Omega-3 supplement does not reduce hot flushes, says EFSA

by Jane Byrne , 15-Jan-2010

A health claim, under Article 13.5, for a French fish oil-based dietary supplement Catalgine that it can help to reduce the frequency of hot flushes in middle aged women has been rejected by the European Food Safety Authority (EFSA).

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that causality had not been established between the consumption of Catalgine (also called OM3 menopause) and the reduction in the frequency of episodes of hot flushes despite the submission of newly developed science by manufacturer Laboratoire Vie et Santé.

The product, which the Panel said was sufficiently characterised, is a dietary supplement rich in omega-3 fatty acids and is made with concentrated wild fish oil from sardines and anchovies.

The amount of fish oil per capsule is 500 mg with total n-3 fatty acids being about 90 per cent by weight, eicosapentaenoic acid (EPA) about 73 per cent (688.6 mg/g) and docosahexaenoic acid (DHA) about 13 per cent (123.4 mg/g) expressed as ethyl esters.

The health claim relates to the omega-3 fish oil in Catalgine playing a role in the ‘management of vasomotor symptoms, particularly hot flushes’ and the target population for the product is middle aged women prone to hot flushes during the peri- and the post-menopausal period.

The Panel said it considers that “the reduction in the frequency of episodes of hot flushes is beneficial to the health of peri- and post-menopausal women.”

EFSA said that the Laboratoire Vie et Santé had included two publications (three studies) which it said were pertinent to its claim for Catalgine.

The NDA, in its opinion, however noted that weaknesses such as unsuccessful blinding and limited power in one of the studies submitted – a post-hoc analysis of a subsample of women participating in a randomised, placebo controlled intervention evaluating the effects of Catalgine on psychological distress, greatly limited its value as a source of data to substantiate the claimed effect.

“A significantly higher percentage of women in the OM3 group declared a fish taste of the capsules compared to the placebo group indicating a failure in the subjects’ blinding, which is a major drawback for self-reported outcomes such as HF (hot flushes) frequency and intensity,” said the Panel.

Another publication was identified by the applicant as being important for substantiation of the claim, and it reported on two double-blinded randomised controlled trials (RCT) with cross-over design of 24 week duration.

But the NDA maintained that no conclusions could be drawn from this study as it was uncontrolled with respect to the PUFA supplement, which in turn also differed substantially from the PUFA profile of Catalgine.

A comment from Vie et Santé was sought in relation to the EFSA opinion but was not forthcoming in time for publication.