Why was the study done?
Chronic pain, including neuropathic pain (nerve pain), affects 1 in 3 Canadians and costs approximately $650 billion/year in North America. Current therapies have limited efficacy (effectiveness) and can cause adverse effects that limit the dose that patients can tolerate.
Using combinations of medications to treat fibromyalgia has shown potential to improve pain relief and quality of life and reduce healthcare utilization. Today, more than half of fibromyalgia patients receive 2 or more analgesics (pain medications) but combination use is based on little evidence. Research is urgently needed to identify safer (and more effective) combinations of medications for fibromyalgia.
How was the study done?
Our previous CIHR chronic pain trials showed that analgesics and sedatives (medications that can cause drowsiness) are more effective than analgesics alone.
These combinations were as follows:
morphine and gabapentin
gabapentin and nortriptyline
nortriptyline and morphine
However, the benefits were doses had to be reduced during combination therapy to ensure safety and tolerability (and limit adverse effects).
Thus, we wanted to determine whether pain relieving combinations that contain at least one non-sedating agent would reduce pain without causing undue adverse effects.
We were particularly interested in two medications (or agents) to treat fibromyalgia.
Pregabalin (PGB) is a sedating anticonvulsant ( medication) proven effective for fibromyalgia. The antioxidant, (ALA) currently the only non-sedating agent proven effective for chronic neuropathic pain and also shows promise for the treatment of fibromyalgia.
What were the study results?
We will conduct a randomized controlled clinical trial to compare a PGB-ALA combination to single drug therapy for fibromyalgia. The study will include 55 people diagnosed with fibromyalgia and will run until November 2020.