MD, PhD, FMedSci, FSB, FRCP, FRCPEd

supplements

In my very first post on this blog, I proudly pronounced that this would not become one of those places where quack-busters have field-day. However, I am aware that, so far, I have not posted many complimentary things about alternative medicine. My ‘excuse’ might be that there are virtually millions of sites where this area is uncritically promoted and very few where an insider dares to express a critical view. In the interest of balance, I thus focus of critical assessments.

Yet I intend, of course, report positive news when I think it is relevant and sound. So, today I shall discuss a new trial which is impressively sound and generates some positive results:

French rheumatologists conducted a prospective, randomised, double blind, parallel group, placebo controlled  trial of avocado-soybean-unsaponifiables (ASU). This dietary supplement has complex pharmacological activities and has been used since years for osteoarthritis (OA) and other conditions. The clinical evidence has, so far, been encouraging, albeit not entirely convincing. My own review arrived at the conclusion that “the majority of rigorous trial data available to date suggest that ASU is effective for the symptomatic treatment of OA and more research seems warranted. However, the only real long-term trial yielded a largely negative result”.

For the new trial, patients with symptomatic hip OA and a minimum joint space width (JSW) of the target hip between 1 and 4 mm were randomly assigned to  three years of 300 mg/day ASU-E or placebo. The primary outcome was JSW change at year 3, measured radiographically at the narrowest point.

A total of 399 patients were randomised. Their mean baseline JSW was 2.8 mm. There was no significant difference on mean JSW loss, but there was 20% less progressors in the ASU than in the placebo group (40% vs 50%, respectively). No difference was observed in terms of clinical outcomes. Safety was excellent.

The authors concluded that 3 year treatment with ASU reduces the speed of JSW narrowing, indicating a potential structure modifying effect in hip OA. They cautioned that their results require independent confirmation and that the clinical relevance of their findings require further assessment.

I like this study, and here are just a few reasons why:

It reports a massive research effort; I think anyone who has ever attempted a 3-year RCT might agree with this view.

It is rigorous; all the major sources of bias are excluded as far as humanly possible.

It is well-reported; all the essential details are there and anyone who has the skills and funds would be able to attempt an independent replication.

The authors are cautious in their interpretation of the results.

The trial tackles an important clinical problem; OA is common and any treatment that helps without causing significant harm would be more than welcome.

It yielded findings which are positive or at least promising; contrary to what some people seem to believe, I do like good news as much as anyone else.

I WISH THERE WERE MORE ALT MED STUDIES/RESEARCHERS OF THIS CALIBER!

I don’t suppose that many readers of this blog believe all things natural to be entirely safe, but the general public seems to be hard-wired victims of this myth: Mother Nature is benign, and herbal remedies must be harmless!

There are, of course, several reasons why supposedly “natural” herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated.

The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects.

Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen.

We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc.

These substances were implicated in a wide range of serious adverse effects in the unfortunate patients who took the remedies in question: agranulocytosis, meningitis, multi-organ failure, stroke, arsenic poisoning, mercury poisoning, lead poisoning, caner, encephalopathy, hepato-renal syndrome, kidney damage, rhabdomyolosis, metabolic acidosis, renal failure, liver failure, cerebral oedema, coma, and intra-cerebral bleeding. Several patients did not survive.

To avoid such disasters, consumers need to know which types of herbal remedies are most frequently implicated; our review showed that these were foremost Chinese and Indian remedies. While herbal medicines from the US or Europe ought to comply with certain rules and regulations regarding their quality and safety, Chinese and Indian herbal mixtures frequently enter our countries illegally or are bought from dubious sources, for instance, over the Internet. It is this type of herbal remedy that we should be concerned about.

We have to ask whether the risks outweigh the proven benefits of Chinese or Indian herbal mixtures. The short answer to this question is NO. There is very little compelling evidence to suggest that these treatments are efficacious. In the absence of proven benefit, even small or rare risks weigh heavily.

If the risk-benefit profile for any medical intervention fails to be positive, there can only be one reasonable conclusion regarding the use of this therapy – and that is: DON’T DO IT!

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