A randomized, double-blind, placebo-controlled, multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia

We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia (CRA) presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.

A randomized, double-blind, placebo-controlled, multicenter clinical trial was conducted. Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals, including Dongzhimen Hospital, Beijing University of Chinese Medicine, Xiaogan Central Hospital, and Yangzhou Hospital of Traditional Chinese Medicine, from June 1, 2022, to September 30, 2024. Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator (placebo) using a block randomization method under double-blind conditions. Both groups received 15 mL orally three times daily for 28 consecutive days. The primary efficacy indicators included the hemoglobin (Hb) improvement rate (R_Hb) and the traditional Chinese medicine (TCM) syndrome improvement rate (R_TCM) at week 4 of treatment. The secondary efficacy indicators encompassed Hb and red blood cell (RBC) count, Karnofsky Performance Status (KPS) score, TCM syndrome score, individual TCM symptom scores, and changes in each of these indicators compared to the baseline period at weeks 2, 4, and 6 of treatment. Safety evaluations were conducted at week 4 of treatment.

A total of 239 patients were enrolled, with 225 cases included in the Full Analysis Set (FAS) (109 in the experimental group vs. 116 control group), 163 in the Per Protocol Set (PPS) (77 vs. 86), and 225 in the Safety Set (SS) (109 vs. 116). Baseline characteristics between groups showed no significant differences. Significant differences were observed between the experimental and control groups in R_Hb at week 4 (FAS: 49.51% vs. 35.24%, P < 0.05; PPS: 53.25% vs. 36.05%, P < 0.05) and R_TCM at week 4 (FAS: 61.54% vs. 39.62%, P < 0.01; PPS: 64.94% vs. 40.70%, P < 0.01). At weeks 2, 4, and 6, the experimental group showed greater improvements in Hb and RBC counts than the control group. Additionally, the TCM syndrome scores were lower in the experimental group than in the control group at these time points. Except for week 2 in PPS, the KPS improvement was better in the experimental group than in the control group (P < 0.05). The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness, poor appetite and reduced food intake at weeks 4 and 6 compared to the control group (P < 0.05, P < 0.01). Furthermore, the reduction in vertigo score was more pronounced in the experimental group at week 6 (P < 0.01). For the score of pale and lusterless complexion, only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6 (P < 0.05). No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.

Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood, effectively increasing Hb levels, ameliorating TCM syndromes, alleviating clinical symptoms, and enhancing functional status, with no significant difference in adverse drug reactions compared to the placebo.