Objective To explore the recognition capabilities of electronic nose combined with machine learning in identifying the breath odor map of benign and malignant pulmonary nodules and Traditional Chinese Medicine (TCM) syndrome elements. MethodsThe study design was a single-center observational study. General data and four diagnostic information were collected from 108 patients with pulmonary nodules admitted to the Department of Cardiothoracic Surgery of Hospital of Chengdu University of TCM from April 2023 to March 2024. The patients' TCM disease location and nature distribution characteristics were analyzed using the syndrome differentiation method. The Cyranose 320 electronic nose was used to collect the odor profiles of oral exhalation, and five machine learning algorithms including random forest (RF), K-nearest neighbor (KNN), logistic regression (LR), support vector machine (SVM), and eXtreme gradient boosting (XGBoost) were employed to identify the exhaled breath profiles of benign and malignant pulmonary nodules and different TCM syndromes. Results(1) The common disease locations in pulmonary nodules were ranked in descending order as liver, lung, and kidney; the common disease natures were ranked in descending order as Yin deficiency, phlegm, dampness, Qi stagnation, and blood deficiency. (2) The electronic nose combined with the RF algorithm had the best efficacy in identifying the exhaled breath profiles of benign and malignant pulmonary nodules, with an AUC of 0.91, accuracy of 86.36%, specificity of 75.00%, and sensitivity of 92.85%. (3) The electronic nose combined with RF, LR, or XGBoost algorithms could effectively identify the different TCM disease locations and natures of pulmonary nodules, with classification accuracy, specificity, and sensitivity generally exceeding 80.00%.ConclusionElectronic nose combined with machine learning not only has the potential capabilities to differentiate the benign and malignant pulmonary nodules, but also provides new technologies and methods for the objective diagnosis of TCM syndromes in pulmonary nodules.
Objective To assess the efficacy and safety of Chinese herbal medicines for chronic functional constipation. Methods We searched CNKI (1989 to November, 2009), CBM (1989 to November, 2009), VIP (1989 to November, 2009), Cochrane Library (Issue 4, 2009), PubMed (1966 to November, 2009) and EMbase (1986 to November, 2009). All randomized and quasi-randomized clinical trials of treating chronic functional constipation with Chinese herbal medicines versus untreated, placebo or western drug groups were included. Data were extracted independently by two reviewers. The methodological quality of trials was evaluated with Cochrane Handbook 5.0.2 criteria. Meta-analyses were conducted by the RevMan 5.0 software. Results Twenty-one trials involving 2 602 patients were included. The Meta-analysis results showed that: Chinese herbal medicines improved both syndromes and colonic transit function of recipients; moreover, it is superior to both gastrointestinal prokinetic agent in effective rate (RR=1.18, 95%CI 1.12 to 1.25), healing rate (RR=1.59, 95%CI 1.35 to 1.88), and cathartic in effective rate (RR=1.18, 95%CI 1.10 to 1.27), healing rate (RR=1.16, 95%CI 1.29 to 2.10). Integration of Chinese herbal medicines and gastrointestinal prokinetic agent is superior to gastrointestinal prokinetic agent in effective rate (RR=1.21 95%CI 1.09 to 1.34) and healing rate (RR=1.41, 95%CI 1.11 to 1.79). Conclusion Some Chinese herbal medicines may be effective and safe in treating chronic functional constipation, which can not be bly proved at present for lack of studies with high quality.
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.
Objective To analyze the heterogeneity of systematic reviews (SRs)/Meta-analysis on traditional Chinese medicine (TCM), and explore strategies for addressing heterogeneity correctly during the process of conducting TCM related to systematic reviews (SRs). Methods Both electronic and hand searches were used to identify TCM SRs in CBM, CNKI, VIP database, and Chinese Journal of Evidence-Based Medicine. Two researchers performed data extracting and heterogeneity evaluation independently. Results A total of 115 TCM SRs were included, involving 17 types of diseases, among which the cardiovascular and cerebrovascular diseases were the most addressed (n=36, 31.30%). There were 35.65% (n=41) of SRs which integrated two or more types of studies; interventions of the included studies were inconsistent in 53.91% (n=62) of TCM SRs; control groups of the included studies were completely different in 60 (52.17%) SRs; and 8.7% (n=10) of SRs failed to investigate heterogeneity in the process of synthesis analysis. Conclusion The heterogeneity is common in TCM related to SRs, and the most addressed is clinical heterogeneity. Addressing heterogeneity incorrectly would downgrade the quality of TCM related to SRs.
Objective To assess the quality of published systematic reviews and meta-analyses on Traditional Chinese Medicine (TCM) published in Chinese journals. Methods We searched CNKI, CMB from January 1995 to December 2006 and The Cochrane Library (Issue 4, 2006) for systematic reviews and meta-analyses on TCM. We extracted details of the interventions used in the treatment and control groups, analyzed the validity of included studies and investigated whether the reports used QUOROM statement or not. Results We identified 111 reports, of which 1 on prevention, 1 on adverse events, 1 on risk factors and premonitory symptoms, 2 on physiochemical parameters, and 106 on effectiveness and safety assessment. In total, 42 types of diseases were involved, and 41 reports were related to cerebrovascular diseases. As for the investigated interventions, 25 studies assessed TCM and 12 assessed acupuncture. Two had no control intervention design control in the group, 15 did not describe the interventions in the control group, 50 used active control (26 for western medicine, 12 for Chinese medicine, 12 for western plus Chinese medicine), 14 used blank control, 17 used baseline control, 4 used sham acupuncture or acupoint injection control etc., 5 used placebo control and 4 used "mutual control". The interventions used in the treatment and control groups varied widely. The number of trials included in the reviews and meta-analyses ranged from 1 to 35, and 24 studies included non-randomized controlled trials. Of the 111 reports, 14 were Cochrane reviews, 16 did not assess the quality of included randomized trials and a further 22 performed only simple and nonstandard quality assessment of the included trials. None of the reviews or meta-analyses used the QUOROM statement to report their results. Conclusions Because of the unique characteristics of TCM, systematic reviews of TCM should focus on a specific topic, avoid the selection of too many drugs, address the target indications of the test drugs and pay attention on intervention evaluation. High quality systematic reviews of TCM are needed but they will only be produced through the concerted efforts of clinicians, TCM practitioners and methodologists.
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
Objective To investigate inpatient disease constitution in Traditional Chinese Medicine (TCM) Hospital of Xinjiang Uygur Autonomous Region from 2008 to 2010, in order to provide baseline data for medicine allocation of hospitals in western China and development of TCM hospitals. Methods A questionnaire combined with a subject interview was carried out, and the case records of inpatients from 2008 to 2010 were collected. The diseases in discharge records were classified according to International Classification of Diseases (ICD-10) based on the first diagnosis. Data including general information of the inpatients, discharge diagnosis etc. were rearranged and analyzed by Excel software. Results a) The top four systematic diseases seen commonly from 2008 to 2010 were as follows: circulatory system diseases, musculoskeletal system and connective tissue diseases, respiratory system diseases and digestive system diseases. The top four single diseases were hypertension, intervertebral disc disease, diabetes, bronchitis, emphysema and other chronic obstructive pulmonary diseases. Respiratory system diseases ranked the third in 2009 and 2010 from the fourth in 2008, and circulatory system diseases had ranked the first during the past three years; b) The following diseases as hypertension, bronchial emphysema and other chronic obstructive pulmonary diseases, diabetes, fractures, airway (bronchus, lung) cancer, and viral hepatitis were commonly seen in males rather than in females. By contrast, intervertebral disc disease, gallstone disease and cholecystitis, and anemia were commonly seen in females; and c) Hypertension was commonly seen in the aged above 60 years old; intervertebral disc disease mainly focused on the patients at the age of 15 to 59; and bronchial emphysema and other chronic obstructive pulmonary diseases, airway (bronchus, lung) cancer involved in the patients who were mostly over 60 years old. Conclusion a) The top four systematic diseases seen commonly from 2008to 2010 are as follows: circulatory system diseases, musculoskeletal system and connective tissue diseases, respiratory system diseases and digestive system diseases. The top four single diseases are hypertension, intervertebral disc disease, diabetes, bronchitis, emphysema and other chronic obstructive pulmonary diseases. So these diseases should be taken into well consideration when making development plans by hospital and complementing essential drugs list by local development; b) Chronic diseases become the main disease for troubling Xinjiang population; and c) Male and female are susceptible to different diseases which should be rationally avoided in order to prevent the induced occurrence.
Traditional Chinese Medicine (TCM) clinical practice guidelines play essential roles in the development of TCM. However, the existing TCM guidelines are not effectively used in clinic. Based on this phenomenon, this article addresses the characteristics of clinical practice guidelines of TCM, and analyzes its status, problems and resolutions, providing feasible suggestions for the development of high-quality clinical practice guidelines of TCM which are in accordance with clinical practice.
Objective To evaluate the efficacy and safety of Chinese herb compared with an analgesic drug in the treatment of cancer pain. Methods We electronically searched CBM (1990 to 2008), CNKI (1990 to 2008), VIP (1990 to 2008), The Cochrane Library (Issue 3, 2008), and MEDLINE (1990 to 2008). Relevant journals and conference proceedings were also handsearched. The quality of the included trials was assessed according to the criteria recommended by the Cochrane Handbook for systematic reviews of interventions and meta-analyses were performed for homogeneous studies using the Cochrane collaboration’s review manager 4.2.2 software. Results Five randomized controlled trails (RCTs), all published in Chinese, involving 590 participants, were included. The quality of all RCTs was graded C (low). Meta-analyses were not performed due to heterogeneity. Instead, descriptive analyses were conducted. The results showed that as for the total effective rate in pain-relieving, Zhentongsan (RR=1.11, 95%CI 1.00 to 1.24, P=0.05) and Xiaozhengzhitong paste (RR=1.35, 95%CI 1.02 to 1.78, P=0.04) were more effective than Indometacin, with significant differences. There were no significant differences between Duyiwei capsule and Indometacin, and so were between Huajianbadumo as well as Shebingzhitong paste and Tramado. In terms of early potency, there were significant differences between Zhentongsan (SMD= –?9.87, 95%CI –10.84 to –8.89, Plt;0.000 01) as well as Xiaozhengzhitong paste (SMD= –8.74, 95%CI –10.164 to –7.32, Plt;0.000?01) and Indometacin, and so were between Shebingzhitong paste and Tramadol (SMD= –2.24, 95%CI –3.00 to –1.49, Plt;0.000?01). There were no significant differences between Huajianbadumo and Tramodo. With regard to the durative effect on pain-relieving, there were significant differences between Xiaozhengzhitong paste and Indometacin (WMD=4.78, 95%CI 2.99 to 6.57, Plt;0.00001), but not between Shebingzhitong paste and Tramadol. Conclusion Because of low quality of the existing studies, the current evidence is insufficient to define the efficacy and safety of compound Chinese herb, and further large-scale and high-quality RCTs are needed.