Traditional Chinese Medicine treatment with syndrome differentiation for patients with severe community-acquired pneumonia: a multicenter, randomized, placebo-controlled trial.

OBJECTIVE: To assess the effect of Traditional Chinese Medicine (TCM) treatment with syndrome differentiation in patients with severe community-acquired pneumonia (CAP). METHODS: A multicenter, randomized, placebo-controlled trial was conducted. Adult patients with severe CAP were randomly allocated to receive conventional medicine treatment (conventional group) or conventional medicine combine with TCM treatment with syndrome differentiation (combination group) underwent a 28-d treatment time. The primary endpoint was treatment failure. Secondary outcomes included time to clinical stability, 28-d mortality, 90-d mortality, length of hospital stay. RESULTS: A total of 183 patients were included in the intention-to-treat (ITT) population, with 91 allocated to the combination group and 92 to the conventional group. Patients with treatment failure in the combination group (18/91, 19.8%) were lower compared with the conventional group (34/92, 37.0%). Time to clinical stability was shorter in the combination group (11.8 d) than in the conventional group [17.8 d; HR = 2.08, 95% CI (1.38, 3.14); P = 0.001]. The 28-d mortality was lower in the combination group (17.6%) than in the conventional group (31.5%). There was no difference in the length of hospital stay between the two groups (P = 0.901). Adverse events were evenly distributed between the combination and conventional groups (P = 0.837). CONCLUSION: Among patients with severe CAP, TCM treatment with syndrome differentiation reduced treatment failure, time to clinical stability, and the 28-d mortality and the 90-d mortality among patients admitted to the ward, without an increase in complications.