The Efficacy and Safety of Aqueous Fruit Extract among Adult Patients with Dyslipidemia: A Systematic Review and Meta-analysis.

Background: Flavonoids from effectively reduced serum and tissue lipid levels through their inhibitory effect on the hepatic β-hydroxy-β-methylglutaryl coenzyme A reductase activity. This study aimed to determine the efficacy and safety of extract in adults with dyslipidemia.

Methods: We searched the following electronic databases: MEDLINE (PubMed), MEDLINE (Ovid), Google Scholar, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Web of Science, and ClinicalTrials.gov from inception until January 31, 2022. Two reviewers independently screened the abstracts, reviewed full-text papers, and critically appraised the quality of included studies. Meta-analysis was performed using the random-effects model. Our primary outcomes were total cholesterol, LDL-C, serum triglycerides, and HDL-C levels, while secondary outcomes included adverse events.

Results: A total of four randomized trials (N = 227) were included in the final analysis. There were statistically significant decreases in total cholesterol levels (SMD = -21.23 mg/dL, 95% CI: -34.22, -8.25; P = 0.001) and LDL-C levels (SMD = -25.12 mg/dL, 95% CI: -40.24, -10.00; P = 0.001) and significant increase in HDL-C levels (SMD = 4.74 mg/dL, 95% CI: 0.40, 9.07; P = 0.03) after 12 weeks of intervention favoring the use of the extract over placebo. However, there were no statistically significant difference in the serum triglycerides levels following 12 weeks of treatment (SMD = -22.28 mg/dL, 95% CI: -53.33, 8.76; P = 0.16). There was high heterogeneity noted across all outcomes: total cholesterol (P = 0.01, I = 72%), LDL-C (P = 0.0004, I = 83%), HDL-C (P < 0.00001, I = 91%) and serum triglycerides (P < 0.00001, I = 93 %). The intervention was well tolerated and adverse events reported in the three of four studies were all mild: dyspepsia (7 events - treatment), mild diarrhea (3 events - placebo), fever (1 event - placebo), headache (1 event - placebo).

Conclusion: Compared to placebo, fruit extract resulted in lower total cholesterol and LDL-C levels and increased HDL-C levels but with no effect on serum triglyceride levels based on low certainty of evidence. Trials with a larger sample size that directly compare extract to statins, preferably local data, are needed to support its use in patients with dyslipidemia further.