Safety and Efficacy of Bixa orellana (Achiote, Annatto) Leaf Extracts

Abstract

Bixa orellana leaf preparations have been used for many years by indigenous people for a variety of medicinal applications. Published research studies in animals indicate that various extracts of Bixa leaves exhibit antioxidant, broad antimicrobial (antibacterial and antifungal), anti-inflammatory, analgesic, hypoglycemic, and antidiarrheal activities. No studies have specifically assessed the ability of leaf extracts to inhibit urogenital infections although Bixa products have been used in folkloric medicine to treat gonorrhea and other infections. Few human studies have been conducted and published using Bixa leaf preparations. Many more studies have been conducted and published involving Bixa seed (annatto) extracts than with leaf extracts. No subchronic safety (toxicity) studies have been conducted in animals. A 6 month study in humans given 750 mg of leaf powder per day demonstrated no significant or serious adverse effects. Bixa leaf extracts appear to be safe when given under current conditions of use. However, additional human and animal controlled safety and efficacy studies are needed. In addition, detailed chemical analyses are required to establish structure-function relationships.

Systemic administration of the apocarotenoid bixin protects skin against solar UV-induced damage through activation of NRF2

“…Remarkably, bixin is now one of the most consumed food colorants in the world distinguished by a long record of dietary and ethnopharmacological use [33, 34]. In prior studies, bixin has demonstrated antigenotoxic and antioxidant cytoprotective activities, and systemic availability of oral bixin and its demethylated metabolite norbixin has been documented in rodent studies and healthy human subjects [35, 36, 55, 56].…”

“…In an attempt to test the feasibility of NRF2-dependent systemic photoprotection by dietary constituents, we focused our photoprotection studies on the apocarotenoid bixin, an FDA-approved natural food colorant from the seeds of the achiote tree ( Bixa orellana ) native to tropical America [33, 34]. Consumed by humans since pre-Columbian times, this apocarotenoid derived from lycopene through oxidative cleavage is now used worldwide as a dietary additive and cosmetic ingredient (referred to as 'annato'; E160b) with an excellent safety record and established systemic bioavailability and pharmacokinetic profile upon oral administration [35-37].…”

ACUTE ORAL TOXICITY FROM A FRACTION RICH IN PHENOLIC COMPOUNDS FROM THE LEAF EXTRACT OF Swietenia macrophylla KING IN A MURINE MODEL

“…Although some plants have been used in folk medicine for many years is necessary evaluated the safety of them in controlled studies (22). Different plants had been report with inhibitory activity of snake venom (23, 24).…”

A Critical Approach to Evaluating Clinical Efficacy, Adverse Events and Drug Interactions of Herbal Remedies

“…) (Ho et al , ; Rosner, 2012; Elamin and Montori, 2012; Varoni et al , 2014). For this reason, although traditional, narrative review articles on the efficacy and the safety of herbal medicine continue to be published (for example, Bella and Shamloul, ;Gulati, ; Pagano et al , ; Stohs, ; Stohs, ; Chingwaru et al , ; Gulati, ; Stohs and Hartman, ), systematic reviews increasingly are replacing them.…”