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.
Papers published on a yearly basis
Papers
More filters
TL;DR: In this article, the authors provide up-to-date evidence-based guidelines for the optimal treatment of fibromyalgia syndrome (FMS) using a search of all human trials (randomized controlled trials and meta-analyses of randomized controlled trials) of FMS.
Abstract: ContextThe optimal management of fibromyalgia syndrome (FMS) is unclear and
comprehensive evidence-based guidelines have not been reported.ObjectiveTo provide up-to-date evidence-based guidelines for the optimal treatment
of FMS.Data Sources, Selection, and ExtractionA search of all human trials (randomized controlled trials and meta-analyses
of randomized controlled trials) of FMS was made using Cochrane Collaboration
Reviews (1993-2004), MEDLINE (1966-2004), CINAHL (1982-2004), EMBASE (1988-2004),
PubMed (1966-2004), Healthstar (1975-2000), Current Contents (2000-2004),
Web of Science (1980-2004), PsychInfo (1887-2004), and Science Citation Indexes
(1996-2004). The literature review was performed by an interdisciplinary panel,
composed of 13 experts in various pain management disciplines, selected by
the American Pain Society (APS), and supplemented by selected literature reviews
by APS staff members and the Utah Drug Information Service. A total of 505
articles were reviewed.Data SynthesisThere are major limitations to the FMS literature, with many treatment
trials compromised by short duration and lack of masking. There are no medical
therapies that have been specifically approved by the US Food and Drug Administration
for management of FMS. Nonetheless, current evidence suggests efficacy of
low-dose tricyclic antidepressants, cardiovascular exercise, cognitive behavioral
therapy, and patient education. A number of other commonly used FMS therapies,
such as trigger point injections, have not been adequately evaluated.ConclusionsDespite the chronicity and complexity of FMS, there are pharmacological
and nonpharmacological interventions available that have clinical benefit.
Based on current evidence, a stepwise program emphasizing education, certain
medications, exercise, cognitive therapy, or all 4 should be recommended.
802 citations
TL;DR: In patients hospitalized with heart failure, oral tolvaptan in addition to standard therapy including diuretics improved many, though not all, heart failure signs and symptoms, without serious adverse events.
Abstract: ContextHeart failure causes more than 1 million US hospitalizations yearly, mostly related to congestion. Tolvaptan, an oral, nonpeptide, selective vasopressin V2-receptor antagonist, shows promise in this condition.ObjectiveTo evaluate short-term effects of tolvaptan when added to standard therapy in patients hospitalized with heart failure.Design, Setting, and PatientsTwo identical prospective, randomized, double-blind, placebo-controlled trials at 359 sites in North America, South America, and Europe were conducted during the inpatient period of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) between October 7, 2003, and February 3, 2006. A total of 2048 (trial A) and 2085 (trial B) patients hospitalized with heart failure and congestion were studied.InterventionPatients were randomized to receive either tolvaptan (30 mg/d) or matching placebo, within 48 hours of admission.Main Outcome MeasuresPrimary end point was a composite of changes in global clinical status based on a visual analog scale and body weight at day 7 or discharge if earlier. Secondary end points included dyspnea (day 1), global clinical status (day 7 or discharge), body weight (days 1 and 7 or discharge), and peripheral edema (day 7 or discharge).ResultsRank sum analysis of the composite primary end point showed greater improvement with tolvaptan vs placebo (trial A, mean [SD], 1.06 [0.43] vs 0.99 [0.44]; and trial B, 1.07 [0.42] vs 0.97 [0.43]; both trials P<.001). Mean (SD) body weight reduction was greater with tolvaptan on day 1 (trial A, 1.71 [1.80] vs 0.99 [1.83] kg; P<.001; and trial B, 1.82 [2.01] vs 0.95 [1.85] kg; P<.001) and day 7 or discharge (trial A, 3.35 [3.27] vs 2.73 [3.34] kg; P<.001; and trial B, 3.77 [3.59] vs 2.79 [3.46] kg; P<.001), whereas improvements in global clinical status were not different between groups. More patients receiving tolvaptan (684 [76.7%] and 678 [72.1%] for trial A and trial B, respectively) vs patients receiving placebo (646 [70.6%] and 597 [65.3%], respectively) reported improvement in dyspnea at day 1 (both trials P<.001). Edema at day 7 or discharge improved significantly with tolvaptan in trial B (P = .02) but did not reach significance in trial A (P = .07). Serious adverse event frequencies were similar between groups, without excess renal failure or hypotension.ConclusionIn patients hospitalized with heart failure, oral tolvaptan in addition to standard therapy including diuretics improved many, though not all, heart failure signs and symptoms, without serious adverse events.Trial Registrationclinicaltrials.gov Identifier: NCT00071331Published online March 25, 2007 (doi:10.1001/jama.297.12.1332).
801 citations
TL;DR: It is indicated that a short intervention can change alcoholics’ automatic approach bias for alcohol and may improve treatment outcome.
Abstract: This study tested the effects of a new cognitive-bias modification (CBM) intervention that targeted an approach bias for alcohol in 214 alcoholic inpatients. Patients were assigned to one of two experimental conditions, in which they were explicitly or implicitly trained to make avoidance movements (pushing a joystick) in response to alcohol pictures, or to one of two control conditions, in which they received no training or sham training. Four brief sessions of experimental CBM preceded regular inpatient treatment. In the experimental conditions only, patients’ approach bias changed into an avoidance bias for alcohol. This effect generalized to untrained pictures in the task used in the CBM and to an Implicit Association Test, in which alcohol and soft-drink words were categorized with approach and avoidance words. Patients in the experimental conditions showed better treatment outcomes a year later. These findings indicate that a short intervention can change alcoholics’ automatic approach bias for alcohol and may improve treatment outcome.
794 citations
TL;DR: Among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular events.
Abstract: Background The cardiovascular effects of ertugliflozin, an inhibitor of sodium–glucose cotransporter 2, have not been established. Methods In a multicenter, double-blind trial, we randomly...
789 citations
TL;DR: Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older and did not prevent mild cognitive impairment in these women, supporting the conclusion that the risks of estrogen plus progESTin outweigh the benefits.
Abstract: CONTEXT
Postmenopausal women have a greater risk than men of developing Alzheimer disease, but studies of the effects of estrogen therapy on Alzheimer disease have been inconsistent. On July 8, 2002, the study drugs, estrogen plus progestin, in the Women's Health Initiative (WHI) trial were discontinued because of certain increased health risks in women receiving combined hormone therapy.
OBJECTIVE
To evaluate the effect of estrogen plus progestin on the incidence of dementia and mild cognitive impairment compared with placebo.
DESIGN, SETTING, AND PARTICIPANTS
The Women's Health Initiative Memory Study (WHIMS), a randomized, double-blind, placebo-controlled clinical trial, began enrolling participants from the Women's Health Initiative (WHI) estrogen plus progestin trial in May 1996. Of the 4894 eligible participants of the WHI study, 4532 (92.6%) postmenopausal women free of probable dementia, aged 65 years or older, and recruited from 39 of 40 WHI clinical centers were enrolled in the WHIMS.
INTERVENTION
Participants received either 1 daily tablet of 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (n = 2229), or a matching placebo (n = 2303).
MAIN OUTCOME MEASURES
Incidence of probable dementia (primary outcome) and mild cognitive impairment (secondary outcome) were identified through a structured clinical assessment.
RESULTS
The mean (SD) time between the date of randomization into WHI and the last Modified Mini-Mental State Examination (3MSE) for all WHIMS participants was 4.05 (1.19) years. Overall, 61 women were diagnosed with probable dementia, 40 (66%) in the estrogen plus progestin group compared with 21 (34%) in the placebo group. The hazard ratio (HR) for probable dementia was 2.05 (95% confidence interval [CI], 1.21-3.48; 45 vs 22 per 10 000 person-years; P =.01). This increased risk would result in an additional 23 cases of dementia per 10 000 women per year. Alzheimer disease was the most common classification of dementia in both study groups. Treatment effects on mild cognitive impairment did not differ between groups (HR, 1.07; 95% CI, 0.74-1.55; 63 vs 59 cases per 10 000 person-years; P =.72).
CONCLUSIONS
Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older. In addition, estrogen plus progestin therapy did not prevent mild cognitive impairment in these women. These findings, coupled with previously reported WHI data, support the conclusion that the risks of estrogen plus progestin outweigh the benefits.
788 citations