How Do We Know What Treatment Works?

How Do We Know What Treatment Works? – National Pain Report

We’re often told that alternative medicine is unproven and pharmacological treatments are well validated. Is this true?

It’s important for patients to understand

  • the many factors that go into creating the body of medical evidence available,
  • the degree of reliability of that information, and
  • its applicability to their specific situation.

I used to believe that “evidence-based medicine” was a good idea. Then I began noticing how poorly designed and numerically manipulated so much of the research is. 

Recent studies on opioids are shamelessly biased: see Opioids Blamed for Consequences of Chronic Pain

I’ve included a brief discussion of research issues here to meet that need.

Evidence-Based Medicine

Since the early 1990s, there has been a push from many quarters for “evidence-based medicine” (EBM).

According to the British Medical Journal, “The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”

According to EBM, all research is not created equal.

The best evidence is considered to be meta-analyses of randomized clinical trials. A meta-analysis statistically pools results from many similar studies to draw conclusions about treatment effectiveness.

Second best, according to EBM, is evidence obtained from at least one randomized controlled clinical trial.

A randomized controlled trial is a study in which participants are assigned, by chance alone, to receive one of several interventions. One of these interventions is the comparison, or control. The control may be a standard treatment, a placebo (a sugar pill or fake treatment), or no intervention at all.

Double-blind randomized controlled studies are held in even higher regard.

In a double-blind study, no one—patient, researcher, or any other results evaluator—knows which participants received which treatment. This ensures that no biases or expectations will influence results.

Of course, double-blind studies are not possible when the treatment is anything more complicated than a pill, as practitioners administering the treatment must know what they’re doing.

Nonrandomized studies and observational studies are considered less conclusive.

Expert opinion is considered the lowest level of evidence for making treatment decisions

Yet the CDC guidelines were written almost exclusively by “expert opinion” (since there are so few studies on opioids for pain relief),  using only addiction specialists as “experts” even though the drug being evaluated is used for pain management.

Another “fatal flaw” of the EBM model is its restrictions on what is considered valid evidence:

In the EBM model,

  • the evidence that comes from thousands of years of use and observation by healers across many cultures, such as in the use of acupuncture or herbs, is not considered valid,
  • whereas results from a four- to eight-week study of a novel drug is given one of the highest rankings.

Flaws in the Research

EBM sounds good in theory, but its application to medical decision-making has left much to be desired.

A 2014 article in the Journal of Evaluation in Clinical Practice reported that EBM has failed to achieve its main objectives: to improve health care outcomes and reduce health care costs.

Summarizing critics’ concerns about EBM, authors Susanna Every-Palmer and Jeremy Howick wrote that one issue of major concern is that most studies available in medical literature are funded by parties that have a financial interest in the outcome, such as pharmaceutical companies.

These entities manipulate the outcome of the research by their choice of issues studied and by manipulating the study design to favor their desired results.

When the study still does not turn out as they had hoped, they fail to publish it and bury the results.

Howick and Every-Palmer concluded that relying indiscriminately on industry-funded studies to make clinical decisions is like trusting politicians to count their own votes.

Low-dose studies of natural treatments have also been funded by parties with an interest in discrediting competing treatments

Failure to disclose the risks of pharmaceuticals is another issue with published research conducted by the drug’s manufacturer

Another problem with the available body of evidence is that after research has been discredited, it is not retracted or labeled as fraudulent. The research studies remain available for the unwary to draw false conclusions regarding treatment safety and effectiveness.

The prevailing research models are not appropriate for many alternative therapies, such as acupuncture or homeopathy, in part because treatments are not the same for every patient who presents for treatment of a specific condition.

The choice of intervention is based on an assessment of the whole person, not just the presenting symptoms.

As a result, studies that give every patient with back pain, for instance, the same intervention are not valid measures of the effectiveness of these therapies.

Another related issue is the averaging of results in a study.

This is one of my main gripes: using averages to determine “standards” of medical care.

The problem is that there is no such thing as the “average patient”; the “average human” has one breast and one testicle, yet no individual human is configured that way. 

Averages ignore the proportion and distribution of the differences. Clearly, most humans either have 2 breasts or 2 testicles, yet by adding them all together to calculate the average we come up with humans having, on average, one of each.

In some cases, the gender may not matter, but we don’t know enough about the human body to determine which kind of averaging makes sense and which is meaningless.

What does or does not work for most people with a condition is not necessarily applicable to every individual in a study or in the overall population.

Patients are individuals with different characteristics and combinations of symptoms, which might have different causes.

Treatment decisions that don’t take individual differences into account are less likely to be effective and can cause harm.

Bias in Funding

Another significant problem in evaluating evidence is that there is an uneven playing field when it comes to funding for research.

Pharmaceutical companies, which can earn tens of billions of dollars in profit from patenting a single successful drug, can easily afford the hundreds of thousands of dollars it takes to conduct a drug study.

Adding to the problem is the limited government funding available for medical research, and the fact that this funding rarely goes to those who challenge either the prevailing paradigm or those with power and influence.

All recent studies on opioids are ridiculously biased: see Opioids Blamed for Consequences of Chronic Pain

What Can Patients Do?

Patients need to recognize that claims of pharmaceutical safety and effectiveness are often overblown and the benefits of alternative therapies are often minimized.

I’ve found that studies of alternative therapies are designed to be just as unrealistic and overblown as pharma-funded studies. 

Alternative therapies are much safer than pharmaceuticals and, if accessible and affordable, are worth trying first.

I believe this is true… but with caution, because alternative therapies are only harmless for the “average person”, not necessarily for those of us with non-normative physical traits.

The most obvious case is that of Yoga, which is being pushed by medical organizations.

My book, The Truth About Chronic Pain Treatments: The Best and Worst Strategies for Becoming Pain Free evaluates the evidence for a broad range of conventional and alternative treatments for chronic pain. My new online Alternative Pain Treatment Directory also provides information and resources for pain patients.

Cindy Perlin is a Licensed Clinical Social Worker, certified biofeedback provider and chronic pain survivor who lives and works in the Albany, NY area.

Original article: How Do We Know What Treatment Works?

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