Abstract
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) on lung function and quality of life of idiopathic pulmonary fibrosis (IPF) patients by meta-analysis. Methods Randomized controlled trials (RCTs) related to TCM and IPF were searched on PubMed, EMBASE Cochrane Library, ClinicalTrials, China National Knowledge Infrastructure (CNKI), Wanfang Database, Chin VIP Information (VIP), and Chinese Biomedical Database (CBM) until December 2018. Standard mean difference (SMD) and 95% CI were calculated for the measurements related to lung function (FEV1/FVC, FVC%, FEV1%, TLC%, DLCO% or DLCO, and VC%) and other parameters (PO2, 6MWD, and SGRQ) when comparing TCM treatment to the control group. Relative risk (RR) and 95% CI of adverse events (AEs) were calculated to assess the safety of TCM. Results A total of 40 RCTs comparing TCM to western medicine (WM) and involving 3194 IPF patients were eligible for the meta-analysis. The pooled results showed that TCM treatment improved significantly PO2 (SMD = 0.80, 95% CI 0.54 to 1.06, p < 0.001), FEV1% (SMD = 0.57, 95% CI 0.42 to 0.71, p < 0.001), DLCO% (SMD = 0.38, 95% CI 0.28 to 0.48, p < 0.001), 6MWD (SMD = 0.70, 95% CI 0.56 to 0.84, p < 0.001) and other measurements and reduced SGRQ scores (SMD = −0.51, 95% CI −0.70 to −0.22, p < 0.001). Subgroup analysis of different study durations (3 months, ≥ 6 months) and comparison models (TCM vs. WM, TCM + WM vs. WM or TCM vs. placebo) showed similar results. No significant difference of risk of AEs was observed between both groups (RR = 0.66, 95% CI: 0.27–1.60, p=0.352). There was no obvious publication bias, and the pooled results were stable according to sensitivity analysis. Conclusion To the best of our knowledge, the present study had the largest sample size. Our results indicated that TCM treatment may help provide benefit to the lung function, exercise capacity, and quality of life of IPF patients, alone or combined with WM, when compared to WM. More rigorous RCTs were needed in the future.
Highlights
Idiopathic pulmonary fibrosis (IPF) is a rare disease characterized by chronic, progressive, and fibrosing interstitial pneumonia with undetermined etiology
A total of 3194 participants were involved in the analysis, of which 1647 were in the intervention group (TCM only or traditional Chinese medicine (TCM) + western medicine (WM)) and 1547 were in the control group (WM or placebo). e sample size of each study ranged from 34 to 324 and the duration varied from 3 months to 18 months
As for the regimen, 29 studies compared the effect of TCM plus WM to WM alone in IPF, of which 21 were TCM + glucocorticoid versus glucocorticoid [12,13,14, 17, 18, 20, 21, 23, 24, 29, 31, 32, 35,36,37, 39, 40, 42, 44, 48, 49], 6 were TCM + N-acetylcysteine versus N-acetylcysteine [26, 28, 33,34,35, 40], one was TCM + edaravone versus edaravone [30] and one was TCM + pirfenodone versus pirfenodone [37]
Summary
Idiopathic pulmonary fibrosis (IPF) is a rare disease characterized by chronic, progressive, and fibrosing interstitial pneumonia with undetermined etiology. It is the most common type of idiopathic interstitial pneumonia. Lung transplantation can prolong survival with a 5year survival of near 50% and improve quality of life of IPF patients [9]. Traditional Chinese medicine (TCM) has been reported to have effect on IPF in animal models and patients [10]. Due to the lack of largescale, multicentered, randomized controlled trials, the treatment efficacy of TCM on IPF is still in controversy. We aimed to evaluate the efficacy of TCM on IPF by meta-analysis
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