylactic cytotoxic chemotherapy in potentially curable breast cancer.

A randomized controlled trial of the value of oral adjuvant cytotoxic chemotherapy in the treatment of potentially curable breast cancer has been in progress in the Oxford Region since 1977. Eighty-seven patients were allocated to treatment with melphalan 0.2 mg/kg for 5 consecutive days every 6 weeks for 2 years; 98 patients were allocated to treatment with oral combination therapy consisting of melphalan 10 mg daily for 5 consecutive days, plus methotrexate 15 mg and 5-fluorouracil 250 mg on the first day, courses being repeated every 6 weeks for 2 years; and 88 patients were allocated to a control group which received no adjuvant chemotherapy. So far, 125 patients have suffered a recurrence of breast cancer and 85 have died. No statistically significant differences in outcome are apparent between the three treatment groups, although there is some indication of a beneficial effect of chemotherapy on disease-free interval in pre-menopausal women. Toxic effects of treatment, notably nausea, vomiting and bone marrow depression, have been moderately severe. In our view, the beneficial effects of current adjuvant cytotoxic chemotherapy, if any, are too modest to justify the suffering which such treatment can cause at a time when a woman with breast cancer might otherwise expect to feel physically well.

Adult↗
PubMed2026

Role of nicotine metabolite ratio in pharmacological interventions on smoking cessation: A systematic review and meta-analyses of randomized controlled trials.

BACKGROUND AND OBJECTIVES: Emerging evidence suggests that the nicotine metabolite ratio (NMR) may influence the efficacy of smoking cessation, yet its role across pharmacotherapies remains unclear. This study aims to investigate how NMR affects cessation outcomes under different medications to guide personalized treatment. METHODS: We searched PubMed, Medline, EMBASE, and the Cochrane Central Register of Controlled Trials (inception to September 30, 2024) for randomized controlled trials on pharmacotherapy for smoking cessation with NMR data. Data were synthesized using random-effects models, with heterogeneity assessment. The primary outcome was verified smoking cessation rate at the end of treatment or the closest time-point. RESULTS: Eleven RCTs with accessible full text were included in the qualitative analyses and nine were included in the quantitative synthesis. For non-titratable nicotine replacement therapy (NRT), normal/fast metabolizers demonstrated lower odds of smoking cessation than slow metabolizers (Odds Ratio, OR=0.81, 95% confidence interval, CI=0.68-0.96; 5 studies, I&#xb2;=62.5%). No significant associations were shown between normal/fast and slow metabolizers using titratable NRT (OR=1.04, 95% CI=0.95-1.14; 2 studies, I&#xb2;=0%), bupropion (OR=0.67, 95% CI=0.38-1.16; 2 studies, I&#xb2;=51.4%), or varenicline (OR=1.17, 95% CI=0.79-1.74; 4 studies, I&#xb2;=59.8%). CONCLUSION: Current evidence demonstrates that NMR moderates' treatment efficacy among those who smoke using non-titratable NRT, with slow metabolizers achieving significantly better cessation outcomes than normal/fast metabolizers. Substantial further research is needed to determine optimal medication hierarchies across metabolic profiles.

Humans↗
PubMed1996

Assessing the quality of randomized controlled trials. Current issues and future directions.

Assessing the quality of randomized controlled trials is a relatively new and important development. Three approaches have been developed: component, checklist, and scale assessment. Component approaches evaluate selected aspects of trials, such as masking. Checklists and scales involve lists of items thought to be integral to study quality. Scales, unlike the other methods, provide a summary numeric score of quality, which can be formally incorporated into a systematic review. Most scales to date have not been developed with sufficient rigor, however. Empirical evidence indicates that differences in scale development can lead to important differences in quality assessment. Several methods for including quality scores in systematic reviews have been proposed, but since little empirical evidence supports any given method, results must be interpreted cautiously. Future efforts may be best focused on gathering more empirical evidence to identify trial characteristics directly related to bias in the estimates of intervention effects and on improving the way in which trials are reported.

Data Interpretation, Statistical↗
PubMed2005

Calcium- and vitamin D3-fortified milk reduces bone loss at clinically relevant skeletal sites in older men: a 2-year randomized controlled trial.

UNLABELLED: In this 2-year randomized controlled study of 167 men >50 years of age, supplementation with calcium-vitamin D3-fortified milk providing an additional 1000 mg of calcium and 800 IU of vitamin D3 per day was effective for suppressing PTH and stopping or slowing bone loss at several clinically important skeletal sites at risk for fracture. INTRODUCTION: Low dietary calcium and inadequate vitamin D stores have long been implicated in age-related bone loss and osteoporosis. The aim of this study was to assess the effects of calcium and vitamin D3 fortified milk on BMD in community living men >50 years of age. MATERIALS AND METHODS: This was a 2-year randomized controlled study in which 167 men (mean age +/- SD, 61.9 +/- 7.7 years) were assigned to receive either 400 ml/day of reduced fat ( approximately 1%) ultra-high temperature (UHT) milk containing 1000 mg of calcium plus 800 IU of vitamin D3 or to a control group receiving no additional milk. Primary endpoints were changes in BMD, serum 25(OH)D, and PTH. RESULTS: One hundred forty-nine men completed the study. Baseline characteristics between the groups were not different; mean dietary calcium and serum 25(OH)D levels were 941 +/- 387 mg/day and 77 +/- 23 nM, respectively. After 2 years, the mean percent change in BMD was 0.9-1.6% less in the milk supplementation compared with control group at the femoral neck, total hip, and ultradistal radius (range, p < 0.08 to p < 0.001 after adjusting for covariates). There was a greater increase in lumbar spine BMD in the milk supplementation group after 12 and 18 months (0.8-1.0%, p < or = 0.05), but the between-group difference was not significant after 2 years (0.7%; 95% CI, -0.3, 1.7). Serum 25(OH)D increased and PTH decreased in the milk supplementation relative to control group after the first year (31% and -18%, respectively; both p < 0.001), and these differences remained after 2 years. Body weight remained unchanged in both groups at the completion of the study. CONCLUSIONS: Supplementing the diet of men >50 years of age with reduced-fat calcium- and vitamin D3-enriched milk may represent a simple, nutritionally sound and cost-effective strategy to reduce age-related bone loss at several skeletal sites at risk for fracture in the elderly.

Aged↗
PubMedDate not supplied

The reporting of randomized controlled trials in prosthodontics.

PURPOSE: This article evaluates the reporting of randomized controlled trials (RCT) in prosthodontics, excluding endosseous implant-based prosthetics. MATERIALS AND METHODS: Reports of RCTs published to the end of 2000 in any language were identified using a multilayered search strategy. The Cochrane Oral Health Group specialized register, Medline, and personal libraries were searched. Three researchers appraised the articles independently using guidelines following Jadad and CONSORT, complemented with an evaluation of the appropriateness of the reported statistics. RESULTS: Ninety-two reports of RCTs were evaluated, covering a wide spectrum of study hypotheses, topics, and issues within various prosthodontic domains. The interrater agreements on appraisal criteria were relatively high, with median kappa values ranging between 0.65 and 0.79. The reports were in general of poor methodologic quality. Randomization and procedures for concealment allocation were not described in 70% of the articles. The methods used to generate the random allocation sequence were not mentioned in 82%. The methods used to implement the random allocation sequence, clarifying whether it was concealed until all interventions were assigned, was not mentioned in 94%. Reporting who generated allocation sequence, who enrolled patients, and who assigned participants to groups was not reported in 7%. Reasons for withdrawals were not given in 23% of the reports. No attempt at blinding was reported in 72%. Statistical analysis was not described in 6% of the papers, while these analyses were assessed as appropriate for 75%, unclear in 12%, and inappropriate in 7%. CONCLUSION: Few RCTs in prosthodontics are reported in accordance with contemporary guidelines for adequate reporting of trials.

Adhesives↗
PubMed2003

Preventive treatments for recurrence after curative resection of hepatocellular carcinoma--a literature review of randomized control trials.

To review the inhibitory effect of preventive approaches on recurrence after operation in patients with hepatocellular carcinoma (HCC), we summarized all available publications reporting randomized control trial indexed in PubMed. The treatment approaches presented above included pre-operative transcatheter arterial chemoembolization (TACE), post-operative TACE, systemic or locoregional chemotherapy, immunotherapy, Interferons and acyclic retinoic acid. Although no standard treatment has been established, several approaches presented promising results, which were both effective and tolerable in post-operative patients. Pre-operative TACE was not effective on prolonging survivals, while post-operative TACE was shown with both disease-free survival and overall survival benefits in some papers, however, it was also questioned by others. Systemic chemotherapy was generally not effective on prolonging survival but also poorly tolerated for its significant toxicities. Adoptive immunotherapy using LAK cells was proved to be beneficial to patients' survival in a recent paper. Interferon alpha and Interferon beta can inhibit recurrence in HCC patients with HCV infection background, though the mechanism is not fully understood. Acyclic retinoic acid was shown to decrease multi-centric recurrence after operation, which was reported by only one group. In conclusion, several adjuvant approaches have been studied for their efficacy on recurrence in HCC patients in randomized control trials; however, multi-centric randomized control trial is still needed for further evaluation on their efficacy and systemic or local toxicities; in addition, new adjuvant treatment should be investigated to provide more effective and tolerable methods for the patients with HCC after operation.

Carcinoma, Hepatocellular↗