Traditional Chinese medicine classic herbal formula Xiaoqinglong decoction for acute exacerbation of chronic obstructive pulmonary disease: A systematic review protocol.

BACKGROUND: Xiaoqinglong decoction (XQLD) is 1 of the traditional Chinese medicine (TCM) classic herbal formula that is widely used in Asian for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). In recent years, there has been increasing interest in the use of XQLD to treat COPD in China. So it is necessary to update the research and re-evaluate the efficacy and safety of XQLD to provide up-to-date evidence for COPD management. Therefore, we provide a protocol for a systematic review of XQLD for COPD. This protocol is described for a systematic review to investigate the beneficial effects and safety of XQLD for AECOPD. METHODS: A systematic literature search for article up to October 2018 will be performed in 3 Chinese electronic databases and 2 English electronic databases: Pubmed, Cochrane library, China national knowledge infrastructure (CNKI), Chinese science and technology periodical database (VIP), and Wanfang database. Inclusion criteria are randomized control trials of XQLD in treating AECOPD. The primary outcomes were total clinical efficacy rate, TCM symptom scores, TCM Symptom relief time. The secondary outcome was lung function, blood gas analysis, inflammatory cytokines and C-reactive protein (CRP). The summary results will be pooled using the random-effects model or fixed-effects model according to the heterogeneity of the included studies. RESULT: This systematic review will provide an evidence of XQLD for AECOPD, and will submit to a peer-reviewed journal for publication. CONCLUSION: The conclusion of this systematic review will provide evidence to judge whether XQLD is an effective intervention for AECOPD patients.

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).

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).

Effect of Abnormal Savda Munziq, a Traditional Uighur Herbal Medicine, on Pulmonary Function and Aquaporins of COPD Rat Model with Abnormal Savda Syndrome.

OBJECTIVE: To investigate the effect of abnormal savda munziq (ASM) on the pulmonary function and expression of lung-specific aquaporins in the rat model of chronic obstructive pulmonary disease with abnormal savda syndrome (ASSCOPD). METHODS: Eighty male rats were randomized into ASSCOPD, COPD, and control groups. ASSCOPD was further categorized into ASM and non-ASM groups. COPD model was established by combining fumigation with airway instillation of elastase; ASSCOPD model was developed based on COPD by induction with dry cold diet, cold dry environment, and plantar electric stimulation. ASM was administered twice daily. The pulmonary function was evaluated based on respiration. The mRNA and protein levels of AQPs were estimated by real-time PCR and Western blot, respectively. RESULTS: MV, TV, the mRNA level of AQP5, and the protein expression of AQP1, AQP4, and AQP5 were increased in ASMCOPD compared to ASSCOPD. CONCLUSION: The pulmonary function was impaired in ASSCOPD group; the expression of AQP1, AQP4, and AQP5 was decreased at protein and mRNA levels in ASSCOPD group. ASM can improve the pulmonary function in ASSCOPD for MV and TV. ASM could elevate the protein expression of AQP1, AQP4, and AQP5 and the mRNA level of AQP5 in lung tissue.

Effect of sequential treatment with TCM syndrome differentiation on acute exacerbation of chronic obstructive pulmonary disease and AECOPD risk window.

OBJECTIVE: To evaluate the efficacy and safety of the comprehensive interventions based on three Traditional Chinese medicine (TCM) patterns therapy in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and AECOPD risk window. METHODS: A prospective, multi-center, single-blinded, double-dummy and randomized controlled clinical trial is being conducted to test the therapeutic effects of a sequential two stage treatment. A total of 364 patients were enrolled into this study with 182 in each treatment group (TCM and conventional). Patients received medication (or control) according to their assigned group. TCM treatment according to syndrome differentiation for AECOPD were administered twice daily to patients with AECOPD over 7-21days, followed by TCM for AECOPD risk window (RW) over 28days. All patients were followed up for 6 months. Exacerbations were used as the primary outcome measures. Forced expiratory volume in the first second (FEV1) and the modified medical research council dyspnea (MMRC) scale, quality of life and mortality rate were used as secondary outcome measures. RESULTS: Of 364 randomized patients, 353 were included in the intention-to-treat analysis and 290 in the per-protocol analysis. In the TCM group, 16 patients (10.4%) reached the primary end point; 24 (17.7%) in the conventional group (RR 0.59, 95% CI 0.33-1.06; p=0.074). Among patients with a re-exacerbation, the median time to event was 107.5days (interquartile range [IQR], 39.5-129.0) in the TCM and 50days (IQR, 31-130.5) in the conventional group (P=0.011). After exacerbation therapy and a further 180-days follow-up, patients in the TCM group had significant improvements in dyspnea, as measured by MMRC (P=0.003), Patients in the TCM group also had improvements in health-related quality of life (P=0.002), as measured COPD Assessment Test (CAT). There was no difference between groups in death, and recovery of lung function. There were no differences between the TCM and conventional treatment group in adverse events. CONCLUSIONS: In patients presenting to the respiratory department with acute exacerbations of COPD, TCM treatments with syndrome differentiation will have beneficial effects with regard to re-exacerbation, relieving symptoms, improving quality of life for COPD patients.