--- title: "Tramadol vs codeine + acetaminophen in chronic pain. | Sutter Health" description: "Results: Tramadol/APAP tablets are as effective as codeine/ APAP capsules in tx of chronic nonmalignant low back and OA pain and are better tolerated." url: "https://www.sutterhealth.org/research/publications/tramadol-vs-codeine-and-acetaminophen-chronic-pain-1055312321" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Research publications](https://www.sutterhealth.org/research/publications) / 4. Tramadol vs codeine + acetaminophen in chronic pain. # Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial. Mullican WS & Lacy JR; TRAMAP-ANAG-006 Study Group. _Clin Ther. 23(9):1429-45._ 2001-09-01 ## Abstract BACKGROUND: Opioid/acetaminophen (APAP) combination analgesics are widely prescribed for the relief of moderate pain. Tramadol is a synthetic analgesic that has been shown to be effective both alone and in combination with APAP. OBJECTIVE: The purpose of this study was to compare the efficacy and tolerability of tramadol/APAP tablets with codeine/APAP capsules. METHODS: This 4-week, randomized, double-blind, parallel-group, active-control, double-dummy, multicenter trial compared tramadol/APAP (37.5 mg/325 mg) with codeine/APAP (30 mg/300 mg) for the management of chronic nonmalignant low back pain, osteoarthritis (OA) pain, or both in adults. Pain relief (scale, 0 = none to 4 = complete) and pain intensity (scale, 0 = none to 3 = severe) were measured 30 minutes and then hourly for 6 hours after the first daily dose each week. Patients and investigators assessed the efficacy (scale, 1 = poor to 5 = excellent) of each medication, and patients recorded daily doses of study and rescue medications. RESULTS: A total of 462 patients (mean age, 57.6 years) were randomly assigned to treatment, with 112 (24%) reporting chronic low back pain, 162 (35%) reporting OA pain, and 188 (41%) reporting both low back and OA pain; 309 patients (67%) received tramadol/APAP and 153 (33%) received codeine/APAP. Pain relief and changes in pain intensity were comparable from day 1, as early as 30 minutes after the first dose, and lasted for at least 6 hours. Total pain relief scores (11.9 for tramadol/APAP; 11.4 for codeine/APAP) and sum of pain intensity differences (3.8 for tramadol/APAP; 3.3 for codeine/APAP) were also comparable throughout. Overall assessments of efficacy by patients (mean score 2.9 in each treatment group) and investigators (mean score 3.0 for tramadol/APAP, 2.9 for codeine/APAP) were similar for the 2 treatment groups. Equivalent mean doses (3.5 tablets or capsules daily) and maximum daily doses (5.5 tablets or 5.7 capsules) were used in the 2 treatment groups. The overall incidence of adverse events was comparable, with a significantly higher proportion of patients in the codeine/APAP group reporting somnolence (24% \[37/153\] vs 17% \[54/309\], P = 0.05) or constipation (21% \[32/153\] vs 11% \[35/309\], P < 0.01) and a larger proportion of patients in the tramadol/APAP group reporting headache (11% \[34/309\] vs 7% \[11/153\], P = 0.08). CONCLUSION: The results of this study suggest that tramadol/APAP tablets (37.5 mg/325 mg) are as effective as codeine/ APAP capsules (30 mg/300 mg) in the treatment of chronic nonmalignant low back pain and OA pain and are better tolerated. [PubMed abstract](https://www.ncbi.nlm.nih.gov/pubmed/11589258) ## Research topics - [Comparative Effectiveness](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Comparative+Effectiveness%5C%22%22) - [Disease Management](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Disease+Management%5C%22%22) - [Musculoskeletal Disorders](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Musculoskeletal+Disorders%5C%22%22) - [Pain](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Pain%5C%22%22) ## Related publications [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) - Publication ### [Patient characteristics and healthcare utilization of a chronic pain population within an integrated healthcare system.](https://www.sutterhealth.org/research/publications/pt-characteristics-healthcare-use-chronic-pain-1055312340) Romanelli RJ, Shah SN, Ikeda L, Lynch B, Craig TL, Cappelleri JC, Jukes T, Ishisaka D. Am J Manag Care. 23(2):e50-e56. 2017 Feb 01 - Publication ### [Opioid prescribing for chronic pain in a community-based healthcare system.](https://www.sutterhealth.org/research/publications/opiod-prescribing-chronic-pain-community-health-1055312298) Romanelli RJ, Ikeda LI, Lynch B, Craig T, Cappelleri JC, Jukes T, Ishisaka DY. Am J Manag Care. 23(5):e138-e145. 2017 May 01 - Publication ### [Management of chronic pain among older patients: inside primary care in the US.](https://www.sutterhealth.org/research/publications/chronic-pain-older-patients-in-pc-in-united-states-1055312613) Tai-Seale M, Bolin J, Bao X, Street R. Eur J Pain. 15(10):1087.e1-8. doi: 10.1016/j.ejpain.2011.06.012. Epub 2011 Jul 23. 2011 Nov 01 - Publication ### [Subtalar joint arthrodesis using a single lag screw.](https://www.sutterhealth.org/research/publications/subtalar-joint-arthrodesis-use-one-lag-screw-1055312972) Haskell A, Pfeiff C, Mann R. Foot Ankle Int. 25(11):774-7. 2004 Nov 01 - Publication ### [Synovial chondromatosis of the ankle: report of two cases with 23 and 126 loose bodies.](https://www.sutterhealth.org/research/publications/synovial-chondromatosis-of-the-ankle-1055312460) Saxena A, St Louis M. J Foot Ankle Surg. pii: S1067-2516(16)00130-7. doi: 10.1053/j.jfas.2016.02.009. \[Epub ahead of print\] 2016 Apr 05 [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/publications/tramadol-vs-codeine-and-acetaminophen-chronic-pain-1055312321#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Research publications","item":"https://www.sutterhealth.org/research/publications"},{"@type":"ListItem","position":4,"name":"Tramadol vs codeine + acetaminophen in chronic pain."}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalScholarlyArticle","@id":"https://www.sutterhealth.org/research/publications/tramadol-vs-codeine-and-acetaminophen-chronic-pain-1055312321#medicalscholarlyarticle","name":"Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial.","headline":"Tramadol vs codeine + acetaminophen in chronic pain.","abstract":"BACKGROUND: Opioid/acetaminophen (APAP) combination analgesics are widely prescribed for the relief of moderate pain. Tramadol is a synthetic analgesic that has been shown to be effective both alone and in combination with APAP. OBJECTIVE: The purpose of this study was to compare the efficacy and tolerability of tramadol/APAP tablets with codeine/APAP capsules. METHODS: This 4-week, randomized, double-blind, parallel-group, active-control, double-dummy, multicenter trial compared tramadol/APAP (37.5 mg/325 mg) with codeine/APAP (30 mg/300 mg) for the management of chronic nonmalignant low back pain, osteoarthritis (OA) pain, or both in adults. Pain relief (scale, 0 = none to 4 = complete) and pain intensity (scale, 0 = none to 3 = severe) were measured 30 minutes and then hourly for 6 hours after the first daily dose each week. Patients and investigators assessed the efficacy (scale, 1 = poor to 5 = excellent) of each medication, and patients recorded daily doses of study and rescue medications. RESULTS: A total of 462 patients (mean age, 57.6 years) were randomly assigned to treatment, with 112 (24%) reporting chronic low back pain, 162 (35%) reporting OA pain, and 188 (41%) reporting both low back and OA pain; 309 patients (67%) received tramadol/APAP and 153 (33%) received codeine/APAP. Pain relief and changes in pain intensity were comparable from day 1, as early as 30 minutes after the first dose, and lasted for at least 6 hours. Total pain relief scores (11.9 for tramadol/APAP; 11.4 for codeine/APAP) and sum of pain intensity differences (3.8 for tramadol/APAP; 3.3 for codeine/APAP) were also comparable throughout. Overall assessments of efficacy by patients (mean score 2.9 in each treatment group) and investigators (mean score 3.0 for tramadol/APAP, 2.9 for codeine/APAP) were similar for the 2 treatment groups. Equivalent mean doses (3.5 tablets or capsules daily) and maximum daily doses (5.5 tablets or 5.7 capsules) were used in the 2 treatment groups. The overall incidence of adverse events was comparable, with a significantly higher proportion of patients in the codeine/APAP group reporting somnolence (24% [37/153] vs 17% [54/309], P = 0.05) or constipation (21% [32/153] vs 11% [35/309], P \u003c 0.01) and a larger proportion of patients in the tramadol/APAP group reporting headache (11% [34/309] vs 7% [11/153], P = 0.08). CONCLUSION: The results of this study suggest that tramadol/APAP tablets (37.5 mg/325 mg) are as effective as codeine/ APAP capsules (30 mg/300 mg) in the treatment of chronic nonmalignant low back pain and OA pain and are better tolerated.","description":"Results: Tramadol/APAP tablets are as effective as codeine/ APAP capsules in tx of chronic nonmalignant low back and OA pain and are better tolerated.","keywords":["Comparative Effectiveness","Disease Management","Musculoskeletal Disorders","Pain"],"datePublished":"2001-09-01","url":"https://www.sutterhealth.org/research/publications/tramadol-vs-codeine-and-acetaminophen-chronic-pain-1055312321","inLanguage":"en-US","identifier":[{"@type":"PropertyValue","propertyID":"PMID","value":"11589258"}],"sameAs":["https://pubmed.ncbi.nlm.nih.gov/11589258/"],"isPartOf":{"@type":"Periodical","name":"Clin Ther"},"sourceOrganization":{"@type":"MedicalOrganization","name":"Palo Alto Medical Foundation Research Institute"},"about":[{"@type":"DefinedTerm","name":"Comparative Effectiveness","url":"https://www.sutterhealth.org/research-search-results?facets=%5B%7B%22i%22%3A%22c_researchTopics.name%22%2C%22v%22%3A%5B%22Comparative+Effectiveness%22%5D%7D%5D&verticalKey=research_publication"},{"@type":"DefinedTerm","name":"Disease Management","url":"https://www.sutterhealth.org/research-search-results?facets=%5B%7B%22i%22%3A%22c_researchTopics.name%22%2C%22v%22%3A%5B%22Disease+Management%22%5D%7D%5D&verticalKey=research_publication"},{"@type":"DefinedTerm","name":"Musculoskeletal Disorders","url":"https://www.sutterhealth.org/research-search-results?facets=%5B%7B%22i%22%3A%22c_researchTopics.name%22%2C%22v%22%3A%5B%22Musculoskeletal+Disorders%22%5D%7D%5D&verticalKey=research_publication"},{"@type":"DefinedTerm","name":"Pain","url":"https://www.sutterhealth.org/research-search-results?facets=%5B%7B%22i%22%3A%22c_researchTopics.name%22%2C%22v%22%3A%5B%22Pain%22%5D%7D%5D&verticalKey=research_publication"}],"mainEntityOfPage":{"@type":"WebPage","@id":"https://www.sutterhealth.org/research/publications/tramadol-vs-codeine-and-acetaminophen-chronic-pain-1055312321","breadcrumb":{"@id":"https://www.sutterhealth.org/research/publications/tramadol-vs-codeine-and-acetaminophen-chronic-pain-1055312321#breadcrumblist"}}} ```