Essential phospholipids for nonalcoholic fatty liver disease associated with metabolic syndrome: A systematic review and network meta-analysis

Abstract

BACKGROUND Essential phospholipids (EPL) are used for the supportive treatment of non-alcoholic fatty liver disease (NAFLD), but data are mostly from small-scale studies. AIM To evaluate the efficacy of EPL treatment in adult patients with NAFLD and type 2 diabetes and/or obesity. METHODS The MEDLINE, PubMed, Embase, and Cochrane databases were searched up to March 2019 for clinical trials and comparative observational studies. Eligible studies were those published in English or Chinese that enrolled adult patients (≥ 18 years) with NAFLD and type 2 diabetes mellitus and/or obesity receiving EPL as monotherapy or as add-on therapy to existing therapy, and that included at least one of the efficacy outcomes of interest. A variety of studies were identified; thus, direct, indirect and cohort meta-analyses were performed. Mean difference (MD) and 95% confidence interval (CI) were calculated for continuous variables, and relative risk with 95%CI for disease response and recovery. A random-effects model was used to address between-study heterogeneity. RESULTS Ten studies met the inclusion criteria ( n = 22-324). EPL treatment duration ranged from 4 to 72 wk. In the direct meta-analysis (four randomized controlled trials), compared with antidiabetic therapy alone, EPL plus antidiabetic therapy was associated with a significantly greater reduction in [alanine aminotransferase (ALT); MD: 11.28 U/L (95%CI: -17.33, -5.23), P = 0.0003], triglyceride [MD: -49.33 mg/dL (95%CI: -66.43, -32.23), P < 0.0001] and total cholesterol levels [MD: -29.74 mg/dL (95%CI: -38.02, -21.45), P < 0.0001]. There was also a significant increase in the rate of overall improvement [relative risk 1.50 (95%CI: 1.26-1.79), P < 0.0001], and risk of no disease ( P = 0.0091), and a reduction in moderate disease ( P = 0.0187); there were no significant differences in severe disease, mild disease, or significant improvement. In the cohort meta-analysis of three non-randomized clinical trials, the MD in ALT levels was -16.71 U/L (95%CI: -24.94, -8.49) and 23% of patients had improved disease. In the cohort meta-analysis of five randomized trials, MD in ALT levels was –28.53 U/L (95%CI: -35.42, -21.65), and 87% (95%CI: 81%, 93%) and 58% (95%CI: 46%, 70%) of patients showed clinical improvement and significant clinical improvement. CONCLUSION This analysis provides evidence for a benefit of EPL in patients with NAFLD and diabetes and/or obesity. Further large-scale trials are warranted.

Correlation of Objective Endpoints and Subjective Patient-Reported Outcomes in NAFLD Treatment with Essential Phospholipids: Real-World Data Based on Pooled Analysis of Observational Studies

“…Although many of the studies are associated with a risk of bias and reporting issues, a large cumulative body of evidence suggests that EPLs are useful as adjunctive treatment in patients with NAFLD [36]. However, limited data are available on the treatment adherence and satisfaction with EPLs.…”

Exploring the Protective Effects and Mechanism of Crocetin From Saffron Against NAFLD by Network Pharmacology and Experimental Validation

“…After 7 days of adaptive feeding, mice were randomly assigned to seven groups ( n = 10 in each group) as follows: (1) Mice in the control group (control) were fed normal chow diets and given 0.5% sodium carboxyl methyl cellulose (CMC-Na) daily by oral gavage; (2) The high-fat diet group (HFD) mice were fed with HFD and given 0.5% CMC-Na daily by oral gavage; (3) The biphenyldimethylesterate group (DDB) mice were fed with HFD and given 200 mg/kg of biphenyldimethylesterate daily by oral gavage; (4) The Essentiale N group (Essential N) mice were fed with HFD and given 200 mg/kg of Essentiale N daily by oral gavage; (5) The Low-dose CCT group (CCT-L) mice were fed with HFD and given 10 mg/kg of CCT daily by oral gavage; (6) The Medium-dose CCT group (CCT-M) mice were fed with HFD and given 30 mg/kg of CCT daily by oral gavage; (7) The High-dose CCT group (CCT-H) mice were fed with HFD and given 50 mg/kg of CCT daily by oral gavage. DDB and Essential N, two drugs previously shown to be effective in the treatment of NAFLD and liver injury, were used as positive controls during the validation experiment ( 33 – 35 ).…”

“…The Medium-dose CCT group (CCT-M) mice were fed with HFD and given 30 mg/kg of CCT daily by oral gavage; (7) The Highdose CCT group (CCT-H) mice were fed with HFD and given 50 mg/kg of CCT daily by oral gavage. DDB and Essential N, two drugs previously shown to be effective in the treatment of NAFLD and liver injury, were used as positive controls during the validation experiment (33)(34)(35).…”

Nonalcoholic liver disease: review with a focus on risks of progression

“…Интересно, что более широкий анализ по всем зарегистрированным безрецептурным лекарственным препаратам фармакотерапевтических категорий гепатопротекторные средства, препаратов для терапии заболеваний печени, а также прочих препаратов для желудочно-кишечного тракта и обмена веществ не позволил обнаружить других лекарственных средств, для которых патогенетическое действие в отношении регресса стеатоза было бы отражено в инструкции по показанию НАЖБП. Недавний обзор фармакотерапевтических возможностей НАЖБП также подтвердил высокий потенциал эссенциальных фосфолипидов в отношении регресса стеатоза [76].…”