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Dieses Dokument Ist Eine Zweitveröffentlichung (Verlagsversion) / This Is a Self-Archiving Document (Published Version) View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Technische Universität Dresden: Qucosa Dieses Dokument ist eine Zweitveröffentlichung (Verlagsversion) / This is a self-archiving document (published version): Jan Gaertner, Ulrike M. Stamer, Constanze Remi, Raymond Voltz, Claudia Bausewein, Rainer Sabatowski, Stefan Wirz, Gabriele Müller-Mundt, Steffen T. Simon, Anne Pralong, Friedemann Nauck, Markus Follmann, Lukas Radbruch, Winfried Meißner Metamizole/dipyrone for the relief of cancer pain: A systematic review and evidence-based recommendations for clinical practice Erstveröffentlichung in / First published in: Palliative Medicine. 2017, 31(1), S. 26 – 34 [Zugriff am: 19.08.2019]. SAGE journals. ISSN 1477- 030X. DOI: https://doi.org/10.1177/0269216316655746 Diese Version ist verfügbar / This version is available on: https://nbn-resolving.org/urn:nbn:de:bsz:14-qucosa2-353637 „Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFGgeförderten) Allianz- bzw. Nationallizenz frei zugänglich.“ This publication is openly accessible with the permission of the copyright owner. The permission is granted within a nationwide license, supported by the German Research Foundation (abbr. in German DFG). www.nationallizenzen.de/ 6557467464 PMJ0010.1177/0269216316655746Palliative10.110.1177/0269216316655746177/0269216316655746Palliative MedicineGaertner et al. research-article2016 Review Article Palliative Medicine 2017, Vol. 31(1) 26 –34 Metamizole/dipyrone for the relief © The Author(s) 2016 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav of cancer pain: A systematic review DOI: 10.1177/0269216316655746 and evidence-based recommendations pmj.sagepub.com for clinical practice Jan Gaertner1*, Ulrike M Stamer2*, Constanze Remi3, Raymond Voltz4, Claudia Bausewein3, Rainer Sabatowski5, Stefan Wirz6, Gabriele Müller-Mundt7, Steffen T Simon4, Anne Pralong4, Friedemann Nauck8, Markus Follmann9, Lukas Radbruch10+ and Winfried Meißner11+ Abstract Background: Dipyrone (metamizole) is one of the most widely used non-opioid analgesics for the treatment of cancer pain. Aim: Because evidence-based recommendations are not yet available, a systematic review was conducted for the German Guideline Program in Oncology to provide recommendations for the use of dipyrone in cancer pain. Design: First, a systematic review for clinical trials assessing dipyrone in adult patients with cancer pain was conducted. Endpoints were pain intensity, opioid-sparing effects, safety, and quality of life. Data sources: The search was performed in MedLine, Embase (via Ovid), and the Cochrane Library (1948–2013) and additional hand search was conducted. Finally, recommendations were developed and agreed in a formal structured consensus process by 53 representatives of scientific medical societies and 49 experts. Results: Of 177 retrieved studies, 4 could be included (3 randomized controlled trials and 1 cohort study, n = 252 patients): dipyrone significantly decreased pain intensity compared to placebo, even if low doses (1.5–2 g/day) were used. Higher doses (3 × 2 g/day) were more effective than low doses (3 × 1 g/day), but equally effective as 60 mg oral morphine/day. Pain reduction of dipyrone and non-steroidal anti-inflammatory drugs did not differ significantly. Compared to placebo, non-steroidal anti-inflammatory drugs, and morphine, the incidence of adverse effects was not increased. Conclusion: Dipyrone can be recommended for the treatment of cancer pain as an alternative to other non-opioids either alone or in combination with opioids. It can be preferred over non-steroidal anti-inflammatory drugs due to the presumably favorable side effect profile in long-term use, but comparative studies are not available for long-term use. Keywords Dipyrone, palliative care, neoplasms, pain management, review, non-steroidal anti-inflammatory agents 1 Clinic for Palliative Care, Medical Center - University of Freiburg, 8Department of Palliative Medicine, University Medical Center Faculty of Medicine, University of Freiburg, Germany Göttingen, Göttingen, Germany 2 Department of Anesthesiology and Pain Medicine, Inselspital, 9Department of Guideline Development, German Cancer Society University of Bern, Bern, Switzerland (DKG), Berlin, Germany 3 Department of Palliative Medicine, University Hospital Bonn, Germany 10 Department of Palliative Medicine, University Hospital Bonn, Germany 4 Department of Palliative Care, University Hospital Cologne, Cologne, 11 Department of Palliative Care, Jena University Hospital, Jena, Germany Germany ,+ 5 Comprehensive Pain Centre, University Hospital Carl Gustav Carus * Both authors contributed equally Dresden, Dresden, Germany Corresponding author: 6Department for Anaesthesiology, Intensive Medicine, Pain/Palliative Jan Gaertner, Clinic for Palliative Care, Medical Center - University Care, GFO CURA Hospital, Bad Honnef, Germany of Freiburg, Faculty of Medicine, University of Freiburg, Robert-Koch- 7Institute for General Practice, Hannover Medical School, Hannover, Straße 3, 79106 Freiburg, Germany. Germany Email: [email protected] Gaertner et al. 27 What is already known about the topic? x Dipyrone and other non-opioid analgesics (NOAs) are frequently used to treat cancer pain. x Dipyrone is one of the most widely used NOAs worldwide. x Use of NOAs is associated with significant safety concerns. What this paper adds? x A systematic review on dipyrone for cancer pain was conducted. x The findings of this systematic review were discussed in a formal, standardized consensus process by delegates and experts of German Medical Scientific Associations. x Evidence-based recommendations on a national level are now available for the treatment of cancer pain with dipyrone. Implications for practice, theory, or policy? x Experts agreed that dipyrone and other non-opioids can be used alone or in combination with opioids to treat cancer pain. x Clinicians should critically outweigh safety concerns of the particular non-opioid before initiating long-term therapy. x In the light of scarce evidence despite high relevance of the questions concerning efficacy and safety of non-opioid therapy for cancer pain, high-quality randomized controlled trials (RCTs) are urgently needed. Introduction Dipyrone (metamizole, novaminsulfone) is a widely used field of cancer pain management.11 Resulting safety con- non-opioid analgesic (NOA) in parts of Europe, the cerns eventually lead to the withdrawal of the drug in sev- Middle East, Asia, South Africa, and Latin America, eral countries, such as the Anglo-American and although it is not available in other European regions, Scandinavian countries. In other countries, where dipy- Japan, India, the United States, and the United Kingdom.1,2 rone is available, the prescription is steadily increasing.12 It was first synthesized in 1920, and the first mass pro- For example, in Germany and other countries, up to four- duction started already in 1922.1 Meanwhile, it is the fold increase in dipyrone prescriptions has been reported main representative of this group.3,4 Dipyrone is a non- over a 12-year period (2000–2012)13 and dipyrone is acidic, antipyretic analgesic just as paracetamol/acetami- among the most extensively used analgesics.14,15 Also, in nophen but belongs to the group of phenazones vulnerable patients such as elderly patients in nursing (phenylpyrazolones).3 In contrast to non-steroidal anti- homes, dipyrone is one of the most frequently used analge- inflammatory drugs (NSAIDs), it exerts minor antiphlo- sics,12,15,16 although the approval of the drug is strictly lim- gistic and anti-inflammatory properties, but strong ited to specific indications. hypothermic actions.1,5,6 Additionally, clinicians wel- For Germany, these indications are as follows:17,18 come its spasmolytic properties, although the scientific evidence for this mechanism is sparse.1 1. Fever that is unresponsive to other measures; Dipyrone is a prodrug, but the pharmacological mecha- 2. Postoperative pain; nism of action of its multiple active metabolites is not pre- 3. Pain due to trauma; cisely known. Similar to paracetamol/acetaminophen, its 4. Pain due to intestinal colic; effects may result from the interference with prostaglandin 5. Cancer pain; synthesis through the inhibitory potential on different 6. Other cases of severe pain, if other therapeutic cyclo-oxygenase (COX) isoenzymes.7 Yet, interactions measures are not indicated. with the endogenous opioid, peroxidase, cannabinoid, and glutamate systems are also discussed.6,8,9 Despite its widespread and increasing use, little Dipyrone is available in formulations for oral and rectal is known about the overall effectiveness of the drug. For drug administration. Intravenous administration is possi- the National Guideline “Palliative Care for patients with ble, but sudden and profound arterial hypotension has been incurable cancer” in the context of the German Guide- reported in case of rapid infusion. Especially in palliative line Program in Oncology http://leitlinienprogramm- care and hospice settings, the subcutaneous route is also onkologie.de/Palliativmedizin.80.0.html we aimed to used (unlicensed use) but has been associated with local identify, critically appraise, and summarize the efficacy granuloma and skin lesions.10 Agranulocytosis is one of and effectiveness of dipyrone in order to provide evidence- the most threatening toxicities of dipyrone.11 This has been based recommendations for its use
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