{"id":11657,"date":"2026-02-05T16:31:12","date_gmt":"2026-02-05T05:31:12","guid":{"rendered":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/?p=11657"},"modified":"2026-03-26T16:32:15","modified_gmt":"2026-03-26T05:32:15","slug":"promising-cannabis-trial-for-back-pain-sparks-limited-optimism-amid-safety-concerns-but-larger-studies-contradict-2","status":"publish","type":"post","link":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/promising-cannabis-trial-for-back-pain-sparks-limited-optimism-amid-safety-concerns-but-larger-studies-contradict-2\/","title":{"rendered":"Promising\u2019 Cannabis Trial for Back Pain Sparks Limited Optimism Amid Safety Concerns \u2013 But Larger Studies Contradict."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"11657\" class=\"elementor elementor-11657\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5dfd2bef e-flex e-con-boxed e-con e-parent\" data-id=\"5dfd2bef\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-78c34981 elementor-widget elementor-widget-text-editor\" data-id=\"78c34981\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><img fetchpriority=\"high\" decoding=\"async\" class=\"size-medium wp-image-11393 alignright\" src=\"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-content\/uploads\/2026\/02\/leafglobe-300x169.jpg\" alt=\"\" width=\"300\" height=\"169\" srcset=\"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-content\/uploads\/2026\/02\/leafglobe-300x169.jpg 300w, https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-content\/uploads\/2026\/02\/leafglobe-1024x576.jpg 1024w, https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-content\/uploads\/2026\/02\/leafglobe-768x432.jpg 768w, https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-content\/uploads\/2026\/02\/leafglobe.jpg 1407w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><strong>\u2018<\/strong>A large phase 3 trial in\u00a0<a href=\"https:\/\/www.cochranelibrary.com\/cdsr\/doi\/10.1002\/14651858.CD012182.pub2\/full\" target=\"_blank\" rel=\"noopener\"><em>Nature Medicine<\/em>\u00a0<\/a>has delivered a \u2018stronger\u2019 clinical signal that a proprietary cannabis extract, VER-01, can modestly reduce chronic low back pain \u2013 but the effect is small, side effects are common, and broader evidence from other pain conditions remains weak and inconsistent. Experts say the findings should temper rather than fuel enthusiasm, especially for general cannabis use or over-the-counter products.<\/p><p><strong>Trial highlights: modest benefit over placebo (a very close second)<\/strong><\/p><p>The multicentre randomized controlled trial enrolled 820 adults with chronic low back pain and compared VER-01, a standardized full\u2011spectrum\u00a0<em>Cannabis sativa<\/em>\u00a0extract containing THC, CBD and other cannabinoids, with placebo over 12\u201315 weeks, followed by extension phases.<a href=\"https:\/\/www.nature.com\/articles\/s41591-025-03977-0\" target=\"_blank\" rel=\"noopener\"><strong><sup>1<\/sup><\/strong><\/a><\/p><p>Key efficacy findings include:<\/p><ul><li>Average pain reduction of 1.9 points on an 11\u2011point numeric rating scale (NRS) with VER\u201101 vs 1.3\u20131.4 points with placebo, producing a mean between\u2011group difference of about \u22120.6 NRS points (95% CI roughly \u22120.9 to \u22120.3).<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41023483\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>2<\/sup><\/strong><\/a><\/li><li>About 42% of VER\u201101 patients achieved at least 30% pain reduction vs 31% on placebo, giving a number needed to treat (NNT) of 6.8 for this threshold.<a href=\"https:\/\/www.news-medical.net\/news\/20250930\/Cannabis-extract-eases-chronic-back-pain-and-improves-quality-of-life-in-major-clinical-trial.aspx\" target=\"_blank\" rel=\"noopener\"><strong><sup>3\u00a0 <\/sup><\/strong><\/a><\/li><li>Secondary outcomes showed statistically significant improvements in sleep quality, physical function and patient global impression of change, with reduced use of rescue analgesics.<a href=\"https:\/\/reachmd.com\/news\/ver-01-phase-3-trial-a-new-era-in-chronic-low-back-pain-management\/2485085\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>4<\/sup><\/strong><\/a><\/li><\/ul><p>Clinically, that means most participants in both arms felt somewhat better, but only a minority derived clearly meaningful extra benefit from VER\u201101 beyond placebo, and the average advantage was modest.<a href=\"https:\/\/www.news-medical.net\/news\/20250930\/Cannabis-extract-eases-chronic-back-pain-and-improves-quality-of-life-in-major-clinical-trial.aspx\" target=\"_blank\" rel=\"noopener\"><strong><sup>5<\/sup><\/strong><\/a><\/p><p><strong>Safety profile: frequent adverse effects, limited durability<\/strong><\/p><p>VER\u201101\u2019s safety signal is not benign. Adverse events (AEs) were substantially more common in the active arm:<\/p><ul><li>Any AE occurred in 83.3% of VER\u201101 recipients vs 67.3% on placebo, mostly dizziness, fatigue, somnolence, nausea and related nervous\u2011system symptoms.<a href=\"https:\/\/www.nature.com\/articles\/s41591-025-03977-0\" target=\"_blank\" rel=\"noopener\"><strong><sup>6<\/sup><\/strong><\/a><\/li><li>Treatment discontinuation due to AEs was around 17% with VER\u201101 compared with 3.5% on placebo.<a href=\"https:\/\/www.sciencemediacentre.org\/expert-reaction-to-phase-3-trial-of-cannabis-extract-ver-01-for-chronic-low-back-pain\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>7<\/sup><\/strong><\/a><\/li><li>In the randomized withdrawal phase, VER\u201101 did not significantly prolong time to treatment failure compared with placebo (HR 0.75; p=0.288), suggesting limited durability or strong contextual\/placebo contributions.<a href=\"https:\/\/www.sciencemediacentre.org\/expert-reaction-to-phase-3-trial-of-cannabis-extract-ver-01-for-chronic-low-back-pain\/\" target=\"_blank\" rel=\"noopener\"> <strong><sup>8<\/sup><\/strong><\/a><\/li><\/ul><p>Importantly, the trial reports no clear signals of abuse, dependence or withdrawal in the controlled period or the six\u2011month open\u2011label extension, but the follow\u2011up is still relatively short for judging long\u2011term neurocognitive or psychiatric risks. The absence of formal blinding checks and dedicated cognitive testing leaves some uncertainty about expectation effects and subtle harms.<a href=\"https:\/\/reachmd.com\/news\/ver-01-phase-3-trial-a-new-era-in-chronic-low-back-pain-management\/2485085\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>9<\/sup><\/strong><\/a><\/p><p><strong>What the broader evidence shows: small gains, real harms<\/strong><\/p><p>The VER\u201101 findings sit within a larger, more sobering evidence base on cannabis\u2011based medicines for chronic pain. A major Cochrane review of 16 randomized trials (n=1,750) in chronic neuropathic pain \u2013 using oral THC\/CBD sprays, synthetic THC (nabilone), dronabinol, and smoked herbal cannabis \u2013 found only small benefits and clear safety concerns.<\/p><p>Across pooled neuropathic pain studies, the review reported:<\/p><ul><li>50% pain relief: 21% with cannabis\u2011based medicines vs 17% with placebo (risk difference 0.05; NNT \u2248 20; low\u2011quality evidence).<\/li><li>30% pain relief: 39% vs 33% (risk difference 0.09; NNT \u2248 11; moderate\u2011quality evidence).<\/li><li>Withdrawals due to adverse events: 10% vs 5% (NNH \u2248 25; moderate\u2011quality evidence).<\/li><li>Any nervous\u2011system AE (e.g. dizziness, somnolence): 61% vs 29% (risk difference 0.38; NNH \u2248 3).<\/li><li>Psychiatric AEs (e.g. confusion, mood or perceptual changes): 17% vs 5% (risk difference 0.10; NNH \u2248 10).<\/li><\/ul><p>The authors concluded that \u201cthe potential benefits of cannabis\u2011based medicine\u2026 in chronic neuropathic pain might be outweighed by their potential harms\u201d and that there is no high\u2011quality evidence supporting any cannabis\u2011based product for chronic neuropathic pain. Evidence for smoked or herbal cannabis was rated very low quality and showed no clear advantage over placebo.<\/p><p>Although neuropathic pain differs from mechanical low back pain, both are chronic pain states in which placebo responses are high and NNTs for cannabis\u2011based products tend to cluster in the 6\u201320 range, with frequent nervous\u2011system and psychiatric adverse events. This broader context undercuts simple narratives that \u201ccannabis works for chronic pain\u201d and suggests any benefit is typically modest and tightly bound to specific formulations and trial conditions.<a href=\"https:\/\/www.cannabisevidence.org\/cannabis-blunts-back-pain-in-2-new-studies\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>1<\/sup><\/strong><\/a><strong><sup>0 <\/sup><\/strong><\/p><p><strong>Experts urge caution: specific product, specific setting<\/strong><\/p><p>Though some investigators of this trial had a clear conflict of interest, which the literature hasn\u2019t made clear, some specialists commenting on the VER\u201101 trial have welcomed it as a methodologically stronger study than most past cannabis pain trials, (which quality and depth have all been very sub-standard) but stress several caveats:<\/p><ul><li>The results are specific to VER\u201101 \u2013 a standardized, pharmaceutical\u2011grade extract \u2013 and cannot be generalized to smoked cannabis, edibles, or unregulated oils.<a href=\"https:\/\/www.cannabisevidence.org\/cannabis-blunts-back-pain-in-2-new-studies\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>11<\/sup><\/strong><\/a><\/li><li>The effect size is small; in practice, it equates to about a 30% average pain reduction on VER\u201101 vs 20% on placebo over 12 weeks.<a href=\"https:\/\/www.vpm.org\/npr-news\/npr-news\/2025-10-20\/cannabis-blunts-back-pain-in-2-new-studies\" target=\"_blank\" rel=\"noopener\"><strong><sup>12<\/sup><\/strong><\/a><strong><sup>\u200b<\/sup><\/strong><\/li><li>Given Cochrane\u2019s finding that cannabis\u2011based medicines for neuropathic pain offer only minor additional benefit over placebo with substantial nervous\u2011system and psychiatric AEs, routine first\u2011line use in back pain would be hard to justify.<\/li><\/ul><p>Guidelines cited by the Cochrane review generally position cannabis\u2011based medicines, if considered at all, as third\u2011 or fourth\u2011line options after established treatments such as NSAIDs, antidepressants, anticonvulsants, and non\u2011pharmacologic therapies have been tried and found inadequate. Some expert groups even give a weak recommendation\u00a0<em>against<\/em>\u00a0routine use in neuropathic pain because of low\u2011quality benefits and safety concerns.<\/p><p><strong>What this means for patients, clinicians and policy<\/strong><\/p><p>Taken together, the VER\u201101 trial and the Cochrane synthesis point to a cautious, tightly targeted role for cannabis\u2011based medicines in chronic pain:<\/p><ul><li><strong>Not a miracle drug:<\/strong>\u00a0VER\u201101 offers statistically significant but clinically modest improvements in chronic low back pain; placebo comes a close second on most endpoints.<a href=\"https:\/\/www.news-medical.net\/news\/20250930\/Cannabis-extract-eases-chronic-back-pain-and-improves-quality-of-life-in-major-clinical-trial.aspx\" target=\"_blank\" rel=\"noopener\"><strong><sup>13<\/sup><\/strong><\/a><\/li><li><strong>Meaningful benefit for a minority:<\/strong>\u00a0NNTs around 6\u201311 for 30% pain relief \u2013 in both VER\u201101 and the neuropathic pain literature \u2013 imply that many patients will not gain substantial extra benefit over optimized standard care.<a href=\"https:\/\/www.news-medical.net\/news\/20250930\/Cannabis-extract-eases-chronic-back-pain-and-improves-quality-of-life-in-major-clinical-trial.aspx\" target=\"_blank\" rel=\"noopener\"><strong><sup>14<\/sup><\/strong><\/a><strong><sup>\u200b<\/sup><\/strong><\/li><li><strong>Real risk of side effects:<\/strong>\u00a0Dizziness, somnolence, cognitive and psychiatric symptoms are common, with NNHs as low as 3 for nervous\u2011system events in neuropathic pain trials, and discontinuation rates notably higher than placebo in both VER\u201101 and Cochrane data.<a href=\"https:\/\/www.news-medical.net\/news\/20250930\/Cannabis-extract-eases-chronic-back-pain-and-improves-quality-of-life-in-major-clinical-trial.aspx\" target=\"_blank\" rel=\"noopener\"><strong><sup>15\u00a0 <\/sup><\/strong><\/a><strong><sup>\u200b<\/sup><\/strong><\/li><li><strong>Formulation matters:<\/strong>\u00a0Evidence supports specific, trial\u2011tested preparations (like VER\u201101 or THC\/CBD oromucosal sprays), not generic plant material or over\u2011the\u2011counter products.<a href=\"https:\/\/pharmaceutical-journal.com\/article\/news\/cannabis-could-be-effective-for-chronic-lower-back-pain-phase-iii-trial-results-suggest\" target=\"_blank\" rel=\"noopener\"><strong><sup>16 <\/sup><\/strong>\u00a0<\/a>\u200b<\/li><li><strong>Research, not routine:<\/strong>\u00a0Longer\u2011term safety, comparative effectiveness vs opioids, NSAIDs and guideline\u2011recommended non\u2011drug therapies, and performance in more heterogeneous real\u2011world populations all remain open questions.<a href=\"https:\/\/reachmd.com\/news\/ver-01-phase-3-trial-a-new-era-in-chronic-low-back-pain-management\/2485085\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>17<\/sup><\/strong> <\/a>\u200b<\/li><\/ul><p>For now, chronic low back pain patients and clinicians may reasonably view VER\u201101 as a potential non\u2011opioid option for carefully selected individuals who have not responded to established treatments and who accept a high likelihood of transient but bothersome side effects. Yet in light of the broader evidence base, these new data are better seen as an incremental advance than as proof that cannabis, in general, reliably and safely relieves chronic back pain.<a href=\"https:\/\/reachmd.com\/news\/ver-01-phase-3-trial-a-new-era-in-chronic-low-back-pain-management\/2485085\/\" target=\"_blank\" rel=\"noopener\"><strong><sup>18 <\/sup><\/strong><\/a><strong><sup>\u200b<\/sup><\/strong><\/p><p>For complete research \u2013 Major Sources<\/p><ul><li><a href=\"https:\/\/www.cochranelibrary.com\/cdsr\/doi\/10.1002\/14651858.CD012182.pub2\/full\" target=\"_blank\" rel=\"noopener\"><strong>Cannabis\u2010based medicines for chronic neuropathic pain in adults &#8211; M\u00fccke, M &#8211; 2018 | Cochrane Library<\/strong><\/a><\/li><li><a href=\"https:\/\/www.nature.com\/articles\/s41591-025-03977-0?fbclid=IwdGRzaAPv-9ZjbGNrA-_7xWV4dG4DYWVtAjExAHNydGMGYXBwX2lkDDM1MDY4NTUzMTcyOAABHg4PMJjsys38sLn8sJYVkBRRvr77GEohyVbTDSjSk2ys5HiEPZiFy6r_cb2M_aem_l3FWmCH9ZNcryNuo3aez-Q&amp;sfnsn=mo\" target=\"_blank\" rel=\"noopener\"><strong>Full-spectrum extract from\u00a0<em>Cannabis sativa<\/em>\u00a0DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial<\/strong><\/a><\/li><li><a href=\"https:\/\/www.cochrane.org\/about-us\/news\/no-clear-evidence-cannabis-based-medicines-relieve-chronic-nerve-pain\" target=\"_blank\" rel=\"noopener\"><strong>No clear evidence that cannabis-based medicines relieve chronic nerve pain | Cochrane<\/strong><\/a><\/li><\/ul><p>Dalgarno Institute<\/p><p><strong>\u00a0<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\u2018A large phase 3 trial in\u00a0Nature Medicine\u00a0has delivered a \u2018stronger\u2019 clinical signal that a proprietary cannabis extract, VER-01, can modestly reduce chronic low back pain \u2013 but the effect is small, side effects are common, and broader evidence from other pain conditions remains weak and inconsistent. Experts say the findings should temper rather than fuel [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":11393,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":"","_wp_rev_ctl_limit":""},"categories":[15],"tags":[],"class_list":["post-11657","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cannabis-as-medicine"],"_links":{"self":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts\/11657","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/comments?post=11657"}],"version-history":[{"count":1,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts\/11657\/revisions"}],"predecessor-version":[{"id":11658,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts\/11657\/revisions\/11658"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/media\/11393"}],"wp:attachment":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/media?parent=11657"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/categories?post=11657"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/tags?post=11657"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}