Efficacy and safety of Shen-Qi Paste, a Traditional Chinese Medicine, in dialysis patients with sarcopenia: A randomized, double-blind, placebo-controlled trial.

BACKGROUND

The lack of effective treatments for sarcopenia remains a major unmet medical need. Shen-Qi Paste (SQP), a Traditional Chinese Medicine (TCM) dietary formulation developed on the basis of the theory of "same origin of medicine and food," offers a novel therapeutic strategy. Unlike conventional approaches that are focused solely on nutrition and exercise, SQP targets the underlying TCM-defined etiologies (e.g., spleen-kidney deficiency) to address the root causes of muscle wasting. Studies have shown that the traditional herbal ingredients of SQP has anti-inflammatory, antioxidant, and muscle protein inhibition properties and can enhance muscle mass and strength.

HYPOTHESIS/PURPOSE: This study aimed to assess the efficacy and safety of SQP in dialysis patients with sarcopenia by using a two-center, randomized, double-blind, placebo-controlled clinical trial.

METHODS

A total of 128 dialysis patients (age: 45-89 years old) with sarcopenia (as identified by the Asian Sarcopenia Group for Sarcopenia 2019) were randomly allocated to either the SQP group or control group for intervention. Patients in the SQP group and control group were respectively administered oral SQP and placebo at 1 vial/15 g twice daily for 12 weeks. At the same time, all participants maintained low-intensity exercise for 20-30 min/d at a frequency of 3-4 d/wk during the trial. The indexes and scales were examined and evaluated before and after the intervention. The primary indicators were changes in sarcopenia measures, including skeletal muscle mass index (SMI), grip strength, and physical function by five-times sit-to-stand test (FTSST).

RESULTS

A total of 163 patients aged 45-89 years were screened, and 128 patients were randomized to receive the study intervention. Some patients (SQP group, n = 6; control group, n = 5) stopped the intervention because of various reasons. A total of 117 patients (55.56 % of whom were male) completed the 12 weeks intervention. The statistical results of the study were as follows: (1) Intra-group comparison: compared to pre-intervention, SQP intervention significantly improved SMI (t, -0.248, [95 %CI, -0.37 to -0.127], p < 0.001), and decreased FTSST, myostatin levels, and serum uric acid levels (P<0.05). Both groups had significant changes in grip strength and 36-Item Short Form Health Survey (SF-36) scores post-intervention (p < 0.05). (2) Inter-group comparison: compared to the control group, SQP intervention improved the SMI (t, -0.384, [95 %CI, -0.66 to -0.109], p = 0.007); even though the grip strength of SQP group decreased, it was still significantly higher (t, -2.113, [95 %CI, -3.755 to -0.123], p = 0.037); the score for Mini Nutritional Assessment Short Form significantly increased (p < 0.05); Pittsburgh Sleep Quality Index, TCM syndrome score, C-reactive protein level, and blood urea nitrogen level significantly decreased (p < 0.05); and the change in the score of International Physical Activity Questionnaire-Short Form was statistically significant (p = 0.026). There were no notable differences between the two groups in terms of Fatigue, Resistance, Aerobic Capacity, Illnesses, and Loss of Weight scale score, FTSST scores, SF-36 score, Irisin level, serum creatinine level, hemoglobin level, and metabolic markers (p > 0.05).

CONCLUSION

SQP has the potential to notably enhance muscle mass; therefore, it could be a viable option for treating sarcopenia. Further research should investigate its effectiveness in a broader group of patients and delve into its mechanism of action to offer more detailed evidence for SQP in treating sarcopenia.