High‐dose opioids for chronic non‐cancer pain: an overview of Cochrane Reviews Edited (no change to conclusions)

Abstract

Abstract Background

Chronic pain is typically described as pain on most days for at least three months. Chronic non‐cancer pain (CNCP) is any chronic pain that is not due to a malignancy. Chronic non‐cancer pain in adults is a common and complex clinical issue where opioids are routinely used for pain management. There are concerns that the use of high doses of opioids for chronic non‐cancer pain lacks evidence of effectiveness and may increase the risk of adverse events.

Objectives

To describe the evidence from Cochrane Reviews and Overviews regarding the efficacy and safety of high‐dose opioids (here defined as 200 mg morphine equivalent or more per day) for chronic non‐cancer pain.

Methods

We identified Cochrane Reviews and Overviews through a search of the Cochrane Database of Systematic Reviews (The Cochrane Library). The date of the last search was 18 April 2017. Two review authors independently assessed the search results. We planned to analyse data on any opioid agent used at high dose for two weeks or more for the treatment of chronic non‐cancer pain in adults.

Main results

We did not identify any reviews or overviews meeting the inclusion criteria. The excluded reviews largely reflected low doses or titrated doses where all doses were analysed as a single group; no data for high dose only could be extracted.

Authors' conclusions

There is a critical lack of high‐quality evidence regarding how well high‐dose opioids work for the management of chronic non‐cancer pain in adults, and regarding the presence and severity of adverse events. No evidence‐based argument can be made on the use of high‐dose opioids, i.e. 200 mg morphine equivalent or more daily, in clinical practice. Trials typically used doses below our cut‐off; we need to know the efficacy and harm of higher doses, which are often used in clinical practice.

Author(s)

Charl Els, Tanya D Jackson, Reidar Hagtvedt, Diane Kunyk, Barend Sonnenberg, Vernon G Lappi, Sebastian Straube

Abstract

Plain language summary

High doses of opioid drugs for the management of chronic non‐cancer pain

Bottom line

There is no high‐quality evidence to show how well high doses of opioids work, or what side effects there are, when these medications are used for the treatment of chronic pain that is not due to cancer in adults. Trials typically used doses below our cut‐off; we need to know how well high‐dose opioid medication works in this situation, and what side effects there may be.

Background

Opioids are a type of pain medication related to morphine. This overview aimed to summarise the knowledge in Cochrane Reviews and Overviews about opioid drugs. We were interested in opioid medications used at high doses (equivalent to 200 mg of morphine per day or more) for pain relief in adults who have chronic pain not due to cancer. We wanted to describe how well high‐dose opioid medications work in this situation, and what side effects there might be.

Key results

Despite a systematic search in April 2017, we did not find any information about this. Studies on opioids rarely reported on high‐dose use and, if so, they did not report separate information for participants who used high‐dose opioids.

Author(s)

Charl Els, Tanya D Jackson, Reidar Hagtvedt, Diane Kunyk, Barend Sonnenberg, Vernon G Lappi, Sebastian Straube

Reviewer's Conclusions

Authors' conclusions

Implications for practice For persons suffering from chronic non‐cancer pain

There is an absence of high‐quality evidence to support the use of high‐dose opioids for chronic non‐cancer pain. Opioids are associated with increased risks for adverse events, including addiction, overdose, and death (Dowell 2016). When selecting a treatment modality and dosage, risks and benefits have to be considered. Patients should be made aware of the potential risks and the absence of evidence for benefit of high‐dose opioids for chronic non‐cancer pain. Physicians should have frank and open conversations with patients in this regard, supplemented with a discussion on alternative strategies.

For policy makers

There is insufficient evidence to either support or refute the efficacy of high‐dose opioids in chronic non‐cancer pain. In view of the established risks, including addiction, overdose and death, policy makers should consider not supporting the use of high‐dose opioids for treating chronic non‐cancer pain.

For funders

There is insufficient evidence to support the use of high‐dose opioids for the treatment of chronic non‐cancer pain. In the absence of such evidence, it should not be recommended.

Implications for research General

Although we know that opioids are more commonly prescribed to patients, and at higher doses, for the treatment of chronic non‐cancer pain than heretofore, there is no evidence to refute or support the efficacy of this clinical practice. The risks associated with high‐dose opioid use are, however, well established. We do not at present have dependable information about how well high‐dose opioids work or what adverse effects may accompany their use when they are used on a long‐term basis for chronic non‐cancer pain.

Design

On the one hand, the absence of high‐quality evidence for high‐dose opioid use would typically call for more randomised controlled trials to be conducted, specifically addressing this question. On the other hand, the potential for significant adverse events with high‐dose opioids provides an argument against conducting these studies. The ethics of conducting studies on high‐dose opioids would need to be considered carefully.

Where possible, data from patients receiving high‐dose opioids in existing datasets should be re‐analysed separately.

Measurement

Many of the outcomes of interest for high‐dose opioids are the same as for opioids studied at a lower dose range. Dworkin 2005 outlined six domains that should be considered for chronic pain clinical trials, including pain, physical functioning, emotional functioning, treatment satisfaction, symptoms and adverse events, and participant disposition.

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