Collagen supplement for patients with Rheumatoid Arthritis. Elgenoflex - BioCell Collagen tablets. Vitaminized - supplements and vitamins online

BENEFITS OF TAKING ELGENOFLEX FOR PATIENTS WITH ARTHRITIS

Elgenoflex contains the following active ingredients: hydrolyzed type II collagen from chicken (which naturally contains chondroitin sulfate and hyaluronic acid), glucosamine, and methylsulfonylmethane (MSM). In this article, the beneficial effects of Elgenoflex components in patients with rheumatoid arthritis and osteoarthritis are considered.

 

Rheumatoid arthritis is an autoimmune disorder that occurs predominantly in women and mainly affects small joints in the hands and feet, resulting in inflammation, pain, and eventually joint deformation [1,2]. No definitive cure exists for rheumatoid arthritis and treatment is aimed mainly at preventing joint damage and alleviating symptoms. Surgery is sometimes used in patients with severely deformed joints. One of the auto antigens thought to play a role in the development of rheumatoid arthritis is cartilage collagen type II [3,4,5,6].

 

Unlike rheumatoid arthritis, osteoarthritis is not an autoimmune disease. It develops with age when the cartilage on bone ends wears down and affects mostly joints that are under continuous stress; joint injuries and repetitive stress on particular joints caused by professional or sports activities increase the risk of osteoarthritis development [2,7]. As in the case of rheumatoid arthritis, no cure exists for osteoarthritis, and in severe cases joint replacement may be needed. Degradation of collagen type II is associated with the progression of knee and hand osteoarthritis [8] and with osteoarthritis flares [11]. Accordingly, a recent study of 3,582 osteoarthritis patients concluded that a fragment of collagen type II is the most informative biochemical marker for prediction of this disease[12]. A partial replacement of collagen II with the “incorrect” collagen I in osteoarthritic joints, especially in the later stages of the disease, has also been reported [13].

 

Collagen hydrolysates

Collagens are structural proteins found in various connective tissues. Collagen type II is the major collagen of the cartilage [14]. A number of studies have documented the beneficial effects of supplementation with collagen type II hydrolysates in patients with rheumatoid arthritis and osteoarthritis.

 

After a pioneering study was published in 1993 in Science [15] , a number of studies have reported positive effects of chicken type II collagen and its hydrolysates in patients with rheumatoid arthritis. An early pilot study found that administration of chicken collagen type II for three months resulted in a reduction in joint swelling and tender joints in 8 out of 10 participants with juvenile rheumatoid arthritis [16]. However, the exact origin of the supplement in this study was not specified, and it was unclear whether the collagen was hydrolyzed. A larger study (36 rheumatoid arthritis patients) found statistically significant improvements in the joint swelling score, Ritchie's index (a measure of joint tenderness), disease activity score, and Health Assessment Questionnaire score in patients given collagen tripeptides for three months in comparison with the placebo group, although no improvement in the subjective condition of the patients was found [17]. However, these responses did not reach statistical significance when more stringent assessment criteria were used.

 

Another pilot study (13 participants) assessed the effects of chicken type II collagen hydrolysate on juvenile rheumatoid arthritis as well as uveitis associated with this condition [18]. The authors found that six participants showed improvement in arthritis and four in uveitis, although the ophthalmic outcomes of two participants worsened. Since this study did not include a placebo group and the number of participants was small, the statistical significance of these results remained uncertain.

 

A much larger phase III clinical trial assessed the effects of a chicken type II collagen hydrolysate in patients with rheumatoid arthritis in comparison with methotrexate, a drug that is approved for treatment of this disease [19]. This multicenter, double-blind, randomized study, which enrolled a total of 503 participants, used administration of 0.1 g of chicken type II collagen hydrolysate daily for 24 weeks. Using several variables to assess the effects of the treatments on the disease, the authors found that the collagen hydrolysate effectively alleviated rheumatoid arthritis symptoms. Some of its effects were slightly weaker than the effects of methotrexate, but collagen hydrolysate also had fewer and milder side effects in comparison with methotrexate. These studies indicate that chicken type II collagen hydrolysate can be used as a supplement for patients with rheumatoid arthritis.

 

At least one study used exactly the same collagen type II hydrolysate as that included in Elgenoflex—BioCell Collagen, a patented preparation produced by BioCell Technology LLC (Newport Beach, CA, USA). This randomized, double-blind, placebo-controlled trial involved 80 patients with osteoarthritis in the knee and/or hip joints [20]. The authors found that ingestion of BioCell Collagen (2 g daily) for 10 weeks resulted in a significant reduction in pain in comparison with the placebo group. Both physical activity and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were significantly improved in the BioCell Collagen group in comparison with the placebo group after five weeks of supplementation, and this effect persisted until the end of the trial (10 weeks). No difference in tolerability was noted between BioCell Collagen and the placebo [20]. These data suggest that formulations containing BioCell Collagen, such as Elgenoflex, can be expected to be beneficial for patients with osteoarthritis.

 

Another randomized, double-blind, controlled study that enrolled 250 patients with primary osteoarthritis of the knee used a similar collagen type II hydrolysate preparation (10 g daily for three months) [21]. The authors found significant improvement in knee joint comfort, especially in patients with the greatest joint deterioration and those who consumed less meat.

 

A more recent phase IV multicenter trial conducted in Spain involved 108 physically active patients with knee osteoarthritis, who received collagen hydrolysate and hyaluronic acid (7 g and 25 mg daily, respectively) for 90 days [22]. The authors reported a gradual, highly statistically significant decrease in functional disability, joint stiffness, and pain. As the formulation contained not only collagen hydrolysate, but also hyaluronic acid (similar to Elgenoflex), its strong positive effect may have been due to a combination of the individual effects of its components. In fact, there is ample evidence for the positive effects of other components of Elgenoflex when they are used as separate supplements or in combinations. Examples of such studies are described below.

 

Glucosamine, hyaluronic acid, and chondroitin sulfate

Glucosamine is a precursor of the polysaccharides glycosaminoglycans, which include hyaluronic acid and chondroitin sulfate. A progressive loss of glycosaminoglycans is observed during the progression of osteoarthritis, and glycosaminoglycan content in cartilage tissue is used to grade the osteoarthritis stages [8].

 

Hyaluronic acid is necessary for the production of the synovial fluid in the joints and is a component of articular cartilage; its injection directly into the knee joint is widely used in patients with knee osteoarthritis [23]. Although this approach is efficient, its major drawback is the necessity for regular injections. However, several studies suggest that oral hyaluronic acid is also effective. A pilot randomized, double-blind, placebo-controlled trial conducted in the USA enrolled 20 patients with osteoarthritis, who received an extract of chicken combs with high content (~60%) of hyaluronic acid (80 mg daily, corresponding to ~50 mg of hyaluronic acid daily) for eight weeks [24]. The authors found statistically significant improvements in the WOMAC scores both in the hyaluronic acid group and the placebo group, but the improvement in the hyaluronic acid group was significantly higher than that in the placebo group. Similar changes were found in several markers of life quality: whereas both groups showed statistically significant improvements compared to baseline, the improvements in bodily pain and social functioning were greater in the in the hyaluronic acid group than in the placebo group [24].

 

Similar findings were reported by studies conducted in Japan. A randomized, double-blind, placebo-controlled study enrolled 43 patients with knee osteoarthritis, who received a chicken comb extract (equivalent to 60 mg of hyaluronic acid daily) for 16 weeks [25]. In the hyaluronic acid group, the authors found moderate but significant improvements in parameters related to pain and walking function or going up and down stairs, although not in joint flexion or swelling. Although improvements were also observed in the placebo group, they were not statistically significant [25]. The authors also examined the markers of collagen degradation and synthesis and found that the synthesis to degradation ratio was increased in the hyaluronic group [25]. This finding indicates that the presence of hyaluronic acid in collagen type II hydrolysates would have a synergistic positive effect in osteoarthritis patients. A more recent double-blind, placebo-controlled study that enrolled 60 patients who were asked to perform daily physical exercise found that oral administration of hyaluronic acid (0.2 g daily) for one year alleviated the symptoms of knee osteoarthritis, especially in participants younger than 70 years of age [26]. This study also found improvements in the placebo group, however they were less pronounced than in the hyaluronic acid group, with the differences between the two groups reaching statistical significance on the second and fourth months of treatment [26].

 

Similar to hyaluronic acid, chondroitin sulfate is an important component of synovial fluid and cartilage, and is a component of a number of proteoglycans in the extracellular matrix, where it plays a variety of regulatory roles. Glucosamine and chondroitin sulfate, as well as their combinations, are widely used as supplements in patients with osteoarthritis, and their beneficial effects have been documented in multiple clinical trials (see a review by Iovu and colleagues [27] and references therein). Whereas the US Federal Drug Administration (FDA) considers glucosamine and chondroitin sulfate as food supplements, chondroitin is recognized as an osteoarthritis drug in European countries [28].

 

Chondroitin is one of the most popular supplements used by osteoarthritis patients. The authors of a recent systematic meta-analysis of 43 randomized controlled trials, which lasted between one month and three years and involved a total of 9,110 participants (mainly with knee osteoarthritis, with fewer cases of hip or hand osteoarthritis), concluded that chondroitin significantly reduced the narrowing of minimum joint space [29]. In studies shorter than six months, the authors also found that an index that takes into account pain, function, and disability showed statistically significant improvements in patients taking chondroitin in comparison with those taking a placebo. Curiously, this meta-analysis also found that chondroitin resulted in significantly fewer side effects than placebo [29].

 

Although glucosamine is often used in combination with chondroitin sulfate, it is also effective alone. An example of a study that assessed long-term effects of glucosamine in patients with knee osteoarthritis is a randomized, placebo-controlled clinical trial by Reginster and colleagues conducted in Belgium, Italy, and the UK, which was published in the highly respected British journal The Lancet [30]. This study enrolled 212 patients who were taking either glucosamine sulfate (1.5 g daily) or a placebo for three years. The authors found significant narrowing of the joint space in the placebo group but not in the glucosamine group. The WOMAC scores revealed some worsening of osteoarthritis symptoms in the placebo group but improvement in the glucosamine group [30].

 

Despite a large number of clinical trials, the efficiency of glucosamine and chondroitin sulfate is surrounded by controversy. This can be illustrated by the simultaneous publication in 2007 of reviews of available clinical trials by two different groups: a group from Belgium concluded that glucosamine and chondroitin sulfate are effective in slowing the progression of osteoarthritis [31,32], whereas a group from Switzerland concluded that chondroitin has only minimal or no beneficial effects in osteoarthritis patients [33]. Possible causes of the confusion might include the “placebo effect” (improvements seen in groups taking placebo) and the difficulty in quantitatively assessing pain. In this respect, using techniques that allow objective pain measurements may resolve some of these controversies. For example, using functional magnetic resonance imaging (fMRI), Montfort and colleagues [34] found that this technique made it possible to reveal statistically significant improvements in pain in osteoarthritis patients, whereas evaluation of subjective pain by the same patients did not produce clear results. Finally, it should be noted that patients with rheumatoid arthritis do not benefit from glucosamine and chondroitin sulfate supplements [35].

 

Methylsulfonylmethane (MSM), which is also included in Elgenoflex, has been suggested by several clinical trials to have beneficial effects in patients with osteoarthritis. For example, in a randomized, double-blind, placebo-controlled pilot trial, 50 patients with knee osteoarthritis received MSM (6 g daily) or a placebo for 12 weeks [36]. The supplement was reported to result in a statistically significant reduction in pain and physical function impairment (according to WOMAC scores) and in improvement in performing daily activities, although not in WOMAC joint stiffness and total symptoms scores [36]. Another 12-week double-blind, placebo-controlled trial that involved 118 patients with knee osteoarthritis found that MSM reduced pain in comparison with the placebo group [37].

 

A more recent randomized, double-blind, controlled clinical trial enrolled 49 patients with knee osteoarthritis, who received MSM (ca. 7 g daily) or a placebo; the treatment period (12 weeks) was the same as in the two previous studies [38]. The authors found statistically significant improvements in WOMAC physical function and the total score, but not in joint stiffness. Disparate results were obtained for pain when it was assessed using two different approaches [38].

 

Although Usha and Naidu [37] found pain reduction in patients taking MSM, this supplement alone was inferior to glucosamine, and a combination of MSM and glucosamine was more effective than each supplement individually. Similarly, glucosamine and chondroitin sulfate are known to act synergistically [39]. These observations, together with the controversy regarding the effects of glucosamine and chondroitin, suggest that beneficial effects of each of these substances may be relatively small and noticeable only under certain circumstances or in certain groups of patients. Whereas it is far from clear under which circumstances which substances are most effective, formulations that contain combinations of several active ingredients, like Elgenoflex, may hold more promise than formulations containing one or few ingredients.

References

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