Construction of the "Spleen-Kidney Deficiency" symptom scale for postmenopausal female and the effect of Lingxian Powder on bone metabolism: A randomised trial

“Spleen-Kidney Deficiency” (A Traditional Chinese Medicine Syndrome in Postmenopausal Osteoporosis) lacks a standard evaluation scale. Lingxian Powder has been clinically proved to significantly improve the symptoms of spleen and kidney deficiency. This study aimed to construct a Patient-Reported Outcome (PRO) scale for the "Spleen-Kidney Deficiency" syndrome in Postmenopausal Female and observe the effects of Lingxian Powder on this syndrome, bone metabolism, sex hormones, and cytokines. A total of 2,387 literatures related to "Spleen-Kidney Deficiency" were retrieved from Chinese and English databases. After screening and standardization, an initial pool of 52 symptom items was formed, and three versions of the scale were developed sequentially, and 25 items were finally determined as the scale evaluation items. The reliability and validity of the scale were verified using Cronbach's α coefficient, KMO test, and Bartlett's test of sphericity. Meanwhile, 69 Postmenopausal Female (Follow-up missing for 9 participants) diagnosed with "Spleen-Kidney Deficiency" and abnormal bone mass were randomly divided into a control group (calcium & vitamin D supplementation) and an observation group (additional Lingxian Powder). After 4 weeks of intervention, syndrome scores, bone metabolism markers, sex hormones, and cytokine levels were compared between the two groups. Ethical approval was obtained from the Second Affiliated Hospital of Zhejiang Chinese Medical University on October 21, 2023 (Approval No.: 2024-KY-FS-0010). This study has been clinically registered on the International Traditional Medicine Clinical Trial Registry (ITMCTR) ( https://itmctr.ccebtcm.org.cn/mgt/project/user/user-project-view/5888B718-4038-490B-B86E-7B503AACFC97 ), with the registration number: ITMCTR2025001726, registered on July 11, 2025. The Consensus Version of the scale showed good reliability (Cronbach's α = 0.763) and valid validity (KMO = 0.560, Bartlett's test of sphericity P < 0.001). The total effective rate of improving "Spleen-Kidney Deficiency" syndrome in the observation group (93.33%) was significantly higher than that in the control group (36.67%, P < 0.001). After treatment, the observation group exhibited increased levels of bone formation markers (PINP, BALP, P < 0.05), sex hormone E2 ( P < 0.001), and anti-inflammatory cytokines (TGF-β, IFN-γ, P < 0.001), along with decreased levels of bone resorption markers (β-CTX, TRACP, RANKL, P < 0.001), pro-inflammatory cytokines (IL-17A, TNF-α, P < 0.01), and FSH ( P < 0.01). The constructed "Spleen-Kidney Deficiency" PRO scale is applicable for syndrome assessment in Postmenopausal Female. Lingxian Powder can effectively improve this syndrome and regulate bone metabolism, sex hormones, and immune-inflammatory status.