Fibromyalgia Clinical Trial
Official title:
Comparative Effectiveness of Newer Antidepressants in Combination With Pregabalin for Fibromyalgia Syndrome: A Controlled Randomized Study
Background: The investigator hypothesized that the combined use of pregabalin and paroxetine
would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and higher tolerability
than amitriptyline or venlafaxine.
Methods: After ethical approval, 75 patients with diagnosed fibromyalgia who were receiving
pregabalin 75 mg/day, were randomly allocated to receive amitriptyline 25 mg/day (n = 24),
venlafaxine 75 mg/day (n = 25), or paroxetine 25 mg/day (n = 26). All patients were assessed
bi-monthly for consequent six months for the changes in the SSS-8, Center for
Epidemiological Studies Depression Scale (CESDS), life satisfaction, mood, sleep quality,
fatigue and medication tolerability and adverse effects.
Fibromyalgia is a common cause of chronic widespread disabling pain affecting 2-5% of the
young to middle-aged women in developed countries. The American College of Rheumatology has
been established new diagnostic criteria for fibromyalgia in 2010 included a widespread pain
index (WPI) and categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and
number of somatic symptoms. The definite pathophysiology of chronic pain in fibromyalgia
remains unclear.
Fibromyalgia is usually associated with depression, anxiety, and alexithymia increasing over
age which contribute significantly to reduced patient wellbeing. These may be due to
alterations of central pain pathways, hyporeactivity of the hypothalamus-pituitary-adrenal
axis, and disturbances in the dopaminergic and serotonergic systems. Thus the European
League Against Rheumatism (EULAR) recommends the use of serotonin and noradrenaline reuptake
inhibitors (SNRIs) for the treatment of fibromyalgia, to reduce pain and improve function.
However, few patients achieve satisfactory pain relief with the sole use of SNRIs. A recent
Cochrane review demonstrated only modest improvement in relieving pain without reducing of
sleep disturbances, fatigue, or the poor quality of life with the use of duloxetine and
milnacipran than placebo in patients with fibromyalgia. More patients experienced adverse
events like as nausea, dry mouth, constipation, headache, somnolence, dizziness and insomnia
leading to stopping medications. Whereas, the evidence from clinical studies shows that
combined use of pregabalin and SNRIs such as duloxetine has potential efficacy and better
tolerability during the treatment of improvement of pain, fatigue, and sleep disorders in
patients with fibromyalgia.
The use of the second-generation antidepressants like as paroxetine (a selective serotonin
reuptake inhibitors (SSRIs)) and venlafaxine (SNRIs) may be associated with more
tolerability and reduce pain in patients with major depressive disorder.
To the best of the investigator's knowledge, the comparison of the long-term efficacy,
tolerability, and safety of the combined use of pregabalin with one of the three
antidepressants, namely, amitriptyline, venlafaxine, or paroxetine for the treatment of
fibromyalgia has not yet been studied.
The investigators hypothesized that the combined use of pregabalin and paroxetine would be
associated with comparable Somatic Symptoms Scale-8 (SSS-8) and Center for Epidemiological
Studies Depression scales (CESD) and higher tolerability than the use of pregabalin with
either amitriptyline or venlafaxine.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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