1.Reliability and Validity of Dampness Syndrome Scale of Chinese Medicine Using for Persistent Asthma Patients: a Cross-Sectional Study
Yihe CHI ; Feiting FAN ; Shushan WEI ; Yuewei LI ; Jingmin XIAO ; Lei WU ; Lin LIN ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2024;65(11):1132-1138
ObjectiveTo evaluate the reliability and validity of the Dampness Syndrome Scale of Chinese Medicine (DSSCM) among patients with persistent asthma, and to explore the correlation between dampness syndrome and clinical characteristics of persistent asthma. MethodsA cross-sectional survey was conducted. Basic information, examination results, DSSCM, Asthma Control Test (ACT), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) scores were collected from 206 patients with persistent asthma to evaluate the reliability and validity of DSSCM and to explore the correlation between dampness syndrome and clinical characteristics. ResultsThe mean score of DSSCM among 206 patients was 14.59 ± 10.53. The overall Cronbach α coefficient and Spearman-Brown split-half reliability coefficient of the scale were both greater than 0.8, and the success rate of scale convergent and discriminant validity calibration were greater than 80%. The confirmatory factor analysis showed that the χ2/df was 2.309, and the root mean square error of approximation (RMSEA) was 0.08; the root mean square residual (RMR) was 0.049, whereas the comparative fit index (CFI), the goodness of fit index (GFI), the adjusted goodness of fit index (AGFI), the normed fit index (NFI) and the incremental fit index (IFI) were less than 0.9. Correlation analysis showed that DSSCM scores were positively correlated with disease duration, GAD-7 scores, and PHQ-9 scores (P<0.05), and negatively correlated with ACT scores (P<0.01). The DSSCM scores were significantly different between patients with different disease severity (H = 10.92, P = 0.01), and the DSSCM scores of allergic patients were higher than those of non-allergic patients (Z = -4.19, P<0.001). ConclusionDSSCM has acceptable reliability and validity for patients with persistent asthma. The scores of DSSCM correlated with the disease duration, ACT score, GAD-7 score, PHQ-9 score, disease severity and allergic status of persistent asthmatics.
2.A Non-inferiority Randomized Controlled Trial of Topical Bisaitong (鼻塞通) in Treatment of Moderate to Severe Allergic Rhinitis
Jintao PANG ; Feiting FAN ; Jingmin XIAO ; Bing HE ; Lei WU ; Yisheng XU ; Fuping XU ; Zhongwen WANG ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2023;64(19):1995-2002
ObjectiveTo evaluate the efficacy and safety of topical Bisaitong (鼻塞通) in treating moderate-to-severe allergic rhinitis (AR). MethodsA randomized, positive-controlled, non-inferiority clinical trial design was adopted. Totally, 108 cases of moderate-to-severe AR were randomly divided into Bisaitong group and mometasone furoate group,with 54 cases in each group. The Bisaitong group was treated with Bisaitong smeared at the nasal cavity twice a day, and the mometasone furoate group received inhalation of mometasone furoate nasal spray 100 μg in each nostril, once a day. Both groups were treated for 4 weeks and followed up after additional 4 weeks. Both groups were compared on the rhinoconjunctivitis quality of life questionnaire (RQLQ), rhinoconjunctivitis total symptom score (RTSS), visual analogue score (VAS) of sneezing, runny nose, nasal itching, nasal congestion degree, days of AR episodes at enrollment, after 2- and 4-week, and at follow-up. The peripheral blood eosinophil (EOS) count and percentage (EOS%), serum eosinophil cationic protein (ECP), serum dust mite, dermatophagoides farinae, and cockroach allergen-specific IgE (sIgE) levels were compared between groups at enrollment and after 4-week treatment. Drug overuse rate was calculated, and the safety was evaluated. The analysis of all efficacy outcomes was based on both full analysis set (FAS) and per-protocol set (PPS). ResultsThe lower limit of the 95% confidence interval for the differences in RQLQ scores were greater than -0.6 measured after 2- and 4-week treatment and at follow-up compared to that measured at the enrollment in both groups, indicating of the Bisaitong group being non-inferior to the mometasone furoate group. There was no statistically significant difference between groups on RTSS score, VAS scores of sneezing, runny nose, nasal itching, nasal congestion degree and days of episodes at all timepoints (P>0.05), but each outcome changed significantly over time in both groups (P<0.01). The differences between groups in EOS count, EOS%, ECP levels, serum dust mite, dermatophagoides farinae, cockroach sIgE levels, and drug overuse rate were not statistically significant at enrollment and after 4-week treatment (P>0.05). Adverse events occurred in eight cases (15.10%) in the Bisaitong group and five cases (9.30%) in the mometasone furoate group, showing no significant difference between groups (P>0.05). ConclusionTopical Bisaitong is non-inferior to mometasone furoate nasal spray in the treatment of moderate to severe AR in terms of clinical symptom relief,reduction in the episodes, improvement of quality of life, and sound safety.