Nutraceuticals research.

Nutraceutical: 5-Loxin (Boswellia serrata extract)

Indication: Osteoarthritis (OA) of the knee

Source: Arthritis Res Ther, July 30, 2008;10(4):R85.

Research: Using a double-blind, placebo-controlled model, researchers assigned 75 patients to receive either 100 mg (n = 25) or 250 mg (n = 25) of 5-Loxin daily or a placebo (n = 25) for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC) at the baseline (day 0), and at days 7, 30, 60 and 90. Additionally, the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid from OA patients.

Results: Seventy patients completed the study. In the end, both doses of 5-Loxin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA patients. Interestingly, researchers said, significant improvements in pain score and functional ability were recorded in the treatment group supplemented with 250 mg 5-Loxin as early as 7 days after the start of treatment. Corroborating the improvements in pain scores in treatment groups, they also noted significant reduction in synovial fluid matrix metalloproteinase-3. Researchers believe 5-Loxin may exert its beneficial effects by controlling inflammatory responses by reducing pro-inflammatory modulators, and it may improve joint health by reducing the enzymatic degradation of cartilage in OA patients.

Nutraceutical: Fish oil

Indication: Asthma (in children)

Source: Am J Clin Nutr, July 2008;88(1):167-75.

Research: Evidence suggests that asthma is rooted in the intrauterine environment and that intake of marine omega 3 fatty acids (omega 3s) in pregnancy may have immunomodulatory effects on the child. The aim of this study was to examine whether or not increasing maternal intake of omega 3s in pregnancy would affect offspring risk of asthma. In 1990, a population-based sample of 533 women with normal pregnancies were randomly assigned to receive four 1-gram gelatin capsules per day of fish oil providing 2.7 grams omega 3s (n = 266); four 1-gram, similar-looking capsules per day with olive oil (n = 136); or no oil capsules (n = 131). Women were recruited and randomly assigned around gestation week 30 and asked to take capsules until delivery.

Results: During the 16 years that passed since childbirth, 19 children from the fish oil and olive oil groups had received an asthma-related diagnosis; 10 had received the diagnosis allergic asthma. This risk of developing asthma was reduced in those whose mothers had been given fish oil supplements. Under the assumption that intake of olive oil in the dose provided here was inert, researchers said their results indicate that increasing omega 3s in late pregnancy may carry an important prophylactic potential in relation to offspring asthma.

Nutraceutical: Omega 3

fatty acids (omega 3s)

Indication: Age-related macular

degeneration (AMD)

Source: Arch Ophthalmol, June 2008;126(6): 826-33.

Research: Researchers systematically reviewed the evidence on dietary omega 3 fatty acid and fish intake in the primary prevention of age-related macular degeneration (AMD). Seven databases were systematically searched with no limits on publication year or language using standardized criteria. Randomized, controlled trials and prospective cohort, case-control, and cross-sectional studies were included. Of 2754 abstracts identified, 3 prospective cohort, 3 case-control, and 3 cross-sectional studies met the criteria.

Results: These 9 studies provided data on a total sample of 88,974 people, including 3203 AMD cases. A high dietary intake of omega 3 fatty acids was associated with a 38% reduction in the risk of late AMD. Fish intake at least twice a week was also associated with a reduced risk of both early AMD and late AMD. Although this meta-analysis suggests that consumption of fish and foods rich in omega 3s may be associated with a lower risk of AMD, researchers still believe there is insufficient evidence from the current literature--with few prospective studies and no randomized clinical trials---to support their routine consumption for AMD prevention.

Nutraceutical: Pycnogenol

(pine bark extract)

Indication: Menstrual pain

Source: J Reprod Med, May 2008;53(5):338-46.

Research: This randomized, double-blind, placebo-controlled study was conducted at four Japanese hospitals (Kanazawa University Hospital, Keiju Medical Center, Hamamatsu University Hospital and Sugiura Clinic) and sampled 116 women, ages 18 to 48, suffering from menstrual pain. Patients were monitored for five menstrual cycles. They were supplied with a diary to note the pain during days of menstruation, which was evaluated using the established Visual Analog Scale. The first two pre-treatment menstrual cycles were utilized for establishing baseline values for pain sensation and NSAIDs (non-steroidal anti-inflammatory drugs). During the following two menstrual cycles women were randomly assigned to groups receiving daily regimens of Pycnogenol or placebo. Thereafter, supplementation was discontinued to investigate the recurrence of symptoms. The use of NSAIDs was not restricted during the entire study. However, patients were required to note the dose and the type of analgesics, as well as the time taken in their diary.

Results: Treatment with Pycnogenol lowered pain during menstruation, which was reflected by a significant reduction of NSAID used. The number of painful days due to dysmenorrhea decreased from an average of 2.1 days prior to treatment to 1.3 at both the third and fourth cycle. Discontinuation of Pycnogenol did not cause an immediate relapse, and pain medication use did not increase.

Nutraceutical: Red yeast rice

Indication: Second heart attack

Source: Am J Cardiol, June 15, 2008;101(12):1689-93.

Research: This multicenter study was conducted to determine the effects of Xuezhikang (XZK), a partially purified extract of red yeast rice, on lipoprotein and cardiovascular (CV) endpoints in Chinese patients who experienced a previous myocardial infarction. Nearly 5000 of these patients with average low-density lipoprotein (LDL) cholesterol levels at baseline were randomly assigned either to placebo or to XZK daily for an average of 4.5 years. The primary endpoint was a major coronary event that included nonfatal myocardial infarction and death from coronary heart disease.

Results: Those taking the partially purified red yeast rice experienced a 45% reduction in risk for second heart attack. Further, treatment with XZK significantly decreased total and LDL cholesterol and triglycerides, and raised high density lipoprotein (HDL) cholesterol levels. In the end, researchers concluded that long-term therapy with XZK significantly decreased the recurrence of coronary events and the occurrence of new CV events and deaths, improved lipoprotein regulation, and was safe and well tolerated.

Nutraceutical: Therapeutic lifestyle (lifestyle changes, red yeast rice, fish oil)

Indication: Lipid-lowering

Source: Mayo Clin Proc, July 2008;83(7):758-64.

Research: The point of this study was to compare the lipid-lowering effects of an alternative regimen (lifestyle changes, red yeast rice, and fish oil) with a standard dose of a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin). The trial enrolled 74 patients with hypercholesterolemia who met Adult Treatment Panel III criteria for primary prevention using statin therapy. All participants were randomized to an alternative treatment group (AG) or to receive simvastatin (40 mg/d). The alternative treatment included therapeutic lifestyle changes, along with ingestion of red yeast rice and fish oil supplements for 12 weeks. The simvastatin group received medication and traditional counseling. The primary outcome measure was the percentage change in low-density lipoprotein cholesterol (LDL-C). Secondary measures were changes in other lipoproteins and weight loss.

Results: There was a statistically significant reduction in LDL-C levels in both the AG (42%) and the simvastatin group (39%). No significant differences were noted between groups. The AG also demonstrated significant reductions in triglycerides (29%) and weight (5%) compared with the simvastatin group. These results led researchers to conclude that lifestyle changes combined with ingestion of red yeast rice and fish oil reduced LDL-C in proportions similar to standard therapy with simvastatin. Pending confirmation in larger trials, they believe this multifactorial, alternative approach to lipid-lowering has promise for a subset of patients unwilling or unable to take statins.

LOG ON, LEARN MORE @ NUTRACEUTICALSWORLD.COM

FIND OUT EVERYTHING YOU WANTED TO KNOW AND MORE ABOUT PYCNOGENOL WHEN YOU VISIT THE SEPTEMBER ONLINE EDITION OF NUTRACEUTICALS RESEARCH AND DOWNLOAD THE NATURAL STANDARD MONOGRAPH.