In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial
Background: According to clinical experience, Traditional Chinese Medicine (TCM) herbs added to platinum-based therapy (PBT) improve the Quality of Life (QOL) in metastatic non-small cell lung cancer (NSCLC) patients, but this must be prospectively validated.Patients and Methods: Based on clinical i...
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Frontiers Media S.A.
2017-07-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | http://journal.frontiersin.org/article/10.3389/fphar.2017.00454/full |
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| author | Huiru Guo Jia X. Liu Hegen Li Jan P. A. Baak Jan P. A. Baak Jan P. A. Baak Jan P. A. Baak |
| author_facet | Huiru Guo Jia X. Liu Hegen Li Jan P. A. Baak Jan P. A. Baak Jan P. A. Baak Jan P. A. Baak |
| author_sort | Huiru Guo |
| collection | DOAJ |
| description | Background: According to clinical experience, Traditional Chinese Medicine (TCM) herbs added to platinum-based therapy (PBT) improve the Quality of Life (QOL) in metastatic non-small cell lung cancer (NSCLC) patients, but this must be prospectively validated.Patients and Methods: Based on clinical impressions regarding the effect of adding TCM herbs to platinum-based chemotherapy, we anticipated that 2 × 21 patients would be sufficient to obtain significant results with an α < 0.05 and power (1 - β) of 90%. To be on the safe side, we enrolled at least 28 patients in each group. In a prospective randomized controlled trial, 61 uniquely defined consecutive patients (PBT+PLACEBO, N = 32; PBT+TCM, N = 29) with stage IIIB-IV, Eastern Cooperative Oncology Group (ECOG) performance scores (PS) = 0–1 and TCM syndrome combined Qi-Yin deficiency were enrolled. These 61 patients were selected from originally 154 consecutive stage IIIB-IV lung cancer patients in the enrollment period. Patients were hospitalized and strictly controlled/surveyed during the entire 2-month treatment period, to guarantee use of or abstinence from TCM herbal and placebo fluids. Occurrence of nausea-vomiting, QOL by Functional Assessment of Cancer Therapy-Lung (FACT-L) scales and changes in ECOG “improved and stable rates” were compared before and after two treatment cycles.Results: Before treatment, the clinico-pathologic and QOL features in PBT+PLACEBO and PBT+TCM patients did not differ (P > 0.10). The only side effects attributed by some of the patients to the TCM herbs were transient, mild gastric/abdominal heaviness in the first 2 weeks, but these also occurred amongst the PBT+PLACEBO patients (17 and 13%, P > 0.10). The incidence rates of nausea during treatment were 17% in PBT+TCM versus 75% in PBT+PLACEBO; vomiting rates were 14 and 56% (P < 0.0001 and 0.002). Moreover, ECOG “improved and stable rates” were 90% in the PBT+TCM versus 69% in the PBT+PLACEBO group (P = 0.04). In PBT+TCM patients, FACT-L social/familial and functional subscales were better after 2 months’ treatment (P = 0.02 and 0.03). Contrarily, in PBT+PLACEBO patients, the QOL variables total score, physical and emotional subscales were worse after PBT treatment (P = 0.03, 0.0001, and 0.003).Conclusion: In stage IIIB-IV ECOG-PS = 0–1 NSCLC patients with Qi-Yin deficiency and platinum-based chemotherapy, adding TCM herbal medication improves the QOL. As this category of patients constitutes 40% of all metastatic NSCLCs, these results could have significant clinical impact. |
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| language | English |
| last_indexed | 2024-12-18T08:36:40Z |
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| spelling | doaj.art-4a19aafcc713441b99e44ddc63b664812022-12-21T21:14:18ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122017-07-01810.3389/fphar.2017.00454273550In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical TrialHuiru Guo0Jia X. Liu1Hegen Li2Jan P. A. Baak3Jan P. A. Baak4Jan P. A. Baak5Jan P. A. Baak6Department of Medical Oncology, Longhua Hospital, Shanghai UniversityShanghai, ChinaDepartment of Medical Oncology, Longhua Hospital, Shanghai UniversityShanghai, ChinaDepartment of Medical Oncology, Longhua Hospital, Shanghai UniversityShanghai, ChinaDivision of Research, Dr. Med. Jan Baak ASTananger, NorwayDivision of Clinical Care Medical Practice, Dr. Med. Jan Baak ASAkersloot, NetherlandsFaculty of Sports and Health Sciences, Technical University of MunichMunich, GermanyDepartment of Pathology – Department for Molecular Biology, Stavanger University HospitalStavanger, NorwayBackground: According to clinical experience, Traditional Chinese Medicine (TCM) herbs added to platinum-based therapy (PBT) improve the Quality of Life (QOL) in metastatic non-small cell lung cancer (NSCLC) patients, but this must be prospectively validated.Patients and Methods: Based on clinical impressions regarding the effect of adding TCM herbs to platinum-based chemotherapy, we anticipated that 2 × 21 patients would be sufficient to obtain significant results with an α < 0.05 and power (1 - β) of 90%. To be on the safe side, we enrolled at least 28 patients in each group. In a prospective randomized controlled trial, 61 uniquely defined consecutive patients (PBT+PLACEBO, N = 32; PBT+TCM, N = 29) with stage IIIB-IV, Eastern Cooperative Oncology Group (ECOG) performance scores (PS) = 0–1 and TCM syndrome combined Qi-Yin deficiency were enrolled. These 61 patients were selected from originally 154 consecutive stage IIIB-IV lung cancer patients in the enrollment period. Patients were hospitalized and strictly controlled/surveyed during the entire 2-month treatment period, to guarantee use of or abstinence from TCM herbal and placebo fluids. Occurrence of nausea-vomiting, QOL by Functional Assessment of Cancer Therapy-Lung (FACT-L) scales and changes in ECOG “improved and stable rates” were compared before and after two treatment cycles.Results: Before treatment, the clinico-pathologic and QOL features in PBT+PLACEBO and PBT+TCM patients did not differ (P > 0.10). The only side effects attributed by some of the patients to the TCM herbs were transient, mild gastric/abdominal heaviness in the first 2 weeks, but these also occurred amongst the PBT+PLACEBO patients (17 and 13%, P > 0.10). The incidence rates of nausea during treatment were 17% in PBT+TCM versus 75% in PBT+PLACEBO; vomiting rates were 14 and 56% (P < 0.0001 and 0.002). Moreover, ECOG “improved and stable rates” were 90% in the PBT+TCM versus 69% in the PBT+PLACEBO group (P = 0.04). In PBT+TCM patients, FACT-L social/familial and functional subscales were better after 2 months’ treatment (P = 0.02 and 0.03). Contrarily, in PBT+PLACEBO patients, the QOL variables total score, physical and emotional subscales were worse after PBT treatment (P = 0.03, 0.0001, and 0.003).Conclusion: In stage IIIB-IV ECOG-PS = 0–1 NSCLC patients with Qi-Yin deficiency and platinum-based chemotherapy, adding TCM herbal medication improves the QOL. As this category of patients constitutes 40% of all metastatic NSCLCs, these results could have significant clinical impact.http://journal.frontiersin.org/article/10.3389/fphar.2017.00454/fulllung cancernon-small cellmetastaticQuality of LifeTraditional Chinese Medicinenausea |
| spellingShingle | Huiru Guo Jia X. Liu Hegen Li Jan P. A. Baak Jan P. A. Baak Jan P. A. Baak Jan P. A. Baak In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial Frontiers in Pharmacology lung cancer non-small cell metastatic Quality of Life Traditional Chinese Medicine nausea |
| title | In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial |
| title_full | In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial |
| title_fullStr | In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial |
| title_full_unstemmed | In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial |
| title_short | In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial |
| title_sort | in metastatic non small cell lung cancer platinum based treated patients herbal treatment improves the quality of life a prospective randomized controlled clinical trial |
| topic | lung cancer non-small cell metastatic Quality of Life Traditional Chinese Medicine nausea |
| url | http://journal.frontiersin.org/article/10.3389/fphar.2017.00454/full |
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