Patients' and clinicians' expectations on integrative medicine Services for Diabetes: a focus group study.

BACKGROUND: Difference of perspective between patients and physicians over integrative medicine (IM) research and service provision remains unclear despite significant use worldwide. We observed an exceptionally low utilisation of IM and potential underreporting in diabetes. We aimed to explore the barriers and recommendations regarding service delivery and research of IM service among diabetes patients and physicians. METHODS: A 10-group, 50-participant semi-structured focus group interview series was conducted. Twenty-one patients with diverse severity of disease, comorbidities and education levels; and 29 physicians (14 conventional medicine (ConM) and 15 Chinese medicine (CM)) with diverse clinical experience, academic background and affiliation were purposively sampled from private and public clinics. Their perspectives were qualitatively analysed by constant comparative method. RESULTS: Seven subthemes regarding barriers towards IM service were identified including finance, service access, advice from medical professionals, uncertainty of service quality, uncertainty of CM effect, difficulty in understanding CM epistemology and access to medical records. Patients underreported the use of CM due to the concern over neutrality of medical advice among physicians. Inconvenience of service access, frequent follow-up, use of decoction and long-term financial burden were identified as key obstacles among patients. Regarding research design, ConM physicians emphasised standardisation and reproducibility while CM physicians emphasised personalisation. Some CM-related outcome measurements were suggested as non-communicable. Both physicians acknowledged the discordance in epistemology should be addressed by pragmatic approach. CONCLUSION: Key obstacles of CAM clinical utilisation are different between patients. Further assessment on IM should be pragmatic to balance between standardisation, reproducibility and real-world practice. Evidence-based IM programs and research should merge with existing infrastructure.

Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial.

INTRODUCTION: Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin-angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese-Western medicine protocol for the management of DN. OBJECTIVE: To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2-3 chronic kidney disease and macroalbuminuria. METHODS AND ANALYSIS: This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-ß1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015. ETHICS AND REGISTRATION: This protocol is approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (reference number UW 14-301). TRIAL REGISTRATION NUMBER: NCT02488252.

A 3-year, prospective, randomized, controlled study on amino acid dialysate in patients on CAPD.

BACKGROUND: Malnutrition is prevalent in patients on continuous ambulatory peritoneal dialysis (CAPD) and confers a poor prognosis. Inadequate nutrient intake is an important contributing factor. Although short-term studies have shown mild to modest nutritional benefit with amino acid dialysate, its long-term effects and tolerability remain obscure. METHODS: The authors have performed a 3-year, randomized, prospective, controlled study of amino acid dialysate in malnourished Chinese patients on CAPD. Sixty patients were assigned randomly to either replace 1 exchange daily with amino acid dialysate (Nutrineal; DAA group, n = 30) or to continue with dextrose dialysate (Dianeal; DD group, n = 30). RESULTS: The 2 groups had similar mortality, hospitalization duration, serial C-reactive protein levels, and drop-out rates during the study. Biochemical nutritional parameters including albumin and cholesterol decreased in the DD group but remained stable or increased in the DAA group. The composite nutritional index did not differ between the 2 groups throughout the study period. Triglyceride decreased only in DAA-treated patients. Normalized protein equivalent of nitrogen appearance and dietary protein intake showed a sustained increase only in DAA patients. The nutritional benefit of DAA appeared more prominent in women, whose lean body mass and body mass index was maintained with DAA but not with DD. Mass transfer area coefficient for creatinine increased in DAA-treated patients, whereas that for urea as well as macromolecular restriction coefficients remained stable. Total Kt/V(urea) and daily ultrafiltration volume were similarly maintained in the 2 groups throughout the study. CONCLUSION: Long-term administration of amino acid dialysate is well tolerated and presents a means to improve the nutritional status in high-risk patients. The current study, however, has not shown a significant effect of amino acid dialysate on patient survival.