Psychophysiologic Disorders and Controlled Research

Acceptance by the health care profession that Psychophysiologic Disorders (PPD) can be successfully diagnosed and treated will depend on completion of at least two randomized controlled trials (RCT).  The RCT is the gold standard method for documenting that a new form of treatment is superior to a placebo.  Only when a treatment passes this test and that passing is then confirmed by at least one additional RCT will clinicians consider making the effort to apply it to their patients.

Countless  forms of treatment with numerous supportive testimonials from patients have failed the RCT test.  In 2011 I wrote about Dr Edzard Ernst who published 160 papers showing a 95% failure rate of such treatments as acupuncture, chiropractic medicine, Reiki, herbal remedies, Ayurvedic medicine, homeopathy, reflexology and many others.

RCTs about PPD are beginning to appear.  In the first, in 2010 (1), a group from Michigan randomly divided forty-five women with fibromyalgia (FM) into two groups.  The first group received Affective Self-Awareness (ASA) treatment in three 2-hour sessions designed to uncover and reduce emotions linked to symptoms through written emotional disclosure and emotional awareness exercises.  The second group (the control or comparison group) was placed on a waiting list and received the treatment after conclusion of the study.

Six months after treatment, nearly half the patients treated with ASA had at least a 30% reduction in pain compared to no one achieving that level of improvement in the control (no treatment) group.  Self-reported physical function level also improved more in the ASA group than the control group.  The probability of these improvements happening just by chance was less than 1 in 1000.  This strongly suggests that the ASA was effective in reducing pain and improving function.

However, experienced researchers will point out that it could have been the extra six hours of personal attention that caused the improvement and not the ASA treatment itself.  To prove that the ASA was essential requires what is known as an active control group that receives six hours of, say, education about FM but without the ASA.  That way the amount of supportive professional contact is equal in both groups and ASA is the only difference.

A study that avoided this flaw, using cognitive behavioral therapy (CBT) instead of ASA, was published in 2013 (2).  In this study a group from Cincinnati studied 135 children aged 10-17 who suffered migraines at least 15 days per month.  They randomly assigned one group to medication plus CBT and the other group to the same medication plus headache education (HE).  Both groups had the same amount of contact with health care clinicians.  Twenty weeks later, the CBT group had a 55% reduction in days with migraine compared to a 32% drop in the HE group.  The probability of this difference being due to chance was 1 in 500, strongly implying that it was the CBT that accounted for the extra improvement.

Another study of FM using an active control group is nearing completion.  Several of the  researchers in the Michigan ASA study are involved and they have a multimillion dollar budget from the National Institute of Health.  I look forward to writing about their results soon.

1.  Michael C. Hsu, MD,1 Howard Schubiner, MD,2,3 Mark A. Lumley, PhD,3,4 John S. Stracks, MD,5 Daniel J. Clauw, MD,6,7,8 and David A. Williams, PhD.  Sustained Pain Reduction Through Affective Self-awareness in Fibromyalgia: A Randomized Controlled Trial.  J Gen Intern Med. 2010 Oct; 25(10): 1064–1070

2. Powers SW et al.  Cognitive Behavioral Therapy Plus Amitriptyline for Chronic Migraine in Children and Adolescents.  A Randomized Clinical Trial.  JAMA 310(24): 2622-2630. 2013.

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