scholarly journals Do β-Blockers Cause Depression?

Hypertension ◽  
2021 ◽  
Author(s):  
Thomas G. Riemer ◽  
Linda E. Villagomez Fuentes ◽  
Engi A.E. Algharably ◽  
Marie S. Schäfer ◽  
Eva Mangelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Psychological Health ◽  
Odds Ratio ◽  
Controlled Trials ◽  
Double Blind ◽  
Blocker Therapy ◽  
Randomized Controlled ◽  
Cardiovascular Morbidity And Mortality ◽  
Β Blocker ◽  
Β Blockers

β-Blockers are important drugs in the treatment of cardiovascular diseases. They are suspected of inducing various psychiatric adverse events (PAEs), particularly depression, affecting cardiovascular morbidity and mortality. We performed a systematic search for double-blind, randomized controlled trials investigating β-blockers to analyze the risk of PAEs or withdrawal of therapy due to PAEs. We extracted the frequencies of PAEs and rates of withdrawals and reviewed them to the number of exposed patients. For β-blockers versus placebo or other active treatment, we calculated odds ratios for individual PAEs and withdrawal rates. We retrieved overall 285 eligible studies encompassing 53 533 patients. The risk of bias was judged to be high in 79% of the studies. Despite being the most frequently reported PAE with a total of 1600 cases, depression did not occur more commonly during β-blockers than during placebo (odds ratio, 1.02 [95% CI, 0.83–1.25]). β-Blocker use was also not associated with withdrawal for depression (odds ratio, 0.97 [95% CI, 0.51–1.84]). Similar results were obtained for comparisons against active agents. Among other PAEs, only unusual dreams, insomnia, and sleep disorder were possibly related to β-blocker therapy. In conclusion, this analysis of large-scale data from double-blind, randomized controlled trials does not support an association between β-blocker therapy and depression. Similarly, no effect for β-blockers was found for other PAEs, with the possible exceptions of sleep-related disorders. Consequently, concerns about β-blockers’ impact on psychological health should not affect their use in clinical practice.

scholarly journals The Efficacy and Safety of Topical β-Blockers in Treating Infantile Hemangiomas: A Meta-Analysis Including 11 Randomized Controlled Trials

Dermatology ◽  
2020 ◽  
pp. 1-11
Author(s):  
Xinhui Wang ◽  
Wei Feng ◽  
Xufeng Zhao ◽  
Ziyu Liu ◽  
Liang Dong
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Pulsed Dye Laser ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Β Blocker ◽  
Β Blockers ◽  
Oral Propranolol

<b><i>Background:</i></b> To evaluate the efficacy and safety of topical β-blockers in the treatment of superficial infantile hemangiomas (SIH) and mixed infantile hemangiomas (MIH), respectively, and compare the efficacy and safety of topical β-blockers with other interventions. <b><i>Methods:</i></b> The PRISMA guidelines were adhered to. We searched for randomized controlled trials in databases from 2010 to 2018 comparing topical β-blockers with other interventions for infantile hemangiomas. The outcomes evaluated were efficacy and adverse effects. Data analyses were performed using RevMan 5.3. Publication bias was assessed to account for bias in patient selection. <b><i>Results:</i></b> Eleven studies, involving 1,235 patients, were subjected to this meta-analysis. Six studies compared topical β-blockers with other interventions (propranolol, placebo, corticosteroids or pulsed dye laser) in treating SIH, and 5 studies evaluated the efficacy and safety of a topical β-blocker when it was combined with another intervention in treating MIH. A topical β-blocker was discovered to be as effective as oral propranolol in treating SIH (risk ratio, RR, 0.96, 95% confidence interval, CI, 0.91–1.02, <i>p</i> = 0.20, <i>I</i><sup>2</sup> = 0%), and topical β-blockers were more beneficial than placebo, corticosteroids or pulsed dye laser in treating SIH (RR 2.25, 95% CI 1.66–3.05, <i>p</i> &#x3c; 0.00001, <i>I</i><sup>2</sup> = 0%). Topical β-blockers combined with another intervention gave rise to a better clinical response in the treatment of MIH than intervention alone (RR 1.99, 95% CI 1.10–3.60, <i>p</i> = 0.02, <i>I</i><sup>2</sup> = 55%) (standard mean difference 0.80, 95% CI 0.28–1.31, <i>p</i> = 0.002, <i>I</i><sup>2</sup> = 0%). Compared with oral propranolol, topical β-blockers were associated with fewer incidences of adverse effects (RR 0.05, 95% CI 0.01–0.39, <i>p</i> = 0.004, <i>I</i><sup>2</sup> = 0%). No significant difference in adverse effects was found when a topical β-blocker was combined with another intervention in treating MIH (RR 1.01, 95% CI 0.58–1.74, <i>p</i> = 0.98, <i>I</i><sup>2</sup> = 0%). <b><i>Conclusions:</i></b> This meta-analysis provided evidence that topical β-blockers may replace oral propranolol as first-line therapy for SIH and that they are of additive value in treating MIH.

scholarly journals Vitamin D supplementation, COVID-19 and disease severity: a meta-analysis

QJM ◽  
2021 ◽  
Author(s):  
K Shah ◽  
D Saxena ◽  
D Mavalankar
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trials ◽  
Usual Care ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Hospitalized Patients ◽  
Controlled Trials ◽  
Randomized Controlled

Abstract Objective: Current meta-analysis aims to understand the effect of oral supplementation of vitamin D on intensive care unit (ICU) requirement and mortality in hospitalized COVID-19 patients. Methods: Databases PubMed, preprint servers, and google scholar were searched from December 2019 to December 2020. Authors searched for the articles assessing role of vitamin D supplementation on COVID-19. Cochrane RevMan tool was used for quantitative assessment of the data, where heterogeneity was assessed using I2 and Q statistics and data was expressed using odds ratio with 95% confidence interval. Results: Final meta-analysis involved pooled data of 532 hospitalized patients (189 on vitamin D supplementation and 343 on usual care/placebo) of COVID-19 from three studies (Two randomized controlled trials, one retrospective case-control study). Statistically (p&lt;0.0001) lower ICU requirement was observed in patients with vitamin D supplementation as compared to patients without supplementations (odds ratio: 0.36; 95% CI: 0.210-0.626). However, it suffered from significant heterogeneity, which reduced after sensitivity analysis. In case of mortality, vitamin D supplements has comparable findings with placebo treatment/usual care (odds ratio: 0.93; 95% CI: 0.413-2.113; p=0.87). The studies did not show any publication bias and had fair quality score. Subgroup analysis could not be performed due to limited number of studies and hence dose and duration dependent effect of vitamin D could not be evaluated. Conclusions: Although the current meta-analysis findings indicate potential role of vitamin D in improving COVID-19 severity in hospitalized patients, more robust data from randomized controlled trials are needed to substantiate its effects on mortality.

scholarly journals Penerapan DASH (Dietary Approach to Stop Hypertension) pada Penderita Hipertensi

2019 ◽  
Vol 14 (2) ◽  
pp. 17-22
Author(s):  
Bagas Mukti
Keyword(s):  
Calcium Channel ◽  
Randomized Controlled Trials ◽  
Ace Inhibitor ◽  
Channel Blocker ◽  
Angiotensin Receptor Blockers ◽  
Controlled Trials ◽  
Angiotensin Receptor ◽  
Randomized Controlled ◽  
Receptor Blockers ◽  
Β Blocker

Hipertensi merupakan suatu manifestasi dari gangguan hemodinamik kardiovaskular yang penyebabnya multifactor. Prevalensi penderita hipertensi di Indonesia sendiri pada tahun 2018 meningkatkan dari tahun 2013 dan peningkatan tersebut sebesar 8,3 %. Seseorang dikatakan hipertensi jika tekanan darah diatas atau sama dengan 140/90 mmHg dan harus persisten. Hipertensi sendiri masih menjadi penyebab kematian tertinggi dan dapat menyebabkan komplikasi yang serius seperti stroke, penyakit jantung iskemik, gagal ginjal, retinopati dan sebagainya. Ada banyak guidelines yang menjelaskan bagaimana manajemen terapi untuk mengurangi tekanan darah tinggi. Ada dua cara untuk mentatalaksana penderita hipertensi, yaitu dengan terapi farmakologis (Diuretik, β-blocker, ACE Inhibitor, Angiotensin Receptor Blockers (ARB), Calcium-channel blocker (CCB) dan sebagainya) dan terapi non farmakologi dengan memodifikasi gaya hidup seperti olahraga teratur, mengurangi konsumsi alcohol, menghentikan rokok, serta menurunkan berat badan, mengurangi konsumsi garam dengan cara mengadaptasi diet DASH (Dietary Approaches to Stop Hypertension). Diet DASH menerapkan pola makan yang kaya akan sayuran, buah-buahan, susu dan produk-produk susu tanpa lemak atau rendah lemak, biji-bijian, ikan, unggas, kacang-kacangan dan diet ini juga mengandung sedikit natrium, makanan manis, gula, lemak, dan daging merah. Pada penelitian meta-analisis dan sistematik review dari randomized controlled trials (RCTs), mengungkapkan bahwa penerapan diet DASH pada pasien hipertensi dapat menurunkan tekanan darah sistolik sebesar 6,74 mmHg dan tekanan darah diastolic sebesar 3,54 mmHg. Studi meta-analisis lain dari RCTs membuktikan bahwa dengan penerapan diet ini dapat menurunkan berat badan pada pasien yang mengalami obesitas sebesar 1,42 kg dalam waktu 8-24 minggu. Sehingga diet DASH ini sangat bermanfaat untuk diterapkan pada pasien hipertensi.

scholarly journals Thoracoscopic surgical ablation or catheter ablation for patients with atrial fibrillation? A systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 31 (6) ◽  
pp. 763-773
Author(s):  
Shaolei Yi ◽  
Xiaojun Liu ◽  
Wei Wang ◽  
Lianghua Chen ◽  
Haitao Yuan
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Invasive Procedure ◽  
Controlled Trials ◽  
Surgical Ablation ◽  
Randomized Controlled

Abstract OBJECTIVES There is an urgent need to understand the difference in the influence of thoracoscopic surgical ablation (TSA) and catheter ablation (CA) on clinical outcomes in patients with atrial fibrillation (AF). This meta-analysis of randomized controlled trials aimed to examine the efficacy and safety of TSA versus CA in patients with AF. METHODS Databases including EMBASE, Clinical Trials, PubMed and Cochrane Central Registered Control System were screened for the retrieval of articles. A direct meta-analysis of TSA versus CA was conducted. The I2 test analysis was performed to evaluate heterogeneity. The Begg–Mazumdar test and the Harbord–Egger test were used to detect publication bias. The primary efficacy outcome was freedom from atrial tachyarrhythmia, while the primary safety outcome was severe adverse event (SAE) occurrence. RESULTS Of the 860 identified articles, 6, comprising 466 participants, were finally included. The rate of freedom from AT was higher in the TSA group (75%) than in the CA group (57.1%) (odds ratio 0.41; 95% confidence interval 0.2–0.85; P = 0.02; I2 = 57%). A larger number of SAEs were observed in the TSA group than in the CA group (odds ratio 0.16; 95% confidence interval 0.006–0.46; P = 0.0006; I2 = 44%). The result of the subgroup analysis of 3 studies that enrolled AF patients without a history of ablation showed that the incidence of AT was comparable in both arms. The ablation procedure and hospitalization durations were longer in the TSA arm. CONCLUSIONS In our study, TSA was associated with better efficacy but a higher rate of SAEs compared to CA. In addition, TSA did not show better efficacy results as the first invasive procedure in the sub-analysis of patients with paroxysmal AF or early persistent AF. Therefore, doctors should recommend either TSA or CA to patients with AF after due consideration of the aforementioned findings.

Tamoxifen for the Prevention of Breast Cancer: Psychosocial Impact on Women Participating in Two Randomized Controlled Trials

2001 ◽  
Vol 19 (7) ◽  
pp. 1885-1892 ◽  
Author(s):  
Lesley Fallowfield ◽  
Anne Fleissig ◽  
Rob Edwards ◽  
Andrea West ◽  
Trevor J. Powles ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Randomized Controlled Trials ◽  
Sexual Functioning ◽  
Self Report ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Prevention Of Breast Cancer

PURPOSE: The purpose of this study was to evaluate the psychosocial implications of tamoxifen versus placebo in women who are at increased risk of breast cancer. PATIENTS AND METHODS: The 488 women in the psychosocial study were recruited from participants in two placebo-controlled, double-blind, randomized, controlled trials that investigated the efficacy of tamoxifen in the prevention of breast cancer in women who are at high familial risk. During a 5-year period, repeated assessments were made of anxiety, psychological distress, and sexual functioning using standardized questionnaires before treatment at baseline and at 6-month intervals during the trial. RESULTS: Questionnaire completion over 5 years was good, with 71.1% of women returning at least 8 of 10 follow-up assessments. Although scores from individuals showed considerable fluctuation and variation over time, changes in anxiety, mood, and sexual functioning were not associated with treatment group. The number of symptoms reported at 48 months via a self-report cheklist were not associated with treatment group, but vasomotor symptoms were more frequent among tamoxifen-treated women. Symptoms of low energy, breast sensitivity, and visual blurring were reported most frequently in the placebo group. CONCLUSION: In general, these results are comparable to those from the National Surgical Adjuvant Breast and Bowel Project psychosocial study despite differences in study populations, methodology, and instruments. The long-term use of tamoxifen and other selective estrogen response modulators as preventive agents in high-risk groups has been questioned, but we found no evidence of treatment-related side effects that affect women’s psychosocial and sexual functioning.

scholarly journals Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients

2020 ◽  
Vol 7 (10) ◽  
Author(s):  
Robert J Ulrich ◽  
Andrea B Troxel ◽  
Ellie Carmody ◽  
Jaishvi Eapen ◽  
Martin Bäcker ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Disease Progression ◽  
Severe Disease ◽  
Small Sample ◽  
Hospitalized Patients ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomized Controlled ◽  
End Point ◽  
Clinical Scores

Abstract Background Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. Methods We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. Results A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. Conclusions In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.

scholarly journals Prior Beta-Blocker Therapy for Hypertension and Sex-Based Differences in Heart Failure Among Patients With Incident Coronary Heart Disease

Hypertension ◽  
2020 ◽  
Vol 76 (3) ◽  
pp. 819-826 ◽  
Author(s):  
Raffaele Bugiardini ◽  
Jinsung Yoon ◽  
Sasko Kedev ◽  
Goran Stankovic ◽  
Zorana Vasiljevic ◽  
...  
Keyword(s):  
Heart Failure ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Odds Ratio ◽  
Acute Coronary Syndromes ◽  
Relative Risk Ratio ◽  
Blocker Therapy ◽  
Coronary Syndromes ◽  
Β Blocker ◽  
Β Blockers

The usefulness of β-blockers has been questioned for patients who have hypertension without a prior manifestation of coronary heart disease or heart failure. In addition, sex-based differences in the efficacy of β-blockers for prevention of heart failure during acute myocardial ischemia have never been evaluated. We explored whether the effect of β-blocker therapy varied according to the sex among patients with hypertension who have no prior history of cardiovascular disease. Data were drawn from the ISACS (International Survey of Acute Coronary Syndromes)-Archives. The study population consisted of 13 764 patients presenting with acute coronary syndromes. There were 2590 patients in whom hypertension was treated previously with β-blocker (954 women and 1636 men). Primary outcome measure was the incidence of heart failure according to Killip class classification. Subsidiary analyses were conducted to estimate the association between heart failure and all-cause mortality at 30 days. Outcome rates were assessed using the inverse probability of treatment weighting and logistic regression models. Estimates were compared by test of interaction on the log scale. Among patients taking β-blockers before admission, there was an absolute difference of 4.6% between women and men in the rate of heart failure (Killip ≥2) at hospital presentation (21.3% versus 16.7%; relative risk ratio, 1.35 [95% CI, 1.10–1.65]). On the opposite, the rate of heart failure was approximately similar among women and men who did not receive β-blockers (17.2% versus 16.1%; relative risk ratio, 1.09 [95% CI, 0.97–1.21]). The test of interaction identified a significant ( P =0.034) association between sex and β-blocker therapy. Heart failure was predictive of mortality at 30-day either in women (odds ratio, 7.54 [95% CI, 5.78–9.83]) or men (odds ratio, 9.62 [95% CI, 7.67–12.07]). In conclusion, β-blockers use may be an acute precipitant of heart failure in new-onset coronary heart disease among women, but not men. Heart failure increases the risk of death. Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT04008173.

Presentation of Nonfinal Results of Randomized Controlled Trials at Major Oncology Meetings

2009 ◽  
Vol 27 (24) ◽  
pp. 3938-3944 ◽  
Author(s):  
Christopher M. Booth ◽  
Aurélie Le Maître ◽  
Keyue Ding ◽  
Kristen Farn ◽  
Michael Fralick ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Odds Ratio ◽  
Multivariate Analyses ◽  
Small Cell ◽  
Controlled Trials ◽  
Small Cell Lung ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Group Trial

Purpose To assess the frequency, implications, and factors associated with reporting nonfinal analyses (NFAs) of randomized controlled trials (RCTs) as abstract publications. Methods We identified 138 consecutive reports of RCTs testing systemic therapy for lymphoma, breast, colorectal, or non–small-cell lung cancer published in six major journals between 2000 and 2004. We then searched proceedings of seven major cancer meetings, 1990 to 2004, for abstracts related to these publications which presented efficacy results. Articles and abstracts were compared for discordance in sample size, median follow-up, results, and conclusions. Abstracts were evaluated for statements explicitly noting or implying that results were not final. Factors associated with discordance were assessed by uni- and multivariate analyses. Results We identified 303 related abstracts; 197 were eligible. In 86 abstracts (44%), results were stated or implied to be NFA; this was explicitly stated in 41 (21%). The NFAs included 12 where accrual was ongoing. Discordance with article was found in 124 abstracts (63%) and was more common with NFAs (67 of 86 [78%] v 57 of 111 [51%]; P = .0001). When compared with articles, authors' conclusions were substantively different in 17 abstracts (10%). Factors most associated with data discordance were lymphoma trial (odds ratio [OR], 3.8; 95% CI, 1.5 to 10.8), cooperative group trial (OR, 2.8; 95% CI, 1.4 to 5.6), and presentation of a NFA (OR, 2.9; 95% CI, 1.5 to 5.8). Conclusion Meeting abstracts often include NFAs and are frequently discordant with subsequent article publication.

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