摘要Objective:Fibromyalgia syndrome(FMS)is a chronic pain condition characterized by central sensitivity to pain,and it is universally ac-knowledged as a recalcitrant disease.A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome,aiming to provide more scientific and effective treatment options.Methods:Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group(n=24)or the pla-cebo group(n=24).The Roujin formula group received 150mLofthe Roujin formula twice daily,whereas the placebo group was given a tenth of the Roujin formula dosage,twice daily.The treatment lasted for 8 weeks,with a follow-up extending to 12 weeks.The primary outcome was the improvement in the pain Visual Analogue Scale(VAS)score,whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index(PSQI),Beck Depression Inventory-Ⅱ(BDI-Ⅱ),Revised Fibromyalgia Impact Questionnaire(FIQR),and 36-item Short-Form Health Survey(SF-36)scores.These measures were assessed at baseline and after 4,8,and 12 weeks.The Pa-tients' Global Impression of Change(PGIC)was collected at week 12.Safety assessments were based on routine blood tests,urine tests,and liver and kidney function evaluations.Results:The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-,8-,and 12-week follow-ups(p＜0.05).At the 8-week treatment and the 12-week follow-up,improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group(p＜0.05).There were no differences between the 2 groups in the improvement of BDI-Ⅱ scores,SF-36 physical component summary,and mental component summary scores at any observation time points.At the 12-week follow-up,PGIC ratings were significantly better in the Roujin formula group(p＜0.05).There were 4 adverse events,all of which occurred in the Roujin formula group,including 3 cases of diarrhea and 1 case of stomach pain;no serious adverse events were reported during the study.Conclusion:The Roujin formula can effectively enhance the overall condition of FMS patients,relieve pain,improve sleep quality,and elevate physical and mental well-being.Only mild gastrointestinal reactions were observed.The Roujin formula may be a viable candi-date for clinical implementation.