Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate?

Abstract

No common nonopioid treatment for chronic pain has been studied in aggregate over longer intervals of active treatment than opioids. To dismiss trials as "inadequate" if their observation period is a year or less is inconsistent with current regulatory standards. The literature on major drug and nondrug treatments for chronic pain reveals similarly shaped distributions across modalities. Considering only duration of active treatment in efficacy or effectiveness trials, published evidence is no stronger for any major drug category or behavioral therapy than for opioids.

Reducing the Oversupply of Prescription Opioids

“…Cochrane reviews have shown the combination of 200 mg ibuprofen/500 mg acetaminophen is one of the strongest pain reliever combinations available, more effective than low-dose opioids alone for chronic pain conditions such as back pain [13,14]. Other studies indicate no major difference between opioid and non-opioid approaches [15]. In terms of OD risk, however, the safety profile is stronger for non-opioids and atypical opioid agents, the latter including tapentadol and buprenorphine (Belbuca or Butrans).…”

“…Non-opioid pharmacology and behavioral interventions, if considered with the same criteria, show no greater efficacy than opioids. It also suggests that the significant morbidity and mortality from non-opioid pain relievers has not been considered fully [15]. This in no way lessens the urgency of safer prescribing but does reflect the lack of scientific rigor of some of the recommendations.…”

Providing chronic pain management in the “Fifth Vital Sign” Era: Historical and treatment perspectives on a modern-day medical dilemma

“…Included are opioid and non-opioid pharmacotherapies, physical therapy, psychological and behavioral therapies, complementary and alternative medicine strategies, peripheral procedures, spinal procedures, and surgery ( Table 1 ). As with opioid clinical trials, controlled trials of non-opioid analgesic strategies are typically short (< 12 weeks) and so long-term effectiveness data for chronic pain using these strategies is limited ( Tayeb et al, 2016 ).…”

Misperceptions about the ‘Opioid Epidemic:’ Exploring the Facts

“…It is worth noting that the 2016 CDC guidelines themselves have been criticized for inappropriately categorizing their recommendations as grade A, which is defined as the highest standard of evidence and usually requires RCT data. According to some critics, the CDC guidelines were based on case studies and expert opinion, which does not typically qualify for grade A ratings (American Medical Association, 2016;Mundkur, Gordon, & Kertesz, 2017;Tayeb, Barreiro, Bradshaw, Chui, & Carr, 2016).…”