Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)

Inclusion Criteria: * Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1 levels included in a rehabilitation and psychological program and stable under standard intensive treatment for at least 6 months. * All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level \<250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and body surface according to laboratory reference value). * Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ \> 75. * The study was conducted in accordance with the Declaration of Helsinki and received the local institutional review board and Spanish Drug Agency (nº03-0456) approvals. All patients gave written informed consent prior to their inclusion in the study. Exclusion Criteria: * Disabling physical or mental status * Previous or current malignancies, either active or inactive * Intracranial space occupying lesion * Any relevant endocrine disorder including diabetes mellitus * History of another pituitary disorder * Previous treatment with growth hormone * Other systemic or joint inflammatory rheumatic conditions; and * Known to be hypersensitive to somatropin or any of the excipients. * Pregnant women, nursing mothers, or women with childbearing potential not using adequate contraceptive methods were also excluded.