29 April 2008

The end of homeopathy?

Clinical trials repeatedly prove that the effect of homeopathic remedies does not exceed the effect of placebo. Why, then, do many sane people swear that homeopathy helps them? Why do homeopaths claim that a smear campaign has been launched against them? Ben Goldacre plunged into the world of falsified statistics, unreliable research and wishful thinking.

The end of homeopathy?
Ben Goldacre, The Guardian, November 16 2007
Translation: es_ist_gut ljnaukaSometimes quackery looks naive and even childish.

Unfortunately, the situation can be very serious. Janet Winterson gave me great pleasure, starting on Tuesday to prove the scientific nature of homeopathy in this blog. She juggled words like "nano"; she suggested that homeopathic remedies could rid Africa of HIV; she said that today's article in the Lancet magazine encourages doctors to tell patients that homeopathic "medicines" are useless.

The mentioned article does not call for anything, I know for sure. Because he wrote it himself. I am not trying to put pressure on anyone with authority, with all my desire I would not have succeeded: I look about 12 years old, and only a few years ago I received a medical degree. But here's the thing: my authority is not required. And there is no need for authority here. The entire evidence base of homeopathy is clear and understandable if it can be explained in simple words (as, indeed, anything in this world).

One catch: Winterson, like any fan of homeopathy, is trying to convey to us that, for some mystical reason (which no one can clearly explain), homeopathic medicines act in some special special way, and therefore they cannot be reliably tested like any other medicine. Manufacturers who benefit from a completely confused consumer have so firmly hammered this idea into everyone's heads that even some doctors now consider it to be true.

That's enough. Evidence–based medicine is beautiful, elegant, witty, and, most importantly, you can't do without it. It is only thanks to her that we know what will kill a person and what will heal. It's amazing why what I'm going to explain next is not taught at school yet.

So let's imagine a conversation with a fan of homeopathy, a reasonable and thinking individual. "You see," he says, "I firmly believe that when I take a homeopathic remedy, I feel better." Great, you say. Absolutely agree. No one will take away the right to feel better from a supporter of homeopathy.

But maybe it's a placebo effect? You both think you know what the placebo effect is–and you're both wrong. The body and mind interact in a mysterious, complex way. But in the primitive, mechanistic, simplified world of the homeopath there is no place for such difficulties, there the whole effect comes solely from the medicine.

The placebo effect is not just a reaction to a dummy pill. This is the perception of treatment and drugs existing in this culture, a reflection of the patient's expectations, and much more. It is known that four dummy pills a day cure an ulcer faster than two of the same pills. Injections of saline solution relieve pain better than dummy pills. Green pills are better than red ones to help with anxiety. Branded packaging enhances the effect of painkillers.

The child reacts to the expectations and behavior of parents, so the placebo effect also occurs in children and animals. Products that do not contain active ingredients can even cause changes in biochemical parameters in humans and animals if there is a persistent association between the tablet and the active substance. This is undoubtedly the most interesting field of medicine.

"Maybe," says your honest, reasonable fan of homeopathy. "But you can't be sure. And I don't think so. But I clearly know that I am being treated with homeopathy – and I feel better."

What if the improvement is a "return to the mean"? This phenomenon can explain what is happening even better: everything is subject to natural cycles, as it is now customary to say. Back pain increases and decreases throughout the day, week, month, or year. The mood drops and rises. A strange bump on the wrist appears and disappears. A person catches a cold, the cold passes.

If you take a dummy pill at the peak of the disease, there are good chances that after taking the pill there will be an improvement. Similarly, if you roll the dice and two sixes fall out, sacrifice a goat, and the next roll is likely to give a smaller result. This is the return to the average value.

"Maybe so," says a fan of homeopathy. "But I think that's not the point. Homeopathy benefits me."

Negotiations have reached an impasse. How is it possible to find out the truth without resorting to logic? Fortunately, homeopaths have formulated a simple, understandable statement: if you take prescribed homeopathic medicines, you will feel better.

You can make a randomized controlled study of almost anything: compare two teaching methods, two forms of psychotherapy, two plant feedings. The first study is described in the Bible (Daniel 1:1-16, since you ask), it compared the effect of two diets on the morale of soldiers. This is not a new and simple idea, and testing pills is the easiest.

Here's how you can test homeopathic remedies. We take 200 people and randomly divide them into two groups of 100. All patients go to see their homeopaths, receive prescriptions for homeopathic medicines (because homeopaths like to prescribe medicines even more than ordinary doctors), for any medications that a homeopath considers it necessary to prescribe. Each of the patients then goes to the pharmacy of homeopathic medicines. Each of the patients can receive as many "individual" medications as they want, it does not matter.

What's the trick? The fact that one group receives real homeopathic remedies according to the prescription, and the other – pacifiers. The main thing is that neither the patients nor those who meet them during the study do not know who belongs to which group.

Such a study of homeopathic remedies was carried out repeatedly, over and over again. The overall result is this: people who receive placebo show approximately the same reactions as those who receive real, chic, expensive, authentic, magical homeopathic medicines.
Why, then, do homeopaths appeal to completely different results of studies in which homeopathic remedies worked better than placebo? That's a good question. Take a closer look at it – and you will see that homeopaths, and all alternative medicine, successfully use the same tricks as the giants of the pharmaceutical industry when they want to confuse doctors.

Yes, in some studies, homeopathy shows the best results. Firstly, because a lot of studies are simply unreliable. For example (and this is the simplest example) – alternative medicine journals have published the results of many studies in which patients were not "blind" – that is, they knew what they were getting, a real medicine or a pacifier. For obvious reasons, the results of such tests are much more favorable for their organizers. What is the point of conducting such tests? If a study is conducted in violation of standards, it is not a study, but just a marketing ritual.

There is also a more elegant option. In some studies, patients are not randomly assigned to "homeopathic" and "placebo" groups. According to the rules, sealed envelopes with randomly assigned numbers should be distributed to patients. These envelopes are opened only after the patient is properly registered to participate in the trials. Let's say you "randomly" distribute patients, mmm, like this: the first one gets homeopathy, the next one gets a placebo, and so on. Thus, you see the patient and know which group he will fall into, even before you decide whether these people meet the criteria for your test. That is, a homeopath conducting tests can – say, unconsciously – place healthier patients in the homeopathy group, and relatively sick patients in the placebo group, and this will affect the results. This is also an unreliable study.

Congratulations. Now you know as much about evidence-based medicine as a certified specialist.

Therefore, when doctors say that the study is unreliable and does not meet the standards, it does not mean that conventional medicine wants to maintain dominance, or push through someone's interests. The point is simple: the study did not show how the drug actually works. It costs as much to conduct a study incorrectly as it does to comply with all the necessary conditions, and this is just stupidity – or falsification of results in favor of homeopathy.

Not all medical research is conducted correctly, it's true. But a critical approach is cultivated in the medical environment. Doctors are taught to recognize unreliable tests (as I am teaching you now) and bad medications. The British Medical Journal recently cited three of the most frequently requested and cited studies in the past year. Here they are, in order: undesirable effects of the anti-inflammatory drug Vioxx; problems with the antidepressant Paroxetine; risks associated with the use of serotonin reuptake inhibitors as antidepressants. This is a normal practice.

With alternative medicine, the situation is different. Pointing out a weak point in the evidence, do not count on a calm discussion, do not expect that opponents will read your work or refer to it. Instead, they burn with righteous anger. They refuse to answer calls and emails. They make passes with their hands, muttering clever words like "quantum" and "nano". They claim that you sold out to pharmaceutical monsters. They threaten to sue. They shout "what about thalidomide, you smartass"? They cry, call bad names, make presentations at conferences about your unprofessionalism, call you at work and get your superiors, try to find dirt about your private life, and even threaten violence. I have experienced all this for myself, and I'm going to publish an extensive collection of real facts (so please don't stop there).

Let's get back to the serious questions. Where does so much research with a positive result come from? The answer is that the results of not every study are published. This is the sin of many scientists, in any scientific field. A study with positive results is much more likely to be published. Confirmation of the theory is interesting news, it's a plus for a career, but it's just nice. This is a problem of science in general. Doctors are trying to solve the problem by demanding to register the study in a special database first, and then conduct it. So the organizers will not be able to hide the negative result and pretend that nothing happened.

How selectively do representatives of alternative medicine approach the publication of research results? In 1995, only 1% of studies published in alternative medicine journals had a negative result. The most recent figure is 5%. That's very, very little.
There is only one conclusion to be drawn. Obviously, if the study gives a negative result, representatives of alternative medicine, homeopaths or manufacturing companies simply hide it in the table. Somewhere there are boxes, boxes, files, garages and whole offices of documentation about the trials of homeopathic remedies that did not give a result suitable for their organizers. At least one homeopath reading these lines keeps folders full of disappointing data in a distant closet, and is not going to present them to the world. Preved!

So, you can publish only positive research results, as homeopaths do. This is an old and dishonest trick that distorts the real picture. There is a special mathematical tool called meta-analysis. The point of it is that you collect data on all studies on one topic and put them in a giant summary table to get the most representative average result. If we analyze studies related to homeopathy in this way over and over again, having previously eliminated unreliable ones and taking into account the selective nature of publications, it turns out that homeopathy is no more effective than placebo.

All this text fit into three sentences in my article in the Lancet magazine, simply because its readers do not need to explain what meta-analysis is. Let's get to the point of the question. Should we even care that homeopathy works no better than a placebo? The answer is strange – probably not.

I will tell you about the real conspiracy of doctors against alternative medicine. In the 19th century, during the cholera epidemic, the mortality rate in the London homeopathic hospital was three times lower than in the Middlesex hospital. Of course, homeopathic sugar balls cannot help with cholera. But the real reason for the success of homeopathy during this epidemic is even more interesting than the placebo effect. At that time there were no ways to fight cholera at all. Therefore, when conventional methods of treatment, such as bloodletting, were extremely harmful, homeopathy at least did not worsen the patient's condition.

Today, in many situations, medicine also has practically nothing to offer. Back pain, stress from work, chronic fatigue unexplained by medical reasons, most colds, and so on and so forth. With such ailments, sugar balls are a much more reasonable choice than going through the drugs from the pharmacological handbook, which in the end will only give side effects.

In this sense, homeopathy is useful. On the other hand, homeopathy has its side effects. It would seem that what's wrong – well, prescribed medicine? However, the very fact that a person takes medication makes the problem "medical". This can strengthen the patient's belief that he is sick, or that social problems can be solved by taking a pill, or that for any diseases – for example, a mild cold, it is necessary to take medications.

In addition, there are ethical issues. Just 50 years ago, in medical institutes, there was only one item in the course "communication skills with patients" – how to hide from a patient that he has inoperable cancer. Currently, it is believed that the patient has the right to complete and reliable information about his condition. If a medical professional (of any kind) understands that he recommends an effective remedy no more than a placebo, but does not tell the patient about it, thereby violating the requirements of modern medical ethics. The doctor is obliged to explain what measures he is going to take and why, so that, based on the information received from the doctor, the patient can consciously agree to the proposed treatment plan.

Or maybe sometimes lying is good? The argument is interesting, and it would be possible to discuss this topic. At the very least, you need to realize that this is an outdated, patronizing approach. After all, if a doctor deceives a patient, it undermines the very foundation of their relationship, which should be based on honesty – and trust. On the other hand, if you prescribe homeopathic medicines and do not know that they work no better than placebo, then you are not familiar with the literature on research, and thus are not competent enough to prescribe such treatment. An interesting ethical problem, but I do not know a single fact of discussing this issue in homeopathic circles.

The matter is not limited to ethical difficulties. Homeopaths, as a rule, tend to deny the possibilities of conventional medicine. The benefits of such a position are clear. As the results of surveys show, it is the disappointment in modern medicine that makes people make a choice in favor of alternative therapy. This explains the actions of homeopaths, but does not justify them. And "actions" doesn't just mean abstract conversations. One study found that more than half of the homeopaths involved advised parents not to vaccinate their children with the MMR (rubella–measles–mumps) vaccine.

How did the alternative therapy world react to the fact that so many of its representatives were working to disrupt the vaccination program? The office of Prince Charles tried to get the dismissal of the leading researcher.

An investigation of the BBC Newsnight TV program showed that almost all homeopaths who were contacted for recommendations on protection against malaria advised against drug prevention of malaria, and at the same time did not even explain how to protect themselves from mosquito bites. A very holistic approach. Very comprehensive. What measures can be taken to the mentioned homeopaths? None.

In the worst case, even leaving aside the subversive work against vaccination, as well as advice to patients to face a deadly disease face to face, homeopaths who do not have medical qualifications may miss serious illnesses or even actively ignore them, inciting patients to throw away their inhalers and heart pills. The Society of Homeopaths holds a symposium on AIDS treatment. One of the works under consideration belongs to Peter Chapel, who claims to have found a homeopathic remedy to combat the epidemic. And we all laugh at the fantasies of homeopaths and read tall tales about the successes of their "science".

And what tall tales! Strikingly, positive customer reviews of the homeopathic clinic are widely advertised in the media, as if patient satisfaction is a stronger argument than the results of randomized clinical trials. It is not surprising that the general public has difficulty understanding what medical research is. If you read about the "study" in the newspaper, it is most likely some kind of pseudo-study of the virtues of fish oil, or a homeopath who colorfully tells about his own successes. And all because a real, picky, scrupulous, boring medical study is just a longing compared to the flowery revelation of another charlatan.

Homeopaths rigidly push their product through quasi-scientific chatter. As a result, people no longer understand what the evidence base is in relation to the drug. And this is happening at a time when real scientists are working to provide everyone with access to the results of clinical trials, and most good doctors are trying to attract patients to the choice of a treatment method, explaining medical nuances in an accessible way. This is no longer an abstract topic for theoretical debates. This is vital.

And that's the strangest thing. All the questions I have asked can be resolved in an honest and open discussion. However, for some reason homeopaths avoid discussions accepted in academic medicine. Justified criticism is often met with fits of anger, cries of harassment, or a simple refusal to discuss the issue. The Society of Homeopaths (the largest professional body in Europe, the one that holds a frightening symposium on HIV), even threatened to sue bloggers who criticized the Society in their magazines. My colleagues and I have requested information about the curriculum of university courses on homeopathy. They refused to provide it to us! It's hard to think of something more unhealthy in an academic environment.

In today's issue of the Lancet, the largest British medical journal, I wrote the same thing, albeit in somewhat more "scientific" terms. This opinion is called "attack" by homeopaths. However, I have made my point clear. There is a lot of accessible and truthful information about homeopathy. But it is simply impossible to draw the only correct conclusion from it.

Sometimes, in a good mood, I think – let it be! Homeopathy may well take its place in the healthcare system, because placebo also has its value. Let's forget about ethical issues and serious cultural side effects.

But when people are sued instead of responding to their arguments, they tell patients to refuse treatment, leading patients to death, hold delusional conferences on HIV treatment, undermine public confidence in scientific medicine, and, in the end, refuse to have a reasonable discussion of simple ethical and cultural problems that their practice causes, I think – yes, they are just idiots. Yes, I can't do anything about it, I'm human. Facts are sacred, but my perception is changing day by day.

My attitude to homeopathy depends, by and large, only on the homeopaths themselves.

However, this is not all…

"Scientific justification" of homeopathy.

Homeopathic medicines are prepared as follows: you take an active ingredient, such as arsenic, and dilute it until not a single molecule of the starting substance remains in the solution. The ingredients are selected according to the principle "like is treated like". For example, a substance that makes a person sweat in normal doses is suitable for combating sweating.

Many people confuse homeopathy with herbal medicine and do not realize how much homeopathic medicines are diluted. The typical degree of dilution is called 30C: this means that one drop of the starting substance was diluted in 100 drops of water 30 times consecutively. On the website of the Society of Homeopaths, in the section "what is homeopathy", you can read: "Potency 30C contains less than one part of the starting substance per million parts of water."

This is, to put it mildly, an inaccurate statement. The drug in the potency of 30C is a solution in the proportion of 1 to 100 to the 30th degree, or 1 to 10 to the 60th degree, which means one with sixty zeros, or – to be clear – a solution in the proportion of 1 to 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000.

In terms of the Society of Homeopaths, it will sound like this: "The potency of 30C contains less than one part of the starting substance per million million million million million million million million million parts of water."

In medicines in the homeopathic potency of 100C, which are sold everywhere (and claim that they act even more strongly than medicines in the potency of 30C), there are more water molecules per molecule of the active substance than there are atoms of matter in the universe at all. Homeopathy was invented before it became known what an atom was, or how many of them there were, or what size they were. And although we all know this now, the belief system of homeopaths has not changed at all.

How can an almost infinitely diluted substance cure anything?

Most homeopaths claim that water has a "memory". However, no one can clearly explain how this "memory" works, and experiments confirming the memory effect usually look strange, to put it mildly. James Randy, an American magician and exposer of miracles, announced many years ago that he would pay a million dollars to someone who would demonstrate paranormal abilities, namely, be able to reliably and accurately distinguish a homeopathic solution from ordinary water. The prize remains unclaimed.

Many homeopaths also believe that homeopathic medicines can be transmitted over the Internet, by phone, through a computer, as a CD recording, or with music. Peter Chapell, the one whose work will be presented at the conference of the Society of Homeopaths next month, sensationally declares that he can defeat the AIDS epidemic in Africa through a self-developed homeopathic medicine "PC Aids" and specially encoded music. To quote Chapell, "the AIDS situation in Africa can be improved very quickly if you start broadcasting a simple melody on the radio."

Portal "Eternal youth" www.vechnayamolodost.ru29.04.2008

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