Gut microbiome-metabolomics integration explores the adjunctive effect of Naoxintong capsule on atorvastatin in ameliorating hyperlipidemia: A randomized controlled pilot study.

Combination therapy of NXT plus atorvastatin produced an 11.3% greater reduction in LDL-C compared to atorvastatin monotherapy.

• 32 hyperlipidemia patients were randomly divided into two groups for 12 weeks of treatment
• LDL-C levels: 2.65 mmol/l (combination) vs. 2.99 mmol/l (monotherapy), p = 0.027
• The study was a randomized controlled pilot trial (Trial registration No. ChiCTR2500097533)

Combination therapy produced a 24.7% increase in HDL-C and an 18.8% greater reduction in triglycerides compared to atorvastatin monotherapy.

• HDL-C levels: 1.06 vs. 0.85 mmol/l, p = 0.011
• TG levels: 1.77 vs. 2.18 mmol/l, p = 0.011
• Both comparisons favored the NXT plus atorvastatin combination group

Combination therapy demonstrated systemic anti-inflammatory benefits with reductions in both IL-6 and TNF-α compared to monotherapy.

• IL-6 showed an 11.8% reduction: 69.13 vs. 78.39 ng/l, p < 0.001
• TNF-α showed a 10.4% decrease: 90.16 vs. 100.63 ng/l, p = 0.030
• These findings indicate adjunctive anti-inflammatory effects of NXT beyond lipid-lowering

Myocardial injury biomarkers showed marked improvement with combination therapy compared to atorvastatin monotherapy.

• LDH decreased by 19.3%: 193.60 vs. 239.96 U/l, p < 0.001
• CK-MB decreased by 26.2%: 31.69 vs. 42.90 U/l, p < 0.001
• Both biomarkers favored the NXT plus atorvastatin group

Several key gut bacteria were identified as associated with the enhanced therapeutic effect of NXT added to atorvastatin via correlation analysis.

• Key bacteria identified included Streptococcus_salivarius, Veillonella_parvula, Streptococcus_thermophilus, Anaerobutyricum_hallii, and Ruminococcus_sp_5_1_39BFAA
• These associations were identified through gut microbiome-metabolomics integration analysis
• The analysis linked microbiota composition alterations to the adjunctive clinical outcomes

Several metabolic pathways were found to be closely involved in the outcomes of NXT combination treatment.

• Pathways identified included citrate cycle, ether lipid metabolism, propanoate metabolism, and glutathione metabolism
• These pathways were uncovered through metabonomics analysis of plasma metabolite abundances
• Changes in plasma metabolite abundances were proposed as a potential mechanism for NXT's adjunctive effects