Impact of self-designed Ningxin Anshen Decoction on the resting-state network functional connectivity in patients with mild to moderate generalized anxiety disorders: a Clinical Trial (Preprint)

BACKGROUND Generalized anxiety disorder (GAD) is a persistent chronic excessive anxiety that is hard to control. Our previous study indicated that self-designed Ningxin Anshen Formula (NXAS) was effective to improve the symptoms and Hamilton anxiety scale (HAMA) of mild to moderate GAD patients. OBJECTIVE This study aimed to investigate the imapct of self-designed NXAS on the resting-state functional connectivity (RSFC) in patients with mild to moderate GAD and explore the potential mechanisms. METHODS A total of 61 patients diagnosed with mild to moderate GAD were recruited and divided into two groups: NXAS group (n=31) and placebo group (n=30). Before and after treatment, the RSFC was examined by resting-state functional MRI (rs-fMRI), the anxiety was assessed with HAMA, and the independent component analysis (ICA) was used to analyze the resting-state functional connectivity (RSFC). The correlation between HAMA score and abnormal RSFC was further evaluated. RESULTS The default mode network (DMN) showed evident RSFC interaction in the PCUN in both groups before and after therapy. The salience network (SN) showed obvious RSFC interaction in the bilateral gyrus frontalis inferiors and bilateral gyri temporalis superiors before and after therapy. In the NXAS group, the RSFC interction reduced significantly in the left gyrus frontalis inferior, but remained unchanged in the right gyrus frontalis inferior and bilateral gyri temporalis superiors after therapy. In the control group, the RSFC interaction increased dramatically after treatment. In addition, the abnormal RSFC had no relationship with HAMA score. CONCLUSIONS The self-designed NXAS can increase the RSFC in the PUCN on DMN and reduce RSFC in the orbIFG.L on SN to exert anti-anxiety effect. CLINICALTRIAL The study was registered on the Clinical Trials (NO. ChiCTR-OCC-12002329).