The development of the evaluation methodology of the methodological quality of scientific publications about clinical trials and requirements for the information system for its automation

Author(s):  
Stanislav S. Otstavnov ◽  
Andrey N. Briko ◽  
George R. Khachatryan ◽  
Nuriya Z. Musina ◽  
Vlada K. Fediaeva ◽  
...  
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.


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.


2019 ◽  
Vol 69 ◽  
pp. 150-156 ◽  
Author(s):  
Cláudia M. Silva ◽  
André M. Travessa ◽  
Raquel Bouça-Machado ◽  
Daniel Caldeira ◽  
Joaquim J. Ferreira

2019 ◽  
Vol 2019 ◽  
pp. 1-18
Author(s):  
Jing Guo ◽  
Bin Li ◽  
Wenbin Wu ◽  
Zhichao Wang ◽  
Fei Wang ◽  
...  

Background. Idiopathic pulmonary fibrosis (IPF) is a major global health problem. The prevalence of the disease appears to be increasing. There is no curative therapy for IPF except lung transplantation. Chinese herbal medicines (CHMs) are showing promise for treatment of IPF. However, their effectiveness and safety are still unclear and deserve further investigation. The aim of this systematic review is to access the efficacy and safety of CHMs in treating IPF. Methods. The protocol of this review is registered at PROSPERO. We searched seven main databases for randomized clinical trials (RCTs) on CHMs for IPF from their inception to June 4, 2018. The methodological quality of RCTs was assessed using the Cochrane risk of bias tool. All trials included were analyzed according to the criteria of the Cochrane Handbook. Review Manager 5.3, R-3.5.2 software, and Grade pro GDT web solution were used for data synthesis and analysis. Results. Thirteen randomized clinical trials enrolling 733 patients were included. All trials included had clear outcome indicators. The methodological quality of included trials was generally “poor.” Few trials reported methods of randomization. One trial on Xuefu-zhuyu capsule assessed rate of acute exacerbation and mortality after treatment for 72 weeks and found no statistically significant difference between two groups. This meta-analysis demonstrated a significant improvement in QOL of IPF patients when CHMs was applied or combined with conventional medicine treatment. 6MWT was significantly improved in IPF patients after using CHMs or combined with conventional medicine treatment. CHMs treatment also had a certain improvement in TLC and DLCO, but the effect on FVC was not significant. Besides, CHMs failed to provide benefits in terms of PaO2. The reported adverse events were not obvious and severe. Conclusions. Some CHMs seem effective and safe as alternative remedies for patients with IPF, suggesting that further study of CHMs in the treatment of IPF is warranted. Although this systematic review suggests that CHMs may have positive effect on quality of life, 6-minute walk test distance, and lung function (TLC, DLOC%) and seem to be relatively safe during the course of treatment, the results must be treated with great caution because of the methodological flaws of the included trials. Long-term and high-quality trials are needed in the future to provide clear evidence for the use of CHMs.


2020 ◽  
Vol 33 (04) ◽  
pp. 257-262
Author(s):  
Anupam Mukherjee ◽  
Neeti Sinha ◽  
Joy Kumar Dey ◽  
Arun Bhargav Jadhav

Abstract Introduction In view of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the rise in cases of influenza-like illness (ILI), there is urgent need of developing and scientifically establishing treatment strategies. Homoeopathy has been used effectively in various pandemics for a long-time showing potential of combating such outbreaks effectively. This study aims at evaluating the methodological quality of the clinical trials conducted with a motive of assessing the efficacy of homoeopathy in management of ILI. Methods The randomised clinical research manuscripts from various databases were included for the narrative review. In this study, the Jadad scale was applied as an assessment tool with the criteria of randomisation, blinding and withdrawals to evaluate the methodological quality of the selected randomised controlled trials. Results The seven randomised controlled trials fulfilling the inclusion criteria evaluated on Jadad scale lay between the ranges of 2 to 5 with a mean score of 3.71 implicating the efficacy of homoeopathy in ILI. Six studies showed significant role of homoeopathy in the faster recovery of ILI symptoms. One trial, however, reported no noticeable difference in intergroup (treatment and placebo group) improvement but distinct intragroup comparison was observed. Conclusion It was concluded from this narrative review that homoeopathy has significant role in faster recovery of ILI symptoms in comparison to placebo group, and it can be employed as a potential treatment strategy in the recurrent pandemics of ILI and the currently prevailing coronavirus disease 2019 (COVID-19) crisis. It is suggested that more clinical trials with standard methodology should be conducted in this regard.


Sign in / Sign up

Export Citation Format

Share Document