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Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial

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Abstract

Objective

To evaluate the impact of Jinlongshe Granule (金龙蛇颗粒, JLSG) on quality of life (QOL) of stage IV gastric cancer patients.

Methods

This randomized, double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer. They were equally randomized into a JLSG group and a placebo group. Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine (CM) treatment based on syndrome differentiation. Patients in JLSG group received additional JLSG, and those in the placebo group received an additional placebo. In the JLSG group, 19 patients who completed the study were used for analysis. In the placebo group, finally the data of 20 patients who completed the study were used for analysis. The treatment course was at least 3 months, and the follow-up duration was at least 6 months in 5 interviews. Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) obtained at the 5 interviews were compared using different patient groups, changes over time and changes within one group over time independently to observe the tendency of changes in the scores.

Results

Using time as the variant, there was signifificant difference in 4 functional scales (physical, role, emotional and social, P<0.05), 3 symptom scales (fatigue, nausea and vomiting and pain,P<0.05) and a global health status/QOL scale (P<0.05) and 6 single symptoms dyspnoea (P>0.05), insomnia (P<0.05), appetite loss (P<0.05), constipation (P<0.05), diarrhea (P>0.05) and financial difficulties (P<0.05). There was also signifificant difference in these items between the two groups when the placebo group and group over time were used as variants (P<0.05 or P<0.01).

Conclusion

Additional use of JLSG on the basis of routine CM treatment could improve the somatic function, role function, emotional function, social function, cognitive function and general QOL of patients with advanced gastric cancer, and relieve the symptoms of fatigue, nausea and vomiting, pain, loss of appetite and constipation.

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References

  1. Van Cutsem E. The treatment of advanced gastric cancer: new findings on the activity of taxanes. Oncologist 2004;9(suppl 2):9–15.

    Article  PubMed  Google Scholar 

  2. Velikova G, Weis J, Hjermstad MJ, Kopp M, Morris P, Watson M, et al. The EORTC QLQ-HDC29: a supplementary module assessing the quality of life during and after high-dose chemotherapy and stem cell transplantation. Eur J Cancer 2007;43:87–94.

    Article  CAS  PubMed  Google Scholar 

  3. Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, et al. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer 2005;41:1135–1139.

    Article  CAS  PubMed  Google Scholar 

  4. Kato J, Nagahara A, Iijima K, Yoshimura M, Osada T, Yoshizawa T, et al. Evaluation of EORTC QLQ-C30 questionnaire in patients undergoing in-hospital chemotherapy for gastrointestinal cancer in Japan. J Gastroenterol Hepatol 2008;23(Suppl 2):S268–S272.

    Article  PubMed  Google Scholar 

  5. Que HF, Chen HF, Xu JN, Liu S, Lu DM, Tang HJ. Discussion of relationship between quality of life and clinical effect assessment of malignant tumor treated with traditional Chinese medicine. J Chin Integr Med (Chin) 2005;3:253–256.

    Article  Google Scholar 

  6. Wei PK, Xu L, Sun DZ, Shi J, Qin ZF, Lu Y. Relation between phlegm and generation and development of Gastric Cancer. J Tradit Chin Med 2008;28:152–155.

    Article  PubMed  Google Scholar 

  7. Vickery CW, Blazeby JM, Conroy T, Arraras J, Sezer O, Koller M, et al. Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer. Eur J Cancer 2001;37:966–971.

    Article  CAS  PubMed  Google Scholar 

  8. Isobe Y, Nashimoto A, Akazawa K, Oda I, Hayashi K, Miyashiro I, et al. Gastric cancer treatment in Japan: 2008 annual report of the JGCA nationwide registry. Gastric Cancer 2011;14:301–316.

    Article  PubMed Central  PubMed  Google Scholar 

  9. Sun DZ, Xu L, Wei PK, Liu L, He J. Syndrome differentiation in traditional Chinese medicine and E-cadherin/ICAM-1 gene protein expression in gastric carcinoma. World J Gastroenterol 2007;13:4321–4327.

    PubMed Central  PubMed  Google Scholar 

  10. Roca O, Pérez-Terán P, Masclans JR, Pérez L, Galve E, Evangelista A, et al. Patients with New York Heart Association class III heart failure may benefit with high flow nasal cannula supportive therapy: high flow nasal cannula in heart failure. J Crit Care 2013;28:741–746.

    Article  PubMed  Google Scholar 

  11. Combe C1, McCullough KP, Asano Y, Ginsberg N, Maroni BJ, Pifer TB. Kidney Disease Outcomes Quality Initiative (K/DOQI) and the Dialysis Outcomes and Practice Patterns Study (DOPPS): nutrition guidelines, indicators, and practices. Am J Kidney Dis 2004;44(5 Suppl 2):39–46.

    Article  PubMed  Google Scholar 

  12. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–376.

    Article  CAS  PubMed  Google Scholar 

  13. Zheng XY, ed. Chinese medicine clinical research guidelines. Beijing: Chinese Medical Science and Technology Press; 2002:29–32.

  14. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000;284:3043-3045.

  15. Food and Drug Administration. Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. US Food-Washington, DC, US Food and Drug Administration, 2007.

  16. Sun DZ, Ju DW, He J, Lu Y, Wu F, Li C, et al. Tumor interstitial fluid and postoperative recurrence of tumors: an experimental study for verifying hypothesis of "tumor-phlegm microenvironment". J Tradit Chin Med 2010;16:435–441.

    CAS  Google Scholar 

  17. Wiig H, Tenstad O, Iversen PO, Kalluri R, Bjerkvig R. Interstitial fluid: the overlooked component of the tumor microenvironment? Fibrogenesis Tissue Repair 2010;3:12.

    Article  PubMed Central  PubMed  Google Scholar 

  18. Wang JY, Xu L, Zhang RX, Lao L. Traditional Chinese medicine for cancer pain. J Chin Integr Med (Chin) 2011;9:129–134.

    Article  Google Scholar 

  19. You J. Significance and necessity of developing quality of life questionnaire for cancer patients adapting to traditional Chinese medicine. J Chin Integr Med (Chin) 2006;4:473–477.

    Article  Google Scholar 

  20. Lin LZ, Zhou DH, Zheng XT. Effect of traditional Chinese medicine in improving quality of life of patients with non-small cell lung cancer in late stage. Chin J Integr Tradit West Med (Chin) 2006;26:389–393.

    Google Scholar 

  21. Liu X, Hua BJ. Effect of traditional Chinese medicine on quality of life and survival period in patients with progressive gastric cancer. Chin J Integr Tradit West Med (Chin) 2008;28:105–107.

    Google Scholar 

  22. Zhou W, Li YJ, Wei PK. Effects of Xiaotan Sanjie Recipe on vasculogenic mimicry of human gastric cancer xenografts in nude mice. Chin J Integr Tradit West Med (Chin) 2011;31:532–536.

    Google Scholar 

  23. Pang B, Wei PK, Li YJ. Effect of xiaotan sanjie recipe on expressions of VEGF-C and VEGFR-3 in nude mice with transplanted human gastric adenocarcinoma cell MKN-45. Chin J Integr Tradit West Med (Chin) 2011;31:204–208.

    Google Scholar 

  24. Li CJ, Wei PK, Yue BL. Study on the mechanism of Xiaotan Sanjie Recipe for inhibiting proliferation of gastric cancer cells. J Tradit Chin Med(Chin) 2010;30:249–253.

    Article  CAS  Google Scholar 

  25. Ju DW, Wei PK, Lin HM, Sun DZ, Yu S, Xiu LJ. Effects of Xiaotan Sanjie Decoction on expressions of interleukin-8 and its receptors in gastric tumor xenografts and gastric tissue adjacent to the tumor in mice. J Chin Integr Med (Chin) 2010;8:74–79.

    Article  Google Scholar 

  26. Guo XD, Wei PK. Effect of Xiaotan Sanjie Recipe on growth of transplanted tumor and expressions of proliferating cell nuclear antigen and epidermal growth factor receptor in tissue of gastric carcinoma of nude mice. J Chin Integr Med (Chin) 2007;5:432–436.

    Article  Google Scholar 

  27. Zheng J, Zheng J, Zheng PY. Application of quality of life scale in evaluating the efficacy of gastric cancer treatment. J Chin Integr Med (Chin) 2008;6:304–310.

    Article  Google Scholar 

  28. Perwitasari DA, Atthobari J, Dwiprahasto I, Hakimi M, Gelderblom H, Putter H, et al. Translation and validation of EORTC QLQ-C30 into Indonesian version for cancer patients in Indonesia. Jpn J Clin Oncol 2011;41:519–529.

    Article  PubMed  Google Scholar 

  29. Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Domínguez Domínguez MA, Lainez Milagro N, Manterola Burgaleta A, et al. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol 2008;61:949–954.

    Article  PubMed  Google Scholar 

  30. Silpakit C, Sirilerttrakul S, Jirajarus M, Sirisinha T, Sirachainan E, Ratanatharathorn V. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): validation study of the Thai version. Qual Life Res 2006;15:167–172.

    Article  PubMed  Google Scholar 

  31. Luo N, Fones CS, Lim SE, Xie F, Thumboo J, Li SC. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30): validation of English version in Singapore. Qual Life Res 2005;14:1181–1186.

    Article  CAS  PubMed  Google Scholar 

  32. Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol 1997;50:441–450.

    Article  CAS  PubMed  Google Scholar 

  33. Park SH, Cho MS, Kim YS, Hong J, Nam E, Park J, et al. Self-reported health-related quality of life predicts survival for patients with advanced gastric cancer treated with first-line chemotherapy. Qual Life Res 2008;17:207–214.

    Article  PubMed  Google Scholar 

  34. Rodary C, Pezet-Langevin V, Garcia-Acosta S, Lesimple T, Lortholary A, Kaminsky MC, et al. Patient preference for either the EORTC QLQ-C30 or the FACIT Quality Of Life (QOL) measures: a study performed in patients suffering from carcinoma of an unknown primary site (CUP). Eur J Cancer 2004;40:521–528.

    Article  CAS  PubMed  Google Scholar 

  35. Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, et al. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol 2008;19:2053–2060.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  36. Zhao H, Kanda K. Translation and validation of the standard Chinese version of the EORTC QLQ-C30. Qual Life Res 2000;9:129–137.

    Article  CAS  PubMed  Google Scholar 

  37. Sadighi S, Mohagheghi MA, Montazeri A, Sadighi Z. Quality of life in patients with advanced gastric cancer: a randomized trial comparing docetaxel, cisplatin, 5-FU (TCF) with epirubicin, cisplatin, 5-FU (ECF). BMC Cancer 2006;6:274.

    Article  PubMed Central  PubMed  Google Scholar 

  38. Park SH, Lee WK, Chung M, Bang SM, Cho EK, Lee JH, et al. Quality of life in patients with advanced gastric cancer treated with second-line chemotherapy. Cancer Chemother Pharmacol 2006;57:289–294.

    Article  PubMed  Google Scholar 

  39. Cao ND, Zhao AG, Yang JK. Survival time of advanced gastric cancer patients treated with integrated traditional Chinese and Western medicine therapy. J Chin Integr Med (Chin) 2010;8:116–120.

    Article  Google Scholar 

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Authors and Affiliations

  1. Department of Traditional Chinese Medicine, Changzheng Hospital, Second Military Medical University, Shanghai (, 200003), China

    Da-zhi Sun  (孙大志), Jian-peng Jiao  (矫健鹏), Xuan Zhang  (张 璇), Jing-yu Xu  (徐晶钰), Min Ye  (叶 敏), Li-juan Xiu  (修丽娟), Ying Zhao  (赵 颖), Ye Lu  (陆 烨), Xuan Liu  (刘 煊), Jing Zhao  (赵 婧), Jun Shi  (施 俊), Zhi-feng Qin  (秦志丰) & Pin-kang Wei  (魏品康)

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  1. Da-zhi Sun  (孙大志)
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  12. Zhi-feng Qin  (秦志丰)
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  13. Pin-kang Wei  (魏品康)
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Corresponding author

Correspondence to Pin-kang Wei  (魏品康).

Additional information

Supported by Shanghai Changzheng Hospital Youth Foundation Project (No. 200917)

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Sun, Dz., Jiao, Jp., Zhang, X. et al. Therapeutic effect of Jinlongshe Granule (金龙蛇颗粒) on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial. Chin. J. Integr. Med. 21, 579–586 (2015). https://doi.org/10.1007/s11655-014-1950-z

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  • DOI: https://doi.org/10.1007/s11655-014-1950-z

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