Effects of Tongdu Tiaofu method combined with Zaoren Ningshen capsules on arousal level and serum melatonin content in insomnia patients with heart-spleen deficiency syndrome

Li Jinwen; Li Jianzhong; Ma Hongqing; Zhang Yongqin

doi:10.3760/j.issn.1673-4777.2026.07.020

Abstract：Objective To explore the effects of Tongdu Tiaofu method combined with Zaoren Ningshen capsules on arousal level and serum melatonin content in insomnia patients with heart-spleen deficiency syndrome.Methods A total of 96 insomnia patients treated at Shanxi Traditional Chinese Medical Hospital from September 2024 to September 2025 were selected as research subjects.Patients were divided into control group and observation group according to random number table method,with 48 cases in each group.The control group was treated with Zaoren Ningshen capsules,and the observation group was additionally treated with Tongdu Tiaofu method on the basis of the control group.The therapeutic effects,scores of traditional Chinese medicine(TCM)syndrome scale,Pittsburgh Sleep Quality Index(PSQI),Athens Insomnia Scale(AIS),Hyperarousal Scale(HAS),Hamilton Anxiety Scale(HAMA)before treatment,2 weeks after treatment,4 weeks after treatment and 4 weeks after the end of treatment,as well as serum levels of melatonin,cortisol,vasoactive intestinal peptide(VIP)and orexin A before and after treatment were compared between the two groups.Results The total effective rate of the observation group was higher than that of the control group[95.8％(46/48)vs 81.2％(39/48)](x2=5.031,P=0.025).At 2 weeks after treatment,4 weeks after treatment and 4 weeks after the end of treatment,TCM syndrome scores,PSQI,HAS and AIS scores in the observation group were significantly lower than those in the control group(all P＜0.05).At 4 weeks after treatment and 4 weeks after the end of treatment,HAMA scores in the observation group were significantly lower than those in the control group(both P＜0.05).After treatment,melatonin levels in both groups were higher than those before treatment,and the observation group was higher than the control group;levels of cortisol,VIP and orexin A in both groups were lower than those before treatment,and the observa-tion group were lower than the control group(all P＜0.05).Conclusion Tongdu Tiaofu method combined with Zaoren Ningshen capsules has definite efficacy in the treatment of insomnia with heart-spleen deficiency syndrome.It can effectively improve patients' TCM syndromes,sleep quality and anxiety state,regulate the body's arousal level,and exert therapeutic effects by affecting serum levels of related hormones and neuropeptides.