A rare double-face palm, so you can't see the tears

A rare double-face palm, so you can’t see the tears

I run across a lot of information in my feeds that I need to save for further evaluation. The study “Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population“, I saved with the file name, ‘jaw droppingly stupid’.

The worst homeopathy clinical trial ever doesn’t spring full formed like Athena from the head of Zeus. No. The worst homeopathy clinical trial ever started with a seed. The seed is “Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: A randomized, double-blind, placebo-controlled trial, which is a standard lousy homeopathic study.

Would that it were syrup of Lethe

Individualization of care, so beloved by homeopaths as a reason their particular form of magic cannot be tested, was ignored so that 80 adults were randomized to receive either a homeopathic nostrum or a placebo. The nostrum, delivered as a syrup, was:

Anemone pulsatilla 6 CH, Rumex crispus 6 CH, Bryonia dioica 3 CH, Ipecacuanha 3 CH, Spongia tosta 3 CH, Sticta pulmonaria 3 CH, Antimonium tartaricum 6 CH, Myocarde 6 CH, Coccus cacti 3 CH, Drosera MT. It is important to note that concentrations are expressed in the usual format for homeopathic products, where 1 CH stands for a 1:100 dilution, so that a dilution of 3 CH means that three serial 1:100 dilutions were performed from a starting concentration of 1 M (i.e., 1 mol/L), and thus the overall dilution is 1:1003 , which corresponds to a final concentration of 1 μM. Similarly, a 6 CH dilution corresponds to a final concentration of 1 pM.

Unlike most homeopathic products, it appears that there are some actual chemicals left behind in this product. A homeopathic product needs to be deluded, er, I mean diluted past 12 C to contain nothing, 12 C being “the greatest dilution reasonably likely to contain even one molecule of the original substance.”
They followed patients for cough resolution and on one day, the 7th, there was a statistically significant difference but the error bars overlapped (I have become convinced that the minimum significant p is 0.005, and that presumes a high prior plausibility). At the end of the two weeks both groups had equal cough resolution. They measured sputum viscosity (I gag just thinking about it) and while the measured viscosity was improved in the homeopathic group:

…the patients did not appear to significantly perceive this difference.

Whether blinding was successful is not mentioned. Oh yeah and:

Publication of this article was supported by an unrestricted grant from Boiron.

See, they are paid shills of Big Homeo. A positive study is what you would expect given who funded it, and the authors delivered as a lackey should*:

study shows that the tested homeopathic medicine was more effective and faster than a placebo in alleviating cough caused by uncomplicated URTIs.

Nope. I see the results as demonstrating no difference between placebo and placebo, but given there may be actual active molecules in the product, perhaps it had some effect. But I doubt it.

Turn your head and retch

I suspect that any product that really could suppress a cough, and all OTC products do not, would require the patient to be intubated. I do suffer from the naturalistic fallacy when it comes to treating the symptoms of infections for comfort reasons. Fever, cough and diarrhea, among others, have evolved for a purpose and there should be compelling reasons beyond comfort to suppress them. While there is good information to suggest usually treating fever is counter-productive, I can find little literature for the downsides of suppressing cough, probably as nothing is really effective. The urge to cough is too strong. The only good cough suppressant I know of is a rib fracture, and that has its own issues.
The seed was planted. I see fallow ground. The authors? The chance to grow the Worst. Homeopathic. Study. Ever.
Background: cough is common in children. The cough is usually viral and/or asthma. Viruses do not respond to antibiotics. Duh. Giving antibiotics for a viral infection is, from the perspective of an infectious disease doctor, stupid. Real stupid. Jaw-droppingly stupid, as noted by the file name. Patients often expect antibiotics and responsible/ethical physicians resist the pressure, since antibiotics cost money, have side effects and, when given inappropriately, only help breed antibiotic resistance, a growing problem.

Jaw-droppingly stupid is a term that does not usually appear in the medical literature. Instead they prefer the kinder, gentler inappropriate use of antibiotics.

Antibiotics should be used only for bacterial infections and are not effective against the viruses that cause many illnesses including influenza and most upper respiratory tract infections, including the common cold, or fungal infections like those caused by yeast. The inappropriate use of antibiotics for these types of infections as well as the more frequent use of broad-spectrum antibiotics has caused the emergence of newer strains of bacteria that are resistant to many antibiotics.

But in 2015 deliberately using antibacterials for non-bacterial infections is, let’s be honest, incompetent and/or stupid.

This study took children with a cough. Arguing that patients’ parents expect antibiotics (!?!), they decided to do a study comparing homeopathy to homeopathy plus antibiotics.

That is what made this the most jaw-droppingly worst study ever. They did not compare homeopathy with or without standard therapy. No. They compared the use of homeopathy with or without inappropriate unethical antibiotics. Or you could say they compared pseudo-medicine to pseudo-medicine combined with the deliberate practice of bad medicine.

Laser-guided incompetence

Quite a feat when you think of it. It is not often that a study is deliberately designed to provide and reinforce incompetent care. I cannot remember a study with such a flaw in all the time I have been reading SCAM papers.

The results? Remember: no placebo group. Well, no deliberate placebo group. Both interventions were, in reality, placebo. And there was no difference in time to resolution of cough. What a surprise. Treat a self-limited disease with two useless and one inappropriate intervention and patients get better at the same rate.

Their conclusion? The discussion says:

The data of the present study also indicate that adding antimicrobial agents to the homeopathic syrup does not in any way benefit the symptomatic treatment

And then suggest in the conclusion:

Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well

It does nothing of the sort. The study demonstrated that cough gets better when you give one of two placebos. Did the reviewers even read this paper? Another example of peer review, as in peer: look keenly or with difficulty at someone or something. Someone peered at the paper and suggested publication.

Remember that 24% of the children had a side effect to the antibiotics, an intervention that none of them would, or at least should, have received under appropriate medical care. The interventions in this study ONLY caused harm.

Worst thing to happen to Helsinki since Stalin

This study was approved, with another fail, by an institutional review board. They note the study:

was conducted according to the Helsinki declaration, which is here.

Since it is a homeopathy study they immediately fail:

Medical research involving human subjects must conform to generally accepted scientific principles.

And since the use of antibiotics in this study would, in the real world, be considered awful practice that should only give side effects without benefit, I do not see how they pass:

The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

Not only jaw-droppingly stupid, but jaw-droppingly unethical, even for a pseudo-medicine study. This is a run up to a larger, and probably even more jaw-droppingly awful, study. It:

was a pilot study conducted before starting a larger trial on the role of antitussive and mucolytic drugs in children; however, the results of this preliminary study can provide valuable information for the sizing of future rigorous controlled studies

So expect more of the same, only bigger. But I bet not better. They will only harm more children without any potential benefit.

Worst. Homeopathy. Study. Ever.

Find me one that is worse.

* sarcasm for the irony impaired.

Note: Clay has already reviewed this study, but why should he get all the “fun”?

Posted by Mark Crislip

Mark Crislip, MD has been a practicing Infectious Disease specialist in Portland, Oregon, since 1990. He is a founder and  the President of the Society for Science-Based Medicine where he blogs under the name sbmsdictator. He has been voted a US News and World Report best US doctor, best ID doctor in Portland Magazine multiple times, has multiple teaching awards and, most importantly,  the ‘Attending Most Likely To Tell It Like It Is’ by the medical residents at his hospital. His growing multi-media empire can be found at edgydoc.com.