random allocation

Background: The appropriate antithrombotic regimen for patients with chronic coronary syndrome who are at high atherothrombotic risk and receiving long-term oral anticoagulation remains unknown.

Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial in France involving patients with chronic coronary syndrome who had undergone a previous stent implantation (>6 months before enrollment) and were at high atherothrombotic risk and currently receiving long-term oral anticoagulation. The patients were randomly assigned in a 1:1 ratio to receive aspirin (100 mg once daily) or placebo; all the patients continued to receive their current oral anticoagulation therapy. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia. The key safety outcome was major bleeding.

Results: A total of 872 patients underwent randomization; 433 were assigned to the aspirin group, and 439 to the placebo group. The trial was stopped early at the advice of the independent data and safety monitoring board after a median follow-up of 2.2 years because of an excess of deaths from any cause in the aspirin group. A primary efficacy outcome event occurred in 73 patients (16.9%) in the aspirin group and in 53 patients (12.1%) in the placebo group (adjusted hazard ratio, 1.53; 95% confidence interval [CI], 1.07 to 2.18; P = 0.02). Death from any cause occurred in 58 patients (13.4%) in the aspirin group and in 37 (8.4%) in the placebo group (adjusted hazard ratio, 1.72; 95% CI, 1.14 to 2.58; P = 0.01). Major bleeding occurred in 44 patients (10.2%) in the aspirin group and in 15 patients (3.4%) in the placebo group (adjusted hazard ratio, 3.35; 95% CI, 1.87 to 6.00; P<0.001). A total of 467 and 395 serious adverse events were reported in the aspirin group and placebo group, respectively.

Conclusions: Among patients with chronic coronary syndrome at high atherothrombotic risk who were receiving an oral anticoagulant, the addition of aspirin led to a higher risk of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia than placebo, as well as higher risks of death from any cause and major bleeding. (Funded by the French Ministry of Health and Bayer Healthcare; ClinicalTrials.gov number, NCT04217447.).

Author/s:

Gilles Lemesle, M.D., Ph.D., Romain Didier, M.D., Ph.D., Philippe Gabriel Steg, M.D., Tabassome Simon, M.D., Ph.D., Gilles Montalescot, M.D., Ph.D., Nicolas Danchin, M.D., Christophe Bauters, M.D., Ph.D.

Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention

Aubrey Delammermore — Wed, 18 Jan 2023 06:00:00 +0000

Date Added:

January 18, 2023

Journal/Publication:

American Journal of Preventative Medicine

Publisher:

Elsevier

Publication Date:

January 13, 2023

Pages:

1-5

URL:

Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1016/j.amepre.2022.12.010

Keywords

PMID (1):

36642643

MeSH

air pollution

Surveys and Questionnaires

child

random allocation

asthma

Adding instructions regarding use of the Air Quality Index to asthma action plans improved asthma control in children. James W. Mold, MD, MPH

Free full text

View

Introduction: To reduce air pollution exposure, the U.S. asthma guidelines recommend that children check the Air Quality Index before outdoor activity. Whether adding the Air Quality Index and recommendations to asthma action plans reduces exacerbations and improves control and quality of life in children with asthma is unknown.

Methods: A pilot, unblinded, randomized clinical trial of 40 children with persistent asthma, stratified by age and randomized 1:1, recruited from the University of Pittsburgh Medical Center Children's Hospital of Pittsburgh (Pittsburgh, PA) was conducted. All participants received asthma action plans and Air Quality Index education. The intervention group received printed Air Quality Index information and showed the ability to use AirNow. Asthma exacerbations were assessed through a questionnaire, asthma control was assessed with the Asthma Control Test and Childhood Asthma Control Test, and quality of life was assessed with the Pediatric Asthma Quality of Life Questionnaire. After randomization (July-October 2020), participants were followed monthly for 6 months (exit January-March 2021). Outcome differences between groups were evaluated at the exit visit and over time (analysis was in 2021).

Results: At randomization, there were no significant differences in age, sex, race, or asthma severity. At exit, more intervention participants checked the Air Quality Index (63% vs 15%) with no differences in the proportion of asthma exacerbations or mean Childhood Asthma Control Test or Pediatric Asthma Quality of Life Questionnaire scores. The mean change in Asthma Control Test score was higher in the intervention group (change in Asthma Control Test=2.00 vs 0.15 for the control), which was modified by time (β=1.85, CI=0.09, 3.61). Physical activity was decreased overall and showed modification by treatment and time.

Conclusions: Addition of the Air Quality Index to asthma action plans led to improved asthma control by Asthma Control Test scores but may decrease outdoor activity.

Author/s:

Rosser, F. J., Rothenberger, S. D., Han, Y., Forno, E., Celedón, J. C.

Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial

Bethie Seay — Sun, 07 Nov 2021 05:00:00 +0000

Date Added:

November 7, 2021

Journal/Publication:

JAMA

Publication Date:

November 2, 2021

Issue:

Volume:

326

Pages:

1713-1724

Type:

Clinical Research Results

DOI (1):

10.1001/jama.2021.17843

3 days of standard dose amoxicillin was as effective as 7 days of high-dose amoxicillin for treatment of CAP in children discharged from an ED. In both cases, additional antibiotic treatment was required subsequently in around 12.5% of kids.

View

Importance
The optimal dose and duration of oral amoxicillin for children with community-acquired pneumonia (CAP) are unclear.

Objective
To determine whether lower-dose amoxicillin is noninferior to higher dose and whether 3-day treatment is noninferior to 7 days.

Design, Setting, and Participants
Multicenter, randomized, 2 × 2 factorial noninferiority trial enrolling 824 children, aged 6 months and older, with clinically diagnosed CAP, treated with amoxicillin on discharge from emergency departments and inpatient wards of 28 hospitals in the UK and 1 in Ireland between February 2017 and April 2019, with last trial visit on May 21, 2019.

Interventions
Children were randomized 1:1 to receive oral amoxicillin at a lower dose (35-50 mg/kg/d; n = 410) or higher dose (70-90 mg/kg/d; n = 404), for a shorter duration (3 days; n = 413) or a longer duration (7 days; n = 401).

Main Outcomes and Measures
The primary outcome was clinically indicated antibiotic re-treatment for respiratory infection within 28 days after randomization. The noninferiority margin was 8%. Secondary outcomes included severity/duration of 9 parent-reported CAP symptoms, 3 antibiotic-related adverse events, and phenotypic resistance in colonizing Streptococcus pneumoniae isolates.

Results
Of 824 participants randomized into 1 of the 4 groups, 814 received at least 1 dose of trial medication (median [IQR] age, 2.5 years [1.6-2.7]; 421 [52%] males and 393 [48%] females), and the primary outcome was available for 789 (97%). For lower vs higher dose, the primary outcome occurred in 12.6% with lower dose vs 12.4% with higher dose (difference, 0.2% [1-sided 95% CI –∞ to 4.0%]), and in 12.5% with 3-day treatment vs 12.5% with 7-day treatment (difference, 0.1% [1-sided 95% CI –∞ to 3.9]). Both groups demonstrated noninferiority with no significant interaction between dose and duration (P = .63). Of the 14 prespecified secondary end points, the only significant differences were 3-day vs 7-day treatment for cough duration (median 12 days vs 10 days; hazard ratio [HR], 1.2 [95% CI, 1.0 to 1.4]; P = .04) and sleep disturbed by cough (median, 4 days vs 4 days; HR, 1.2 [95% CI, 1.0 to 1.4]; P = .03). Among the subgroup of children with severe CAP, the primary end point occurred in 17.3% of lower-dose recipients vs 13.5% of higher-dose recipients (difference, 3.8% [1-sided 95% CI, –∞ to10%]; P value for interaction = .18) and in 16.0% with 3-day treatment vs 14.8% with 7-day treatment (difference, 1.2% [1-sided 95% CI, –∞ to 7.4%]; P value for interaction = .73).

Conclusions and Relevance
Among children with CAP discharged from an emergency department or hospital ward (within 48 hours), lower-dose outpatient oral amoxicillin was noninferior to higher dose, and 3-day duration was noninferior to 7 days, with regard to need for antibiotic re-treatment. However, disease severity, treatment setting, prior antibiotics received, and acceptability of the noninferiority margin require consideration when interpreting the findings.

Trial Registration
ISRCTN Identifier: ISRCTN76888927

Author/s:

Bielicki, J. A., Stöhr, W., Barratt, S., Dunn, D., Naufal, N., Roland, D., Sturgeon, K., Finn, A., Rodriguez-Ruiz, J. P., Malhotra-Kumar, S., Powell, C., Faust, S. N., Alcock, A. E., Hall, D., Robinson, G., Hawcutt, D. B., Lyttle, M. D., Gibb, D. M., Sharland, M.

Facilitating rapid access to addiction treatment: a randomized controlled trial

Bethie Seay — Thu, 03 Jun 2021 05:00:00 +0000

Date Added:

June 3, 2021

Type:

Clinical Research Results

DOI (1):

10.1186/s13722-021-00240-y

PMID (1):

34034821

MeSH

referral and consultation

Emergency Service, hospital

patient acceptance of healthcare

National Institutes of Health (U.S.)

Not surprisingly, rapid access to addiction treatment works better than delayed access.

View

Background: Obtaining timely access to addiction medicine treatment for patients with substance use disorders is challenging and patients often have to navigate complex referral pathways. This randomized controlled trial examines the effect of providing an expedited pathway to addiction medicine treatment on initial treatment engagement and health care utilization.

Methods: Individuals with possible alcohol or opioid use disorder were recruited from three residential withdrawal management services (WMS). Subjects randomized to the Delayed Intervention (DI) group were given contact information for a nearby addiction medicine clinic; those randomized to the Rapid Intervention (RI) group were given an appointment at the clinic within 2 days and were accompanied to their first appointment.

Results: Of the 174 individuals who were screened, 106 were randomized to either the DI or RI group. The two groups were similar in demographics, housing status, and substance use in the last 30 days. In the 6-month period following randomization, 85% of the RI group attended at least one clinic appointment, compared to only 29% in the DI group (p < 0.0001). The RI group had a mean of 6.39 ED visits per subject in the 12 months after randomization, while the DI group had a mean of 13.02 ED visits per subject in the same 12-month period (p = 0.0469). Other health utilization measures did not differ between the two groups.

Conclusion: Providing immediate facilitated access to an addiction medicine service resulted in greater initial engagement and reduced emergency department visits at 6 months. Trial registration This trial is registered at the National Institutes of Health (ClinicalTrials.gov) under identifier #NCT01934751.

Author/s:

Srivastava, Anita, Clarke, Sarah, Hardy, Kate, Kahan, Meldon

Effect of Vitamin D3 Supplements on Development of Advanced Cancer: A Secondary Analysis of the VITAL Randomized Clinical Trial

Brian Desmarais — Thu, 19 Nov 2020 18:03:28 +0000

Date Added:

November 19, 2020

Journal/Publication:

JAMA Network Open

Publication Date:

November 8, 2020

Issue:

Volume:

URL:

Effect of Vitamin D3 Supplements on Development of Advanced Cancer: A Secondary Analysis of the VITAL Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2020.25850

MeSH

cardiovascular diseases

This large RCT suggests that supplementation with Vit D3 2000 IU daily may reduce the risk of metastatic cancer. James W. Mold, MD, MPH

Free full text

View

Importance Epidemiologic and trial data suggest that vitamin D supplementation may reduce metastatic cancer and cancer mortality, reflecting shared biological pathways.

Objective To follow up on the possible reduction in cancer death in the Vitamin D and Omega-3 Trial (VITAL) with an evaluation of whether vitamin D reduces the incidence of advanced (metastatic or fatal) cancer and an examination possible effect modification by body mass index.

Design, Setting, and Participants VITAL is a randomized, double-blind, placebo-controlled, 2 × 2 factorial clinical trial of vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (1 g/d). This multicenter clinical trial was conducted in the United States; participants included men aged 50 years or older and women aged 55 years or older who were free of cancer and cardiovascular disease at baseline. Randomization took place from November 2011 through March 2014, and study medication ended on December 31, 2017. Data for this secondary analysis were analyzed from November 1, 2011, to December 31, 2017.

Interventions Vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (1 g/d) supplements.

Main Outcomes and Measures For the present analysis, the primary outcome was a composite incidence of metastatic and fatal invasive total cancer, because the main VITAL study showed a possible reduction in fatal cancer with vitamin D supplementation and effect modification by body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) for total cancer incidence reduction for individuals with normal BMI, but not for individuals with overweight or obesity. Secondary analyses included examination of BMI (<25, 25 to < 30, and ≥30) as effect modifiers of the observed associations.

Results Among 25 871 randomized VITAL participants (51% female; mean [SD] age, 67.1 [7.1] years), 1617 were diagnosed with invasive cancer over a median intervention period of 5.3 years (range, 3.8-6.1 years). As previously reported, no significant differences for cancer incidence by treatment arm were observed. However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83 [95% CI, 0.69-0.99]; P = .04). When stratified by BMI, there was a significant reduction for the vitamin D arm in incident metastatic or fatal cancer among those with normal BMI (BMI<25: HR, 0.62 [95% CI, 0.45-0.86]) but not among those with overweight or obesity (BMI 25-<30: HR, 0.89 [95% CI, 0.68-1.17]; BMI≥30: HR, 1.05 [95% CI, 0.74-1.49]) (P = .03 for interaction by BMI).

Conclusions and Relevance In this randomized clinical trial, supplementation with vitamin D reduced the incidence of advanced (metastatic or fatal) cancer in the overall cohort, with the strongest risk reduction seen in individuals with normal weight.

Trial Registration ClinicalTrials.gov Identifier: NCT01169259

Author/s:

Chandler, P.D., Chen, W.Y., Ojala, O.N.

Colchicine in Patients with Chronic Coronary Disease

Brian Desmarais — Sat, 07 Nov 2020 22:20:46 +0000

Date Added:

November 7, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

November 5, 2020

URL:

Colchicine in Patients with Chronic Coronary Disease

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2021372

MeSH

Heart Diseases

Myocardial Ischemia

coronary artery disease

myocardial infarction

In this RCT involving patients with chronic coronary artery disease, 0.5mg of colchicine daily reduce the risk of a composite endpoint of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. James W. Mold, MD, MPH

Commercial full text (fees may apply)

View

Abstract

Background: Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.

Methods: In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.

Results: A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).

Conclusions: In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo. (Funded by the National Health Medical Research Council of Australia and others; LoDoCo2 Australian New Zealand Clinical Trials Registry number, ACTRN12614000093684.).

Author/s:

LoDoCo2 Trial Investigators

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Brian Desmarais — Wed, 03 Jun 2020 14:42:13 +0000

Date Added:

June 3, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

May 14, 2020

Issue:

Volume:

382

Pages:

1906-1915

URL:

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1915254

MeSH

Lactobacillus crispatus

Vaginosis, Bacterial

Societies, Medical

Administration, Intravaginal

risk factors

random allocation

Intention to Treat Analysis

follow-up studies

double-blind method

Confidence Intervals

anti-bacterial agents

incidence

Odds Ratio

RPR Commentary: This RCT suggest that intravaginal Lactin V (a probiotic) delayed recurrence of bacterial vaginosis in women following treatment with metronidazole. James W. Mold, MD, MPH

Commercial full text (fees may apply)

View

Abstract

Background: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.

Methods: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.

Results: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.

Conclusions: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

Author/s:

Cohen, C.R., Wierzbicki, C.R., French, A.L., Morris, S., Newmann, S., Reno, H., Green, L., Miller, S., Powell, J., Parks, T., Hemmerling, S.

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial

Brian Desmarais — Wed, 13 May 2020 23:54:05 +0000

Date Added:

May 13, 2020

Journal/Publication:

Annals of Family Medicine

Publication Date:

May 1, 2020

Issue:

Volume:

Pages:

235-242

URL:

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1370/afm.2520

MeSH

Personal Satisfaction

In this relatively small RCT, prolotherapy was more effective than saline injections for relieving pain and improving function in patients with OA of the knee at 4, 6, and 12 months. James W. Mold, MD, MPH

Commercial full text (fees may apply)

View

Purpose: To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).

Methods: A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model.

Results: Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, P = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, P = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, P = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, P = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, P = 0.020). No adverse events were reported.

Conclusion: Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

Keywords: intra-articular hypertonic dextrose; knee osteoarthritis; normal saline; prolotherapy; randomized clinical trial.

Author/s:

Sit, R.W.S., Wu, R.W., Reeves, K.D., Chan, D.C.C., Yip, B.H.K., Chung, V.C.H., Wong, S.

Alcohol Abstinence in Drinkers with Atrial Fibrillation

Brian Desmarais — Fri, 03 Jan 2020 22:27:35 +0000

Date Added:

January 3, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

January 2, 2020

Issue:

Volume:

382

Pages:

20-28

URL:

Alcohol Abstinence in Drinkers with Atrial Fibrillation

Type:

Clinical Research Results

Format:

Article

DOI (1):

https://doi.org/10.1093/ntr/ntz234

Keywords

MeSH

Not surprisingly, reducing alcohol intake reduces the frequency of atrial fibrillation in patients known to have had episodes of atrial fibrillation.

Commercial full text (fees may apply)

View

BACKGROUND:

Excessive alcohol consumption is associated with incident atrial fibrillation and adverse atrial remodeling; however, the effect of abstinence from alcohol on secondary prevention of atrial fibrillation is unclear.

METHODS:

We conducted a multicenter, prospective, open-label, randomized, controlled trial at six hospitals in Australia. Adults who consumed 10 or more standard drinks (with 1 standard drink containing approximately 12 g of pure alcohol) per week and who had paroxysmal or persistent atrial fibrillation in sinus rhythm at baseline were randomly assigned in a 1:1 ratio to either abstain from alcohol or continue their usual alcohol consumption. The two primary end points were freedom from recurrence of atrial fibrillation (after a 2-week "blanking period") and total atrial fibrillation burden (proportion of time in atrial fibrillation) during 6 months of follow-up.

RESULTS:

Of 140 patients who underwent randomization (85% men; mean [±SD] age, 62±9 years), 70 were assigned to the abstinence group and 70 to the control group. Patients in the abstinence group reduced their alcohol intake from 16.8±7.7 to 2.1±3.7 standard drinks per week (a reduction of 87.5%), and patients in the control group reduced their alcohol intake from 16.4±6.9 to 13.2±6.5 drinks per week (a reduction of 19.5%). After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) in the control group. The abstinence group had a longer period before recurrence of atrial fibrillation than the control group (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; P = 0.005). The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P = 0.01).

CONCLUSIONS:

Abstinence from alcohol reduced arrhythmia recurrences in regular drinkers with atrial fibrillation. (Funded by the Government of Victoria Operational Infrastructure Support Program and others; Australian New Zealand Clinical Trials Registry number, ACTRN12616000256471.).

Author/s:

Voskoboinik, A., Kalman, J.M., De Silva, A., Nicholls, T., Costello, B., Nanayakkara, S., Prabhu, S., Stub, D., Azzopardi, S., Vizi, D., Wong, G., Nalliah, C., Sugumar, H., Wong, M., Kotschet, E., Kaye D., Taylor, A.J., Kistler, P.M.

Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years

Brian Desmarais — Mon, 19 Aug 2019 15:00:24 +0000

Date Added:

August 19, 2019

Journal/Publication:

Journal of Pediatrics

Publication Date:

June 25, 2019

URL:

Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years

Type:

Clinical Research Results

Format:

Article

Keywords

MeSH

Anemia, Iron-Deficiency

infants

Perhaps we are overprescribing iron fortified formulas for infants without iron deficiency anemia. James W. Mold, MD, MPH

Free full text

View

OBJECTIVES:

To test differences in cognitive outcomes among adolescents randomly assigned previously as infants to iron-fortified formulaor low-iron formula as part of an iron deficiency anemia prevention trial.

STUDY DESIGN:

Infants were recruited from community clinics in low- to middle-income neighborhoods in Santiago, Chile. Entrance criteria included term, singleton infants; birth weight of ≥3.0 kg; and no major congenital anomalies, perinatal complications, phototherapy, hospitalization >5 days, chronic illness, or iron deficiency anemia at 6 months. Six-month-old infants were randomized to iron-fortified(12 mg/L) or low-iron (2.3 mg/L) formula for 6 months. At 16 years of age, cognitive ability, visual perceptual ability, visual memory, and achievement in math, vocabulary, and comprehension were assessed, using standardized measures. We compared differences in developmental test scores according to randomization group.

RESULTS:

At the follow-up assessment, the 405 participants averaged 16.2 years of age and 46% were male. Those randomized to iron-fortified formula had lower scores than those randomized to low-iron formula for visual memory, arithmetic achievement, and reading comprehension achievement. For visual motor integration, there was an interaction with baseline infancy hemoglobin, such that the iron-fortified group outperformed the low-iron group when 6-month hemoglobin was low and underperformed when 6-month hemoglobin was high.

CONCLUSIONS:

Adolescents who received iron-fortified formula as infants from 6 to 12 months of age at levels recommended in the US had poorer cognitive outcomes compared with those who received a low-iron formula. The prevention of iron deficiency anemia in infancy is important for brain development. However, the optimal level of iron supplementation in infancy is unclear.

TRIAL REGISTRATION:

Clinicaltrials.gov: NCT01166451.

Author/s:

Gahagan, S., Delker, E., Blanco, E., Burrows, R., Lozoff, B.

C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations

John Bayhi — Thu, 11 Jul 2019 19:47:05 +0000

Date Added:

July 11, 2019

Journal/Publication:

New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Publication Date:

July 11, 2019

Issue:

Volume:

381

Pages:

111-120

URL:

C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1803185

Keywords

C-reactive protein

primary care

chronic obstructive pulmonary disease

copd

CRP

randomized control trial

antibiotics

PMID (1):

31291514

MeSH

Point-Of-Care Testing

anti-bacterial agents

technology assessment, biomedical

Wales

follow-up studies

random allocation

pulmonary disease, chronic obstructive

health status

Surveys and Questionnaires

primary health care

referral and consultation

England

In adults with acute COPD exacerbations, serum CRP-based decision-making led to fewer antibiotic prescriptions with no adverse consequences. Physicians and patients in the intervention group were advised to consider all clinically relevant information. However, they were advised to consider that CRP levels < 4omg/L indicated that antibiotics were probably not needed, levels between 20 and 40 mg/L were indeterminant, and levels above 40 mg/L suggested that antibiotics were probably necessary. Note: In this study, physicians were able to obtain CRP levels at the point of care. James W. Mold, MD, MPH

Commercial full text (fees may apply)

View

BACKGROUND

Point-of-care testing of C-reactive protein (CRP) may be a way to reduce unnecessary use of antibiotics without harming patients who have acute exacerbations of chronic obstructive pulmonary disease (COPD).

METHODS

We performed a multicenter, open-label, randomized, controlled trial involving patients with a diagnosis of COPD in their primary care clinical record who consulted a clinician at 1 of 86 general medical practices in England and Wales for an acute exacerbation of COPD. The patients were assigned to receive usual care guided by CRP point-of-care testing (CRP-guided group) or usual care alone (usual-care group). The primary outcomes were patient-reported use of antibiotics for acute exacerbations of COPD within 4 weeks after randomization (to show superiority) and COPD-related health status at 2 weeks after randomization, as measured by the Clinical COPD Questionnaire, a 10-item scale with scores ranging from 0 (very good COPD health status) to 6 (extremely poor COPD health status) (to show noninferiority).

RESULTS

A total of 653 patients underwent randomization. Fewer patients in the CRP-guided group reported antibiotic use than in the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31; 95% confidence interval [CI], 0.20 to 0.47). The adjusted mean difference in the total score on the Clinical COPD Questionnaire at 2 weeks was −0.19 points (two-sided 90% CI, −0.33 to −0.05) in favor of the CRP-guided group. The antibiotic prescribing decisions made by clinicians at the initial consultation were ascertained for all but 1 patient, and antibiotic prescriptions issued over the first 4 weeks of follow-up were ascertained for 96.9% of the patients. A lower percentage of patients in the CRP-guided group than in the usual-care group received an antibiotic prescription at the initial consultation (47.7% vs. 69.7%, for a difference of 22.0 percentage points; adjusted odds ratio, 0.31; 95% CI, 0.21 to 0.45) and during the first 4 weeks of follow-up (59.1% vs. 79.7%, for a difference of 20.6 percentage points; adjusted odds ratio, 0.30; 95% CI, 0.20 to 0.46). Two patients in the usual-care group died within 4 weeks after randomization from causes considered by the investigators to be unrelated to trial participation.

CONCLUSIONS

CRP-guided prescribing of antibiotics for exacerbations of COPD in primary care clinics resulted in a lower percentage of patients who reported antibiotic use and who received antibiotic prescriptions from clinicians, with no evidence of harm. (Funded by the National Institute for Health Research Health Technology Assessment Program; PACE Current Controlled Trials number, ISRCTN24346473.)

Author/s:

Butler, Christopher C., Gillespie, David, White, Patrick, Bates, Janine, Lowe, Rachel, Thomas-Jones, Emma, Wootton, Mandy, Hood, Kerenza, Phillips, Rhiannon, Melbye, M., Llor, Carl, Cals, Jochen W.L.