Gabapentinoids (Lyrica, Neurontin, Topamax) for Low Back and Sciatic Pain

Are they helpful? Are they worth it?

Introduction:

Over the last 5-10 years the use of anticonvulsants (Neurontin) (Lyrica) to treat low back pain and/or sciatica has increased dramatically. This has occurred despite clinical guidelines that recommend non-pharmacologic interventions rather than the use of stronger analgesics such as opioids and anticonvulsants. (1, 2)

Physicians are increasingly prescribing both gabapentin (Neurontin) and pregabalin (Lyrica) for almost any type of pain, according to a perspective published in the New England Journal of Medicine. (3) This is occurring despite the FDA only approving both drugs for postherpetic neuralgia, fibromyalgia and neuropathic pain due to diabetes or spinal cord injury.

The researchers further noted that, in 2016, gabapentin was the 10th most frequently prescribed medication in the US, with prescriptions jumping from 39 million in 2012 to 64 million in 2016. Lyrica had sales of $4.4 billion in 2016, more than double the 2012 sales. (3)

Increasing utilization of these drugs (Neurontin, Lyrica) could be justified if the benefits of such use would outweigh the potential harms. However, the scientific evidence to date on this has been equivocal. (4, 5) In fact, relatively recent research has cast doubt on the effectiveness of these medications which also carry an increased risk of not only abuse/misuse but suicidality for those taking them. (6 ,7 ,8)

This article will summarize some of the scientific studies on this topic so that you can be more informed about the treatment decisions you make and the medications that you may or may not choose to take.

It is common for people with chronic low back pain to use some form of medication. However, for a large percentage of such individuals, the results are unsatisfactory, leading them to explore other options, including gabapentinoids. (9, 10)

The Cochrane Research Group has found these medications to be reasonably effective for some people suffering with severe neuropathic pain from conditions like diabetic neuropathy and shingles. But, for other types of neuropathic pain (including low back and sciatic pain), the evidence of effectiveness is lacking. (11)

How is “successful” treatment defined?

It is important to know that “successful” treatment does NOT usually mean a complete resolution of symptoms. This is true for any type of low back pain treatment you may be considering.

Here is how the Cochrane Research Group defined success in their recent gabapentinoid (Lyrica, Neurontin) study. Also pay attention to the number of people treated who achieved this level of “success.”

“The outcome of at least 50% pain intensity reduction is regarded as a useful outcome of treatment by patients, and the achievement of this degree of pain relief is associated with important beneficial effects on sleep interference, fatigue, and depression, as well as quality of life, function, and work.”(11)
- In pain after shingles, 3 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. The pain was reduced by a third or more for 5 in 10 with gabapentin and 3 in 10 with placebo.”
- In pain caused by diabetic neuropathy, 4 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 4 in 10 with placebo.
- There was no reliable evidence that Lyrica or Neurontin led to significant relief for any other type of neuropathic pain. (Including low back/sciatic pain)
This study also stated that, “It is not possible to know beforehand who will benefit from these medications and who will not.”

In other words… it’s a hit or miss proposition and, similar to any treatment for low back pain, requires one to carefully assess the potential risks versus benefits.

Two other relatively recent studies have come to similar conclusions casting doubt on the effectiveness of gabapentin (Neurontin) and pregabalin (Lyrica)

The first study I want to mention was published on-line in 2017. It looked at randomized controlled trials (comprising over 800 patients) reporting the use of gabapentinoids (Neurontin, Lyrica) for the treatment of chronic low back pain of >3 months duration, in adult patients, where a clear assessment of outcomes could be established. (12)

The researchers came to 2 main conclusions:

1. “Existing evidence on the use of gabapentinoids (Lyrica and Neurontin) in chronic low back pain is limited and demonstrates significant risk of adverse effects without any demonstrated benefit.” (12)

2. “Given the lack of efficacy, risks, and associated costs, the use of gabapentinoids for CLBP merits caution. There is need for large high-quality trials to more definitively inform this issue.” (12)

Additionally, they stated, “While GB (Neurontin) showed minimal improvement of pain compared to placebo, pain relief with PG (Lyrica) was inferior compared to other analgesics. GB (Neurontin) and PG (Lyrica) were both associated with increased risk of dizziness compared with placebo. GB (Neurontin) was additionally associated with increased risk of fatigue, visual disturbances, and difficulties with mentation when compared with placebo.” (12)

The researchers summarized their findings by noting, “There is limited evidence to support the use of either PG (Lyrica) or GB (Neurontin) in nonspecific chronic low back pain.”

In Canada, a different group of researchers also sought to identify the benefit (or not) of Lyrica (pre-gabalin) Neurontin (gabapentin), and Topamax (topiramate) on chronic low back pain as well as radicular pain (often referred to as sciatica or a “pinched nerve.”)

Their systematic review found 9 placebo-controlled randomized trials investigating the effects of these anticonvulsants.

Here are the results:

“For chronic low back pain with or without radiating leg pain, there was high-quality evidence showing that gabapentinoids (Lyrica, Neurontin) did not reduce pain or disability compared with placebo in the short term, and similarly with low-quality evidence in the intermediate term.”
“For lumbar radicular pain (sciatica, “pinched nerve”), there was generally moderate- to high-quality evidence showing that anticonvulsants had no effect on pain or disability at all time points.”
“For adverse events, there was high-quality evidence showing that gabapentinoids (Lyrica, Neurontin) were associated with increased adverse events.”

The authors summarized their findings by stating, “We have shown, with mostly high- and moderate-quality evidence, that common anticonvulsants (Lyrica, Neurontin) are ineffective for chronic low back pain and lumbar radicular pain and are accompanied by increased risk of adverse events.”

The final study I will illustrate was reported in the prestigious New England Journal of Medicine and evaluated the effect of pregabalin (Lyrica) on recent onset or long-standing sciatic pain. (sciatica, “pinched nerve”, lumbar radiculopathy)

A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo. (14) The outcome assessed was the intensity of leg pain (on a 0-10 scale) at 8 weeks and 52 weeks.

Baseline (prior to being given Lyrica or placebo) was 6.3 for those who would receive pregabalin and 6.1 for those who would be taking the placebo.

Here’s what was found at 8 weeks:

Pain was reduced, on average, by 3.7 in those taking pregabalin (Lyrica)
Pain was reduced, on average, by 3.1 in those who had been given the placebo.

Statistically, the difference between those taking Lyrica versus those on a placebo was not considered to be clinically significant.

Here are the results at 52 weeks:

Pain reduction of 3.4 in the those taking Lyrica
Pain reduction of 3.0 in those given the placebo.

Again, these differences were not considered clinically significant.

However, the number of adverse events reported in the pregabalin group (227 events in 68 patients) was significantly higher than the number reported in the placebo group (124 events in 43 patients) Dizziness was the most commonly reported adverse event in each group and was more common in the pregabalin group than in the placebo group.

These researchers summarized their finding by stating:

“This double-blind, placebo-controlled trial showed that pregabalin (Lyrica) was no more effective than placebo in reducing leg-pain intensity in patients with moderate-to-severe sciatica of varying durations. Most patients had had sciatica for less than 3 months. Although the mean leg-pain intensity score decreased and secondary outcome measures improved over the course of the year in each trial group, the between-group difference was not significant for any outcome. The incidence of adverse events was higher in the pregabalin group than in the placebo group.”

In closing, several contemporary reviews have shown that the use of anticonvulsants (Lyrica, Neurontin, Topamax) are not only ineffective for low back and sciatic pain, but also carry a significantly higher risk of suffering adverse side effects.

As always, I would love to hear your comments and/or suggestions on other topics that you would like me to write about.

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REFERENCES

Low back pain and sciatica in over 16s: assessment and management. NICE guideline (NG59). London (UK): National Institute for Health and Care Excellence; 2016. Available: www.nice.org.uk/guidance/ng59
Qaseem A, Wilt TJ, McLean RM, et al.; Clinical Guidelines Committee of the American College of Physicians. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2017;166:514-30.
Goodman CW and Brett, AS. Gabapentine and Pregabalin for Pain—Is Increased Prescribing a Cause for Concern? New England Journal of Medicine, Aug. 3, 2017. http://www.nejm.org/doi/full/10.1056/NEJMp1704633
10. Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009(3):Cd007076 doi: 10.1002/14651858.CD007076.pub2
Chaparro LE, Smith SA, Moore RA, Wiffen PJ, Gilron I. Pharmacotherapy for the prevention of chronic pain after surgery in adults. Cochrane Database Syst Rev. 2013(7):Cd008307 doi:
Arana A, Wentworth CE, Ayuso-Mateos JL, et al. Suicide-related events in patients treated with antiepileptic drugs. N Engl J Med 2010;363:542-51.
Chiappini S, Schifano F. A decade of gabapentinoid misuse: an analysis of the European Medicines Agency’s ‘Suspected Adverse Drug Reactions’ database. CNS Drugs 2016;30:647-54.
Stannard C. Misuse of gabapentin and pregabalin: a marker for a more serious malaise? Addiction 2016;111:1699-700
Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147(7):505–14.
White AP, Arnold PM, Norvell DC, Ecker E, Fehlings MG. Pharmacologic management of chronic low back pain: synthesis of the evidence. Spine. 2011;36(21 Suppl):S131–43
The Cochrane Group: Gabapentin for Chronic Neuropathic Pain in Adults https://www.cochrane.org/CD007938/SYMPT_gabapentin-chronic-neuropathic-pain-adults
Benefits and safety of gabapentinoids in chronic low back pani: A systematic review and meta-analysis of randomized controlled trials. PLoS Med. 2017 Aug; 14(8): e1002369. Published online 2017 Aug 15. doi: 10.1371/journal.pmed.1002369
Anticonvulsants in the treatment of low back pain and lumbar radicular pain: a systematic review and meta-analysis CMAJ | JULY 3, 2018 | Volume 190 | Issue 26
Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med 2017; 376:1111-1120

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