Additional file 1: of Quantifying traditional Chinese medicine patterns using modern test theory: an example of functional constipation

S1. Longitudinal data used for the validation of the tool. With respect to variable names, T1, T2, and T3 prefix indicate baseline, 1st follow-up, and 2nd follow-up, respectively. I1 to I10 suffix indicate number of item. (XLSX 32 kb

Cognitive Improvement during Treatment for Mild Alzheimer’s Disease with a Chinese Herbal Formula: A Randomized Controlled Trial

<div><p>Objectives</p><p>To explore the efficacy of Chinese herbal formula compared with donepezil 5mg/day in patients with mild Alzheimer’s disease (AD).</p><p>Methods</p><p>Patients with mild AD meeting the criteria were randomized into Chinese herbal formula Yishen Huazhuo decoction (YHD) group and donepezil hydrochloride (DH) group during the 24-week trial. The outcomes were measured by ADAS-cog, MMSE, ADL, and NPI with linear mixed-effect models.</p><p>Results</p><p>144 patients were randomized. The mean scores of ADAS-cog and MMSE in both YHD group and DH group both improved at the end of the 24-week treatment period. The results also revealed that YHD was better at improving the mean scores of ADAS-cog and MMSE than DH. Linear mixed-effect models with repeated measures showed statistical significance in time × group interaction effect of ADAS-cog and also in time × group interaction effect of MMSE. The data showed YHD was superior to DH in improving the scores and long term efficacy.</p><p>Conclusions</p><p>Our study suggests that Chinese herbal formula YHD is beneficial and effective for cognitive improvement in patients with mild AD and the mechanism might be through reducing amyloid-β (Aβ) plaque deposition in the hippocampus.</p><p>Trial Registration</p><p>Chinese Clinical Trial Registry <a href="http://www.chictr.org/en/proj/show.aspx?proj=3692/12002846" target="_blank">ChiCTR-TRC-12002846</a></p></div

Flow diagram and disposition of the two groups.

<p>Flow diagram and disposition of the two groups.</p

Baseline demographics and disease characteristics.

<p>Notes:</p><p><i>a</i> indicates time since Alzheimer’s disease was first diagnosed by a physician.</p><p>Baseline demographics and disease characteristics.</p

Mean efficacy scores at all time points and change at week 24, and 48 (Mean±SD).

<p>* indicates significance between the two study groups.</p><p>Mean efficacy scores at all time points and change at week 24, and 48 (Mean±SD).</p

Reported adverse events.

<p>Notes: LFTs indicates liver function tests.</p><p>Reported adverse events.</p

Linear mixed effect model estimates of fixed effects (ADAS-cog, MMSE, ADL, NPI).

<p>* indicates the main effects after dropping the insignificant group x time interaction.</p><p>Time × group interaction effect was observed in the scores of MMSE (F107.776 = 3.251, p = 0.025). The scores in both groups increased in week 12 and 24, by 1.72±2.59 in YHD group and 1.27±2.23 in DH group, but there is no significant difference between groups during the 24-week treatment. Compared with week-24, the scores of ADAS-cog in the follow up in week 48 showed a decrease of 0.40±1.63 in YHD group, but significantly less than the decrease of 1.38±2.68 in DH group (p<0.05).</p><p>Linear mixed effect model estimates of fixed effects (ADAS-cog, MMSE, ADL, NPI).</p