Skip to content

Pharma grade chondroitin scores for knee osteoarthritis

May 26, 2017

A pharmaceutical-grade formulation of chondroitin sulfate was superior to placebo and similar in effect to celecoxib for knee osteoarthritis (OA) in a 6-month randomized study.

Among 604 patients with knee OA, pain reduction on a 100-mm visual analog scale (VAS) by 6 months was -42.6 mm for those receiving chondroitin, 800 mg/day, and -39.5 mm for those given celecoxib, 200 mg/day, compared with -33.3 mm for those given placebo, according to Jean-Yves Reginster, MD, head of the Bone and Cartilage Metabolism Unit of the University of Liège in Belgium, and colleagues.

The difference between the two active treatments did not differ significantly, but both changes were statistically greater than with placebo (P=0.001 for chondroitin and P=0.009 for celecoxib), the researchers reported online in Annals of the Rheumatic Diseases.

Conventional therapeutic approaches to knee OA have focused on use of acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), but concerns have been raised about efficacy for acetaminophen and safety for both types of drugs, the team noted.

Chondroitin sulfate is available in pharmaceutical-grade and neutraceutical-grade formulations — “the latter exhibiting striking variations in preparation, composition, purity, as well as clinical effects.” This may explain why in previous clinical studies using pharmaceutical-grade preparations, pain and function improved but did not in studies with the lower-grade products.

Another factor potentially influencing the contradictory findings in earlier studies was trial design, Reginster et al said. Accordingly, the European Medicines Agency has established guidelines for studies of treatments for symptomatic OA, requiring a minimum of 6 months’ follow-up, using both an active comparator and placebo controls, and endpoints assessing pain and function.

The current study is the first to have been conducted according to those guidelines, the researchers noted.

Patients were enrolled from centers in five European countries during 2014 and 2015. Pharmaceutical-grade chondroitin (Chondrosulf) was supplied by IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland, and celecoxib tablets were encapsulated to provide blinding.

Rescue tablets of acetaminophen were permitted up to a maximum dosage of 3 g/day.

Study participants were predominantly women, whose mean age was 65 and whose body mass index was approximately 30.

The two study endpoints were pain VAS and score (0 to 24) on the Lequesne Index, which combines pain and function. The results on the Lequesne Index were similar to those seen for pain, with changes after 6 months of treatment of -4.7 for chondroitin and -4.6 for celecoxib compared with -3.7 for placebo (P=0.023 for chondroitin and P=0.015 for celecoxib).

The decrease on this score achieved statistical significance versus placebo by day 30 for celecoxib, whereas for chondroitin, it took until day 91. “Although impossible to know definitively, this observation may be related to an intrinsic difference in the mechanism of action of the two molecules,” the investigators suggested.

A secondary endpoint was the Minimal Clinically Important Improvement, which was a 20-mm decrease for the pain VAS. This was reached by 68%, 69%, and 61% of the chondroitin, celecoxib, and placebo groups, respectively — differences that were not statistically different.

Another secondary endpoint was the Patient Acceptable Symptom State (the extent of symptoms beyond which patients consider themselves as being well), reached by 57%, 59%, and 49% of the chondroitin, celecoxib, and placebo groups, respectively. Only the celecoxib-placebo difference was significant.

In the chondroitin group, the effect sizes for pain and function were 0.35 and 0.27, respectively, while the corresponding effect sizes in the celecoxib group were 0.27 and 0.30. Effect sizes of 0.2 or less are generally considered small, while effect sizes from 0.2 to 0.5 are considered medium. The effect size for pain “compares well” with the estimated effect sizes for most nonsteroidal ant-inflammatory drugs (NSAIDs), and is twice as high as that frequently reported for acetaminophen in knee OA, Reginster and colleagues noted.

There were no differences between any of the groups for adverse events, serious adverse events, or withdrawals relating to adverse events. Abdominal discomfort was the most frequent complaint, occurring in 2.5% of the chondroitin group, 4.5% of the celecoxib group, and 2.9% of the placebo group.

The study confirmed the efficacy and safety of chondroitin, the researchers concluded. “This compelling benefit-risk profile, in light of the known clinical risks associated with chronic usage of NSAIDs and [acetaminophen], underscores the potential importance of pharmaceutical-grade chondroitin sulfate in the management of knee OA, especially in this older population requiring long-term treatment.”

The study was sponsored by IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland, a pharmaceutical company marketing chondroitin sulfate.

The authors reported no financial disclosures.

Primary Source

Annals of the Rheumatic Diseases

Source Reference: Reginster J, et al “Pharmaceutical-grade chondroitin sulfate is as effective as celecoxib and superior to placebo in symptomatic knee osteoarthritis: the ChONdroitin versus CElecoxib versus Placebo Trial (CONCEPT)” Ann Rheum Dis 2017; doi:10.1136/annrheumdis-2016-210860.


From → Uncategorized

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

%d bloggers like this: