Pengfei Tian, Zonglin Chen, Xin Yu, Biaojie Fang, Zhengjian Chen, Kexun Yu, Mingdian Lu
This case series describes heterogeneous clinical trajectories after individualised integrative management including TCM in selected biologic-refractory, surgery-intended ASUC patients. The small non-randomised cohorts, major baseline imbalance, concomitant treatment, surgical heterogeneity, and imprecise effect estimates preclude efficacy or causal inference. The observations should be considered descriptive and hypothesis-generating.
OBJECTIVE: Acute severe ulcerative colitis (ASUC) is a life-threatening condition, and biologic-refractory patients may ultimately require surgery. The clinical role of individualised integrative management including traditional Chinese medicine (TCM) in surgery-intended ASUC remains uncertain.
METHODS: This single-centre retrospective exploratory case series included 39 biologic-refractory, surgery-intended ASUC patients treated between January 2020 and June 2025. Eleven accepted adjunctive preoperative TCM and 28 did not. Five selected TCM-treated patients experienced remission after integrative management including TCM and surgery was cancelled; 6 underwent surgery and were compared descriptively with 28 non-TCM surgical patients. Baseline imbalance was summarised using absolute standardised mean differences (SMDs). Continuous postoperative outcomes were reported as Hodges-Lehmann location shifts with 95% confidence intervals (CIs), and binary outcomes as risk differences with Newcombe-Wilson 95% CIs. Clinically relevant postoperative outcomes were prioritised, whilst postoperative day (POD) 1 white blood cell count (WBC) and POD3 C-reactive protein (CRP) were retained as exploratory inflammatory markers.
RESULTS: Important baseline imbalances were present in the surgical comparison cohort, including surgical scope, urinalysis, haemoglobin, haematocrit, albumin, platelet count, baseline WBC, and CRP. Thirty-day postoperative complications occurred in 10/28 (35.7%) non-TCM patients and 1/6 (16.7%) TCM surgical patients (risk difference -19.0 percentage points, 95% CI -42.0 to 23.4). The Hodges-Lehmann location shift was -4.00 days (95% CI -11.00 to 3.00) for length of stay, -3.17 mg/L (95% CI -6.15 to 0.48) for POD3 CRP, and -2.59 ×109/L (95% CI -6.98 to 0.76) for POD1 WBC. No 95% CI excluded the null value. In the five selected remission cases, pre-treatment Mayo endoscopic subscore (MES) was 3 and post-treatment MES was 0 or 1; surgery was cancelled, four patients subsequently received infliximab maintenance therapy, and no subsequent surgery was recorded during 27-48 months of available follow-up.
CONCLUSIONS: This case series describes heterogeneous clinical trajectories after individualised integrative management including TCM in selected biologic-refractory, surgery-intended ASUC patients. The small non-randomised cohorts, major baseline imbalance, concomitant treatment, surgical heterogeneity, and imprecise effect estimates preclude efficacy or causal inference. The observations should be considered descriptive and hypothesis-generating.