Strengthening the clinical evidence provided by observational studies

2017 ◽  
Vol 06 (03) ◽  
Author(s):  
Abraham G Hartzema
Keyword(s):  
Observational Studies ◽  
Clinical Evidence

scholarly journals Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
M. Y. Di ◽  
J. L. Tang
Keyword(s):  
Observational Studies ◽  
Randomized Trials ◽  
Clinical Evidence ◽  
Evaluation Process ◽  
Laboratory Research ◽  
Safety And Efficacy ◽  
Chinese Medicines ◽  
Investigational Drugs ◽  
Staged Testing ◽  
And Control

Four phases of trial are widely used in testing drugs, surgery, and diagnosis in Western medicine (WM). The staged testing process helps protect patients from unnecessary harms and control costs while assessing safety and efficacy. In this paper we adapt the four phase trials for traditional Chinese medicine (TCM). As TCM has been used in humans for thousands of years and there has been good preliminary clinical evidence on safety and efficacy for many of its therapies, in most cases its evaluation can start directly in humans, and preclinical laboratory research can be conducted in phase 4 trials after the efficacy is firmly demonstrated. Furthermore, unlike investigational drugs, TCM therapies are various in the certainty of their safety and efficacy and thus should not enter the evaluation process at the same stage. Unlike in WM, clarifying and refining PICO (patients, intervention, comparator, and outcome) are an important part of evaluation of newly designed TCM therapies. The incommensurability between WM and TCM causes additional difficulties in TCM trials regarding defining and choosing PICO, for which some suggestions are made. Observational studies seem to have a greater role in evaluation for TCM although the efficacy must be confirmed with randomized trials.

scholarly journals S-Amlodipine: An Isomer with Difference—Time to Shift from Racemic Amlodipine

2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Jamshed Dalal ◽  
J. C. Mohan ◽  
S. S. Iyengar ◽  
Jagdish Hiremath ◽  
Immaneni Sathyamurthy ◽  
...  
Keyword(s):  
Observational Studies ◽  
Clinical Evidence ◽  
Controlled Trials ◽  
Channel Blockers ◽  
Efficacy And Safety ◽  
First Line ◽  
Randomized Controlled ◽  
Treatment Of Hypertension ◽  
Meta Analyses ◽  
Difference Time

Calcium channel blockers are among the first-line drugs for treatment of hypertension (HTN). S-amlodipine (S-AM), an S-enantiomer of amlodipine, is available in India and in other countries like China, Korea, Russia, Ukraine, and Nepal. Being clinically researched for nearly two decades, we performed in-depth review of S-AM. This review discusses clinical evidence from total 42 studies (26 randomized controlled trials, 14 observational studies, and 2 meta-analyses) corroborating over 7400 patients treated with S-AM. Efficacy and safety of S-AM in HTN in comparison to racemic amlodipine, used as monotherapy and in combination with other antihypertensives, efficacy in angina, and pleiotropic benefits with S-AM, are discussed in this review.

scholarly journals Compilation of registered clinical trials for the treatment of COVID-19 infection

2021 ◽  
Vol 10 (4) ◽  
pp. 457
Author(s):  
Sukhpreet Kaur ◽  
Harminder Singh ◽  
Kamalpreet Kaur
Keyword(s):  
Clinical Trials ◽  
Observational Studies ◽  
Clinical Evidence ◽  
Focal Point ◽  
Age Groups ◽  
Clinical Trial Registry ◽  
Wuhan City ◽  
Study Recruitment ◽  
Long Time ◽  
Drug Interventions

The Wuhan city, the capital of Hubei province in China became the focal point for origin of virulent disease which later named as COVID-19. This paper aims to analyze the on-going clinical trials for drugs/interventions used for treatment of COVID-19 infection in open domain. The data on ongoing clinical trials on COVID-19 was retrieved from database clinicaltrials.gov. The data extracted includes national clinical trial registry number, title of study, recruitment status, results availability, intervention, outcome measure, sponsorship, study types, study design, start and completion dates, and location. All the extracted data was analyzed. As on 10th August 2020, a total of 2935 trials were registered in different countries. Of which 1115 trials are being conducted in Europe and 640 in United States of America (USA). Majority of COVID-19 clinical trials (95%) were enrolling all age groups including children and older adults. Similarly, majority of trials were including both genders (97%). Among all these clinical trials ongoing on COVID-19, 1645 were interventional, 1266 were observational studies. In interventional study 876 trials used drug intervention. Among all these trials 390 different drug interventions are being tried. Among these hydroxychloroquine, antiretrovirals and angiotensin converting enzyme (ACE) inhibitors were top three drug groups. The conduct of clinical trials in time of pandemic have so many tenacious issues that need to be addressed. It is very important to utilize the resources efficiently such as following a standard protocol then one can easily pool the data of various trials conducted at various places. Given the smaller sample sizes, long completion period, high risk of bias and imprecise information, it will take quite a long time to obtain high quality clinical evidence for the treatment of COVID-19 infection.

Ultrastructural Study of Human Testicular Biopsies in Infertility

1976 ◽  
Vol 34 ◽  
pp. 156-157
Author(s):  
Shirley Siew ◽  
Philip Troen ◽  
Howard R. Nankin
Keyword(s):  
Electron Microscopy ◽  
Transmission Electron Microscopy ◽  
Basement Membrane ◽  
Leydig Cells ◽  
Clinical Evidence ◽  
Young Male ◽  
Germinal Epithelium ◽  
Transmission Electron ◽  
Age Range ◽  
Male Subjects

Testicular biopsies were obtained from six young male subjects (age range 24-33) who complained of infertility and who had clinical evidence of oligospermia. This was confirmed on histological examination which showed a broad spectrum from profound hypospermatogenesis to relatively normal appearing germinal epithelium. Thickening of the tubular walls was noted in half of the cases and slight peritubular fibrosis in one. The Leydig cells were reported as normal or unremarkable.Transmission electron microscopy showed that the thickening of the supporting tissue of the germinal epithelium was caused more by an increase in the thickness of the layers of the lamina propria than of the tubular wall itself. The changes in the basement membrane of the tubular wall consisted mostly of a greater degree of infolding into the tubule and some reduplication which gave rise to a multilayered appearance.

Severe Drooling and Treatment With Botulinum Toxin

2012 ◽  
Vol 21 (1) ◽  
pp. 15-21
Author(s):  
Merete Bakke ◽  
Allan Bardow ◽  
Eigild Møller
Keyword(s):  
Botulinum Toxin ◽  
Side Effects ◽  
Health Risk ◽  
Flow Rate ◽  
Clinical Evidence ◽  
Acetylcholine Release ◽  
Psychosocial Problems ◽  
Rate Reduction ◽  
Local Inhibition ◽  
Surgical Treatments

Severe drooling is associated with discomfort and psychosocial problems and may constitute a health risk. A variety of different surgical and non-surgical treatments have been used to diminish drooling, some of them with little or uncertain effect and others more effective but irreversible or with side effects. Based on clinical evidence, injection with botulinum toxin (BTX) into the parotid and submandibular glands is a useful treatment option, because it is local, reversible, and with few side effects, although it has to be repeated. The mechanism of BTX is a local inhibition of acetylcholine release, which diminishes receptor-coupled secretion and results in a flow rate reduction of 25–50% for 2–7 months.

The association between dietary inflammatory index and risk of central obesity in adults: An updated systematic review and meta-analysis

2020 ◽  
Vol 90 (5-6) ◽  
pp. 535-552 ◽  
Author(s):  
Mahdieh Abbasalizad Farhangi ◽  
Mahdi Vajdi
Keyword(s):  
Systematic Review ◽  
Observational Studies ◽  
Central Obesity ◽  
Assessment Tool ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Dietary Factors ◽  
Cross Sectional ◽  
Inflammatory Status ◽  
Obesity Indices

Abstract. Backgrounds: Central obesity, as a pivotal component of metabolic syndrome is associated with numerous co-morbidities. Dietary factors influence central obesity by increased inflammatory status. However, recent studies didn’t evaluate the association between central obesity and dietary inflammation index (DII®) that give score to dietary factors according to their inflammatory potential. In the current systematic review and meta-analysis, we summarized the studies that investigated the association between DII® with central obesity indices in the general populations. Methods: In a systematic search from PubMed, SCOPUS, Web of Sciences and Cochrane electronic databases, we collected relevant studies written in English and published until 30 October 2019. The population of included studies were apparently healthy subjects or individuals with obesity or obesity-related diseases. Observational studies that evaluated the association between DII® and indices of central obesity including WC or WHR were included. Results: Totally thirty-two studies were included; thirty studies were cross-sectional and two were cohort studies with 103071 participants. Meta-analysis of observational studies showed that higher DII® scores were associated with 1.81 cm increase in WC (Pooled weighted mean difference (WMD) = 1.813; CI: 0.785–2.841; p = 0.001). Also, a non-significant increase in the odds of having higher WC (OR = 1.162; CI: 0.95–1.43; p = 0.154) in the highest DII category was also observed. In subgroup analysis, the continent, dietary assessment tool and gender were the heterogeneity sources. Conclusion: The findings proposed that adherence to diets with high DII® scores was associated with increased WC. Further studies with interventional designs are necessary to elucidate the causality inference between DII® and central obesity indices.

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