What is the comparative effectiveness of combining different Chinese herbal medicine and salmeterol and fluticasone propionate (SFP) in treating chronic obstructive pulmonary disease as compared to SFP alone?
Date of publication of systematic review and network meta-analysis: May 2016
Design
Systematic review and network meta-analysis of 11 randomized controlled trials (RCTs).
Participants
925 patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (mean age: 65.5 years; gender proportion was not reported by the reviewers). 9 studies applied the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline [postbronchodilator forced expiratory volume in 1 second (FEV1) <80% of the predicted value, with a ratio of FEV1 to forced vital capacity (FVC) <70%] for diagnosis and management of COPD.
Intervention
The Chinese herbal medicine (CHM) formulations were different for each trial. Among the 11 types of CHM interventions, 7 were herbal decoctions, 1 was prescribed as pills, and the remaining 3 were capsules. SFP were used twice daily. Duration of treatments were at least 12 weeks.
Comparator
Comparison: Different CHM plus SFP vs SFP alone.
Major Outcomes
Outcome 1: Change in FEV1, follow-up period varied from 3 months to 1 year;
Outcome 2: Change in health-related quality of life measured by the St George’s Respiratory Questionnaire (SGRQ), follow-up period varied from 3 months to 1 year.
Settings
5 trials were conducted in outpatient settings and 5 trials were conducted in both inpatient and outpatient settings. One trial did not specify the study settings.
Comparison    Different CHM plus SFP vs SFP alone
Main Results
From the results of meta-analysis, compared to SFP alone, the combination of CHM and SFP showed significant improvement in FEV1 (pooled weighted mean difference (WMD): 0.20, 95% CI: 0.06 to 0.34) and patients’ quality of life (pooled WMD: -4.99, 95% CI: -7.33 to -2.24) with follow-up period varying from 3 months to 1 year.
Comparison: Different CHM plus SFP vs SFP alone among patients with COPD
Outcomes No. of studies (Total number of participants) Mean/ No. of participants Heterogeneity test (I2) Pooled WMD (95% CI) Overall quality of evidence*
Intervention Comparator
1 (L) 7 (532) Not reported/266 Not reported/ 266 85% 0.20 (0.06 to 0.34) High
2 (NA) 5 (429) Not reported/ 215 Not reported/ 204 97% -4.99 (-7.33 to -2.24) Moderate
Keys: WMD = weighted mean difference; CI = confidence interval.
Comparison    Results of Network meta-analysis (NMA) on changes in FEV1
Main Results
Regarding changes in FEV1, there was no statistically significant difference between 7 CHM formulae from the results of network meta-analysis. The 7 formulae consisted of similar herbal compositions, such as Cordyceps sinensis (冬蟲夏草), Astragalus membranaceus (黃芪) , Rehmanniae radix preparata (熟地黃), Fructus Schisandrae (五味子), Radix codonopsis (黨參), Gecko (蛤蚧), Root bark of paeonia suffruticosa andr (牡丹皮) and Radix et rhizoma ginseng (人參). The comparative effectiveness rankings of the 8 different treatments were as follow: (1st) Jiaweisanao decoction+ SFP, (2nd) Baining capsule+ SFP, (3rd) Jiajianbufei decoction+ SFP, (4th) Baoyuan decoction+ SFP, (5th) Shenha capsule+ SFP, (6th) Yiqihuoxue decoction+ SFP, (7th) SFP only, and (8th) Jiaweiqiweiduqi decoction+ SFP.
Comparison    Results of NMA on changes in QOL
Main Results
Regarding changes in SGRQ scores, there was statistically significant difference between 4 CHM formulae from the results of network meta-analysis. The 4 formulae consisted of similar herbal compositions, such as Astragalus membranaceus (黃芪) , Atractylodis macrocephalae rhizome (白朮), Rehmanniae radix preparata (熟地黃), Radix codonopsis (黨參) and Root bark of paeonia suffruticosa andr (牡丹皮). The comparative effectiveness rankings of the 8 different treatments were as follow: (1st) Runfeijianpibushen decoction+ SFP, (2nd) Renshenbufei pills+ SFP, (3rd) Yiqihuoxue decoction+ SFP, (4th) Jiaweiqiweiduqi decoction+ SFP, and (5th) SFP only.
Comparison    Different CHM plus SFP vs SFP alone
Main Results
From the results of meta-analysis, compared to SFP alone, the combination of CHM and SFP showed significant improvement in FEV1 (pooled weighted mean difference (WMD): 0.20, 95% CI: 0.06 to 0.34) and patients’ quality of life (pooled WMD: -4.99, 95% CI: -7.33 to -2.24) with follow-up period varying from 3 months to 1 year.
Comparison: Different CHM plus SFP vs SFP alone among patients with COPD
Outcomes 1 (L) 2 (NA)
No. of studies (Total number of participants) 7 (532) 5 (429)
Mean/ No. of participants Intervention Not reported/266 Not reported/ 215
Comparator Not reported/ 266 Not reported/ 204
Pooled WMD (95% CI) 0.20 (0.06 to 0.34) -4.99 (-7.33 to -2.24)
Overall quality of evidence* High Moderate
Keys: WMD = weighted mean difference; CI = confidence interval.
Comparison    Results of Network meta-analysis (NMA) on changes in FEV1
Main Results
Regarding changes in FEV1, there was no statistically significant difference between 7 CHM formulae from the results of network meta-analysis. The 7 formulae consisted of similar herbal compositions, such as Cordyceps sinensis (冬蟲夏草), Astragalus membranaceus (黃芪) , Rehmanniae radix preparata (熟地黃), Fructus Schisandrae (五味子), Radix codonopsis (黨參), Gecko (蛤蚧), Root bark of paeonia suffruticosa andr (牡丹皮) and Radix et rhizoma ginseng (人參). The comparative effectiveness rankings of the 8 different treatments were as follow: (1st) Jiaweisanao decoction+ SFP, (2nd) Baining capsule+ SFP, (3rd) Jiajianbufei decoction+ SFP, (4th) Baoyuan decoction+ SFP, (5th) Shenha capsule+ SFP, (6th) Yiqihuoxue decoction+ SFP, (7th) SFP only, and (8th) Jiaweiqiweiduqi decoction+ SFP.
Comparison    Results of NMA on changes in QOL
Main Results
Regarding changes in SGRQ scores, there was statistically significant difference between 4 CHM formulae from the results of network meta-analysis. The 4 formulae consisted of similar herbal compositions, such as Astragalus membranaceus (黃芪) , Atractylodis macrocephalae rhizome (白朮), Rehmanniae radix preparata (熟地黃), Radix codonopsis (黨參) and Root bark of paeonia suffruticosa andr (牡丹皮). The comparative effectiveness rankings of the 8 different treatments were as follow: (1st) Runfeijianpibushen decoction+ SFP, (2nd) Renshenbufei pills+ SFP, (3rd) Yiqihuoxue decoction+ SFP, (4th) Jiaweiqiweiduqi decoction+ SFP, and (5th) SFP only.
Conclusion
Benefits
This study showed that the combination of CHM and SFP significantly improved FEV1 and SGRQ measured quality of life when compared to SFP alone. For outcome 1, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect. For outcomes 2, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect. This study indicated that Jiaweisanao decoction+ SFP had a slightly higher probability of being the best treatment in improving patients’ FEV1. However, there was no statistically significant difference between the treatments. The common herbal compositions are Cordyceps sinensis (冬蟲夏草), Astragalus membranaceus (黃芪) , Rehmanniae radix preparata (熟地黃), Fructus Schisandrae (五味子), Radix codonopsis (黨參), Gecko (蛤蚧), Root bark of paeonia suffruticosa andr (牡丹皮) and Radix et rhizoma ginseng (人參). In addition, Runfeijianpibushen decoction+ SFP had a slightly higher probability of being the best treatment in improving patients’ quality of life. The common herbal compositions are Astragalus membranaceus (黃芪) , Atractylodis macrocephalae rhizome (白朮), Rehmanniae radix preparata (熟地黃), Radix codonopsis (黨參) and Root bark of paeonia suffruticosa andr (牡丹皮).
Harms
No adverse events were reported in the included trials.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/27196484
The synopsis is based on the following article: Chung VC, Wu X, Ma PH, Ho RS, Poon SK, Hui DS, Wong SY, Wu JC. Chinese Herbal Medicine and Salmeterol and Fluticasone Propionate for Chronic Obstructive Pulmonary Disease: Systematic Review and Network Meta-Analysis. Medicine. 2016 May;95(20).


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.