Issue link: https://www.massageandbodyworkdigital.com/i/1208028
50 m a s s a g e & b o d y w o r k m a r c h / a p r i l 2 0 2 0 Evolution of RCTs Basic forms of randomized controlled testing (of different variables) have been reported from the time of Hippocrates and the ancient Persians. The RCT as we know it today developed through an impressive instance of cross-border transfer of knowledge via psychology investigations evolving in the mid- to late 19th century—when psychology was still in its infancy—across three different countries. Additional statistical testing was developed in the 1930s, and the notion of placebo in the 1950s. The standardization of the RCT and its use in modern medical experimentation only became a requirement for drug approval by the FDA in 1980. 13 At its simplest, the RCT model breaks down into the following: • Researchers divide the participants into a minimum of two groups. One will receive the treatment being tested, and one will not. The one that receives no treatment is known as the control group. • The participants do not know which group they are in (single-blinding), nor do the researchers in direct contact with them (double-blinding). • To avoid the participants in the control group from suspecting anything, they are often given a harmless "false" or sham treatment, known as a placebo. This is to avoid psychological factors affecting the results. Properly conducted, the RCT is considered the gold standard for scientific research, and must be conducted before a drug, for example, can be approved by the FDA. The higher the quality of an RCT (that provides supporting evidence for a given therapy), the more likely it is to be met with approval by the medical establishment. In establishing these domains, the authors point out that "Because of the prominence of the biomedical and reductionist models of medical research in our society, there is a strong tendency for people to honor research in Domains 3 and 4 over research in Domains 1 and 2." Quantitative laboratory research tends to be considered more important and is usually better funded, and few realize that one needs a deeper understanding of several areas in Domains 1 and 2 before being able to successfully ask questions in the other domains. The reason for this is that the first two domains essentially define and identify the character of the field under investigation, establishing the key players and areas where inquiry is needed. It's like looking at a full map of a city before zooming in to see the individual neighborhood and street you are trying to reach. You need to orient yourself before becoming too specific, or the danger is that you will miss the mark. BEWARE OF CONFIRMATION BIAS There's definite irony in the following statement by Lind: "The mischief done by an attachment to delusive theories and false hypothesis is an affecting truth . . . It is indeed not probable, that a remedy for the scurvy will ever be discovered, from a preconceived hypothesis; or by speculative men in the closet, who never saw the disease, or who have seen, at most, only a few cases of it." 10 Even though he stumbled on the cure for scurvy, Lind was so focused on his own false hypothesis of its cause, thinking scurvy was due to digestive and excretory dysfunction rather than nutrition, that he missed his findings altogether. In modern terms, this is known as confirmation bias. Lind was right, however, in noting that those who speculate with no, or little, clinical experience are unlikely to ask the right questions. Confirmation bias is as important now as it was in Lind's day. If we are not asking the right questions, and indeed, if we do not know precisely why we are asking them, then it doesn't matter how much research we have with the words massage therapy in the title, because it ultimately offers little to the profession itself. That is why it is essential for practitioners to participate actively in the building and appraisal of the research base—in all professions. And, although many inroads have been made since this agenda was published two decades ago (thanks to the dedicated work of leaders in this field), a quick survey of the available research literature confirms that the overwhelming majority of studies involving "massage" all fall within Domains 3 and 4, which are mostly supportive of the effects of massage