| ObjectivesThe purpose of this study was to investigate changes in quality of life (QOL) in patients with advanced non-small-cell lung cancer (NSCLC) receiving extra-corporeal high-frequency thermotherapy(EHFT) combined with traditional Chinese medicine(TCM), additionally, the value of the scales in QOL was investigated.MethodsSeventy patients with advanced NSCLC will be enrolled in this study. Patients would be randomly assigned into two groups:control group (arm A) and the treatment group(arm B). Patients in arm A would receive TCM treatment only (include oral decoction and Chinese patent intravenous therapy), while in arm B EHFT combined with TCM treatment would be given. Patients were observed for two courses and each course lasted for one month. Evaluations would be carried out within a week when the treatment began and finished. The evaluation contents included the European Organization for Research and Treatment of Cancer(EORTC)Quality of Life Questionnaire(QLQ-LC43), Functional Assessment of Cancer Therapy-Lung Scale(FACT-L), Eastern cooperative oncology group (ECOG)PS score and the TCM Syndrome score. Data would be statistical analysed. Results1 General dataFrom October 2008 to December 2009,70 patients form Guangdong province hospital of traditional Chinese medicine were enrolled in the study. There were 2 patients fell off,68 patients finished. Thirty-five patients were randomly assigned to the arm A, and 33 patients were randomly assigned to the arm B. There was no significant difference in general informations, tumor status, quality of live in the two groups (P>0.05). Date of the two groups was comparable.2 Clinical efficacyTwo out of 16 patients with pleural effusion reached complete remission, while the other patients reached partial remission after treatment. Excluding the 6 patients who refused to review, target lesions of 62 patients were stable(NC), in which 3 patients in arm B with lung metastases(non-target lesions)partial relieve.3 Change of quality of lifeTCM Syndrome score of arm A and ECOG PS score, TCM Syndrome score of arm B were significantly increased(P＜0.01) after treatment;TCM Syndrome score of arm B was more significantly increased than arm A(P<0.05). In arm A, score of several aspects in EORTC QLQ-LC43 decreased after treatment, including physical functioning, symptoms scale, fatigue, dyspnoea, insomnia, loss of appetite, constipation and lung cancer specific scales (P＜0.05), while the role functioning, emotional functioning and global health increased(P＜0.05). Comparing with the scores before treatment, the scores of social/family well-being of the FACT-L had no significant different after treatment (P＞0.05), while the scores of others well-being increased significantly (P＜0.05). In arm B, scores of several aspects in EORTC QLQ-LC43 decreased after treatment, including physical functioning, symptom scales, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation and lung cancer specific scales(P＜0.05), while scores of several aspects increase, role functioning, emotional functioning, social functioning and global health (P＜0.05). Scores of all well-being in FACT-L increased after treatment (P＜0.05). The improvement of physical functioning, role functioning, emotional functioning and pain in EORTC QLQ-LC43 was significantly better in arm B than in arm A(P＜0.01). The improvement in physical well-being, social/family well-being, functional well-being and total score in FACT-L was significantly better in arm B than arm A(P＜0.01).4 Correlation of EORTC QLQ-LC43, FACT-L, ECOG PS score and TCM syndromes scoreCorrelation of EORTC QLQ-LC43 and FACT-L was different, in which the relevant modules of the two scales were better, such as physical functioning, lung cancer specific scale and the total scale. Correlation of ECOG PS score and TCM syndromes score was good(Spearman correlation coefficient=0.732, P＜0.01). ECOG PS score had medium correlation with certain aspects of EORTC QLQ-LC43 scale (such as symptom scales,global health and lung cancer specific scale)(Spearman correlation coefficient=-0.470,-0.572, 0.503,0.468, P＜0.01) and certain aspects of FACT-L scale (such as physical well-being,additional concerns and total score)(Spearman correlation coefficient=-0.480,-0.552,-0.478,-0.515, P＜0.01). TCM syndromes score had medium correlation with certain aspects of EORTC QLQ-LC43 scale(such as physical functioning, role functioning, emotional functioning, social functioning and lung cancer specific scale)(Spearman correlation coefficient=0.414,-0.439,-0.462,-0.515,0.645, P＜0.01) and certain aspects of FACT-L scale(such as functional well-being, additional concerns and total score) (Spearman correlation coefficient=-0.605,-0.646,-0.689, P＜0.01), additionally TCM syndromes score had good correlation with certain aspects of EORTC QLQ-LC43 scale(such as global health and symptom scales) (Spearman correlation coefficient=-0.806,0.870, P＜0.01) and physical well-being of FACT-L scale (Spearman correlation coefficient=-0.737, P＜0.01).Conclusions1. EHFT combined with TCM could improve quality of life in patients with advanced NSCLC, especially had a better improvement in physical functioning,role functioning, emotional functioning and relief in pain than TCM treatment only. 2. EHFT combined with TCM plays a positive role on tumor stable, additionally,could control formation of malignant pleural effusion significantly.3. Correlation of EORTC QLQ-LC43 and FACT-L was different. The scope of application of the two scales was different too. EORTC QLQ-LC43 was better in evaluating clinical symptoms and adverse reactions, while FACT-L was better in evaluating long-term efficacy. On analysing of the correlation of each scale, TCM syndrome score had better correlation with QOL scales than ECOG PS scale. That was to say TCM syndrome score was much closer than the level of quality of life. The score of TCM syndrome score had a certain extant referential value.
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