Core outcome set for stable angina pectoris in traditional Chinese medicine(COS-SAP-TCM)

Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.

Analysis on the outcomes in randomized controlled trials of perimenopausal syndrome treated with acupuncture and moxibustion

Objective:To search systematically the application situation of the outcomes in the randomized controlled trials(RCTs) of perimenopausal syndrome treated with acupuncture and moxibustion so as to provide the foundation for the core outcome sets in treatment of periomenopausal syndrome with acupuncture and moxibustion.Methods:The articles of RTCs on perimenopausal syndrome treated with acupuncture and moxibustion were searched in China National knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform(Wanfang),VIP Chinese Journal Service Platform(VIP),Pubmed,Excerpt medica database(Embase)and Cochrane central register of controlled trials(CENTRAL) databases from January 1,2010 to December31,2020.Two reviewers screened the articles,extracted data and analyzed the application of outcomes in the eligible trials independently.Results:A total of 9391 articles were retrieved initially and 79 articles of them were eligible,including 43 articles in English and 36 articles in Chinese.115 outcomes were involved totally and collected according to 7 outcome domains,of which,the effective rate was the outcome with the highest use frequency.35 articles reported adverse events and 17 articles reported the effect in followup.Conclusion:At present,the outcomes of RCTs on perimenopausal syndrome in treatment with acupuncture and moxibustion are big in divergence,absent in normalization and lack of indicators for long-term prognosis and economics outcomes,as well as have the issues on the incomplete reports on the differentiation between the primary and the secondary outcomes,safety indicators and followup outcomes.It needs to construct the core outcome sets in line with the characteristics of acupuncture-moxibustion discipline so as to improve the quality of clinical trials of acupuncture and moxibustion.