A Chinese herbal medicine (Xilei-san) for mild/moderate ulcerative proctitis

INTERVENTION: Dexamethasone was formulated as 5 mg/60 ml and Xilei‐San as 1000 mg/60 ml (Beijing Tong Ren Tang Ltd., Co., Beijing, China). Patients were instructed to take the formulation as enema once a day for 4 weeks and monitored the usage of drug and the compliance of patients by weekly clinic visit. Only those patients attaining clinical response were recruited in the second stage treatment. In the second stage treatment, dexamethasone was formulated as 2 mg/60 ml. Patients in group I were received rectal preparation once a day for 2 weeks, followed by once every 2 days for 1 week, and once every 3 days for 1 week, then discontinue the dexamethasone therapy for 12 weeks. Patients in group II were received the same dosage of rectal Xilei‐San preparation once a day for 4 weeks, then discontinued the Xilei‐San therapy for 12 weeks. All patients were assigned to be administered oral mesalazine 1000 mg (Etiasa, Ferring, Ipsen, Germany) 3 times a day as the foundation treatment and not allowed to use other medicine during the whole trial. Patients were enrolled consecutively following a medical evaluation of the initial clinical and endoscopic severity of the condition using full colonoscopy. They were evaluated at inclusion, and at week 4, 8 and 20. Colonoscopy was done by the same gastroenterologist and all biopsy specimens were studied by the same experienced pathologist. Clinical severity of the disease was determined according to the refined criteria of Marteau considering the major clinical manifestations of mild to moderate UP was rectal bleeding, but not obvious systemic symptoms. Remission was defined as a score = 0, and last 3 times fecal occult blood test was negative within the last 1 week. Improvement was defined as a decrease in the score by 2 points from baseline. Partial improvement was defined as a decrease in the score by 2 points from baseline and sum score > 2 points. Non‐improvement was defined as a decrease in the score by < 2 points from baseline or a CONDITION: Mild or moderate ulcerative proctitis ; Digestive System ; Ulcerative (chronic) proctitis PRIMARY OUTCOME: Clinical remission rate at week 4 SECONDARY OUTCOME: 1. Clinical and endoscopic remission rates at week 8; 2. Clinical relapse rates at week 20; 3. Adverse events were assessed at week 4, 8 and 20 INCLUSION CRITERIA: Patients between the ages of 18 and 80 years were eligible to participate if they had previously established UP with mild to moderate exacerbation at least 7 days