Why is this? What is so special about the double-blind, placebo-controlled test? To find the answer, we need to look at the different ways that treatments can be tested and what the pitfalls are.

Open testing.

In historical terms this was the earliest method used. The idea is to simply test a remedy on patients and see if they get better. A good example is that of using vitamin C (in the form of oranges and lemons) to treat scurvy. Many treatments had been tried, but they all failed until fresh fruit was used (see: James Lind’s treatise of the scurvy). However, this is a case of what is called a high effect size treatment, which means that the effect is so large that it is outside the range of normal variation and simple observation confirms the treatment’s effectiveness.

Unfortunately this is not the case for most treatments. Many treatments have a small effect and the subjective views of the researcher can overlap with the subjective views of the patient. This can lead to error.

Confounding factors.

Confounding factors are variables which can lead to false conclusions in studies by showing associations where there are none and vice versa. Confounding factors include:

• Placebo effects.
  
  This is where a perceived improvement is felt by the patient due to expectations and beliefs. (see: placebo effect). The patient cannot tell the difference between the placebo effect and improvement due to treatment: the improvement feels the same.
  
  
• Reinterpretation.
  
  Having been given a treatment, a patient will often report a reduction in symptoms or an improvement in their condition. Someone given a treatment to reduce itching, for example, may report that their itching has indeed reduced; yet if they are monitored, it can be shown that they are scratching just as frequently as before. Reinterpretation is a form of placebo effect.
  
  
• Observer bias.
  
  This is similar to reinterpretation except it is the doctor/researcher who commits the fallacy. If the researcher believes the treatment to be beneficial, they may well interpret results to match their expectations. Although a researcher should be impartial, this does indeed happen.
  
  
• Self-limiting illness.
  
  Many illnesses are fought off naturally by the body. A useless treatment given during the course of an illness could mistakenly be attributed as curing a disease that would have healed naturally.
  
  
• The regressive fallacy.
  
  This is similar to self-limiting illnesses, only it applies to chronic conditions. A treatment given whilst a condition is at its worst, a flare up, will see an improvement whether the treatment works or not as the condition, being at its worst, can only get better. (see: The Regressive Fallacy).
  
  
• The Hawthorne effect.
  
  This effect was first noticed in the workplace (see: The Hawthorne Effect). It is where staff will perform better if some attention is paid to them. Just taking an interest can improve their productivity for example.This effect shows up in medical trials too. A patient who has been chosen to take part in a trial and is monitored will behave better than they would normally. e.g. a diabetic who is given a new pill to try may eat better and take more exercise simply because they are on the trial; any improvement shown could be due to the altered behaviour rather than the treatment.

Confounding factors were not all discovered at the same time, but as they were realised, they had to be eliminated.

The open trial.

In these trials both the researcher and the patient know the details of the test. These trials are open to all of the biases and are not shielded from placebo effects. Open trials are still used today; however, they are restricted to procedures where there is no alternative, such as surgery.

The placebo comparison.

As placebo effects can make treatments appear successful, it was realised that the treatment under investigation would have to be compared to something known not to work: the placebo control. A treatment cannot be considered effective unless it is compared to a placebo (or at least something else that has previously been tested against placebo or is a proven high-effect sized treatment).

A placebo control, however, is of little value if the patient knows that they are taking a placebo.

The single-blind trial.

Researchers adopted the method of blinding their subjects as to whether they were receiving the treatment under review or the placebo control. The idea was to remove any bias the patient may have regarding their treatment. If the treatment was effective, the benefit should show up clearly in the treated group compared to the control group.

It was also realised that not only could patients have a bias; so could the researchers. Observer bias could lead researchers to the results that they were expecting to find.

There was also the problem that the researchers, through their unintentional bias, could influence patients by unconscious signalling, the Clever Hans effect, or by simply treating those they knew had received the treatment in a different manner to those who had not.

The double-blind trial.

In the double-blind trial neither the patient nor the researchers administering the treatment know who is being treated and who is in the placebo control group. Patients are randomly assigned to one of the groups independently of the researchers, and the actual treatment they receive is coded so that no one knows whether it is real or placebo. This ensures that all possible biases that could be introduced to the trial by the researchers or the patients are eliminated.

Only after the trial, and once all data has been gathered are the results decoded and analysed. If the treated group shows significantly better results than the placebo control group, then the treatment has passed the trial.

This is not the end, however. One trial is not enough as it could be an anomaly, or a poorly designed or controlled trial, so the test needs to be repeated again independently. If the results are repeated in subsequent high-quality trials, the treatment is deemed to be effective.

Conclusion.

As with all tests, it is important to ensure that the results can only be produced by that which is under consideration: all potential biases and complications need to be eliminated or reduced to a minimum.

The randomised, placebo-controlled, double-blind trial is the way in which this is achieved in modern, evidence-based medicine.

John Jackson © UK-Skeptics

When looked at logically, alternative remedies make no sense. Why then are so many people placing their faith in these treatments that, essentially, do nothing?

What type of people are attracted to alternative medicine?

The first, and most obvious, answer that critics come up with is that those who use alternative remedies do so because they are stupid and gullible. This, however, is wrong.

The tendency is that people are more likely to use alternative treatments the more educated they are. The level of education a person has attained is probably the the best indicator that a person is likely to use some form of alternative treatment. This apparent paradox may be explained by the fact that more educated people are more likely to be interested in and read up on things that they are exposed to, they are more likely to question the perceived authority of conventional medical practitioners, and if they have an illness, be more likely to learn about it and consider other forms of treatment for it. Of course, educated people are likely to have more money to spend on alternative medicine too.

Being intelligent or well educated does not mean that a person is going to think more logically; in fact, it often results in them becoming better at defending and justifying their irrational beliefs.

There is not a single answer to who will use alternative remedies but there are some generalised groups of people who will use it based on perceptions of their health or their world view:

1. Those in poor general health.
   
   Someone in poorer than average health has obviously had less success in dealing with it than someone in good general health. This could be the reason why they are more likely to try all kinds of remedies in the hope that they will find one that will work for them.
   
   It is known that many people who use alternative remedies consider their health to be poorer than average. Many chronic (long term) conditions do not respond well to conventional treatments and this can lead to disillusionment in the sufferer, who may, understandably, seek out alternatives.
   
   
2. Somatizers.
   
   A somatizer is someone who experiences or reports physical symptoms yet there is no actual physical cause for their symptoms (this was originally called psychosomatic illness). Somatizers are often regarded as malingerers, and dismissed as such, which can leave them frustrated. They therefore turn, or may even be encouraged to turn by their doctor, to alternative remedies.
   
   Somatizers’ symptoms are thought to have psychological causes but people with such conditions strongly reject any psychological diagnosis, explanation or treatment; insisting that their symptoms are due to a physiological condition. It is this unwillingness to even consider any psychological explanation for their illness that is the reason why somatizers’ psychological problems are so difficult to treat with conventional medicine.
   
   Often, these people are after some sympathy, reassurance, and recognition; the emotional comfort of someone caring and taking them seriously. Alternative practitioners are very patient-focused, so they cater for this need better than conventional doctors do; however, the patient’s underlying cause is never addressed.

There are two aspects to giving treatments: the remedy and the doctor/patient relationship. Conventional medicine is strong on effective remedies but a consultation may be very short and the doctor may spend more time looking at a computer screen than at the patient.

Alternative remedies on the other hand, offer little or nothing in the way of effective treatments, but a good practitioner will spend a lot of time focusing on the patient. People who have conditions which are not being successfully treated or which are psychosomatic are more likely to be attracted to the alternative practitioner who offers a patient-centred, sympathetic approach.

1. Cultural beliefs and influences.
   
   Many new-age and eastern spiritual beliefs are based on an ideology called “pantheism”. This is a world view where God does not exist as taught by the monotheistic religions, the concept is a one of God being the spiritual essence or life force of the universe rather than being a separate entity and its creator. Chi, Prana, Innate Intelligence, Mana, and Vital Energy are all examples of this proposed, but never detected, life force.
   
   This is where the spirit-mind-body concept and the belief in a holistic approach to treatments originate. Reinforced by advertisers’ hyperbole, a large proportion of people have been led to believe that everything deemed natural, green, herbal, organic, or ‘in harmony with nature’ is somehow better than manufactured or scientific alternatives. This concept is based on the Naturalistic Fallacy: the false notion that there’s inherent good in nature.
   
   Alternative medicine is congruent with this world view. Those who see themselves as spiritual, environmentally friendly, in touch with nature etc. are the largest group of alternative medicine users.
   
   
2. Uncritical believers.
   
   Most people believe that conventional medicine works because that is what they have been told. They are not inquisitive and do not worry about how or why orthodox medicine works, as long as it does. They place trust in their doctor and the system of medicine they practise.
   
   The same is true for alternative medicine. People who use it, believe it works. They are not interested in the theory of how alternative remedies are meant to work or whether they have passed clinical trials; they place trust in the practitioners and the system in which they practise.
   
   It is unlikely that people would use something if they did not believe it worked. The belief in medicine, whether conventional or alternative, is usually formed with the same unquestioning attitude.

Some reasons that people seek out alternative remedies:

1. They are unhappy with, or distrustful of, conventional medicine.
   
   Unfortunately, conventional medicine is not perfect; people do have bad experiences with it. This can lead people to distrust conventional medicine and sometimes shun it. This is only true of a small proportion of people, but the big danger for them is that they are more likely to use alternative remedies as their primary source of healthcare. These people often decide to take full control of their own, and possibly also their family’s, health. The consequences of this may be damaging, even fatal.
   
   
2. Alternative remedies give them more personal control of their situation.
   
   People in poor health and those who have chronic conditions often like taking charge of their own health. Using alternative treatments gives them this autonomy. However, they do not shun conventional medicine; they are more likely to use alternative remedies in conjunction with conventional medicine.
   
   
3. The idea of alternative medicine closely matches their culture or belief system.
   
   Alternative treatments are appealing to those who hold new-age ideas and philosophies. Treatments are claimed to be holistic, and healing is the result of achieving spiritual harmony.
   
   There are probably not many people who would claim to be pantheistic new-agers; however, the advertising industry has embraced these philosophies and coupled them with a distorted view of the natural world to create the illusion that everything that is ‘natural’ and ‘in harmony with nature’ is somehow better for us.
   
   This has resulted in a substantial subculture, or market sector, of people who believe in the spirit-mind-body concept. Therefore, words like: holistic; natural; herbal; organic; etc. appeal to them.

Conclusion.

People use alternative medicines because they accept the claims made for them at face value and believe that they work; the concept of alternative medicine matches their (often spiritual) world-view; or those in poor health are looking in hope for something that works for their condition.

Alternative remedies may not be capable of passing a clinical trial, or even of actually curing anything, but they do fulfil a need in many people. Fulfilling emotional needs and curing illnesses are two different aspects of treatment.

The big problem, of course, is that because alternative remedies do little or nothing with regard to curing illness, there is an inherent, major assumption (made clear by the lack of government regulation) that people who use alternative remedies will know when conventional treatment is needed in the case of serious illness: sadly, this is not always the case.