N-of-1 Trial of Jianpiqingrehuashi Granular Decoction with Mesalamine in the Treatment of Ulcerative Colitis in Remission with Spleen Deficiency-induced Damp-heat Syndrome

BackgroundThe patient with ulcerative colitis (UC) in remission has a long course of disease, and needs a long-term maintenance treatment. Traditional Chinese medicine (TCM) has proved to be partially effective in treating UC in remission, but the efficacy of Jianpiqingrehuashi granular decoction (JPQRHSGD) against UC in remission is not yet clear.ObjectiveTo evaluate the efficacy and safety of JPQRHSGD with mesalamine versus mesalamine in the treatment of UC in remission using an N-of-1 trial.MethodsAn N-of-1 trial was conducted between June 2020 and March 2021. Participant was an outpatient with UC in remission with spleen deficiency-induced dampness-heat syndrome who was selected from the First Affiliated Hospital, Guangzhou University of Chinese Medicine. The patient received a treatment program, namely four rounds of treatment without washout consisting of eight cycles〔each round includes two cycles, that was, one-month intervention treatment (use of JPQRHSGD with mesalamine) alternating with one-month control treatment (taking mesalamine only) 〕. Efficaciesof two types of treatment were evaluated by of the TCM Syndrome Score (TCMSS) , Bristol Stool Form Scale (BSFS) , visual analogue scale (VAS) for abdominal pain and diarrhea, and Short Health Scale (SHS) . Safety was also compared between the two treatments.ResultsThe total TCMSS in intervention period was significantly lower than that in control period (P