Objective,2,To observe the clinical effect of modified Shaoyao Gancao Decoction combined with pregabalin on patients with fibromyalgia syndrome (FMS) of liver depression and spleen deficiency syndrome.,Methods,2,Sixty-four patients with FMS of liver depression and spleen deficiency syndrome were randomly divided into treatment group (,n,=32) and control group (,n,=32). The control group was administered with pregabalin, while the treatment group was administered with Shaoyao Gancao Decoction besides pregabalin. The course of treatment in both groups was 1 month. The clinical effect and incidence of adverse reactions were observed, and the changes of scores of visual analogue scale (VAS), TCM syndrome, Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Index (PSQI) and the 36-item Short Form (SF-36) Health Survey were compared.,Results,2,①The total effective rates of the treatment group and the control group were 96.88% and 75.00%, respectively, and the clinical effect of the treatment group was better than that of the control group (,P,<,0.05). ②The VAS scores, TCM syndrome scores, FIQ scores and PSQI total scores of both groups decreased after treatment (,P,<,0.05) and the VAS scores, TCM syndrome scores, FIQ scores and PSQI total scores in the treatment group were lower than those in the control group (,P,<,0.05). ③The scores of each item in SF-36 Health Survey in the treatment group increased after treatment (,P,<,0.05), while in the control group only the scores of physiological function, somatic pain and psychological health items increased (,P,<,0.05); There were significant differences in the scores of each item in SF-36 Health Survey between the groups after treatment (,P,<,0.05). ④The incidence of adverse reactions in the treatment group and the control group were 15.63% and 12.50% respectively, with no significant difference between the groups (,P,>,0.05).,Conclusion,2,Modified Shaoyao Gancao Decoction and pregabalin have synergistic effects, Thus the combined use has satisfactory therapeutic effect on patients with FMS of liver depression and spleen deficiency syndrome by better relieving clinical symptoms such as pain, and improving sleep and quality of life of patients with good safety.