Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study / 中国结合医学杂志

BACKGROUND@#Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC.@*OBJECTIVE@#To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy.@*METHODS@#The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score.@*DISCUSSION@#This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).

Study on the four-year retention rate and influencing factors for 2,353 AIDS patients by Chinese medicine / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To analyze the retention rate and its influencing factors of HIV/AIDS patients by Chinese medicine (CM) maintenance treatment in the first 5 provinces in China.</p><p><b>METHODS</b>Kaplan-Meier method was used to analyze the retention rate of treatment in patients. Cox hazard regression model was used to assess factors that might influence the treatment time of Chinese medication.</p><p><b>RESULTS</b>Totally 2,353 patients took part in this four-year study. Of them, 1,156 (49. 1%) were male, 2,344 (99. 6%) were Han nationality, 2,260 (96%) were married, 2,219 (94.3%) had junior middle-schooling or below, the average age was 41.52 +/- 8.98 years, 1,758 (74.7%) received paid blood donation, 478 (20.3%) received blood transfusion, 737 (31.3%) were absent of symptoms, 963 (40.9%) received combined treatment of CM and Western medicine. The median time within the four years was 44.84 months. The average retention rate for 1, 2, 3, 4 years of CM treatment were 86.6%, 78.4%, 72.2%, 65.6%, respectively. The results of Cox model indicated that the drop-out risk could be reduced in combined treatment of CM and Western medicine patients (HR=0. 805, P<0.01) and AIDS patients (HR=0. 769, P<0.01). The drop-out risk could be increased by the infection route of paid blood donation (HR =1. 373, P<0.01).</p><p><b>CONCLUSIONS</b>The four-year retention rate of the 2 353 patients by CM treatment in the first 5 provinces in China was 65. 6%. Route of infection, whether or not in combination of Western medicine, and staging showed influence on CM maintenance treatment time.</p>

Cohort study on the effect of a combined treatment of traditional Chinese medicine and Western medicine on the relapse and metastasis of 222 patients with stage II and III colorectal cancer after radical operation / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine (TCM) in reducing the relapse and metastasis of stage II and III colorectal cancer based on conventional Western medicine (WM) therapy.</p><p><b>METHODS</b>Two hundred and twenty-two patients in total, diagnosed as stage II and III colorectal cancer from February 2000 to March 2006, were recruited from Xiyuan Hospital, China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area. They were followed-up once every 3-6 months. Twenty cases dropped out from the cohort. The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation, or chemotherapy or/and radiotherapy according to national comprehensive cancer network (NCCN) clinical guidelines]. These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy (orally administered with a decoction according to syndrome differentiation, combined with a traditional patent drug over one year). Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM (combined group), and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone (WM group). The demographic data at baseline were comparable, including the operation times, age, sex, TNM staging, and pathological types. The patients were followed-up for one to five years. Up to now, there are 98, 98, 77, 64, and 47 patients with 1, 2, 3, 4, and 5 years of follow-up in the combined group, respectively; and 104, 104, 97, 81, and 55 patients in the WM group, respectively. The results of the 5-year follow-up of all the patients will be available in 2011.</p><p><b>RESULTS</b>The relapse/metastasis rate of 1-, 2-, 3-, 4-, and 5-year were 0 (0/98), 2.04% (2/98), 11.69% (9/77), 14.06% (9/64), and 21.28% (10/47) in the combined group, and were 4.80%(5/104), 16.35% (17/104), 21.65% (21/97), 25.93% (21/81), and 38.18%(21/55) in the WM group, respectively. A significant difference was found in the second year between the two groups (chi (2)=12.117, P=0.000). Median relapse/metastasis time was 26.5 months in the combined group and 16.0 months in the WM group.</p><p><b>CONCLUSION</b>The combined therapy of TCM and WM may have great clinical value and a potential for decreasing the relapse or metastasis rate in stage II and III colorectal cancer after conventional WM therapy.</p>