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SAT0148 Fibromyalgia syndrome characterised by patient-reported sleep, fatigue, mood and quality of life
  1. AM Sesti1,
  2. AE Corbin1,
  3. C McLaughlin-Miley1,
  4. M Jaffe1,
  5. J Moore1,
  6. JP Young1,
  7. L LaMoreaux1,
  8. U Sharma1,
  9. M Versavel2
  1. 1Clinical, Pfizer, Ann Arbor, USA
  2. 2Clinical, Pfizer, Fresnes, France

Abstract

Background Fibromyalgia (FM) is a chronic condition of pain, tender points and multiple associated symptoms. A diagnosis is made by the ACR 1990 criteria requiring a history of widespread pain and pain in 11 of 18 tender points. Although pain is required for a diagnosis, the associated symptoms contribute to the syndromatic nature of the condition. This trial included measures of sleep, fatigue, mood, QoL and pain.

Methods 529 fibromyalgia patients per ACR criteria were assessed at baseline after discontinuing meds used for FM pain/insomnia (e.g. antidepressants, sedatives). The questionnaires were the Medical Outcomes Study Sleep Scale (MOS-SS), Multidimensional Assessment of Fatigue (MAF), Hospital Anxiety and Depression Scale (HADS) and SF-36. The MOS-SS has 12-items with an index score and 7 subscales: disturbance, snoring, awakening short of breath/headache (SOB/HA), adequacy, somnolence (range 0–100); quantity of sleep (reported hours); and, optimal sleep (% with 7–8 h). Higher scores on the MOS-SS indicate more of the measured domain. The MAF has 16 items and 1 global index score from items measuring severity, distress, impact on activities and frequency of fatigue (range 1–50). The HADS has 14-items for anxiety/depression ranging from 0–21. Higher MAF and HADS scores indicate greater impairment. The SF-36 has 8 subscales measuring general health status with higher scores indicating better health states.

Results Demographics and pain scores are reported in the companion abstract by Corbin, et al. 2001. Baseline MOS-SS were: overall problems (62.3), disturbance (62.5), snoring (36.9), SOB/HA (36.1), adequacy (19.7), somnolence (49.5), quantity (5.6), and 21.7% reported optimal sleep. The fatigue index was 38.9 and the HADS scores were mild with anxiety (10.1) and depression (8.6). SF-36 scores were physical function (40.5), role physical (15.2), bodily pain (27.6), general health (47.5), vitality (20.4), social functioning (48.8), role-emotional (46.0) and mental health (58.7).

Conclusion These data suggest that FM patients have impaired sleep and concomitant fatigue based on relatively high index scores. The predominant sleep problems were disrupted and inadequate sleep with a fair amount of somnolence. Patients reported low quality of life, particularly on domains of bodily pain, role physical, and vitality. Along with a high level of pain, impairments in sleep, fatigue and QoL were reported in this FM population.

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