Randomized, double-blind, placebo-controlled superiority trial of the Yiqigubiao pill for the treatment of patients with chronic obstructive pulmonary disease at a stable stage

Li, Fengsen; Zheng, Li; Xu, Dan; Liao, Chunyan; Ma, Hu; Gong, Liang; Su, Jun; Sun, Qiang; Xu, Quangang; Gao, Zhen; Wang, Ling; Jing, Jing; Wang, Jing; Jiang, Min; Tian, Ge; Hasan, Bilal

doi:10.3892/etm.2016.3680

Cited by 11 publications

(15 citation statements)

References 40 publications

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“…In recent years, great achievement has been made in the clinical research in the treatment of stable COPD patients by TCM. Various studies in the treatment of stable COPD show that TCM can bring a reduction of AE and improve the clinical symptoms, exercise capacity, lung function, and quality of life [29–31]. We can see that the clinical effect of TCM in the treatment for stable COPD patients is obvious, which is the basis of health economics evaluation.…”

Section: Discussionmentioning

confidence: 99%

Preliminary Study to Evaluate Three Different Treatments on Stable Chronic Obstructive Pulmonary Disease Patients Based on Markov Model

Yang

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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This study evaluates the costs and utilities of different treatment strategies for stable chronic obstructive pulmonary disease (COPD) patients based on Markov model and provides guidance for clinical decision and health policy making. Patients with stable COPD from four subcenters had been investigated. A Markov model with three states, namely, GOLD 1-2, GOLD 3-4, and death, was built using TreeAge Pro 2011 software. Cost-utility ratio (CUR) and incremental cost-utility ratio (ICUR) from forty Markov circles were applied to measuring the economics evaluation of three different treatments. A total of 236 stable COPD patients were randomly assigned into three groups, Western medicine group (79 cases), traditional Chinese medicine (TCM) group (79 cases), and combined group (78 cases). The results of Markov cohort simulation showed that the accumulative quality-adjusted life years (QALYs) of the three above groups per 100 000 people in 40 years were 1 702 773, 1 616 797, and 1 709 668 years, respectively, and the accumulative costs were 13 582 138 466, 1 207 904 113, and 14 656 607 371 Yuan, respectively. The CURs of the three groups were 87 235, 74 602, and 87 223 Yuan/QALY, respectively. ICURs of combined group were 8 707 and 41 705 Yuan as against Western medicine group and TCM group, respectively. Therefore, combined treatment has a lower cost, higher health output, and more socioeconomic benefits in the long run. Markov model is recommended to conduct health economics evaluation of different treatments for COPD.

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Section: Discussionmentioning

confidence: 99%

Preliminary Study to Evaluate Three Different Treatments on Stable Chronic Obstructive Pulmonary Disease Patients Based on Markov Model

Yang

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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“…is used to treat COPD at a stable stage. We found that the Yi Qi Gu Biao pill improves the quality of life of COPD patients at a stable stage, reducing the number of annual acute exacerbation events [ 5 ]. COPD is a publicly recognized heterogeneous disease, with therapeutic responses greatly differing even for patients with the same symptoms and drugs [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

“…A previous research demonstrated that [ 5 ] Yi Qi Gu Biao pill can prolong the interval of acute exacerbation in COPD patients by 77.68 days, while reducing the number of acute exacerbations by 1.42/6 months. Moreover, its therapeutic effects are consistent with the main treatment purpose for the frequent exacerbator phenotype in COPD, that is, reduction of the number of acute exacerbations.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Controlled Study of the Yi Qi Gu Biao Pill in the Treatment of Frequent Exacerbator Phenotype in Chronic Obstructive Pulmonary Disease (Lung and Spleen Qi Deficiency Syndrome)

Gao

Jing

et al. 2017

Evidence-Based Complementary and Alternative Medicine

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Objective To evaluate the efficacy and safety of Yi Qi Gu Biao (YQGB) pill in treating frequent exacerbator phenotype in chronic obstructive pulmonary disease (lung and spleen qi deficiency syndrome) (FEPCOPD). Methods This prospective, randomized, double-blind, controlled study assessed 112 cases (64 included) of FEPCOPD treated at the outpatient department in our hospital in January–August 2016. The patients were randomly divided into YQGB and placebo (Pb) and treated for three months. Lung function, CAT, mMRC, and TCM symptom scores (TCMs) were observed. Results Compared with Pb, YQGB showed decreased wheezing symptom scores (WSs) and TCMs at one month and decreased CAT and TCMs at three months. From one to three months, CAT, cough, sputum, WSs, and TCMs in YQGB were lower than pretreatment values. But in Pb, CAT was lower than pretreatment values after one month; CAT, sputum, and TCMs were lower than pretreatment values after two months; CAT, cough, sputum, WSs, and TCMs were lower than pretreatment values after three months. Conclusion Yi Qi Gu Biao pill can improve wheezing, health status, and TCMs in FEPCOPD and also can shorten the durations of cough, sputum, and wheezing. This trial is registered in the Clinical Trials Registry of China: ChiCTR-IOR-15007542 (on 8 December 2015).

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“…[7] CHM alone or integrated with routine pharmacologic therapy has been widely used for the treatment of COPD in China, [8] and has been considered promising for improving symptoms, physiological impairment, and relieving comorbidities. [9–11] A number of clinical trials [8,12,13] have shown the clinical efficacy of CHM in the treatment of stable COPD, which is associated with the reduction in exacerbation frequency, relieving of clinical symptoms, and improvement of pulmonary function and quality of life. However, because of the difference in the study design, included studies, and outcome measurements of these clinical trials, the results were inconsistent; therefore, meta-analyses [14–16] addressing the clinical efficacy of CHM on COPD yielded variable results, which hinders the explanation of study results and subsequently its clinical use.…”

Section: Introductionmentioning

confidence: 99%

Chinese Herbal Medicine Versus Placebo for the Treatment Of Chronic Obstructive Pulmonary Disease

Xiong¹,

Yu²,

Zeng³

et al. 2019

Medicine

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Background:Chinese herbal medicine (CHM) has been shown to be effective in the treatment of stable chronic obstructive pulmonary disease (COPD) by published meta-analyses. However, disease outcomes were inconsistent and heterogeneity was observed attributed to placebo-controlled studies. We present a protocol for a systematic review aiming to evaluate the clinical efficacy and safety of CHM comparing to placebo in the treatment of stable COPD, to provide robust evidence for the use of CHM in COPD.Methods:We will comprehensively search the following 9 databases from inception to March 2019: Web of Science, PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese National Knowledge Infrastructure (CNKI), WANFANG Database, Chinese Scientific and Technological Periodical Database (VIP) and Chinese Biomedical Database (CBM), and the Cochrane Library database. All clinical randomized controlled trials comparing CHM to placebo for the treatment of stable COPD in English or Chinese will be included. The primary outcome will be quality of life, symptom score and exacerbation frequency, and the secondary outcomes include traditional Chinese medicine syndrome score and effective rate, lung function, 6-minute walk distance, and adverse events. Data extraction and quality assessment will be performed independently by 2 reviewers. Data synthesis and risk of bias will be assessed using the Review Manager software. This protocol will be conducted according to the Preferred Reporting Item for Systematic Review and Meta-analysis Protocols (PRISMA-P) guidance.Results:This systematic review and meta-analysis will provide a high-quality comprehensive evaluation of the efficacy and safety based on current literature evidence of CHM intervention for stable COPD.Conclusion:The conclusion of this study will present the evidence of whether CHM is an effective and safe intervention for stable COPD patients.

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Randomized, double-blind, placebo-controlled superiority trial of the Yiqigubiao pill for the treatment of patients with chronic obstructive pulmonary disease at a stable stage

Cited by 11 publications

References 40 publications

Preliminary Study to Evaluate Three Different Treatments on Stable Chronic Obstructive Pulmonary Disease Patients Based on Markov Model

Preliminary Study to Evaluate Three Different Treatments on Stable Chronic Obstructive Pulmonary Disease Patients Based on Markov Model

A Randomized Controlled Study of the Yi Qi Gu Biao Pill in the Treatment of Frequent Exacerbator Phenotype in Chronic Obstructive Pulmonary Disease (Lung and Spleen Qi Deficiency Syndrome)

Chinese Herbal Medicine Versus Placebo for the Treatment Of Chronic Obstructive Pulmonary Disease

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