Clinical study on modified self-made Qingxin Buqi Pinggan Decoction combined with atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder / 国际中医中药杂志

ABSTRACT

Objective:To evaluate the efficacy of modified self-made Qingxin Buqi Pinggan Decoction combined with atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder (ADHD).Methods:Randomized controlled trial. A total of 200 children with ADHD admitted to our hospital from January 2020 to January 2022 were selected as observation subjects by prospective cohort study, and were divided into two groups according to the random number table method. The control group was given oral administration of atomoxetine hydrochloride capsules, and the observation group was given self-made Qingxin Buqi Pinggan Decoction on the basis of the control group. Both groups were treated continuously for 3 months. Before and after treatment, the Traditional Chinese Medicine symptoms were scored, and the core symptoms of the children were evaluated by Swanson Nolan and Pelham-versionⅣ (SNAP-Ⅳ), and the hyperactivity tendency was assessed by Parent Symptom Questionnaire (PSQ). The serum cortisol (COR) and adrenocorticotropic hormone (ACTH) levels were measured by chemiluminescence immunoassay. Adverse reactions during treatment were observed and clinical efficacy was evaluated.Results:The total effective rate was 97.0% (97/100) in observation group and 88.0% (88/100) in control group ( χ2=5.84, P=0.016). After treatment, the scores of restlessness, hyperactivity, unsteadiness, emaciation, lusterless complexion and restless sleep in the observation group were significantly lower than those in the control group ( t=17.90, 11.79, 10.01, 23.27, 11.79, 12.03, P<0.01). The scores of impulsivity factor, learning factor, hyperactivity factor, behavior factor, psychosomatic factor and anxiety factor were significantly lower than those in the control group ( t=4.65, 42.83, 10.01, 41.89, 39.42, 18.30, P<0.01). The scores of attention deficit, hyperactivity-impulsivity and behavior performance were significantly lower than those in the control group ( t=11.68, 9.69, 28.42, P<0.01). After treatment, the levels of serum COR [(337.26±17.22) nmol/L vs. (275.51±15.49) nmol/L, t=26.66] and ACTH [(24.47±1.12) ng/L vs. (19.23±1.43) ng/L, t=28.85] were significantly higher in observation group than those in the control group ( P<0.01). During treatment, the incidence rate of adverse reactions was 6.0% in observation group and 5.0% in control group ( χ2=0.10, P=0.756). Conclusion:Modified self-made Qingxin Buqi Pinggan Decoction combined with atomoxetine hydrochloride can improve the clinical symptoms of children with ADHD, reduce the degree of hyperactivity disorder, increase the levels of serum COR and ACTH, and enhance the clinical efficacy.