Randomized controlled multicenter clinical trial for integrated treatment of community-acquired pneumonia based on traditional Chinese medicine syndrome differentiation.

OBJECTIVE: To evaluate the efficacy and safety of treatment based on syndrome differentiation of Traditional Chinese Medicine (TCM) for community-acquired pneumonia (CAP). METHODS: A total of 240 CAP patients were randomly divided into the following two groups: the control group was treated by anti-infection plus conventional medicine treatment; and the trial group was treated by TCM plus the above-mentioned treatment given to the controls. The course of treatment was 14 days, and the patients were followed up for 7 days. RESULTS: Of the 240 patients, 235 accomplished the whole process of treatment. The five patients who withdrew from the study were brought into an intent-to-treat analysis. The therapeutic effects of the trial group were superior to those of the control group (P < 0.01). The trial group took less time to become clinically stable, with a higher score in the quality of life (P < 0.01). There were no significant differences in mortality rate (P > 0.05), white blood cell count (P > 0.05), bacterial clearance rate (P > 0.05), and adverse reactions between the two integrated groups. CONCLUSION: Treatment based on TCM syndrome differentiation for CAP has the advantages of resulting in less time to achieve a stable clinical condition, improvement of clinical symptoms and quality of life, and is comparatively safe.