Dataset Information

Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial.

ABSTRACT:

Background

Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease and a leading cause of death worldwide. The clinical utility of commonly used lipid-lowering drugs such as statins and fibrates is sometimes limited by the occurrence of various adverse reactions. Recently, berberine (BBR) has received increasing attention as a safer and more cost-effective option to manage dyslipidemia. Thus, a high-quality randomized controlled trial to evaluate the efficacy and safety of BBR in the treatment of dyslipidemia is deemed necessary.

Methods/design

This is a randomized, double-blind, and placebo-controlled clinical trial. A total of 118 patients with dyslipidemia will be enrolled in this study and randomized into two groups at a ratio of 1:1. BBR or placebo will be taken orally for 12?weeks. The primary outcome is the percentage of low-density lipoprotein cholesterol reduction at week 12. Other outcome measures include changes in other lipid profiles, high sensitivity C-reactive protein, blood pressure, body weight, Bristol Stool Chart, traditional Chinese medicine symptom form, adipokine profiles, and metagenomics of intestinal microbiota. Safety assessment includes general physical examination, blood and urine routine test, liver and kidney function test, and adverse events.

Discussion

This trial may provide high-quality evidence on the efficacy and safety of BBR for dyslipidemia. Importantly, the findings of this trial will help to identify patient and disease characteristics that may predict favorable outcomes of treatment with BBR and optimize its indication for clinical use.

Trial registration

Chinese Clinical Trial Registry ChiCTR1900021361 . Registered on 17 February 2019.

SUBMITTER: Zhao Y

PROVIDER: S-EPMC7825207 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial.

Zhao Ying Y Yang Yuan-Yuan YY Yang Bao-Lin BL Du Ya-Wei YW Ren Da-Wei DW Zhou Hong-Mei HM Wang Jing J Yang Hui-Min HM Wang Yao-Xian YX Zhang Ying-Ying YY Wu Sheng-Xian SX

Trials 20210122 1

<h4>Background</h4>Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease and a leading cause of death worldwide. The clinical utility of commonly used lipid-lowering drugs such as statins and fibrates is sometimes limited by the occurrence of various adverse reactions. Recently, berberine (BBR) has received increasing attention as a safer and more cost-effective option to manage dyslipidemia. Thus, a high-quality randomized controlled trial to evaluate the efficacy and s ...[more]

PMID: 33482853

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Project description:BACKGROUND:Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla (Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia. METHODS:A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500?mg) or a matching placebo capsule was administered twice daily for 12?weeks to the respective group of patients. The patients were followed up for 12?weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH). RESULTS:In 12?weeks, the major lipids such as total cholesterol (TC) (p?=?0.0003), triglyceride (TG) (p?=?0.0003), low density lipoprotein cholesterol (LDL-C) (p?=?0.0064) and very low density lipoprotein cholesterol (VLDL-C) (p?=?0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) (p?=?0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more (p?=?0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla (p?=?0.2942) or placebo groups (p?=?0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS?>?100?mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study. CONCLUSIONS:The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins. TRIAL REGISTRATION:Registered with Clinical Trials Registry- India at www.ctri.nic.in (Registration number: CTRI/2015/04/005682 ) on 8 April 2015 (retrospectively registered).

Dataset Information

Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial.

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