Clinical Investigation of Wendan Decoction and Dingxiang Shidi Decoction in Preventing Nausea and Vomiting Following Cisplatin-based Chemotherapy
Author(s): ZHAI Linzhu, CAO Yang, ZHAO Yuanyuan, CHEN Changming, LIN Lizhu, Dept. of Neoplasma, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Dept. of Medical Oncology, Cancer Center of Sun Yat-sen University
Pages: 343-347
Year: 2014 Issue: 3
Journal: Journal of Guangzhou University of Traditional Chinese Medicine
Keyword: Tumor / chemotherapy; Nausea and vomiting / TCD therapy; Wendan Decoction / therapeutic use; Dingxiang Shidi Decoction / therapeutic use;
Abstract: Objective To investigate the clinical efficacy and safety of Wendan Decoction and Dingxiang Shidi Decoction in preventing gastrointestinal reactions such as nausea and vomiting following cisplatin-based chemotherapy in patients with malignant tumors. Methods Self-controlled study was adopted for the study. Thirty patients were enrolled into the study and received two consecutive cycles of cisplatin-containing chemotherapy. The antiemetic treatment of the first chemotherapy cycle(named as Chinese medicine group) consisted of western medicine antiemetic therapy combined with Wendan Decoction and Dingxiang Shidi Decoction, and the antiemetic treatment of the second chemotherapy cycle(named as control group) included western medicine antiemetic therapy alone. Western medicine antiemetic therapy involved tropisetron and dexamethasone given in acute phase(day 1-3), and dexamethasone given in delayed phase(day 4-6). By self-control method, we compared complete remission(CR) rate, complete control(CC) rate, time to failure(TTF), severity of nausea and vomiting, and medication safety between two groups in the acute phase and delayed phase. Results( 1) In the acute phase, CR rate was 66.7% and CC rate was 60.0% in Chinese medicine group, and was 60.0% and 46.7% in the control group, the differences between the two groups were insignificant(P >0.05). In the delayed phase, CR rate was 83.3% and CC rate was 76.7% in Chinese medicine group, and was 56.7% and 50.0% in the control group, the differences between the two groups were significant(P<0.05). During chemotherapy(including both acute phase and delayed phase), CC rate in Chinese medicine group was higher than that of the control group(56.7% vs 30.0%, P < 0.05).(2) Eleven failure events occurred in Chinese medicine group, and the average TTF was 2.5 ± 0.28 days. In the control group, 13 failure events occurred and the average TTF was 1.8 ± 0.30 days. There was significant difference of TTF between the two groups(P < 0.05).(3) No statistically significant difference was found between the two groups in the severity of vomiting in acute phase( P>0.05), but vomiting in delayed phase of Chinese medicine group was significantly milder than that of the control group(P<0.01).(4) The vital signs, urine and stool routine, liver and kidney function and electrocar diogram in Chinese medicine group remained steady before and after treatment. No adverse effect occurred during the observation.Conclusion With satisfactory safety in clinical use, Wendan Decoction and Dingxiang Shidi Decoction can improve the efficacy of modern antiemetic therapy in cisplatin-based chemotherapy, especially in the delayed phase. It is valuable for further clinical verification and promotion of the prescriptions.
Pages: 343-347
Year: 2014 Issue: 3
Journal: Journal of Guangzhou University of Traditional Chinese Medicine
Keyword: Tumor / chemotherapy; Nausea and vomiting / TCD therapy; Wendan Decoction / therapeutic use; Dingxiang Shidi Decoction / therapeutic use;
Abstract: Objective To investigate the clinical efficacy and safety of Wendan Decoction and Dingxiang Shidi Decoction in preventing gastrointestinal reactions such as nausea and vomiting following cisplatin-based chemotherapy in patients with malignant tumors. Methods Self-controlled study was adopted for the study. Thirty patients were enrolled into the study and received two consecutive cycles of cisplatin-containing chemotherapy. The antiemetic treatment of the first chemotherapy cycle(named as Chinese medicine group) consisted of western medicine antiemetic therapy combined with Wendan Decoction and Dingxiang Shidi Decoction, and the antiemetic treatment of the second chemotherapy cycle(named as control group) included western medicine antiemetic therapy alone. Western medicine antiemetic therapy involved tropisetron and dexamethasone given in acute phase(day 1-3), and dexamethasone given in delayed phase(day 4-6). By self-control method, we compared complete remission(CR) rate, complete control(CC) rate, time to failure(TTF), severity of nausea and vomiting, and medication safety between two groups in the acute phase and delayed phase. Results( 1) In the acute phase, CR rate was 66.7% and CC rate was 60.0% in Chinese medicine group, and was 60.0% and 46.7% in the control group, the differences between the two groups were insignificant(P >0.05). In the delayed phase, CR rate was 83.3% and CC rate was 76.7% in Chinese medicine group, and was 56.7% and 50.0% in the control group, the differences between the two groups were significant(P<0.05). During chemotherapy(including both acute phase and delayed phase), CC rate in Chinese medicine group was higher than that of the control group(56.7% vs 30.0%, P < 0.05).(2) Eleven failure events occurred in Chinese medicine group, and the average TTF was 2.5 ± 0.28 days. In the control group, 13 failure events occurred and the average TTF was 1.8 ± 0.30 days. There was significant difference of TTF between the two groups(P < 0.05).(3) No statistically significant difference was found between the two groups in the severity of vomiting in acute phase( P>0.05), but vomiting in delayed phase of Chinese medicine group was significantly milder than that of the control group(P<0.01).(4) The vital signs, urine and stool routine, liver and kidney function and electrocar diogram in Chinese medicine group remained steady before and after treatment. No adverse effect occurred during the observation.Conclusion With satisfactory safety in clinical use, Wendan Decoction and Dingxiang Shidi Decoction can improve the efficacy of modern antiemetic therapy in cisplatin-based chemotherapy, especially in the delayed phase. It is valuable for further clinical verification and promotion of the prescriptions.
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