scholarly journals A Systematic Review of Randomized Trials of Long-Term Opioid Management for Chronic Non-Cancer Pain

2011 ◽  
Vol 3;14 (2;3) ◽  
pp. 91-121
Author(s):  
Laxmaiah Manchikanti

Background: Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain. Study Design: A systematic review of randomized trials of opioid management for chronic noncancer pain. Objective: The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain. Methods: A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects. Results: Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence. Limitations: A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions. Conclusions: This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies. Key words: Chronic non-cancer pain, opioids, opioid efficacy, opioid effectiveness, significant pain relief, functional improvement, adverse effects, morphine, hydrocodone, hydromorphone, fentanyl, tramadol, buprenorphine, methadone, tapentadol, oxycodone, oxymorphone, systematic reviews, randomized trials

2012 ◽  
Vol 3S;15 (3S;7) ◽  
pp. ES39-ES58 ◽  
Author(s):  
Lakshmi Koyyalagunta

Background: In all recommended guidelines put forth for the treatment of cancer pain, opioids continue to be an important part of a physician’s armamentarium. Though opioids are used regularly for cancer pain, there is a paucity of literature proving efficacy for long-term use. Cancer is no longer considered a “terminal disease”; 50% to 65% of patients survive for at least 2 years, and there are about 12 million cancer survivors in the United States. There is a concern about side effects, tolerance, abuse and addiction with long-term opioid use and a need to evaluate the effectiveness of opioids for cancer pain. Objective: The objective of this systematic review was to look at the effectiveness of opioids for cancer pain. Study Design: A systematic review of randomized trials of opioids for cancer pain. Methods: A comprehensive review of the current literature for randomized controlled trials (RCTs) of opioids for cancer pain was done. The literature search was done using PubMed, EMBASE, Cochrane library, clinical trials, national clearing house, Web of Science, previous narrative systematic reviews, and cross references. The studies were assessed using the modified Cochrane and Jadad criteria. Analysis of evidence was done utilizing the modified quality of evidence developed by United States Preventive Services Task Force (USPSTF). Outcome Measures: Pain relief was the primary outcome measure. Secondary outcome measures are quality of life (QoL) and side effects including tolerance and addiction. Results: The level of evidence for pain relief based on the USPSTF criteria was fair for transdermal fentanyl and poor for morphine, tramadol, oxycodone, methadone, and codeine. Limitations: Randomized trials in a cancer setting are difficult to perform and justify. There is a paucity of long-term trials and this review included a follow-up period of only 4 weeks. Conclusion: This systematic review of RCTs of opioids for cancer pain showed fair evidence for the efficacy of transdermal fentanyl and poor evidence for morphine, tramadol, oxycodone, methadone, and codeine. Key words: Opioids, pain relief, cancer pain, morphine, hydromorphone, methadone, fentanyl, oxymorphone, hydrocodone, oxycodone, buprenorphine.


2009 ◽  
Vol 2;12 (2;3) ◽  
pp. 349-360
Author(s):  
Vikram B. Patel

Background: Disability, societal, and health impact of chronic intractable pain secondary to various failed therapies is a major issue. As advanced therapy, implantable therapies, which include intrathecal devices and spinal cord stimulation systems, are frequently used in managing chronic intractable pain. Thus, continuous infusion of intrathecal medication is one of the methods used for the control of chronic, refractory, cancer, and non-cancer pain. However, despite the high costs of chronic non-cancer pain, it has been claimed that there is a lack of evidence for intrathecal infusion systems and the cost effectiveness of these systems has been questioned in improving pain and function. Study Design: A systematic review of intrathecal infusion devices for chronic non-cancer pain. Objective: To determine the efficacy, utilization, safety, and complications associated with the use of intrathecal infusion devices for long-term management of chronic non-cancer pain. Methods: Literature search was performed through EMBASE, Medline, Cochrane databases, and systematic reviews identified from 1966 to December 2008. Studies were then reviewed and assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for randomized trials. The level of evidence was determined using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Outcome Measures: The primary outcome measure was pain relief (short-term relief ≤ one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were also utilized. Results: The level of evidence for intrathecal infusion systems indicated either Level II-3 or Level III (limited) based on U.S. Preventive Services Task Force (USPSTF) criteria. Limitations: The limitations of this study include the paucity of literature, lack of quality evidence, and lack of randomized trials. Conclusion: This systematic review illustrates Level II-3 or Level III (limited) evidence for intrathecal infusion systems for long-term relief in chronic non-cancer pain. Key words: Intrathecal infusion, intraspinal infusion, programmable infusion systems, spinal infusion, intra-spinal infusion devices, baclofen infusion, intrathecal opiates


2011 ◽  
Vol 3;14 (2;3) ◽  
pp. E85-E102
Author(s):  
James Colson

Background: The prevalence of cancer-related pain and residual pain in cancer survivors is high. Opioids serve as the gold standard for treating moderate to severe cancer pain. The evaluation of the effectiveness of opioids in chronic non-cancer pain has shown a lack of effectiveness, or rather weak evidence for some of the drugs. In contrast, in cancer pain, opioids are expected to be very effective. Due to the nature of the disease, there is evidence of a paucity of randomized trials investigating opioid effectiveness in cancer pain on a long-term basis. Consequently, the effectiveness of opioids in managing cancer-related pain warrants further evidence-based review beyond randomized trials, including observational studies and case reports. Methods: The comprehensive literature search was conducted for the period 1996 through June 2010. Databases for the search included PubMed, EMBASE, Cochrane Reviews, and clinicaltrails.gov, along with reviews and cross references. Methodologic quality assessment of the observational studies managing chronic cancer pain with opioids was conducted utilizing the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. Analysis of evidence included 5 levels of evidence developed by the United States Preventive Services Task Force (USPSTF) ranging from Level I to III with 3 subcategories in Level II. Grading recommendations were based on Guyatt et al’s recommendations with 6 levels: 3 in the strong category and 3 in the weak category. Results: This evaluation is of 18 manuscripts considered for inclusion; 7 manuscripts met the inclusion criteria based on AHRQ quality assessment. Level of evidence for opioid therapy in cancer pain was Level II-3, and recommendations were 1C/strong recommendation based on observational studies, which could change based on future evidence. Conclusion: This systematic review of observational studies indicates Level II3 evidence for effectiveness of opioids in cancer pain therapy, with 1C/strong recommendation based on observational studies, which could change based on future evidence. Key words: Chronic pain, cancer pain, non-cancer pain, randomized trials, observational studies, case reports, opioids, effectiveness


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rattaphol Seangrung ◽  
Thongchai Tempeetikul ◽  
Supasit Pannarunothai ◽  
Supalak Sakdanuwatwong

Abstract Background Opioids are currently prescribed for chronic non-cancer pain (CNCP), and some patients use opioids continuously for long-term treatment. Stakeholders’ awareness about long-term opioid therapy is essential for improving the safety and effectiveness of pain treatment. The purpose of this study is to explore the perspectives of pain specialists, patients, and family caregivers about long-term opioid use in CNCP management. Methods This study was a qualitative study and adhered to the COREQ guidelines. Pain specialists (n = 12), patients (n = 14), and family members (n = 9) were recruited to the study by purposive sampling at the Pain Clinic of Ramathibodi Hospital. Semi-structured interviews were recorded, verbatim transcribed, conceptually coded, and analyzed using Atlas.ti 8.0. Results All groups of participants described opioids as non-first-line drugs for pain management. Opioids should be prescribed only for severe pain, when non-opioid pharmacotherapy and non-pharmacological therapies are not effective. Patients reported that the benefits of opioids were for pain relief, while physicians and most family members highlighted that opioid use should improve functional outcomes. Physicians and family members expressed concerns about opioid-related side effects, harm, and adverse events, while patients did not. Patients confirmed that they would continue using opioids for pain management under supervision. However, physicians stated that they would taper off or discontinue opioid therapy if patients’ pain relief or functional improvement was not achieved. Both patients and family members were willing to consider non-pharmacological therapies if potential benefits existed. Patient education, doctor–patient/family relationships, and opioid prescription policies were proposed to enhance CNCP management. Conclusion Long-term opioid therapy for CNCP may be beneficial in patients who have established realistic treatment goals (for both pain relief and functional improvement) with their physicians. Regular monitoring and evaluation of the risks and benefits, adverse events, and drug-related aberrant behaviors are necessary. Integrated multimodal multidisciplinary therapies and family member collaborations are also important for improving CNCP management.


2008 ◽  
Vol 2s;11 (3;2s) ◽  
pp. S181-S200 ◽  
Author(s):  
Andrea M. Trescot

For thousands of years, opioids have been used to treat pain, and they continue to be one of the most commonly prescribed medications for pain. It is estimated that 90% of patients presenting to pain centers and receiving treatment in such facilities are on opioids. Opioids can be considered broad-spectrum analgesics that act at multiple points along the pain pathway. Unfortunately, opioids also have the potential for great harm, with multiple side effects and potential complications, some of which are lethal. They are also uniquely addictive, which can lead to misuse and diversion. We reviewed the relevant English literature and did thorough manual searches of the bibliographies of known primary and review articles. We utilized pain relief as the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, improvement in work status, and evidence of addiction. Shortterm use and improvement was defined as less than 6 months and long-term relief was defined as 6 months or longer. The 3 systematic reviews evaluating long-term effectiveness of opioids for chronic noncancer pain provided unclear and weak evidence. The results of this review showed that many patients in the included studies were dissatisfied with adverse events or insufficient pain relief from opioids and withdrew from the studies. For patients able to continue on opioids, evidence was weak suggesting that their pain scores were lower than before therapy and that this relief could be maintained long-term (> 6 months). There was also weak evidence that long-term opioid therapy with morphine and transdermal fentanyl not only decreases pain but also improves functioning. Limited evidence was available for the most commonly used opioids, oxycodone and hydrocodone. Evidence for the ability to drive on chronic opioid therapy was moderate without major side effects or complications. It is concluded that, for long-term opioid therapy of 6 months or longer in managing chronic non-cancer pain, with improvement in function and reduction in pain, there is weak evidence for morphine and transdermal fentanyl. However, there is limited or lack of evidence for all other controlled substances, including the most commonly used drugs, oxycodone and hydrocodone. Key words: Opioids, opioid effectiveness, pain relief, functional improvement, adverse effects, codeine, morphine, hydrocodone, hydromorphone, fentanyl, methadone.


2013 ◽  
Vol 2s;16 (2s;4) ◽  
pp. SE185-SE216
Author(s):  
Laxmaiah Manchikanti

Background: Intrathecal infusion systems are often used for patients with intractable pain when all else fails, including surgery. There is, however, some concern as to the effectiveness and safety of this treatment. Study Design: A systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain. Objective: To evaluate and update the effect of intrathecal infusion systems in managing chronic non-cancer pain. Methods: The available literature on intrathecal infusion systems in managing chronic pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventative Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief with short-term relief < 12 months and long-term relief ≥ 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: There were 28 studies identified for this systematic review. Of these, 21 were excluded from further review. A total of 7 non-randomized studies met inclusion criteria for methodological quality assessment. No randomized trials met the inclusion requirements. The evidence is limited based on observational studies. Limitations: The limitations of this systematic review include the paucity of literature. Conclusion: The evidence is limited for intrathecal infusion systems. Key words: Spinal pain, chronic low back pain, intrathecal infusion, intrathecal infusion systems, intrathecal drug delivery systems, intrathecal pumps, chronic non-cancer pain, chronic non-malignant pain, morphine, bupivacaine, ziconotide


2009 ◽  
Vol 3;12 (3;5) ◽  
pp. 589-599 ◽  
Author(s):  
Vijay Singh

Background: In recent years, a number of minimally invasive nuclear decompression techniques for lumbar disc prolapse, protrusion, and/or herniation have been introduced, including the Dekompressor® a device utilizing an Archimedes screw. The primary goal of the surgical treatment of nerve root compression from a disc protrusion continues to be the relief of compression by removing the herniated nuclear material with open discectomy. However, poor results have been reported for contained disc herniations with open surgical interventions. The results with several alternative techniques including the Dekompressor, automated percutaneous discectomy, and laser discectomy have been described, but are not convincing. There is a paucity of evidence for all decompression techniques. Study Design: A systematic review of the mechanical disc decompression with Dekompressor literature. Objective: The objective of this systematic review is to evaluate the clinical effectiveness of the Dekompressor, a high rotation per minute device utilizing an Archimedes screw, used in mechanical lumbar disc decompression. Methods: The literature search was conducted utilizing a comprehensive strategy for mechanical disc decompression utilizing the Dekompressor. A literature search was conducted using only English language literature in a comprehensive search of databases including PubMed, EMBASE, the Cochrane Library, along with systematic reviews, and cross-references from reviews, systematic reviews, and individual articles. The quality of the manuscripts included was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs), and for observational studies with the criteria developed by the Agency for Healthcare Research and Quality (AHRQ). The level of evidence developed by the United States Preventive Services Task Force (USPSTF) was utilized in this review. The evidence was classified as Level I, II, or III with 3 subcategories in Level II for a total of 5 levels of evidence. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas, long-term effectiveness was defined as greater than one year. Results: Based on USPSTF criteria the indicated level of evidence for the mechanical high RPM device or Dekompressor is Level III for short- and long-term relief. Limitations: Lack of literature, both randomized and observational. Conclusion: This systematic review illustrates Level III evidence for mechanical percutaneous disc decompression procedures with the high RPM device or Dekompressor. Key words: Intervertebral disc disease, chronic low back pain, mechanical disc decompression, disc protrusion, disc extrusion, radiculitis, and mechanical high RPM device, Dekompressor


Pharmacy ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 150
Author(s):  
Eleanor Black ◽  
Kok Eng Khor ◽  
Apo Demirkol

Chronic non-cancer pain is common and long-term opioid therapy is frequently used in its management. While opioids can be effective, they are also associated with significant harm and misuse, and clinicians must weigh any expected benefits with potential risks when making decisions around prescribing. This review aimed to summarise controlled trials and systematic reviews that evaluate patient-related, provider-related, and system-related factors supporting responsible opioid prescribing for chronic non-cancer pain. A scoping review methodology was employed, and six databases were searched. Thirteen systematic reviews and nine controlled trials were included for analysis, and clinical guidelines were reviewed to supplement gaps in the literature. The majority of included studies evaluated provider-related factors, including prescribing behaviours and monitoring for misuse. A smaller number of studies evaluated system-level factors such as regulatory measures and models of healthcare delivery. Studies and guidelines emphasise the importance of careful patient selection for opioid therapy, development of a treatment plan, and cautious initiation and dose escalation. Lower doses are associated with reduced risk of harm and can be efficacious, particularly when used in the context of a multimodal interdisciplinary pain management program. Further research is needed around many elements of responsible prescribing, including instruments to monitor for misuse, and the role of policies and programs.


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