Diabetes and chronic kidney disease (CKD) are pandemic, requiring more therapeutic options. This retrospective cohort evaluated the effectiveness, safety profile and prescription pattern of a pilot integrative medicine service program in Hong Kong. Data from 38 patients with diabetes and CKD enrolled to receive 48-week individualized add-on Chinese medicine (CM) were retrieved from the electronically linked hospital database. A 1:1 cohort was generated with patients from the same source and matched by propensity score. The primary outcomes are the change of estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) analyzed by analysis of covariance and mixed regression model adjusted for baseline eGFR, age, gender, duration of diabetes history, history of hypertension, diabetic retinopathy, and the use of insulin and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. The rate of adverse events and the change of key biochemical parameters were analyzed. After a median of 51 weeks, patients who received add-on CM had stabilized eGFR (difference in treatment period: 0.74 ml/min/1.73m2, 95% CI: –1.01 to 2.50) and UACR (proportional difference in treatment period: 0.95, 95% CI: 0.67 to 1.34). Add-on CM was associated with significantly preserved eGFR (Inter-group difference: 3.19 ml/min/1.73m2, 95%CI: 0.32 to 6.06, [Formula: see text] 0.030) compared to standard care. The intergroup ratio of UACR was comparable (0.70, 95% CI: 0.45 to 1.08, [Formula: see text] 0.104). The result is robust in sensitivity analysis with different statistical methods, and there was no interaction with CKD stage and UACR. The rate of serious adverse events (8.1% vs. 18.9%, [Formula: see text] 0.174), moderate to severe hyperkalemia (8.1% vs. 2.7%, [Formula: see text] 0.304) and hypoglycemia (13.5% vs. 5.4%, [Formula: see text] 0.223), and the levels of key biochemical parameters were comparable between groups. The top seven most used CMs contained two classical formulations, namely Liu-wei-di-huang-wan and Si-jun-zi-tang. Individualized add-on CM was associated with significant kidney function preservation and was well tolerated. Further randomized controlled trials using CM prescriptions based on Liu-wei-di-huang-wan and Si-jun-zi-tang are warranted.
Background: Previous UK Biobank studies showed that symptoms and physical measurements had excellent prediction on long-term clinical outcomes in general population. Symptoms and signs could intuitively and non-invasively predict and monitor disease progression, especially for telemedicine, but related research is limited in diabetes and renal medicine.Methods: This retrospective cohort study aimed to evaluate the predictive power of a symptom-based stratification framework and individual symptoms for diabetes. Three hundred two adult diabetic patients were consecutively sampled from outpatient clinics in Hong Kong for prospective symptom assessment. Demographics and longitudinal measures of biochemical parameters were retrospectively extracted from linked medical records. The association between estimated glomerular filtration rate (GFR) (independent variable) and biochemistry, epidemiological factors, and individual symptoms was assessed by mixed regression analyses. A symptom-based stratification framework of diabetes using symptom clusters was formulated by Delphi consensus method. Akaike information criterion (AIC) and Bayesian information criterion (BIC) were compared between statistical models with different combinations of biochemical, epidemiological, and symptom variables.Results: In the 4.2-year follow-up period, baseline presentation of edema (−1.8 ml/min/1.73m2, 95%CI: −2.5 to −1.2, p < 0.001), epigastric bloating (−0.8 ml/min/1.73m2, 95%CI: −1.4 to −0.2, p = 0.014) and alternating dry and loose stool (−1.1 ml/min/1.73m2, 95%CI: −1.9 to −0.4, p = 0.004) were independently associated with faster annual GFR decline. Eleven symptom clusters were identified from literature, stratifying diabetes predominantly by gastrointestinal phenotypes. Using symptom clusters synchronized by Delphi consensus as the independent variable in statistical models reduced complexity and improved explanatory power when compared to using individual symptoms. Symptom-biologic-epidemiologic combined model had the lowest AIC (4,478 vs. 5,824 vs. 4,966 vs. 7,926) and BIC (4,597 vs. 5,870 vs. 5,065 vs. 8,026) compared to the symptom, symptom-epidemiologic and biologic-epidemiologic models, respectively. Patients co-presenting with a constellation of fatigue, malaise, dry mouth, and dry throat were independently associated with faster annual GFR decline (−1.1 ml/min/1.73m2, 95%CI: −1.9 to −0.2, p = 0.011).Conclusions: Add-on symptom-based diagnosis improves the predictive power on renal function decline among diabetic patients based on key biochemical and epidemiological factors. Dynamic change of symptoms should be considered in clinical practice and research design.
Background: Allergic rhinitis (AR) is an upper airways chronic inflammatory disease mediated by IgE, which affects 10%–20% of the population. The mainstay for allergic rhinitis nowadays include steroids and antihistamines, but their effects are less than ideal. Many patients therefore seek Chinese medicine for treatment and Yupingfeng Powder is one of the most common formulae prescribed. In this study, we aim to investigate the efficacy and safety of Yupingfeng Powder with variation for the treatment of allergic rhinitis.Study design: This is a double-blind, randomized, placebo-controlled trial. A 2-week screening period will be implemented, and then eligible subjects with allergic rhinitis will receive interventions of either “Yupingfeng Powder with variation” granules or placebo granules for 8 weeks, followed by post treatment visits at weeks 12 and 16. The change in the Total Nasal Symptom Score (TNSS) will be used as the primary outcome.Discussion: This trail will evaluate the efficacy and safety of Yupingfeng Powder in treating allergic rhinitis. The study may provide the solid evidence of Yupingfeng Powder with variation can produce better clinical efficacy than the placebo granules.Trial registration:ClinicalTrials.gov, identifier NCT04976023.
BACKGROUND AND AIMS Chronic kidney disease (CKD) and diabetes are key contributors of disability-adjusted life years globally awaiting more therapeutic options. This registry-based retrospective cohort study aimed to evaluate the effectiveness, safety profile and prescription pattern of a pilot integrative Chinese–Western medicine service program in Hong Kong. METHOD Data from 38 patients with diabetes and CKD received 48 weeks of individualized add-on Chinese medicine (CM) were retrieved from electronic hospital database. Patients from the same source were matched by propensity score to generate a 1:1 cohort. Primary outcomes were the change of estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) analyzed by analysis of covariance (ANCOVA) and mixed-effect regression model adjusted for baseline eGFR, age, gender, duration of diabetes history, history of hypertension, diabetic retinopathy, and the use of insulin and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Rate of adverse events and the change of key biochemical parameters were also analyzed. RESULTS After a median follow-up of 51 weeks, patients who received add-on CM had stabilized eGFR [0.74 mL/min/1.73 m2 (95% CI −1.01–2.50)] and UACR [0.95 (95% CI 0.67–1.34)]. Add-on CM was associated with significantly preserved eGFR [inter-group difference: 3.19 mL/min/1.73 m2 (95% CI 0.32–6.06), P = 0.030] compared with standard care. The intergroup ratio of UACR were comparable [0.70 (95% CI 0.45–1.08), P = 0.104] between groups. The result is robust in sensitivity analysis with different statistical methods. The rate of serious adverse events (8.1% versus 18.9%, P = 0.174), moderate-to-severe hyperkalemia (8.1% versus 2.7%, P = 0.304) and hypoglycemia (13.5% versus 5.4%, P = 0.223), and the levels of key biochemical parameters were comparable between groups. Top 7 most used CMs contained two classical formulations namely Liu-wei-di-huang-wan and Si-jun-zi-tang. CONCLUSION Add-on individualized CM was associated with kidney function preservation. Further randomized controlled trial using CM prescriptions based on Liu-wei-di-huang-wan and Si-jun-zi-tang is warranted.
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