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Table 1 Medical and psychiatric history in patients entering the open-label period of the randomized withdrawal study

From: Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program

  Patients
N = 116
Fibromyalgia diagnosis, n (%)  
Yunus and Masi criteria only 19 (16.4)
1990 ACR criteria only 1 (0.9)
Both criteria 96 (82.8)
Psychiatric disorders or symptoms, n (%)a  
Insomnia 20 (17.2)
Depression 19 (16.4)
Anxiety 11 (9.5)
Attention deficit/hyperactivity disorder 8 (6.9)
Sleep disorder 5 (4.3)
Lifetime suicidality, n (%)  
Suicidal ideation 24 (20.7)
Suicidal behavior 4 (3.4)
Pain disorders or symptoms, n (%)a  
Headache 40 (34.5)
Migraine 26 (22.4)
Gastroesophageal reflux disease 17 (14.7)
Back pain 14 (12.1)
Dysmenorrhea 14 (12.1)
Irritable bowel syndrome 8 (6.9)
Arthralgia 7 (6.0)
Fatigue 6 (5.2)
Restless leg syndrome 5 (4.3)
Abdominal pain 4 (3.4)
Hypermobility syndrome 4 (3.4)
Abdominal pain upper 3 (2.6)
Myalgiab 3 (2.6)
Raynaud’s phenomenon 3 (2.6)
Temporomandibular joint syndrome 3 (2.6)
Other medical symptoms or conditions, n (%)c  
Asthma 27 (23.3)
Drug hypersensitivity 21 (18.1)
Seasonal allergy 19 (16.4)
Tonsillectomy 18 (15.5)
  1. aIncludes MedDRA preferred terms related to symptoms or disorders that have been associated with fibromyalgia. Additional terms of potential interest that were reported in 1 patient each: bipolar disorder, carpal tunnel syndrome, chronic fatigue syndrome, dysthymic disorder, juvenile arthritis, major depression, obsessive-compulsive disorder, osteoarthritis, osteochondrosis, panic attack, post-traumatic stress disorder, psychotic disorder, seasonal affective disorder, social phobia, spinal osteoarthritis, tendonitis, tic; scoliosis was reported in 5 patients
  2. bDoes not include symptoms that would be classified under the MedDRA preferred term of “fibromyalgia”
  3. cIncludes all other MedDRA preferred terms that were reported in ≥10 % of the open-label population
  4. ACR = American College of Rheumatology