Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Introduction Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. Methods and analysis This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. Ethics and dissemination This study has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019

Delta Tocotrienol as a Supplement to FOLFOXIRI in First Line Treatment of Metastatic Colorectal Cancer. A Randomized, Double-blind, Placebo-controlled Phase II Study

Purpose Triplet chemotherapy might be more effective than doublet chemotherapy in metastatic colorectal cancer (mCRC), but it may also be marked by increased toxicity. To investigate whether δ-tocotrienol, a vitamin E analogue, with its possible neuroprotective and anti-inflammatory effects reduces the toxicity of triplet chemotherapy, we conducted a randomized, double-blind, placebo controlled trial in mCRC patients receiving first line 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI).Methods We randomly assigned 70 mCRC patients to FOLFOXIRI plus δ-tocotrienol or FOLFOXIRI plus placebo. FOLFOXIRI was given in eight cycles followed by four cycles of 5-fluorouracil. δ-tocotrienol 300 mg or placebo x 3 daily was added during chemotherapy and for a maximum of two years. The primary endpoint was time to hospitalization or death during treatment with chemotherapy.Results Median time to first hospitalization or death was 3.7 months in the placebo group (95% CI 1.93-not reached (NR)), and NR in the δ-tocotrienol group (95% CI 1.87-NR) with a hazard ratio (HR) of 0.70 (95% CI 0.36-1.36, p=0.29)). In the placebo group 24 patients (71%) had oxaliplatin dose reductions compared to 17 patients (47%) in the δ-tocotrienol group (p=0.047).Conclusion The addition of δ-tocotrienol to FOLFOXIRI did not significantly prolong the time to first hospitalization or death compared to FOLFOXIRI plus placebo. Toxicity was manageable and not statistically different between the two groups. There was a statistically significant difference in dose reductions of oxaliplatin pointing to a possible neuroprotective effect of δ-tocotrienol.Clinicaltrials.gov identifier NCT02705300. Date of registration March 10, 2016.

The Effect of An Aloe-Based Polyherbal Formulation in Adults with Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled, Six-Months Clinical Follow-up Trial

The most common functional gastrointestinal problem in the world is functional constipation. "Ayarij-e-Faiqra (AF)" is a polyherbal formula that has been recommended by Persian Medicine as an efficent purgative agent . The purpose of this study was to evaluate the effect of AF on functional constipation using a double-blind, placebo-controlled clinical trial. According to the Rome III classification, 79 adults with functional constipation were included in this trial. The diagnostic criteria were according to the Rome III classification. Patients with constipation symptoms who referred to the traditional medicine clinic of Shahid Beheshti University of Medical Sciences from April 2014 to September 2016 were randomly allocated to the AF and placebo groups. The AF and placebo groups received AF and placebo for three months, respectively and followed up for another three months. During the study, the treatment efficacy was assessed by a questionnaire. AF treatment significantly decreased most of the symptoms by 84% at the end of the first month (p < 0.05) and by 90% at the end of the third month in comparison to placbo group (p < 0.001). However, three months after the end of the intervention, the frequency of constipation symptoms in both groups was not statistically significant. Based on the satisfaction questionnaire, the treatment satisfaction score during the intervention was increased to 9 in the AF group, but no significant difference was found between the two groups three months after the intervention (p > 0.005). Although AF could be beneficial for treating functional constipation without significant side effects, changing patients’ lifestyles has great importance in this process.

Supplementation with a Highly Concentrated Docosahexaenoic Acid (DHA) in Non-Proliferative Diabetic Retinopathy: A 2-Year Randomized Double-Blind Placebo-Controlled Study

We assessed the effect of a 2-year supplementation with a highly concentrated docosahexaenoic acid (DHA) product with antioxidant activity on non-proliferative diabetic retinopathy (NPDR) in a randomized double-blind placebo-controlled study. A total of 170 patients with diabetes were randomly assigned to the DHA group (n = 83) or the placebo group (n = 87). NPDR was diagnosed using non-contact slit lamp biomicroscopy examination, and classified into mild, moderate, and severe stages. Patients in the DHA group received a high rich DHA triglyceride (1050 mg/day) nutritional supplement, and those in the placebo group received olive oil capsules. The percentages of mild NPDR increased from 61.7% at baseline to 75.7% at the end of the study in the DHA group, and from 61.9% to 73.1% in the placebo group. Moderate NPDR stages decreased from 35.1% at baseline to 18.7% at the end of the study in the DHA group, and from 36.8% to 26.0% in the placebo group. In the DHA group, there were five eyes with severe NPDR at baseline, which increased to one more at the end of the study. In the placebo group, of two eyes with severe NPDR at baseline, one eye remained at the end of the study. Changes in visual acuity were not found. There were improvements in the serum levels of HbA1c in both groups, but significant differences between the DHA and the placebo groups were not found. In this study, the use of a DHA triglyceride nutraceutical supplement for 2 years did not appear to influence the slowing of the progression of NPDR.