Strong Pain Tx Recommendations Based on Low-quality Evidence

Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain | Annals of Internal Medicine | American College of Physicians

Recommendation 1:

Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatmentwith

  • superficial heat (moderate-quality evidence),
  • massage,
  • acupuncture, or
  • spinal manipulation (low-quality evidence).

If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence).

(Grade: strong recommendation)

Recommendation 2:

For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with

  • exercise,
  • multidisciplinary rehabilitation,
  • acupuncture,
  • mindfulness-based stress reduction (moderate-quality evidence),
  • tai chi,
  • yoga,
  • motor control exercise,
  • progressive relaxation,
  • electromyography biofeedback,
  • low-level laser therapy,
  • operant therapy,
  • cognitive behavioral therapy, or
  • spinal manipulation (low-quality evidence).

(Grade: strong recommendation)

This, despite the fact that almost all evidence is low-quality, with only very few studies showing moderate quality evidence, and then usually only for ineffectiveness.

Recommendation 3:

In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy.

they still issue this recommendation in the face of so many studies showing the ineffectiveness of NSAID’s.

There is higher-quality evidence of the danger from NSAID’s as there is for their effectiveness against back pain. 

Clinicians should only consider opioids as an option

  • in patients who have failed the aforementioned treatments and
  • only if the potential benefits outweigh the risks for individual patients
  • and after a discussion of known risks and realistic benefits with patients.

(Grade: weak recommendation, moderate-quality evidence)

After they issue their first 2 recommendations as “Strong” despite low-quality evidence, this one is rated as “weak” despite better evicence.

Low back pain is frequently classified and treated on the basis of

  • symptom duration,
  • potential cause,
  • presence or absence of radicular symptoms, and
  • corresponding anatomical or radiographic abnormalities
  • Acute back pain is defined as lasting less than 4 weeks, subacute back pain lasts 4 to 12 weeks, and
  • chronic back pain lasts more than 12 weeks.

Radicular low back pain results in lower extremity pain, paresthesia, and/or weakness and is a result of nerve root impingement.

Most patients with acute back pain have self-limited episodes that resolve on their own; many do not seek medical care (4).

For patients who do seek medical care, pain, disability, and return to work typically improve rapidly in the first month (5).

However, up to one third of patients report persistent back pain of at least moderate intensity 1 year after an acute episode, and 1 in 5 report substantial limitations in activity (6).

Many noninvasive treatment options are available for radicular and nonradicular low back pain, including pharmacologic and nonpharmacologic interventions

Guideline Focus and Target Population

These recommendations are based on 2 background evidence reviews (7, 8) and a systematic review sponsored by the Agency for Healthcare Research and Quality (AHRQ) (9).

The study population included adults (aged ≥18 years) with acute, subacute, or chronic nonradicular low back pain, radicular low back pain, or symptomatic spinal stenosis.

Yet there is no count given, even though that number was used to generate statistics.

Evaluated outcomes included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability, return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects.

The magnitude of effect (small, moderate, or large) was determined as previously described (10, 11).

A small effect on pain was defined as a mean between-group difference after treatment of 5 to 10 points on a visual analogue scale of 0 to 100 or equivalent, a mean between-group difference of 0.5 to 1.0 point on a numerical rating scale of 0 to 10, or a standardized mean difference of 0.2 to 0.5.

This is only 1/2 point on the normal scale shown to patients in medical settings

moderate effect was defined as a mean between-group difference of greater than 10 to no more than 20 points on a visual analogue scale of 0 to 100 or equivalent, a mean between-group difference of greater than 1.0 to no more than 2.0 points on a numerical rating scale of 0 to 10 or equivalent, or a standardized mean difference greater than 0.5 but no more than 0.8

No large effects were found with any intervention.

Normally a scientifically significant change is considered a 30% improvement – 3 points, but none of their methods can lower pain more than 2 points.

Acetaminophen

Low-quality evidence showed no difference between acetaminophen and placebo for pain intensity or function through 4 weeks or between acetaminophen and NSAIDs for pain intensity or likelihood of experiencing global improvement at 3 weeks or earlier

NSAIDs

Moderate-quality evidence showed that NSAIDs were associated with a small improvement in pain intensity compared with placebo (14, 15), although several randomized, controlled trials (RCTs) showed no difference in likelihood of achieving pain relief with NSAIDs compared with placebo

SMRs

Moderate-quality evidence showed that SMRs improved short-term pain relief compared with placebo after 2 to 4 and 5 to 7 days (20, 21). Low-quality evidence showed no differences between different SMRs for any outcomes in patients with acute pain (20). Low-quality evidence showed inconsistent findings for the effect on pain intensity with a combination of SMRs plus NSAIDs compared with NSAIDs alone

Systemic Corticosteroids

Low-quality evidence showed no difference in pain or function between a single intramuscular injection of methylprednisolone or a 5-day course of prednisolone compared with placebo in patients with acute low back pain (24, 25).

Other Therapies

Evidence was insufficient to determine effectiveness of antidepressants, benzodiazepines (26, 27), antiseizure medications, or opioids versus placebo in patients with acute or subacute low back pain.

Opioids

Opioids have better evidence of effectiveness than any other treatment:

Moderate-quality evidence showed that strong opioids (tapentadol, morphine, hydromorphone, and oxymorphone) were associated with a small short-term improvement in pain scores (about 1 point on a pain scale of 0 to 10) and function compared with placebo

Moderate-quality evidence showed no differences among different long-acting opioids for pain or function (33, 41–44), and low-quality evidence showed no clear differences in pain relief between long- and short-acting opioid

Moderate-quality evidence showed that tramadol achieved moderate short-term pain relief and a small improvement in function compared with placebo

SMRs

Evidence comparing SMRs versus placebo was insufficient

Benzodiazepines

Low-quality evidence showed that tetrazepam improved pain relief at 5 to 7 days and resulted in overall improvement at 10 to 14 days compared with placebo

Antidepressants

Moderate-quality evidence showed no difference in pain between tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs) versus placebo, and low-quality evidence showed no differences in function for antidepressants

Other Therapies

Evidence was insufficient to determine the effect of acetaminophen, systemic corticosteroids, or antiseizure medications on chronic low back pain.

Exercise

Low-quality evidence showed no difference between exercise therapy and usual care for pain or function in patients with acute or subacute pain (11); additional trials reported inconsistent results (73–75).

Acupuncture

Low-quality evidence showed that acupuncture resulted in a small decrease in pain intensity compared with sham acupuncture with nonpenetrating needles, but there were no clear effects on function

Massage

Low-quality evidence showed that massage moderately improved short-term (1 week) pain and function compared with sham therapy for subacute low back pain

Low-quality evidence showed that a combination of massage plus another intervention (exercise, exercise and education, or usual care) was superior to the other intervention alone for short-term pain in patients with subacute to chronic low back pain

They are really grasping at straws here, It’s hard to come up with recommendations without anything but low-quality or inconsistent evidence.

MCE

Motor control exercise focuses on restoring coordination, control, and strength of the muscles that control and support the spine.

Low-quality evidence showed that MCE resulted in small improvements in pain intensity at short-term (≥6 weeks to <4 months) and intermediate-term (≥4 to <8 months) follow-up compared with general exercise, although improvements were small and no longer significant at long-term follow-up

Pharmacologic therapy should be considered for patients with chronic low back pain who do not improve with nonpharmacologic interventions

Nonsteroidal anti-inflammatory drugs had a small to moderate effect on pain (moderate-quality evidence) and no to small effect on function (low-quality evidence) and should be the first option considered.

Nonsteroidal anti-inflammatory drugs are associated with gastrointestinal and renal risks.

From the evidence provided, the first recommended option is ineffective and dangerous.

For second-line therapies, moderate-quality evidence showed that tramadol had a moderate effect on pain and a small effect on function in the short term. Of note, tramadol is a narcotic and, like other opioids, is associated with the risk for abuse (181). Moderate-quality evidence showed that duloxetine had a small effect on pain and function

Moderate-quality evidence showed that opioids (morphine, oxymorphone, hydromorphone, and tapentadol) had a small effect on short-term pain and function.

Low-quality evidence showed that buprenorphine (patch or sublingual) resulted in a small improvement in pain.

Moderate-quality evidence showed that Tri-cyclic Antidepresants did not effectively improve pain or function (low-quality evidence) in patients with chronic low back pain, which is contrary to the 2007 guideline. In addition, moderate-quality evidence showed that SSRIs did not improve pain.

Systemic Pharmacologic Therapies for Low Back Pain | Annals of Internal Medicine | American College of Physicians – Reviews |14 February 2017

This whole document shows their recommendations are based on a limited number of low-quality evidence for the “Strong” recommendations, while they disregard moderate-quality evidence for opiods.

A 2007 American College of Physicians guideline addressed pharmacologic options for low back pain. New evidence and medications have now become available.

Data Synthesis:

The number of trials ranged from 9 (benzodiazepines) to 70 (nonsteroidal anti-inflammatory drugs).

New evidence found that

  • acetaminophen was ineffective for acute low back pain,
  • nonsteroidal anti-inflammatory drugs had smaller benefits for chronic low back pain than previously observed,
  • duloxetine was effective for chronic low back pain, and
  • benzodiazepines were ineffective for radiculopathy.
  • For opioids, evidence remains limited to short-term trials showing modest effects for chronic low back pain; trials were not designed to assess serious harms.
  • Skeletal muscle relaxants are effective for short-term pain relief in acute low back pain but caused sedation.
  • Systemic corticosteroids do not seem to be effective.

For effective interventions, pain relief was small to moderate and generally short-term; improvements in function were generally smaller. Evidence is insufficient to determine the effects of antiseizure medications.

Here, we review the current evidence on benefits and harms of medications for low back pain.

This article has been used by ACP to update a clinical practice guideline, also in this issue.

Considering that there was no good evidence for anything they recommend, creating a guideline from such low-quality evidence is dangerous.

Literature Search

Database searches found 2847 potentially relevant articles. After dual review of abstracts and titles, we selected 746 articles for full-text dual review; 46 publications met inclusion criteria. 

The fact that only 46 out of 2847 studies (1.6%) showed any of the obviously sought out desired evidence at all is disturbing.

Acetaminophen

For acute low back pain, 1 new trial found no differences between 4 weeks or less of scheduled or as-needed acetaminophen (about 4 g/d) and placebo in pain, function, or risk for serious adverse events after 12 weeks

One trial of acetaminophen versus no treatment included in the ACP/APS review (26) also found no differences.

We found no difference between acetaminophen and NSAIDs in pain intensity (standardized mean difference

at 3 weeks or less based on 3 low-quality trials, although estimates favored NSAIDs (22). Acetaminophen had a lower risk for adverse events than NSAIDs (relative risk [RR], 0.57 [CI, 0.36 to 0.89])

For acute back pain, 1 systematic review (22) found that NSAIDs were associated with greater mean improvements in pain intensity than placebo

NSAIDs

Three trials in this review found no differences between an NSAID and placebo in the likelihood of pain relief

For chronic low back pain, 1 systematic review (22) found that NSAIDs were associated with greater mean pain relief than placebo after 12 weeks

For radiculopathy, the ACP/APS review (22) reported small and inconsistent effects on pain from 2 trials

The systematic review (22) found that NSAIDs were associated with more adverse effects than placebo

Opioids, Tramadol, and Tapentadol

For acute low back pain, 1 trial found no difference between oxycodone or acetaminophen plus naproxen (n = 108) and placebo plus naproxen (n = 107) in pain or function

For chronic low back pain, 1 systematic review (46) found that strong opioids (morphine, oxymorphone, hydromorphone, and tapentadol) were associated with greater short-term relief than placebo for pain and function.

Tramadol also resulted in greater short-term relief than placebo for pain and function (5 trials: SMD, −0.18 [CI, −0.29 to −0.07];

Two trials found that buprenorphine patches were associated with greater short-term pain relief (about 1 point on a 0- to 10-point scale) than placebo patches

Four trials found no clear differences among various long-acting opioids in pain or function

Six trials found no clear differences between long- and short-acting opioids in pain

Although some trials found long-acting opioids associated with greater pain relief, patients randomly assigned to these drugs also received higher doses.

Skeletal Muscle Relaxants

For acute low back pain, the systematic review (79) found skeletal muscle relaxants superior to placebo for short-term pain relief (≥2-point or 30% improvement on a 0- to 10-point visual analogue scale [VAS]) after 2 to 4 days

Evidence was insufficient from 3 small placebo-controlled trials with inconsistent results and methodological shortcomings to determine the effects of skeletal muscle relaxants on chronic low back pain (

Benzodiazepines

For acute nonradicular low back pain, 2 trials reported inconsistent effects of benzodiazepines versus placebo

the higher-quality trial found no difference between diazepam and placebo in the likelihood of reduced pain and tenderness at 5 days

Evidence was inconsistent from 2 trials on the effects of benzodiazepines versus skeletal muscle relaxant

The new trial found no difference in function between diazepam, 5 mg 3 times daily, and placebo for acute radiculopathy

Antidepressants

For chronic low back pain, a systematic review (95) found no difference in pain between tricyclic antidepressants or selective serotonin reuptake inhibitors and placebo. Antidepressants were not associated with reduced depression or improved function

Three trials not in that review found that the serotonin norepinephrine reuptake inhibitor duloxetine, 60 mg/d, was associated with lower pain intensity at 12 to 13 weeks, although effects were small (differences, 0.60 to 0.79 point on the 0- to 10-point Brief Pain Inventory severity scale) (

One trial of duloxetine also found an increased likelihood of 50% or greater pain relief after 12 weeks

All 3 trials found that duloxetine was associated with greater improvement in function than placebo on the Brief Pain Inventory interference scale

One fair-quality trial (n = 85) found no differences between duloxetine and escitalopram (a selective serotonin reuptake inhibitor) in pain or function

Antiseizure Medications

For chronic nonradicular back pain, 2 fair-quality trials found that pregabalin was associated with no effects on pain intensity versus placebo

One trial found no effect on function on the Oswestry Disability Index (ODI) (108), and the other found that pregabalin had slightly worse scores on the RDQ

For chronic radicular back pain, 3 poor-quality trials reported inconsistent findings for gabapentin (dose titrated up to 1200 to 3600 mg/d) versus placebo (

Effects on pain intensity ranged from 0.3 to 1.9 points on a 0- to 10-point scale.

Systemic Corticosteroids

For acute nonradicular low back pain, 2 trials (n = 86 and 67) found no differences between a single intramuscular injection or a 5-day course of systemic corticosteroids and placebo in pain or function

For radicular low back pain of varying duration, 6 trials consistently found no differences between systemic corticosteroids and placebo in pain

In the largest trial, oral prednisone (initial dose, 60 mg/d) increased risk for any adverse event

Discussion

Many systemic pharmacologic therapies have some evidence of effectiveness in acute or chronic low back pain.

“Some evidence” turns out to be “low-quality”, but it sounds better.

Benefits were generally observed for short-term (generally <3 months) pain and were small (5 to 10 points on a 100-point VAS) to moderate (10 to 20 points), based on the ACP/APS categories

Evidence on other outcomes (for example, quality of life, mood, work, analgesic use, or health care use) was sparse and is described in the full report

The ACP/APS review concluded that acetaminophen was effective for acute low back pain, primarily based on trials showing similar effectiveness of acetaminophen compared with NSAIDs. However, the first large, well-conducted, placebo-controlled trial found that acetaminophen was ineffective for acute low back pain (low SOE)

Newer trials reported that NSAIDs had smaller benefits than placebo for chronic low back pain than previously observed

For antidepressants, several trials found duloxetine, a serotonin norepinephrine reuptake inhibitor introduced after the prior ACP/APS review, to be more effective than placebo for chronic low back pain, although effects were small (moderate SOE)

Previous reviews found that tricyclic antidepressants were modestly effective for chronic low back pain; however, a meta-analysis with newer trials found no differences versus placebo (moderate SOE)

For antiseizure medications, new placebo-controlled trials on pregabalin for radicular low back pain are available but had methodological shortcomings and reported inconsistent results

Our findings have implications for clinical practice. Guidelines currently recommend acetaminophen as a first-line option for acute and chronic low back pain

Since the ACP/APS guideline was published, the antidepressant duloxetine has been approved by the U.S. Food and Drug Administration for low back pain and seems to be more effective and safer than tricyclic antidepressants.

In conclusion, several systemic pharmacologic therapies for low back pain are associated with small to moderate, primarily short-term effects on pain.

Effects on function were generally smaller than effects on pain.

New evidence suggests that acetaminophen is ineffective for acute low back pain and that duloxetine is associated with modest effects for chronic low back pain

 

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