Efficacy and safety of Yunxiangjing derived from Chinese herbal medicine administered as an enema in the management of acute radiation-induced proctitis in patients with pelvic malignancy.

OBJECTIVE

To assess the efficacy and safety of Yunxiangjing (YXJ), derived from Chinese herbal medicine, in the management of acute radiation-induced proctitis (ARIP) in patients with pelvic malignancy.

METHODS

Forty-eight patients with grade 2 ARIP were administered YXJ as an enema (1 : 30 dilution) for 2 weeks and followed up for 2 years. All were assessed for response and ARIP grade. Quality of life (QOL) was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.

RESULTS

Of the 48 patients, six (12.5%) achieved complete remission of ARIP and 28 (58.3%) showed a decrease from grade 2 to grade 1 ARIP. No patient experienced a grade ≥3 toxicity. At the end of radiotherapy, patients showed significant improvements in QOL (P < 0.05). Two years after treatment, 46 patients showed no late toxicity, with only two experiencing grade 1 late toxicity.

CONCLUSION

YXJ can be used as an enema to manage acute radiation-induced proctitis in cancer patients undergoing radiotherapy. These findings suggest that YXJ enema may be an alternative treatment of ARIP.