Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial / 中国结合医学杂志

BACKGROUND@#The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer.@*METHODS@#A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy.@*DISCUSSION@#This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518).

Thoughts on post-marketing evaluation of classical Chinese patent medicines based on clinical value / 中国中药杂志

Classical Chinese patent medicines(CPMs) are a kind of modern preparation developed from the experience of compatibility and application about ancient prescriptions. Its rich history of human use and reliable clinical efficacy imply the unique theoretical essence and precious value of traditional Chinese medicine(TCM). With the development of evidence-based medicine and the improvement of medical policy, it is particularly urgent to evaluate the clinical values of post-marketing classical CPMs. In this paper, some problems on the clinical value evaluation of CPMs would be described, and it is considered that the simplified evaluation procedures can lead to the lack of evidence for evaluating clinical value of CPMs, causing the difficulty in evaluating the quality of CPM, lack of R&D motivation of enterprises, low content of science and technology, and poor international development. Based on this background, it points out that the clinical value evaluation is the core of the post-marketing evaluation of the classical CPMs, and the eva-luation should be based on the direction of literature research and the latest practice. We should adhere to the research mode of combination disease with syndrome, and select the appropriate type of trials, with clinical efficacy, health economic benefits and safety eva-luation as the main content of the studies, in order to refine the indications and standardize the clinical positioning. Clinical value eva-luation is the basis and main content of post-marketing comprehensive researches on classic and famous CPMs to clarify their clinical value, obtain the conditions for continued marketingand standardize their clinical application, so as to optimize the evidence and quality service of classic and famous CPMs and inherit the core value concept of Chinese medicine.

Progressive Muscle Relaxation Combined with Chinese Medicine Five-Element Music on Depression for Cancer Patients: A Randomized Controlled Trial / 中国结合医学杂志

<p><b>OBJECTIVES</b>To evaluate the effects of progressive muscle relaxation training (PMRT) combined with fifive elements music therapy of Chinese medicine (CM) for improving anxiety and depression of cancer patients.</p><p><b>METHODS</b>From June 2015 to March 2016, 60 cancer patients were included into the study. The patients were randomly assigned to a control group and a treatment group by envelope randomization, receiving PMRT and PMRT plus CM five elements music therapy, respectively, for 8 weeks. Hospital Anxiety and Depression Scale (HADS), Benefit Finding Scales (BFS), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), and Intervention Expectations Questionnaire (IEQU) were adopted to assess the depression of the two groups before and after the treatment.</p><p><b>RESULTS</b>Four cases dropped out during the study, and 29 cases in the treatment group and 27 in the control group were included in the fifinal analysis. Prior to the treatments, the baselines of the 4 questionnaires in the two groups showed no difference. After the 8-week treatment, the treatment group presented better levels of HADS, BFS and FACIT-Sp scores compared with the control group (P<0.05). Among the single items of HADS, 4 items involving vexation, feeling fifidgeted, pleasure and prospecting the future in the treatment group were improved compared with the control group (P<0.05).</p><p><b>CONCLUSIONS</b>As a simple and reliable and effective intervention, PMRT combined with fifive elements music therapy mitigated anxiety and depression of cancer patients. Cancer patients have been found to respond well to psychological intervention in areas regarding stabilisation of emotions, disease awareness, and therapeutic compliance. This brings about a great difference in improving their quality of life and psychological state, offers an effective approach to better self-management in cancer treatment.</p>

Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To verify the efficacy and safety of Quxie Capsule () in patients with metastatic colorectal cancer (mCRC).</p><p><b>METHODS</b>The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016.</p><p><b>RESULTS</b>The median OS was 23 months in the treatment group [95% confidence interval (CI): 15-not calculated] vs. 14 months in the control group (95% CI: 11-22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.</p><p><b>CONCLUSIONS</b>Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).</p>

Cohort Study on Prognosis of Patients with Metastatic Colorectal Cancer Treated with Integrated Chinese and Western Medicine / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the efficacy of integrated Chinese and Western medicine (IM) in the treatment of metastatic colorectal cancer (mCRC) in a cohort study.</p><p><b>METHODS</b>The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone. The study design was adopted with "continuous administration of Chinese medicine for ⩾ 3 months" as the exposure factor. Patients who met this exposure factor were assigned to the IM cohort (Group A, 110 patients). Patients who did not meet this exposure factor were assigned to the Western medicine cohort (Group B, 225 patients). The overall survival (OS), progression-free survival (PFS), and 1st year, 2nd year, and 3rd year survival in the two cohorts were compared.</p><p><b>RESULTS</b>The median OS in Group A and B were 18 months [95% confidence interval (CI) 15-21] and 16 months (95% CI 14-18), respectively, and the median PFS in Group A and B were 6 months (95% CI 4-7) and 5 months (95% CI 4-6), respectively. No statistically significant differences were observed between the groups (P=0.186, P=0.223). Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups: female patients, patients with lesions in the right half of the colon, and those who received first-line treatment (P<0.05). In the subgroup of elderly patients (age>65 years), the OS in Group A was longer than that in Group B (P<0.05).</p><p><b>CONCLUSION</b>IM could prolong the survival of patients with mCRC. (Registry No. ChiCTR-IOR-17010497).</p>

Effects of Chinese medicine five-element music on the quality of life for advanced cancer patients: a randomized controlled trial / 中国结合医学杂志

<p><b>OBJECTIVES</b>To evaluate the effects of the Chinese medicine (CM) five-element music on quality of life for senior and non-senior advanced cancer patients.</p><p><b>METHODS</b>With a randomized controlled trial, 170 advanced cancer patients were randomly assigned to three groups: the CM five-element music group (68 patients), the Western music therapy group (68 cases), and the no music therapy group (34 cases). All patients of 70 years old or older were considered seniors and the remaining patients younger than 70 years were considered nonseniors. Patients in the CM five-element music group listened to CM five-element music, the patients in the Western music group listened to Western music, and the patients in the no music group did not listen to music. A course of treatment was 3 weeks, with 30 min each day, 5 days a week. The Hospice Quality of Life Index-Revised (HQOLI-R) and Karnofsky performance score (KPS) were measured in the three groups before and after treatment. The symptom diary score was measured in the three groups every 3 days, 7 times in total.</p><p><b>RESULTS</b>CM five-element music group showed a significant difference of HQOLI-R, KPS and symptom diary score with other groups (all P<0.01). There were significant differences of HQOLI-R, symptom diary score, and KPS after treatment in CM five-element music group and other groups in the non-senior subgroup (P<0.05). Additionally, there were significant differences in HQOLI-R and KPS after treatment among the three groups in the senior subgroup (P<0.05).</p><p><b>CONCLUSIONS</b>CM five-element music therapy could improve the quality of life and KPS for senior and non senior advanced cancer patients, and it could improve subjective symptoms for non-senior advanced cancer patients.</p>

Dietary therapy of qi-yin-reinforcing porridge for the alleviation of chemotherapy related symptoms of gastrointestinal tumors: a single-case randomized controlled study / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the efficacy of dietary therapy of qi-yin-reinforcing porridge for the alleviation of clinical symptoms during FOLFOX chemotherapy.</p><p><b>METHODS</b>A single-case randomized controlled study was carried out. Fourteen patients with gastrointestinal tumors accepting FOLFOX chemotherapy were enrolled using self-crossover control design. On days 1-7 of chemotherapy, the dietary therapy experimental group and the placebo control group were given dietary therapy of qi-yin-reinforcing porridge and dextrin-prepared porridge which had the same appearance, smell, color and taste as the qi-yin-reinforcing porridge, respectively. Fourteen clinical symptoms, including debility, vomiting and nausea, etc. were observed.</p><p><b>RESULTS</b>Ten patients completed the study and were estimable. The qi-yin-reinforcing porridge demonstrated certain efficacy in alleviating clinical symptoms of patients with gastrointestinal tumors during the period of chemotherapy. Better effect of alleviating debility was found in the dietary therapy experimental group than in the placebo control group, and the difference was statistically significant (Z=2.27, P=0.02). No statistically significant difference was found between the experimental group and the control group with respect to the effect of alleviating the other 13 clinical symptoms including anorexia, nausea, vomiting, dry stool, loose stool, etc. and body weight (P>0.05).</p><p><b>CONCLUSION</b>Dietary therapy of qi-yin-reinforcing porridge shows an additional benefit in alleviating debility of patients during chemotherapy and deserves clinical use and popularization.</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>

Randomized controlled study on effect of Quxie capsule on the median survival time and qualify of life in patients with advanced colorectal carcinoma / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the effect of Quxie Capsule (QXC) on the median survival time and quality of life in patients with advanced colorectal carcinoma.</p><p><b>METHODS</b>Forty patients with advanced colorectal carcinoma were observed in a randomized controlled clinical trial (RCT). Out of them the 37 evaluable patients were assigned into the treatment group (18 patients) and the control group (19 patients). They were all treated by the routine treatment for cancer, including chemotherapy and radiotherapy, while those in the treatment group were administered with QXC additionally. After being treated for 3 months, the follow-up study was carried out to evaluate the fatality rate (FR), survival time (ST), median survival time (mST), time to progression (TTP), and quality of life (QOF).</p><p><b>RESULTS</b>FR, mST, ST and TTP in the treatment group were 11.1% (2/18), 17 months, 22.63 +/- 7.34 months, and 17.76 +/- 5.62 months respectively, and those in the control group were 42.1% (8/19), 13 months, 19.76 +/- 8.28 months and 12.68 +/- 9.26 months respectively, showing significant difference between the two groups (P < 0.05). The scores of TCM symptom, QOF and KPS in the treatment group were 15.59 +/- 3.78, 54.06 +/- 3.96 and 64.71 +/- 6.24 before treatment, and 10.53 +/- 5.57, 58.65 +/- 4.03, 69.41 +/- 4.29 after treatment, respectively, showing significant improvement (P < 0.05). While the three scores in the control group were 16.11 +/- 3.99, 54.06 +/- 4.39 and 64.44 +/- 5.11 before treatment, and 19.61 +/- 7.78, 50.17 +/- 8.26 and 60.00 +/- 9.70 after treatment, respectively, showing a statistically significant worsening tendency in the latter two (P <0.05).</p><p><b>CONCLUSION</b>QXC can reduce the FR, prolong the ST, mST, mCFPT, and improve the QOF in patients with advanced colorectal carcinoma.</p>

Progress in postoperative management of colorectal cancer with integrative medicine / 中国中西医结合杂志

The comprehensive treatment of colorectal cancer has been quickly progressing in recent years, and TCM treatment plays an active role in the postoperative management of colorectal cancer. In this paper, the progress of postoperative management of colorectal cancer with integrative medicine was reviewed to provide a reference for guiding the researches on this topic.

Clinical randomized double-blinded controlled study on Quxie Capsule in reducing post-operational relapse and metastasis of colorectal cancer / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the clinical effect of Quxie Capsule (QXC) in subsequent therapy for post-operational colorectal cancer.</p><p><b>METHODS</b>By the scheme matched to the requirement of randomized controlled trial, 44 patients chosen from 48 patients with colorectal cancer at post-operational period (with 2 dropped out and 2 loss of follow-up) were assigned into two groups (A and B) according to randomiced block design and received intervention treatment with QXC and placebo, respectively, which started after terminating the post-operational adjuvant treatment and lasted for 6 months. Out of the 44 patients, 28 were of stage II (15 in Group A and 13 in Group B) and 16 of stage III (8 in Group A and 8 in Group B). The relapse-metastasis (R-M) rate, median time of R-M, changes of symptoms, Karnofsky (KPS) score and immune function before and after intervention, as well as the safety of QXC were observed.</p><p><b>RESULTS</b>The follow-up study till April 2007 showed, the 1-year, 2-year and 3-year R-M rate in Group A was 0%, 0% and 50%, and in Group B was 9.5%, 18.2% and 50.0%, respectively, showing insignificant difference between the two groups (P >0.05). Difference in median time of R-M between the two groups (31.5 +/- 7.8 months vs 19.0 +/- 13.9 months) also showed no statistical significance (P >0.05). However, the symptoms and KPS score in Group A were better obviously (P <0.05), with improvement in B lymphocyte (P <0.05) superior to that in Group B. No obvious adverse reaction to QXC was found.</p><p><b>CONCLUSION</b>QXC might be effective in delaying the R-M of colorectal cancer, but the ultimate confirmation only could be obtained through 1 to 2 years observation. Post-operational intervention with QXC in patients with colorectal cancer could apparently improve the quality of life and raise the immune function of patients, it is safe and might have some clinical significance in preventing the R-M of cancer.</p>

Cohort study on fuzheng capsule and quxie capsule in reducing relapse and metastasis of cancer in patients with stage II and III colorectal carcinoma after operation / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the effect of Fuzheng Capsule (FC) and Quxie Capsule (QC) in reducing relapse and metastasis of colorectal cancer in stage II and III after the cancer had been treated by radical operation and succedent routine radiotherapy and chemotherapy.</p><p><b>METHODS</b>A prospective cohort controlled study was conducted in 101 patients with colorectal cancer in stage II and III after radical operation and routine radiotherapy and chemotherapy, among whom 53 patients were treated with FC and QC and 48 were given no treatment, they were followed up regularly. The rate and time of relapse and metastasis were observed after 1, 2 and 3 years.</p><p><b>RESULTS</b>One-year, 2-year and 3-year relapse-metastasis rate was 0, 2.7% and 14.8% respectively in the treated group, and 6.2% , 24.2% and 30.8% in the control group. Significant difference was found only in the 2-year rate between the two groups (chi-squared = 5.428, P < 0.05). Average time of relapse and metastasis was 26.2 +/- 4.5 months in the treated group and 14.2 +/- 4.2 months in the control group, showing significant difference between the two groups (P < 0.05).</p><p><b>CONCLUSION</b>FC and QC applying in the succedent consolidating treatment for stage II and III colorectal cancer after radical operation might be favourable to reduce relapse and metastasis and improve quality of life, further clinical study with randomized and controlled method is worthwhile to be conducted.</p>

Clinical observation of qingxue granules in treating post-nephrotransplantation erythrocytosis / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the therapeutic efficacy of Qingxue Granules (QX) in treating postnephrotransplant erythrocytosis (PNTE).</p><p><b>METHODS</b>Twenty patients were randomly divided into two groups according to the randomized table. QX was given to patients in the TCM treated group (QX group) and Enalapril given to patients in the Western medicine treated group (WM group), and the clinical efficacy in the two groups was observed. Results In the QX group, 3 patients got markedly effective, 2 effective, 2 improved, 1 ineffective, 1 dropped from the treatment, 1 absconded, with the total effective rate of 77.78%. The corresponding numbers in the WM group were 4, 2, 2, 1, 1 and 66.67%. There was no significant difference in comparison of the efficacies between the two groups (P > 0.05). There was no difference between the Intent-to-Treat population and Per-protocol Pouplation after statistical management of lost cases.</p><p><b>CONCLUSION</b>It has proved that QX has the same therapeutic effects as classic Western medical treatment in treating PNTE. The reliability and scientificity of QX was proved by Intent-to-Treat analysis.</p>

Oxaliplatin in combination with LV5FU2 for advanced/metastatic gastric cancer-a multicenter study / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the effects and safety of OXA-LV5FU2 regimen for patients with advanced/metastatic gastric cancer.</p><p><b>METHODS</b>OXA 100 mg/m(2) i.v. 2hr d1, LV200 mg/m(2) i.v. 2hr followed by 5-Fu 400 mg/m(2) i.v. bolus and 5-Fu 600 mg/m(2) i.v. 22hr d1, 2 were given, and repeated every 2 weeks. Efficacy was evaluated at 4 cycles (8 weeks).</p><p><b>RESULTS</b>Forty three patients have been entered into the study. Patients with primary tumor resected or non-resected were 17 and 26. The evaluable lesions were 26 primary lesions, 22 lymph node metastases, 12 liver metastases, 1 pancreas metastasis and 2 soft tissue metastases. Forty patients were evaluable for clinical response. Four patients achieved CR (10.0%), 13 PR (32.5%), ORR 42.5% (95% CI 27.2 - 57.8), 17 SD (42.5%) and 6 PD (15.0%). Overall response rate (ORR) for chemotherapy naive (1(st) line) and pretreated (2(nd) line) patients were 50.0% (14/28) and 25.0% (3/12), respectively. Median time to progress (mTTP) was 5 months and median overall survival (mOS) was 8 months. Forty-three patients were evaluable for toxicity, with Grade 3, 4 WHO toxicity of neutropenia in 7 patients (16.3%), thrombocytopenia in 3 patients (7.0%), nausea/vomiting in 1 patient (2.3%). There were no Grade 3, 4 peripheral neuropathy toxicity or any deaths during treatment.</p><p><b>CONCLUSION</b>OXA-LV5FU2 is a high response regimen for advanced gastric cancer with mild toxicity, which can be practiced safely.</p>