scholarly journals Participation of epidemiologists and/or biostatisticians and methodological quality of published controlled clinical trials

2001 ◽  
Vol 55 (8) ◽  
pp. 569-572 ◽  
Author(s):  
M Delgado-Rodriguez
2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Igho Onakpoya ◽  
Rohini Terry ◽  
Edzard Ernst

The purpose of this paper is to assess the efficacy of green coffee extract (GCE) as a weight loss supplement, using data from human clinical trials. Electronic and nonelectronic searches were conducted to identify relevant articles, with no restrictions in time or language. Two independent reviewers extracted the data and assessed the methodological quality of included studies. Five eligible trials were identified, and three of these were included. All studies were associated with a high risk of bias. The meta-analytic result reveals a significant difference in body weight in GCE compared with placebo (mean difference: kg; 95%CI: , ). The magnitude of the effect is moderate, and there is significant heterogeneity amongst the studies. It is concluded that the results from these trials are promising, but the studies are all of poor methodological quality. More rigorous trials are needed to assess the usefulness of GCE as a weight loss tool.


Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 1058-1066 ◽  
Author(s):  
Marie Deen ◽  
Daniele Martinelli ◽  
Judith Pijpers ◽  
Hans-Christoph Diener ◽  
Stephen Silberstein ◽  
...  

Introduction Since the definition of chronic migraine as a new disease entity in 2004, numerous clinical trials have examined the efficacy of preventive treatments in chronic migraine. Our aim was to assess the adherence of these trials to the Guidelines of the International Headache Society published in 2008. Methods We searched PubMed for controlled clinical trials investigating preventive treatment for chronic migraine in adults designed after the release of the Guidelines and published until December 2017. Trial quality was evaluated with a 13-item scoring system enlisting essential recommendations adapted from the Guidelines. Results Out of 3352 retrieved records, we included 16 papers in the analysis dealing with pharmacological treatment of chronic migraine. The median score was 6.5 (range 2–13). All trials were randomized, the large majority (81.25%) were placebo-controlled and double-blinded (87.5%). Adherence was lowest on i) a priori definition of outcomes (31.25%), ii) primary endpoint definition (37.5%%) and iii) trial registration (37.5%). Discussion Most clinical trials adhered to the recommendations of the IHS, whereas adherence to migraine-specific recommendations was lower. Greater awareness and adherence to the guidelines are essential to improve the quality of clinical trials, validity of publications and the generalizability of the results.


Author(s):  
Antti Malmivaara ◽  
Pekka Kuukasjärvi ◽  
Ilona Autti-Ramo ◽  
Niina Kovanen ◽  
Marjukka Mäkelä

Objectives:Despite controversies, endoscopic thoracic sympathectomy (ETS) has been used as a treatment for excessive sweating of hands and face and for facial blushing. This study aims to evaluate the effectiveness of ETS for the current indications in a systematic review.Methods:Controlled clinical trials and cohort studies with more than 100 patients were included. Abstracts were searched from MEDLINE and CCTR from 1966 to June 2004. Two reviewers extracted the data and assessed study quality. Data on effectiveness and safety were synthesized qualitatively.Results:We did not find any controlled clinical trials. Fifteen prospective studies were included. The internal and external quality of these studies were poor overall. Follow-up was commonly less than 2 years, during which time excessive sweating and facial blushing seemed to decrease among most patients. Immediate complications related to thoracoscopy occurred in up to 10 percent of patients. Compensatory sweating below breast level was reported in up to 90 percent of the patients. Other common side effects included dryness of face and hands, gustatory sweating, and neuralgic pain. Several other less common side effects were reported.Conclusions:The evidence of the effectiveness of ETS is weak due to a lack of randomized trials. The intervention leads to severe immediate complications in some of the patients, and to persistent side-effects for many of the patients.


2021 ◽  
Vol 22 (1) ◽  
pp. 28-47
Author(s):  
Fereshteh Poursaeed ◽  
◽  
Nahid Tahan ◽  
Farideh Dehghan Manshadi ◽  
Ali Reza Akbarzade Bagheban ◽  
...  

Objective: Spasticity is one of the components of an Upper Motor Neuron (UMN) lesion that occurs usually after a period of flaccidity in the form of velocity-dependent resistance to passive stretch. Spasticity is a significant cause of limited mobility and disability in neurological diseases. There are several clinical approaches to control spasticity. Recently, Shock Wave Therapy (SWT) has been reported to be a new, safe, and effective method for reducing spasticity for people with upper motor neuron lesions. We conducted a meta-analysis of relevant clinical trials to assess the effect of applying SWT on spasticity in UMN lesions. Materials & Methods: An electronic search was performed in PubMed, ISI Web of Science, Scopus, Science Direct, MEDLINE, and Google scholar from January 2005 to January 2020. Studies were included if they measured spasticity with the Modified Ashworth Scale (MAS) or/and neurophysiological indices in patients with stroke, multiple sclerosis, and cerebral palsy. The keywords of muscle hypertonia or spasticity, extracorporeal shock wave therapy, stroke, multiple sclerosis, and cerebral palsy were used. Two independent researchers searched articles, screened eligible studies against the inclusion criteria, and assessed the methodological quality of included studies. The methodological quality of studies was evaluated using the Downs and Black tool. The difference between the means was considered as the effect size in the MAS and Hoffman reflex/motor response (H/M) ratio before and after the intervention with 95% CI in random-effects models. Analyzes were performed using STATA software version 11. Results: The initial search led to the retrieval of 98 studies based on the inclusion and exclusion criteria, of which 24 full-text articles were reviewed and 14 articles were included in the meta-analysis process. All 14 articles had examined the effects of shockwave on the MAS. Four studies with 120 patients had examined the effects of shockwave therapy on the H/M ratio. Significant reduction in MAS grade was observed immediately [I2 = 100%, P<0.001, SMD=1.38 with 95%CI: (0.80, 1.87)] and three months after SWT [I2 = 100%, P<0.001, SMD=1.13 with 95%CI: (0.50, 1.76)] in comparison with the baseline values. ESWT had no significant effects on the H/M ratio [I2 = 97.5%, P<0.001, SMD=1.09 with 95%CI: (-0.54, 2.73)]. Conclusion: SWT can improve spasticity based on the MAS. The lack of SWT effects on the neurophysiological parameter of spasticity supports this opinion that SWT acts on the non-neural component of spasticity. Differences observed in studies in terms of treatment sessions, intervals of treatment sessions, energy density, number of shocks, and follow-up duration need to be examined more closely. More randomized clinical trials are needed in the future to analyze the impact of these factors on the efficacy of SWT for spastic patients.


1997 ◽  
Vol 36 (03) ◽  
pp. 172-178 ◽  
Author(s):  
U. Haag

The main thesis of the PATriCIa project is that a knowledge-based system can provide efficient and reliable support for biometricians as well as physicians involved in planning of controlled clinical trials, resulting in a higher quality of medical research. Structure and contents of study protocols are analyzed, and an object-oriented method for formally representing biometric knowledge is proposed. A study protocol can be generated from this formal representation. The programming language Prolog is used to realize the system based on a blackboard architecture. It is concluded that the knowledge representation method developed in the PATriCIa project is well suited for the purpose of generating study protocols for controlled clinical trials.


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