β-Glucan Improves Protective Qi Status in Adults with Protective Qi Deficiency——A Randomized,Placebo-Controlled,and Double-Blinded Trial

Objective:To test the hypothesis thatβ-glucan enhances protective qi(PQi),an important Chinese medicine(CM)concept which stipulates that a protective force circulates throughout the body surface and works as the first line of defense against"external pernicious influences".Methods:A total of 138 participants with PQi deficiency(PQD)were randomized to receiveβ-glucan(200 mg daily)or placebo for 12 weeks.Participants’PQi status was assessed every 2 weeks via conventional diagnosis and a standardized protocol from which a PQD severity and risk score was derived.Indices of participants’immune and general health status were also monitored,including upper respiratory tract infection(URTI),saliva secretory Ig A(s Ig A),and self-reported measures of physical and mental health(PROMIS).Results:PQi status was not significantly different between theβ-glucan and placebo treatment groups at baseline but improved significantly in theβ-glucan(vs.placebo)group in a time-dependent manner.The intergroup differences[95%confidence interval(CI)]in severity score(scale:1-5),risk score(scale:0-1),and proportion of PQD participants(%)at finish line was 0.49(0.35-0.62),0.48(0.35-0.61),and 0.36(0.25-0.47),respectively.Additionally,β-glucan improved URTI symptom(scale:1-9)and PROMIS physical(scale:16.2-67.7)and mental(scale:21.2-67.6)scores by a magnitude(95%CI)of 1.0(0.21-1.86),5.7(2.33-9.07),and 3.0(-0.37-6.37),respectively,over placebo.Conclusions:β-Glucan ameliorates PQi in PQD individuals.By using stringent evidence-based methodologies,our study demonstrated that Western medicine-derived remedies,such asβ-glucan,can be employed to advance CM therapeutics.(Clinical Trial.Gov registry:NCT03782974)

Proof-of-Concept and Feasibility Study to Evaluate the Effect of β-Glucan on Protective Qi Deficiency in Adults

Objective:To preliminarily explore the potential effect ofβ-glucan on Chinese medicine(CM)concept protective qi deficiency(PQD),and the methodology for future definitive studies.Methods:To have a standardized assessment of PQD,a list of 13 potentially PQD-relevant parameters were firstly created,each with defined quantitative or categorial scales.Using the data from 37 participants with(21 cases)or without(16 cases)PQD,multivariate logistic modeling was conducted to create a preliminary diagnostic PQD risk score.Subsequently,21 participants diagnosed with PQD were treated withβ-glucan in a dose of 200 mg/day for 8 weeks.Data were collected for trial acceptability measures(rate of recruitment,withdrawal,and compliance),and the participants were assessed for PQD status at baseline and every 2 weeks thereafter.Results:The preliminary logistic model consisted of 3 parameters(low voice and apathy,aversion to wind and cold,and Cun pulse).The resulting risk score demonstrated a degree of PQD-predicting accuracy that,as evaluated by statistical(discrimination and classification)methods,was higher than those obtained from any of the individual candidate parameters.The 21 PQD participants treated withβ-glucan demonstrated good receptibility and a time-dependent improvement in PQD status as evidenced by the decrease of PQD participant to 9.5%at the end of study.Conclusions:This study demonstrated the effect of proof-of-concept ofβ-glucan on improving PQD and the proof-of-concept of a multivariate-model-derived diagnostic PQD risk score.It also indicated feasibility for future definitive studies.Studies like this embody an innovative approach that uses therapies derived from the mainstream biomedicine to enrich therapeutics guided by CM principle.(Trial registration No.NCT03829228).