Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee

Levy, Robert M.; Khokhlov, A. L.; Копенкин, С. С.; Барт, Б. Я.; Ермолова, Т. В.; Kantemirova, Raiasa; Mazurov, Vadim I.; Bell, Marjorie; Caldron, Paul H.; Pillai, Lakshmi; Burnett, Bruce

doi:10.1007/s12325-010-0064-z

Cited by 50 publications

(32 citation statements)

References 41 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Small clinical trials have suggested that Limbrel shows efficacy in OA (e.g. (80) ), but recently severe liver toxicity has been described in some patients (81) . A grape seed proanthocyanidin extract is protective in the monosodium iodoacetate model of OA in the rat, showing chondroprotection and decreased pain (82) .…”

Section: Flavan-3-olsmentioning

confidence: 99%

The potential for dietary factors to prevent or treat osteoarthritis

et al. 2014

View full text Add to dashboard Cite

Osteoarthritis (OA) is a degenerative joint disease for which there are no disease-modifying drugs. It is a leading cause of disability in the UK. Increasing age and obesity are both major risk factors for OA and the health and economic burden of this disease will increase in the future. Focusing on compounds from the habitual diet that may prevent the onset or slow the progression of OA is a strategy that has been under-investigated to date. An approach that relies on dietary modification is clearly attractive in terms of risk/benefit and more likely to be implementable at the population level. However, before undertaking a full clinical trial to examine potential efficacy, detailed molecular studies are required in order to optimise the design. This review focuses on potential dietary factors that may reduce the risk or progression of OA, including micronutrients, fatty acids, flavonoids and other phytochemicals. It therefore ignores data coming from classical inflammatory arthritides and nutraceuticals such as glucosamine and chondroitin. In conclusion, diet offers a route by which the health of the joint can be protected and OA incidence or progression decreased. In a chronic disease, with risk factors increasing in the population and with no pharmaceutical cure, an understanding of this will be crucial.Osteoarthritis: Diet: Cartilage: Bioactive: Polyphenol: Phytochemical: Flavonoid Osteoarthritis (OA) is a degenerative joint disease characterised by degradation of articular cartilage, thickening of subchondral bone and osteophyte formation. Incidence and prevalence of OA has been difficult to assess, in part because of heterogeneity in definitions of the disease. A recent meta-analysis suggested that overall prevalence of OA at different anatomical sites was 23·9 % (knee), 10·9 % (hip) and 43·3 % (hand), although only the prevalence of knee OA showed a gender difference between women and men (27·3 and 21 %, respectively)(1) . Osteoarthritis is a leading cause of disability in the UK. A recent survey (2) found 8·5 million people in the UK with OA, with 71 % of these in constant pain. There are no effective disease-modifying drugs to treat OA and drugs that relieve pain are often insufficient. Joint replacement is offered to patients at end-stage disease with 66 436 hip and 77 578 knee replacements due to OA performed in the UK in 2011 (3) . Two major risk factors for OA are increasing age (most affected patients are aged >45 years and the greatest morbidity is seen in patients aged >60 years) (4) and increasing obesity (5) . With changing demographics, OA is an increasing public health and economic burden. The economic costs of OA in the UK are largely unknown, but direct costs have been estimated at approximately £1 billion/year. With inclusion of indirect costs, estimates from the USA range up to £8 billion/ year (6) .*Corresponding author: I. M. Clark, fax 01603-592250, email i.clark@uea.ac.uk †These authors contributed equally to this review.Abbreviations: ADAMTS, a disintegrin and metalloproteina...

show abstract

Section: Flavan-3-olsmentioning

confidence: 99%

The potential for dietary factors to prevent or treat osteoarthritis

et al. 2014

View full text Add to dashboard Cite

show abstract

“…Of the studies in our survey, four studies were performed without running a placebo group [12,14,16,17] and five trials did not include an active comparator [15,[18][19][20][21], clearly limiting the informative value of the studies. The particular importance of control groups for trials on OA has been underscored by a systematic review and meta-analysis involving 193 placebo (16,364 patients) and 14 untreated control groups (1167 patients) from RCTs, showing that the overall effect size (95 % CI) for pain relief was 0.51 (0.46 to 0.55) for placebo, and 0.03 (−0.13 to 0.18) for untreated controls [65].…”

Section: Discussionmentioning

confidence: 99%

“…Finally, 11 clinical trials investigating a total of 7 different plant extracts were selected and are reviewed in the following section [12][13][14][15][16][17][18][19][20][21][22]. Key parameters of the trials are summarized in Table 1.…”

Section: Pubmed Literature Surveymentioning

confidence: 99%

See 1 more Smart Citation

Medical Plant Extracts for Treating Knee Osteoarthritis: a Snapshot of Recent Clinical Trials and Their Biological Background

2015

View full text Add to dashboard Cite

In light of the growing global health problem associated with osteoarthritis, herbal remedies have become an important research focus in the scientific and medical community, and numerous studies have been published to identify their biological effects and mechanisms in vitro and in vivo. This review is a snapshot of the most recent clinical trials on the efficacy of medical plant extracts in knee osteoarthritis patients, and provides relevant background information on the biological mechanisms that may underlie the clinical observations. Therefore, we performed a PubMed literature survey and discussed a selection of clinical trials in the field, with special attention being drawn to the design and outcome measures of the studies. We further spotlighted on issues relating to the efficacy and safety of the plant extracts and discussed major challenges for upcoming studies in the field, which include the need for rigorously designed in vivo and in vitro studies, as well as the elucidation of potential additive effects and structure-modifying activities beyond symptom relief.

show abstract

“…Unlike NSAIDs, flavocoxid also inhibits 5-LOX presumably preventing this shunting of AA metabolism 15 . Flavocoxid has been studied in the management of OA of the knee and found to be as effective as naproxen 20,21 . In clinical trials, both flavocoxid and naproxen showed significant abatement in the signs and symptoms of knee OA, with no statistically detectable differences between groups with respect to any of the efficacy outcome variables studied.…”

Section: Introductionmentioning

confidence: 99%

Cost analysis of flavocoxid compared to naproxen for management of mild to moderate OA

Walton

Schumock

McLain³

2010

Current Medical Research and Opinion

View full text Add to dashboard Cite

show abstract

Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee

Abstract: Flavocoxid, a first-in-class flavonoid-based therapeutic that inhibits COX-1 and COX-2 as well as 5-LOX, was as effective as naproxen in managing the signs and symptoms of OA of the knee. Flavocoxid demonstrated better UGI, renal (edema), and respiratory safety profiles than naproxen.

Cited by 50 publications

References 41 publications

The potential for dietary factors to prevent or treat osteoarthritis

The potential for dietary factors to prevent or treat osteoarthritis

Medical Plant Extracts for Treating Knee Osteoarthritis: a Snapshot of Recent Clinical Trials and Their Biological Background

Cost analysis of flavocoxid compared to naproxen for management of mild to moderate OA

Contact Info

Product

Resources

About