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Samira Ait Abdellah,1 Caroline Gal,1 Anne Leblanc,2 Anne-Priscille Trouvin,3 Serge Perrot3 1Clinical Research Department, PiLeJe Laboratoire, Paris, France; 2Applied Research Department, PiLeJe Laboratoire, Paris, France; 3Pôle Ostéo-Articulaire, Hôpital Cochin, Paris, FranceCorrespondence: Serge PerrotPôle Ostéo-Articulaire, Hôpital Cochin, 27 Rue Du Faubourg Saint-Jacques, Paris 75014, FranceTel +33 158 411 507Email serge.perrot@aphp.frPurpose: This observational study evaluated a combination of boswellia, turmeric, and red algae extracts in patients with knee osteoarthritis (KOA). Given the growing interest in patient-centered care in osteoarthritis, effects were assessed by an arsenal of patient-reported outcome measures (PROMs): Patient Acceptable Symptom Scale (PASS), Minimal Clinically Important Improvement (MCII), Patient Global Impression of Change (PGIC), and Lequesne algofunctional index (LAFI). Patients also completed a list of 17 items on pain quality.Patients and Methods: Patients with painful unilateral or bilateral KOA had to take 1– 4 capsules per day of a dietary supplement containing boswellia, turmeric, and red algae extracts for 90 days. Patients completed PROMs on Days 0 (baseline), 10, 20, 30, 60, and/or 90.Results: A total of 118 patients [female: 69.5%; age: 62.9 (9.5) years, mean (SD)] were included in the study and took at least one capsule. Mean (SD) follow-up duration was 100.7 (54.9) days. Pain relief was maximal on Day 90: 64.5% of patients were responders (positive PASS); 68.8% and 58.4% had MCII and PGIC scores indicating positive effect (score ≥ 3) or global improvement (score ≥ 5); 73.3% (versus 47.5% at baseline) were mildly/moderately disabled (LAFI score < 8); 55.2% had meaningful decrease (− 30%) in pain intensity (VAS), 35.1% (versus 59.2% at baseline) took analgesics as supplementary treatment. Median time to the first PASS change was 34 days. Pain intensity (VAS), as well as two pain characteristics (ie, “Stabbing pain” and “Widespread pain”), were independent factors associated with non-response on Day 30. Four clusters of responders were isolated according to pain characteristics, with one cluster exhibiting a higher responder rate.Conclusion: The results of this preliminary study suggest that the combination of boswellia, turmeric, and red algae extracts tested could improve KOA patients. Beyond these results, this study showed the importance of PROMs and specific pain qualitative descriptors for the accurate evaluation of dietary supplement approaches in painful conditions.Keywords: Curcuma, dietary supplement, joint disease, Porphyra, self-reported questionnaire

Tyler Knight,1 Caroline Schaefer,1 Arthi Chandran,2 Gergana Zlateva,2 Andreas Winkelmann,3 Serge Perrot4 1Health Economics and Outcomes Research, Covance Market Access Services, Gaithersburg, MD, USA; 2Primary Care Health Economics and Outcomes Research, Pfizer Global Health Economics, New York, NY, USA; 3Department of Physical Medicine and Rehabilitation, University Hospital Munich, Munich, Germany; 4Service de Médecine Interne et Thérapeutique, Université Paris Descartes, Paris, France Background: Fibromyalgia (FM) is a chronic disorder characterized by widespread, persistent pain. Prospective and retrospective studies have demonstrated substantial health-care costs associated with FM in a number of countries. This study evaluated and compared health-resource use (HRU) and associated costs related to FM in routine clinical practice across the US, France, and Germany. Methods: Two separate, cross-sectional, observational studies of subjects with FM were conducted: one in the US and one in France and Germany. HRU related to prescription medication, physician office visits, diagnostic tests, and hospitalizations was abstracted from chart review; patient out-of-pocket costs and lost productivity were collected via subject self-report. Costs were assigned to HRU based on standard algorithms. Direct and indirect costs were evaluated and compared by simple linear regression. Results: A total of 442 subjects (203 US, 70 France, 169 Germany) with FM were analyzed. The mean (standard deviation) age in the US, France, and Germany was 47.9 (10.9), 51.2 (9.5), and 49.2 (9.8), respectively (P = 0.085). Most subjects were female (95% US, 83% France, 80% Germany) (P < 0.001). Adjusted annual direct costs per subject for FM were significantly higher in the US ($7087) than in France ($481, P < 0.001) or Germany ($2417, P < 0.001). Adjusted mean annual indirect costs per subject for FM were lower in the US ($6431) than in France ($8718) or Germany ($10,001), but represented a significant proportion of total costs in all countries. Conclusion: The significant HRU and costs associated with FM in the US, France, and Germany documented in this study highlight the substantial global economic burden of FM. Indirect costs represented a significant proportion of the total costs, particularly in Europe. Comparisons between the three countries show differences in HRU, with significantly higher direct costs in the US compared with France and Germany. Keywords: fibromyalgia, cost, burden of illness, United States, France, Germany

Joanne O’Brien,1 Joseph V Pergolizzi Jr,2 Mart van de Laar3, Hans-Ulrich Mellinghoff,4 Ignacio Morón Merchante,5 Srinivas Nalamachu,6 Serge Perrot,7 Robert B Raffa81Department of Pain Medicine, Beaumont Hospital, Beaumont, Dublin, Ireland; 2Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; Association of Chronic Pain Patients, Houston, TX; Department of Pharmacology, Temple University School of Medicine, Philadelphia, PA, USA; 3Arthritis Center Twente, Enschede, The Netherlands; 4Department of Endocrinology, Diabetology and Osteology, Kantonsspital St Gallen, Switzerland; 5Centro de Salud Universitario Goya, Madrid, Spain; 6Kansas University Medical Center, Kansas City, and International Clinic Research, Leawood, KS, USA; 7Service de Médecine Interne et Consultation de la Douleur, Hôpital Hotel Dieu, Paris Descartes University, Paris, France; 8Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia PA, USAAbstract: Pain should be treated promptly and effectively to restore the patient to full function, avoid pain chronification, and preserve quality of life. A recent pain specialists' meeting discussed the use of different pharmacological treatment options, such as topical analgesics, nonopioid agents (such as paracetamol and nonsteroidal anti-inflammatory drugs), weak and strong opioids, and fixed-dose combination products in the management of moderate to severe pain from different etiologies. One of the topics discussed in, and subsequent to, this meeting was the role of fixed-dose combination products for nurse-prescribers who are in many ways at the front line of managing both acute and chronic pain syndromes. The panel agreed that proper product selection should take into account the patient's age, condition, type of pain, and comorbidities, as well as balance safety with effectiveness. Although nurse-prescribers need to be aware of cumulative paracetamol dosing, fixed-dose combination products, such as tramadol-paracetamol, may offer important advantages, eg, by providing opioid-sparing without sacrificing efficacy.Keywords: tramadol, paracetamol, fixed-dose combination analgesics, pain management

Joseph V Pergolizzi Jr,1,2 Mart van de Laar,3 Richard Langford,4 Hans-Ulrich Mellinghoff,5 Ignacio Morón Merchante,6 Srinivas Nalamachu,7,8 Joanne O'Brien,9 Serge Perrot,10 Robert B Raffa111Department of Medicine, Johns Hopkins University, Baltimore, MD, USA; 2Association of Chronic Pain Patients, Houston, TX, USA; 3Arthritis Center Twente (MST and UT), Enschede, The Netherlands; 4Anaesthetics Laboratory, St Bartholomew's Hospital, London, UK; 5Department of Endocrinology, Diabetology and Osteology, Kantonsspital St Gallen, St Gallen, Switzerland; 6Centro de Salud Universitario Goya, Madrid, Spain; 7Kansas University Medical Center, Kansas City, KS, USA; 8International Clinic Research, Leawood, KS, USA; 9Department of Pain Management, Beaumont Hospital, Beaumont, Dublin, Ireland; 10Service de Médecine Interne et Consultation de la Douleur, Hôpital Dieu, Paris, France; 11Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, PA, USAAbstract: Pain is the most common reason patients seek medical attention and pain relief has been put forward as an ethical obligation of clinicians and a fundamental human right. However, pain management is challenging because the pathophysiology of pain is complex and not completely understood. Widely used analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol (acetaminophen) have been associated with adverse events. Adverse event rates are of concern, especially in long-term treatment or at high doses. Paracetamol and NSAIDs are available by prescription, over the counter, and in combination preparations. Patients may be unaware of the risk associated with high dosages or long-term use of paracetamol and NSAIDs. Clinicians should encourage patients to disclose all medications they take in a "do ask, do tell" approach that includes patient education about the risks and benefits of common pain relievers. The ideal pain reliever would have few risks and enhanced analgesic efficacy. Fixed-dose combination analgesics with two or more agents may offer additive or synergistic benefits to treat the multiple mechanisms of pain. Therefore, pain may be effectively treated while toxicity is reduced due to lower doses. One recent fixed-dose combination analgesic product combines tramadol, a centrally acting weak opioid analgesic, with low-dose paracetamol. Evidence-based guidelines recognize the potential value of combination analgesics in specific situations. The current guideline-based paradigm for pain treatment recommends NSAIDs for ongoing use with analgesics such as opioids to manage flares. However, the treatment model should evolve how to use low-dose combination products to manage pain with occasional use of NSAIDs for flares to avoid long-term and high-dose treatment with these analgesics. A next step in pain management guidelines should be targeted therapy when possible, or low-dose combination therapy or both, to achieve maximal efficacy with minimal toxicity.Keywords: NSAIDs, opioids, combination analgesics, moderate pain, severe pain, analgesics, tramadol/paracetamol

Joseph Pergolizzi1, Eli Alon2, Ralf Baron3, Cesare Bonezzi4, Jan Dobrogowski5, Rafael Gálvez6, Troels Jensen7, Hans-Georg Kress8, Marco AE Marcus9, Bart Morlion10, Serge Perrot11, Rolf-Detlef Treede121Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Universitätsspital Zurich, Switzerland; 3Universitätsklinikum Schleswig-Holstein, Kiel, Germany; 4Fondazione Salvatore Maugeri, Pavia, Italy; 5Zaklad Badania i Leczenia Bólu, Kraków, Poland; 6Hospital Universitario Virgen de las Nieves, Granada, Spain; 7Aarhus University, Denmark; 8Medical University of Vienna, Austria; 9Maastricht University Medical Center and University of Muenster, Maastricht, The Netherlands; 10University Hospitals Leuven, Belgium; 11Hôpital Dieu, Paris, France; 12Ruprecht-Karls-University, Heidelberg, GermanyAbstract: Chronic pain affects approximately 1 in 5 people in Europe, and around half of sufferers receive inadequate pain management. The most common location is the lower back. Pharmacological treatment of this condition is challenging because of the range of causative mechanisms and the difficulty of balancing analgesic efficacy and tolerability. An international panel of clinical pain specialists met in September, 2009, to discuss the treatment of chronic low back pain, and to review preclinical and clinical data relating to the new analgesic, tapentadol. A lack of consensus exists on the best treatment for low back pain. The range of regularly prescribed pharmacological agents extends from nonopioids (paracetamol, NSAIDs, and COX-2 inhibitors) to opioids, antidepressants and anticonvulsants. Pain relief may be compromised, however, by an undetected neuropathic component or intolerable side effects. Treatment is potentially life-long and effective analgesics are urgently needed, with demonstrable long-term safety. Combining separate agents with different mechanisms of action could overcome the limitations of present pharmacological therapy, but clinical evidence for this approach is currently lacking. Tapentadol combines µ-opioid agonism with noradrenaline reuptake inhibition in a single molecule. There is strong evidence of synergistic antinociception between these two mechanisms of action. In preclinical and clinical testing, tapentadol has shown efficacy against both nociceptive and neuropathic pain. Preclinical data indicate that tapentadol’s µ-opioid agonism makes a greater contribution to analgesia in acute pain, while noradrenaline reuptake inhibition makes a greater contribution in chronic neuropathic pain models. Tapentadol also produces fewer adverse events than oxycodone at equianalgesic doses, and thus may have a ‘µ-sparing effect’. Current evidence indicates that tapentadol’s efficacy/tolerability ratio may be better than those of classical opioids. However, further research is needed to establish its role in pain management.Keywords: chronic low back pain, neurophysiological changes, neuropathic component, multimechanistic approach, efficacy/side effect ratio, tapentadol

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Copyright of Douleur et Analgésie is the property of John Libbey Eurotext Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)