No Relief for Sciatica Sufferers

Dakota Thaxton Craft, Mercer University College of Pharmacy

Sciatica is leg pain that originates in the lower back and travels down the back of the leg as a result of irritation or compression of the sciatic nerve.  Symptoms may include tingling, numbness, or searing pain on one side of the buttock or leg.  These symptoms may be mild and infrequent or constant and debilitating.  Treatment strategies include providing pain relief and addressing the cause of symptoms. [1]

Lyrica® (pregabalin) is approved by the Food and Drug Administration for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, spinal cord injury, and postherpetic neuralgia.  The onset of pain relief may occur as early as the first week of therapy. [2]

Trial of Pregabalin for Acute and Chronic Sciatica [3]
Design Randomized, double-blind, placebo-controlled; N= 209
Objective To determine the efficacy, safety, and cost-effectiveness of pregabalin in patients with sciatica
Study Groups Pregabalin (n= 108); placebo (n= 101)
Methods Sciatica was defined as radiating pain into one leg below the knee accompanied by nerve-root or spinal-nerve involvement as indicated by the presence of one of the following: dermatomal leg pain, myotomal weakness, sensory deficits, or diminished reflex.  The episode of sciatica must have been present for a minimum of 1 week and a maximum of 1 year.  Leg pain was required to be moderate in intensity or moderately interfering with daily activities during the previous week.  Patients were started on pregabalin 75 mg twice daily or matching placebo.  The dose was adjusted over the first 3 weeks based on patient progress and side effects to a maximum of 300 mg twice daily to be taken for 4 weeks.  Over the last week of the trial, the dose was gradually reduced and the regimen discontinued.  If leg pain adequately decreased before the 8-week period, the decreased dose and cessation of treatment could take place earlier.  Leg pain was ranked on a numerical scale from 0 to 10, with 0 indicating no pain and 10 the worst possible pain.  
After randomization, two patients in the pregabalin group were excluded from analysis because they were taking other medications that were not permitted.
Duration September 2013 to March 2015
Primary Outcome Measure Leg-pain intensity score at weeks 8 and 52
Baseline Characteristics
Pregabalin Placebo
Female, n (%) 66 (62.3) 49 (48.5)
Mean age, yrs ± SD 52.4 ± 17.2 55.2 ± 16.0
Mean duration of leg pain, days ± SD 63.7 ± 75.9 62.4 ± 78.7
Mean leg-pain intensity score ± SD 6.3 ± 1.8 6.1 ± 1.9
Dermatomal pain, n (%) 93 (87.7) 82 (81.2)
Motor deficit, n (%) 33 (31.1) 29 (28.7)
Neurologic deficit, n (%) 42 (39.6) 34 (33.7)
Sensory deficit, n (%) 47 (44.3) 44 (43.6)
Results
Pregabalin Placebo Adjusted mean difference (95% CI) p-value
Week 8 3.7 3.1 0.5 (-0.2 to 1.2) 0.19
Week 52 3.4 3.0 0.3 (-0.5 to 1.0) 0.46
Adverse Events Common Adverse Events: dizziness (n= 42); dorsalgia (n= 19); sweating (n= 9); malaise (n= 9)
Serious Adverse Events: hospitalization for dyspnea and nausea (n= 1); suicidal thoughts (n= 1)
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica.

Included patients had sciatica pain ranging from acute to chronic, with 80.2% of participants having leg pain for less than 3 months.  With the unpredictability of sciatica duration, the delayed onset of action may indicate that pregabalin is not ideal for patients who suffer from acute, short-term symptoms.  Patients with sciatica are also urged to stay active, which may not be feasible due to pregabalin’s side effect profile.  All patients, including those treated with placebo, had a reduction in leg pain, indicating that results may be attributed to time rather than medication since sciatica symptoms typically improve on their own over 8 to 12 weeks.  

References

[1] Hochschuler SH. What You Need to Know About Sciatica. http://www.spine-health.com/conditions/sciatica/what-you-need-know-about-sciatica. Accessed March 29, 2017.

[2] Pregabalin. Lexi-Drugs. Lexicomp Online [database online]. Hudson, OH: Lexi-Comp, Inc; 2017. Accessed March 30, 2017.

[3] Mathieson S, Maher CG, Mclachlan AJ, et al. Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med. 2017;376(12):1111-1120.

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s