Clinical observation of the effect of modified Ginseng-Schisandra decoction (MGSD) on trace elements and immune function in children with spleen deficiency syndrome after recurrent respiratory tract infection (RRTI): a randomized controlled trial

BACKGROUND: Recurrent respiratory tract infection (RRTI) is common disease in childhood, and the incidence rate is increasing in China. The cause is complex, which is related to the physiological characteristics of children’s respiratory system and the immature immune function, lack of trace elements and environmental pollution. Immunomodulators and antibiotics are often used to treat RRTI, but the clinical efficacy still needs to be improved. Chinese medicine has unique advantages in the treatment of RRTI. In the clinical treatment of RRTI, the authors often use modified Ginseng-Schisandra decoction (MGSD). In order to study the clinical effect of MGSD on serum trace elements and immune function in children with spleen deficiency syndrome after RRTI, we conducted this clinical observation. METHODS: This is a single-center randomized trial with two parallel groups. Eighty children who developed spleen deficiency syndrome following RRTI were randomly and equally divided into a control group and an observation group. The control group was given Medilac-vita and the observation group was given MGSD. The participants, care givers, and those assessing the outcomes were blinded to group assignment. The treatment course was 4 weeks. Clinical efficacy, traditional Chinese medicine (TCM) syndrome scores, humoral immunity, and trace element index values before and after treatment were compared between the two groups of children. RESULTS: The trial was finished. The total effective rate of the observation group (n=40, 95%) was significantly higher than control group (n=40, 65%) (P<0.05). After treatment, the TCM syndrome scores of the two groups were reduced compared to those before treatment, while the serum immunoglobulin A and G levels were increased (P<0.05); however, the observation group had significantly lower TCM syndrome scores than the control group. Significant improvements in serum immunoglobulins (IgA and IgG) levels, T lymphocyte subsets (CD3(+), CD4(+), and CD4(+)/CD8(+)), and trace elements (Zn and Fe) indicators were observed in the observation group compared to the control group (P<0.05). CONCLUSIONS: The application of MGSD in the treatment of children with spleen deficiency syndrome after RRTI has a definite clinical effect. MGSD can effectively improve the immune function of the patients and the content of the trace elements iron and zinc, and thus has potential value for promotion and application. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100047128.