Clinical study of self-made Xiaogan Tiaopi Kaiwei Decoction combined with conventional western medicine therapy in the treatment of infantile anorexia of spleen-stomach weakness / 国际中医中药杂志

ABSTRACT

Objective:To evaluate the efficacy of self-made Xiaogan Tiaopi Kaiwei Decoction combined with conventional western medicine therapy in the treatment of infantile anorexia of spleen-stomach weakness.Methods:Randomized controlled trial. A total of 100 children with anorexia of spleen-stomach weakness ,who were treated in the First Clinical Medical College of Shaanxi University of Chinese Medicine between April 2020 and September 2021, were selected as the observation subjects in a prospective cohort study, and they were divided into two groups by the random number table method, with 50 in each group. The control group was given routine treatment, and the Traditional Chinese Medicine (TCM) group was given self-made Xiaogan Tiaopi Kaiwei Decoction on the basis of the control group. The TCM syndromes were scored before and after treatment. The levels of trace elements such as iron, zinc and calcium were detected by atomic spectrometer, the absorptivity of D-xylose was measured by colorimetry. The adverse events during treatment were recorded. After 6 months of follow-up, the height, weight and BMI were measured and recorded, and the clinical efficacy was assessed.Results:The total response rate was 96.0% (48/50) in the TCM group and that in the control group was 84.0% (42/50) ( χ2=4.00, P=0.046). The scores of decreased appetite, anorexia, sallow complexion, abdominal fullness and distention and shortness of breath and laziness to speak and total score in the TCM group after treatment were significantly lower than those in the control group ( t=12.47, 13.42, 14.19, 16.39, 9.15, 17.72, P<0.01). The levels of blood trace elements such as iron [(414.58 ± 57.52) mg/L vs. (350.85 ± 53.33) mg/L, t=5.75 ], zinc [(8.26 ± 1.55) mg/L vs. (7.64 ± 1.37) mg/L, t=2.12 ] and calcium [(77.26 ± 15.30) mg/L vs. (71.05±14.26) mg/L, t=2.10] and urine D-xylose absorption rate [(31.76±5.28) % vs. (27.97 ± 4.61) %, t=3.82 ] in the TCM group were significantly higher than those in the control group ( P<0.01 or P<0.05). During treatment, there was no serious adverse reaction in the TCM group and 1 case of nausea in the control group. There was no statistical significance in the incidence rate of adverse reactions between the two groups ( χ2=1.01, P=0.315). After follow-up, the weight in the TCM group was significantly higher than that of the control group ( t=2.17, P=0.032). Conclusion:Self-made Xiaogan Tiaopi Kaiwei Decoction combined with conventional western medicine therapy can relieve the clinical symptoms, promote the absorption of trace elements and improvement of spleen-stomach function, and enhance the long-term efficacy in the treatment of children with anorexia of spleen-stomach weakness, and it has no adverse reactions.