Longer time to be sure there are no unexpected side effects
Use drugs according to symptoms
TCA useful for sleep AND pain
SSRI may help with energy
Can use combinations
What about the drugs really tested in fibromyalgia?
Works in 30-50% of patients to reduce symptoms about 30-50% in studies
In practice, works a bit better if used early and if no side effects
Dry eyes and mouth, rapid heart beat (do not use if heart disease), somnolence
A little less potent, but fewer side effects
Good place to start!
Doesn’t work very well (as a single agent) for pain
Can be used at lower doses for depressive symptoms
May need higher doses to improve pain
Same as above
What about the drugs really tested in fibromyalgia?
Balanced and potent serotonin and norepinephrine reuptake inhibitor
Approved for the treatment of major depressive disorder in adults and diabetic peripheral neuropathy
Duloxetine (DLX) also reduced painful physical symptoms associated with depression
DLX has been studied, but not approved, for the treatment of FM
Arnold LM et al. Arthritis Rheum. 2004;50:2974-2984. This information concerns a use that has not been approved by the US Food and Drug Administration.
BPI Average Pain Severity Mean Change from Baseline * P < .05 vs placebo. ** P < .01 vs placebo. *** P < .001 vs placebo. BPI = Brief Pain Inventory. Arnold LM et al. Arthritis Rheum. 2004;50:2974-2984; Wernicke JF et al. Presented at: 68th Annual Scientific Meeting of the American College of Rheumatology; October 16-21, 2004; San Antonio, Tex. This information concerns a use that has not been approved by the US Food and Drug Administration.
Treatment-Emergent Adverse Events Statistically Significant from Placebo * P < .05 vs placebo; *** P < .001 vs placebo. The treatment-emergent adverse events were generally mild to moderate in severity. Arnold LM et al. Arthritis Rheum. 2004;50:2974-2984. This information concerns a use that has not been approved by the US Food and Drug Administration.
Summary of Studies of TCA, SSRI, and SNRI for Treatment of FMS
Inhibition of both serotonin and norepinephrine gives optimal results
Moderate overall efficacy
For TCA, improvement may be attributed to the sedative effects
Low doses TCA useful, e.g. cyclobenzaprine 10-30 mg or amitriptyline 10-50 mg
Higher doses may be required for efficacy of SSRI and SNRI
No study identified predictors of response
Arnold LM et al. Psychosomatics. 2000;41:104-113. This information concerns a use that has not been approved by the US Food and Drug Administration.
Drugs that block neuronal excitability
Called “anticonvulsants,” but many other actions
Gabapentin/Neurontin and pregabalin/Lyrica
Pregabalin indicated for neuropathic pain
Diabetic peripheral neuropathy
Pregabalin effective for spinal cord injury and FMS
Pregabalin relieves generalized anxiety disorder, but not approved
Pregabalin indicated as add-on for epilepsy
Binds to 2 subunit of voltage-gated calcium channels of neurons
Reduces calcium influx at nerve terminals and therefore inhibits release of neurotransmitters
Glutamate, substance P
Crofford LJ et al. Arthritis Rheum. 2005;52:1264-1273. Pregabalin
Proportion of Responders
A significantly larger proportion of patients receiving pregabalin 450 mg/day experienced pain relief (defined by a ≥ 50% reduction in pain from baseline to endpoint) compared with those receiving placebo
*** P = .003 vs placebo. Crofford LJ et al. Arthritis Rheum. 2005;52:1264-1273. This information concerns a use that has not been approved by the US Food and Drug Administration.
Most Common Adverse Events 1
Withdrawal rate for dizziness in PGB 450-mg group: 3.8%
Withdrawal rate for somnolence in PGB 450-mg group: 2.3%
Don’t use drugs until you have optimized sleep hygiene
Generally prefer to use drugs that treat other symptoms in addition to sleep first
Most other sleep drugs can cause dependence and don’t necessary improve sleep quality
If you don’t use them all the time, they work more consistently when you really need them
Treat primary sleep disorders
Restless leg syndrome
Drugs for pain
Drugs used for “normal” pain (anti-inflammatory drugs, e.g. ibuprofen, naproxen) don’t work well for “central” pain
Narcotic drugs cause problems it is better to avoid
Changes in the spinal cord that actually worsen pain
If you feel you must use these drugs, know what your goal is …
Don’t treat to absence of pain
Treat to improved function
Able to work
Able to exercise
Complementary and alternative treatments (CAM) Research Widespread Use Research Widespread Use Conventional Medicine Bottom Up Complementary Medicine Top Down VS Yet Common Goals Management of symptoms (pain, fatigue, poor sleep etc.) Enhancement of cognitive and physical function
Why do people choose CAM?
Frustration: alternatives are often sought when there are no clearly effective conventional options.
Personal Choice: people often chose complementary therapies because they want to play an active role in their healing and because they prefer a “natural” approach
Be aware that most “natural” products are manufacture
CAM products are not regulated by the FDA
Unstudied Alternative Therapies
If it sounds too good to be true, it probably is … It doesn’t have to be true to say/write it
If it costs a lot … Beware of quackery
Use an “n-of-1” trial approach - and apply same standard to all treatments
Record how you feel before you start
Try it for a month and record how you feel
If you think you are better, stop it for 2 weeks
If you are better on drug and worse off drug, then if works for you!