Can Tibetan medicine Honghua Ruyi pills relieve endometriosisassociated dysmenorrhea?Protocol for a randomized placebocontrolled trial

Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.

Traditional Chinese medicine for acute mountain sickness prevention: A systematic review and meta-analysis of randomized controlled trials

Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.

Reliability and validity of the Tibetan medicine constitution scale: a cross-sectional study of the general population in Beijing, China

Background:The constitutional theory is an important aspect of Tibetan medicine,however a quantitative measurement tool for constitution identification still does not exist.The objective of this study is to evaluate the reliability and validity of a Tibetan medicine constitution scale(TMCS)that consists of three sub-scales and 31 items.Methods:From June to July 2019,622 people from the general population in Beijing,China,aged 18 to 60 were investigated.We employed Cronbach’s alpha(α),split-half reliability,and test-retest reliability to determine the reliability of the scale.The content validity and contract validity of the TMCS were evaluated using factor analysis and correlation analysis based on Tibetan medicine theory.The items were screened according to the reliability test results.Results:After the items were screened,22 items remained in the scale.The Cronbach’s alpha value for the internal consistency reliability of the TMCS was 0.754(95%confidence interval(CI):0.700–0.761).The correlation coefficient for the two-week test-retest of the total score was 0.726(95%CI:0.571–0.834).The split-half coefficient was 0.689(95%CI:0.640–0.734).The scale can be explained by eight potential factors,including morphological structure,physiological function,personality,adaptability,etc.The body mass index was negatively correlated with the score of the sub-rlung scale(r=−0.376),slightly positively correlated with the sub-mkhris pa scale(r=0.099),and positively correlated with the sub-bad kan scale(r=0.362).Conclusion:The TMCS is a reliable and valid instrument that can be used to assess the body constitution of the general population in Beijing,China.Future studies are needed to explore the differences in biological characteristics among the constitutional types and the association between constitution and disease.

Correlation between Tibetan and traditional Chinese medicine body constitutions: A cross-sectional study of Tibetan college students in the Tibet Autonomous Region

Objective:To evaluate the correlation between the body constitution types of Tibetan medicine and traditional Chinese medicine (TCM).Methods:The cluster sampling method was employed to recruit participants from a university in the Tibet Autonomous Region.Tibetan medicine and TCM questionnaires were respectively used to assess the participants' constitution information.Descriptive statistics were applied to analyze the baseline and constitution characteristics of the participants.Two-factor correlation analysis and the paired chi-square test were applied to analyze the correlation between Tibetan and TCM constitution types.Results:Data from 466 Tibetan students were analyzed.The mean scores of the rlung,mkhris pa,and bad kan constitution types in Tibetan medicine were 43.2 (11.1),42.1 (10.1),and 45.0 (8.0),respectively;participants with the three-factor convergence body constitution type accounted for 13.7% of the whole population.Among the TCM constitution types,qi stagnation was the most common (21.5%),followed by the balance type (16.5%);the other constitutions detected were qi deficiency,yin deficiency,and yang deficiency.The rate of consistency for the identification of the three-factor convergence constitution in Tibetan medicine and the balance constitution in TCM was 89.1%,with a Kappa coefficient of 0.57 (P >.05).The rlung constitution in Tibetan medicine was associated with the yin deficiency,yang deficiency,and blood stasis constitutions in TCM.The mkhhris pa constitution in Tibetan medicine was associated with the damp heat and yin deficiency constitutions in TCM.The bad kan constitution in Tibetan medicine was associated with the phlegm dampness,qi deficiency,and yin deficiency constitutions in TCM.Conclusion:There is a correlation between the body constitution types of Tibetan medicine and TCM.The reliability and validity of the Questionnaire for TibetanMedicine Constitution requires improvement,and more studies with larger sample sizes and more varied populations are warranted to verify the correlation between Tibetan medicine and TCM constitutions.

The gap between clinical practice and limited evidence of traditional Chinese medicine for COVID-19

Background Traditional Chinese medicine(TCM)is the set of knowledge and practices concerning life,health,illness prevention,and treatment that originated in China thousands of years ago.Presently,TCM is still one of the mainstream medical systems,and has been given an equal legal status and place as Western medicine in the healthcare system of China[1].Whether it was the plague in ancient times or the SARS and influenza A in the past decades,TCM has always played a major role in the prevention and treatment of diseases[2].

Association between metabolic syndrome and body constitution of traditional Chinese medicine:A systematic review and meta-analysis

Background:The constitution theory of traditional Chinese medicine(TCM)states that body constitution and disease are associated;therefore,the identification of body constitution can provide reference for disease prevention and treatment.A series of clinical studies evaluating the association between TCM constitution and metabolic syndrome(MetS)have been conducted in recent years.The aim of this systematic review is to summarize and evaluate the clinical evidence of the relationship between constitution and MetS.Methods:The PubMed,Embase,China National Knowledge Infrastructure(CNKI),Chongqing VIP,and Wanfang Data electronic databases were searched from April 2009 to July 2020.The search terms included“metabolic syndrome,”“constitution,”and“Chinese medicine.”Observational studies evaluating the relationship between body constitution of TCM and MetS were included.The primary outcome included the distribution of constitutional types in the MetS population,and odds ratio(OR)or relative risk(RR)between constitution and MetS.Effect size was expressed as proportion or OR with 95%confidence interval(CI).Methodological quality of included studies was evaluated by the NewcastleeOttawa Scale(NOS)or the American Agency for Healthcare Research and Quality(AHRQ)criteria.Results:Three caseecontrol and 26 cross-sectional studies involving 30435 cases were included.Phlegm-dampness,qi-deficiency,and damp-heat were the main constitution types in patients with MetS,accounting for 29%(22%e39%),18%(13%e24%),and 12%(9%e17%)of the population,respectively;the risk of MetS in people with phlegm-dampness and qi-deficiency constitution was 1.74[1.27,2.38]and 1.29[1.01,1.65]times higher than that in those with other constitutions.There were sex-and age-related differences in the distribution of TCM constitution in patients with MetS.Conclusion:Phlegm-dampness and qi-deficiency were associated with the occurrence of MetS.Welldesigned cohort and caseecontrol studies are needed to provide evidence for the use of TCM to prevent and treat MetS.

Can Chinese Medicine Be Used for Prevention of Corona Virus Disease 2019 (COVID-19)? A Review of Historical Classics, Research Evidence and Current Prevention Programs

Objective:Since December 2019,an outbreak of corona virus disease 2019(COVID-19)occurred in Wuhan,and rapidly spread to almost all parts of China.This was followed by prevention programs recommending Chinese medicine(CM)for the prevention.In order to provide evidenee for CM recommendations,we reviewed ancient classics and human studies.Methods:Historical records on prevention and treatment of infections in CM classics,clinical evidence of CM on the prevention of severe acute respiratory syndrome(SARS)and H1N1 in flue nza,and CM preve ntion programs issued by health authorities in China since the COVID-19 outbreak were retrieved from differe nt databases and websites till 12 February,2020.Research evide nee in eluded data from clinical trials,cohort or other population studies using CM for preventing contagious respiratory virus diseases.Results:The use of CM to prevent epidemics of infectious diseases was traced back to ancient Chinese practice cited in Huangdi's Internal Classic(Huang Di Nei Jing)where preventive effects were recorded.There were 3 studies using CM for prevention of SARS and 4 studies for H1N1 influenza.None of the participants who took CM contracted SARS in the 3 studies.The infection rate of H1N1 in flue nza in the CM group was significantly lower than the non-CM group(relative risk 0.36,95%confidence interval 0.24-0.52;n=4).For prevention of COVID-19,23 provinces in China issued CM programs.The main principles of CM use were to tonify qi to protect from external pathoge ns,disperse wind and discharge heat,and resolve damp ness.The most frequently used herbs in eluded Radix astragali(Huangqi),Radix glycyrrhizae(Gancao),Radix saposhnikoviae(Fangfeng),Rhizoma Atractylodis Macrocephalae(Baizhu),Lonicerae Japonicae Flos(Jinyinhua),and Fructus forsythia(Lianqiao).Conclusions:Based on historical records and human evidenee of SARS and H1N1 influenza prevention,Chinese herbal formula could be an alternative approach for prevention of COVID-19 in high-risk population.Prospective,rigorous population studies are warranted to confirm the potential preventive effect of CM.

Chinese herbal medicine for subacute thyroiditis:a systematic review of randomized controlled trials

OBJECTIVE:To evaluate the effectiveness and safety of Chinese herbal medicine(CHM) in the treatmentofsubacutethyroiditis.METHODS: Randomized controlled trials found in PubMed, Cochrane Library, and three Chinese databases were selected. RevMan 5.2 software was used to analyze the data with relative risk or mean difference, expressed with 95% of confidence interval. The quality of trials was assessed and gradedthe quality of evidence with GRADE profiler software.RESULTS: Twenty one studies were included. CHM was superior to Western Medicine(include prednisone and NSAIDs) in abating fever, relieving thyroid pain, recovering blood sedimentation, improving thyroid function, and preventing hypothyroidism(P<0.05), while no statistical differences were found in eliminating goiter and reducing relapse rate.CHM plusWestern Medicine were superior toWestern Medicine in abating fever, relieving thyroid pain, eliminating goiter, and reducing relapse rate,while no statistical differences(P>0.05) were found in recovering blood sedimentation and improving thyroid function. The incidence of adverse reactions in treatment group was lower than that in control group(relative risk was 0.12 and 95% confidence interval was 0.03-0.51). The methodological quality of trials is generally poor with a high risk of bias.CONCLUSION: CHM(particularly CHM combined withWestern Medicine) used to treat subacute thyroiditis may improve clinical symptoms and signs,reduce relapse rate, and alleviate the side effects of hormones. Due to poor methodological quality of included trials, further more high-quality studies are warranted to confirm the effectiveness and safety of CHM.

Clinical research linking Traditional Chinese Medicine constitution types with diseases:a literature review of 1639 observational studies

OBJECTIVE:To analyze clinical studies on correlations between Traditional Chinese Medicine(TCM)body constitution types and diseases published in the past 10 years,and to provide an evidence base to support the use of such correlations for health maintenance and disease prevention.METHODS:We searched five databases for the period April 2009 to December 2019:China National Knowledge Infrastructure Database,Wanfang Database,China Science and Technology Journal Database,PubMed and Embase.Three types of observational studies on correlation between constitution types and diseases were included:cross-sectional,case-control and cohort studies.Descriptive statistical methods were employed for data analysis.RESULTS:A total of 1639 clinical studies were identified:1452(88.59%)cross-sectional studies,115(7.02%)case-control studies and 72(4.39%)cohort studies covering 30 regions of China and five other countries(Malaysia,South Korea,Singapore,Thailand and France).The collection of studies comprised 19 disease categories and 333 different diseases.The 10 most commonly studied diseases were hypertension,diabetes,stroke,coronary atherosclerotic heart disease(CAHD),sleep disorders,neoplasm of the breast,dysmenorrhea,fatty liver disease,chronic viral hepatitis B and dyslipidemia.We found high distributions for each biased constitution type in different patient populations as follows:Qi-deficiency constitution in stroke,diabetes,chronic obstructive pulmonary disease,acquired immunodeficiency syndrome and hypertension;Yang-deficiency constitution in female infertility,osteoporosis,irritable bowel syndrome,gonarthrosis and dysmenorrhea;Yin-deficiency constitution in hypertension,diabetes,constipation,female climacteric states and osteoporosis;phlegm-dampness constitution in hypertension,stroke,fatty liver disease,diabetes and metabolic syndrome;damp-heat constitution in acne,chronic gastritis,chronic viral hepatitis B,human papillomavirus infection and hyperuricemia;blood-stasis constitution in CAHD,endometriosis and stroke;Qi-stagnation constitution in hyperplasia and neoplasms of the breast,insomnia,depression and thyroid nodules;and inherited-special constitution in asthma and allergic rhinitis.CONCLUSION:Eight biased TCM constitutions were closely related to specific diseases,and could be used to guide individualized prevention and treatment.More rigorously designed studies are recommended to further verify the constitution-disease relationship.

Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections:A Multicenter Randomized Controlled Trial

Objective:To assess the effectiveness of Jiuwei Zhuhuang Powder(JWZH),a Tibetan patent medicine in treating upper respiratory tract infection(URTI)associated cough in children.Methods:The study was a multicenter,randomized,open-label,controlled trial.A total of 142 children aged 2 to 14 years old,with URTIassociated cough within 48 h of onset,were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence.Children were treated with JWZH(1 to 1.5 g,twice to thrice daily)in the treatment group or conventional treatment(Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Granules,0.25 to 1 g,thrice daily)in the control group for 5 days.The primary endpoints were the time to cough resolution and 4-day cough resolution rate.The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.Results:A total of 138 children were included in the intention-to-treat analysis,with 71 cases in the treatment group and 67 cases in the control group.Compared with the conventional treatment,the children receiving JWZH had a shorter time to cough resolution[hazard ratio,2.10;95%confidence interval(CI),1.29-3.40;P=0.003].The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment(2 days vs.3 days;P<0.001).The 4-day cough resolution rate in the JWZH group was higher than that of the control group(94.4%vs.74.6%;risk difference:19.8%,95%CI:8.1%-31.5%;relative risk:1.265,95%CI:1.088-1.470;P=0.001).There were no statistically significant differences in the improvement of other symptoms caused by URTI(P>0.05).Adverse events was reported in 5.6%(4/71)and 4.5%(3/67)in participants of JWZH and PPACCM groups(P>0.05),respectively,which were all mild and resolved without treatment.Conclusion:JWZH seemed to be a safe and effective therapy for URTI-associated cough in children.(Trial registration No.Chi CTR2000039421)