Clinical outcomes following a traditional Chinese medicine foot bath preparation for lower-limb edema and sleep disturbance: a single-center retrospective study of 2,000 patients.

Objective: To evaluate clinical outcomes and documented adverse events following treatment with a traditional Chinese medicine (TCM) foot bath preparation in patients with lower-limb edema and sleep disturbance. Methods: This single-center retrospective observational study included 2,000 patients treated at Lanzhou Second People's Hospital between May 2017 and May 2022. All patients had varying degrees of lower-limb edema, peripheral circulatory dysfunction, and sleep disturbance. Patients received a standardized TCM foot bath preparation consisting of stir-fried peach kernel (10 g), bush cherry seed (15 g), Chinese angelica root (10 g), and safflower (10 g). The preparation was administered once daily for 20 sessions, comprising two consecutive 10-day treatment courses. Clinical outcomes were assessed by comparing ankle circumference, ABI, and PSQI values before and after treatment. Results: Using the routine record-based classification, 1,120 patients (56.0%) were classified as "markedly effective," 770 (38.5%) as "effective," and 110 (5.5%) as "ineffective." The combined proportion was 94.5%; however, this classification is not internationally validated and is reported descriptively rather than as evidence of effectiveness. After treatment, ankle circumference and PSQI scores were significantly lower than baseline values (both P < 0.01), whereas ABI values were significantly higher (P < 0.05). Mild local adverse reactions, including transient redness and dryness, were observed in a small proportion of patients. Conclusion: In this single-center retrospective observational study, post-treatment changes were observed in lower-limb edema, peripheral circulation, and sleep quality.