The objective of this study was to identify adverse drug reactions (ADR) associated with the use of so-called alternative medicine (SCAM) in Malaysia and to define factors which are associated with the more serious reactions. For this purpose, all ADR associated with the use of SCAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.
From a total of 74 997 reports in the database, 930 (1.2%) involved SCAM products. From a total of 930 reports, 242 (26%) were serious ADR with 36 deaths. Six people died as a result of taking the SCAM, while another 30 cases were possibly associated with the SCAM products. Among the 36 mortality cases, adulterants were detected in 30% of cases. Examples of adulterants were dexamethasone, avanafil, nortadalafil and banned drugs such as phenylbutazone and sibutramine
About a third of the reports involved used SCAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the SCAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).
The authors concluded that the prevalence of serious ADR associated with SCAM products is high. Factors identified with serious ADR included ethnicity, SCAM users with pre-existing diseases, use of SCAM for chronic illnesses and concomitant use of SCAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of SCAM products.
The authors also point out that underreporting of ADRs remains a major ongoing issue in pharmacovigilance. Many SCAM consumers may not be vigilant or may be unaware of ADR they experience due to misconceptions on the
safety of SCAM products. Most doctors rarely ask their patients about the use of SCAM.
To this, I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.
I expect that some readers of this post will now point out that the rate of SCAM-related ADRs is very small compared to that of conventional drugs. They would be correct, of course. But they would also miss the point that the value of a treatment is not determined by its risk alone. It is determined by the risk/benefit balance. Where there is no effectiveness, this balance is negative, even if the risk is tiny.
So, now let me challenge the defenders of SCAM to name a few SCAMs that are demonstrably associated with a positive risk/benefit balance.
31 Responses to The prevalence of serious side-effects of SCAM products is high
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Alexander Technique, perhaps?
for what condition?
Please check your own comments re. Alexander Technique. Are they still valid?
I replied already: please check your earlier comments/blogs re. Alexander Technique.
I merely made a suggestion, i seems up to you to respond since you invited suggestions.
yes, in my book (virtually: https://www.amazon.co.uk/Alternative-Medicine-Critical-Assessment-Modalities-ebook/dp/B07TS1QXX6/ref=sr_1_5), AT can do more good than harm – but only for a very limited number of indications.
In Clin J Pain 2004 Jul-Aig. 20 (4) 244-55 Authors Weiner DK, Ernst E
“Some evidence exists to support the superiority of homeopathic remedies over placebo for treating osteoarthritis and rheumatoid arthritis”.
https://pubmed.ncbi.nlm.nih.gov/15218409/
1) some evidence does not mean good or convincing evidence.
2) the paper is now 16 years old and the evidence has become clearer: some means very little unconvincing in this case.
How you can measure “good” or “convincing” evidence?
How much is “good” or “convincing” evidence?
Why evidence must be “convincing”? Who is the judge?
there are fairly objective criteria for all of that
Sandra,
You are quoting from the abstract. Unfortunately the paper itself is behind a paywall. Could you please tell us what this evidence is, which is presumably discussed in the main body of the paper? Or perhaps you are referencing something that you haven’t actually read.
… and she quoted wrongly!
Another example, from 1997. Note that the same homeopathic remedies can be and are used in 2020 by homeopaths worldwide.
Journal Clinical Gastroenterology Homeopathy for post-operative ileus, Barnes JB, Resch Karl-udwig, & Ernst Edzard
6 trials,766 patients, medicines: Opium, Arnica, Raphanus sativus, China, Pyrogenum. Two of the four studies that also measured time to first feces reported a positive effect for homeopathy. A meta-analysis of all six included studies revealed a statistically significant effect in favour of homeopathy for time to first flatus. This effect remained even with the exclusion of the two low quality studies. A significant effect in favour of homeopathy was also found for time to first flatus when a homeopathic remedy of less thatn 12C potency was used. Conclusion: There is some evidence to support the administration of a homeopathic remedy immediately after surgery to reduce the duration of ileus.
oh Sandra!
we had this before, didn’t we?
the conclusions in the original were as follows:
There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery. However, several caveats preclude a definitive judgment. These results should form the basis of a randomized controlled trial to resolve the issue.
SINCE WHEN ARE YOU IN THE BUSINESS OF FABRICATING STUFF?
So 23 years on, what are the results of the randomised controlled trials that were recommended?
to the best of my knowledge, no further studies were published
Interview The Alternative Preofessor by Sarah Boseley
Sarah Boseley meets the world-class scientist who turned his back on the Viennese medical elete to becomethe UK’s first (and only) professor of complementary medicine.
This is a scientist willing to explore the unthinkable and unwilling to be told what to think. Scientific logic says homeopathy cannot work, but Ernst continues to study its therapies not to shoot it down, but in the hope of discovering what it is that does work. He treats his French wife with homeopathy he says. “We were both broght up with it.”
https/www.theguardian.com/science/2003/sep/25/scienceinterviews.health
do you have a point?
@Ernst By quoting from an interview where you stated you treated your wife with homeopathy, what do you think my *point” was/is?
is it perhaps that you are a broken record with a very daft message?
do tell!
@Ernst
Yes, or no. Did you tell the Guardian reporter in that interview you treated your French wife with homeopathy?
https/www.theguardian.com/science/2003/sep/25/scienceinterviews.health
Huuuuuuuuh, I like your forceful ultimatum!
yes, I did tell her that I used to treat my wife homeopathically for a while
Sandra
Yes or no. Did you consent to have your teeth filled with amalgam?
By the logic you are applying, you must still be happy to have amalgam used as a restorative material.
“I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.”
Again, there is no basis your non-sense statement. The data base only reported 36 deaths, an impressionant low rate mortality data if you compare versus common treatments (allopathic). For homeopathy and ayurveda, the database contains only 68 cases for both. Finally, the main cause of Adeverse Serious Effects were caused mainly by adulteration with dexamethasone, a synthetized substance. The solution is very simply: quality control.
risk/benefit!!!
@Ernst
Did you quantify your statement to the Guardian reporter? If so, she did not mention that. The implication was that your treatment of your wife with homeopathy was ongoing: “He treats his French wife with homeopathy, he says. “We were both brought up with it.”
I think it’s important for your blog followers to know that you love your wife enough to admit you treated her with homeopathy.
The quoted statement is from the Guardian article
“Interview. The alternative professor, by Sarah Boseley
Sarah Boseley meets the world-class scientist who turned his back on the Viennese medical elite to become the UK’s first (and only) professor of complementary medicine.
guess what dearest Sandra: I know very well what I treat my wife with, but I do not remember the exact wording I gave in an interview. this is mainly because I have just one wife but gave about 500 interviews.
and yes, I love my wife – enough to stop homeopathy and use real medicine some 40 years ago.
I sincerely hope that this is clear to you; it has been clear to everyone else for a while, I’m sure.
sorry you are a bit slow on the uptake.
Dearest Ernst,
The Guardian reporter Sarah Boseley published her interview with you “The alternative professor” in September, 2003 which was 17 (not 40) years ago. I do not fault you for treating your wife with real medicine (your terminology for allopathic medicine). But, why don’t you stop misleading your blog readers? At that time, you told the reporter you were treating your French wife with homeopathy. “He treats his French wife with homeopathy, he says. “We were both brought up with it.”
“Oh, What a Tangled Web We Weave, When First We Practice to Deceive!” (Sir Walter Scott, 1808)
time to change the broken record and come up with something a little less stupid
btw: my 1st name is edzard and my family name is ernst; try to get at least something right
Corrected.
https://twitter.com/BrownBagPantry
Sandra
Forty years ago, did you consent to your children having amalgam restorations placed in their teeth?
It is important for people to know.