HealthWatch, The Campaign Against Health Fraud, is concerned over the promotion to the public of the vitamin/mineral supplements Confiance and Magnesium-OK, both manufactured by Wassen International Ltd.
On the pack the claim is made that Confiance is "The major breakthrough once-a-day nutritional supplement for women going through the menopause". No other specific therapeutic claims are made on the packaging, nor in the package insert, but the reader is left in no doubt that Confiance is designed to alleviate menopausal symptoms. Further, a Press Release dated November 1989 states that:
"Confiance has been specifically formulated to reduce menopausal symptoms such as hot flushes, depression, insomnia and dizziness by providing the specific nutritional requirements that a woman needs during this time of life. The vitamins and minerals can help regularise hormone levels and supplement dietary deficiencies which may result from stress resulting from the way so many people have to live today, quite apart from alcohol and smoking."
If it was known to the Medicines Control Agency of the Department of Health that these health claims were made by the manufacturer (as they would be if they were printed on the package or product information), the product would be subject to the Medicines Act and require licensing for these indications. A licence would only be issued when proof of efficacy was produced. There is the risk that statements in the Press Release might encourage journalists to make claims not permitted to the manufacturer. In turn, this might encourage assistants in health food shops to repeat them at the time of sale. Thus the purchaser might be given the impression that Confiance can do more for them than can legally be claimed.
HealthWatch has studied the product literature, including the references cited in it, and can find no evidence to show that Confiance does have any effect upon the symptoms associated with the menopause. Until such evidence becomes available for Confiance, HealthWatch cannot advise women to use this unproven product.
Magnesium-OK is directed at women suffering from pre-menstrual tension. As with Confiance, no specific therapeutic claims are made on the package or in the package insert, but the prominent boxed heading "PMT (Pre-Menstrual Time)", though isolated from any specific claim, makes its intended use obvious.
A News Release dated June 1989 again goes much beyond the carefully restrained package statements with:
…can help up to 70% of British women between the ages of 15 and 45 (around 10 million) who suffer from the symptoms of pre-menstrual tension according to the results of recent trials.
In support of this claim, the News Release refers to one uncontrolled study in which 71.8% of 103 participants are said to have benefited from taking Magnesium-OK for a one to three month period.
This trial has not been published in the medical literature; HealthWatch has not been able to obtain details of the criteria used for defining pre-menstrual tension on entry to the trial, nor find out what scientific measurements were used to assess the results of treatment.
Many medical conditions show a marked response to any treatment, including placebo, and review of the scientific literature shows this is definitely true for pre-menstrual tension. An uncontrolled clinical study cannot provide serious evidence for the effectiveness of a product in pre-menstrual tension.
Another statement in the Company's News Release is worrying:
"Our decision to launch Magnesium-OK meant that we were able to offer consumers a product which is affordable, and which gave a fast return to the retailer".
Again, it concerns HealthWatch that there may be a financial incentive for health food stores, whose sales assistants have limited medical or scientific background (and certainly do not understand the Medicines Act as well as do Wassen International Ltd), to make claims for the product which the manufacturer is prohibited by law from making.
It is the position of HealthWatch that products (medicinal or not) offered to the public for the treatment of medical conditions should have been properly tested in adequate clinical trials to demonstrate their safety and effectiveness.
What Constitutes an adequate trial?
An adequate trial of a treatment must have:
- measurement of the baseline condition of all participants entering the study;
- the group randomly divided into two so that half can receive the treatment under test and the other half can receive an established treatment or placebo;
- measurements repeated after an appropriate treatment period;
- statistical tests applied to see if the differences could have occurred by chance
- It is the position of HealthWatch that promotion of products, licensed or unlicensed, should always be within the limits of the claims that the law permits the manufacturer to place in the product literature, and that no encouragement should be given to sales assistants to make additional and uncontrolled statements at the time of sale, nor should journalists be encouraged to make such statements in the media.
HealthWatch challenges the manufacturer of Confiance and Magnesium-OK to show their faith in these products by subjecting them to adequate testing. HealthWatch will provide a scientific peer group which will assist Wassen International Ltd with the design of the study and will publicly endorse the value of the products if their benefit is established in this way. Until such evidence can be produced, HealthWatch advises women considering the purchase of these products that they have not been adequately tested and that there is no evidence that they have any effect on the symptoms of menopause or pre-menstrual tension.
Prepared by: Walli Bounds SCM