For those of you not familiar with homeopathy, it is the practice of treating patients “with diluted natural substances aimed at stimulating the body’s healing systems” (this definition is from the paper used as the pilot study for the clinical trial we are discussing). The more dilute a substance, the stronger it becomes.
Homeopathy also seems to suggest practitioners use what they think is best based on what sounds like an assessment of humors and symptoms, so there isn’t a lot of standardization. The vagueness of medication selection and “healing systems” aside (does that mean immune system and if so which branch?) the medications are often so dilute that they are chemically impossible. For example a 30 c dilution is 1 part in 1,000,000,000,000,000,000,000,000,000,000. This is not biologically possible. There is a nice run down here at Quackwatch, but basically what a homeopath calls medication we call expensive water (and studies tell us that expensive placebos work better than cheap ones).
Because all researchers are biased (we all think our work is genius and our study methods sound) and human subjects need to be protected we have Institutional Review Boards (IRB) to review our proposals. An IRB considers many things when looking at a study with medication, such as:
- Does the condition merit studying?
- What is the expectation based on previous research/biology that this drug could work?
- Is the study appropriately designed to answer the research question?
- What is the side effect profile of the drug?
Vulnerable populations get an even closer scrutiny, for example pregnant women, prisoners, and children.
This is from ClinicalTrials.gov on the intervention medication for the University of Toronto Study:
The homeopathic remedy (study medication) for each patient will be chosen from among the homeopathic medicines manufactured by Boiron Canada and currently approved for sale in Canada by Health Canada. As per classical homeopathy practice, once the most appropriate homeopathic remedy has been chosen, it will be prescribed by the homeopath according to her/his clinical judgment (maximum on a daily basis, 3 times per day, minimum 1 dose (or zero doses on the second consult or later)) with administration instructions given to the parent and patient as appropriate. Water dosing, in which a lactose/sucrose granule remedy is dissolved in 250 ml of water will be used based on the homeopath’s clinical judgment. Only one remedy will be administered at a time.
There is no mention of the actual study drug. The Homeopath is apparently just going to choose what they think is best. Not believing this to be right I read the pilot study (35 patients, open label) upon which the protocol is based…
An Open-Label Pilot Study of Homeopathic Treatment of Attention Deficit Hyperactivity Disorder in Children and Youth
Brulé D.a, b · Sule L.a · Landau-Halpern B.b · Nastase V.b · Jain U.c · Vohra S.d · Boon H.a in the journal Research in Complementary Medicine
This is from the material and methods section of the pilot study…
Dosage regimens were at the discretion of the homeopath and ranged from one single dose between consultations to once daily dosing between consultations. Homeopathic remedy potencies were in the centesimal scale and were chosen at the discretion of the homeopath within the range of 6CH and 1M.
And this is what they used
Phosphorus (9/2), Hyoscyamus niger (8/1), Tuberculinum (6/4), Tarentula hispanica (5/0), Lycopodium clavatum (4/3), Anacardium orientale (4/1), Lachesis muta (4/1), Stramonium (4/1), Veratrum album (4/0), Lac caninum (3/1), Nux vomica (3/1), Pulsatilla (3/1), Belladonna (3/0), Saccharum officinalis (2/1), Calcarea phophorica (2/0), Aconitum (2/0), Aranea ixabola (2/0), Gallicum acidum (2/0), Natrum muriaticum (2/0), Agnus castus (1/0), Agaricus muscarius (1/0), Apis mellifica (1/0), Baryta carbonica (1/0), Bryonia alba (1/0), Bufo rana (1/0), Calcarea carbonica (1/1), Cuprum metallicum (1/1), Ferrum phosphoricum (1/0), Hepar sulphuris calcareum (1/0), Kalium phosphoricum (1/1), Luesinum (1/0), Magnesium carbonica (1/0), Medorrhinum (1/1), Natrum silicata (1/0), Silicea (1/1),Staphysagria (1/0), Sulphur (1/0), Thuja occidentalis (1/0), Veratrum viride (1/0).
The brackets are “the frequency as well as the number of times the remedy was chosen prior to significant improvement.”
So here are some of my problems with the study and why I think it is completely unethical…
The dosing, frequency, and choice of a drug is totally at the discretion of the provider.
Typically with medication trials one has to state the medication, the dose, and the frequency because one needs to study the drug’s effect. Complete randomness in dosing and frequency (never mind actual drug) can not be accounted for statistically. Not in my wildest dreams could I ever imagine and IRB saying, “Sure do what you think is best, as long as it’s an antibiotic from Roche!” (Boiron even gets a plug on ClinicalTrials.gov, and CAM providers complain about Big Pharma).
There is no basic science to support the medications.
The pilot study used dilutions of 6CH or less. A 6 CH dilution (CH = C apparently) is 1 in 1,000,000,000,000,000. It hurts my brain to work out a 1M dilution. Regardless, most homeopathic dilutions are not possible in this dimension. Knowing the principles of chemistry how did the IRB approve this?
If homeopaths and their defenders crave legitimacy then the first thing they need to do is prove these dilutions can be made, one doesn’t get to skip basic science and proceed to directly to human studies. Did the IRB really accept the more dilute the drug the stronger the medicine?
Boiron doesn’t have any kind of regulation standards so the actual contents of the medication are unknown.
Children are a vulnerable population and should not be exposed to a non standardized medication that has not proven to be effective in adults
In my opinion the study is unethical and the IRB at the University of Toronto needs to explain how this study was approved. They can start with the mechanism of action (and “healing systems” better not be one of them) and follow-up with exactly how the cauldrons at Boiron mix up a 6CH dilution.
The Dean of the School of Pharmacy has defended the study by claiming people are using homeopathic medications so they should be studied. Some people use witchcraft in healing, but that doesn’t mean we should turn U of T into Hogwarts.
The only homeopathy study that should be approved at the University of Toronto (and very appropriate for the School of Pharmacy) is a chemical evaluation of the products sold by Boiron to search for active ingredients.