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The Efficacy of Heat-Clearing (Qingre) and Detoxifying (Jiedu) Traditional Chinese Medicine Gargle for Chemotherapy-Induced Oral Mucositis: A Systematic Review and Meta-Analysis.

ABSTRACT: Objective: Chemotherapy-induced oral mucositis (CIOM) is an extremely serious complication of cancer. In China, the heat-clearing (Qingre) and detoxifying (Jiedu) traditional Chinese medicine QRJD-TCM gargle has been widely used to treat CIOM. To date, no systematic evaluation has been conducted on the clinical efficacy of QRJD-TCM gargle in treating CIOM. The objective of this systematic review and meta-analysis was to evaluate the efficacy of QRJD-TCM gargle in the treatment of CIOM. Methods: Relevant randomized controlled trials (RCTs) comparing QRJD-TCM gargle with conventional Western medicine mouthwash (CWMM) for CIOM were confirmed by systematically searching PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Wanfang Database, and Sinomed until October 20, 2020. Two researchers independently assessed the risk of bias according to the Cochrane risk-of-bias criteria. Excel 2010 was used in setting up a database of extracted information, and RevMan 5.3.0 was used in analyzing included trial data. The composition of the QRJD-TCM gargle was evaluated. Results: A total of 25 articles were included in this meta-analysis. Results showed that compared with CWMM, QRJD-TCM gargle can reduce the incidence of CIOM (OR = 0.23, 95% CI [0.18, 0.29], p < 0.00001) and severity of CIOM (grade I-II: OR = 0.36, 95%CI [0.28, 0.46], p < 0.00001; grade III-IV: OR = 0.15, 95%CI [0.09, 0.28], p < 0.00001). In addition, QRJD-TCM gargle improved the effective rate of CIOM (OR = 15.91, 95% CI [7.93, 31.89], p < 0.00001). Conclusion: QRJD-TCM gargle is effective in preventing and treating CIOM. However, more standard, double-blind, and multicenter randomized controlled studies are needed to further confirm the efficacy of QRJD-TCM gargle in the prevention and treatment of CIOM.

SUBMITTER: Lin Z

PROVIDER: S-EPMC8040107 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PurposeThe purpose of this study is to study the effects of heat-clearing Traditional Chinese Medicine (TCM) in the stable stage of bronchiectasis via N-of-1 trials.MethodsThe N-of-1 trials in this study were randomized and double-blinded with crossover comparisons consisting of three pairs. Each pair was of two 4-week periods. Each patient took the individualized decoction in the experimental period and the individualized decoction was removed of heat-clearing drugs, mainly including heat-clearing and detoxifying drugs, in the control period for three weeks. After three weeks, the patients stopped taking the decoction for one week. The primary outcome was from patients' self-reporting symptoms scores on a 1-7-point Likert scale. Mixed-effects models were used to conduct statistical analysis on these N-of-1 trials.ResultsOf the 21 patients enrolled, 15 completed three pairs of N-of-1 trials (71.43%). (1) Seen from the individual level, no statistical difference between the experimental decoction and the control (P > 0.05) was observed. However, 5 patients found better decoctions according to the clinical criteria. (2) As revealed by the group data of all the N-of-1 trials, the control was better than the individualized decoction in terms of symptom scores on the Likert scale (1.94 ± 0.69 versus 2.08 ± 0.68, P = 0.04, mean difference, and 95% CI: 0.19 (0.01, 0.37)) and on CAT scores (13.66 ± 6.57 versus 13.95 ± 6.97, P = 0.04, mean difference, and 95% CI: 0.86 (0.042, 1.67)), but such differences were not clinically significant. The other outcomes, such as Likert scale score of respiratory symptoms and 24-hour sputum volume, showed no statistical difference.ConclusionThe experimental design of this study can make the TCM individualized treatment fully play its role and can detect the individualized tendencies according to the severity of phlegm and heat in some subjects. With the intermittent use or reduced use of heat-clearing drugs, most of the subjects, at the group level, enrolled in the series of N-of-1 trials may improve the symptoms and quality of life while saving the cost of TCM and reducing the potential side effects of heat-clearing TCM. This trial is registered with clinicaltrials.goc (NCT03147443).

Project description:"Shanghuo" ("excessive internal heat") is caused by exuberant endogenous fire, which does not have a comprehensive and systematic traditional Chinese medicine theory. In previous study, we had evaluated the therapeutic effect of Huanglian Jiedu Decoction (HLJDD) (granule) on patients with "Shanghuo", however, the specific mechanism was not clear, which need further exploration. To explain its intervention mechanism, we select 57 patients with oral diseases caused by "Shanghuo" and 20 health volunteers to divide into oral disease group, HLJDD intervention group and healthy control group. Firstly, biochemical indicators before and after HLJDD intervention are detected, such as inflammatory factors, oxidative stress factors and energy metabolism factors. The results exhibit that HLJDD significantly decreases indicators succinic acid (p < 0.001); tumor necrosis factor-alpha, adenosine triphosphate, citric acid (p < 0.01); interleukin-8 (IL-8), 4-hydroxynonenal, pyruvic acid, lactate dehydrogenase (p < 0.05). The levels of glucocorticoid, adrenocorticotropic hormone (p < 0.01); lactic acid, IL-4, IL-10 (p < 0.05) significantly increase after HLJDD intervention. In addition, we adopt multi-omics analysis approach to investigate the potential biomarkers. Nontargeted metabolomics demonstrate that the levels of 7 differential metabolites approach that in the healthy control group after HLJDD intervention, which are correlated with histidine metabolism, beta-alanine metabolism and sphingolipid metabolism through metabolic pathway analysis. Targeted lipidomics results and receiver operating characteristic curve analysis show that 13 differential lipids are identified in the three groups mainly focuse on lysophosphatidylcholines, lysophosphatidylethanolamines. Finally, the network associations of those differential biomarkers reveal the regulation of adenosine triphosphate and tricarboxylic acid cycle play essential role in the therapeutic effect mechanism of HLJDD in "Shanghuo". The study has laid the foundation for further revealing the mechanism and finding clinical biomarkers related to "Shanghuo".

Project description:BackgroundAction ("gongxiao" in Chinese) of traditional Chinese medicine (TCM) is the high recapitulation for therapeutic and health-preserving effects under the guidance of TCM theory. TCM-defined herbal properties ("yaoxing" in Chinese) had been used in this research. TCM herbal property (TCM-HP) is the high generalization and summary for actions, both of which come from long-term effective clinical practice in two thousands of years in China. However, the specific relationship between TCM-HP and action of TCM is complex and unclear from a scientific perspective. The research about this is conducive to expound the connotation of TCM-HP theory and is of important significance for the development of the TCM-HP theory.MethodsOne hundred and thirty-three herbs including 88 heat-clearing herbs (HCHs) and 45 blood-activating stasis-resolving herbs (BAHRHs) were collected from reputable TCM literatures, and their corresponding TCM-HPs/actions information were collected from Chinese pharmacopoeia (2015 edition). The Kennard-Stone (K-S) algorithm was used to split 133 herbs into 100 calibration samples and 33 validation samples. Then, machine learning methods including supported vector machine (SVM), k-nearest neighbor (kNN) and deep learning methods including deep belief network (DBN), convolutional neutral network (CNN) were adopted to develop action classification models based on TCM-HP theory, respectively. In order to ensure robustness, these four classification methods were evaluated by using the method of tenfold cross validation and 20 external validation samples for prediction.ResultsAs results, 72.7-100% of 33 validation samples including 17 HCHs and 16 BASRHs were correctly predicted by these four types of methods. Both of the DBN and CNN methods gave out the best results and their sensitivity, specificity, precision, accuracy were all 100.00%. Especially, the predicted results of external validation set showed that the performance of deep learning methods (DBN, CNN) were better than traditional machine learning methods (kNN, SVM) in terms of their sensitivity, specificity, precision, accuracy. Moreover, the distribution patterns of TCM-HPs of HCHs and BASRHs were also analyzed to detect the featured TCM-HPs of these two types of herbs. The result showed that the featured TCM-HPs of HCHs were cold, bitter, liver and stomach meridians entered, while those of BASRHs were warm, bitter and pungent, liver meridian entered.ConclusionsThe performance on validation set and external validation set of deep learning methods (DBN, CNN) were better than machine learning models (kNN, SVM) in sensitivity, specificity, precision, accuracy when predicting the actions of heat-clearing and blood-activating stasis-resolving based on TCM-HP theory. The deep learning classification methods owned better generalization ability and accuracy when predicting the actions of heat-clearing and blood-activating stasis-resolving based on TCM-HP theory. Besides, the methods of deep learning would help us to improve our understanding about the relationship between herbal property and action, as well as to enrich and develop the theory of TCM-HP scientifically.

Dataset Information

The Efficacy of Heat-Clearing (Qingre) and Detoxifying (Jiedu) Traditional Chinese Medicine Gargle for Chemotherapy-Induced Oral Mucositis: A Systematic Review and Meta-Analysis.

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