The aim of this three-armed, parallel, randomized exploratory study was to determine, if two types of acupuncture (auricular acupuncture [AA] and traditional Chinese acupuncture [TCA]) were feasible and more effective than usual care (UC) alone for TBI–related headache. The subjects were previously deployed Service members (18–69 years old) with mild-to-moderate TBI and headaches. The interventions explored were UC alone or with the addition of AA or TCA. The primary outcome was the Headache Impact Test (HIT). Secondary outcomes were the Numerical Rating Scale (NRS), Pittsburgh Sleep Quality Index, Post-Traumatic Stress Checklist, Symptom Checklist-90-R, Medical Outcome Study Quality of Life (QoL), Beck Depression Inventory, State-Trait Anxiety Inventory, the Automated Neuropsychological Assessment Metrics, and expectancy of outcome and acupuncture efficacy.
Mean HIT scores decreased in the AA and TCA groups but increased slightly in the UC-only group from baseline to week 6 [AA, −10.2% (−6.4 points); TCA, −4.6% (−2.9 points); UC, +0.8% (+0.6 points)]. Both acupuncture groups had sizable decreases in NRS (Pain Best), compared to UC (TCA versus UC: P = 0.0008, d = 1.70; AA versus UC: P = 0.0127, d = 1.6). No statistically significant results were found for any other secondary outcome measures.
The authors concluded that both AA and TCA improved headache-related QoL more than UC did in Service members with TBI.
The stated aim of this study (to determine whether AA or TCA both with UC are more effective than UC alone) does not make sense and should therefore never have passed ethics review, in my view. The RCT followed a design which essentially is the much-lamented ‘A+B versus B’ protocol (except that a further groups ‘C+B’ was added). The nature of such designs is that there is no control for placebo effects, the extra time and attention, etc. Therefore, such studies cannot fail but generate positive results, even if the tested intervention is a placebo. In such trials, it is impossible to attribute any outcome to the experimental treatment. This means that the positive results are known before the first patient has been enrolled; hence they are an unethical waste of resources which can only serve one purpose: to mislead us. It also means that the conclusions drawn above are not correct.
An alternative and in my view more accurate conclusion would be this one: both AA and TCA had probably no effect; the improved headache-related QoL was due to the additional attention and expectation in the two experimental groups and is unrelated to the interventions tested in this study.
In our new book, MORE HARM THAN GOOD, we discuss that such trials are deceptive to the point of being unethical. Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.