Pain and Therapy最新文献

{"title":"Additional Effect of Extracorporeal Shockwave Therapy with Lidocaine Injection on Clinical and MRI Findings in Frozen Shoulder: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial.","authors":"Gopal Nambi, Mshari Alghadier, Mudathir Mohamedahmed Eltayeb, Osama R Aldhafian, Ayman K Saleh, Nesreen Alsanousi, Mohamed Nagah Ahmed Ibrahim, Abdehamid A Attallah, Mohammed Abdelgwad Ismail, Mohamed Elfeshawy, Yaser El Sayed Hasan Wahd, Alaa Jameel A Albarakati","doi":"10.1007/s40122-024-00575-9","DOIUrl":"10.1007/s40122-024-00575-9","url":null,"abstract":"<p><strong>Introduction: </strong>Frozen shoulder is a very common musculoskeletal condition and the evidence related to the additional effects of extracorporeal shockwave therapy (ESWT) with intra-articular (IA) lidocaine injection in individuals with frozen shoulder is rare. Therefore, this study aims to compare and investigate the additional effects of extracorporeal shockwave therapy (ESWT) with intra-articular (IA) lidocaine injection in a frozen shoulder.</p><p><strong>Methods: </strong>Sixty eligible participants with frozen shoulder were included and the active group (n = 30, age 52.12 ± 5.2 years) received a lidocaine injection (1% lidocaine (Xylocaine) and 2cc (80 mg) methylprednisolone acetate) with active ESWT (3.5 bar air pressure and 2000 pulses with an energy flux density (EFD) ¼ 0.16 mJ/mm²) three sessions a week for 4 weeks. The placebo group (n = 30, age 53.56 ± 5.5 years) received lidocaine injection with placebo treatment (a special head that blocked the shock waves) three sessions a week for 4 weeks. Both groups received progressive resistance exercises (PRE) to the shoulder muscles. The primary outcome was pain intensity, measured with the visual analogue scale. The other outcome measures were the thickness of the coracohumeral ligament (CHL) measured by magnetic resonance imaging (MRI), abduction, and lateral rotation range of motion (ROM), functional disability, kinesiophobia, depression status, and quality of life. Participants were assessed at baseline, after 4 weeks, 8 weeks, and at 6-month follow-up.</p><p><strong>Results: </strong>The post-intervention at 4 weeks showed an improvement of 2.0 (CI 95% 1.71-2.28) in the active group compared to the placebo group. Similar effects were noted after 8 weeks (2.2) (CI 95% 1.91-2.48) and at the 6-month (1.9) (CI 95% 1.61-2.18) follow-up. Similar improvements were also found in the thickness of the CHL ligament (0.6) (CI 95% 0.46-0.73), abduction and lateral rotation (ROM) (- 23.6) (CI 95% - 27.47 to -19.72), (- 18.10) (CI 95% - 19.72 to - 16.47), functional disability (16.2) (CI 95% 14.85-17.54), kinesiophobia (11.0 (CI 95% 10.21-11.98), depression status (4.4) (CI 95% 4.03-4.76) and quality of life (0.9) (CI 95% 0.79-1.00) (p = 0.001) at the 6-month follow-up period, where mean estimates and their confidence intervals all included worthwhile effects. There were no adverse reactions or side effects noted in either the active or placebo groups during and after the treatment.</p><p><strong>Conclusions: </strong>The study concluded that the addition of extracorporeal shockwave therapy after intra-articular lidocaine injection improves pain, functional disability, range of motion, kinesiophobia, depression status, and quality of life in people with frozen shoulder.</p><p><strong>Trial registration: </strong>https://ctri.nic.in , identifier; CTRI/2020/04/024834 prospectively registered on 24/04/2020.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139692635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the Editor Regarding \"The Role of Ultrasound-Guided Multipoint Fascial Plane Block in Elderly Patients Undergoing Combined Thoracoscopic-Laparoscopic Esophagectomy: A Prospective Randomized Study\".","authors":"Xin-Tao Li, Fu-Shan Xue, Yi Cheng","doi":"10.1007/s40122-024-00582-w","DOIUrl":"10.1007/s40122-024-00582-w","url":null,"abstract":"","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139932366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the Editor Regarding \"Effect of Erector Spinae Plane Block in Terms of Analgesic Efficacy in Elderly Patients Undergoing Posterior Lumbar Spine Surgery\".","authors":"Raghuraman M Sethuraman, Shanmuga Priya Arulmozhi, Divyashree Sathyaprakash, Raj Murugan","doi":"10.1007/s40122-024-00579-5","DOIUrl":"10.1007/s40122-024-00579-5","url":null,"abstract":"","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139571185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sacroiliac Joint Denervation-A Novel Approach to Target Sacral Lateral Branches: A Practical Approach.","authors":"Victor M Silva-Ortiz, Kenneth B Chapman, George C Chang Chien, Sudhir Diwan, Alaa Abd-Elsayed","doi":"10.1007/s40122-024-00585-7","DOIUrl":"10.1007/s40122-024-00585-7","url":null,"abstract":"<p><strong>Introduction: </strong>Sacroiliac joint (SIJ) pain is a relatively common cause of low back pain. Percutaneous radiofrequency (RF) techniques for SIJ are limited to ablation of the posterior SIJ innervation. Different techniques have been described for SIJ radiofrequency ablation, including conventional thermal, cooled RF, pulsed RF, bipolar RF, and specialized tip RF needle (i.e., multi-tined); however, additional costs may limit these applications.</p><p><strong>Methods: </strong>This new technique for SIJ denervation uses anatomical landmarks and a single RF cannula. Two spinal needles are placed lateral to the posterior S1 and S2 sacral foramina; then, with caudal tilt we get a coaxial view of the sacral bone, we advance an 18-G curved 15-mm active tip RF cannula just lateral to the aligned finder needles. Ablation is performed, and then the RF cannula is retracted 2 cm and ablation is repeated for a total of four lesions.</p><p><strong>Results: </strong>The two spinal needles placed lateral to the posterior sacral foramina S1 and S2 guide the final needle in the posterior aspect of the sacrum, lateral to the sacral foramina, where the lateral sacral branches are located.</p><p><strong>Conclusion: </strong>We introduce a cost and time efficient technique to perform radiofrequency ablation of the sacral lateral branches using a single RF needle. This technique utilizes the sacrum's reliable anatomy and angulation and maximizes the surface area of the active tip lesioning. This technique creates a strip lesion lateral to the sacral foramina and reduces time and cost efficacy compared to several of the other techniques and/or commercially available special devices designed for sacroiliac denervation.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928047/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139973042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Observational Retrospective Study in Patients Treated with Galcanezumab as Preventive Treatment for Migraine: The ORYGAM Study","authors":"Samuel Díaz Insa, Ángel Guerrero, Javier Viguera, Vicente Medrano Martínez, Carlos Calle de Miguel, Jesús Porta-Etessam, Antonio Ciudad, Silvia Diaz-Cerezo, Ana Roncero Martín, Mercedes Núñez","doi":"10.1007/s40122-024-00586-6","DOIUrl":"https://doi.org/10.1007/s40122-024-00586-6","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>The efficacy of galcanezumab has been demonstrated in randomized controlled trials, but evidence about its use under clinical practice conditions is still limited. This study aimed to describe the characteristics of the patients treated with galcanezumab in routine clinical practice in Spain as well as treatment patterns, persistence, and effectiveness.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A retrospective chart review study was carried out in six hospitals. Information of adults with migraine, who started treatment with galcanezumab between November 2019 and September 2021, was analyzed until end or loss of follow-up. Continuous variables were described as mean (standard deviation, SD) and median (interquartile range, IQR), and categorical variables as frequency and percentages. Persistence to treatment was estimated using Kaplan–Meier analysis.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>A total of 314 patients were analyzed over median follow-up period of 17.5 months (13.8–20.7), with a mean age of 46.3 (12.6), 85% women, 80.6% chronic migraine, and reporting a mean of monthly migraine days of 16.7 (7.8). Overall, 72.9% had comorbid conditions, with anxiety and depression disorders being the most frequent. More than 60% had received ≥ 6 previous preventive drugs, the most common being antiepileptics, antidepressants, and botulinum toxin (95.2%, 89.8% and 84.1%, respectively). Overall, 60.3% of the patients with other preventive treatments maintained them after galcanezumab initiation. The median time on galcanezumab was 14.6 months (9.4–22.8); 95.7%, 82.0%, 76.2% and 59.8% of patients were persistent to treatment at 3, 6, 9 and 12 months, respectively. Of the patients who discontinued (151: 48.1%), 57.6% were due to lack of effectiveness and 31.1% were due to improvement in migraine. The average reduction of monthly migraine days at 3, 6, 9 and 12 months was 7.9 (7.2), 9.1 (7.5), 8.8 (6.6) and 9.0 (6.9) days, respectively.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>In real clinical practice, galcanezumab is an effective treatment and has a high persistence in patients with migraine, mostly chronic and with multiple use of previous preventive treatments.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140312275","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}

{"title":"Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lobectomy: Study Protocol for a Prospective Randomized Controlled Trial","authors":"Shuang Chen, Ying Ding, Xiaoming Zhang, Xue Zhang, Jiajia Xiang, Yiling Deng, Xingran Tao, Wenke Cai, Zhigui Li, Jiayu Chen, Fanyi Kong, Na Li","doi":"10.1007/s40122-024-00580-y","DOIUrl":"https://doi.org/10.1007/s40122-024-00580-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Patients undergoing video-assisted thoracoscopic lobectomy (VATL) often experience chronic postsurgical pain (CPSP). Postoperative pain can affect the recovery of postoperative lung function, prolong postoperative recovery time, and increase patient hospitalization expenses. Transcutaneous electrical acupoint stimulation (TEAS) is an alternative therapy based on acupuncture that has shown promise in postoperative recovery and pain management across various medical fields. However, research specifically focused on the improvement of CPSP after VATL is currently lacking. The purpose of this study is to evaluate whether TEAS can effectively reduce the severity and occurrence of chronic postsurgical pain in patients undergoing VATL. By investigating the potential benefits of TEAS in mitigating CPSP after VATL, this study aims to provide valuable clinical evidence to support the integration of TEAS into postoperative care protocols for patients undergoing VATL.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This study is a prospective, single-center, double-blinded, randomized controlled trial to be conducted at the 920th Hospital of Joint Logistics Support Force. Eighty patients undergoing VATL will be randomly divided into an experimental group (TEAS group) and a control group (sham group). The experimental group will receive TEAS at bilateral PC6, LI4, LR3, LU5, TE5, and LI11. The control group will not receive TEAS at the same acupoints. Both groups will receive TEAS or no TEAS before anesthesia induction and 1–7 days after surgery, with each session lasting 30 min.</p><h3 data-test=\"abstract-sub-heading\">Planned Outcomes</h3><p>The primary outcome will be the incidence of CPSP at 3 months after surgery. Secondary outcomes will include the incidence of CPSP at 6 months after surgery, the numerical rating scale (NRS) scores at 3 and 6 months after surgery, as well as the NRS scores at 24, 48, and 72 h after surgery, remifentanil consumption during general anesthesia, demand for rescue analgesics, number and duration of indwelling chest tubes, incidence of postoperative nausea and vomiting, and changes of norepinephrine (NE), cortisol (Cor), tumor necrosis factor (TNF- α), and interleukin 6 (IL-6) in serum.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>ChiCTR2300069458. Registered on March 16, 2023.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139768092","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}

{"title":"Potential Role of Focal Microvibration (Equistasi^®) in the Management of Chronic Pain: A Pilot Study.","authors":"Pasquale Buonanno, Carmine Iacovazzo, Annachiara Marra, Andrea Uriel de Siena, Tatiana Josu, Maddalena Zampi, Davide Sedda, Giuseppe Servillo, Maria Vargas","doi":"10.1007/s40122-023-00562-6","DOIUrl":"10.1007/s40122-023-00562-6","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pain is one of the leading causes of medical consultation with a dramatic psychophysical and socioeconomic impact. Focal microvibration (Equistasi^®) is a revolutionary technology that converts the thermal energy of the skin into vibration. Equistasi^® was shown to be effective in the treatment of gait and balance dysfunction in many pathological conditions such as Parkinson's disease and multiple sclerosis. Our aim was to explore the efficacy of focal microvibration in the management of chronic pain.</p><p><strong>Methods: </strong>We randomized 60 patients with pain of different origin into two groups: an experimental group (group E) treated with Equistasi, and a control group (group C) treated with standard pharmacological therapy. Pain, disability, and working capacity were evaluated by Brief Pain Inventory (BPI), Oswestry Disability Index (ODI), and Work Ability Index (WAI) at the baseline and after 7 (T7), 15 (T15), 30 (T30), 60 (T60), and 90 (T90) days.</p><p><strong>Results: </strong>According to BPI, average and worst pain in the last 24 h significantly decreased in group E at T15 and this result persisted up to T90; pain interference on general activity, mood, waling ability, normal work, relations with other people, sleep, and enjoyment of life decreased in group E with a significant improvement from T15. Lifting activity and work ability in relation to demands also significantly improved in group E. No significant changes in BPI, ODI, and WAI scores were recorded in group C during the follow-up.</p><p><strong>Conclusions: </strong>Focal microvibration can be an effective tool for managing chronic pain in combination with other therapies.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138499086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Percutaneous Stylomastoid Foramen Pulsed Radiofrequency Combined with Steroid Injection for Treatment of Intractable Facial Paralysis After Herpes Zoster.","authors":"Ruyun Deng, Ruxiang Wang, Ming Yao, Ling Ma","doi":"10.1007/s40122-023-00571-5","DOIUrl":"10.1007/s40122-023-00571-5","url":null,"abstract":"<p><strong>Introduction: </strong>We investigated the safety and efficacy of percutaneous facial nerve pulsed radiofrequency combined with drug injection for treatment of intractable facial paralysis of herpes zoster. The authors provide a detailed description of percutaneous facial nerve pulsed radiofrequency combined with steroid injection for treatment of intractable facial paralysis after herpes zoster, and they examine its clinical efficacy. This is the first time in the literature to our knowledge that this procedure has been applied in facial paralysis after herpes zoster.</p><p><strong>Methods: </strong>A total of 43 patients with a history of facial paralysis after herpes zoster for > 1 month were enrolled in this retrospective study. The patients were subjected to percutaneous stylomastoid foramen pulsed radiofrequency of the facial nerve under computed tomography (CT) guidance combined with drug injection. The House-Brackmann grades and NRS (Numerical Rating Scale) data collection were performed at different time points (preoperatively, 1 day post-procedure, and 2, 4, and 12 weeks postoperatively). The occurrence of complications was also assessed.</p><p><strong>Results: </strong>The 43 participants successfully completed the CT-guided percutaneous stylomastoid foramen pulsed radiofrequency of the facial nerve combined with drug injection. Both approaches [posterior approach of the ear (7 cases) and anterior approach of the ear (36 cases)] were efficacious and safe. The House-Brackmann grades (I, II, III, IV, V, VI) were 4 (3-4), 2 (2-3), 1 (1-2), and 1 (0-2) at different operation times (T0, T1, T2, T3, T4); patients felt significant recovery at T1 after operation and had gradually recovered at each time point but had no significant recovery after T3. The NRS scores at different operation times were 2.690 ± 2.213, 0.700 ± 0.939, 0.580 ± 1.006, 0.440 ± 0.908, and 0.260 ± 0.759, respectively. Differences in NRS scores between T0 and T1/2/3/4 were significant while differences between T1 and T2/3/4 were not significant. Six patients developed mild numbness, nine patients exhibited muscle tension, while one patient exhibited facial stiffness. During surgery, there was no intravascular injection of drugs, no nerve injury was reported, and there was no local anesthetic poisoning or spinal anesthesia.</p><p><strong>Conclusions: </strong>Percutaneous stylomastoid foramen pulsed radiofrequency combined with drug injection of the facial nerve for treatment of intractable facial paralysis after herpes zoster is a minimally invasive technique with high rates of success, safety, and effective outcomes. It is a potential therapeutic option for cases of facial paralysis of herpes zoster with a > 1 month history even for those with severe facial paralysis and whose treatment has failed after oral medication and physiotherapy.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139087997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Model-Based Meta-Analysis Supporting the Combination of Acetaminophen and Topical Diclofenac in Acute Pain: A Therapy for Mild-to-Moderate Osteoarthritis Pain?","authors":"Vidhu Sethi, Li Qin, Eugène Cox, Iñaki F Trocóniz, Oscar Della Pasqua","doi":"10.1007/s40122-023-00569-z","DOIUrl":"10.1007/s40122-023-00569-z","url":null,"abstract":"<p><strong>Introduction: </strong>Acetaminophen and topical diclofenac (AtopD) have complementary mechanisms of action and are therefore candidates for combination use in osteoarthritis (OA) pain. However, an evidence gap exists on their combination use in OA pain. This study aimed to assess the effects of this combination and compare its performance relative to monotherapies on pain score reduction and opioid-sparing effect by leveraging evidence from acute pain setting using a model-based meta-analysis (MBMA).</p><p><strong>Methods: </strong>A literature search was conducted using the MEDLINE database to identify randomized controlled trials (RCTs) studying the combination for acute pain. Subsequently, an MBMA of RCTs was implemented in conjunction with extrapolation principles to infer efficacy in the population of interest. Pain score reduction and opioid-sparing effect (OSE) were selected as the measures of efficacy.</p><p><strong>Results: </strong>A total of 11 RCTs encompassing 1396 patients were included. Exploratory evaluation revealed AtopD combination to show greater pain score reduction versus acetaminophen monotherapy. However, pain score reduction was more susceptible to confounding by opioid patient-controlled analgesia (PCA) than OSE. Therefore, a parsimonious MBMA evaluating OSE was developed from 5 of the 11 RCTs (n = 353 patients). The analysis revealed a statistically significant interaction coefficient, suggesting a reduction of 32% in opioid use with the combination versus acetaminophen monotherapy. Differences in the effect size of the combination were less conclusive versus diclofenac monotherapy.</p><p><strong>Conclusion: </strong>Our results indicate greater pain reduction and opioid-sparing efficacy for the AtopD combination versus acetaminophen monotherapy. Given the similar pain pathways and mechanisms of action of the two drugs in acute and mild-to-moderate OA pain, comparable beneficial effects from the combination therapy may be anticipated following extrapolation to chronic OA pain. Prospective RCTs and real-world studies in OA pain are needed to confirm the differences in the efficacy of the combination treatment observed in our study.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139111146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Model-Based Assessment of the Liver Safety Profile of Acetaminophen to Support its Combination Use with Topical Diclofenac in Mild-to-Moderate Osteoarthritis Pain.","authors":"Vidhu Sethi, Li Qin, Iñaki F Trocóniz, Luke Van der Laan, Eugène Cox, Oscar Della Pasqua","doi":"10.1007/s40122-023-00566-2","DOIUrl":"10.1007/s40122-023-00566-2","url":null,"abstract":"<p><strong>Introduction: </strong>The use of combination therapy of oral acetaminophen and topical diclofenac, having complementary mechanisms of action, is an attractive strategy to enhance the analgesic response in osteoarthritis (OA) pain. While topical diclofenac is considered as well tolerated due to its low systemic exposure, concerns of liver toxicity with acetaminophen at standard analgesic doses remain. Thus, this study aimed to assess the liver safety profile of acetaminophen, particularly in OA management, using a model-based meta-analysis (MBMA).</p><p><strong>Methods: </strong>A literature review was conducted using the MEDLINE database to identify randomized clinical trials (RCTs) reporting liver toxicity on acetaminophen use. An MBMA was implemented to assess the deviation from the upper limit of normal (ULN) of alanine aminotransferase or aspartate aminotransferase, namely > 0-1 × ULN, > 1.5-2 × ULN, and > 3 × ULN representing mild, moderate, and severe risk of liver abnormality, respectively.</p><p><strong>Results: </strong>A total of 15 RCTs were included in the MBMA, encompassing over 4800 subjects and exposure to acetaminophen ranging from 2 to 26 weeks. Of the 15 included studies, eight involved patients with OA pain, four involved healthy subjects and three were in patients with conditions such as asthma, glaucoma, chronic pain, and cardiovascular disease. Acetaminophen 1500-4000 mg/day was found to exhibit 23% (95% confidence interval (CI): 17.74-29.20), 1.35% (95% CI: 0.17-2.51) and 0.01% (95% CI: 0.00-0.32) increased risk for mild, moderate, and severe liver injury, respectively, versus placebo. Moreover, at therapeutic doses, no correlation was identified between acetaminophen intake and liver abnormality risk.</p><p><strong>Conclusions: </strong>Overall, our analysis shows that short-term (~ 8-16 weeks) acetaminophen use at therapeutically recommended doses is associated with a low risk of clinically relevant changes in liver enzymes. Given the good tolerability of topical diclofenac, the findings support the safety of the combination of acetaminophen and topical diclofenac, at least over the short term, as treatment for mild-to-moderate OA pain.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139111068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}