Published and Unpublished Studies on BCM-95®

With Study Results Summary

 Published Studies:

1. A Randomized, Pilot Study to Assess the Efficacy and Safety of Curcumin in Patients with Active Rheumatoid Arthritis. In this study, 45 patients with rheumatoid arthritis were randomized into 3 groups, with patients receiving either BCM-95 curcumin 500 mg twice daily, the prescription drug diclofenac sodium (one brand name is Voltaren®) 50 mg twice daily, or a combination of the two. The results were judged using the clinically validated Disease Activity Score (DAS) 28 and also with the American College of Rheumatology (ACR) criteria and scores for pain and swelling in joints. Patients in all 3 groups improved. The curcumin group showed the greatest improvement, and the endpoint scores were significantly better than the patients in the drug group. Using both interventions concurrently did not show any additional benefit with regards to disease scores. Curcumin was found to be safe with no adverse effects in this study. IN the drug group. 14% of the patients withdrew because of adverse effects. [Chandran B, Goel A. A Randomized, Pilot Study to Assess the Efficacy and Safety of Curcumin in Patients with Active Rheumatoid Arthritis. Phytother Res. March 9, 2012 doi: 10.1002/ptr.4639]
2. Randomized, Controlled Human Clinical Study to Assess the efficacy and safety of BCM-95® & Bospure® compared to Celecoxib in the management of Knee Osteoarthritis. Originally presented at the Osteoarthritis Research Symposium Internationale (OARSI) Annual World Congress on Osteoarthritis, September 15-18, 2011. San Diego, CA. 28 subjects with diagnosed osteoarthritis of the knee were randomized to a 500 mg blend BCM-95 curcumin and Bospure® Boswellia twice a day or to the prescription drug celecoxib (one brand name is Celebrex®) 100 mg twice a day. Symptom scoring and clinical evaluation yielded superior results on pain relief and distance walked for the BCM-95 and Bospure blend compared to celecoxib. BCM-95 and Bospure equaled celecoxib on joint flexibility. No serious adverse effects noted.  [Antony B, Kizhakedath R, Benny M, Kuruvilla BT. Clinical Evaluation of a herbal product (Rhulief™) in the management of knee osteoarthritis. Abstract 316. Osteoarthritis Cartilage. 2011;19(S1):S145-S146.]
3. Comparative Study of the Efficacy of Curcumin and Turmeric as Chemopreventative Agents in Oral Submucous Fibrosis: A Clinical and Histopathological Evaluation. Oral Submucous Fibrosis (OSMF) is a chronic disease of the oral mucosa. Premalignant lesions form, with a high progression rate to oral cancer. The goal of this study was to determine if BCM-95 curcumin and turmeric essential oil could improve health of the tissue and help prevent conversion to oral cancer. Participants were randomized to 3 groups of 16 people each: Group one received 1 capsule of BCM-95 curcumin, 500 mg curcuminioids, twice daily; group 2 received 12 drops of turmeric essential oil, held in the mouth twice daily then swallowed, for an approximate dosage of 600 mg, and the last group was placebo twice daily. Both BCM-95 curcumin and turmeric essential oil reduced oral discomfort/mouth burning significantly. The study lasted 6 months, and there were significant reductions in disease scores for both group 1 and 2 at each measurement. The authors reported “remarkable improvements after only the first 15 days of use.” After 6 months of use, 7 of the 16 participants in the placebo group were in the advanced disease stage (meaning closer to malignancy) compared to only 1 person in the BCM-95 curcumin group. No serious adverse effects were noted, and the authors called for more and larger trials, as this holds good promise for treatment of OSMF in the future.” [Deepa Das A, Balan A, Sreelatha KT. Comparative Study of the Efficacy of Curcumin and Turmeric as Chemopreventative Agents in Oral Submucous Fibrosis: A Clinical and Histopathological Evaluation. Journal of Indian Academy of Oral Medicine and Radiology; April-June 2012;22(2):88-92.]
4. Human Clinical Study to evaluate the bioavailability of BCM-95®.  15 healthy men and women ages 24-45; 8 assigned to plain curcumin and 7 assigned to BCM-95 curcumin. Results: overall, 7-fold increase over course of 12 hours. BCM-95 peak at 1600 ng/g; plain curcumin peak at ~230 ng/g. BCM-95 curcumin remained above 200 ng/g for 12 hours. Plain curcumin remained above 200 ng/g for less than 2 hours. Two hours after ingestion, BCM-95 levels are 10-fold over plain curcumin. [Benny M, Antony B. Bioavailability of BioCurcumax™ (BCM-095™). Spice India. September, 2006:11-15.]
5. A Pilot Cross-Over Study to evaluate human oral bioavailability of BCM-95®, A Novel Bioenhanced Preparation of Curcumin. This study compared BCM-95 curcumin’s absorption in human subjects to plain curcumin and also to curcumin enhanced with piperine (black pepper extract) and lecithin. The results showed that BCM-95 curcumin was absorbed 7 times (or 700%) better than plain curcumin, and at one time measure point, showed a blood level 10 times that of plain curcumin. BCM-95 was absorbed 6.3 (or 630%) better than curcumin with piperine and lecithin. [Antony B, Merina B, Iyer VS, et al. A Pilot Cross-Over Study to Evaluate Human Oral Bioavailability of BCM-95CG (Biocurcumax), A Novel Bioenhanced Preparation of Curcumin. Ind J Pharm Sci. 2008;70(4):445-449.]
6. Six-Month Randomized Placebo-Controlled, Double-Blind, Pilot Clinical Trial of Curcumin in Patients with Alzheimer’s Disease.  34 participants were randomized to either 1 gram BCM-95® curcumin, 4 grams BCM-95 curcumin, or placebo. All participants were over age 50, and had a diagnosis of probable or possible Alzheimer’s disease based on the National Institute of Neurological and Communicative Disorders and Stroke–Alzheimer Disease and Related Disorders Association diagnostic criteria. Some measures were serum markers of amyloid beta, plasma isoprostanes (a measure of oxidative stress) and antioxidant status. Both 1 gram and 4 grams reduced oxidative stress and improved antioxidant status. There were more adverse effects in the placebo group than in either 1 g or 4 g BCM-95 group. There was a noted increase in serum amyloid beta in both 1 g and 4 g groups, but not placebo. The authors noted this “possibly reflected an ability of curcumin to disaggregate amyloid beta deposits in the brain, releasing the amyloid beta for circulation and disposal.” [Baum L et al. Six-Month Randomized Placebo-Controlled, Double-Blind, Pilot Clinical Trial of Curcumin in Patients with Alzheimer’s Disease.  Journal of Clinical Psychopharmacology. Vol 28, Number 1, Feb 2008 pg 110-114)
7. Curcumin effects on Blood Lipid profile in a 6-month human Study. No significant cholesterol lowering effects found, though authors speculate curcumin has other cardioprotective physiological effects. [Elsevier Pharmacological Research 56(2007) pg 509-514.]
8. Oral Bioavailability of BCM-95® in Dogs. This study looked specifically at bioavailability in dogs for veterinary purposes. Six healthy adult male and female dogs were divided between plain curcumin and BCM-95 curcumin (reported as the veterinary NMXCC-95 designation). No adverse effects reported. The BCM-95 group had approximately 7-fold increase in absorption over plain curcumin over 8 hours and approximately 9-fold increase over plain curcumin when measured for 12 hours. [Poster presentation. Oral Bioavailability of BCM-95 Curcumin in Dogs. 2009 ACVIM Forum/Canadian VMA Convention: June 3-6, 2009; Montréal, Québec, Canada.]
9. Effect of Citrus Polyphenol- and Curcumin-supplemented Diet on Inflammatory State in Obese Cats. Veterinary study looking at obesity-induced pro-inflammatory state in cats and impact of BCM-95 on liver and inflammatory markers. Showed safe use in cats, and significant impact on interleukin 2 (IL-2) and reduction of AGP (a1-acid glycoprotein) which shows that curcumin impacts hepatocytes (liver cells) to reduce AGP, illustrating that BCM-95 is helping liver cells to behave more like liver cells in non-obese cats. [Leray V, Freuchet B, Le Bloc'h J, Jeusette I, Torre C, Nguyen P. Effect of Citrus Polyphenol- and Curcumin-supplemented Diet on Inflammatory State in Obese Cats. Br J Nutr. 2011 Oct;106 Suppl 1:S198-201.]
10. Evaluation of Antidepressant Like Activity of Curcumin and its Combination with Fluoxetine and Imipramine: an Acute and Chronic Study. In animal model of depression, BCM-95 curcumin is compared to generic fluoxetine (one brand name is Prozac®) and imipramine (one brand name is Tofranil®). BCM-95 curcumin performed as well as either prescription anti-depressant drug on all measures of depression. However, adding BCM-95 curcumin to the prescription drugs did not increase antidepressant effects. [Sanmukhani J, Anovadiya A, Tripathi CB. Evaluation of Antidepressant Like Activity of Curcumin and its Combination with Fluoxetine and Imipramine: an Acute and Chronic Study. Acta Pol Pharm. 2011 Sep-Oct;68(5):769-75.
11. The Effect of Exercise and Nutritional Supplementation on Proinflammatory Cytokine Expression in Young Racehorses During Training. The inflammatory response to vigorous exercise ranges from the mild symptoms of delayed-onset muscle soreness to debilitating injuries affecting soft tissue, joint, and bone. Although there is a great deal of information available on the inflammatory response to exercise in human athletes, less information is available regarding the inflammatory response to exercise in young horses undergoing training for racing careers. Here, we assessed the cytokine response to exercise in a group of young Thoroughbred racehorses during their initial training. Because there is interest in nonpharmacologic approaches to control or ameliorate exercise-induced inflammation, we also examined the anti-inflammatory effect of a nutritional supplement [containing BCM-95^® curcumin, BosPure^® boswellia, coenzyme Q10, glycine proprionyl-L-carnitine HCl, and D-ribose] fed to half of the horses undergoing training. Twenty-five Thoroughbred horses aged 2 years were followed through their initial race training. Peripheral blood samples were collected at various times during the exercise for the quantitation of lactic acid, oxidative stress, and inflammatory cytokine gene expression. There was an intensity-dependent effect of exercise on lactate, malondialdehyde, and proinflammatory cytokine gene expression. Although training itself was associated with an overall reduction in inflammatory markers, horses receiving the supplement exhibited further reductions in their indicators of inflammation. As such, this study provides novel evidence of nutritional supplementation reducing postexercise inflammation. [Horohov DW, Sinatra ST, Chopra RK, Jankowitz S, Betancourt A, Bloomer RJ. The effect of exercise and nutritional supplementation on proinflammatory cytokine expression in young racehorses during training. J Equine Vet Sci. 2012. In Press.]
12. Comparative Bioavailability of Curcumin, Turmeric, and Biocurcumax™ in Traditional Vehicles using Non-Everted Rat Intestinal Sac Model. The bioavailability of curcumin from turmeric, Biocurcumax and as plain curcumin was investigated using conventional vehicles by a non-everted rat intestinal model. Results of ex vivo intestinal permeability studies showed an enhancement in the permeability of curcumin with increase in lipophilicity of the vehicle used. Maximum permeability of curcumin was obtained from corn oil (13.4%) followed by clarified butter (9.82%), milk (4.24%) and aqueous suspension (1.66%) in 8 h. Another very interesting and important observation was that the permeation of curcumin was more from turmeric and Biocurcumax than from plain curcumin. These studies strongly suggest that curcumin may be consumed as turmeric/Biocurcumax_ in lipophilic vehicles instead of plain curcumin for maximum beneficial effects. [Shishu MM. Comparative bioavailability of curcumin, turmeric, and Biocurcumax™ in traditional vehicles using non-everted rat intestinal sac model. J Functional Foods. 2010;2(1):60-65.]

 Unpublished Studies

1. Toxicity study: The results of the study indicated that treatment of Sprague Dawley rats with BCM-95 for a prolonged period of 45 days (dose of 75mg/100gm of body weight) did not significantly affect the feed intake and body weight. There was no significant change in the hematological and biochemical parameters. There was decrease in serum cholesterol level. Histopathological evaluations did not reveal any histological lesions in rats.
2. BCM-95 Hepatoprotective Effect. Department of Biochemistry, University of Kerala. Assess effect of BCM-95 on CCl4 and alcohol induced liver injury in rats. Liver injury was induced in rats by low doses of CCl for 3 months as evidenced by abnormal liver function tests, lipid profile and increase in hepatic collagen content. Alcoholic hepatitis was induced by alcohol (9g/100 g body weight) daily for 3 months as evidenced by altered liver function tests, accumulation of lipids and collagen in liver.  Observations: Noted reduction in serum GOT, GPT, bilirubin, LDH and an increase in A/G ratio.  Reduction in serum cholesterol and triglycerides as well as a reduction in liver cholesterol and triglycerides was noted, as well as decrease in hepatic GOT, LDH, and collagen. Conclusions: BCM-95 was found to be hepatoprotective against CCl4 and alcohol induced liver injury in rats.

Current Completed Studies Under Peer Review for Publications:

1. BCM-95® vs. fluoxetine for antidepressant effects. 60 subjects divided into 3 groups: curcumin; fluoxetine (one brand name Prozac®); and curcumin plus fluoxetine.

Current Ongoing Clinical Studies in process:

1. Phase one trial on concomitant use of BCM-95 curcumin with chemotherapy for individuals with lung cancer. Jewish General Hospital, Montreal, Quebec, CA. In recruitment. The staff of the Peter Brojde Lung Cancer Unit is recruiting lung cancer patients for an initial trial of tolerability with concomitant dosing with chemotherapy, in preparation for a larger phase II treatment trial that may have a sub-focus on patients with chemo resistance.
2. Phase II randomized, multi-center, double-blind, placebo chemoprevention clinical trial of [BCM-95®] curcumin in oral premalignant lesions and cervical cancer. Awaiting statistical analysis. 140 participants. Primary Objective: to evaluate the clinical efficacy and safety or oral BCM-95 therapy for period of 6 months in subjects with oral premalignant lesions (OPL) by clinical response (reduction in size of all lesions, prevention of malignant transformation in the index lesion and occurrence of any new lesions) and histological response (change in histological grade). Secondary Objective: to investigate in-vivo modulation of Nuclear Factor Kappa B (NF-kB) and biomarkers, by BCM-95 and further elucidate the pharmacokinetics of oral administration of BCM-95.
3. Martins R. Evaluation of the nutritional extract Bio-curcumin (BCM-95) to preserve cognitive functioning in a cohort of mild cognitively impaired (MCI) patients over 12 months. Edith Cowan University. Joondalup, Western Australia. Study in process. Placebo-controlled, double blind study with 150 participants with MCI (mild cognitive impairment/early stage Alzheimer’s disease). Both cognitive factors and blood biomarkers to be assessed, as well as safety data reported.
4. Bioavailability in healthy human volunteers. Baylor University, Texas. Both male and female volunteers of various ages, testing a variety of curcumin delivery systems.
5. Pilot study: Comparison of 5 curcumin types in vitro: phosphatidylcholine (lecithin) bound curcumin with cellulose in 4 to 1 ratio; BCM-95® curcumin; synthetic curcumin; bisdemethoxycurcumin; and plain 95% curcumin on cellular anti-cancer activity. Gastrointestinal Cancer Research Lab at Baylor University Medical Center in Dallas.
6. BCM-95® curcumin impact on “sleeping gene” as partial mechanism of action for cancer prevention. Gastrointestinal Cancer Research Lab at Baylor University Medical Center in Dallas.