RESUMEN
BACKGROUND RELEVANCE: A plethora of literature is available regarding the clinical trials for natural products however; no information is available for critical assessments of the quality of these clinical trials. AIM OF STUDY: This is a first time report to critically evaluate the efficacy, safety and large scale applications of up-to-date clinical trials for diabetes, based on the three scales of Jadad, Delphi, and Cochrane. METHODOLOGY: An in-depth and extensive literature review was performed using various databases, journals, and books. The keywords searched included, "clinical trials," "clinical trial in diabetes," "diabetes," "natural products in diabetes," "ethnopharmacological relevance of natural products in diabetes," etc. RESULTS: Based on eligibility criteria, 16 plants with 74 clinical trials were found and evaluated. Major drawbacks observed were; "non-randomization and blindness of the studies," "non-blindness of patients/healthcare/outcome assessors," "lack of patient compliance and co-intervention reports," "missing information regarding drop-out/withdrawal procedures," and "inappropriate baseline characteristics." Principal component analysis and Pearson correlation revealed four components with %variability; PC1: 23.12, PC2: 15.83, PC3: 13.11, and PC4: 11.38 (Pâ≤â.000). According to descriptive statistics, "non-blinding of outcome assessors" was the major drawback (82%) whereas, "not mentioning the timing of outcome assessment" was observed lowest (6.8%). An in-house quality grading (scale 0-24) classified these clinical trials as; poor (67.6%), acceptable (19.9%), and good quality trials (13.5%). CONCLUSION: Proper measures in terms of more strict regulations with pharmacovigilance of plants are utmost needed in order to achieve quality compliance of clinical trials.
Asunto(s)
Productos Biológicos/uso terapéutico , Diabetes Mellitus/terapia , Control Glucémico/métodos , Adulto , Ensayos Clínicos como Asunto , Etnofarmacología , Femenino , Humanos , Masculino , Análisis de Componente Principal , Resultado del TratamientoRESUMEN
OBJECTIVES: There has been no review on the prevalence, possible causes, and clinical outcomes of self-medication with antibiotics (SMA) in the Middle East. METHODS: Databases were searched (January 2000 through June 2016) for articles on SMA among adults aged ≥18 years living in the Middle East. A hand search for relevant citations and key journals was also performed. RESULTS: Twenty-two studies were found. The prevalence of SMA ranged from 19% to 82%. Age, sex, and educational and income levels were the main determinants of SMA. Socio-cultural, economic, and regulatory factors were the most commonly cited reasons for SMA. Penicillins were the antibiotics most commonly used; the antibiotics were obtained mainly via stored leftover drugs, pharmacies without prescriptions, and friends/relatives. SMA was mainly for upper respiratory tract problems. The primary sources of drug information included relatives/friends and previous successful experience. Inappropriate drug use such as wrong indication, short and long duration of treatment, sharing of antibiotics, and storing antibiotics at home for use at a later time were reported. Negative and positive outcomes of SMA were identified. CONCLUSIONS: It is important to understand the links between different factors promoting SMA and to assess the changing trends in order to derive strategies aimed at reducing drug-related health risks.