Add-on Rehmannia-6-Based Chinese Medicine in Type 2 Diabetes and CKD: A Multicenter Randomized Controlled Trial.

BACKGROUND: Diabetes is the leading cause of CKD and kidney failure. We assessed the real-world effectiveness of Rehmannia-6-based Chinese medicine treatment, the most used Chinese medicine formulation, on the change in eGFR and albuminuria in patients with diabetes and CKD with severely increased albuminuria. METHODS: In this randomized, assessor-blind, standard care-controlled, parallel, multicenter trial, 148 adult patients from outpatient clinics with type 2 diabetes, an eGFR of 30-90 ml/min per 1.73 m 2 , and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g were randomized 1:1 to a 48-week add-on protocolized Chinese medicine treatment program (using Rehmannia-6-based formulations in the granule form taken orally) or standard care alone. Primary outcomes were the slope of change in eGFR and UACR between baseline and end point (48 weeks after randomization) in the intention-to-treat population. Secondary outcomes included safety and the change in biochemistry, biomarkers, and concomitant drug use. RESULTS: The mean age, eGFR, and UACR were 65 years, 56.7 ml/min per 1.73 m 2 , and 753 mg/g, respectively. Ninety-five percent ( n =141) of end point primary outcome measures were retrievable. For eGFR, the estimated slope of change was -2.0 (95% confidence interval [CI], -0.1 to -3.9) and -4.7 (95% CI, -2.9 to -6.5) ml/min per 1.73 m 2 in participants treated with add-on Chinese medicine or standard care alone, resulting in a 2.7 ml/min per 1.73 m 2 per year (95% CI, 0.1 to 5.3; P = 0.04) less decline with Chinese medicine. For UACR, the estimated proportion in the slope of change was 0.88 (95% CI, 0.75 to 1.02) and 0.99 (95% CI, 0.85 to 1.14) in participants treated with add-on Chinese medicine or standard care alone, respectively. The intergroup proportional difference (0.89, 11% slower increment in add-on Chinese medicine, 95% CI, 0.72 to 1.10; P = 0.28) did not reach statistical significance. Eighty-five adverse events were recorded from 50 participants (add-on Chinese medicine versus control: 22 [31%] versus 28 [36%]). CONCLUSIONS: Rehmannia-6-based Chinese medicine treatment stabilized eGFR on top of standard care alone after 48 weeks in patients with type 2 diabetes, stage 2-3 CKD, and severely increased albuminuria. CLINICAL TRIAL REGISTRY: Semi-individualized Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy (SCHEMATIC), NCT02488252 .

Tai chi exercise for patients with heart disease: a systematic review of controlled clinical trials.

CONTEXT: To summarize and evaluate the available evidence from controlled clinical trials of tai chi (TC) exercise for patients with heart disease. SEARCH METHODS: Fourteen databases were searched up to November 2010 with the terms tai chi, taichi, tai ji, taiji, taijichuan, cardiac, heart, coronary, myocardial, and atrial fibrillation in the title, abstract, or key words. No language restrictions were imposed. The quality and validity of randomized clinical trials (RCTs) were evaluated using the Jadad Scale. The strength of the evidence for all included studies was evaluated using the Oxford Centre for Evidence-based Medicine Levels of Evidence. RESULTS: Nine studies including 5 RCTs and 4 nonrandomized controlled clinical trials met the inclusion criteria. Three studies examined the effectiveness of TC exercise for patients with chronic heart failure (CHF), and 6 studies examined the effectiveness of TC exercise among patients with coronary heart disease (CHD). Overall, these studies demonstrated favorable effects of TC exercise for the patients with heart disease. CONCLUSIONS: The existing evidence suggests that TC exercise is a good option for heart patients with very limited exercise tolerance and can be an adjunct to rehabilitation programs for patients with CHD or CHF.

A systematic review of the effectiveness of qigong exercise in cardiac rehabilitation.

The objective of this study was to assess evidence for the efficacy and effectiveness of Chinese qigong exercise in rehabilitative programs among cardiac patients. Thirteen databases were searched through to November 2010, and all controlled clinical trials on Chinese qigong exercise among patients with chronic heart diseases were included. For each included study, data was extracted and validity was assessed. Study quality was evaluated and summarized using both the Jadad Scale and the criteria for levels of evidence. Seven randomized controlled trials (RCTs) and one non-randomized controlled clinical trial (CCT) published between 1988 and 2007 met the inclusion criteria. In total, these studies covered 540 patients with various chronic heart diseases including atrial fibrillation, coronary artery disease, myocardial infarct, valve replacement, and ischemic heart disease. Outcome measures emerged in these studies included subjective outcomes such as symptoms and quality of life; and objective outcomes such as blood pressure, ECG findings, and exercise capacity, physical activity, balance, co-ordination, heart rate, and oxygen uptake. Overall, these studies suggest that Chinese qigong exercise seems to be an optimal option for patients with chronic heart diseases who were unable to engage in other forms of physical activity; however, its efficacy and effectiveness in cardiac rehabilitation programs should be further tested.

Randomized non-invasive sham-controlled pilot trial of electroacupuncture for postpartum depression.

BACKGROUND: Postpartum depression affects 10-15% of mothers. Although acupuncture was efficacious for major depressive disorder in pregnancy and in women outside the perinatal period, there has been no randomized controlled study on the feasibility, tolerability, and efficacy of acupuncture for postpartum depression. METHODS: This was a randomized, subject- and assessor-blind, parallel-group, sham-controlled trial. Twenty women within six months postpartum with DSM-IV-diagnosed major depressive disorder of mild severity, defined as a 17-item Hamilton Depression Rating Scale (HDRS(17)) score of 12 to 19, were randomly assigned to either electroacupuncture or non-invasive sham acupuncture two sessions weekly for four weeks. RESULTS: There was significant reduction in HDRS(17) score from baseline to 4-week posttreatment in both groups, with an effect size 1.4 and 1.8 for electroacupuncture and sham acupuncture, respectively. Improvement was observed as early as two weeks after commencing acupuncture. The response and remission rate in the electroacupuncture group at 4-week posttreatment was 33% and 44%, respectively; for the sham acupuncture group, it was 60% and 50%, respectively. There was no significant between-group difference in all outcome measures, including the HDRS(17), Edinburgh Postnatal Depression Scale, Hospital Anxiety and Depression Scale, Clinical Global Impression, and Sheehan Disability Scale. Treatment credibility, success of blinding, and adverse events were similar between groups. LIMITATION: Small sample size and high attrition rate. No waiting list observation group. CONCLUSION: Both electroacupuncture and non-invasive sham acupuncture were effective for postpartum depression. Further studies utilizing larger sample size, better recruitment strategies, and home-based acupuncture treatment are warranted. CLINICAL TRIAL INFORMATION: Pilot Study on the Use of Acupuncture for Postpartum Depression; ClinicalTrials.gov Registration #NCT01178008; URL - http://clinicaltrials.gov/ct2/show/NCT01178008?term=postpartum+acupuncture&rank=1.