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To test the hypothesis that β -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”. A total of 138 participants with PQi deficiency (PQD) were randomized to receive β -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 IgA (sIgA), and self-reported measures of physical and mental health (PROMIS). PQi status was not significantly different between the β -glucan and placebo treatment groups at baseline but improved significantly in the β -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 (20.37–6.37), respectively, over placebo. β -glucan ameliorates PQi in PQD individuals. By using stringent evidence-based methodologies, our study demonstrated that Western medicine-derived remedies, such as β -glucan, can be employed to advance CM therapeutics. (ClinicalTrial.Gov registry: NCT03782974)

To preliminarily explore the potential effect of β-glucan on Chinese medicine (CM) concept protective qi deficiency (PQD), and the methodology for future definitive studies. 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 with β-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. 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 with β-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. This study demonstrated the effect of proof-of-concept of β-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)

Introduction Standardized diagnosis is required and therefore advocated for evidence-based research in Traditional Chinese Medicine (TCM). In this study, we aimed to standardize and validate a protocol that assesses Protective Qi Deficiency (PQD), a common TCM condition that predisposes individuals to pathogenic invasion. Methods 3 TCM practitioners evaluated 151 participants for PQD status via conventional TCM methods and a standardized protocol consisting of 13 PQD-related variables identified as potential predictors of a diagnostic algorithm of PQD. The collected data served as the training dataset to determine which predictors that significantly contributed to PQD diagnosis and their coefficients in the resulting algorithm. The algorithm was then reviewed and modified by an independent expert panel following the Delphi method, and subsequently validated using a separate validation dataset (n = 56). Results The Delphi-modified algorithm contained 8 predictor variables and accounted for 73.4 % of the PQD variance in the training dataset. Using the validation dataset, the algorithm predicted a TCM practitioner’s conventional diagnosis of PQD with a high degree of accuracy. The protocol also demonstrated significant precision as demonstrated by a high between-practitioner consistency (0.993) measured by intraclass correlation coefficient. Conclusion Our study provides evidence that, through rigorous standardization, quantitation, and statistical analysis, reliable assessment of a TCM concept can be achieved and applied for researching TCM therapeutics. Nonetheless, the generalizability of these findings need to be tested in future studies with increased numbers of practitioners and participants and in studies conducted at multiple geographical venues.