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.
STUDY DESIGN: Randomised controlled trial.
SETTING: Tertiary level hospital in Malaysia.
PATIENTS: 77 patients undergoing elective Caesarean delivery.
INTERVENTION: Differing speeds of spinal injection.
MEASUREMENTS: Systolic blood pressure was assessed every minute for the first 10min and incidence of hypotension (reduction in blood pressure of >30% of baseline) was recorded. The use of vasopressor and occurrence of nausea/vomiting were also recorded.
MAIN RESULTS: 36 patients in SLOW group and 41 patients in FAST group were recruited into the study. There was no significant difference in blood pressure drop of >30% (p=0.497) between the two groups. There was no difference in the amount of vasopressor used and incidence of nausea/vomiting in both groups.
CONCLUSION: In our study population, there was no difference in incidence of hypotension and nausea/vomiting when spinal injection time is prolonged beyond 15s to 60s.
TRIAL REGISTRATION: ClinicalTrials.govNCT02275897. Registered on 15 October 2014.