Does EMPowerplus need randomized controlled and double blind studies to prove it works?

One of the demands EMPowerplus critics continue to put to us is the need for randomized controlled, double blind, placebo controlled studies. To many in the scientific world (particularly those analyzing quantitative data), those three elements are a holy grail of sorts.

The premise is that these trials eliminate bias: bias from the participant and bias from the researcher.

The problem with insisting on this type of research as being the only research that can produce reliable data is that, at least in Truehope’s case, it dismisses any validity of the 18 studies we already have on EMPowerplus and ignores the fact that no other broad spectrum formula has had as much research poured into it as EMPowerplus has.

We’re not opposed to randomized controlled trials. In fact, we just had one go to print last month. We’re not opposed to double blind or placebo-controlled studies. We actually have some under way. At Truehope, we believe that a variety of research is needed to ensure accurate representation of results.

Last year, researchers from the University of Calgary and the University of Colorado published a paper in the BMC Medical Research Methodology journal, raising questions about over-reliance on randomized controlled trials and pointing out an additional perspective for evaluating healthcare evidence.

In the paper, they outline several limitations of RCTs:

  1. They usually lack external validity
  2. They may increase health risks in the general population over the long term
  3. They are not the only form of evidence capable of providing an unbiased estimate of treatment effects
  4. They cannot tell clinicians everything they want to know
  5. Excessive expense leads to vulnerability in evidence quality

The researchers do not dismiss the need for RCTs. Actually, they believe such studies serve a useful purpose:

No other study design rivals the RCT’s ability to eliminate selection bias and reduce the risk of a serious imbalance in known and unknown factors that could influence outcomes (when the randomization procedure is executed properly).

That being said, they point out that such studies are implemented often after other interventions (such as case studies) and that they rarely are the major source of scientific discovery.

In fact, one could argue that most major discoveries in health have evolved from observations first documented in case reports and case series.

The research done on Truehope’s EMPowerplus formula includes case-control designs, case studies using with-subject crossover designs, open-label case series, case reports with extensive historical treatment information, large database analyses, and randomized controlled trials. We have placebo-controlled and double blind studies underway, and we hope some of them will be published shortly.

We’re not going to conduct RCT or DBPC studies just because EMPowerplus critics won’t believe us unless we do. (Actually, they likely will find other ways to try discrediting us once we do.) We do these studies because the other work the 34 independent researchers at 13 universities around the world have poured into EMPowerplus is promising and corroborating, and those types of studies seem like the next most logical step.

We know Truehope EMPowerplus works. We have seen it change the lives of tens of thousands of people. And we’ll prove it to you. But in the proper order and in the proper time.