By Daniel Benor, MD

Conventional medicine has asserted that the gold standard for research is the randomized, double blinded controlled study. Without such studies, and preferably ones with large numbers of ‘subjects,’ they claim that there is insufficient evidence to accept the efficacy of a treatment.

Conventional medicine largely relies on medications for treatments of most problems. They offer a standard ‘shoe’ (drug) that is available in different sizes (doses). For side effects, they offer other standard ‘over-shoes’ or ‘in-soles’ (other drugs) to counteract the problems created by the shoe that didn’t quite fit that person in the first place.

Conventional medicine and the pharmaceutical companies generally test how their shoes fit and how people get along with them in a modest number of people, over a period of 3-6 months. If these people find that the shoes fit reasonably well, the doctors and pharma then put the shoes out for everyone to use. Over a period of 10 years, about half of the shoes have to be withdrawn because it turns out that they cause corns or bunions or more serious problems, and even death. So we, the public who are sold these shoes with great claims for how they’ll help us walk better through life, end up becoming the experimental group for long-term benefits or dangers. This is one of the principal reasons that conventional medicine is now the third leading cause of death (after cancer and cardiac problems).

Not everyone likes the standard, store-bought shoes of one manufacturer. The nice thing about shoes is that if you don’t like the shoes in one store, you can find hundreds of different models in other stores.

Not so with pharmaceuticals. If you’re lucky, as with antibiotic shoes, when one doesn’t fit, there may be a limited number of others that do. But your choices are increasingly restricted by growing microbial resistance.

This is an idealized assessment of the conventional, standardized research protocol. We are finding increasingly that drug research may be unreliable in 30-40% of so-called scientific reports. Drug companies and many doctors paid by these companies will distort the results, the analyses of the results and the conclusions derived from the studies in order to make the drugs appear to be more effective than they are.

In my opinion, the reliance on drug therapies as the primary approach to dealing with medical problems is probably not the best choice.

Conventional medicine assumes that it is going to cure problems by addressing the foot the shoe is worn on. The medical shoe salesmen called doctors are trained primarily in selling the shoe that they – with an educated guess – believe will fit the foot presented to them.

Few doctors have training in recognizing other factors that might affect the person wearing the shoe, such as the posture, gait, diet, weight, allergies to materials in the shoes, behavioral habits, attitudes and aesthetic preferences of the wearer of the shoes, relationships of the wearer with others in their family or community, interactive effects of wearing several different in-soles, overshoes, and so on. All of these could influence how the shoe and the foot and the wearer get along with each other.

There are numerous other purveyors of completely different types of footwear, as well as those who teach how to strengthen muscles, increase flexibility, enhance balance, and to choose smoother terrain an avoid rough roads in order to walk a happier path in life. Others teach how to release old habits that were acquired through having had to journey through difficult terrains.

Energy Psychology (EP) is one of these alternative options, distributed under the broad umbrella of Complementary and Alternative Medicine (CAM), and showcased through the Association for Comprehensive Energy Psychology ( ACEP ). Transformative Wholistic Reintegration ( TWR , a rebranding of WHEE ) is one of the EP variants. In using TWR you alternate stimulating the left and right sides of your body while focusing your mind on emotions, thoughts and physical conditions that are troublesome in your life. A favorite method of many is to alternate tapping their feet on the floor, or alternating tightening their toes inside their right and left shoes. One can also use the alternating stimuli of walking or riding a stationary bicycle.

CAM approaches are helpful because:

That is the good news. The challenging news is that the high degrees of individualizing of the CAM tools makes it difficult to do randomized controlled studies. Such studies require standardized interventions for all of the study participants in the treatment groups. This is a serious problem. If you standardize the treatments, you are not really giving people the best chance for benefiting from the interventions. If you individualize the treatments, you are not adhering to the standardized protocol of the double blinded, controlled study.

Controlled studies are also very costly. Drug companies have enormous revenues and can afford these expenses. CAM practitioners have no such resources and are at a tremendous disadvantages on this playing field, particularly when cheating is widely practiced in the competitive sport of getting the public to buy into the use of conventional therapies.

I believe observational studies are a helpful intermediary research alternative. These are studies of series of people with the same sorts of problems, treated individually with the same CAM modalities. This is, in fact, the way that CAM approaches such as acupuncture (and its derivatives of Shiatsu, Reflexology, and related therapies), Ayurveda, homeopathy, and other treatments were developed through the ages.

Critics will say that such studies are unreliable, because:

There was no comparison/ control group. The concurrent control group is touted as the best, most neutral comparison group because it eliminates extraneous factors that might create differences between treatment. This is a highly fraught argument, because there is no way to know that the people in the control group did not differ significantly in many and varied respects in comparison with the people in the treatment group.

This last issue (3) is the most serious problem I see with concurrent control groups. It is absolutely inevitable that here must be countless unknown extraneous factors between concurrent control groups and treatment groups. The simultaneous, separate control and treatment groups are supposed to eliminate such differences between the treatment(s) being evaluated – because it is statistically probable that all the possible extraneous factors will be randomly distributed in and between each group and therefore will be less likely to bias the responses of either group. This is a problematic argument. The opposite may, in fact, be the case. When you have different people in simultaneous control and treatment groups, you have people living different lives, under different conditions, so there are actually far more extraneous factors that are likely to be present between the groups.

The best control group, in my opinion, is the self-control group, where each individual is observed for a period of time and given standardized tests at the start and end of that time period, and then given the treatment(s), with a repeat of the testing. This way we have each person as his or her own control – which eliminates enormous varieties of differences between groups.

Self-control groups are also far less expensive. This would go a long way towards leveling the research playing field between the mega-rich drug companies and medical establishment and the CAM practitioners.

A helpful step in the direction of self-controlled studies are observational studies. These are collections of reports of treatments of groups of individuals under standardized procedures but individualized routines for application of the procedures. Thus, for instance, in a study of homeopathic treatments for a particular type of pain the protocol might include:

Informal observational studies are in fact the way that most established treatments have come into use over the centuries. Acupuncture, Ayurveda, Tibetan Medicine, Native American Medicine, Shamanism and other traditional systems of treatment grew out of trial and error over centuries of explorations of what worked and what didn’t.

Most of the traditional medical systems are also much broader in their theoretical frameworks than conventional medicine. Traditional medicine almost always acknowledges that:

Conventional medicine is focused almost exclusively on the body, occasionally acknowledging psychological and social aspects of a disease but not investing much focus on anything beyond the body.

Within the broader frameworks of traditional medical systems, observational studies offer much more broad and flexible frameworks for assessing the causes of diseases, their treatments and the cures of the individuals suffering the problems.

There is no guarantee, of course, that the initial, control period of observation and assessment will be unbiased – relative to the following period of treatment. However, if the subjects for the study are chosen with histories of long-standing problems, and their control period data do not demonstrate a difference in assessments from their history or from their initial control period assessment, there is a reasonable expectation that the control period represents a valid comparison for the subsequent treatment period.

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