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Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials. 曲马多-塞来昔布共晶体(CTC)在急性中度至重度疼痛患者中的安全性:三项第三阶段随机试验的汇总分析。
IF 4.1 2区 医学
Pain and Therapy Pub Date : 2024-09-24 DOI: 10.1007/s40122-024-00655-w
Eugene R Viscusi, Richard Langford, Adelaida Morte, Anna Vaqué, Jesús Cebrecos, Mariano Sust, José María Giménez-Arnau, Oscar de Leon-Casasola
{"title":"Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials.","authors":"Eugene R Viscusi, Richard Langford, Adelaida Morte, Anna Vaqué, Jesús Cebrecos, Mariano Sust, José María Giménez-Arnau, Oscar de Leon-Casasola","doi":"10.1007/s40122-024-00655-w","DOIUrl":"https://doi.org/10.1007/s40122-024-00655-w","url":null,"abstract":"<p><strong>Introduction: </strong>Multi-modal analgesia is desirable for the management of acute pain since it can provide effective pain relief at lower doses, thereby aiding tolerability. Co-crystal of tramadol-celecoxib (CTC) provides effective analgesia in models of acute pain. Co-crystallization can alter the pharmacokinetics of individual components, potentially improving tolerability. We sought to better understand the safety and tolerability of CTC in patients with acute postoperative pain.</p><p><strong>Methods: </strong>We conducted a pooled analysis of safety data from three phase 3 randomized controlled trials in adults with acute moderate-to-severe pain following oral surgery, bunionectomy, and elective abdominal hysterectomy. We present data for CTC 200 mg twice daily (BID) and its comparators: tramadol 50 mg four times daily (QID) (one trial), tramadol 100 mg QID (two trials), celecoxib 100 mg BID (two trials), and placebo (three trials).</p><p><strong>Results: </strong>In total, n = 551 patients received CTC 200 mg BID, n = 183 received tramadol 50 mg QID, n = 368 received tramadol 100 mg QID, n = 388 received celecoxib 100 mg BID, and n = 274 received placebo. The prevalence of adverse events (AEs) related to study drug up to 48 h was numerically lower with CTC 200 mg BID (35.9%) than with tramadol 50 mg QID (47.5%) and 100 mg QID (44.8%) but greater than with celecoxib 100 mg BID (12.4%) and placebo (20.4%). The most frequent AEs related to study drug up to 48 h were somnolence, nausea, dizziness, and vomiting, which occurred more frequently in patients receiving tramadol 100 mg QID than in those receiving CTC 200 mg BID.</p><p><strong>Conclusion: </strong>CTC 200 mg BID appears to be better tolerated than tramadol 100 mg QID, possibly because of reduced total exposure to tramadol. This may contribute to a more favorable benefit-risk profile for CTC versus individual components, making it a promising treatment for acute pain.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers: NCT03108482, NCT02982161 (EudraCT: 2016-000592-24), NCT03062644 (EudraCT: 2016-000593-38).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Present and Future of Pharmacological Management for Acute Moderate-to-Severe Postoperative, Traumatic, or Musculoskeletal Pain in Europe: A Narrative Review. 欧洲急性中重度术后、创伤或肌肉骨骼疼痛药物治疗的现状与未来:叙述性综述》。
IF 4.1 2区 医学
Pain and Therapy Pub Date : 2024-09-21 DOI: 10.1007/s40122-024-00645-y
Eugene R Viscusi, Francisco Epelde, Luis Javier Roca Ruiz, Eva Trillo-Calvo
{"title":"Present and Future of Pharmacological Management for Acute Moderate-to-Severe Postoperative, Traumatic, or Musculoskeletal Pain in Europe: A Narrative Review.","authors":"Eugene R Viscusi, Francisco Epelde, Luis Javier Roca Ruiz, Eva Trillo-Calvo","doi":"10.1007/s40122-024-00645-y","DOIUrl":"https://doi.org/10.1007/s40122-024-00645-y","url":null,"abstract":"<p><p>Acute moderate-to-severe pain is common after surgery, trauma, or musculoskeletal injury, but its management remains suboptimal. Current single-agent treatments are limited by safety concerns, narrow therapeutic windows, and abuse potential, leaving substantial unmet needs. Here, we aimed to review guidelines for the management of acute moderate-to-severe post-surgical, trauma-related, or musculoskeletal pain in adults and discuss existing and potential future analgesics in this setting. We searched PubMed to identify relevant guidelines and existing analgesics for acute pain. To identify compounds in development, we searched ClinicalTrials.gov and the European Union Clinical Trials Register. Guidelines universally recognize the limitations of single-agent analgesics (particularly those with a single mechanism of action [MoA]) and recommend a multimodal approach as an established standard for acute pain. The benefit-risk profiles of traditional treatments, including paracetamol (acetaminophen), nonsteroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, and opioids, can be improved by combining agents targeting different pain pathways. In multimodal approaches, lower doses of constituent agents can be used to achieve the same or superior analgesic effects relative to the individual agents. In some cases, novel formulations and co-crystal technology offer enhanced physicochemical and pharmacokinetic properties over individual agents. Lastly, initiatives to increase patient awareness and education around pain management may improve treatment satisfaction and quality of life, and hasten recovery. In conclusion, management of acute moderate-to-severe pain remains inadequate. Multimodal analgesics may offer advantages over traditional single-agent treatments (that often have a single MoA) for acute moderate-to-severe post-surgical, trauma-related, or musculoskeletal pain in adults. Multimodal analgesics, combined with patient education initiatives and non-pharmacological measures, when necessary, offer promise in addressing unmet needs in this setting.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142292999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patients’ Experiences During the Long Journey Before Initiating Migraine Prevention with a Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody (mAb) 患者在开始使用降钙素基因相关肽 (CGRP) 单克隆抗体 (mAb) 预防偏头痛之前的漫长旅程中的经历
IF 4 2区 医学
Pain and Therapy Pub Date : 2024-09-19 DOI: 10.1007/s40122-024-00652-z
Elizabeth Seng, Christian Lampl, Lars Viktrup, William R. Lenderking, Hayley Karn, Margaret Hoyt, Gilwan Kim, Dustin Ruff, Michael H. Ossipov, Maurice Vincent
{"title":"Patients’ Experiences During the Long Journey Before Initiating Migraine Prevention with a Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody (mAb)","authors":"Elizabeth Seng, Christian Lampl, Lars Viktrup, William R. Lenderking, Hayley Karn, Margaret Hoyt, Gilwan Kim, Dustin Ruff, Michael H. Ossipov, Maurice Vincent","doi":"10.1007/s40122-024-00652-z","DOIUrl":"https://doi.org/10.1007/s40122-024-00652-z","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Migraine is under-diagnosed and under-treated. Many people with migraine do not seek medical care, and those who do may initially receive a different diagnosis and/or be dissatisfied with provided care on their journey before treatment with a CGRP-mAb (calcitonin-gene-related-peptide monoclonal antibody).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This is a cross-sectional, self-reported, online survey of subjects in Lilly’s Emgality<sup>®</sup> Patient Support Program in 2022. Questionnaires collected insights into subjects’ prior experiences with migraine and interactions with healthcare professionals before receiving CGRP-mAbs.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Of the 250 participants with episodic and 250 with chronic migraine, 90% were female and white with a mean age of 26.2 years (± 11.9) at diagnosis and 40.6 (± 12.0) years at survey enrollment. Many participants (71%) suspected they had migraine before diagnosis, with 31% reluctant to seek help. Of these, approximately one-third were unaware of treatment, did not think that a physician could do anything more for migraine, would not take them seriously, or were reluctant due to a previous unhelpful experience. Participants mainly received information from friends/family (47%) or the internet (28%). Participants initially sought treatment due to an increase in migraine frequency (77%), attacks interfering with work or school (75%), or increased pain intensity (74%). Subjects saw a mean of 4.1 (± 4.3) healthcare providers before migraine diagnosis, and 20% of participants previously received a different diagnosis. Participants reported migraine causes included stress/anxiety/depression (42%), hormonal changes (30%), nutrition (20%), and weather (16%). Acute treatment of migraine included prescription (82%) and over-the-counter (50%) medications, changes in nutrition (62%), adjusting fluid intake (56%), and relaxation techniques (55%). Preventive medications included anticonvulsants (61%), antidepressants (44%), blood pressure-lowering medications (43%), and botulinum toxin A injections (17%). Most discontinuations were due to lack of efficacy or side effects.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>People with migraine describe reluctance in seeking health care, and misunderstandings seem common especially in the beginning of their migraine journey.</p><p>Graphical abstract available for this article.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\u0000","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142254626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-World Evidence of the Safety and Effectiveness of Atogepant Added to OnabotulinumtoxinA for the Preventive Treatment of Chronic Migraine: A Retrospective Chart Review 阿托格潘与奥那博妥珠单抗(OnabotulinumtoxinA)并用预防性治疗慢性偏头痛的安全性和有效性的真实世界证据:回顾性病历审查
IF 4 2区 医学
Pain and Therapy Pub Date : 2024-09-17 DOI: 10.1007/s40122-024-00649-8
Andrew M. Blumenfeld, Laszlo Mechtler, Lisa Cook, Christopher Rhyne, Brian Jenkins, Olivia Hughes, Brett Dabruzzo, Aubrey Manack Adams, Merle Diamond
{"title":"Real-World Evidence of the Safety and Effectiveness of Atogepant Added to OnabotulinumtoxinA for the Preventive Treatment of Chronic Migraine: A Retrospective Chart Review","authors":"Andrew M. Blumenfeld, Laszlo Mechtler, Lisa Cook, Christopher Rhyne, Brian Jenkins, Olivia Hughes, Brett Dabruzzo, Aubrey Manack Adams, Merle Diamond","doi":"10.1007/s40122-024-00649-8","DOIUrl":"https://doi.org/10.1007/s40122-024-00649-8","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Combination use of atogepant and onabotulinumtoxinA has the potential to be more effective than either alone for the preventive treatment of chronic migraine (CM) due to their complementary mechanisms of action. This analysis collected real-world data to evaluate the safety, tolerability, and effectiveness of adding atogepant to onabotulinumtoxinA as a combination preventive treatment for CM.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This retrospective, longitudinal, multicenter chart review included adults with CM who received ≥ 2 consecutive cycles of onabotulinumtoxinA before ≥ 1 month of onabotulinumtoxinA and atogepant combination treatment. Charts at atogepant prescription (index date) and two subsequent onabotulinumtoxinA treatment visits (~ 3 and ~ 6 months post-index) were reviewed for change from baseline in monthly headache days (MHDs), ≥ 50% reduction in MHDs, discontinuation rates, and adverse events (AEs).</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Of the 55 charts that met safety analysis criteria, 31 had data on headache days at index and first post-index visit and were eligible for effectiveness analysis (mean age 46.7 years, 94.5% female). For those with data available prior to onabotulinumtoxinA treatment (<i>n</i> = 25), the mean MHD was 24.0 days, reduced by 8.15 days after onabotulinumtoxinA treatment. After atogepant was added, MHD was incrementally reduced by 4.53 days and 8.75 days from index date to the first (<i>N</i> = 31) and second (<i>N</i> = 23) post-index onabotulinumtoxinA treatment visit, respectively. A ≥ 50% reduction in MHDs was achieved by 45.2% of patients ~ 3 months post-index. Atogepant and onabotulinumtoxinA were discontinued by 16.1% and 6.5% of patients, respectively. In the safety population, 32.7% of patients experienced ≥ 1 AE. No serious AEs were reported.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>This real-world study of patients with CM demonstrated that adding atogepant to onabotulinumtoxinA as a combination preventive treatment for CM was effective by providing an additional reduction in MHDs over ~ 3 and ~ 6 months of combination treatment. Safety results were consistent with the known safety profiles of onabotulinumtoxinA and atogepant, with no new safety signals identified.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142254627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pain Characteristics of the Posterior Longitudinal Ligament in Percutaneous Endoscopic Lumbar Discectomy and its Significance: A Retrospective Study 经皮内窥镜腰椎间盘切除术中后纵韧带的疼痛特征及其意义:回顾性研究
IF 4 2区 医学
Pain and Therapy Pub Date : 2024-09-14 DOI: 10.1007/s40122-024-00656-9
Kaining Zhang, Yun Yang, Wen Yu, Yubin Qi, Yanjun Ren, Yingguang Wu, Wa Shan, Fengxiang Zhu, Feifei Chen
{"title":"Pain Characteristics of the Posterior Longitudinal Ligament in Percutaneous Endoscopic Lumbar Discectomy and its Significance: A Retrospective Study","authors":"Kaining Zhang, Yun Yang, Wen Yu, Yubin Qi, Yanjun Ren, Yingguang Wu, Wa Shan, Fengxiang Zhu, Feifei Chen","doi":"10.1007/s40122-024-00656-9","DOIUrl":"https://doi.org/10.1007/s40122-024-00656-9","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>In percutaneous endoscopic lumbar discectomy (PELD), pain occurs when the posterior longitudinal ligament (PLL) is exposed, removed, and decompressed. However, pain characteristics of the PLL stimulated in PELD have not been reported.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A total of 932 patients underwent PELD under local anesthesia. Pain distribution and intensity were recorded on a posterior body diagram during the operation. Pain intensity was assessed by the visual analog scale scores for the back (VAS-B). The PLL specimens were collected and observed using hematoxylin–eosin (HE) staining and immunohistochemistry.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Patients with lumbar disc herniation (LDH) at L4/5 and L5/S1 had pain foci in different regions. The mean VAS-B scores between the ventral and dorsal sides of the PLL were 6.14 ± 0.97 and 4.80 ± 1.15, respectively (<i>P</i> &lt; 0.05). The distribution of nociceptive nerve fibers in the dorsal side was uniform and scattered, while those in the ventral side were mainly distributed near the outer surface of the annulus fibrosus. The positive expression of substance P (SP) and calcitonin gene-related peptide (CGRP) was higher in the ventral side of the PLL than in the dorsal side (<i>P</i> &lt; 0.0001).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Differences in pain distribution and intensity were observed when the PLL was incited at different spinal levels during PELD surgery.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142254628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Idiopathic Distal Sensory Polyneuropathy and Fibromyalgia Syndrome: A Comparative Phenotyping Study 特发性远端感觉多神经病和纤维肌痛综合征:表型比较研究
IF 4 2区 医学
Pain and Therapy Pub Date : 2024-09-12 DOI: 10.1007/s40122-024-00646-x
Jamie Burgess, Anne Marshall, Leandros Rapteas, David Riley, Kohei Matsumoto, Cheng Boon, Alia Alchawaf, Maryam Ferdousi, Rayaz A. Malik, Andrew Marshall, Stephen Kaye, David Gosal, Bernhard Frank, Uazman Alam
{"title":"Idiopathic Distal Sensory Polyneuropathy and Fibromyalgia Syndrome: A Comparative Phenotyping Study","authors":"Jamie Burgess, Anne Marshall, Leandros Rapteas, David Riley, Kohei Matsumoto, Cheng Boon, Alia Alchawaf, Maryam Ferdousi, Rayaz A. Malik, Andrew Marshall, Stephen Kaye, David Gosal, Bernhard Frank, Uazman Alam","doi":"10.1007/s40122-024-00646-x","DOIUrl":"https://doi.org/10.1007/s40122-024-00646-x","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Painful idiopathic distal sensory polyneuropathy (IDSP) and fibromyalgia syndrome (FMS) are cryptogenic chronic pain syndromes. The contribution of small fibre pathology (SFP) in FMS remains controversial. This study aims to quantify small nerve pathology in participants with IDSP and FMS and identify relationships of SFP with sensory phenotypes.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>In this study, 73 individuals (FMS: 25, IDSP: 23, healthy volunteers: 25) underwent comprehensive assessment, including neurological exams, questionnaires, sensory tests, and corneal confocal microscopy.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>IDSP participants displayed lower wind-up ratio (WUR) relative to FMS (<i>p</i> &lt; 0.001), loss of function to thermal and mechanical stimuli and elevated neuropathy disability scores compared to FMS and healthy volunteers (all <i>p</i> &lt; 0.001). FMS participants demonstrated gain of function to heat and blunt pressure pain responses relative to IDSP, and healthy volunteers (heat: <i>p</i> = 0.002 and <i>p</i> = 0.003; pressure: both <i>p</i> &lt; 0.001) and WUR (both <i>p</i> &lt; 0.001). FMS participants exhibited reduced corneal nerve fibre density (<i>p</i> = 0.02), while IDSP participants had lower global corneal nerve measures (density, branch density, and length) relative to healthy volunteers (all <i>p</i> &lt; 0.001). Utilising corneal nerve fibre length, SFP was demonstrated in 66.6% of participants (FMS: 13/25; IDSP: 22/23).</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Participants with SFP, in both FMS and IDSP, reported symptoms indicative of small nerve fibre disease. Although distinctions in pain distributions are evident between individuals with FMS and IDSP, over 50% of participants between the two conditions displayed both a loss and gain of thermal and mechanical function suggestive of shared mechanisms. However, sensory phenotypes were associated with the presence of SFP in IDSP but not in FMS.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142182453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Conditioned Pain Modulation in Trigeminal Neuralgia Patients 经皮耳廓迷走神经刺激对三叉神经痛患者条件性疼痛调节的影响
IF 4 2区 医学
Pain and Therapy Pub Date : 2024-09-11 DOI: 10.1007/s40122-024-00654-x
Yu Zhang, Yiyuan Luo, Qixing Wu, Mingming Han, Haitao Wang, Fang Kang
{"title":"Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Conditioned Pain Modulation in Trigeminal Neuralgia Patients","authors":"Yu Zhang, Yiyuan Luo, Qixing Wu, Mingming Han, Haitao Wang, Fang Kang","doi":"10.1007/s40122-024-00654-x","DOIUrl":"https://doi.org/10.1007/s40122-024-00654-x","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Conditioned pain modulation (CPM) is a quantitative estimation of the capacity for endogenous pain modulation. Reduced CPM enables chronic painful event development or exacerbates pre-existing pain symptoms. Emerging reports indicate that patients with trigeminal neuralgia (TN) have dysregulated endogenous pain modulation. Transauricular vagus nerve stimulation (taVNS) is known to alleviate both acute and chronic pain symptoms. Its role in modulation or management of TN remains unknown. Here, we evaluated the taVNS efficacy in modulating CPM among TN patients. Conclusions from this investigation may facilitate establishment of novel non-invasive adjunctive approaches to treating TN patients.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>All research work was conducted at the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital). In all, we recruited 62 study participants, 31 TN patients and 31 healthy volunteers, for a 2-day experimental test. At the beginning of the experiment (Day 1), all subjects received 30 min of active taVNS. On Day 2, they received sham taVNS with the same duration and intensity. Meanwhile, technicians documented participant pressure pain thresholds (PPT) and CPM values at baseline, and at 15 and 30 min post-active or sham taVNS.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>A 30-min active taVNS exposure substantially elevated the PPT and CPM effect (<i>P</i> &lt; 0.05) among TN patients, and we also observed a notable rise in the PPT and CPM effect (<i>P</i> &lt; 0.05) among healthy controls. Additionally, there were no serious adverse events from the administered treatment.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Exposure to 30 min of active taVNS strongly augmented the CPM effect and elevated the PPT among TN patients and healthy controls. These effects were not observed with sham stimulation. Despite the limitations inherent to survey studies, such as duration and compliance biases, we consider that taVNS is a promising, safe, and cost-effective therapy. In future investigations, we recommend assessment of long-term taVNS application and its effects on CPM and clinical pain.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>ChiCTR2300078673 (www.Chictr.org.cn).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142182455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol 急性腰痛治疗中的多模式镇痛方法:新型镇痛组合依托考昔/曲马多的 III 期研究
IF 4 2区 医学
Pain and Therapy Pub Date : 2024-09-10 DOI: 10.1007/s40122-024-00653-y
Miguel A. Zuqui-Ramírez, Victor M. Belalcazar-López, Adelfia Urenda-Quezada, Alejandro González-Rebatu y González, José G. Sander-Padilla, Laura A. Lugo-Sánchez, Ileana C. Rodríguez-Vázquez, Kevin F. Rios-Brito, María M. Arguedas-Núñez, Emmanuel Canales-Vázquez, Jorge González-Canudas
{"title":"Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol","authors":"Miguel A. Zuqui-Ramírez, Victor M. Belalcazar-López, Adelfia Urenda-Quezada, Alejandro González-Rebatu y González, José G. Sander-Padilla, Laura A. Lugo-Sánchez, Ileana C. Rodríguez-Vázquez, Kevin F. Rios-Brito, María M. Arguedas-Núñez, Emmanuel Canales-Vázquez, Jorge González-Canudas","doi":"10.1007/s40122-024-00653-y","DOIUrl":"https://doi.org/10.1007/s40122-024-00653-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Pain and disability management are crucial for a speedy recovery. Combining analgesics with different mechanisms of action provides greater pain relief with lower doses, promoting efficient multimodal analgesia. This study evaluated the efficacy and safety between two fixed-dose combinations (FDC): etoricoxib/tramadol compared to paracetamol/tramadol for the management of acute low back pain (LBP) in a 7-day treatment.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We conducted a phase IIIb, prospective, randomized, and multicenter study in patients with acute LBP treated with etoricoxib 90 mg/tramadol 50 mg (one packet of granules diluted in 100 ml of water, once a day [QD], for 7 days) or paracetamol 975 mg/tramadol 112.5 mg (one tablet of 325 mg/37.5 mg, three times a day [TID], for 7 days) to assess the efficacy (in terms of pain and disability improvement) and safety.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>One hundred and twenty-four patients were randomized to receive either etoricoxib/tramadol QD (<i>n</i> = 61) or paracetamol/tramadol TID (<i>n</i> = 63). From the magnitude of change in pain evaluations, differences were observed between the treatment groups at 3 [<i>p</i> = 0.054, CI 95% − 0.648 (− 0.010 to 1.306)] and 5 days (<i>p</i> = 0.041). The proportion of patients with a 30% reduction in Visual Analogue Scale (VAS) score was statistically significant when comparing the treatment groups on the third day of follow-up [<i>p</i> = 0.008, CI 95% 0.241 (0.061–0.421)]. An improvement in LBP’s disability to perform activities of daily routine (Oswestry and Roland–Morris questionnaires) was observed in both treatment groups. A total of 79 adverse events (AEs) (38 [48.1%] with etoricoxib/tramadol and 41 [51.9%] with paracetamol/tramadol) were reported. The most frequent AEs were nausea (17.7%) and dizziness (16.4%).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>The results show the clinical benefits of etoricoxib/tramadol FDC, such as the sparing effect of tramadol dose per day, early therapeutic response rate compared with paracetamol/tramadol; which translates into faster pain relief, better adherence, less tramadol drug dependency, and a reduction of related AEs incidence.</p><h3 data-test=\"abstract-sub-heading\">Trial registration</h3><p>ClinicalTrials.gov identifier, NCT04968158.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142182454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Methadone Conversion Using a 3-Day Switch Strategy in Patients with Cancer on High-Dose Opioids: A Retrospective Study. 使用大剂量阿片类药物的癌症患者采用 3 天转换策略进行美沙酮转换:回顾性研究。
IF 4.1 2区 医学
Pain and Therapy Pub Date : 2024-09-07 DOI: 10.1007/s40122-024-00651-0
Lei Lei, Qinfei Zhou, Xi Liu, Guanai Bao, Haiying Ding, Qunfang Ding, Liyan Gong
{"title":"Methadone Conversion Using a 3-Day Switch Strategy in Patients with Cancer on High-Dose Opioids: A Retrospective Study.","authors":"Lei Lei, Qinfei Zhou, Xi Liu, Guanai Bao, Haiying Ding, Qunfang Ding, Liyan Gong","doi":"10.1007/s40122-024-00651-0","DOIUrl":"https://doi.org/10.1007/s40122-024-00651-0","url":null,"abstract":"<p><strong>Introduction: </strong>Methadone has shown effectiveness in pain control in patients with cancer who are intolerant to other opioids in China. However, the optimal strategy for methadone conversion from previous high doses of opioids in refractory cancer pain remains debatable. This study aimed to describe the efficacy and safety of a 3-day switch (3DS) strategy for methadone conversion in patients with refractory cancer pain on high doses of opioids.</p><p><strong>Methods: </strong>We retrospectively reviewed 30-day medical records of 70 patients with refractory cancer pain who used a 3DS strategy for methadone conversion from previous high doses of opioids from July 2018 to December 2022. The 3DS strategy indicated that the methadone dose was increased by one third every day for 3 days. Data on the rate of successful conversion, the time to stable analgesia after conversion, the conversion efficiency, the corrected QT (QTc) interval, the actual conversion ratios, adverse events (AEs), and quality of life were analyzed.</p><p><strong>Results: </strong>Seventy patients received 3DS methadone conversion and 64 patients were eligible for analysis. Fifty patients (78%) achieved stable analgesia, and the median time to stable analgesia was 8.14 ± 2.70 (range 6-14) days. The average dose of methadone was 77.94 ± 42.74 mg. The most common AEs (≥ 10%) included constipation, dry mouth, nausea, and cold sweats. The incidence of constipation was reduced post-methadone conversion, and a statistically significant but asymptomatic prolongation of the QTc interval was observed. Additionally, the actual conversion ratios were lower than Ayonrinde's recommended ratios.</p><p><strong>Conclusions: </strong>The 3DS strategy for methadone conversion is applicable in Chinese patients with refractory cancer pain on high doses of opioids.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Impact of Different Regional Anesthesia Techniques on the Incidence of Chronic Post-surgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Network Meta-analysis. 不同区域麻醉技术对视频辅助胸腔镜手术患者术后慢性疼痛发生率的影响:网络 Meta 分析
IF 4.1 2区 医学
Pain and Therapy Pub Date : 2024-09-06 DOI: 10.1007/s40122-024-00648-9
Yue Zhao, Yaming Guo, Xue Pan, Xinyue Zhang, Fang Yu, Xuezhao Cao
{"title":"The Impact of Different Regional Anesthesia Techniques on the Incidence of Chronic Post-surgical Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Network Meta-analysis.","authors":"Yue Zhao, Yaming Guo, Xue Pan, Xinyue Zhang, Fang Yu, Xuezhao Cao","doi":"10.1007/s40122-024-00648-9","DOIUrl":"https://doi.org/10.1007/s40122-024-00648-9","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic post-surgical pain (CPSP) remains a prevalent issue following video-assisted thoracic surgery (VATS), despite advancements in surgical techniques. Various regional anesthesia techniques, including thoracic paravertebral block (PVB), intercostal nerve block (ICNB), serratus anterior plane block (SAPB), erector spinae plane block (ESPB), and thoracic epidural anesthesia (TEA), have been employed in VATS procedures to mitigate this issue. This study aims to compare the efficacy of these analgesia methods in reducing the incidence of CPSP in VATS patients through a network meta-analysis.</p><p><strong>Methods: </strong>A systematic search was conducted in PubMed, the Cochrane Library, and EMBASE for randomized controlled trials (RCTs) comparing the incidence of CPSP associated with PVB, ICNB, SAPB, ESPB, and TEA. The occurrence of CPSP was evaluated at both 2-3 months and 6 months post-surgery.</p><p><strong>Results: </strong>Six RCTs, involving 652 patients, were included in the analysis of CPSP incidence at 2-3 months, while seven RCTs, involving 715 patients, were included for 6 months analysis. PVB, ICNB, or TEA reduced CPSP incidence compared with control group (without regional anesthesia techniques) at both 2-3 months and 6 months post-surgery. However, SAPB was found less effective in reducing CPSP incidence at 2-3 months post-VATS compared to PVB, ICNB, or TEA.</p><p><strong>Conclusions: </strong>PVB, ICNB, and TEA exhibit significant effects on reducing CPSP incidence following VATS. Conversely, SAPB is not recommended for reducing CPSP incidence post-VATS. Nonetheless, considering the limitation of a small sample size in this network meta-analysis, additional RCTs are necessary to validate these conclusions and enhance the management of CPSP after VATS.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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