Page 71 - Read Online

Page 4 of 14 Tian et al. Microbiome Res Rep 2024;3:49 https://dx.doi.org/10.20517/mrr.2024.33

Figure 1. Flow chart of study procedures. A total of 46 patients were initially screened for this study. Thirty-nine patients who met the
inclusion criteria were randomly assigned to either the Placebo group (n = 19) or the CCFM6432 group (n = 20). All participants
completed the trial and were included in the data analysis.

daily, while those in the probiotic CCFM6432 intervention group were instructed to take 1 sachet of
CCFM6432 freeze-dried bacterial powder daily (with a viable count of ≥ 10 CFU/d). See Figure 1 for the
9
specific trial flowchart.

Scale analysis
The Self-Rating Anxiety Scale (SAS), developed by Zung in 1971, has been clinically used for over fifty
years . This scale assesses the severity of anxiety symptoms and tracks changes in patients’ emotions
[21]
during treatment. The HADS, developed by Zigmond AS and Snaith RP in 1983, is primarily used to assess
anxiety and depression in patients in general hospitals . HADS is a self-report scale consisting of two
[22]
subscales, HADS-Anxiety and HADS-Depression, each containing seven items, with half of the items
assessing anxiety and the other half assessing depression. This study simultaneously used both SAS and
HADS to comprehensively evaluate the emotional status of patients, eliminating biases that may arise from
the different focuses of the scales.

The Pittsburgh Sleep Quality Index (PSQI) is widely used for clinical assessment of sleep quality in patients
with sleep disorders and mental disorders. Developed by Dr. Buysse et al. in 1989, the PSQI comprises 19
items used to evaluate an individual’s sleep quality over the past four weeks . The PSQI has a sensitivity of
[23]
89.6%, a specificity of 86.5%, and a cutoff score of 5, with higher scores indicating poorer sleep quality.