Efficacy and Safety of Medicine-Food Homology Shenqi Paste in Older Adults with Diabetic Sarcopenia: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Ethnopharmacological relevance: Diabetic sarcopenia (DS), an emerging diabetes complication, poses an increasing challenge to the elderly population. Shenqi paste (SQP) consists of 8 medicine-food homology substances: Astragalus membranaceus (Fisch.) Bge., Codonopsis pilosula (Franch.) Nannf., Polygonatum sibiricum Red., Dioscorea opposita Thunb., Poria cocos (Schw.) Wolf, Eucommia ulmoides Oliv., Hordeum vulgare L., and Ophiopogon japonicus (L.f.) Ker Gawl.. SQP has shown potential benefits for sarcopenia in clinical practice. Its efficacy and safety in DS have not been validated in a randomized controlled trial.

Aim of the study: This study aimed to evaluate the efficacy, safety, and limitations, and provide insights into methods and strategies for utilizing SQP in DS management.

Materials and methods: In this randomized, double-blind, placebo-controlled trial, community-dwelling older adults (≥ 60 years) with DS and spleen-kidney deficiency syndrome were allocated 1:1 to receive either SQP or placebo paste for 12 weeks. Primary outcomes were skeletal muscle mass index (SMI), handgrip strength, and five-time chair stand test (FCST) duration. Secondary outcomes included health-related scales and biochemical indicators. Assessments were conducted at the baseline (T0), week 6 (T1), and week 12 (T2). Safety evaluation included blood routine, liver and kidney function tests. Intention-to-treat analysis was applied to the primary outcomes data from all participants, with per-protocol analysis for sensitivity. Generalized estimating equations with covariate adjustment and t-tests or Wilcoxon rank-sum tests were used for statistical analysis.

Results: Of 90 randomized participants, the SQP group showed greater improvements in handgrip strength (T2: interact p < 0.001), SMI (T2: interact p < 0.001), and FCST (T2: interact p < 0.001) versus control. Secondary outcome measures of 74 participants, including frailty, nutrition, physical activity, sleep quality, depression, and TCM syndrome scores, significantly improved (p < 0.05), with significant fasting blood glucose reduction (T2: interact p = 0.018) and C-reactive protein decrease (T2: interact p < 0.001). There was no statistically significant difference in the change in the difference between the two groups in fasting insulin, glycated hemoglobin and insulin resistance index before and after intervention (p > 0.05). Within-group analysis demonstrated significant reductions of SQP group in inflammatory cytokines, and sarcopenia-related biomarkers (p < 0.001) post-intervention. No serious adverse events occurred.

Conclusion: A 12-week SQP intervention enhanced muscle mass, strength, function, and metabolic and inflammatory profiles in older adults with DS, with good tolerability, supporting its potential as a safe, complementary therapy.

Keywords: Clinical efficacy; Randomized controlled trial; Sarcopenia; Shenqi Paste; TCM Dietary Therapy; Type 2 diabetes mellitus.