Clinical Study To Explore The Efficacy Of Combination Therapy Of Gu Chang Zhi Xie Pill And Loperamide In Treating Irinotecan-induced Delayed-onset Diarrhea After Chemotherapy

Context: Irinotecan(Irinotecan, CPT-11) is widely used nowadays. However, the irinotecan-induced delayed-onset diarrhea is considered as a common side effect, which hinders the clinical application of irinotecan.Based on traditional Chinese medicine theory �use coldness and heat jointly, relieve diarrhea with astringents�,along with loperamide, Gu Chang Zhi Xie Pill, a Chinese herb anti-diarrheal medicine which can stop diarrhea by strengthening intestinal functions, is also used to mitigate this side effect. Now we combine these two medicines as a combination therapy, and use them in chemotherapy coordinating with irinotecan. We want to explore the efficacy of both the combination therapy and independent use of loperamide in treating and preventing irinotecan-induced delayed-onset diarrhea.Methods: We designed a randomized clinical trial. We recruited 60 qualified cancer patients who had heterozygote or wild type gene based on the UGA1A1*28 genotype test. These patients also had diarrhea after using irinotecan in chemotherapy. Then we randomly assigned them to treatment group and control group. Control group received general treatment(only use loperamide when diarrhea happened) while treatment group received combination therapy when diarrhea happened. Patients in both groups received two chemotherapy cycles clinical intervention in addition to treatment of underlying diseases. Then their diarrhea level, symptom improvement, life quality assessment and toxicity reaction were recorded.Results: Compared with using loperamide independently, patients who received the combination therapy lay in milder stage of diarrhea level. Overall, they had significantly reduced defecation frequency, mitigated abdominal pain, improved stool status, steady increasing body weight and increased life quality. However, there was no statistical significance between two groups when comparing the improvement of fecal occult blood status. Neither group had significant evidence to prove potential damage to liver and kidney functions.Conclusions: For cancer patients who had heterozygote or wild type gene based on the UGA1A1*28 genotype test, our combination therapy of Gu Chang Zhi Xie Pill and loperamide can effectively treat and prevent irinotecan-induced delayed-onset diarrhea after chemotherapy. It can help mitigate symptoms of diarrhea. This combination therapy can be seen as one of the effective integrated Chinese medicine and western medicine therapies in treating chemotherapy-related diarrhea.