scholarly journals Clinical Trials with Herbal Products for the Prevention of Dental Caries and Their Quality: A Scoping Study

Author(s):  
Robert Ancuceanu ◽  
Adriana Iuliana Anghel ◽  
Camelia Ionescu ◽  
Marilena Viorica Hovaneț ◽  
Maria Cojocaru-Toma ◽  
...  

It is currently recognized that an injudicious strategy in the last decades has been not only focusing of research typically on caries in children, but also the narrow focusing on fluoride, because despite sufficient availability of fluoride in water and oral healthcare products, caries levels escalate steadily as people get older and caries remain a main public health issue to be settled. In the last two decades the scientific community intensified efforts of exploring other products for caries prevention, herbal products being one of these approaches. Because preliminary evidence indicated that clinical trials for caries prevention with herbal products are heterogeneous in design, quality and products evaluated, we performed a scoping review intended to explore the main characteristics of such clinical trials. From an initial collection of 1986 unique papers from different literature databases, 56 articles satisfied the inclusion and exclusion criteria. The species investigated, dosage forms, study designs, duration of intervention, controls, endpoints, quality of reporting and risk of bias are discussed. 85.71% of the trials reviewed here reported positive results but given the methodological flaws and biases affecting them, it is difficult to conclude on the efficacy of those products based on the studies published thus far.

Biomolecules ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. 884 ◽  
Author(s):  
Robert Ancuceanu ◽  
Adriana Iuliana Anghel ◽  
Camelia Ionescu ◽  
Marilena Viorica Hovaneț ◽  
Maria Cojocaru-Toma ◽  
...  

It is currently recognized that an injudicious strategy about caries in the last decades has been not only focusing of research mostly in children, but also the narrow focusing on fluoride, because despite sufficient availability of fluoride in water and oral healthcare products, caries levels escalate steadily as people get older and caries remain a main public health issue to be settled. In the last two decades the scientific community intensified efforts of exploring other products for caries prevention, herbal products being one of these approaches. Preliminary evidence indicated that clinical trials for caries prevention with herbal products are heterogeneous in design, quality and products evaluated, we therefore performed a scoping review intended to explore the main characteristics of such clinical trials. From an initial collection of 1986 unique papers from different literature databases, 56 articles satisfied the inclusion and exclusion criteria. The species investigated, dosage forms, study designs, duration of intervention, controls, endpoints, quality of reporting, and risk of bias are discussed. Of the trials reviewed here, 85.71% reported positive results but given the methodological flaws and biases affecting them, it is difficult to conclude on the efficacy of those products based on the studies published thus far.


2021 ◽  
pp. 1-10
Author(s):  
Jan P. Vandenbroucke ◽  
Erik Von Elm ◽  
Douglas G. Altman ◽  
Peter C. Gotzsche ◽  
Cynthia D. Mulrow ◽  
...  

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www. strobe-statement.org/) should be helpful resources to improve reporting of observational research. This article is the reprint with Russian translation of the original that can be observed here: Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med 2007;4(10):e297. doi:10.1371/journal.pmed.0040297


2020 ◽  
Vol 10 (22) ◽  
pp. 7961
Author(s):  
Rizwan Ahmad ◽  
Lina Hussain AlLehaibi ◽  
Abdulrahman K. Alshammari ◽  
Saif M. Alkhaldi

The amount of data regarding the use of herbs/herbal products in cancer clinical trials at times creates a great challenge for oncologists to prescribe or counsel patients. It urges critical evaluation of the quality of clinical trials. Herein, for the first time, the clinical trials for herbs used in cancer were critically evaluated on the basis of three widely used scales, i.e., Jadad, Delphi, and Cochrane scales. The literature was collected with the help of online databases, journals, libraries, and books using a number of specific keywords as mentioned in detail in forthcoming sections. A total of 73 clinical trials were extracted, evaluated, and scored for 14 herbs, according to the predefined criteria mentioned below. A major deficiency of “non-blinding of clinical trials” was observed. The principal component analysis revealed four components (PC1–PC4) with a total variability of 68.21%, wherein the highest percentage variability was observed for PC1 loaded with “non-blinding of the clinical trials, no concealment of the treatment allocation, non-blindness of the patient and care provider”, which accounted for 30.81% of the total variability. The next major variability of 14.70% was observed for PC2 loaded with “non-randomization of the studies, non-blinding of the outcome assessors, no proper drop-out procedures, and lack of information regarding baseline characteristics for the groups”. Pearson’s correlation further confirmed a similar correlation pattern for the mentioned deficiencies (p = 0.05). An in-house grading scale was developed, showing a very small portion (16.44%), i.e., 12/73 studies with a good quality, whereas the majority (57.54%) of the studies, i.e., 42/73, were found to be of poor quality. The rules and regulations governing the quality of clinical trials needs to be more stringent and updated for the natural products/herbs used in cancer clinical trials.


2007 ◽  
Vol 60 (8) ◽  
pp. 965-966 ◽  
Author(s):  
Vincent K.L. Yeow ◽  
Seng Teik Lee ◽  
Joanne J. Cheng ◽  
Angeline Koh ◽  
Hwee Bee Wong ◽  
...  

2010 ◽  
Vol 24 (12) ◽  
pp. 2067-2073 ◽  
Author(s):  
Riccardo Autorino ◽  
Claudio Borges ◽  
Michael A. White ◽  
Fatih Altunrende ◽  
Sisto Perdoná ◽  
...  

2005 ◽  
Vol 33 (9) ◽  
pp. 1937-1945 ◽  
Author(s):  
Karen E. A. Burns ◽  
Neill K. J. Adhikari ◽  
Michelle Kho ◽  
Maureen O. Meade ◽  
Rakesh V. Patel ◽  
...  

2020 ◽  
Author(s):  
Mairead McErlean ◽  
Jack Samways ◽  
Peter Godolphin ◽  
Yang Chen

This is a systematic review protocol which outlines the basis and methodology for our intended review which at the time of writing is in the study screening phase. Our aim is to answer the fundamental questions:To systematically identify RCTs published in the four leading medical journals between January 1st 2019 to May 31st 2020.To assess the quality of reporting of such RCTs using the CONSORT 2010 statement.To identify any association with medical specialty or size or type of RCT and the rate of adherence to the CONSORT 2010 statement.


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