scholarly journals Drug-induced gynecomastia: A systematic review and meta-analysis of randomized clinical trials

2021 ◽  
Vol 93 (4) ◽  
pp. 489-496
Author(s):  
Alberto Trinchieri ◽  
Gianpaolo Perletti ◽  
Vittorio Magri ◽  
Konstantinos Stamatiou ◽  
Margherita Trinchieri ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Lipid Lowering ◽  
Controlled Trials ◽  
Drug Induced ◽  
Randomized Controlled ◽  
Reductase Inhibitors ◽  
Increased Risk ◽  
Significant Difference ◽  
5 Alpha Reductase Inhibitors

Objective: To review the evidence concerning treatment-related gynecomastia in patients taking spironolactone, antiandrogens, 5 alpha-reductase inhibitors, lipid-lowering and psychotropic drugs. Material and methods: A search of Medline and EMBASE was performed up to 30 June 2021. We included randomized controlled trials comparing the effects of a drug belonging to these classes versus placebo or versus a drug of the same class. Results: A total of 32 randomized controlled trials were included in the final review. There was an increased odds of gynecomastia in men receiving antiandrogens (OR = 17.38, 95% CI: 11.26 to 26.82; 6 trials, 9599 participants) and 5 alpha-reductase inhibitors compared to controls (OR = 1.77, 95% CI: 1.53 to 2.06; 7 series out of 6 trials, 34860 participants). The use of spironolactone in mixed gender populations was characterized by significantly higher odds of having gynecomastia compared to controls (OR = 8.39, 95% CI: 5.03 to 13.99; 14 trials, 3745 participants). No placebo-controlled trials focusing on the risk of gynecomastia in patients taking antipsychotic drugs was available, although there was a significant difference in the odds of having gynecomastia in a comparison between risperidone and quetiapine (OR = 4.32, 95% CI: 1.31 to 14.27; 3 trials, 343 participants). Limited evidence about the effects of statins on mammary glands was found. Conclusions: Antiandrogens and to a lesser extent 5 alphareductase inhibitors and spironolactone are associated with an increased risk of developing gynecomastia. Such effect can be explained by a modification of the testosterone to estradiol ratio. Gynecomastia (and galactorrhea) associated to the use of conventional and certain atypical antipsychotics can be related to high prolactin levels.

scholarly journals Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Vinod Solipuram ◽  
Akhila Mohan ◽  
Roshniben Patel ◽  
Ruoning Ni
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Randomized Controlled Trials ◽  
Random Effect ◽  
Janus Kinase ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Significant Difference ◽  
Risk Of Malignancy

Abstract Background Rheumatoid arthritis (RA) is a systemic autoimmune disease. The combination therapy of methotrexate (MTX) and Janus kinase inhibitor (JAKi) is commonly used. Patients with RA are at increased risk of malignancy, however, it remains unclear whether the combination therapy is associated with a higher risk. Objective To assess the malignancy risk among patients with RA receiving combination therapy of JAKi and MTX compared to MTX alone. Methods PubMed, Cochrane and Embase were thoroughly searched for randomized controlled trials (RCTs) in patients with RA receiving JAKi and MTX, from inception to July 2020. Primary endpoints were malignancy events, Non melanomatous skin cancer (NMSC) and malignancy excluding NMSC and secondary endpoints were serious adverse events (SAE), deaths. Risk ratio (RR) and 95% CI were calculated using the Mantel–Haenszel random-effect method. Results 659 publications were screened and 13 RCTs with a total of 6911 patients were included in the analysis. There was no statistically significant difference in malignancy [RR = 1.42; 95% CI (0.59, 3.41)], neither NMSC [RR = 1.44 (0.36, 5.76)] nor malignancies excluding NMSC [RR = 1.12 (0.40, 3.13)]. No statistically significant difference between the two groups for SAE [RR = 1.15 (0.90, 1.47)] and deaths [RR = 1.99 (0.75, 5.27)] was found. Conclusion The adjunction of JAKi to MTX is not associated with an increased risk of malignancy when compared to MTX alone. There is no increased risk of SAE and deaths when compared to MTX alone in patients with RA.

scholarly journals Hydroxychloroquine plus standard care compared with the standard care alone in COVID-19: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Bahman Amani ◽  
Ahmad Khanijahani ◽  
Behnam Amani
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

AbstractBackground & ObjectiveThe efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease COVID-19 pandemic is disputed. This study aimed to examine the efficacy and safety of HCQ plus the standard of care in COVID-19 patients.MethodsPubMed, The Cochrane Library, Embase, and web of sciences were searched up to June 1, 2020. The references list of the key studies was reviewed for additional relevant resources. Clinical studies registry databases were searched for identifying potential clinical trials. The quality of the included studies was evaluated using the Cochrane Collaboration’s tool. Meta-analysis was performed using RevMan software (version 5.3).ResultsThree randomized controlled trials with total number of 242 patients were identified eligible for meta-analysis. No significant differences were observed between HCQ and standard care in terms of viral clearance (Risk ratio [RR] = 1.03; 95% confidence interval [CI] = 0.91, 1.16; P = 0.68), disease progression (RR = 0.92; 95% CI = 0.10, 0.81; P = 0.94), Chest CT (RR = 1.40; 95% CI = 1.03, 1.91; P = 0.03). There is a significant difference between HCQ and standard care for adverse events (RR = 2.88; 95% CI = 1.50, 5.54; P = 0.002).ConclusionAlthough the current meta-analysis failed to confirm the efficacy and safety of HCQ in the treatment of COVID-19 patients, further rigorous randomized clinical trials are necessary to evaluate conclusively the efficacy and safety of HCQ against COVID-19.

Placebo Cure Rates in the Treatment of Onychomycosis

2014 ◽  
Vol 104 (3) ◽  
pp. 277-282 ◽  
Author(s):  
Aditya K. Gupta ◽  
Maryse Paquet
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Placebo Control ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Pubmed Database ◽  
Significant Difference ◽  
Study Characteristics ◽  
Design Characteristics ◽  
Cure Rates

Placebo cure rates vary among randomized clinical trials for onychomycosis, but the factors influencing these cure rates have not been systematically investigated. The PubMed database and reference sections of relevant publications were searched for randomized controlled trials of dermatophyte toenail onychomycosis that included a placebo control and that assessed cure rates. From 21 studies, the pooled mean ± SD placebo cure rates regarding mycological, clinical, and complete cure were 8.7% ± 3.7%, 3.4% ± 2.2%, and 1.2% ± 1.4%, respectively. There was no statistically significant difference between oral and topical treatments. None of the cure rates significantly correlated with any of the participant or study design characteristics analyzed. Placebo cure rates in randomized controlled trials of toenail onychomycosis are relatively low and are independent of the study characteristics.

scholarly journals The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 10 (8) ◽  
pp. 1585
Author(s):  
Yi-Ting Chen ◽  
Cheuk-Kwan Sun ◽  
Kuan-Yu Wu ◽  
Ying-Jen Chang ◽  
Min-Hsien Chiang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Sleep Endoscopy ◽  
Drug Induced ◽  
Randomized Controlled ◽  
Drug Induced Sleep Endoscopy ◽  
Obstructive Sleep ◽  
Significant Difference ◽  
The Difference

The sedation outcomes associated with dexmedetomidine compared with those of propofol during drug-induced sleep endoscopy (DISE) remains unclear. Electronic databases (i.e., the Cochrane controlled trials register, Embase, Medline, and Scopus) were searched from inception to 25 December 2020 for randomized controlled trials (RCTs) that evaluated the sedation outcomes with dexmedetomidine or propofol in adult patients diagnosed with obstructive sleep apnea (OSA) receiving DISE. The primary outcome was the difference in minimum oxygen saturation (mSaO2). Five RCTs (270 participants) published between 2015 and 2020 were included for analysis. Compared with dexmedetomidine, propofol was associated with lower levels of mSaO2 (mean difference (MD) = −7.24, 95% confidence interval (CI) −12.04 to −2.44; 230 participants) and satisfaction among endoscopic performers (standardized MD = −2.43, 95% CI −3.61 to −1.26; 128 participants) as well as a higher risk of hypoxemia (relative ratios = 1.82, 95% CI 1.2 to 2.76; 82 participants). However, propofol provided a shorter time to fall asleep and a lower risk of failed sedation compared with dexmedetomidine. No significant difference was found in other outcomes. Compared with propofol, dexmedetomidine exhibited fewer adverse effects on respiratory function and provided a higher level of satisfaction among endoscopic performers but was associated with an elevated risk of failed sedation.

scholarly journals Perioperative immunonutrition in esophageal cancer patients undergoing esophagectomy: the first meta-analysis of randomized clinical trials

2020 ◽  
Vol 33 (4) ◽  
Author(s):  
Wang Mingliang ◽  
Ke Zhangyan ◽  
Fan Fangfang ◽  
Wang Huizhen ◽  
Li Yongxiang
Keyword(s):  
Esophageal Cancer ◽  
Randomized Controlled Trials ◽  
Anastomotic Leakage ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Summary Although several randomized controlled trials have been published in recent years, the effect of perioperative immunonutrition in esophageal cancer (EC) patients remains unclear. This initial meta-analysis was conducted to assess whether perioperative enteral immunonutrition reduces postoperative complications in patients undergoing esophagectomy for EC. Relevant randomized controlled trials published before 1st September 2019 were retrieved from the Cochrane Library, PubMed, and EMBASE databases. After the literature was screened, two researchers extracted the information and data from eligible studies according to predefined selection criteria. Obtained data were pooled and analyzed by RevMan 5.3 software. The results were presented as risk ratios (RRs) with 95% confidence intervals (CIs). The heterogeneity among studies was tested by I2 test. Seven high-quality randomized controlled trials were included, with a total of 606 patients, 311 of whom received immunonutrition before and after surgery, while 295 received perioperative standard nutrition. No significant difference was observed between the two groups in the incidence of postoperative infection complications, including total infection complications (RR = 0.97, CI: 0.78–1.20, P = 0.76), pneumonia (RR = 0.97, CI: 0.71–1.33, P = 0.84), wound infection (RR = 0.80, CI: 0.46–1.40, P = 0.44), sepsis (RR = 1.35, CI: 0.67–2.71, P = 0.40), and urinary tract infection (RR = 0.87, CI: 0.54–1.40, P = 0.56). The prevalence of anastomotic leakage in the two groups was 9.4 and 5.4%, but the difference was not statistically significant (RR = 0.59, CI: 0.33–1.04, P = 0.07). Perioperative enteral immunonutrition provided no benefit in terms of the incidence of infection complications and anastomotic leakage in EC patients undergoing esophagectomy. Further large-scale randomized controlled trials are needed to confirm this conclusion.

The Effects of Supplementation with Chromium on Insulin Resistance Indices in Women with Polycystic Ovarian Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

2018 ◽  
Vol 50 (03) ◽  
pp. 193-200 ◽  
Author(s):  
Javad Heshmati ◽  
Reza Omani-Samani ◽  
Samira Vesali ◽  
Saman Maroufizadeh ◽  
Mahroo Rezaeinejad ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Polycystic Ovary ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Model Assessment ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Homeostatic Model Assessment ◽  
Homeostatic Model

AbstractRecently, the effects of nutritional supplementation on improvement or prevention of polycystic ovary syndrome (PCOS) have been considered. Several studies have been carried out on the effect of chromium supplementation in improving PCOS patients. This study aimed to summarize the available findings regarding the effect of chromium on improving the polycystic ovary syndrome. The review includes randomized controlled trials (RCTs) comparing chromium treatment with placebo or other treatments in women with PCOS. Women with PCOS diagnosed according to the ESHRE/ASRM or NIH criteria in reproductive age were eligible. Electronic searches using the MeSH terms were conducted in the following databases: Medline, Embase, Scopus, Web of Science, and The Cochrane Library. Effects were measured as weighted mean difference (WMD) and 95% confidence intervals (CI) for studies of PCOS and control subjects were calculated by using random-effects model. The initial search yielded potentially 100 relevant articles of randomized clinical trials on dietary chromium supplements: 16 from Pubmed, 36 from Embase, 29 from Scopus, and 19 from Web of Science. After studying these publications, 5 were potentially eligible and retrieved in full text. The five studies included in the meta-analysis reported data on 137 women with PCOS and 131 controls. A meta-analysis of 5 studies showed a non-significant difference in fasting insulin between chromium, and placebo or other treatment (mean difference (MD): –1.14; (95% CI: –4.11 to 1.83, p=0.45). We retrieved two randomized controlled trials, in which Quantitative Insulin Sensitivity Check Index (QUICKI) was compared between chromium, and placebo or other treatment in 156 women with PCOS. Meta-analysis of two RCTs showed no significant difference in QUICKI score between chromium and placebo (MD: 0.01; 95% CI: –0.01 to 0.04, p=0.34). Two randomized controlled trials compared Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) between chromium, and placebo or other treatment in 81 women with PCOS. After combining the data, there was a significantly lower HOMA-IR in the chromium group (MD: –1.68; 95% CI: –2.42 to –0.94, p<0.001). One RCT reported a significant difference in Homeostatic Model Assessment-beta-cell function (HOMA-B) between chromium and placebo groups (–15.5±32.3 vs. +13.6±23.1, p<0.001). No significant effect of chromium on fasting insulin and QUICKI score was found in women with PCOS. Chromium supplementation significantly improved HOMA-IR and HOMA-B among patients with diabetes. The magnitude of the effect is small, and the clinical relevance is uncertain. Future trials in well characterized studies that address the limitations in the current evidence are needed before definitive claims can be made about the effect of chromium supplementation.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

Efficacy of Benson’s Relaxation Technique on Anxiety and Depression among Patients Undergoing Hemodialysis: A Systematic Review

2021 ◽  
pp. 105477382110247
Author(s):  
Haya Ibrahim Ali Abu Maloh ◽  
Kim Lam Soh ◽  
Mohannad Eid AbuRuz ◽  
Seng Choi Chong ◽  
Siti Irma Fadhilah Ismail ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Scientific Evidence ◽  
Relaxation Technique ◽  
Anxiety And Depression ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Depression Level ◽  
Ebsco Host

This study aimed to evaluate the efficacy of Benson’s relaxation technique on anxiety and depression among patients undergoing hemodialysis. A systematic review of randomized controlled trials was conducted. Searching databases included EBSCO Host, PubMed, ProQuest, Science Direct, Sage Journals, Ovid, and Google Scholar from January 2000 to September 2020. Five randomized controlled trials were identified. Findings revealed a statistically significant decrease in anxiety score. Concerning depression; one RCT showed a statistically significant decrease and two RCTs revealed a non-significant difference in depression level. The overall quality of the RCTs was not high. Despite that the RCTs showed benefits of BRT in managing anxiety. However, this is not the same for depression. The lack of high-quality scientific evidence supporting its retinue use indicates that additional well designed randomized controlled trials in multiple countries are warranted to support the efficacy of Benson’s relaxation technique on anxiety and depression among patients undergoing hemodialysis.

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