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.
METHODS: A retrospective study was conducted on 25 patients (12 males and 13 females, mean age of 53.9±9.1 years). All patients had positive polymerase chain reaction test for COVID-19 and histopathological proof of AIFS. Patients underwent computed tomography (CT) and magnetic resonance examinations to assess sinonasal, orbital, and cranial spread.
RESULTS: The most prevalent comorbidity among the study cohort was diabetes mellitus (DM). Twenty-one patients (84%) were diagnosed in the post-COVID-19 period after hospital discharge, with a mean interval of 19.1±9.2 days. Steroid treatment was given to 19 patients (76%). Orbital manifestations were the presenting symptoms in all patients, followed by facial edema, nasal discharge, and neurological symptoms. Sinonasal involvement ranged from mucosal thickening to complete sinus opacification by a predominant isodensity on CT, low T1, and high T2 signal intensity with variable enhancement patterns. Twenty-four patients had a unilateral orbital extension, and 12 patients showed signs of intracranial extension. Bone involvement was detected in 16 patients (64%). Follow-up scans in 18 patients (72%) showed rapid progression of the disease. Eight patients (32%) died, six from neurological complications and two from severe respiratory failure.
CONCLUSION: Steroids, DM, and severe COVID-19 are the major risk factors of AIFS in the post-COVID-19 era. Imaging scans in all patients revealed different sinonasal, facial, orbital features, and intracranial involvement with rapid progression of the findings on follow-up scans.
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.