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Fibromyalgia 207
agonist pramipexole (4.5 mg/day) significantly reduced pain (42% of sub-
jects achieving at least 50% pain reduction) and improved myriad quality-oflife
indices. 30
Acetaminophen (paracetamol; 2000–4000 mg/day) monotherapy is no
more effective than placebo. 25 In a double-blind crossover study comparing
acetaminophen with ondansetron (4 mg/day PO), the selective serotonin
blocker achieved significantly greater pain score reductions. 31
The benzodiazepines are also associated with mixed results in fibromyalgia
trials. Alprazolam (0.5–3.0 mg/day PO), either as monotherapy or in
combination with the NSAID ibuprofen (1600–2400 mg/day), was associated
with significant pain score reductions as assessed in a double-blind
placebo-controlled trial. 32 Dual therapy with the benzodiazepine-derivative
bromazepam (3 mg/day PO) plus the NSAID tenoxicam (20 mg/day
PO) was associated with no improvement over placebo in a trial of 164
patients. 33
Given the lack of inflammatory pathophysiology in fibromyalgia, it is not
surprising that no data support use of corticosteroids or NSAIDs in treating
fibromyalgia pain. Both prednisone (20 mg/day) and NSAIDs such as ibuprofen
(1600–2400 mg/day) and naproxen (1000 mg/day) were ineffective in
placebo-controlled studies of fibromyalgia pain. 34,35
Local anesthetics have shown mixed results in fibromyalgia trials. Lidocaine
(4% solution) administered as a topical sphenopalatine block achieved no
efficacy compared with placebo. 36 Investigators in an uncontrolled small trial
(n = 10) employing injection of tender points with lidocaine (0.5–1.0 mL of
0.5–1% solution) found clinically significant pain score reductions at the time
of injection and at 7 and 30 days afterwards. 37
The incomplete success of the preceding approaches has prompted investigation
of novel therapies for fibromyalgia pain. A small uncontrolled study
showed pain score reduction with SC gamma-hydroxybutyrate (2.25 g HS
and 4 h later). 38 Placebo-controlled double-blind trials of the biological
cofactor S-adenosylmethionine showed significant pain relief associated
with oral dosing (400–800 mg/day), but no benefit with IV dosing (400 mg/
day). 39,40 Neither malic acid nor calcitonin provide better pain relief than that
achieved with placebo. 41,42