| Introduction Traditional Chinese medicine(TCM)takes an important role in the treatment of cancer and has a long history.Also,TCM is the key part of the cancer guidelines in China.However,in the field of anticancer treatment,there is still no study of the epidemiology concerning about the clinical application of TCM.The main reason included the huge number of cancer patients and oncologists in China,difficulty in developing a cross-sectional study in such a big country with large population and cancer treatment is not limited in cancer hospital or oncology clinics.Besides,clinical study plays a vital role in the modern medicine,whose level could directly reflect and influence the level of medicine.Nowadays,several studies of systematic literature quality evaluation have been conducted in the field of clinical oncology,whose results improve the level of that field.More and more attention has been put in the field of TCM clinical study in oncology to promote the results to be recognized by international medical researchers,designing and evaluating by the standards of evidence-based medicine.However,there is still no systemic literature quality evaluation of TCM clinical study in oncology.The data above relate not only to the reasonable use and clinical efficacy of TCM in the treatment of cancer,but also to affect the medical policy of the government and the development of TCM.Methods Based on the time background of the high incidence of cancers,the study aimed to use the methods of clinical epidemiology and literature analysis,conducting the following studies.1.Based on similar authoritative epidemiological studies abroad,combined with the domestic medical situation,a study group was formed to design the survey.The national online cross-sectional survey was conducted on the platform,the largest medical and paramedical related website in China,facing to all the clinical oncologists in China.The four-month survey included the clinical use of TCM in anticancer treatment,oncologists' knowledge,attitudes,and clinical practice patterns on TCM.2.The multi-center cross-sectional study of clinical epidemiology was conducted in four big general hospitals to get the baseline information and clinical use of TCM in anticancer treatment of the cancer patients by the hospital's electronic medical record database and survey we designed to learn cancer patients' clinical use of TCM.3.According to the principles of clinical epidemiology and standards for clinical trials(CONSORT statement),articles of clinical study of TCM in anticancer treatment published in Chinese medical journals from Jan 2007 to Dec 2016 were searched in CBMDisc?CNKI?Wanfang Data?VIP database,setting search method and inclusive and exclusive criteria,the data of randomized method,intervention,blind method,sample size,calculation of sample size,registeration of clinical trial,diagnosis criteria,inclusive and exclusive criteria,primary outcome,method of statistics,follow-up,funding support and evaluation safety of each literature was extracted and analyzed.4.According to the guideline of Cochrane and standards for clinical trials,setting search method and inclusive and exclusive criteria,clinical studies for CAM anticancer treatment published in the top five journals of the three categories from Jan 2007 to Dec 2016 were searched in Pub Med,Web of Science?EBSCO and Medline database.the data of randomized method,intervention,blind method,sample size,calculation of sample size,registeration of clinical trial,diagnosis criteria,inclusive and exclusive criteria,method of statistics,follow-up,funding support,evaluation safety and the number of citation of each literature was extracted and analyzed,then was compared with the data of clinical studies of TCM's oncology.Results 1.Among totally 11,270 participants,6,007(53.3%)were identified as oncologists and completed the survey,including all of the 31 provinces,Hongkong and Macau.According to the estimate of the oncologists,about 40.0% of the cancer patients used TCM treatments.Chinese patent medicine(66.2%),Chinese herbal medicine(63.3%)and dietary therapy(41.5%)were the most commonly used TCM therapies.The most common symptoms for TCM therapies were lack of appetite(68.6%),fatigue(62.8%)and sleep disorder(60.1%),respectively.Improving immune system(83.7%)was regarded as the main reason for TCM use by patients.Oncologists reported that 28.7% of their patients underwent anticancer therapy combined with TCM treatment.16.6% of the oncologists showed concerns about the potential adverse interactions between TCM treatments and conventional treatments.Only 20.0% of the oncologists self-reported adequate knowledge and 22.0% reported receiving professional education on TCM.36.5% of the cancer patients discussed TCM with their oncologists.44.9% of the oncologists believed TCM treatment was effective for symptoms and treatment of cancer.By multivariate logistic regression model,oncologists' age,technical title,degree,medical license,type of hospital,knowledge and professional TCM education were found to be significantly associated with oncologists encourage TCM use for treatment.2.Among,a total of 729 cancer patients were included for final analysis.Most(52.7%)of the cancer patients were male,with a mean age of 59.3± 11.7 years and a mean disease duration of 24.0 ± 32.7 months.Lung(25.9%)was the most common cancer site,followed by colorectal(20.0%)and stomach(17.1%).According to the TCM prescription and the results of the survey of cancer patients,59.7% of the cancer patients used TCM treatments.Chinese patent medicine(64.8%)and Chinese herbal medicine(57.9%)were the most commonly used TCM therapies.The most common symptoms for TCM therapies were fatigue(39.1%)and lack of appetite(20.9%).Improving immune system(57.7%)and relieving discomfortable symptoms(48.5%)were regarded as the main reasons for TCM use by patients.It was reported that 26.7% of their patients underwent anticancer therapy combined with TCM treatment while 4.4% of the cancer patients witnessed adverse effects during the combined treatments.TCM use by cancer patients was predicted by age,sex,education and family income in the multivariable logistic regression model.3.A total of 473 TCM clinical studies of oncology were included in final analysis.Lung cancer(38.1%)was the most clinical studies.Prospective study(78.0%)was the most.293(61.9%)published in core journal.109(23.0%)were supported by funding,with 65(13.7%)provincial one and 23(4.9%)national one.For the intervention,TCM formula was the most(71.9%).48.2% of the studies reported the syndrome differentiation and treatment.For the goal of therapy,enhancing efficacy and reducing toxicity by combined therapy was the most(60.3%).The mean sample size of the studies was 81.6±74.1.None of the studies mentioned the estimate of sample size or the registeration of clinical trials.445(94.1%)were single-center study.252(53.3%)had clear inclusion and exclusion criteria.358(75.7%)conducted the randomization,with 103(28.8%)reported detail methods of randomization.Statistics methods were detail reported(69.1%).58(12.3%)reported patient compliance.4.0% of the studies recorded the cases of loss while 2.1% made an analysis.13(2.7%)were approved by the ethics committee.Follow-up visit were conducted in 187 studies(39.5%).295(62.4%)reported side effects.4.A total of 94 complementary and alternative medicine(CAM)clinical studies of oncology were included in this analysis,minority(29.8%)of the studies were identified as TCM,while only 11.7% of the studies' first author came from China.56(59.6%)made the estimate of sample size.86(91.5%)had funding support.68(72.3%)conducted the randomization.72(76.6%)reported the follow-up.71(75.5%)reported side effects.39(41.5%)had a clear registeration.In comparison to the studies in our country,the quality of the TCM studies in our country was lower than that of SCI journals from the aspects of size(P <0.0001),calculation of sample size(P <0.0001),funding support(P <0.0001),method of statistics(P <0.0001),follow-up(P <0.0001)and safety evaluation(P =0.015).Conclusion 1.In China,the use of TCM in the anticancer treatment is quite wide,that can be used in the whole period of the anticancer treatment.The goal of treatment mainly focuses on adjusting immunity while Chinese herb medicine and Chinese patent medicine were the most commonly used TCM therapies.However,oncologists self-reported lack of knowledge on TCM,and the minority of China's oncologists discuss with their patients about TCM.2.Nowadays,prospective study of Chinese herbal compound formula accounts for the most in TCM clinical studies of oncology.From the number and rank of the journals issued TCM clinical studies of oncology and the funding supported the studies,great achievements have been gained in the field of TCM clinical studies of oncology.However,the quality of the studies in this field still needed to be improved,mainly existed such problems as poor design,none of calculation of sample size,ignorance of safety evaluation,patient compliance,cases of loss and follow-up,none of trials' registeration,poor wook of ethics and statistics. |
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