1. Medications: Overview of Evidence-Based Strategies
Richard D. Guyer, M.D.
Co-founder, Texas Back institute
Past President NASS
Associate Clinical Professor
UT Southwestern Medical School
Texas Back Institute

2. Introduction
To date, various medications are commonly used in the treatment of acute and chronic LBP
Often mentioned in treatment guidelines
What evidence is there for this practice?

3. Evidence, What Evidence?
Considering the large number patients receiving medication for LBP, there is little literature providing evidence for specific medications for specific indications

4. Challenges
“Back pain” is a very generic dx at the level of care where many studies are conducted
Often divided into only acute or chronic
Should we expect all back pain dx to react to a medication the same way?
Compliance with amount and timing of medication in studies?

5. Challenges
What other treatments are being received during medication use: PT, modified activities, chiro, acupuncture, over the counter meds, home exercises seen on the Internet, etc.?

6. American Pain Society compiled extensive evidence-based review on LBP, including meds, 2009

7. NSAIDS
Acute LBP: non-selective NSAIDs associated with moderate short-term pain relief and global improvement compared to placebo (6trials) (level of evidence: good)
Chronic LBP: 1 higher-quality trial found non-selective NSAIDs more effective than placebo (level of evidence: fair)
American Pain Society, 2009

8. NSAIDS Most trials evaluated mixed populations of pts +/- sciatica
3 trials (2 higher-quality) specifically evaluated pts with sciatica found no differences between non-selective NSAIDs and placebo (level of evidence: fair)
American Pain Society, 2009

9. NSAIDS AHCPR guidelines: NSAIDs acceptable for treating acute LBP
European COST : NSAIDs 2nd choice after paracetamol for acute LBP, and only for short-term exacerbations of chronic LBP
American Pain Society, 2009

10. Acetaminophen
Acute LBP: conflicting evidence from 4 lower-quality trials on efficacy of acetaminophen vs. NSAIDs, with 3 finding no difference in outcomes (level of evidence: fair)
Chronic LBP: 1 higher quality trial found acetaminophen inferior to NSAID on an overall assessment of efficacy (level of evidence: fair)
American Pain Society, 2009

11. Acetaminophen
AHCPR guidelines: acetaminophen reasonably safe and acceptable for treating patients with acute LBP
European COST guidelines: recommend acetaminophen as first choice when needed for pain relief in patients with acute LBP
American Pain Society, 2009

12. High quality evidence that paracetamol is ineffective in reducing pain and disability or improving quality of life in patients with LBP
3 studies included in analysis

13. Muscle Relaxants (MR)
Acute LBP: in multiple trials MR moderately more effective than placebo for short-term (<1 wk) relief and global response (level of evidence: good)
Chronic LBP or sciatica: insufficient evidence
American Pain Society, 2009

14. Muscle Relaxants (MR) AHCPR: recommend MR as option for LBP
MR probably more effective than placebo, but not shown to be more effective than NSAIDs
American Pain Society, 2009

15. Antiepileptic Drugs: Gabapentin and Pregabalin
Radiculopathy: 2 small (n=50 and n=80) trials found gabapentin slightly superior for short-term relief compared to placebo
No trials evaluated efficacy of gabapentin in patients with non-radicular low back pain
American Pain Society, 2009

16. Gabapentin used to treat fibromyalgia and sometimes prescribed for pts w LBP+ radicular component
108 pts daily pain >6 mo, randomized, 12-week follow-up, gabapentin vs. placebo
Pts stratified by those with and those w/o radicular leg pain

17. Gabapentin for LBP
Pain in both groups improved significantly (~30%), no differences between groups, similar results on ODI
No significant difference +/- radicular pain
No significant correlation between gabapentin plasma concentration and pain intensity
Conclusion: gabapentin appears ineffective in LBP +/- radicular pain
Atkinson et al, Pain, 2016

18. Randomized study comparing pregabalin vs
Randomized study comparing pregabalin vs. opioids in 65 pts aged >65 yrs with chronic LBP
ADL improved more with opioids
Pregabalin effective for LBP with neuropathic pain, opioids effective for non-neuropathic pain

19. Double-blind RCT, 269 pts
Herniated disc, pain <3 mo
Tapering 15-day course of oral prednisone or placebo (n = 88)
Steroid group had modestly better improved function (ODI), no difference in pain or surgery rate, but had greater AE rate

20. Opioids
Acute or chronic LBP: sparse evidence supporting opioids vs. placebo (1 trial showing moderate effects on pain
American Pain Society, 2009

21. Opioids AHCPR: opioids option for time-limited course for acute LBP
European COST : recommend weak opioids for nonspecific chronic LBP for pts who do not respond to other treatment modalities
American Pain Society, 2009

22. Narcotics most powerful painkillers available
Opioids Then
What is lacking is not the way to treat pain effectively but the will to do it
Pain specialists warn that pain is undertreated in US originally meant for cancer patients
Narcotics most powerful painkillers available
Drs afraid to prescribe them due to fear of addiction
Pts also concerned about addiction

23. Because of this philosophy
Pain management and other physicians have used opioids for chronic low back pain and sciatica often inappropriately
Their use is often in the absence of behavioral medicine support which is extremely important especially for the chronic pain patient
And as a result……

24. Cost of Opioid Abuse: Top 10 States
Matrix Global Advisors, LLC
April 2015

25. Estimated Cost of Opioid Abuse
Health care costs: $25 billion
Criminal justice system: $5 billion
Lost workplace productivity: $25.5 billion Birnbaum et al, 2011
Total societal costs of opioid abuse in US: $55 billion a yr
Matrix Global Advisors, LLC, April 2015

26. Opioids Now
"For the vast majority of patients, the risks will outweigh the benefits for chronic pain," Thomas Frieden, CDC Director
The drugs killed more than 47,000 people in more than the 32,000 who died in road accidents

27. CDC rx opioid checklist

28. Opioids: State of TX Shift from Schedule III to Schedule II
Change in regulations prohibits:
Physicians from delegating NP/PAs authority to prescribe opioids outside of a hospital or hospice setting
Physicians from calling in prescriptions for opioids to pharmacies
Refills of opioid prescriptions without a pt visit or consultation

29. Reminder
Many medications do carry risks of side effects including GI, liver/kidney damage, cardiovascular, neurological, bleeding, etc.
Particularly with long-term use and/or combined use with other meds
Physicians prescribing meds are responsible for monitoring pts

30. Future Steps
Can we increase targeting of specific prescriptions for specific symptoms?

31. Goal: Target Medication to Match Individual Patient’s Problem
Pain Mechanism
Medication
Pain Mechanism
Target
Poor Fit,
No Response Likely
Arthroplasty
Pain Mechanism
Medication
Medication
Pain Mechanism
Pathology
Partial Fit,
Some Response Likely
Perfect Fit
Good Response Likely

32. Randomized, double blinded, placebo controlled cross-over study
Assigned to imipramine, oxycodone, or clobazam versus placebo
Assessing predictive value of central hypersensitivity and endogenous pain modulation may allow use of mechanism-based treatment strategy in individual patients

33. Summary
Little evidence available to support use of a specific medication for a specific spine condition
Such studies are very difficult and expensive to conduct

34. Summary
In recent years more high-quality RCTs for specific dx are being conducted
Generally finding investigated med not very effective
Great challenges in such studies:
Identifying appropriate population
Patient compliance

35. Summary Must keep in mind all meds do have some risk involved
All definitely have a cost involved
When prescribing, must carefully and continually monitor which meds pts are using, what for, beneficial, side effects, etc.
Opioid use is much too common and often used inappropriately

36. Thank You