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Fulltext NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials

Hegazi OE, Alalalmeh SO, Alnuaimi GRH, Shahwan M, Jairoun AA, Alorfi NM, et al.

Front Med (Lausanne), 2023;10:1227046.
PMID: 37601777 DOI: 10.3389/fmed.2023.1227046

BACKGROUND: Nonalcoholic Fatty Liver Disease (NAFLD) has become a significant public health concern, affecting approximately one-fourth of the population. Despite its prevalence, no FDA-approved drug treatments specifically target NAFLD.
AIM: To provide a review of clinical trials investigating the use of herbal remedies and dietary supplements in NAFLD management, utilizing the ClinicalTrials.gov database.
METHODS: This review evaluates the current evidence by examining completed phase III and IV clinical trials registered on ClinicalTrials.gov. An exhaustive search was performed on April 17, 2023, using the terms "Nonalcoholic Fatty Liver Disease" and "NAFLD." Two independent reviewers appraised eligible trials based on pre-defined inclusion and exclusion criteria.
RESULTS: An initial search yielded 1,226 clinical trials, with 12 meeting the inclusion criteria after filtration. The majority of trials focused on Omega-3 fatty acids (20.0%) and vitamin D (26.7%), followed by caffeine, chlorogenic acid, ginger, phosphatidylcholine, Trigonella Foenum-graecum seed extract, vitamin C, and vitamin E (each 6.7%). Most studies were Phase 3 (75.0%) and used a parallel assignment model (91.7%). Quadruple masking was the most prevalent technique (58.3%), and Iran was the leading country in terms of trial locations (25.0%). These interventions constitute two herbal interventions and nine supplement interventions.
CONCLUSION: This reveals a diverse range of nutraceuticals, with Omega-3 fatty acids and vitamin D being predominant in the management of NAFLD. The global distribution of trials highlights the widespread interest in these therapeutics. However, more rigorous, large-scale trials are needed to establish safety, efficacy, and optimal dosages.
Fulltext Community pharmacists' skills and practice regarding dispensing fiscalized substances: a cross-sectional survey

El-Dahiyat F, Jairoun AA, Al-Hemyari SS, Shahwan M, Jairoun M, Zyoud SH, et al.

Front Pharmacol, 2023;14:1237306.
PMID: 37719848 DOI: 10.3389/fphar.2023.1237306

Background: The use of drugs containing fiscalized substances is essential in different medical areas, including pain management, obstetric emergencies, and the treatment of mental disorders. However, due to their potential for abuse and negative health effects, the dispensing of these substances demands pharmacists with the requisite skills and practice. Objective: This study assesses the skills and practices of pharmacy personnel in the United Arab Emirates (UAE) regarding the dispensing of tramadol, a medication containing fiscalized substances, in community pharmacies. Methodology: A cross-sectional study was conducted. Community Pharmacies were chosen via random sampling, and seven well-trained final year pharmacy students visited them and conducted face-to-face interviews. The survey tool covered items highlighting the demographic data of the subjects, and items on the practice and skills regarding dispensing the fiscalized substances. The content validity ratio values of all tool questions were more than 0.78, suggesting acceptable validity and the Cronbach's α of 0.75 showed as acceptable internal reliability. The primary outcome measures of interest were the skills and practice regarding dispensing Fiscalized substances. Results: A total of 612 pharmacists were recruited in the study. The average practice score was 80%. There was a statistically significant association (p < 0.05) between practices about dispensing fiscalized substances and gender, age group, pharmacy type, work experience, university of graduation, and receiving training on epilepsy and antiepileptic drugs. Conclusion: The results implied that competency and experience are vital factors for the dispensing of tramadol. Contextually, the majority of the pharmacists evidently have the requisite competencies to provide high-quality and proper medical care, with regards to dispensing tramadol, which will minimize drug abuse and medication errors, and assist outpatients to manage their drugs containing fiscalized substances.
Fulltext Factors influencing community pharmacists' knowledge about women's issues in epilepsy

Jairoun AA, Al-Himyari SS, Shahwan M, Hassan N, Al-Tamimi S, Jairoun M, et al.

Front Public Health, 2023;11:1251393.
PMID: 37766744 DOI: 10.3389/fpubh.2023.1251393

BACKGROUND: Previous studies have highlighted instances where pharmacists lacked knowledge regarding women's health issues related to epilepsy.
OBJECTIVES: To assess UAE community pharmacists' knowledge, toward women's issues in epilepsy.
METHODS: a cross-sectional research method was employed. A team of seven pharmacy students in their final year visited a randomly selected sample of community pharmacies in the UAE and face-to-face interviews were conducted with the pharmacists using a structured questionnaire. The questionnaire includes two parts; Eight questions designed to elicit data about the demographics of the study participants and 12 questions eliciting insights into the participants' knowledge of women's issues in epilepsy.
RESULTS: A total of 412 community pharmacist were recruited in the study. The overall level of knowledge about women's issues in epilepsy was good and the average knowledge score was 81% with a 95% confidence interval (CI) [79.1, 82.7%]. The results of multivariate analysis showed higher knowledge scores in chain pharmacies (OR 1.37; 95% CI 1.12-1.67), Chief pharmacists (OR 1.44; 95% CI 1.01-2.06), Pharmacists in charge (OR 3.46; 95% CI 2.7-4.45), pharmacists with 1-5 Years of experience (OR 2.87; 95% CI 1.71-4.82), pharmacists with 6-10 Years (OR 2.63; 95% CI 1.58-4.38), pharmacists with >10 years (OR 3.13; 95% CI 2.03-4.83), graduation form regional universities (OR 1.37; 95% CI 1.12-1.67), graduation form international universities (OR 1.73; 95% CI 1.36-2.20) and receiving a training on epilepsy (OR 1.36; 95% CI 1.12-1.67).
CONCLUSION: While the findings reveal an overall promising level of knowledge among community pharmacists regarding the issues faced by women with epilepsy, pinpointing which clinical and demographic factors have the most significant impact on this knowledge would permit the implementation of tailored educational interventions. Workshops and modules targeting the issues faced by women with epilepsy would further raise the knowledge and competence among community pharmacists in this area, ensuring better pharmaceutical care for this population.
Community pharmacists' perspectives on cardiovascular disease pharmaceutical care in the United Arab Emirates: a questionnaire survey-based analysis

Jairoun AA, Al-Himyari SS, Shahwan M, Al Ani M, Habeb M, Jairoun M, et al.

Front Pharmacol, 2023;14:1237717.
PMID: 37736347 DOI: 10.3389/fphar.2023.1237717

Background: Community pharmacists play an intermediary role between prescribing physicians and patients in the United Arab Emirates (UAE) and thus are responsible for ensuring that patients receive optimal cardiovascular disease (CVD) pharmaceutical care. Methods: we used a cross-sectional design to assess the perceptions and practices of community pharmacists concerning pharmaceutical care for patients with CVD. A trained researcher visited randomly selected community pharmacies and used a structured questionnaire to conduct in-person interviews with pharmacists. The questionnaire collected demographic data and information on perceptions and practices regarding CVD pharmaceutical care. Results: Five hundred and fifty-one participants were recruited. The average participant age (mean ± SD) was 35 ± 2.7 years. The average perception score regarding CVD prevention and management was 75.6% (95% confidence interval [CI] 77.1%-74.2%), and the average practice score for CVD prevention and management was 87.1% (95% CI 76.5%-79.6%). Bivariate analysis revealed that gender (p = 0.001), education level (p < 0.001), pharmacy position (p = 0.004), work experience (p < 0.001), number of patients served per day (p < 0.001) and being trained on CVD prevention and management (p < 0.001) were significantly associated with perceptions about the prevention and management of CVD. Better practice scores were seen among older participants (OR 1.01; 95% CI 1-1.019), postgraduates (OR 1.77; 95% CI 1.66-1.89), workers at chain pharmacies (OR 1.24; 95% CI 1.11-1.39), pharmacists in charge (OR 1.22; 95% CI 1.01-1.47), pharmacists with >10 years of experience (OR 11.3; 95% CI 6.01-15.62), pharmacists with 6-10 years of experience (OR 4.42; 95% CI 3.90-5) and pharmacists trained on CVD prevention and management (OR 1.29; 95% CI 1.15-1.46). Conclusion: Pharmacy practitioners working in community pharmacies in the UAE actively engage in delivering pharmaceutical care to patients, playing a role in CVD management and prevention. However, they showed low levels of involvement in other healthcare services, specifically in screening and measuring patients' weight, glucose levels, and blood pressure, monitoring treatment responses, maintaining medical records, and reviewing medication refill histories. Activities such as educating patients, providing medication counseling, offering support for treatment adherence, and fostering collaborative relationships with other healthcare providers should be encouraged among UAE community pharmacists to ensure the provision of high-quality patient care.
Fulltext Exploring Promising Therapies for Non-Alcoholic Fatty Liver Disease: A ClinicalTrials.gov Analysis

Hegazi OE, Alalalmeh SO, Shahwan M, Jairoun AA, Alourfi MM, Bokhari GA, et al.

Diabetes Metab Syndr Obes, 2024;17:545-561.
PMID: 38327733 DOI: 10.2147/DMSO.S448476

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a common disease and has been increasing in recent years. To date, no FDA-approved drug specifically targets NAFLD.
METHODS: The terms "Non-alcoholic Fatty Liver Disease" and "NAFLD" were used in a search of ClinicalTrials.gov on August 24, 2023. Two evaluators independently examined the trials using predetermined eligibility criteria. Studies had to be interventional, NAFLD focused, in Phase IV, and completed to be eligible for this review.
RESULTS: The ClinicalTrials.gov database was searched for trials examining pharmacotherapeutics in NAFLD. The search revealed 1364 trials, with 31 meeting the inclusion criteria. Out of these, 19 were finalized for evaluation. The dominant intervention model was Parallel. The most prevalent studies were in Korea (26.3%) and China (21.1%). The most common intervention was metformin (12.1%), with others like Exenatide and Pioglitazone accounting for 9.1%.
CONCLUSION: Therapeutics used to manage NAFLD are limited. However, various medications offer potential benefits. Further investigations are definitely warranted.