Article: Safety and efficacy of Qingre Buyi Decoction in the treatment of acute radiation proctitis: a prospective, randomized and controlled trial

Objective: To investigate the efficiency, safety, and possible mechanisms of Qingre Buyi Decoction (QBD) in the treatment of acute radiation proctitis (ARP).

Methods: This study was a single center, prospective, single blind, randomized, and placebo-controlled clinical trial. A total of 60 patients with ARP was equally and randomly distributed into the control group (conventional treatment) and the combination group (conventional treatment plus QBD). The changes of main Chinese medicine clinical symptoms and signs, including stomachache, diarrhea, mucous or bloody stool before and after treatment, and their adverse reactions were observed after the two-week treatment. Also, D-lactate and diamine oxidase (DAO) levels, hepatic and renal function were measured. Cure rates, effective rates, and recurrence rates were compared between the two groups.

Results: The blood levels of both DAO and D-lactate were significantly decreased in the combination group as compared with those in the control group (P<0.05 or P<0.01). All main clinical symptoms and signs were alleviated more significantly in the combination group (P<0.01). The main symptom scores also were significantly decreased after treatment in the control group (P<0.01), except those for mucous or bloody stool (P>0.05). Compared to the control group, the improvements of stomachache, diarrhea, defecation dysfunction, and stool blood in the combination group were significantly better (P<0.05 or P<0.01). For the combination group, the curative rate, effective rate, and recurrence rate was 76.67%, 16.67%, and 6.67%, respectively. On the other hand, for the control group, the rate was 53.33%, 16.67%, and 30.00%, respectively. The total curative effect was significantly better in the combination group than in the control group (P<0.05). However, the recurrence rate was similar between the two groups (P>0.05). The hepatic and renal function remained normal in both groups (P>0.05). In addition, no severe adverse event was found in both groups.

Conclusions: Addition of QBD to the conventional treatment can effectively alleviate the damage of intestinal mucosal barrier function and improve all main clinical symptoms and signs of the ARP. The combination of conventional treatment with Chinese herbal medicine QBD is effective and safe for ARP.

Citing Articles

Susceptibility to radiation adverse effects in veterans with Gulf War illness and healthy civilians.

Golomb B, Berg B, Han J Sci Rep. 2024; 14(1):874.

PMID: 38195674 PMC: 10776672. DOI: 10.1038/s41598-023-50083-7.

Administration of modified Gegen Qinlian decoction for hemorrhagic chronic radiation proctitis: A case report and review of literature.

Liu S, Hu L, Wang S, Liao Z World J Clin Cases. 2023; 11(5):1129-1136.

PMID: 36874424 PMC: 9979297. DOI: 10.12998/wjcc.v11.i5.1129.

Changrui enema inhibits inflammation-induced angiogenesis in acute radiation proctitis by regulating NF-κB and VEGF.

Gao J, Li Y, Yang X, Hu M, Xu J, Cheng L Acta Cir Bras. 2020; 35(5):e202000502.

PMID: 32638843 PMC: 7341993. DOI: 10.1590/s0102-865020200050000002.

Mesalazine suppository for the treatment of refractory ulcerative chronic radiation proctitis.

Wu C, Guan L, Yao L, Huang J Exp Ther Med. 2018; 16(3):2319-2324.

PMID: 30186474 PMC: 6122487. DOI: 10.3892/etm.2018.6464.

Parallel subgroup design of a randomized controlled clinical trial-comparing the approaches of Chinese medicine and Western medicine.

Fang J, Liu F, Hou Z Chin J Integr Med. 2010; 16(5):394-8.

PMID: 20872114 DOI: 10.1007/s11655-010-0534-9.

References

1.

Assadian A, Assadian O, Senekowitsch C, Rotter R, Bahrami S, FURST W . Plasma D-lactate as a potential early marker for colon ischaemia after open aortic reconstruction. Eur J Vasc Endovasc Surg. 2005; 31(5):470-4. DOI: 10.1016/j.ejvs.2005.10.031. View

2.

Ruan P, Gong Z, Zhang Q . Changes of plasma D(-)-lactate, diamine oxidase and endotoxin in patients with liver cirrhosis. Hepatobiliary Pancreat Dis Int. 2004; 3(1):58-61. View

3.

Vernia P, Fracasso P, Casale V, Villotti G, Marcheggiano A, Stigliano V . Topical butyrate for acute radiation proctitis: randomised, crossover trial. Lancet. 2000; 356(9237):1232-5. DOI: 10.1016/s0140-6736(00)02787-2. View

4.

Kneebone A, Mameghan H, Bolin T, Berry M, Turner S, Kearsley J . The effect of oral sucralfate on the acute proctitis associated with prostate radiotherapy: a double-blind, randomized trial. Int J Radiat Oncol Biol Phys. 2001; 51(3):628-35. DOI: 10.1016/s0360-3016(01)01660-1. View

5.

Sanguineti G, Franzone P, Marcenaro M, Foppiano F, Vitale V . Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study. Strahlenther Onkol. 2003; 179(7):464-70. DOI: 10.1007/s00066-003-1082-4. View

6.

Li J, Lu Y, Hu S, Sun D, Yao Y . Preventive effect of glutamine on intestinal barrier dysfunction induced by severe trauma. World J Gastroenterol. 2002; 8(1):168-71. PMC: 4656612. DOI: 10.3748/wjg.v8.i1.168. View

7.

Kamiya S, Nagino M, Kanazawa H, Komatsu S, Mayumi T, Takagi K . The value of bile replacement during external biliary drainage: an analysis of intestinal permeability, integrity, and microflora. Ann Surg. 2004; 239(4):510-7. PMC: 1356256. DOI: 10.1097/01.sla.0000118594.23874.89. View

8.

Hovdenak N, Sorbye H, Dahl O . Sucralfate does not ameliorate acute radiation proctitis: randomised study and meta-analysis. Clin Oncol (R Coll Radiol). 2005; 17(6):485-91. DOI: 10.1016/j.clon.2005.04.011. View

9.

Jahraus C, Bettenhausen D, Malik U, Sellitti M, St Clair W . Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. Int J Radiat Oncol Biol Phys. 2005; 63(5):1483-7. DOI: 10.1016/j.ijrobp.2005.04.032. View

10.

Korkut C, Asoglu O, Aksoy M, Kapran Y, Bilge H, Kiremit-Korkut N . Histopathological comparison of topical therapy modalities for acute radiation proctitis in an experimental rat model. World J Gastroenterol. 2006; 12(30):4879-83. PMC: 4087625. DOI: 10.3748/wjg.v12.i30.4879. View

Safety and Efficacy of Qingre Buyi Decoction in the Treatment of Acute Radiation Proctitis: a Prospective, Randomized and Controlled Trial