scholarly journals Current Research Trends in Randomized Controlled Trials Investigating the Combined Effect of Korean Medicine and Western Medicine Treatment

2020 ◽  
Vol 37 (1) ◽  
pp. 13-18
Author(s):  
Dohyung Ha ◽  
Seoyeon Kim ◽  
Yong Hyeon Baek ◽  
Jiyoon Won ◽  
Seri Nam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Western Medicine ◽  
Complementary Alternative Medicine ◽  
Controlled Trials ◽  
Research Information ◽  
Korean Medicine ◽  
Randomized Controlled ◽  
Classification Of Diseases ◽  
Based Medicine

This review examined recently published (July 2014 to June 2017), randomized controlled trials (RCTs) which investigated the safety and effectiveness of combined Korean medicine/complementary alternative medicine (CAM) and Western medicine, to indicate the direction for integrative medical practice. The Korean Medicine Convergence Research Information Center evidence-based medicine database (KMCRIC EBM DB) was used to retrieve relevant RCTs indexed in the last 3 years. Study design, country, sample size, disease/condition with the Korean Standard Classification of Diseases code, interventions, direction of outcomes, and adverse events were extracted and summarized. A total of 93 RCTs were included in this review. Acupuncture/moxibustion was the most commonly used intervention (<i>n</i> = 47; 51%), and 19% (<i>n</i> = 18) of the studies treated musculoskeletal disorders, followed by circulatory disorders (<i>n</i> = 16; 17%), and mental and behavioral disorders (<i>n</i> = 9; 10%). Integrative treatment was reported as more effective than monotherapy in approximately 83% of these studies. Adverse events were poorly reported in most studies. This review suggests that integrative treatments are feasible, effective, and safe for various diseases/conditions, based on the evidence from recently published RCTs. Future studies on integrative healthcare are warranted.

scholarly journals Korean-Western Integrative Medicine for Bell’s Palsy: A Review of Randomized Controlled Trials

2020 ◽  
Vol 37 (4) ◽  
pp. 233-240
Author(s):  
Da Yoon Oh ◽  
Soo Jin Lee ◽  
Jae Eun Park ◽  
Min Cheol Lee ◽  
Myung Kyu Jeon ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Integrative Medicine ◽  
Western Medicine ◽  
Literature Search ◽  
Bell’S Palsy ◽  
Controlled Trials ◽  
Bell's Palsy ◽  
High Quality ◽  
Korean Medicine ◽  
Randomized Controlled

This review aimed to compare the effectiveness of Korean medicine (KM) with Korean-Western integrative medicine (KWIM) at treating Bell’s palsy. A literature search of several databases for relevant randomized controlled trials was performed. Six studies that compared KM with KWIM to treat Bell’s palsy were included in this review. Acupuncture and steroids were the most commonly used treatments in KWIM. A comparison of the effectiveness of KW with KWIM did not produce consistent results. Both KM and KWIM were useful intreating Bell’s palsy. KWIM was more effective than KM when the Western medicine was a steroid and was given in the early stages of treatment. However, these findings are limited due to the low quality and number of included studies. KM and KWIM are both effective in Bell’s palsy, and KWIM is more effective than KM. However, more high-quality randomized controlled trials are required.

scholarly journals Herbal Medicine for the Treatment of Coronavirus Disease 2019 (COVID-19): A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (5) ◽  
pp. 1583 ◽  
Author(s):  
Lin Ang ◽  
Eunhye Song ◽  
Hye Won Lee ◽  
Myeong Soo Lee
Keyword(s):  
Herbal Medicine ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Western Medicine ◽  
Combined Therapy ◽  
Herbal Medicines ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Disappearance Rate ◽  
Randomized Controlled

Background: The coronavirus disease 2019 (COVID-19) pandemic has caused a worldwide outbreak of respiratory illness. This review aims to evaluate the effectiveness and adverse events of herbal medicines for the treatment of COVID-19. Methods: Twelve databases were searched through 12 May 2020. Randomized controlled trials (RCTs) and quasi-RCTs assessing the effects of herbal medicines for the treatment of COVID-19 were eligible. The study selection and data extraction were performed by two independent reviewers. The Cochrane risk of bias tool was used for the assessment of the risk of bias in all included RCTs. Mean differences (MDs), risk ratios (RRs) and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated, and the effect sizes of the studies were pooled. Results: Seven RCTs with a total of 855 patients were included. All included trials compared the combined therapy of herbal medicine with Western medicine to Western medicine alone. The combined therapy significantly improved the total effective rate (RR 1.23, 95% CI 1.13 to 1.34, p < 0.001), cough symptom disappearance rate (RR 1.45, 95% CI 1.12 to 1.89, p = 0.005), and sputum production symptom disappearance rate (RR 1.73, 95% CI 1.19 to 2.50, p = 0.004). Beneficial effects of the combined therapy were also seen in TCM syndrome score of cough (MD −1.18, 95% CI −1.34 to −1.03, p < 0.001), fever (MD −0.62, 95% CI −0.79 to −0.45, p < 0.001), dry and sore throat (MD −0.83, 95% CI −1.45 to −0.20, p = 0.009), and fatigue (MD −0.60, 95% CI −1.04 to −0.17, p = 0.007). The overall risk of bias of the included studies was unclear. No serious adverse events were reported. Conclusion: Significant effects of the combined therapy of herbal medicine with Western medicine were found, and revealed the potential role of herbal medicine in treating COVID-19. More high-quality RCTs are needed to further validate the effectiveness and adverse events of herbal medicine in the treatment of COVID-19.

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.

Effects of Teriparatide versus Salmon Calcitonin Therapy for the Treat-ment of Osteoporosis in Asia: A Meta-analysis of Randomized Controlled Trials

2020 ◽  
Vol 20 ◽  
Author(s):  
Changjun Chen ◽  
Mohammed Alqwbani ◽  
Jie Chen ◽  
Ruitong Yang ◽  
Songgang Wang ◽  
...  
Keyword(s):  
Femoral Neck ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Salmon Calcitonin ◽  
Bone Markers ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Asian Patients ◽  
Teriparatide Treatment

Objective: The objective of this meta-analysis was to compare the efficacy and safety of teriparatide versus salmon calcitonin for the treatment of osteoporosis in Asian patients and to investigate whether the results of global studies could be applicable to Asian patients. Methods: PubMed, OVID, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE up to December 2018 were searched. Eligible randomized controlled trials (RCTs) that compared teriparatide versus salmon calcitonin in Asian osteoporosis popula-tion were included. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for data synthe-sis, and Cochrane Collaboration software Review Manager 5.3 was used to analyze the pooled data. Results: Three RCTs involving 529 patients were included (mean age 68.7 yr; 93.4% females; mean follow-up 6 months); outcome measures included bone mineral density (BMD) of the femoral neck, total hip and lumbar spine; bone markers and adverse events. We found that the period of 6-months of teriparatide treatment was helpful for the improvement of the BMD of lumbar vertebra, however, the improvement of BMD was not significant in femoral neck and total hip join. There was a positive correlation between bone-specific alka-line phosphatase (BSAP) and osteocalcin (OCN) and the response of Asian patients to subcutaneous injection of 20 micrograms per day of teriparatide. And the proportion of the occurrence of adverse effect was more obvious in teriparatide group compared with salmon calciton-in, but there was no significant difference. Conclusion: Results suggested that the use of teriparatide could improve the lumbar BMD by short-term (six months) application in Asian osteoporosis patients, which is beneficial to the patients who cannot tolerate adverse events of long-term treatment. The BSAP and OCN bone markers could be useful to monitor the responses of Asian osteoporosis patients to teriparatide treatment. Finally, both of teriparatide and salmon calcitonin were well tolerated by Asian patients.

scholarly journals A guide to do randomized controlled trials in the field of otolaryngology

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Groups ◽  
Controlled Trials ◽  
Main Body ◽  
Main Research ◽  
Randomized Controlled ◽  
New Treatment ◽  
Meta Analyses ◽  
Based Medicine

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.

Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults

NEJM Evidence ◽  
2021 ◽  
Author(s):  
Michael Furian ◽  
Maamed Mademilov ◽  
Aline Buergin ◽  
Philipp M. Scheiwiller ◽  
Laura Mayer ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Older Persons ◽  
Healthy Adults ◽  
Controlled Trials ◽  
Health Events ◽  
Randomized Controlled ◽  
Adverse Health ◽  
Adverse Health Events

Furian and colleagues report on the results of two randomized controlled trials testing the use of acetazolamide to prevent the adverse effects of altitude on healthy older persons and in people with COPD. They find that acetazolamide decreased the incidence of altitude related adverse health events (primarily hypoxemia) in both populations with no evidence of adverse events.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

scholarly journals The Effectiveness and Safety of Probiotic Supplements for Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Preclinical Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Liuting Zeng ◽  
Ganpeng Yu ◽  
Yang Wu ◽  
Wensa Hao ◽  
Hua Chen
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Intestinal Flora ◽  
Controlled Trials ◽  
Skin Thickness ◽  
Randomized Controlled ◽  
Probiotic Treatment ◽  
Preclinical Trials

Background. Patients with psoriasis need long-term medication to control their condition. Recent studies suggest that changing the intestinal flora may be a potential treatment. Methods. The databases were utilized to search the randomized controlled trials (RCTs) and preclinical trials about probiotic supplement in the treatment of psoriasis. The retrieval time is from the establishment of these databases to December 2020. RevMan5.3 was used for the risk assessment of bias and meta-analysis. This systematic review was registered in PROSPERO (CRD42021232756). Results. A total of 3 RCTs involving 164 participants were included. Two RCTs showed that probiotics can improve PASI and thereby improve the condition. For inflammation-related indicators, only one RCT showed that probiotics can improve the levels of CRP and TNF-α but have no obvious improvement effect on IL6. One RCT demonstrated the total effective rate of probiotics in the treatment of psoriasis. For adverse events, one RCT showed that the incidence of adverse events of probiotic treatment was low. Preclinical studies showed that continuous intervention with oral probiotics can significantly improve the progression of psoriasis and reduce the expression of inflammatory factors. The meta-analysis showed that the PASI between two groups was of no statistical significance (SMD 1.83 [-0.41, 4.07], P = 0.11 ). Meanwhile, probiotics may improve skin thickness (SMD -5.87 [-11.34, -0.41], P = 0.04 ) in animal model. Conclusion. Prebiotics may have a positive effect on alleviating the clinical symptoms of psoriasis, but a large sample of RCTs is still needed to support its therapeutic effect in psoriasis.

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