Should BMJ retract guideline that finds commonly used interventional procedures for chronic spine pain aren’t effective?

A guideline recommending against common interventional procedures for chronic non-cancer spine pain has stirred up debate, along with uncertainty about how best to treat theses patients.The Rapid Recommendation guideline, published in the BMJ, garnered an editorial in the same edition of the journal, a multi-society response critical of the guideline, and a detailed feature in Retraction Watch.But the sources all agree: additional high-quality randomized controlled trials (RCTs) are needed to establish the effectiveness of interventional procedures.The guideline and its recommendations apply to adults living with moderate to severe chronic, axial or radicular, spine pain (neck, back, sacroiliac) which persists three months or longer. They do not apply to the management of acute spine pain, or chronic spine pain associated with cancer or inflammatory arthropathy.The key recommendations:Chronic axial spine pain (3 months or longer), strong recommendations against:Joint radiofrequency ablation with or without joint targeted injection of local anaesthetic plus steroidEpidural injection of local anaesthetic, steroids, or their combinationJoint-targeted injection of local anaesthetic, steroids, or their combinationIntramuscular injection of local anaesthetic with or without steroidsChronic radicular spine pain (3 months or less), strong recommendations against: Dorsal root ganglion radiofrequency with or without epidural injection of local anaesthetic or local anaesthetic plus steroids.Epidural injection of local anaesthetic, steroids, or their combination.The recommendations were based on a systematic review and network meta-analysis of RCTs, plus a systematic review of observational studies, summarising evidence for both benefits and harms of common interventional procedures for axial and radicular, chronic, non-cancer spine pain.The guideline falls on the heels of other studies and meta-analyses casting doubt on the effectiveness of interventional procedures. One was a study from 2023 which summarized recommendations on the interventional management of subacute and chronic non-radicular low back pain from 21 clinical practice guidelines. That paper concluded most recommendations “were either weakly for, weakly against, or inconclusive, with several recommendations within each treatment category contradicting each other.”Many guidelines are of poor quality, said Dr. Jason Busse, lead author of the new BMJ guideline and professor of anesthesia and Health Research Methods, Evidence and Impact at McMaster University.Dr. Busse told the Canadian Healthcare Network (CHN), “Our review found 132 RCTs of interventional procedures for chronic spine pain, and our network meta-analysis provided moderate certainty evidence for the lack of effectiveness of five procedures on pain relief and six procedures on physical functioning. We did not find even low-certainty evidence supporting the effectiveness of any interventional procedure for pain relief when compared to sham.”He noted that while “several prior guidelines have used existing meta-analyses to inform their recommendations, ours may be the first to conduct a full systematic review and meta-analysis of all common interventional procedures.” Further, prior clinical practice guidelines have important limitations. A coauthor of the paper is Dr. Gordon Guyatt, also at McMaster University, who is credited with coining the term ‘evidence-based medicine’ and known for promoting approaches to improve the quality of medical research. There are other approaches used for creating guidelines that also don’t necessarily lead to high quality.“Many guidelines use the GOBSAT approach—Good Old Boys Sitting Around the Table. Clinical experts are assembled to develop clinical practice recommendations through discussion and consensus. This approach is particularly vulnerable to bias,” Dr. Busse said.An editorial in the BMJ stated that “The research and guideline recommendations are worthy of attention, especially the conclusion that spine injections [versus sham procedures] result in little or no pain relief for either axial or radicular back pain.” The editorial argued that although commonly used, treatments that work well for acute, subacute, or acute-on-chronic pain may be ineffective for chronic pain. Regardless, reimbursements are often more favourable for procedural than non-procedural treatments for chronic spine pain.However, a multi-society response to the guideline said the conclusions fall short and that the BMJ should retract the paper. Published in Interventional Pain Medicine, it was signed by 34 medical professional societies including the International Pain and Spine Intervention Society, the American Academy of Pain Medicine and others. There were no Canadian signatories.The letter acknowledged that the guideline stimulated important dialogue about the role of interventional procedures in managing chronic spine pain and highlighted a need for additional high-quality RCTs.But added “we, the undersigned societies comprising physicians who prescribe or perform interventional spine procedures, have serious concerns about the methodology and conclusions drawn in these publications.” The key issues relate to things researchers are concerned about: how studies are selected in meta-analyses, and how information from different studies with different approaches should be extracted and summarized.The letter stated “The disappointing truth is that there are not enough high-quality RCTs in interventional spine care to perform a well-powered meta-analysis in this area. As a result, we rely on carefully reasoned and balanced systematic reviews that incorporate the breadth of the available literature.”It also suggested that guideline development should involve participants from different training backgrounds and specialties.(The BMJ guideline included four people living with chronic spine pain, 10 clinicians with experience managing chronic spine pain, and eight methodologists.)It concluded with “When provided with treatment options and informed consent, we remain confident that many patients will continue to choose interventional spine procedures performed by highly skilled and caring physicians.”Regarding the backlash, Dr. Busse told CHN “we published the protocol for our network meta-analysis, each of our articles underwent a rigorous process of peer-review, and our guideline panel members who voted on all recommendations were free of any important financial or intellectual conflicts of interest.” One factor that may contribute to disappointment with the findings includes financial considerations as the use of interventional procedures for chronic spine pain is a multi-billion dollar industry.The guideline pointed out that between 1994 and 2001 the U.S. saw a 271% increase in lumbar epidural steroid injections and a 231% increase in facet injections for low back pain. Facet joint or sacroiliac joint interventions in U.S. Medicare recipients increased from about 425,000 in 2000 to 2.2 million interventions in 2013.And rates keep going up. A report in the Lancet stated in the U.S., Medicare reimbursement data showed that epidural spine injections increased 1,550% between 2000 and 2020, and radiofrequency ablation increased 65% between 2012 and 2020.Dr. Busse noted the apparent effectiveness of interventional procedures in practice doesn’t take the placebo effect into account. Plus, patients often present for care when symptoms are elevated, which means that many will experience improvement over time regardless of what treatment they receive.Patients who perceive benefit from interventional procedures will return for further care, while those that do not perceive benefit will often not return and may not be counted in success rates, he said.A spokesperson for the Canadian Pain Society (CPS) expressed concerns with the guideline. “They don’t really take into account other evidence and challenges involved in managing lower back pain patients,” said Dr. Harsha Shanthanna, chair of the Interventional Special Interest Group for the CPS, and professor of anesthesiology and pain medicine at McMaster University.“Patients with chronic lower back pain would have typically suffered for years before they get to a pain management clinic and most would have tried conservative measures that may or may not have provided meaningful response,” he said. Some patients may have secondary issues or sources of pain, such as leg pain, that aren’t captured in RCTs and hence evidence doesn’t necessarily reflect what’s in real-world practice. These nuances require individualized treatments. “The recommendations seem to ignore that clinical decision making requires us to consider all therapies and their related evidence. It is fool hardly to conduct a meta-analysis of poor quality RCTs and then formulate guidelines on that, and recommend against the use of all spine interventions. This leaves patients with limited options” he said. What should doctors do?They should consider multidisciplinary interventions including non-pharmacological strategies, medications as part of conservative management in all patients and interventions in some patients, Dr. Shanthanna said. In real-world medicine, spine interventions are useful in carefully selected patients, he said.

Should BMJ retract guideline that finds commonly used interventional procedures for chronic spine pain aren’t effective?

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