This abstract is merely an update of a previous PubMed Health Drug Class Review from 2011. The older review is available in full and still has valuable information.
An update on pharmacotherapy for the treatment of fibromyalgia. – PubMed – NCBI | Expert Opin Pharmacother. 2015 Jun;
EXPERT OPINION: Different drugs are recommended for the treatment of fibromyalgia by different published guidelines, although only three of them have been approved for this indication by the US FDA, and none have been approved by the European Medicines Agency.
According to the available evidence, pregabalin, duloxetine and milnacipran should be the drugs of choice for the treatment of this disease, followed by amitriptyline and cyclobenzaprine.
Other drugs with at least one positive clinical trial include some selective serotonin reuptake inhibitors, moclobemide, pirlindole, gabapentin, tramadol, tropisetron, sodium oxybate and nabilone.
None of the currently available drugs are fully effective against the whole spectrum of fibromyalgia symptoms, namely pain, fatigue, sleep disturbances and depression, among the most relevant symptoms.
Combination therapy is an option that needs to be more thoroughly investigated in clinical trials.
List of drugs reviewed in 2011 (left) versus 2015 (right):
The 2015 dropped four drugs from the older review (in red), while adding six (in blue). (results by meregely.com)
This online “book” from PubMed goes into great detail about how patients responded to various medications. The embedded links point to more information from PubMed.
We compared the effectiveness and harms of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, noradrenergic and specific serotonergic reuptake inhibitor, norepinephrine and dopamine reuptake inhibitor, serotonin receptor antagonist, antiepileptic drugs, and skeletal muscle relaxants in adults with fibromyalgia.
We searched Ovid MEDLINE®, the Cochrane Database of Systematic Reviews®, and the Cochrane Central Register of Controlled Trials® and Database of Abstracts of Reviews of Effects through October 2010. For additional data we also hand searched reference lists, US Food and Drug Administration medical and statistical reviews and dossiers submitted by pharmaceutical companies.
Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to standard Drug Effectiveness Review Project review methods.
Results and Conclusions:
We found no eligible studies with the other included drugs and no eligible studies of included interventions when used as adjunctive therapy.
Head-to-head trials were few, and provided low-strength evidence that short-term treatment with immediate-release paroxetine is superior to amitriptyline in reducing pain and sleep disturbance and provided low-strength evidence there are no significant differences between amitriptyline as compared with cyclobenzaprine and nortriptyline.
Although there were some significant differences between drugs in overall adverse events, they did not produce any differences in withdrawals due to adverse events.
Additionally, based on indirect comparison meta-analysis, we found low evidence that duloxetine was superior to milnacipran on outcomes of pain, sleep disturbance, depressed mood, and health-related quality of life.
We found low evidence that both duloxetine and milnacipran were superior to pregabalin on improvement in depressed mood, whereas pregabalin was superior to milnacipran on improvement in sleep disturbance.
Amitriptyline was similar to duloxetine, milnacipran, and pregabalin on outcomes of pain and fatigue, with insufficient data on the other outcomes.
Although there were some significant differences between duloxetine, milnacipran, and pregabalin in specific adverse events, they did not produce any differences in overall withdrawals, overall adverse events, and withdrawals due to adverse events.
For the remaining drugs, there was only evidence of significant improvements in pain over placebo in 1 trial for gabapentin, in 1 of 3 trials for cyclobenzaprine, and in 1 trial of fluoxetine. But, no conclusions can be drawn about comparative effectiveness or harms among these drugs because the numbers of trials/patients in placebo-controlled trials were too few to provide meaningful results in indirect comparisons.
Duloxetine was not effective on pain reduction in male, nonwhite, and older patients based on a small sample size that was underpowered to detect a difference.
Compared with placebo, duloxetine, fluoxetine, controlled-release paroxetine, and pregabalin significantly improved fibromyalgia symptoms regardless of baseline depression but milnacipran was only effective in nondepressed patients.
Controlled -release paroxetine and pregabalin significantly improved fibromyalgia symptoms regardless of baseline anxiety.
Below are direct links to the meatiest parts of the review:
- Key Question 1 For adults with fibromyalgia, what is the comparative effectiveness/efficacy of included interventions?
- Key Question 2 For adults with fibromyalgia, what are the comparative harms of included interventions?
- Key Question 3 Are there subgroups of patients based on demographics (age, racial or ethnic groups, and gender), socioeconomic status, other medications, or comorbidities for which any included drugs are more effective or associated with fewer harms?