Studying homeopathy in Third World countries, revisited

I'd like to start this post by thanking a commenter named Paul Grenville. He provided me with this blogging material and, indeed, may have supplied me with material for two blog posts. He did it by showing up in an old post about a homoepath named Jeremy Sherr, who has been bringing woo to the natives, so to speak, by treating HIV/AIDS patients in Africa with homeopathy. Sherr, as you may recall, Sherr had announced his plans to do "clinical trials" using homeopathy for HIV/AIDS and even bragged about treating Tanzanians with quackery. He then tried--shall we say?--to revise history by making the evidence of his claims disappear from the Internet. It worked as well as it always does, as in not very well at all. In any case, this Grenville character apparently has a habit of showing up on old posts critical of homeopathy and whining, and that's just what he did on my post about Sherr, which is now over a year old, opining:

Homeopathy sceptics have an a priori position on homeopathy, which goes something like this: Homeopathy is "only water" therefore clinical evidence that it works is dismissed out of hand - here's some evidence. There's plenty if you look.

Funny, but I sure have looked, and I've had a really hard time finding any sort of convincing evidence for the efficacy of homeopathy beyond that of a placebo for any ill. Not that that doesn't stop apologists like Grenville from believing and trying to get me to believe, too. In any case, Grenville constructs a typical strawman argument beloved of homeopaths. It starts by correctly stating that the position of skeptics like myself is that homeopathy is "only water," namely because the scientific evidence is overwhelmingly that it is, in fact, just water, at least at dilutions much greater than around 12C. (Many homeopathic dilutions are 20 or 30C.) Indeed, a 30C dilution represents a 10⁶⁰ dilution, which is roughly 10³⁷-fold greater than Avagadro's number. In other words, homeopathic remedies tend to be diluted to the point where the odds that a single molecule of the remedy remains is close to nonexistent. Even homeopaths admit this, at least implicitly, coming up with all sorts of woo-ful "explanations," such as the "memory" of water.

Where the straw man comes in is in the claim that skeptics say that clinical evidence can be "dismissed out of hand." That's a mischaracterization of the skeptical position. A better representation would be to say that, given the huge swaths of very well-established science that show that homeopathy can't work in the way claimed by homoepaths and how physics, chemistry, and biology all conspire to make homeopathy impossible, it would take some incredibly compelling clinical evidence to make us start to question so much established science from so many different scientific disciplines. That's not to say that, were compelling clinical evidence presented, we wouldn't start to think about changing our minds. But it would take evidence of a quality and quantity at least in the same order of magnitude of the quality and quantity of evidence supporting the scientific principles and disciplines that say that homeopathy is impossible. Poorly designed clinical trials that show results barely different than a placebo or the occasional well-designed trials that show an effect slightly greater than a placebo but represent a fraction of clinical trials that would be expected to appear positive by random chance alone just don't cut it. But that's all homeopaths are ever able to muster.

Still, I'm disturbed by the description of the "trial" that Grenville presents as "evidence" for the efficacy of homeopathy in treating AIDS. This "trial" comes from something called the AIDS Remedy Fund, which is described as the product of two Dutch homeopaths, Jan Scholten, MD and Leo van Gelder, MD, the latter of whom is described as one of the founders of Homeopaths Without Borders and a past chairman of the board. My first thought was that this has to be a joke. Homeopaths Without Borders? As if suffering people in Third World countries don't have enough problems without having to worry about a bunch of quacks descending upon them. And--oh, goody!--HWB is looking to help out Haiti! I'm sure that'll work out real well. Besides, Haiti already has plenty of its own "natural healers" pushing unscientific remedies. It doesn't need to import more. What it needs are real doctors, real nurses, and scientific medicine. Donate to Doctors Without Borders or the American Red Cross instead.

So let's take a look at what this "study" supposedly found:

• The aim of the Aids Remedy Fund (ARF) foundation is to study the effectiveness of homeopathic therapy for HIV/Aids and to make the remedy available at low cost to large populations suffering from the disease. The foundation is non-profit.
• The foundation has successfully undertaken a pilot study of the effectiveness of the drug Iquilai to combat the effects of HIV/Aids within an HIV-infected population in Kenya. The most significant result of this pilot is that more than 90% of the patients showed improvement in their health.

So what is Iquilai? According to the website, this:

Homeopathic medicines are prepared in a way that is known as potentiation. In this, the medicinal action of the base ingredients (animal, vegetable and min- eral) is transferred to a substance from which the medications are composed.

Jan Scholten, a doctor based in Utrecht, The Netherlands, has developed a new homeopathic drug. The active ingredient is one of the mineral based substances. His goal was the development of a therapy for the treatment of HIV/Aids aimed at the restoration of the patient's damaged immune system.

Potentiation (or potentization, as I've sometimes seen it called) is the process of vigorously shaking or "succussing" the homeopathic remedy at each dilution step. It is this succussion, homeopaths will oh-so-seriously tell you with a condescending tone in their voice not unlike that of an adult correcting a particularly dumb child, that supposedly imbues the homeopathic remedy with its potency. In other words, it's the shaking that makes the magic water magical.

As for Iquilai itself? A news story describes it thusly:

"The Iquilai is a potentised natural remedy. It has been found to be effective in the treatment of HIV and Aids since it restores the balance of minerals," said Ombaka.

Gelder explained that the mineral balancing was essential to ensure there is no lack or abundance of vital minerals in the body.

"Mineral imbalances are inter- connected with imbalances in the immune system and this helps to reduce insufficiency of the immune system, which is Aids," Gelder explained.

Restoring the balance in the mineral content goes together with the balancing of the mental and emotional state.

The remedy, the researchers disclosed, focused on returning the body to its natural state of balance.

This is, of course, utter nonsense. The pathogenesis of HIV/AIDS has nothing to do with a "lack or abundance of vital minerals in the body" and everything to do with HIV attacking T-helper cells and over several years obliterating them to the point that severe immunodeficiency occurs. Even if Iquilai could "restore vital minerals," it would do nothing for HIV or to slow the progression of HIV infection to AIDS. I also note that Gelder appears to be engaging in a bit of HIV/AIDS denialism in that he doesn't even mention the virus. Of course, this is not surprising, because homeopathy is a pre-germ theory philosophy. It does not sit well in the 21st century. Now, here's a description of the "study," which looked at 250 people in Kenya, and its findings:

Patients were given the opportunity to be treated with the homeopathic drug. This took place within the existing 'home based care' programme run by the Kenyan doctor James Ombaka, a dermatologist and microbiologist at the Ganjoni Hospital in Mombassa. The patient population comprised both patients under ARV treatment and patients who were not undergoing any ARV therapy. The greater part of the patients was in an advanced stage of Aids (stages 3 and 4 according to the WHO classification).

Following a positive HIV test at the start of the treatment, the patients received a dose of the drug once a day for five days. Where there was deterioration in health, a further dose was given (currently this last prescription was adapted to one granule once a month for five months).

The results were described as follows:

Within two weeks, an improvement in appetite and an increase in energy and weight could be observed. In addition, in more than 90 percent of the patients recovery from opportunistic infections, such as the disappearance of diarrhoea, respiratory infections and skin problems was seen.

This applied to both patients treated with conventional drugs and the group not receiving any ARV treatment.

The CD4 tests, which had initial values under 200, showed significant improve- ment. The levels increased by an average of 123 points (a CD4 value of 200 or less is a critical lower limit for which anti-viral therapy is deemed necessary).

An improvement in quality of life could be observed in the whole research group. Restoration of independent functioning became possible for practically the whole population after treatment with Iquilai.

Can anyone tell me why this is at best a highly dubious study? Try not to read on for a minute and think why. Then see if your answer agrees with mine. Also remember that, if the homeopaths were correct and their nostrums actually did produce major clinical improvements for 90% of HIV/AIDS patients and their methodology was sound, they could easily publish this study in a real medical journal (as opposed to fake medical journals like homeopathy journals). Yet they haven't. I wonder why?

So why is this "study" so questionable? Let me count the ways. First, it included patients on and off antiretroviral therapy. That in and of itself wouldn't necessarily be a problem for a pilot project, but nowhere is it adequately described how many patients taking ARV improved on Iliquai compared to how many not taking ARV. More importantly, there is no control group. We have no idea if the number of patients who improved is typical for any patient with HIV or AIDS who simply undergoes routine care for HIV/AIDS, even in Kenya. In fact, when it comes to the quality of life measurements, this study design is almost guaranteed to produce apparent "improvements" just based on the fact that the people doing the measurements know that every person they evaluate periodically is taking the remedy being studied. As for the alleged improvement in an objective measure, namely CD4 cell count, which was claimed to have improved significantly, it turns out that if you read the study you'll find that only 51 out of the 228 patients had serial CD4 counts drawn at three intervals and 85 at two intervals. That's only a little more than half of the patients enrolled on the study. No reasons are given for why so many patients didn't have more than one CD4 counts drawn; we have no idea what happened to their CD4 counts; and no description is given to show whether the group that did get more than CD4 level drawn was the same as the group that did not. Moreover, if you look at the table on page 17, you'll see that the values are 161 ± 93 at the beginning and 284 ± 126 at the end, a rather large overlap that is claimed to be very statistically significant. Maybe so, but again without a control group and not knowing what happened with nearly half the patients I remain underwhelmed. This is not the sort of highly compelling data that would lead me to start to question huge swaths of established science. Extraordinary claims require extraordinary (or at least copious amounts of) evidence, and this study doesn't qualify.

Regardless of the results, without a control group, there is nothing there to provide convincing support to claims made in the report that HIV/AIDS could be treated with a short course of Iquilai; that treatment with the homeopathic magic water can delay the need for ARV therapy; or that there could be "no resistance" to the Iquilai because it "fights the virus causing the illness from the inside out." If prior probability is taken into account, then there's really nothing here, at least nothing compelling enough to convince me that homeopathy is more than water.

In fact, there is only one statement in this report that I can mostly agree with, and that's this:

The drug has not exhibited any side effects so far and their occurrence is not likely. This is a characteristic of all homeopathically prepared medications. The reason for this is that the original substance has been potentiated, which means that it has been shaken and diluted in stages so that no further chemical reactions can occur.

I agree. Homeopathic remedies do not exhibit any side effects because they are nothing more than magic water, and this is indeed a characteristic of all homeopathic remedies. No "further chemical reactions" can occur because there's no chemical from the original remedy left, only water! Indeed, hilarious confirmation of this comes from the description in the report that points out that Iquilai can't be patented because the "present state of technology is not yet able to determine whether a homeopathic drug is authentic or not."

Comedy gold!

What's not funny, though, as I've described before discussing a trial of homeopathy for childhood diarrhea in Honduras, is that trials of this type are profoundly unethical. Given that homeopathy is water (heck, they even admit it in the "study report" with their pointing out that none of substance remains and they can't patent it because a homeopathic remedy can't be distinguished from water), offering homeopathy to patients with a life-threatening disease violates the Helsinki Declaration. If a study must be done, then to be in accordance with the principles of the Helsinki declaration all subjects in the trial must receive the current standard of care, namely ARV therapy. Then, for scientific rigor, it must be randomized and double blinded with rigorous matching of control groups. My guess is that such a trial would very likely be negative. It would also be a colossal waste of time, although because the Helsinki Declaration demands that no human subject in a research trial get less than the standard of care without an incredibly good reason to justify otherwise some Africans might get ARV who otherwise might not get it.

Idiocy like this "study" by the AIDS Remedy Fund really burns me. HIV/AIDS in Africa is a huge problem that has resulted in some horrific abuses from various pseudoscientists, be they quacks like Matthias Rath claiming he can treat AIDS with vitamins or deluded homeopaths. (Is that a redundant statement?) In any case, it doesn't help to have deluded Westerners arrive from their comfortable existences thinking that they are doing good when in fact they are doing nothing more than bringing fairy dust with them and then publishing dubious reports rather than publishing their work in the peer-reviewed literature, where scientists can evaluate the full study design and analysis. And, no, homeopathy journals or "alternative medicine" journals, which are prone to publishing the rankest pseudoscience, don't cut it. If the results are as compelling as the AIDS Remedy Fund claims, then it should try to get it published in a real journal. That in and of itself would not be enough to overturn so much established science (at minimum, multiple replications from other groups in other populations would be required and a mechanism by which the homeopathic remedy works would also be good to know--at least a hint of a real, nonmagical mechanism), but it would at least allow us to see if these seemingly fantastic results stand up to closer scrutiny.