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Table 4 Variables and method of analysis

From: Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF Trial

Outcomes

Hypothesis

Variables

Analysis method

The frequency and time of AECOPD

MBYF improved outcomes

Frequency and days (continuous)

ANCOVA

The severity of AECOPD

Mild, moderate, severe (categorical)

χ2 test

CAT score

Score (continuous)

ANCOVA

Pulmonary function

FEV1%predicted, FEV1/FVC, (continuous)

ANCOVA

Blood gas analysis

Pa (CO2), Pa(O2) (continuous)

ANCOVA

mMRC dyspnea scale

0–5 (categorical)

χ2 test

6MWT

Distance (continuous)

ANCOVA

BODE index

Score (continuous)

ANCOVA

Quantitative scores of TCM syndrome

Score (continuous)

ANCOVA

Inflammation indexes

TNF-α, IL-6, IL-8, IL-10, etc. (continuous)

ANCOVA

HPA axis function

ACTH, CRH, CORT (continuous)

ANCOVA