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Is Phytalgic(R) a goldmine for osteoarthritis patients or is there something fishy about this nutraceutical? A summary of findings and risk-of-bias assessment.

Christensen R, Bliddal H - Arthritis Res. Ther. (2010)

Bottom Line: A food supplement containing fish oils, urtica dioica, zinc, and vitamin E (Phytalgic) for osteoarthritis (OA) has now been tested in a placebo-controlled trial for 3 months and according to the authors has a very large clinical effect, considerably larger than that of any other known product.Even experts endorsing nutraceuticals for OA symptoms would probably agree that a nutraceutical with an effect size above 0.5 is rarely seen.Despite our concerns about the fact that trial registration took place after the study was completed and the likelihood that patients would note the taste of fish, a circumstance that would lead to detection bias, we consider these data promising though with a high risk of bias.

View Article: PubMed Central - HTML - PubMed

ABSTRACT
A food supplement containing fish oils, urtica dioica, zinc, and vitamin E (Phytalgic) for osteoarthritis (OA) has now been tested in a placebo-controlled trial for 3 months and according to the authors has a very large clinical effect, considerably larger than that of any other known product. Even experts endorsing nutraceuticals for OA symptoms would probably agree that a nutraceutical with an effect size above 0.5 is rarely seen. Despite our concerns about the fact that trial registration took place after the study was completed and the likelihood that patients would note the taste of fish, a circumstance that would lead to detection bias, we consider these data promising though with a high risk of bias.

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Related in: MedlinePlus

Forest plot of outcomes showing effect sizes comparing Phytalgic® with placebo in osteoarthritis patients, presented as standardized mean differences. CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug; SD, standard deviation.
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Figure 1: Forest plot of outcomes showing effect sizes comparing Phytalgic® with placebo in osteoarthritis patients, presented as standardized mean differences. CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug; SD, standard deviation.

Mentions: The authors present data for Phytalgic® [1] which are considerably more promising than expected and thus should be scrutinized for clinical effect and possible bias [3]. According to the authors, Phytalgic® consists of capsules containing fish oils, urtica dioica, zinc, and vitamin E. Jacquet and colleagues [1] randomly assigned some 81 OA patients to receive either Phytalgic® or a matching placebo consisting of 'non-fish oil'. Participants were an average of 57 years of age (range of 28 to 84 years) at entry, had either knee or hip OA, and were regular users of nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics. The primary outcome of this 3-month trial was use of NSAIDs or analgesics at follow-up. According to ClinicalTrials.gov [2], Jacquet and colleagues [1] considered the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function scale a secondary outcome measure, and none of the other WOMAC subscales is mentioned in the trial registration. In accordance with recent standards on how to evaluate the results of OA trials [3,4], Figure 1 presents a summary of findings as generic effect sizes (ESs) based on the standardized mean difference, comparing the experimental drug (Phytalgic®) with a placebo, for each of the continuous outcomes measured on different scales.


Is Phytalgic(R) a goldmine for osteoarthritis patients or is there something fishy about this nutraceutical? A summary of findings and risk-of-bias assessment.

Christensen R, Bliddal H - Arthritis Res. Ther. (2010)

Forest plot of outcomes showing effect sizes comparing Phytalgic® with placebo in osteoarthritis patients, presented as standardized mean differences. CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug; SD, standard deviation.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2875636&req=5

Figure 1: Forest plot of outcomes showing effect sizes comparing Phytalgic® with placebo in osteoarthritis patients, presented as standardized mean differences. CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug; SD, standard deviation.
Mentions: The authors present data for Phytalgic® [1] which are considerably more promising than expected and thus should be scrutinized for clinical effect and possible bias [3]. According to the authors, Phytalgic® consists of capsules containing fish oils, urtica dioica, zinc, and vitamin E. Jacquet and colleagues [1] randomly assigned some 81 OA patients to receive either Phytalgic® or a matching placebo consisting of 'non-fish oil'. Participants were an average of 57 years of age (range of 28 to 84 years) at entry, had either knee or hip OA, and were regular users of nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics. The primary outcome of this 3-month trial was use of NSAIDs or analgesics at follow-up. According to ClinicalTrials.gov [2], Jacquet and colleagues [1] considered the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function scale a secondary outcome measure, and none of the other WOMAC subscales is mentioned in the trial registration. In accordance with recent standards on how to evaluate the results of OA trials [3,4], Figure 1 presents a summary of findings as generic effect sizes (ESs) based on the standardized mean difference, comparing the experimental drug (Phytalgic®) with a placebo, for each of the continuous outcomes measured on different scales.

Bottom Line: A food supplement containing fish oils, urtica dioica, zinc, and vitamin E (Phytalgic) for osteoarthritis (OA) has now been tested in a placebo-controlled trial for 3 months and according to the authors has a very large clinical effect, considerably larger than that of any other known product.Even experts endorsing nutraceuticals for OA symptoms would probably agree that a nutraceutical with an effect size above 0.5 is rarely seen.Despite our concerns about the fact that trial registration took place after the study was completed and the likelihood that patients would note the taste of fish, a circumstance that would lead to detection bias, we consider these data promising though with a high risk of bias.

View Article: PubMed Central - HTML - PubMed

ABSTRACT
A food supplement containing fish oils, urtica dioica, zinc, and vitamin E (Phytalgic) for osteoarthritis (OA) has now been tested in a placebo-controlled trial for 3 months and according to the authors has a very large clinical effect, considerably larger than that of any other known product. Even experts endorsing nutraceuticals for OA symptoms would probably agree that a nutraceutical with an effect size above 0.5 is rarely seen. Despite our concerns about the fact that trial registration took place after the study was completed and the likelihood that patients would note the taste of fish, a circumstance that would lead to detection bias, we consider these data promising though with a high risk of bias.

Show MeSH
Related in: MedlinePlus