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INTRODUCTION/BACKGROUND

By Marilyn L. Barrett, PhD

Editor’s note: Although most of the information contained in this monograph is based on research conducted directly on the proprietary BCM-95® (aka CurcugreenTM) curcumin turmeric extract preparation, for the sake of background and appropriate context, a limited number of citations of traditional historical culinary and medicinal uses of turmeric rhizome, as well as limited pharmacological research on generic turmeric and curcumin preparations, have been included. In October 2018, the producer of this proprietary preparation introduced it with another trade name, Curcugreen; all studies cited in this monograph on the proprietary preparation were conducted and published when the ingredient was marketed under its primary name BCM-95. The two names refer to the identical preparation.

INTRODUCTION/BACKGROUND

This monograph covers the preclinical and clinical studies conducted on BCM-95® (CurcugreenTM), a proprietary extract of the rhizome (an underground stem sometimes referred to as root) of Curcuma longa L. (syn. C. domestica Valeton), a plant belonging to the ginger family (Zingiberaceae), native to India and Southeast Asia.1 Turmeric rhizome is a popular food, spice, dietary supplement, and traditional medicine in many parts of the world. Turmeric rhizome powder is yellow in color and supplies the characteristic color to yellow curries.2 Turmeric is also used to color “American mustard,” mayonnaise, and margarines. Turmeric is designated by the European Food Safety Authority as an international food additive (E100).3 In addition to supplying color, turmeric also adds flavoring to numerous condiments and foods. Besides being a common food ingredient and spice, turmeric is also used in the traditional medicines of India, China, and Arabia.1,2,4

Prompted by traditional medicinal use, preclinical and clinical research on turmeric, especially on its principal chemical constituent curcumin, has greatly increased in the last two decades. Preclinical studies with curcumin have found multiple biological targets and cellular effects that indicate anti-inflammatory, antioxidant, and immunomodulatory activities.2,3,5 Curcumin has also been extensively investigated as an anticancer agent due to its documented antioxidant and anti-inflammatory activities.4,5 Clinical studies have suggested numerous health benefits in inflammatory conditions such as rheumatoid arthritis (RA), inflammatory bowel disease, psoriasis, and others.2,3

The list of potential health benefits of curcumin is growing. Researchers are also looking into ways to improve the bioavailability of curcumin, since it has been established that curcuminoids are not easily absorbed by the human gut.6 Accordingly, BCM-95, the proprietary turmeric/curcumin preparation that is the topic of this monograph, was formulated to enhance absorption.

Due to continued reports of their health benefits, turmeric and turmeric-based dietary supplements have become increasingly popular in the United States and other industrialized nations in recent years. Retail sales of turmeric-based dietary supplements (containing powdered turmeric rhizome and/or more concentrated turmeric extracts standardized to curcumin content) in the United States increased every year from 2012 to 2017.7-10c In 2012, turmeric and curcumin-based dietary supplements ranked third in the natural food store channel, with approximately US $17 million in sales, a 40% increase from the previous year.7 In 2013, turmeric supplements rose to the rank of the top-selling single herbal dietary supplement, with total sales increasing by more than 26% to over $21 million (not including sales in Whole Foods Markets)8; sales increased 31% in 2014 in this channel, to over $26 million.9 In 2015, natural channel sales of turmeric totaled more than $37 million, a 32% increase from the previous year,10 and in 2016, turmeric sales increased by 32%, totaling more than $47 million.10b Natural channel sales of turmeric totaled more than $50 million in 2017, a 12% increase from the previous year.10c In contrast, turmeric did not rank in the top 40 single herb supplements in the mass market channel (grocery stores, drug stores, and mass-market retailers, exclusive of Walmart) in 2012.7 However, in 2013, turmeric rose to the rank of 30th single herb supplement in this market,8 with a 60% sales increase to a ranking of 26th in 2014,9 rising to a ranking of 19th in 2015.10 In 2016, mainstream sales of turmeric increased by 85%, making it the 10th top-selling herbal supplement ingredient in this channel.10b Turmeric ranked ninth in mainstream multi-outlet sales in 2017 with a 47% increase in sales from the previous year.10c

In summary, this monograph provides a description of the chemical composition of BCM-95 and the scientific and clinical support for its potential uses. Studies on the bioavailability of curcumin that have been conducted in rats, dogs, and humans are detailed below. Pharmacological studies demonstrating antioxidant and anti-inflammatory activities have been conducted in vitro and in several animal studies (e.g., with rats, cats, and racehorses). The potential for antitumor benefits has been explored in cell culture and rodent studies. Both rodent studies and human clinical trials indicate a potential antidepressant action. Two clinical studies failed to find a definite benefit in cognition for elderly subjects or those with possible Alzheimer’s disease. BCM-95 was reported in two studies to have a positive effect on joint health (osteoarthritis [OA] and RA). A rodent study indicates a protective effect against toxin-induced liver injury. This protective effect was duplicated in human clinical trials in which participants had been exposed to toxicities due to chewing betel (areca palm; Areca catechu, Arecaceae) quid preparations and to radiation therapy. The potential for a clinical cancer chemopreventative effect was observed in two different precancerous conditions. The safety of BCM-95 has been confirmed in acute, sub-acute, and chronic toxicity studies. Safe use has also been reported in human clinical studies, which are detailed below.

Table 1. Abbreviations & Symbols Used in this Monograph  

Abbreviation/Symbol   Full Name
< less than
delta (change)
AUC
area under the curve
C Celsius
cm centimeter
COX-2
cyclooxygenase-2
CYP
cytochrome P450
g gram
h hour
HPLC
high-performance liquid chromatography
ICH
International Council on Harmonisation
IFN-γ
interferon-gamma
IL interleukin
kg kilogram
L liter
m meter
M
molar (concentration)
μM micromolar
µmol micromole
mA milliampere
MDD
major depressive disorder
mg milligram
mL milliliter
MLD
minimum lethal dose
mm millimeter
MS/MS
tandem mass spectrometry
MTD
maximum tolerated dose
NAT2
N-acetyltransferase 2
NF-κB
nuclear factor-kappa B
ng nanogram
nm nanometer
nmol/L
nanomoles per liter
NSAIDs
nonsteroidal anti-inflammatory drugs
OA osteoarthritis
OECD
Organisation for Economic Co-operation and Development
ORAC
oxygen radical absorbance capacity
P-gp P-glycoprotein
pg picogram
pH
measurement unit of the alkalinity or acidity of a solution
PPAR-γ
peroxisome proliferator-activated receptorgamma
RA
rheumatoid arthritis
TE
Trolox equivalent
THC
tetrahydrocurcumin (not to be confused with referring to delta-9-tetrahydrocannabinol, a psychoactive substance in cannabis [Cannabis sativa, Cannabaceae])
TNF-α
tumor necrosis factor-alpha
UV ultraviolet
VAS
visual analog scale
XO xanthine oxidase