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      Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial

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          Abstract

          Background

          Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality. Traditional Chinese medicine (TCM) is used to treat AECOPD as adjunctive therapy. This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs.

          Methods

          A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 244 patients were divided into the intervention group (n = 122, treated with conventional medicine and Xuan Bai Cheng Qi) and the control group (n = 122, treated with conventional medicine and placebo). Total symptom scores (cough, phlegm, wheezing, chest congestion) before treatment and at 3, 5, 7, 10 days post-treatment were recorded. Lung function, arterial blood gas, serum inflammatory cytokines, oxidation/anti-oxidation index were observed before treatment and at the end of the 10-day treatment.

          Results

          A total of 242 patients completed the study. The full analysis set (FAS) population was 244 and the per-protocol analysis set (PPS) population was 229. After the 10-day treatment, symptom scores of the Xuan Bai Cheng Qi group were significantly lower over time compared with the control group (FAS: mean difference -1.84, 95% CI -2.66 to -1.03, P < .001; PPS: mean difference -1.87, 95% CI -2.71 to -1.03, P < .001). FEV 1, FVC, and FEV 1%pred were significantly higher over time in the Xuan Bai Cheng Qi group compared with those in the control group (day 10, FAS and PPS: P < .05). PaO 2 and PaCO 2 were significantly improved in the Xuan Bai Cheng Qi group (day 10, FAS and PPS: P < .05). Xuan Bai Cheng Qi was also found to ameliorate cytokine levels and oxidation/antioxidant index compared with placebo. There were no differences in safety variables and adverse events between the two groups.

          Conclusions

          Xuan Bai Cheng Qi formula appears to be a safe and beneficial treatment for AECOPD of phlegm-heat obstructing the lungs syndrome type.

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          Most cited references11

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          COPD exacerbations .1: Epidemiology.

          Meghan Donaldson, Jadwiga Wedzicha (2006)
          The epidemiology of exacerbations of chronic obstructive pulmonary disease (COPD) is reviewed with particular reference to the definition, frequency, time course, natural history and seasonality, and their relationship with decline in lung function, disease severity and mortality. The importance of distinguishing between recurrent and relapsed exacerbations is discussed.
          Article 0 comments Cited 120 times – based on 0 reviews     Review now
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            Impact on patients' health status following early identification of a COPD exacerbation.

            Belinda Lee, G Ruberto, D H Zackon … (2007)
            The current study aimed to assess the impact on patient health status during an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). A total of 421 COPD patients were enrolled in a multicentre, single-arm study with a 6-month observational follow-up period. Patients received two inhalations of Symbicort 200 Turbuhaler(R) twice a day. Patients were assessed before the run-in period, at baseline and at 1, 3 and 6 months. Patients were instructed to report a change in respiratory symptoms lasting >24 h. This defined an AECOPD. In addition to the initial call, the St George's Respiratory Questionnaire (SGRQ), COPD Control Questionnaire (CCQ), Medical Research Council (MRC) dyspnoea scale and activities of daily living (ADL) were completed at 5-7 and 12-14 days. A group of 176 patients reported at least one AECOPD. Exacerbations were associated with statistically significant mean changes (worsening) in the SGRQ activity and impact domains at onset (mean +/- sd 12.1 +/- 18.1 and 14.0 +/- 15.2), during the first (9.8 +/- 19.0 and 9.4 +/- 16.6) and second weeks (3.1 +/- 15.5 and 3.3 +/- 14.7). Clinically significant deterioration in SGRQ impact scores was shown in 71% of patients following early identification, with 55 and 37% during the first and second weeks of an AECOPD, respectively. Acute exacerbation severely impacts on health status. The current study provides valuable information on the change in health status during an acute exacerbation of chronic obstructive pulmonary disease that can be utilised for future trials that evaluate therapeutic intervention.
            Article 0 comments Cited 35 times – based on 0 reviews     Review now
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              Pulmonary function, oxidative stress and inflammatory markers in severe COPD exacerbation.

              Ivana Stanojkovic, Jelena Kotur-Stevuljevic, Branislava Milenkovic … (2011)
              Oxidative stress and inflammation play an important role in the pathogenesis of chronic obstructive pulmonary disease (COPD). Pulmonary function, oxidative stress parameters and inflammatory markers were measured in 74 patients with severe COPD exacerbation and 41 healthy subjects. In patients all parameters were assessed at two time points: Firstly, one day after admission and secondly, after 7 10 days when they were clinically stable enough to be discharged. Patients were divided in two groups according the presence of ischemic heart disease (IHD): IHD positive (IHD+) patients and IHD negative (IHD-) patients. During hospitalisation O2•-, malondialdehyde (MDA), advanced oxidation protein products (AOPP) and total oxidant status (TOS) increased and were higher at discharge compared with admission and the control group. Superoxide dismutase (SOD) activity was significantly lower in COPD patients at both time points compared with the control group. Total antioxidant status (TAS) was significantly lower and the prooxidant-antioxidant balance (PAB) was higher at both time points in COPD patients compared with the control group. High sensitive C-reactive protein (hsCRP) and also the neutrophil count were significantly higher at admission compared with discharge. Paraoxonase 1 (PON1) enzymatic activities in COPD patients did not differ compared with the control group. IHD+ COPD patients had significantly lower PON1 activity but higher PAB levels and hsCRP concentrations, compared with IHD COPD patients. The oxidant/antioxidant imbalance was significantly pronounced in patients with COPD exacerbation for at least 24 hours following their admission and when they were clinically stable enough to be discharged. Increased oxidative stress, elevated systemic inflammation and decreased antioxidant defence were common in end-stage disease and particularly COPD patients with ischemic heart disease. Copyright © 2011 Elsevier Ltd. All rights reserved.
              Article 0 comments Cited 32 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Miao Liu
                Xianggen Zhong
                Yuhang Li
                Fengjie Zheng
                Ruohan Wu
                Yan Sun
                Jinchao Zhang
                Journal
                Journal ID (nlm-ta): BMC Complement Altern Med
                Journal ID (iso-abbrev): BMC Complement Altern Med
                Title: BMC Complementary and Alternative Medicine
                Publisher: BioMed Central
                ISSN (Electronic): 1472-6882
                Publication date Collection: 2014
                Publication date (Electronic): 11 July 2014
                Volume: 14
                Page: 239
                Affiliations
                [1 ]School of Preclinical Medicine, Beijing University of Chinese Medicine, 11 East Third Ring Road, Beijing 100029, China
                Article
                Publisher ID: 1472-6882-14-239
                DOI: 10.1186/1472-6882-14-239
                PMC ID: 4227061
                PubMed ID: 25014996
                SO-VID: d5d92aa3-2181-45b4-827b-633a03eec2f6
                Copyright © Copyright © 2014 Liu et al.; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

                History
                Date received : 27 July 2013
                Date accepted : 1 July 2014
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Complementary & Alternative medicine
                Keywords: acute exacerbation,chronic obstructive pulmonary disease,xuan bai cheng qi,phlegm-heat obstructing lung,syndrome,traditional chinese medicine
                Data availability:
                ScienceOpen disciplines: Complementary & Alternative medicine
                Keywords: acute exacerbation, chronic obstructive pulmonary disease, xuan bai cheng qi, phlegm-heat obstructing lung, syndrome, traditional chinese medicine

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