Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese medicine and Western medicine

Integrated traditional Chinese medicine(TCM)and Western medicine(WM)is a new medical science grounded in the knowledge bases of both TCM and WM,which then forms a unique modern medical system in China.Integrated TCM and WM has a long history in China,and has made important achievements in the process of clinical diagnosis and treatment.However,the methodological defects in currently published clinical practice guidelines(CPGs)limit its development.The organic integration of TCM and WM is a deeper integration of TCM and WM.To realize the progression of"integration"to"organic integration",a targeted and standardized guideline development methodology is needed.Therefore,the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

Application of multidisciplinary team-based integrated traditional Chinese medicine and Western medicine in rotator cuff injury patients undergoing arthroscopic surgery

BACKGROUND Arthroscopic rotator cuff repair is a common surgical treatment for rotator cuff injuries(RCIs).Although this procedure has certain clinical advantages,it requires rehabilitation management interventions to ensure therapeutic efficacy.AIM To investigate the effect of integrated traditional Chinese medicine and Western medicine(TCM-WM)under the multidisciplinary team(MDT)model on the postoperative recovery of patients undergoing arthroscopic surgery for RCIs.METHODS This study enrolled 100 patients who underwent arthroscopic rotator cuff repair for RCIs at the Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine between June 2021 and May 2024.They were divided into a control group(n=48)that received routine rehabilitation treatment and an experimental group(n=52)that received TCM-WM under the MDT model(e.g.,acupuncture,TCM traumatology and orthopedics,and rehabilitation).The results of the Constant–Murley Shoulder Score(CMS),Visual Analogue Scale(VAS),Shoulder Pain and Disability Index(SPADI),muscular strength evaluation,and shoulder range of motion(ROM)assessments were analyzed.RESULTS After treatment,the experimental group showed significantly higher CMS scores in terms of pain,functional activity,shoulder joint mobility,and muscular strength than the baseline and those of the control group.The experimental group also exhibited significantly lower VAS and SPADI scores than the baseline and those of the control group.In addition,the experimental group showed significantly enhanced muscular strength(forward flexor and external and internal rotator muscles)and shoulder ROM(forward flexion,abduction,and lateral abduction)after treatment compared with the control group.CONCLUSION TCM-WM under the MDT model improved shoulder joint function,relieved postoperative pain,promoted postoperative functional recovery,and facilitated the recovery of muscular strength and shoulder ROM in patients with RCIs who underwent arthroscopic rotator cuff repair.

Comprehensive effects of traditional Chinese medicine treatment on heart failure and changes in B-type natriuretic peptide levels: A meta-analysis

BACKGROUND Heart failure(HF),a common cardiovascular condition,is characterized by significant morbidity and mortality.While traditional Chinese medicine(TCM)is often used as a complementary approach in HF management,systematic evalua-tions of its impact on clinical outcomes,TCM syndrome scores,and B-type natriuretic peptide(BNP)levels are lacking.This study fills this gap through a comprehensive analysis of randomized controlled trials(RCTs)focusing on TCM for HF treatment.It encompasses an assessment of methodological quality,a meta-analysis,and an evaluation of evidence quality based on established standards.The results offer crucial insights into the potential advantages and constraints of TCM in HF management.RCTs on TCM for HF treatment published since the establishment of the database were searched in four Chinese and English databases,including China National Knowledge Infrastructure,Wanfang,VIP Information Chinese Science and Technology Journal,and PubMed.Methodological quality was assessed for the included studies with the Cochrane risk-of-bias assessment tool,and the meta-analysis and publication bias assessment was performed with the RevMan5.3 software.Finally,the quality of evidence was rated according to the GRADE criteria.RESULTS A total of 1098 RCTs were initially retrieved.After screening,16 RCTs were finally included in our study,which were published between 2020 and 2023.These RCTs involved 1660 HF patients,including 832 in the TCM group[TCM combined with conventional Western medicine(CMW)treatment]and 828 in the CWM group(CWM treatment).The course of treatments varied from 1 wk to 3 months.TCM syndrome differentiation was analyzed in 11 of the included RCTs.In all included RCTs,outcome indicators included comprehensive clinical outcomes,TCM syndrome scores,and BNP levels.The meta-analysis results showed significant differences between the TCM and CWM groups in terms of comprehensive clinical outcomes[risk ratio=-0.54;95%confidence interval(CI)=-0.61,-0.47;P<0.00001],TCM syndrome scores[weighted mean difference(WMD)=-142.07;95%CI=-147.56,-136.57;P<0.00001],and BNP levels(WMD=-142.07;95%CI=-147.56,-136.57;P<0.00001).According to the GRADE criteria,RCTs where"TCM improves clinical comprehensive outcomes"were rated as low-quality evidence,and RCTs where"TCM reduces TCM syndrome scores"or"TCM decreases BNP levels"were rated as medium-quality evidence.CONCLUSION TCM combined with CWM treatment effectively improves comprehensive clinical outcomes and diminishes TCM syndrome scores and BNP levels in HF patients.Given the low and medium quality of the included RCTs,the application of these results should be cautious.

Exploring the Application Effect of Flipped Classroom Combined with Problem-Based Learning Teaching Method in Clinical Skills Teaching of Standardized Training for Resident Doctors of Traditional Chinese Medicine

Objective: To explore the application effect of flipped classroom combined with problem-based learning teaching method in clinical skills teaching of standardized training for resident doctors of traditional Chinese Medicine. Methods: The study used the experimental control method. The study lasted from September to November 2022. The subjects of this study were 49 students of standardized training for resident doctors of traditional Chinese Medicine from grades 2020, 2021 and 2022 of Dazhou integrated TCM & Western Medicine Hospital. They were randomly divided into experiment group (25) and control group (24). The experiment group adopted flipped classroom combined with problem-based learning teaching method, and the control group adopted traditional teaching method. The teaching content was 4 basic clinical skill projects, including four diagnoses of traditional Chinese Medicine, cardiopulmonary resuscitation, dressing change procedure, acupuncture and massage. The evaluation method was carried out by comparing the students’ performance and a self-designed questionnaire was used to investigate the students’ evaluation of the teaching method. Results: The test scores of total scores in the experimental group (90.12 ± 5.89) were all higher than those in the control group (81.47 ± 7.96) (t = 4.53, P P Conclusions: The teaching process of the flipped classroom combined with problem-based learning teaching method is conducive to improving the efficiency of classroom teaching, cultivating students’ self-learning ability, and enhancing students’ willingness to learn.

Therapeutic Effect of Integrated Traditional Chinese and Western Medicine on Anal Pruritus After Anorectal Surgery

Objective:To explore the therapeutic effect of integrated traditional Chinese and western medicine on anal pruritus after anorectal surgery.Methods:Ninety-eight patients with anal pruritus after anorectal surgery in our hospital were selected as the research subjects.They were divided into two groups,the control group(50 cases)and the study group(48 cases),according to the treatment plan.The control group was under a simple western medicine treatment plan,while the study group was under an integrated traditional Chinese and western medicine treatment plan.The overall efficacy,severity of anal pruritus,time to eliminate clinical symptoms,and anxiety and depression scores of the two groups of patients under different treatment plans were compared.Results:After two weeks of treatment,the total effective rate of the study group was 95.83%,which was significantly higher than that of the control group(82.00%,P<0.05).After 7 and 14 days of treatment,the anal pruritus scores improved significantly in both the groups,but the study group was superior to the control group,with statistical difference(P<0.01).The time of disappearance of skin itching and skin damage in the study group was shorter than that in the control group.After 14 days of treatment,the anxiety and depression scores of both groups were lower than those after 7 days of treatment;however,there was statistical difference between the two groups(P<0.01).Conclusion:In the clinical treatment of anorectal postoperative diseases,such as anal pruritus,the combination of traditional Chinese and western medicine can significantly improve the symptoms of pruritus,shorten the time of disappearance of clinical symptoms,improve depression and anxiety,and create a positive clinical application value in promoting the rehabilitation of patients and improving their quality of life.

Enhancing ulcerative colitis treatment with traditional Chinese medicine

Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analysis that evaluated the efficacy of and highlighted the superior outcomes achieved by combining each of five traditional Chinese medicine(TCM)formulations with mesalazine for the adjuvant treatment of UC.Clinical outcomes included enhanced mucosal healing,improved quality of life,and reduced recurrence rates.Additionally,the combination therapy resulted in a lower incidence of adverse reactions compared with mesalazine monotherapy.Despite these promising results,limitations such as variability in study quality and TCM dosage highlight the need for further highquality,large-sample,multicenter randomized controlled trials.This editorial underscores the potential of TCM in enhancing UC management and calls for more rigorous research to substantiate these findings and refine clinical guidelines.

Clinical Effect of Fuming-Washing with Traditional Chinese Medicine after Anorectal Surgery

Objective:To observe the effect of fuming-washing with traditional Chinese medicine(TCM)after anorectal surgery.Methods:116 cases of patients with surgical operation were selected in the anorectal department of our hospital,which is Shenzhen Bao'an Hospital of Traditional Chinese Medicine,Shenzhen.According to the different postoperative adjuvant treatment methods implemented by patients,they were divided into two groups under the premise of equal number of patients.Among them,58 cases of patients with traditional Chinese medicine(TCM)fuming-washing treatment were divided into study group,and patients with hip bath treatment with potassium permanganate solution were divided into common group.The efficacy of adjuvant therapy was observed.Results:The observation and analysis showed that the actual effect of TCM adjuvant therapy was more prominent,and the difference between groups was more significant(P<0.05).Conclusion:The effect of traditional Chinese medicine adjuvant therapy is more significant than that of chemical method,which can help patients achieve better postoperative recovery effect.We should popularize this treatment in time for patients after surgery,and improve the prognosis of patients.

A retrospective study on professor Gui-Qi Xuan’s experience in traditional Chinese medicine treatment on attention-deficit hyperactivity disorder: based on data mining and network pharmacology

Background:To investigate the clinical medication approach of Professor Guiqi Xuan(Prof.Xuan)in treating pediatric patients with attention-deficit hyperactivity disorder(ADHD)and the potential mechanism of the core herbal prescription.Methods:Following medical record information pretreatment,the Traditional Chinese Medicine(TCM)inheritance computing platform system V3.0 was utilized to analyze the standardized data.The associate rules were summarized to identify the core prescription for treating ADHD.The extracted core herbal prescription’s active compounds and potential targets were used to establish a protein-protein interaction network of active ingredient-disease targets.Cytoscape 3.9.1 software was used to analyze the network’s topological parameters to obtain the key active ingredients and their targets.The Bioconductor data package of R4.0.2 was used to analyze the gene ontology biological functions and Kyoto Encyclopedia of Genes and Genomes pathways of key targets.Results:Two hundred and twenty-seven entries derived from TCM record information were selected.Through data mining,it was found that 62.5%of pediatric patients had short-tempered behavior,nearly half had sleep problems,and 30%-40%had picky eating and polyphagia issues.The highest-frequency syndrome type was kidney deficiency and liver hyperactivity.Deficiency,fire,phlegm,and dyspeptic food were the main pathological factors for ADHD.Prof.Xuan’s treatment of ADHD mainly focused on replenishing kidney essence and subduing Yang(active,external,ascending,warm,bright,functional and excited pertain to Yang).The core herbal prescription for ADHD included Yuan-zhi,Yi-zhi,Gui-jia,Bai-shao,Long-chi,Ci-shi,Shi-chang-pu,Yu-jin,Fu-shen,and Huang-jing.The protein-protein interaction network showed that MAOA,ADRB2,FOS,MAOB,and SLC6A3 were the five key targets essential in treating ADHD with core herbal prescriptions.The gene ontology biological function of crucial targets mainly involved G protein-coupled amine receptor activity,catecholamine binding,and neurotransmitter transmembrane transporter activity.Analysis of Kyoto Encyclopedia of Genes and Genomes pathways showed that the dopaminergic synapse signaling and neuroactive ligand-receptor interaction pathways were significantly enriched and may be the primary routes for the main treatment of ADHD.Conclusion:Prof.Xuan’s treatment of ADHD has achieved satisfactory clinical effects by supplementing the kidney,replenishing the essence,opening the orifices,nourishing the Yin(static,internal,descending,cold,dim,organic,depressed and pertain to Yin),and subduing the Yang.The major prescription predominantly affects catecholamine binding,neuroactive ligand-receptor interaction,G protein-coupled amine receptor function,and signaling pathways for dopaminergic synapses.Our findings showed that the methodology and software used in this research could explore and analyze the mechanism behind Prof.Xuan’s clinical medication rule for treating ADHD in children.

Property theory of Chinese materia medica: Clinical pharmacodynamics of traditional Chinese medicine

The property theory of Chinese materia medica is one of the foundations of traditional Chinese medicine.The property of Chinese materia medica(PCMM)is a multi-dimensional expression of the effect of Chinese materia medica(CMM),and it is related to the clinical prescription that fully reflects the clinical effect evaluation of CMM in a holistic,systematic,and scientific way.This paper discusses the source,development,and application of the PCMM by considering not only the five dimensions that constitute the PCMM but also the recognition of the human body and disease as given in traditional Chinese medicine.This paper aims to provide theoretical guidance for the rational use and development of CMM.

Clinical evidence of traditional Chinese medicine for the prevention and treatment of chronic heart failure

Objective: To summarize clinical evidence of traditional Chinese medicine for the prevention and treatment of chronic heart failure systematically and comprehensively. Method:By retrieving in the database of VIP, WanFang, CNKI, PubMed, Cochrane Library, the qualifying results obtained in the databases above are summarized into the grading evidence including systematic reviews, randomized controlled trials, observational studies, case studies, basic research these five levels. Results: The numbers of the articles included are 12 systematic reviews, 413 randomized controlled trials, 68 observational studies, 15 case reports and 187 fundamental researches. Conclusion: It is concluded that basing on the clinical evidence of different levels, traditional Chinese medicine has prominent ability of preventing and treatment chronic heart failure.

Clinical distribution and molecular profiling on postoperative colorectal cancer patients with different traditional Chinese medicine syndromes

Background:Traditional Chinese medicine(TCM)syndrome,also named syndrome,are comprehensive and integral analyses of clinical information which helps to guide different individualized treatment prescriptions.Methods:Thirty healthy controls and 80 colorectal cancer(CRC)patients(including 33 Spleen Qi Deficiency syndrome,23 Dampness Heat syndrome,17 Blood Stasis syndrome and 7 other syndrome)were enrolled into this study.Human mRNAs were extracted from peripheral blood mononuclear cells.The gene expression for CRC patients with different TCM syndrome was determined by microarray and qRT-PCR.Results:Spleen Qi Deficiency,Dampness Heat and Blood Stasis were the most common syndromes in CRC patients.There is a significant difference was found in mRNA expression levels(especially for PIK3CA,STAT3,SOX9 and KDM5C)among Spleen Qi Deficiency,Dampness Heat and Blood Stasis syndrome groups.The higher mRNA levels of JNK1,TP53,MLH1,MSH6,PMS2,SOCS3,TCF7L2,FAM123B,PSAP,FBXW7,SALL4 and the lower expression of inflammatory cytokine IL-6 were found in Spleen Qi Deficiency group but not other syndrome types.The higher mRNA levels of KRAS,MUC16,EGFR,GRASP65,PIK3CA,MAPK7,CD24,STAT3,SLC11A1,Bcl-2,TXNDC17 and some inflammatory cytokines(IL-6,IL-23,TNF-a,CXCR4)were found in Dampness Heat group but not other syndrome types.Blood Stasis syndrome showed higher expression of SOX9,MLH1,MSH6,KDM5C,PCDH11X,PSAP and SALL4,and lower mRNA levels of PIK3CA,CD24,STAT3,CXCR4,TXNDC17 and TP53.The CRC patients with Dampness Heat syndrome might have a poor prognosis than other syndrome types.Conclusion:The identification of syndrome conditions had different impacts on CRC prognosis,and which might be related with different mRNA expression levels.Some oncogenes and pro-inflammatory cytokines were highly expressed in Dampness Heat group but not other syndrome types,suggesting that the CRC patients with Dampness Heat syndrome might have a poor prognosis.Our results prelimitarily uncovered the molecular basis of syndrome differences in CRC prognosis,a better understanding for TCM treatment of CRC.

Clinical Research progress of traditional Chinese medicine in treating esophageal cancer

Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.

Effects of Traditional Chinese Medicine Five-element Music Combined with Acupoint Application on Perioperative Sleep Quality in Patients Undergoing Joint Replacement Surgery

OBJECTIVE: To explore the effects of traditional Chinese medicine(TCM) five-element music combined with acupoint application on perioperative sleep quality in patients undergoing joint replacement surgery. METHODS: In this study, a total of 122 patients with joint replacement surgery in Beijing Jishuitan Hospital were targeted from 2015 to 2018. All patients were grouped by random number table method. Among them, 61 patients with routine nursing were included in the control group. On this basis, the other 61 patients with acupoint application and TCM five-element music therapy were included as the observation group. 2 weeks later, the Pittsburgh Sleep Quality Index(PSQI) was used to evaluate sleep quality in all patients. The sleep improvement of the 2 groups was evaluated, and the patient was assessed for anxiety and depression, and the curative efficacy was evaluated. RESULTS: After 2 weeks of nursing, the PSQI of the patients improved significantly. The PSQI of the observation group was only 6.6 ± 2.4, and the control group decreased to 9.9 ± 2.7. The observation group was better than the control group, and the difference was statistically significant(P < 0.05). Comparing the 2 groups, the anxiety score of the observation group decreased to 4.8 ± 1.6, which was significantly lower than that of 6.9 ± 2.2 in the control group. The depression score of the observation group decreased to 4.6 ± 1.3, which was significantly lower than that of 6.8 ± 2.3 in the control group. In the control group, the negative emotion scores after nursing were better than those before nursing, and the difference was statistically significant(P < 0.05). Comparing the 2 groups, the effective rate of sleep improvement in the observation group was 96.6%, and the cure rate was as high as 49.1%. The control group was 82.0%, and the cure rate was 18.0%. The observation group was better than the control group, and the difference was statistically significant(P < 0.05). CONCLUSION: The combination of TCM five-element music with acupoint application can improve the perioperative sleep quality of patients undergoing joint replacement surgery, and it can help patients to relieve negative emotions. It is worth promoting.

Clinical research progress of oral administration of traditional Chinese medicine in the treatment of dry eyes

Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.

Discussion on the Application of Ascending and Descending Property of Traditional Chinese Medicine in Compatibility of Clinical Prescriptions

Through the method of literature mining,the classics of traditional Chinese medicine,materia medica works,medical cases and documents are studied.Based on common prescriptions for the treatment of diseases such as abnormal Zang-fu viscera and qi movement,dysfunction,etc.,and combined with the theory of ascending and descending property of traditional Chinese medicine,the application of ascending and descending property of traditional Chinese medicine in clinical prescription compatibility and the factors affecting the application are summarized.The ascending and descending properties of traditional Chinese medicine have been widely used in prescription compatibility for the clinical treatment of impairment of purifying and descending function of the lung,spleen and stomach's ascending and descending disorders and heart-kidney noninteractionpatte.

Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database

With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.

Clinical observation of traditional Chinese medicine nursing on recovery of gastrointestinal function in patients after abdominal operation

Objective: To observe the clinical effect of traditional Chinese medicine nursing on the recovery of gastrointestinal function after abdominal operation. Methods: A total of 148 patients undergoing abdominal surgery from June 2013 to June 2014 in our hospital were randomly divided into observation group and control group, 74 cases in each group. The control group received routine nursing and the observation group was treated with the pointer, acupuncture and external application of abdominal treatment on the basis of routine nursing, which is 2 times a day,7 days for a course of treatment. Results: The recovery time of bowel sound, the first anal exhaust defecation time the in the observation group and the hospital day was less than the control group. With the comparison of two groups, the difference between the two groups was statistically significant (P < 0.05). The incidence of abdominal pain, abdominal distension, nausea, vomiting and constipation in the observation group was significantly lower than that in the control group (P < 0.05). Conclusion: On the basis of routine nursing, the implementation of traditional Chinese medicine characteristic nursing can effectively promote the recovery of gastrointestinal function, reduce the occurrence of complications, shorten the length of stay and improve the clinical effect.

Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice

Traditional Chinese medicine(TCM)clinical efficacy evaluation runs through the development of TCM and has been progressing so far.With the introduction of evidence-based medicine(EBM)in recent 20 years,TCM clinical efficacy evaluation has developed rapidly,accumulated research and experience,improved the quality and standardization of research,but also gradually found deep-seated deficiencies.In 2019,the China Center for Evidence-based Traditional Chinese Medicine(CCEBTCM)was established,and TCM was included in the 11th revision of the International Statistical Classification of Diseases(ICD-11).In above opportunities for TCM clinical efficacy evaluation,it is necessary to face up to the previous deficiencies,so that the TCM clinical efficacy evaluation can truly reflect the actual clinical practice characteristics,including TCM clinical problems,TCM thinking and TCM diagnosis&treatment mode.Based on the summary and analysis of past research,development concepts are proposed in this article.On the one hand,original concepts of TCM should be confidently paid more attention to the design and implementation of TCM clinical efficacy evaluation to be close to TCM clinical practice.On the other hand,it is necessary to consolidate the foundation of TCM clinical practice before evaluating efficacy.Evaluated object built on TCM ontology knowledge should be demonstrated based on clinical practice,and unknown evaluated object combined with new methods,technologies and concepts should be maturely integrated in clinical practice firstly.

Clinical Effect of Integrated Traditional Chinese and Western Medicine on Diabetic Peripheral Neuropathy

Objective:Patients with diabetic peripheral neuropathy were treated with integrated traditional Chinese and western medicine,and the final results were observed.Methods:70 patients with such symptoms were randomly divided into two groups.The number of people is the same,and the treatment methods are different.The control group uses western medicine,while the observation group uses traditional Chinese medicine to evaluate the treatment effect.Results:After treatment,the effective rate of the observation group was(P<0.05),indicating that the treatment effect was significantly better.Conclusion:Patients with clinical diabetic peripheral neuropathy treated with routine nutrition and nerve repair,and with Chinese medicine,the effect is more satisfactory,and the effect is positive,so as to promote the optimization of their health.

Efficacy and Safety of Lianhua Qingke Tablets in the Treatment of Long Coronavirus Disease (COVID) Cough: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study

Lianhua Qingke tablets,a patented traditional Chinese medicine that has validated clinical efficacy for treating cough caused by severe acute respiratory syndrome coronavirus 2 infection,lack rigorous evidence-based research evaluating their effect on long coronavirus disease(COVID)cough.A randomized,double-blind,placebo-controlled,multicenter clinical study was conducted among patients with long COVID cough from 19 hospitals and 23 community health centers in China.Patients were randomized 1:1 to receive either Lianhua Qingke tablets or placebo orally for 14 days(four tablets,1.84 g,three times a day).The primary endpoint indicator was the disappearance of cough,with the remission of cough also considered.Among 482 randomized patients,480(full analysis set 480;per-protocol set 470;safety set 480)were included in the primary analysis.According to the full analysis,the time until cough disappearance was significantly shorter in the trial group than in the control group,with a significant increase in the 14-day cough disappearance rate.Accordingly,the time to cough remission was significantly shorter in the trial group than in the control group.The change in the total symptom score was significantly greater in the trial group than in the control group on days 7 and 14,consistent with the results indicated by the visual analog scale(VAS)and cough evaluation test(CET)scores.No serious adverse events were recorded during the study.Lianhua Qingke tablets significantly improved the clinical symptoms of patients with long COVID cough.