ABSTRACT
BACKGROUND: Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics plus placebo. METHODS: This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT in patients with moderate to severe diverticulitis treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be success in treating diverticulitis: the success rate will be defined as elimination of abdominal pain within 4 days in all patients, and in patients with fever (body temperature ⧠37.5 °C) on inclusion into this study, fever relief with reduction in body temperature to < 37.5 °C within 3 days. Secondary endpoints will include the number of hospitalization days, changes in inflammatory response (C-reactive protein (CRP), white blood cell (WBC) and neutrophil counts), fever type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration. DISCUSSION: This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence on the efficacy and safety of DBT in the recurrence of acute diverticulitis. TRIAL REGISTRATION: UMIN-CTR: UMIN000027381. Registered on 27 April 2017. https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377, and changed to jRCTs041180063, registered on 30 July 2019; as a result of the revision of the domestic law in 2018 in Japan.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Diverticulitis/drug therapy , Drugs, Chinese Herbal/therapeutic use , Acute Disease , Double-Blind Method , Drug Therapy, Combination , Humans , Japan , Medicine, Kampo , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
Objective: To establish the pancreatic carcinoma models of rats with dimethybenzanthracene (DMBA)embedding method,to discuss the treatment effect of Da Huang Mu Dan Tang (DHMDT)in the rats with pancreatic carcinoma and the protective effects on the liver and kidney function,and to clarify the mechanisms. Methods:Sixty-five SD male rats were divided into blank control (n=10)and modeling group (n=55).DMBA was embedded in the capsule of pancreas to establish the pancreatic carcinoma models of rats. After 3 months, 50 successfully modeling rats were randomly divided into model,5-FU (intravennous injection,12 mg· kg-1 ), low,middle and high doses of DHMDT (intragastric administration,20,40 and 80 mg· kg-1 )groups.After 10 weeks of administration,the levels of alanine aminotransferase (ALT),aspartate transaminase (AST),urea nitrogen (BUN),creatinine (Cr)and total bilirubin (TBiL)in serum of the rats in various groups were measured;the weights and the inhibitory rates of the pancreatic tumor were detected;TUNEL method was used to analyze the apoptotic rates of tumor tissue;the expression levels of SST2R,Bax and Bcl-2 genes in pancreatic tumor tissue of the rats were detected by Q-PCR method.Results:Compared with model group,after treated for 10 weeks,the levels of ALT,AST,BUN,Cr and TBiL in serum of the rats in low,middle and high doses of DHMDT groups were significantly decreased (P <0.05 or P <0.01);the weights of tumor of the rats in middle and high doses of DHMDT groups were decreased (P <0.05 or P <0.01);the apoptotic rates of the cells in pancreatic tumor tissue of the rats in low,middle and high doses of DHMDT groups were increased (P <0.05 or P <0.01);the expression levels of SST2R gene in pancreatic tumor tissue of the rats in low,middle and high doses of DHMDT groups were significantly increased (P <0.05 or P <0.01);the expression levels of Bax gene in pancreatic tumor tissue of the rats in middle and high doses of DHMDT groups were significantly increased (P < 0.05 or P < 0.01),while the expression levels of Bcl-2 in pancreatic tumor tissue of the rats were significantly decreased (P < 0.05 ). Conclusion:DHMDT has the treatment effect in the rats with pancreatic carcinoma and can promote the apoptosis of tumor cells;DHMDT can protect the liver and kidney function of the rats with pancreatic carcinoma.
ABSTRACT
Objective To study the effect of Dahuang-Mudan decoctionby retention enemafor the thepatients with acute pelvic inflammation disease (APID) and toxic heat flourishing type. Methods Ninety patients with APID (toxic heat flourishing type) were randomly divided into treatment group and control group (45 case per group). The patients in both groups were given cefamandolenafate injection and tinidazole injection;and the Dahuang-Mudan decoction by retention enema was added to the treatment group.The C-reactive protein (CRP), tumor necrosis factor-α(TNF-α), interleukin-6 (IL-6) and clinical symptoms scores in both groups before treatment and after 2 weeks of treatment were observed. Results After treatment, CRP (3.16 ± 1.25 mg/L vs. 8.68 ± 1.45 mg/L, t=19.126), TNF-α(4.02 ± 1.06 ng/L vs. 9.64 ± 2.08 ng/L, t=15.966), IL-6 (60.34 ± 14.35 ng/L vs. 88.24 ± 12.16 ng/L, t=9.839), temperature recovery time (3.22 ± 1.13 d vs. 4.73 ± 1.36 d, t=5.638), abdominal pain disappeared time (5.26 ± 1.43 d vs. 7.45 ± 1.32 d, t=7.418), leukocyte recovery time (7.34 ± 2.06 d vs. 9.58 ± 2.26 d, t=4.834), hospital stay time (10.24 ± 3.42 d vs. 13.43 ± 4.38 d, t=3.791) in the treatment group were significantly lower than those in the control group (P<0.01). The clinical effect rate (77.27% vs. 48.84%, χ2=7.562) in the treatment group were significantly higher than that in the control group (P<0.01). Conclusions The treatment of APID (toxic heat flourishing type) with Dahuang-Mudan decoction by retention enema can reduce the inflammatory response of pelvic, promote the absorption of exudate and adhesion in pelvic.
