Topic
Randomized controlled trial
About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.
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TL;DR: It remains puzzling to me why the investigators restricted the entry criteria and consequently selected a population that was not representative of general clinical practice when excluding patients with frequently coexisting medical conditions such as diabetes, chronic obstructive pulmonary disease, and endocrine diseases.
Abstract: To the Editor:
In their recently published, 1-year prospective, double blind, placebo-controlled study, Winblad et al.1 examined the long-term clinical efficacy and safety of donepezil in mild to moderate AD. I congratulate the investigators for their effort. Unfortunately, it remains puzzling to me why the investigators restricted the entry criteria and consequently selected a population that was not representative of general clinical practice. By excluding patients with frequently coexisting medical conditions such as diabetes, chronic obstructive pulmonary disease, and endocrine diseases, the demonstrable effect of the treatment is not obscured by comorbid conditions and is therefore probably the greatest possible effect that can be observed. One clinical trial revealed that including patients with significant comorbidity reduced the beneficial effect of donepezil by almost 50% of that observed in trials with more rigorous entry criteria.2 In addition, the strict lack of any significant effect at the end point (last observation carried forward; LOCF) on the primary efficacy parameter raises questions. Furthermore, it is questionable whether the magnitude of change taken at its highest value (week 52 [6.2 units or 9.6%]) is detectable by the physician and caregivers. …
659 citations
TL;DR: Although this study did not show preoperative radiotherapy to have a statistically significant benefit on overall survival, it does have a clear effect on local control of rectal cancer, therefore, before performing radical surgery, this adjuvant therapy should be administered to patients who have locally extendedrectal cancer.
Abstract: A randomized clinical trial was conducted by the European Organization for Research and Treatment for Cancer (EORTC) Gastrointestinal Cancer Cooperative Group to study the effectiveness of irradiation therapy administered in a dosage of 34.5 Gy, divided into 15 daily doses of 2.3 Gy each before radical surgery for rectal cancer (T2, T3, T4, NX, MO). Four hundred sixty-six patients were entered in the clinical trial between June 1976 and September 1981. Tolerance and side effects of preoperative irradiation were acceptable. The overall 5-year survival rates were similar in both groups. When considering only the 341 patients treated by surgery with a curative aim, the 5-year survival rates were 59.1% and 69.1% in the control group and in the combined modality group, respectively (p = 0.08). The local recurrence rates at 5 years were 30% and 15% in the control group and the adjuvant radiotherapy group, respectively (p = 0.003). Although this study did not show preoperative radiotherapy to have a statistically significant benefit on overall survival, it does have a clear effect on local control of rectal cancer. Therefore, before performing radical surgery, this adjuvant therapy should be administered to patients who have locally extended rectal cancer.
658 citations
TL;DR: The combined therapies was not significantly superior to either therapy alone, but 10% more patients gained relief with the combination, and the neck pain and effects were maintained.
Abstract: STUDY DESIGN: A multicenter, randomized controlled trial with unblinded treatment and blinded outcome assessment was conducted. The treatment period was 6 weeks with follow-up assessment after treatment, then at 3, 6, and 12 months. OBJECTIVES: To determine the effectiveness of manipulative therapy and a low-load exercise program for cervicogenic headache when used alone and in combination, as compared with a control group. SUMMARY OF BACKGROUND DATA: Headaches arising from cervical musculoskeletal disorders are common. Conservative therapies are recommended as the first treatment of choice. Evidence for the effectiveness of manipulative therapy is inconclusive and available only for the short term. There is no evidence for exercise, and no study has investigated the effect of combined therapies for cervicogenic headache. METHODS: In this study, 200 participants who met the diagnostic criteria for cervicogenic headache were randomized into four groups: manipulative therapy group, exercise therapy group, combined therapy group, and a control group. The primary outcome was a change in headache frequency. Other outcomes included changes in headache intensity and duration, the Northwick Park Neck Pain Index, medication intake, and patient satisfaction. Physical outcomes included pain on neck movement, upper cervical joint tenderness, a craniocervical flexion muscle test, and a photographic measure of posture. RESULTS: There were no differences in headache-related and demographic characteristics between the groups at baseline. The loss to follow-up evaluation was 3.5%. At the 12-month follow-up assessment, both manipulative therapy and specific exercise had significantly reduced headache frequency and intensity, and the neck pain and effects were maintained (P < 0.05 for all). The combined therapies was not significantly superior to either therapy alone, but 10% more patients gained relief with the combination. Effect sizes were at least moderate and clinically relevant. CONCLUSION: Manipulative therapy and exercise can reduce the symptoms of cervicogenic headache, and the effects are maintained.
658 citations
Journal Article•
TL;DR: Overall, the clinical outcomes were very similar across sites and conditions; however, after controlling for initial severity, the most cost-effective interventions were MET/CBT5 and MET-CBT12 in Trial 1 and ACRA and MET/ CBT5 in Trial 2.
658 citations
TL;DR: Pretreatment with a 600-mg loading dose of clopidogrel 4 to 8 hours before the procedure is safe and, as compared with the conventional 300-mg dose, significantly reduced periprocedural MI in patients undergoing percutaneous coronary intervention.
Abstract: Background— Aggressive platelet inhibition is crucial to reduce myocardial injury and early cardiac events after coronary intervention. Although observational data have suggested that pretreatment with a high loading dose of clopidogrel may be more effective than a conventional dose, this hypothesis has never been tested in a randomized trial. Methods and Results— A total of 255 patients scheduled to undergo percutaneous coronary intervention were randomized to a 600-mg (n=126) or 300-mg (n=129) loading regimen of clopidogrel given 4 to 8 hours before the procedure. Creatine kinase MB, troponin I, and myoglobin levels were measured at baseline and at 8 and 24 hours after intervention. The primary end point was the 30-day occurrence of death, myocardial infarction (MI), or target vessel revascularization. The primary end point occurred in 4% of patients in the high loading dose versus 12% of those in the conventional loading dose group (P=0.041) and was due entirely to periprocedural MI. Peak values of all...
658 citations