To the Editor:
The American College of Rheumatology (ACR) 1990 criteria (1990 criteria) had been virtually the sole diagnostic criteria for fibromyalgia (FM) until the ACR preliminary diagnostic criteria for FM (2010 criteria)1 were reported. In 2011, a modification of the ACR preliminary diagnostic criteria for FM (2011 criteria)2 was reported. Because the 2011 criteria are confusing, they should be supplemented and revised.
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The abstract of an article that includes the 2011 criteria has the following diagnostic criteria: FM symptom scale/score ≥ 132. However, the appendix has the following diagnostic criteria: Widespread Pain Index ≥ 7 and Symptom Severity Score ≥ 5 or Widespread Pain Index between 3–6 and Symptom Severity Score ≥ 92. Which is correct? Or, do these different descriptions have a clear purpose?
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In the Materials and Methods2 the widespread pain questionnaire asks patients to indicate whether they have had pain or tenderness. However, the appendix notes the number of areas in which the patient has had pain2. Which is correct?
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I would like Dr. Wolfe, et al to show the specific areas that constitute the Widespread Pain Index.
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The appendix states that symptoms have been present at a similar level for at least 3 months2. Do symptoms mean pain (and/or tenderness)? Or do symptoms mean fatigue, waking unrefreshed, and cognitive symptoms?
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According to the article that includes the 2010 criteria the criteria are not meant to replace the ACR classification criteria, but to represent an alternative method of diagnosis1. The article that includes the 2011 criteria does not include this. Are the 2011 criteria meant to replace the 1990 criteria?
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The 1990 criteria state that the presence of a second clinical disorder does not exclude the diagnosis of FM (non-exclusionary regulation). The 2010 criteria1 and the 2011 criteria2 state that the patient does not have a disorder that would otherwise sufficiently explain the pain (exclusionary regulation). For the 2010 criteria, I have submitted that this exclusionary regulation should be eliminated and the 1990 criteria (presence of a second clinical disorder does not exclude the diagnosis of FM) should be reinstated3. According to Wolfe, et al, only if there is another disease present that could explain pain that would ordinarily be attributed to FM (as in metastatic cancer, described above) should the diagnosis of FM not be made3.
I think this reply refers to the 2011 criteria. The exclusionary regulation in the 2011 criteria should be eliminated and the non-exclusionary regulation in the 1990 criteria should be reinstated. My reasoning is as follows:
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Wolfe, et al replied that, for example, they would want to exclude from diagnosis of FM patients with multiple bone metastases and anemia or with extreme hyperparathyroidism, and such patients might have generalized pain and fatigue3. At the very least, diseases that exclude diagnosis of FM should be determined. The exclusionary regulation disrupts the diagnosis. It is very difficult for inexperienced physicians to diagnose FM.
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The concept of FM is not prevalent in some countries such as Japan. In Japan, many physicians think that pain without objective signs is psychogenic or somatoform disorder (somatization disorder or pain disorder), and FM does not exist. I am afraid that other countries are under the same conditions. Psychiatrists may diagnose patients with FM as having somatoform disorder. The exclusionary regulation of the 2011 criteria would assist medical theory in that the diagnosis of somatoform disorder excludes diagnosis of FM.
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The article that includes the 2011 criteria states as follows: complete self-administration would be possible2; however, the exclusionary regulation of the 2011 criteria requires a blood examination and a physician’s examination. If a blood examination is necessary to diagnose FM, epidemiological studies are very difficult. An epidemiological study by Dr. Wolfe, et al that used the 2010 criteria did not include a blood examination4. How did they apply the exclusionary regulation without a blood examination?
Given that the 1990 criteria are superior to the 2011 criteria for epidemiological studies, and that comparison between new information obtained with the 2011 criteria and accumulated information obtained with the 1990 criteria is difficult, overall, the 1990 criteria are superior to the 2011 criteria. The exclusionary regulation in the 2011 criteria should be eliminated.