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|A combination of 6 months of treatment with pyridostigmine and triweekly exercise fails to improve insulin-like growth factor-I levels in fibromyalgia, despite improvement in the acute growth hormone response to exercise|
|Jones KD, Deodhar AA, Burckhardt CS, Perrin NA, Hanson GC, Bennett RM|
|The Journal of Rheumatology 2007 May;34(5):1103-1111|
|5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*|
OBJECTIVE: People with fibromyalgia (FM) often have low insulin-like growth factor-I (IGF-I) levels and a suboptimal growth hormone (GH) response to acute exercise. As previous work had demonstrated a normalization of the acute GH response to exercise with the use of pyridostigmine (PYD), we tested the hypothesis that 6 months of PYD therapy plus supervised exercise would increase IGF-I levels. METHODS: Subjects with primary FM were randomized into 4 groups: (1) PYD/exercise; (2) PYD/diet recall; (3) placebo/exercise; and (4) placebo/diet recall. The dosing of PYD was 60 mg tid for 6 months. Resting IGF-I levels were measured at baseline and after 6 months of treatment. In addition the acute GH response to exercise at VO2max was measured at baseline and after treatment. RESULTS: A total of 165 FM subjects (mean age 49.5 yrs, 5 male) were entered and 154 (93.3%) completed the study. Six months of therapy (PYD plus exercise or exercise alone) failed to improve the IGF-I levels. The use of PYD 1 hour prior to exercise improved the acute GH response (4.54 ng/dl) compared to placebo (1.74 ng/dl) (p = 0.001) at the end of the 6-month trial. The acute GH response to exercise at baseline did not correlate with IGF-I, age, depression, medications, estrogen status, or obesity. CONCLUSION: A combination of triweekly supervised exercise plus the daily use of PYD for 6 months failed to increase IGF-I levels in patients with FM, despite the confirmation that PYD normalizes the acute GH response to strenuous aerobic exercise.