Pang Li-Jian, Liu Jian-Ping, Lv Xiao-Dong
Beijing University of Chinese Medicine, Beijing.
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang.
Medicine (Baltimore). 2019 Jul;98(30):e16325. doi: 10.1097/MD.0000000000016325.
The morbidity of idiopathic pulmonary fibrosis (IPF) was found in an increasing trend, progressive worsening of symptoms and deterioration in lung function tend to trigger off a lower quality of life (QoL). Only pirfenidone and nintedanib have been recommended in the guidelines, which can modify the disease process. However, no evidence was verified to significantly alleviate the main clinical manifestations of IPF. At present, Chinese herbal formula (CHF) is widely prescribed as an adjunct to western medicine to treat the disease, and have shown promising benefits on clinical symptoms and QoL. There are mainly 3 Traditional Chinese Medicine (TCM) treatment methods guiding the composition of CHFs, which are devoting to comfort the common symptoms of IPF. Nevertheless, the paucity of direct comparative evidence of them posed a challenge for clinicians to determine the relative merits options. Therefore, we formulate this protocol, which is described for a systematic review to investigate relative advantages among different TCM treatment method and provide more reliable evidence for clinical decision-making.
A systematic literature search will be employed in 10 electronic databases. Inclusion criteria are randomized control trials of CHFs composed based on the 3 TCM treatment methods, which act as an adjuvant treatment with routine drugs, compared with routine drugs alone. The primary outcomes we focus on include St George's Hospital Respiratory Questionnaire (SGRQ) scores, TCM symptom (dyspnea, cough) scores. The research screening, data extraction, and methodological quality assessment will be conducted by 2 individuals separately, and dispute will be adjudicated by a third senior reviewer. We will employ network meta-analysis (NMA) in a Bayesian framework with vague priors and the surface under the cumulative ranking curve (SUCRA) to obtain the comprehensive rank for the 3 TCM treatment methods.
This systematic review will provide an evidence of CHFs composed under the guidance by 3 TCM treatment methods with routine drugs, compared with routine drugs alone for IPF, and will submit to a peer-reviewed journal for publication.
The conclusion of this systematic review will provide evidence for relative advantages among the 3 TCM treatment methods.
特发性肺纤维化(IPF)的发病率呈上升趋势,症状的进行性加重和肺功能的恶化往往导致生活质量(QoL)下降。指南中仅推荐了吡非尼酮和尼达尼布,它们可以改变疾病进程。然而,尚无证据证实其能显著缓解IPF的主要临床表现。目前,中药配方(CHF)作为西药的辅助药物被广泛用于治疗该疾病,并已在临床症状和生活质量方面显示出良好的效果。指导CHF配方的主要有三种中医(TCM)治疗方法,致力于缓解IPF的常见症状。然而,它们缺乏直接对比证据,这给临床医生确定相对优势的选择带来了挑战。因此,我们制定了本方案,旨在通过系统评价来研究不同中医治疗方法之间的相对优势,为临床决策提供更可靠的证据。
将在10个电子数据库中进行系统的文献检索。纳入标准为基于三种中医治疗方法组成的CHF的随机对照试验,这些试验作为常规药物的辅助治疗,并与单独使用常规药物进行比较。我们关注的主要结局包括圣乔治医院呼吸问卷(SGRQ)评分、中医症状(呼吸困难、咳嗽)评分。研究筛选、数据提取和方法学质量评估将由两名研究人员分别进行,如有争议将由第三位资深评审员裁决。我们将在贝叶斯框架下采用网络meta分析(NMA)并结合累积排序曲线下面积(SUCRA)来获得三种中医治疗方法的综合排名。
本系统评价将提供证据,证明在三种中医治疗方法指导下组成的CHF与单独使用常规药物相比,对IPF的疗效,并将提交给同行评审期刊发表。
本系统评价的结论将为三种中医治疗方法的相对优势提供证据。