Evidence-based risk assessment and recommendations for physical activity clearance: diabetes mellitus and related comorbidities1This paper is one of a selection of papers published in this Special Issue, entitled Evidence-based risk assessment and recommendations for physical activity clearance, and has undergone the Journal’s usual peer review process.

2011 ◽  
Vol 36 (S1) ◽  
pp. S154-S189 ◽  
Author(s):  
Michael C. Riddell ◽  
Jamie Burr
Keyword(s):  
Physical Activity ◽  
Risk Assessment ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Evidence Based ◽  
Safe Procedure ◽  
Randomized Controlled ◽  
Risk Algorithm ◽  
Wide Range

Physical activity (PA) is one of the most powerful treatment options for persons with prediabetes or diabetes. However, some elevation in risk occurs with increased PA, at least initially, and certain precautions need to be made to lower these risks, particularly if these persons are unaccustomed to exercise. We conducted a standardized search of all adverse events associated with increased PA in persons with prediabetes or diabetes (type 1 or type 2) and provided evidence-based guidelines on PA screening in these apparently high-risk individuals. A systematic literature review was performed of all studies reporting on adverse events in persons with prediabetes or diabetes. Studies included were from all designs (retrospective and prospective including randomized controlled trials) and were assessed according to evaluation criteria adapted by a consensus panel. A total of 47 studies, involving >8000 individuals, were deemed eligible. A number of these studies identified a range of mild to severe acute risks with exercise (musculoskeletal injury, hypoglycemia, foot ulceration, proliferative retinopathy, hypotension, sudden death) but the overall prevalence was low. Based on several randomized controlled trials and prospective studies in which prescribed exercise was performed at a wide range of intensities, it appears that increased PA is a relatively safe procedure with no evidence of a loss of life. Based on our assessment of the available literature, we provide a new PA risk algorithm for persons with prediabetes and diabetes and comment on the role of the patient, the qualified exercise professional, and the patient’s physician in the risk screening process.

Evidence-based risk assessment and recommendations for physical activity: arthritis, osteoporosis, and low back pain1This paper is one of a selection of papers published in the Special Issue entitled Evidence-based risk assessment and recommendations for physical activity clearance, and has undergone the Journal’s usual peer-review process.

2011 ◽  
Vol 36 (S1) ◽  
pp. S49-S79 ◽  
Author(s):  
Philip D. Chilibeck ◽  
Hassanali Vatanparast ◽  
Stephen M. Cornish ◽  
Saman Abeysekara ◽  
Sarah Charlesworth
Keyword(s):  
Physical Activity ◽  
Risk Assessment ◽  
Low Back Pain ◽  
Back Pain ◽  
Adverse Events ◽  
Controlled Trials ◽  
Evidence Based ◽  
Cochrane Central Register ◽  
Low Back ◽  
Level 2

We systematically reviewed the safety of physical activity (PA) for people with arthritis, osteoporosis, and low back pain. We searched PubMed, MEDLINE, Sport Discus, and the Cochrane Central Register of Controlled Trials (1966 through March 2008) for relevant articles on PA and adverse events. A total of 111 articles met our inclusion criteria. The incidence for adverse events during PA was 3.4%–11% (0.06%–2.4% serious adverse events) and included increased joint pain, fracture, and back pain for those with arthritis, osteoporosis, and low back pain, respectively. Recommendations were based on the Appraisal of Guidelines for Research and Evaluation, which applies Levels of Evidence based on type of study ranging from high-quality randomized controlled trials (Level 1) to anecdotal evidence (Level 4) and Grades from A (strong) to C (weak). Our main recommendations are that (i) arthritic patients with highly progressed forms of disease should avoid heavy load-bearing activities, but should participate in non-weight-bearing activities (Level 2, Grade A); and (ii) patients with osteoporosis should avoid trunk flexion (Level 2, Grade A) and powerful twisting of the trunk (Level 3, Grade C); (iii) patients with acute low back pain can safely do preference-based PA (i.e., PA that does not induce pain), including low back extension and flexion (Level 2, Grade B); (iv) arthritic patients with stable disease without progressive joint damage and patients with stable osteoporosis or low back pain can safely perform a variety of progressive aerobic or resistance-training PAs (Level 2, Grades A and B). Overall, the adverse event incidence from reviewed studies was low. PA can safely be done by most individuals with musculoskeletal conditions.

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.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT 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.

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