Variability in Potency Among Commercial Preparations of Berberine

Abstract

Berberine is an isoquinoline alkaloid plant extract that is widely available as a dietary supplement in the United States and has demonstrated efficacy in the treatment of type 2 diabetes mellitus and dyslipidemia. Because of its increased use and purported pharmacological properties, potential variations in product quality could pose a barrier to berberine's safety and effectiveness in clinical practice. Thus, this study evaluated the potency of dietary supplements containing berberine available in the U.S. commercial market. Fifteen unique dietary supplements containing berberine were purchased through U.S. dietary supplement vendors. For each product, berberine was extracted from 3 unique capsules and analyzed by ultra-high-performance liquid chromatography tandem mass spectrometry. Percentage content based on the product label claim was determined for each product. The average berberine content across the products was found to be 75% ± 25% of the product label claim, with product potency ranging from 33% to 100%. Nine of the 15 tested products (60%) failed to meet the potency standards of 90% to 110% of labeled content claim, as commonly required of pharmaceutical preparations by the U.S. Pharmacopeial Convention. Evaluation of the relationship between product cost and the measured potency failed to demonstrate an association between quality and cost. Variability in product quality may significantly contribute to inconsistencies in the safety and effectiveness of berberine. In addition, the quality of the berberine product cannot be inferred from its cost.

Exposure to the natural alkaloid Berberine affects cardiovascular system morphogenesis and functionality during zebrafish development

“…In clinical applications, BRB is usually administered orally as sulphate or chloride formulation at 400–1500 mg/day 6 , 7 and exerts multi-target protective action against several pathological conditions, including dyslipidemias, diabetes, arrhythmias, heart failure, cancer and neurodegenerative disorders 4 – 6 . In particular, BRB is already available in over-the-counter dietary supplements for the treatment of type 2 diabetes mellitus and dyslipidemia 8 , 9 .…”

“…particular, BRB is already available in over-the-counter dietary supplements for the treatment of type 2 diabetes mellitus and dyslipidemia 8,9 .…”

Integrated metabolomics and transcriptomics study of traditional herb Astragalus membranaceus Bge. var. mongolicus (Bge.) Hsiao reveals global metabolic profile and novel phytochemical ingredients

“…Another protoberberine alkaloids, Berberine, which also had a significantly higher relative content in the leaf than in the root and stem (Fig. 2b), demonstrated efficacy in anti-diabetic, anti-inflammatory, anti-dyslipidemia [49], and antioxidant activities [46]. These results suggested that other tissues besides AMM root may have potential nutritive value in functions like blood circulation, glucose regulation, and immunity enhancement [50].…”

Critical Differences Between Dietary Supplement and Prescription Omega-3 Fatty Acids: A Narrative Review

“…Patients may view dietary supplements positively and favor taking supplements over medications [52]; however, there have been serious safety concerns with dietary supplements [50,51,53,54]. Patients may choose dietary supplements believing these products to be ''all natural,'' yet many dietary supplements have been documented to include undeclared Rx products or even unapproved drugs [50,53].…”