Publications by authors named "Renato Vellucci"

29 Publications

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A Call to Action by the Italian Mesotherapy Society on Scientific Research.

Drug Des Devel Ther 2021 12;15:3041-3047. Epub 2021 Jul 12.

Department of Vascular Surgery, Limb Salvage and Diabetic Foot, IDI-IRCCS, Rome, Italy.

Mesotherapy (local intradermal therapy, LIT) is a technique used to slowly spread drugs in tissues underlying the site of injection to prolong the pharmacological effect with respect to intramuscular injection. Recommendations for proper medical use of this technique have been made for pain medicine and rehabilitation, chronic venous disease, sport medicine, musculoskeletal disorders, several dermatological conditions, skin ageing, and immune-prophylaxis. Although mesotherapy is considered a valid technique, unresolved questions remain, which should be answered to standardize methodology and dosing regimen as well as to define the right indications in clinical practice. New randomized controlled trials are needed to test single products (dose, frequency of administration, efficacy and safety). Even infiltration of substances for dermo-cosmetic purposes must be guided by safety and efficacy tests before being proposed by mesotherapy. In this article, we put forth a preclinical and clinical research plan and a health technology assessment as a call to action by doctors, researchers and scientific societies to aid national health authorities in considering mesotherapy for prevention, treatment and rehabilitation paths.
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http://dx.doi.org/10.2147/DDDT.S321215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285234PMC
July 2021

Pain reduction induced by tapentadol in patients with musculoskeletal chronic pain fosters better sleep quality.

Drugs Context 2021 19;10. Epub 2021 Apr 19.

Anesthesia, Intensive Care Nord and Pain Management Unit, Bellaria Hospital, Bologna, Italy.

Background: Poor sleep may predict the increase and intensification of pain over time with increased insomnia symptoms being both a predictor and an indicator of worse pain outcomes and physical functioning status over time. However, the impact of different analgesic therapies on quality of life, functional recovery and sleep has been poorly assessed to date, whereas these evaluations may greatly help clinicians in the selection of treatment when dealing with patients with chronic pain (CP).

Methods: To explore whether tapentadol-induced pain relief may drive improved sleep quality, we carried out a pooled analysis of real-world data collected from 487 patients with CP (mean age, 68.3 years; 57.7% women) suffering from a wide range of chronic musculoskeletal pain conditions and treated with tapentadol.

Results: Following tapentadol treatment, patients experienced an 80% reduction in the frequency of very disturbed sleep as well as a 50% reduction in the predominant sleep complaint reported by patients with CP - that is, nocturnal awakenings. A significantly greater proportion of patients reported good/restful sleep at the end of the study period compared to baseline (72.4% 25.3%; <0.01). This benefit was observed regardless of the clinical setting, treatment duration, posology or patient age and was associated with a higher proportion of patients reporting an improved global health status and good tolerability.

Conclusion: The reduction in pain intensity provided by tapentadol fosters sleep quality and favours a better quality of life. Therefore, our findings provide the rationale for addressing sleep quality as a relevant outcome, complementary to pain relief in CP management.
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http://dx.doi.org/10.7573/dic.2020-12-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8060026PMC
April 2021

Personalizing Cancer Pain Therapy: Insights from the Rational Use of Analgesics (RUA) Group.

Pain Ther 2021 Jun 17;10(1):605-617. Epub 2021 Mar 17.

University of Florence, Pain and Palliative Care Clinic, Careggi Hospital, 50139, Florence, Italy.

Introduction: A previous Delphi survey from the Rational Use of Analgesics (RUA) project involving Italian palliative care specialists revealed some discrepancies between current guidelines and clinical practice with a lack of consensus on items regarding the use of strong opioids in treating cancer pain. Those results represented the basis for a new Delphi study addressing a better approach to pain treatment in patients with cancer.

Methods: The study consisted of a two-round multidisciplinary Delphi study. Specialists rated their agreement with a set of 17 statements using a 5-point Likert scale (0 = totally disagree and 4 = totally agree). Consensus on a statement was achieved if the median consensus score (MCS) (expressed as value at which at least 50% of participants agreed) was at least 4 and the interquartile range (IQR) was 3-4.

Results: This survey included input from 186 palliative care specialists representing all Italian territory. Consensus was reached on seven statements. More than 70% of participants agreed with the use of low dose of strong opioids in moderate pain treatment and valued transdermal route as an effective option when the oral route is not available. There was strong consensus on the importance of knowing opioid pharmacokinetics for therapy personalization and on identifying immediate-release opioids as key for tailoring therapy to patients' needs. Limited agreement was reached on items regarding breakthrough pain and the management of opioid-induced bowel dysfunction.

Conclusion: These findings may assist clinicians in applying clinical evidence to routine care settings and call for a reappraisal of current pain treatment recommendations with the final aim of optimizing the clinical use of strong opioids in patients with cancer.
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http://dx.doi.org/10.1007/s40122-021-00248-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119556PMC
June 2021

Oxycodone/Acetaminophen: The Tailoring Combination Treatment for Specific Clinical Profile of Opioid Well-Responsive Cancer Pain.

Cancer Manag Res 2021 19;13:1747-1756. Epub 2021 Feb 19.

Primary Care Unit, ASL RM1, Rome, 00165, Italy.

Background: International guidelines recommend moderate-to-severe cancer pain to be treated with strong opioids. However, pain management remains an unsolved matter, at least in the demanding oncology and palliative care setting. Although cancer pain consists of multiple components, which interact in complex ways where combination therapy can better intercept multiple pain characteristics, few studies have used a non-opioid/opioid association to exploit possible synergistic actions. Even the efforts of a recent approach emphasizing appropriate pain assessment and accurate classification to obtain personalized pain management have not produced a satisfactory analgesic strategy.

Objective: This analysis was intended to evaluate the effectiveness of the immediate release fixed combination of oxycodone/acetaminophen (OxyIR/Par) for the treatment of moderate-to-severe intensity background pain used alone or in combination with other strong opioids in cancer patients with breakthrough cancer pain (BTcP). This is a secondary analysis of a wider observational, prospective, multicenter study [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] performed on 179 patients treated with opioids for cancer pain who received the fixed combination of oxycodone/acetaminophen (OxyIR/Par) for the treatment of background pain (BGP).

Results: Cancer patients with breakthrough cancer pain and controlled BGP (Background Pain) were classified according to the presence of analgesic therapy with tablets of fixed combination OxyIR/Par alone (group A, n=120) or tablets of fixed combination OxyIR/Par combined with other strong opioids (group B, n=59). Clinical features of group A were different to group B: higher mean Karnofsky Performance Status Index 70.3% (95% CI=67.2-73.5; median=70, CI=60-80) vs 58.3 (95% CI=53.4-63.2; median=50, CI=45-70) (<0.001), and mainly group A patients were treated in an ambulatory setting (55.0% group A vs 33.9% group B) (p<0.001). Both groups had managed BGP with similar mean dosages (group A: 12.0, CI=10.5-13.4; group B: 13.1, CI=11.0-15.1) and frequencies of OxyIR/Par alone for group A and in association to other opioids for group B, but Breakthrough cancer Pain (BTcP) exhibited different characteristics in the two groups, showing a lower mean intensity numerical rating scale (NRS) of 7.5 (95% CI=7.2-7.7; median=7, CI=7-8 group A) vs 7.9 (95% CI=7.6, 8.2; median= 8, CI=7-9 group B) (=0.04) and a higher percentage of patients had a faster onset, defined as the maximum intensity reached in less than 10 minutes, 81.7% (N=98) in group A vs 59.3% (n=35) in group B (=0.002).

Conclusion: This is the first analysis about the efficacy of an immediate-release fixed combination of OxyIR/Par in the real world for moderate-to-severe background cancer pain and breakthrough cancer pain. The oral fixed combination OxyIR/Par provided an adequate level of analgesia for moderate-severe background cancer pain, in a different cohort of cancer patients with different performance status, both in ambulatory and palliative settings. The low dosage of fixed combination OxyIR/Par was effective alone or in association with other opioids.
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http://dx.doi.org/10.2147/CMAR.S290551DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903954PMC
February 2021

Breakthrough Cancer Pain Clinical Features and Differential Opioids Response: A Machine Learning Approach in Patients With Cancer From the IOPS-MS Study.

JCO Precis Oncol 2020 4;4. Epub 2020 Nov 4.

Pain Therapy Unit, "A. Businco" Hospital, ASL 8, Cagliari, Italy.

Purpose: A large proportion of patients with cancer suffer from breakthrough cancer pain (BTcP). Several unmet clinical needs concerning BTcP treatment, such as optimal opioid dosages, are being investigated. In this analysis the hypothesis, we explore with an unsupervised learning algorithm whether distinct subtypes of BTcP exist and whether they can provide new insights into clinical practice.

Methods: Partitioning around a k-medoids algorithm on a large data set of patients with BTcP, previously collected by the Italian Oncologic Pain Survey group, was used to identify possible subgroups of BTcP. Resulting clusters were analyzed in terms of BTcP therapy satisfaction, clinical features, and use of basal pain and rapid-onset opioids. Opioid dosages were converted to a unique scale and the BTcP opioids-to-basal pain opioids ratio was calculated for each patient. We used polynomial logistic regression to catch nonlinear relationships between therapy satisfaction and opioid use.

Results: Our algorithm identified 12 distinct BTcP clusters. Optimal BTcP opioids-to-basal pain opioids ratios differed across the clusters, ranging from 15% to 50%. The majority of clusters were linked to a peculiar association of certain drugs with therapy satisfaction or dissatisfaction. A free online tool was created for new patients' cluster computation to validate these clusters in future studies and provide handy indications for personalized BTcP therapy.

Conclusion: This work proposes a classification for BTcP and identifies subgroups of patients with unique efficacy of different pain medications. This work supports the theory that the optimal dose of BTcP opioids depends on the dose of basal opioids and identifies novel values that are possibly useful for future trials. These results will allow us to target BTcP therapy on the basis of patient characteristics and to define a precision medicine strategy also for supportive care.
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http://dx.doi.org/10.1200/PO.20.00158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7713587PMC
November 2020

Mesotherapy: From Historical Notes to Scientific Evidence and Future Prospects.

ScientificWorldJournal 2020 1;2020:3542848. Epub 2020 May 1.

Department of Clinical Science and Translational Medicine, Tor Vergata University, Rome, Italy.

Intradermal therapy, known as mesotherapy, is a technique used to inject a drug into the surface layer of the skin. In particular, it involves the use of a short needle to deposit the drug in the dermis. The intradermal microdeposit modulates the drug's kinetics, slowing absorption and prolonging the local mechanism of action. It is successfully applied in the treatment of some forms of localized pain syndromes and other local clinical conditions. It could be suggested when a systemic drug-sparing effect is useful, when other therapies have failed (or cannot be used), and when it can synergize with other pharmacological or nonpharmacological therapies. Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.
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http://dx.doi.org/10.1155/2020/3542848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305548PMC
June 2021

Factors Influencing the Clinical Presentation of Breakthrough Pain in Cancer Patients.

Cancers (Basel) 2018 Jun 1;10(6). Epub 2018 Jun 1.

PainTherapy, S. Croce e Carle Hospital, 12100 Cuneo, Italy,

The aim of this study was to identify potential variables influencing the clinical presentation of breakthrough cancer pain (BTP). Cancer patients with a diagnosis of BTP were enrolled. Demographic and clinical characteristics, as well as background pain and BTP characteristics were collected. Multivariate analyses were conducted to assess the correlation between BTP characteristics and the variables examined. Data of 4016 patients were analysed. Average daily number of BTP episodes was 2.4, mean intensity was 7.5, and a mean duration was 43.3 min. A short onset BTP was observed in 68.9% of patients. In 30.5% of patients BTP was predictable. There were 86.0% of participants who reported a marked interference of BTP with their daily activities. Furthermore, 86.8% of patients were receiving opioids for the management of BTP. The average time to meaningful pain relief was 16.5 min and 70.9% of patients were satisfied with their BTP medications. Age, head and neck cancer, Karnofsky, background pain intensity, predictable and fast onset BTP were independently associated with the number of BTP episodes. BTP pain intensity was independently associated with background pain intensity, fast onset BTP, and Karnofsky. Neuropathic pain mechanism was independently associated with unpredictable BTP. Variables independently associated with a longer duration of BTP were age, place of visit, cancer diagnosis, disease-oriented therapy, background pain intensity and mechanism, and unpredictable BTP. Age, Karnofsky, background pain intensity, fast onset, and long duration of BTP were independently associated with interference with daily activity. BTP has a variable presentation depending on interdependent relationships among its different characteristics.
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http://dx.doi.org/10.3390/cancers10060175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6025469PMC
June 2018

Assessment and treatment of breakthrough cancer pain: from theory to clinical practice.

J Pain Res 2017 12;10:2147-2155. Epub 2017 Sep 12.

Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.

Breakthrough cancer pain (BTcP) is a common condition in oncological patients. However, its management is still suboptimal. Improved knowledge of BTcP and its management in clinical practice may have immediate importance for all physicians involved in the supportive care of cancer patients. This review critically discusses the most important concepts for the correct diagnosis of BTcP and presents some intriguing cases of the management of this condition in clinical practice. Overall, the most appropriate therapeutic choice appears to be a rapid-onset opioid (ROO), and in particular, the nasal route of administration is the quickest and most convenient mode of administration for the management of BTcP, especially when the patient needs rapid resolution of pain. To this end, intranasal fentanyl spray may have a particular relevance in clinical practice. Future research should focus on accepted definitions of BTcP to investigate the optimal management of this highly heterogeneous pain condition. Therapeutic decision-making of patients, clinicians, and payers will likely be driven from results of well-designed clinical trials of ROOs.
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http://dx.doi.org/10.2147/JPR.S135807DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5604430PMC
September 2017

Oral Prolonged-Release Oxycodone/Naloxone for Managing Pain and Opioid-Induced Constipation: A Review of the Evidence.

Pain Pract 2018 06 28;18(5):647-665. Epub 2017 Nov 28.

Marymount University Hospital and Hospice, Cork, Ireland.

Background: Opioids provide effective relief from moderate-to-severe pain and should be prescribed as part of a multifaceted approach to pain management when other treatments have failed. Fixed-dose oxycodone/naloxone prolonged-release tablets (OXN PR) were designed to address the opioid class effect of opioid-induced constipation (OIC) by combining the analgesic efficacy of oxycodone with the opioid receptor antagonist, naloxone, which has negligible systemic availability when administered orally. This formulation has abuse-deterrent properties, since systemic exposure to naloxone by parenteral administration would antagonize the euphoric effects of oxycodone.

Methods: A literature search was conducted to assess the evidence base for OXN PR to treat moderate-to-severe pain and its impact on bowel function, based on published clinical trials and observational studies.

Results: Extensive data demonstrate that OXN PR provides effective analgesia and clinically relevant improvements in bowel function in patients with OIC and moderate-to-severe cancer-related pain and noncancer pain types such as low back pain, neuropathic pain, and musculoskeletal pain. OXN PR has also been found to improve bowel function in patients with OIC refractory to multiple types of laxatives, and improve Parkinson's disease-related pain. No unanticipated safety concerns have been reported in elderly patients.

Conclusions: Evidence from clinical trials and observational studies confirms that for selected patients OXN PR significantly improves moderate-to-severe chronic pain and provides relief from OIC. Treatment should be tailored to individual patients to establish the lowest effective dose. An absence of analgesic ceiling effect was seen across the clinically relevant dose range investigated (≤ 160/80 mg/day).
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http://dx.doi.org/10.1111/papr.12646DOI Listing
June 2018

Cost-effectiveness analysis of oral fentanyl formulations for breakthrough cancer pain treatment.

PLoS One 2017 27;12(6):e0179523. Epub 2017 Jun 27.

Research Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy.

Breakthrough cancer Pain (BTcP) has a high prevalence in cancer population. Patients with BTcP reported relevant health care costs and poor quality of life. The study assessed the cost-effectiveness of the available Oral Fentanyl Formulations (OFFs) for BTcP in Italy. A decision-analytical model was developed to estimate costs and benefits associated with treatments, from the Italian NHS perspective. Expected reductions in pain intensity per BTcP episodes were translated into, percentage of BTcP reduction, resource use and Quality-Adjusted-Life-Years (QALYs). Relative efficacy, resources used and unit costs data were derived from the literature and validated by clinical experts. Probabilistic and deterministic sensitivity analyses were performed. At base-case analysis, Sublingual Fentanyl Citrate (FCSL) compared to other oral formulations reported a lower patient's cost (€1,960.8) and a higher efficacy (18.7% of BTcP avoided and 0.0507 QALYs gained). The sensitivity analyses confirmed the main results in all tested scenarios, with the highest impact reported by BTcP duration and health care resources consumption parameters. Between OFFs, FCSL is the cost-effective option due to faster reduction of pain intensity. However, new research is needed to better understand the economic and epidemiologic impact of BTcP, and to collect more robust data on economic and quality of life impact of the different fentanyl formulations. Different fentanyl formulations are available to manage BTcP in cancer population. The study is the first that assesses the different impact in terms of cost and effectiveness of OFFs, providing new information to better allocate the resources available to treat BTcP and highlighting the need of better data.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0179523PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5487011PMC
September 2017

High dosage of a fixed combination oxycodone/naloxone prolonged release: efficacy and tolerability in patients with chronic cancer pain.

Support Care Cancer 2017 10 3;25(10):3051-3058. Epub 2017 May 3.

Istituti Clinici e Scientifici Maugeri, Veruno, Italy.

Purpose: Opioids are associated with side effects in the treatment of moderate-to-severe chronic cancer pain. Oral combination of opioid agonist-antagonist oxycodone-naloxone (OXN-PR) attenuates gastrointestinal side effects; however, evidence on high-dose OXN-PR treatment is scant. This study evaluates the efficacy and tolerability of high-dose OXN-PR in chronic cancer pain.

Patients And Methods: This was a multicenter, prospective 60-day observation on consecutive cancer patients with uncontrolled moderate-severe chronic pain or intolerant to other analgesics, who were switched at entry visit (T0) to OXN-PR ≥80 mg daily. Patients were reassessed 14, 30, 45, and 60 days later (T60). Primary endpoint of the study was analgesic response rate (decrease ≥30% of pain intensity from baseline, measured on a 0-10 numerical rating scale, NRS) after 30 days on OXN-PR. Additional endpoints assessed at every visit were the impact of pain on quality of life (QoL), breakthrough cancer pain (BTCP) episodes, opioid dosage escalation index, bowel dysfunction, safety, and other side effects.

Results: One hundred nineteen patients were included (age 64 ± 12, metastatic disease in 91.6%); 101 of them (84.9%) completed the 60-day observation. At T0, the majority had severe pain (NRS ≥7 in 79.8%; neuropathic features in 83.2%). Response rate at 30-day visit was 79.8% (n = 95). OXN-PR resulted in a significant reduction in pain over time (T0: 7.4 ± 1.3; T60: 3.3 ± 1.8; p < 0.001), and the number of daily (BTCP) declined (3.9 ± 2.2 vs. 2.0 ± 0.6, p < 0.001). Daily dosage of OXN-PR slightly increased (T0: 81.3 ± 6.0; T60: 93.6 ± 34.0; p < 0.001). The impact of pain on QoL abated (p < 0.0001), and bowel function improved overtime (p < 0.001). After the switch to OXN-PR, the number of patients complaining for side effects decreased overall (p < 0.0001); laxatives and antiemetic use also declined significantly.

Conclusions: OXN-PR was highly effective and well tolerated even at high doses in cancer patients with chronic pain. The agonist-antagonist combination rapidly alleviated pain and its impact on life style, reducing the number of BTCP and improving opioid side effects.
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http://dx.doi.org/10.1007/s00520-017-3709-5DOI Listing
October 2017

Bone pain mechanism in osteoporosis: a narrative review.

Clin Cases Miner Bone Metab 2016 May-Aug;13(2):97-100. Epub 2016 Oct 5.

Palliative Care and Pain Therapy Unit, University Hospital of Careggi, Florence, Italy.

Bone pain in elderly people dramatically affects their quality of life, with osteoporosis being the leading cause of skeletal related events. Peripheral and central mechanisms are involved in the pathogenesis of the nervous system sensitization. Osteoporosis in the elderly has been associated with increased density of bone sensory nerve fibers and their pathological modifications, together with an over-expression of nociceptors sensitized by the lowering pH due to the osteoclastic activity. The activation of N-methyl-D-aspartate (NMDA) receptors and the microglia, as a response to a range of pathological conditions, represent the leading cause of central sensitization. Unfortunately, osteoporosis is named the "silent thief" because it manifests with painful manifestation only when a fracture occurs. In the management of patients suffering from bone pain, both the nociceptive and the neuropathic component of chronic pain should be considered in the selection of the analgesic treatment.
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http://dx.doi.org/10.11138/ccmbm/2016.13.2.097DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5119722PMC
October 2016

Implications of analgesics use in osteoporotic-related pain treatment: focus on opioids.

Clin Cases Miner Bone Metab 2016 May-Aug;13(2):89-92. Epub 2016 Oct 5.

Palliative Care and Pain Therapy Unit, University Hospital of Careggi, Florence, Italy.

Bone loss is asymptomatic and will progress without pain and other symptoms until the occurrence of a fracture. The occurrence of a breaking bone induce acute pain determined and supported by a mechanical, inflammatory and neuropathic component. Very often the acute component evolves in a chronic musculoskeletal component. Overall objectives of the analgesic therapy can be summarized in pain relief, improving sleep, improve mobility, reduce anxiety, emotional component and depression. Osteoporosis is predominantly a condition of the elderly, more likely to have coexisting cardiovascular disease and age-related decline in renal function, receiving treatment for one or more comorbid conditions, taking multiple medications. Analgesic treatment with NSAIDs has negative effects on skeletal health and healing of the injured skeleton and increase risk of adverse events especially in older patients. Despite all opioids therapy represents a mainstay in the treatment of patients with moderate to severe pain, it can induce an endocrinopathy, which may affect bone metabolism. The negative effects of opioids on hormonal axis are not the same for all molecule and the choice of drug can be crucial in the treatment of patients with chronic pain.
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http://dx.doi.org/10.11138/ccmbm/2016.13.2.089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5119720PMC
October 2016

Use of opioids for treatment of osteoporotic pain.

Clin Cases Miner Bone Metab 2014 Sep;11(3):173-6

Palliative Care and Pain Therapy Unit, University Hospital Careggi, Florence, Italy.

The prevalence of osteoporosis increases markedly with age: currently it is estimated that over 200 million people suffer from osteoporosis worldwide. One of the most feared and more frequent complications of osteoporosis is pain, which affects 85% of patients. Commonly in the treatment of chronic pain the therapeutic strategy is based on a three-ladder approach, involving opioids for moderate and severe pain. As proposed by the World Health Organization (WHO), according to the intensity of chronic pain, analgesic treatment can be established. Despite the debate and updates to the analgesic ladder for pain published in 1986 by the WHO, the benefits resulting from its worldwide use are uncontested. In case the pain was not responsive to drugs of pain ladder, is necessary to resort to specialized practices (e.g. subarachnoid infusion of drugs). The oral route for administering analgesics should be preferred, provided that the patients are able to use it. About 50% of all opioid users experience at least one side effect, and more than 20% discontinued treatment due to a serious adverse event. Despite published guidelines and WHO's pain ladder for the management of chronic pain, the treatment of this condition remains suboptimal. Given the physiopsychopathology and complexity of the problems of chronic osteoporotic pain, a multimodal and multidisciplinary approach is still considered the best way to diagnose and treat this disease.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4269138PMC
September 2014

Pathogenesis and clinical aspects of pain in patients with osteoporosis.

Clin Cases Miner Bone Metab 2014 Sep;11(3):169-72

Palliative Care and Pain Therapy Unit, Oncologic Department, "AOU Careggi", Florence, Italy.

Bone pain is one of the most frequent kinds of chronic pain, mainly in elderly patients. It causes a significant worsening of functional capacity and deterioration in the quality of life in people affected. Mechanisms of pain in osteoporosis are poorly known and often extrapolated by other pathologies or other experimental model. One of principal causes would be a "hyper-remodeling" of bone, that involves osteoclasts activity and pathological modifications of bone innervation. Several studies show that osteoclasts play a significant role in bone pain etiology. Pain in osteoporosis is mainly nociceptive, if it become persistent a sensitization of peripheral and central nervous system can occur, so underlining the transition to a chronic pain syndrome. Central sensitization mechanisms are complex and involve several neuromediators and receptors (Substance P, NMDA, etc.). Most common manifestations of osteoporosis are vertebral compression fractures that cause persistent pain, though to differentiate from pain originating in structures as joint or muscle. First manifestation can be an acute pain due to pathological fracture, those of hip often causes disability. Pain in osteoporosis is an important clinical challenge. Often its complications and consequences on patient quality of life are underestimated with not negligible social implications. A balanced and early multimodal pain therapy including opioids as necessary, even in cases of acute pain, improve the functional capacity of patients and helps to prevent neurological alterations that seems to contribute in significant way in causing irreversible pain chronic syndromes.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4269137PMC
September 2014

Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain.

Support Care Cancer 2015 May 29;23(5):1349-54. Epub 2014 Oct 29.

Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Via San Lorenzo 312, 90146, Palermo, Italy,

Purpose: The aim of the present study was to assess the long-term tolerability and efficacy of intranasal fentanyl (INFS) in opioid-tolerant patients with breakthrough cancer pain (BTP).

Patients And Methods: A 6 months, observational, prospective, cohort study design was employed to follow advanced cancer patients with BTP receiving INFS under routine clinical practice. Eligible adult cancer patients suffering from BTP had been prescribed INFS at effective doses. Data were collected at T0 and at month intervals for six months. The principal outcomes were the evaluation of possible serious adverse effects with prolonged use of INFS, the efficacy of BTP treatment with INFS, the quality of sleep, the rate of INFS discontinuation, and reasons for that.

Results: Seventy-five patients were surveyed. Thirty-four patients (45.3 %) had a follow-up at 3 months, and twelve patients (16 %) were followed up at 6 months. The mean opioid doses, expressed as oral morphine equivalents, ranged 111-180 mg/day, while the mean INFS doses were 87-119 μg. Adverse effects were reported in a minority of patients and were considered to be associated with opioid therapy used for background pain. The quality of sleep significantly improved during the first 3-4 months. Finally, efficacy based on a general impression regarding the efficacy of INFS was good-excellent in most patients and statistically improved in time up to the third month.

Conclusion: The long-term use of INFS in advanced cancer patients is effective and safe. No serious adverse effects were found up to six months of assessment. The level of quality of sleep and patients' satisfaction was relatively good, considering the advanced stage of disease.
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http://dx.doi.org/10.1007/s00520-014-2491-xDOI Listing
May 2015

Patients' and physicians' perspectives on opioid therapy for chronic cancer and musculoskeletal pain in Germany, Italy, and Turkey: PAin RESearch (PARES) survey.

Curr Med Res Opin 2014 Mar 18;30(3):339-47. Epub 2013 Nov 18.

Regional Pain and Palliative Care Centre DGS , Göppingen , Germany.

Objective: Under-treatment or lack of appropriate treatment for chronic pain remains an ongoing major healthcare problem. Opioids are being increasingly recognized as an effective option for chronic pain management. The objective of this survey was to understand the perspective of patients treated with opioids on quality of treatment, preferences, and possibilities to improve treatment and communication between patients and physicians.

Research Design: A large-scale PAin RESearch (PARES) survey of 2860 patients (Germany, Italy, and Turkey) with chronic cancer or musculoskeletal pain prescribed opioid therapy was conducted to assess various factors such as ease of use and compliance, sleep, quality-of-life, and polymedication. A physician component was also included. Relationships between variables and differences between groups were tested using Spearman and Wilcoxon signed-rank tests, respectively.

Results: Of the patients surveyed, 61% received strong opioids (WHO III) and 39% weak opioids (WHO II). Nearly 65% of the patients were currently on a twice daily or more dosing schedule; however, 61.5% of the patients responded that they considered once-daily dosing to be the most convenient schedule. Patients' responses indicated that different dosing schedules significantly influenced the occurrence of end-of-dose pain, feeling limited by the remaining level of pain, problems in falling asleep, and episodes of waking up at night or early in the morning. Physicians' responses showed that they were not surprised by 68.5% of patient responses; they also felt the need to change some aspect of pain treatment for a third of the patients, the commonest being pain medication (52.4%).

Conclusions: The results of the survey suggest that patients prefer a convenient dosing scheme, which may have a positive impact on compliance. Physicians may have to communicate more closely with patients about their needs.
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http://dx.doi.org/10.1185/03007995.2013.861349DOI Listing
March 2014

Adverse effects associated with non-opioid and opioid treatment in patients with chronic pain.

Clin Drug Investig 2012 Feb;32 Suppl 1:53-63

Oncology Unit, Ospedali Riuniti di Bergamo, Bergamo, Italy.

Chronic pain is a debilitating condition that is associated with many common diseases; this places a major burden on the healthcare system. There are currently numerous analgesic agents available for the treatment of chronic pain. In general, the oral non-opioid analgesic, paracetamol, is recommended for the initial treatment of mild to moderate pain. Therapeutic doses of paracetamol do not appear to result in hepatotoxicity, although overdose may lead to acute liver failure. Current data suggest that paracetamol has acceptable gastrointestinal tolerability. Another class of non-opioid analgesic with confirmed efficacy for the treatment of chronic mild to moderate pain are non-steroidal anti-inflammatory drugs (NSAIDs), although this efficacy is offset by the potential of adverse gastrointestinal events. In particular, non-selective NSAIDs, also known as cyclooxygenase (COX) inhibitors, carry an increased risk of serious upper gastrointestinal complications, including ulcers, perforation and bleeding. The introduction of COX-2 inhibitors provided a NSAID-based option with improved gastrointestinal safety, but increased risk of cardiovascular effects. Opioids are powerful analgesic agents used to treat moderate to severe chronic pain. However, treatment with opioids is associated with a number of common adverse effects, including constipation, nausea or vomiting, pruritus, somnolence or cognitive impairment, dry mouth, tolerance or dependence and urinary retention. Although there are multiple strategies in place to manage adverse events that arise from both non-opioid and opioid analgesic therapy, a better understanding of the mechanisms involved in the development of specific drug-related adverse effects is required along with proper prescribing practices and adequate physician/patient education. Balanced against the adverse effects of pain management medications, there is a need to be mindful of the widespread, often serious, adverse consequences of poorly managed pain itself.
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February 2012

The appropriate treatment of chronic pain.

Clin Drug Investig 2012 Feb;32 Suppl 1:21-33

Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.

Chronic pain is a common healthcare problem worldwide that ranks as a predominant reason for consulting a physician, yet effective management of chronic pain remains suboptimal, often resulting in unnecessary suffering and decreased quality of life, lost productivity and excessive healthcare costs. To overcome the challenges associated with the management of chronic pain, increased awareness and both patient and physician education are required. Improving physician knowledge of pain assessment and management guided by recommendations for a comprehensive, multifactorial, personalised treatment approach involving pharmacological and non-pharmacological approaches is key to achieving effective pain relief. Guidelines for the management of non-cancer and cancer pain recommend thorough patient assessment before individualized therapy based on the type and intensity of pain. The availability of mechanism-specific analgesics has facilitated improvements in the treatment of chronic non-cancer pain, which may be of neuropathic, muscle, inflammatory, mechanical/compressive or mixed origin. Stepwise escalation of analgesic therapy (paracetamol, non-steroidal anti-inflammatory drugs, mild to strong opioids) according to the World Health Organization's three-step pain ladder remains the standard approach for the selection of treatment for chronic cancer pain, although there is now a greater awareness of the requirements for effective administration of opioids including dose titration, use of short versus long-acting opioids, opioid rotation, management of adverse effects, and ongoing monitoring. Selection of an effective, appropriate, personalized analgesic regimen for patients with chronic pain is achievable and is expected to enhance compliance, overall functioning and quality of life.
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February 2012

Barriers to pain management : focus on opioid therapy.

Clin Drug Investig 2012 Feb;32 Suppl 1:11-9

Department of Geriatrics, Ospedale Israelitico, Rome, Italy.

Despite the availability of effective pain treatments, there are numerous barriers to effective management resulting in a large proportion of patients not achieving optimal pain control. Chronic pain is inadequately treated because of a combination of cultural, societal, educational, political and religious constraints. The consequences of inadequately treated pain are physiological and psychological effects on the patient, as well as socioeconomic implications. Unreasonable failure to treat pain is viewed as unethical and an infringement of basic human rights. The numerous barriers to the clinical management of pain vary depending on whether they are viewed from the standpoint of the patient, the physician, or the institution. Identification and acknowledgement of the barriers involved are the first steps to overcoming them. Successful initiatives to overcome patient, physician and institutional barriers need to be multifaceted in their approach. Multidisciplinary initiatives to improve pain management include dissemination of community-based information, education and awareness programmes to attempt to change attitudes towards pain treatment. A better awareness and insight into the problems caused by unrelieved pain and greater knowledge about the efficacy and tolerability of available pain management options should enable physicians to seek out and adhere to treatment guidelines, and participate in interventional and educational programmes designed to improve pain management, and for institutions to implement the initiatives required. Although much work is underway to identify and resolve the issues in pain management, many patients still receive inadequate treatment. Continued effort is required to overcome the known barriers to effective pain management.
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http://dx.doi.org/10.2165/11630040-000000000-00000DOI Listing
February 2012

Heterogeneity of chronic pain.

Authors:
Renato Vellucci

Clin Drug Investig 2012 Feb;32 Suppl 1:3-10

Palliative Care and Pain Therapy Unit, University Hospital of Careggi, Florence, Italy.

Chronic pain is a widespread public health issue that has many effects on physical, emotional and cognitive functions. An estimated 10-55% of all adults are thought to have chronic pain. Chronic pain is a multifactorial condition, caused by the complex interplay of nociceptive, neuropathic or mixed pathogenic mechanisms. Chronic pain is associated with specific and non-specific medical conditions such as cancer, HIV/AIDS, rheumatoid arthritis, fibromyalgia, osteoarthritis, low back pain or spinal stenosis and is broadly categorized as cancer pain and non-cancer pain. Evaluation of chronic pain requires a clear understanding of the nature of the pain and its underlying pathophysiology. Adequate assessment of pain, using validated tools, is an essential prerequisite of successful pain management. Unidimensional scales are useful for the measurement of pain intensity, while multidimensional scales measure both pain intensity and the extent to which pain interferes with life activity and emotional functioning. Patients should be reassessed and followed up in order to monitor progress and measure improvements in pain.
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http://dx.doi.org/10.2165/11630030-000000000-00000DOI Listing
February 2012

Breakthrough pain in patients referred to pain clinics: the Italian pain network retrospective study.

Adv Ther 2012 May 21;29(5):464-72. Epub 2012 May 21.

Emergency Care, Critical Care Medicine, Pain Medicine and Anesthesiology Department, Tor Vergata Polyclinic, University of Rome Tor Vergata, Rome, Italy.

Introduction: Despite breakthrough pain (BTP) being one of the most severe forms of pain, there are no definitive data on its prevalence.

Methods: The authors performed a retrospective survey of the prevalence of BTP in consecutive patients in four Italian pain clinics, subsequent to application of an Italian law mandating detailed clinical records on pain characteristics, treatment, and results. Mean pain intensity was assessed with a numerical rating scale from 0 to 10.

Results: The authors analyzed records of 1,401 patients (58% women, 33.1% patients with cancer). Transient episodes of severe pain or BTP were referred by 790 patients (56.4%), including 58.2% of the men (342 of 588) and 55.1% of the women (448 of 813). Among the 464 patients with cancer, 70.3% reported daily exacerbation of pain. The mean BTP intensity was 8.31 ± 1.58 and 31.1% of patients reported experiencing three episodes per day.

Conclusion: Despite some limitations of the study, the authors show that transient episodes of severe pain or BTP are significantly present both in cancer and other diseases, and that many patients are not yet receiving appropriate opioid therapy. The authors need validated tools at international level for the diagnosis and treatment of BTP in patients with cancer and for transitory and patients with severe non-cancer pain. A survey at national level is needed to estimate the prevalence of BTP in different settings, to plan specific medical education.
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http://dx.doi.org/10.1007/s12325-012-0022-zDOI Listing
May 2012

Adverse effects associated with non-opioid and opioid treatment in patients with chronic pain.

Clin Drug Investig 2012 Feb;32 Suppl 1:53-63

Oncology Unit, Ospedali Riuniti di Bergamo, Bergamo, Italy.

Chronic pain is a debilitating condition that is associated with many common diseases; this places a major burden on the healthcare system. There are currently numerous analgesic agents available for the treatment of chronic pain. In general, the oral non-opioid analgesic, paracetamol, is recommended for the initial treatment of mild to moderate pain. Therapeutic doses of paracetamol do not appear to result in hepatotoxicity, although overdose may lead to acute liver failure. Current data suggest that paracetamol has acceptable gastrointestinal tolerability. Another class of non-opioid analgesic with confirmed efficacy for the treatment of chronic mild to moderate pain are non-steroidal anti-inflammatory drugs (NSAIDs), although this efficacy is offset by the potential of adverse gastrointestinal events. In particular, non-selective NSAIDs, also known as cyclooxygenase (COX) inhibitors, carry an increased risk of serious upper gastrointestinal complications, including ulcers, perforation and bleeding. The introduction of COX-2 inhibitors provided a NSAID-based option with improved gastrointestinal safety, but increased risk of cardiovascular effects. Opioids are powerful analgesic agents used to treat moderate to severe chronic pain. However, treatment with opioids is associated with a number of common adverse effects, including constipation, nausea or vomiting, pruritus, somnolence or cognitive impairment, dry mouth, tolerance or dependence and urinary retention. Although there are multiple strategies in place to manage adverse events that arise from both non-opioid and opioid analgesic therapy, a better understanding of the mechanisms involved in the development of specific drug-related adverse effects is required along with proper prescribing practices and adequate physician/patient education. Balanced against the adverse effects of pain management medications, there is a need to be mindful of the widespread, often serious, adverse consequences of poorly managed pain itself.
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http://dx.doi.org/10.2165/11630080-000000000-00000DOI Listing
February 2012

The appropriate treatment of chronic pain.

Clin Drug Investig 2012 Feb;32 Suppl 1:21-33

Rheumatology Unit, L Sacco University Hospital, Milan, Italy.

Chronic pain is a common healthcare problem worldwide that ranks as a predominant reason for consulting a physician, yet effective management of chronic pain remains suboptimal, often resulting in unnecessary suffering and decreased quality of life, lost productivity and excessive healthcare costs. To overcome the challenges associated with the management of chronic pain, increased awareness and both patient and physician education are required. Improving physician knowledge of pain assessment and management guided by recommendations for a comprehensive, multifactorial, personalised treatment approach involving pharmacological and non-pharmacological approaches is key to achieving effective pain relief. Guidelines for the management of non-cancer and cancer pain recommend thorough patient assessment before individualized therapy based on the type and intensity of pain. The availability of mechanism-specific analgesics has facilitated improvements in the treatment of chronic non-cancer pain, which may be of neuropathic, muscle, inflammatory, mechanical/compressive or mixed origin. Stepwise escalation of analgesic therapy (paracetamol, non-steroidal anti-inflammatory drugs, mild to strong opioids) according to the World Health Organization's three-step pain ladder remains the standard approach for the selection of treatment for chronic cancer pain, although there is now a greater awareness of the requirements for effective administration of opioids including dose titration, use of short versus long-acting opioids, opioid rotation, management of adverse effects, and ongoing monitoring. Selection of an effective, appropriate, personalized analgesic regimen for patients with chronic pain is achievable and is expected to enhance compliance, overall functioning and quality of life.
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http://dx.doi.org/10.2165/11630050-000000000-00000DOI Listing
February 2012

Barriers to pain management: focus on opioid therapy.

Clin Drug Investig 2012 Feb;32 Suppl 1:11-9

Department of Geriatrics, Ospedale Israelitico, Rome, Italy.

Despite the availability of effective pain treatments, there are numerous barriers to effective management resulting in a large proportion of patients not achieving optimal pain control. Chronic pain is inadequately treated because of a combination of cultural, societal, educational, political and religious constraints. The consequences of inadequately treated pain are physiological and psychological effects on the patient, as well as socioeconomic implications. Unreasonable failure to treat pain is viewed as unethical and an infringement of basic human rights. The numerous barriers to the clinical management of pain vary depending on whether they are viewed from the standpoint of the patient, the physician, or the institution. Identification and acknowledgement of the barriers involved are the first steps to overcoming them. Successful initiatives to overcome patient, physician and institutional barriers need to be multifaceted in their approach. Multidisciplinary initiatives to improve pain management include dissemination of community-based information, education and awareness programmes to attempt to change attitudes towards pain treatment. A better awareness and insight into the problems caused by unrelieved pain and greater knowledge about the efficacy and tolerability of available pain management options should enable physicians to seek out and adhere to treatment guidelines, and participate in interventional and educational programmes designed to improve pain management, and for institutions to implement the initiatives required. Although much work is underway to identify and resolve the issues in pain management, many patients still receive inadequate treatment. Continued effort is required to overcome the known barriers to effective pain management.
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http://dx.doi.org/10.2165/11630040-000000000-00000DOI Listing
February 2012

Heterogeneity of chronic pain.

Authors:
Renato Vellucci

Clin Drug Investig 2012 Feb;32 Suppl 1:3-10

Palliative Care and Pain Therapy Unit, University Hospital of Careggi, Florence, Italy.

Chronic pain is a widespread public health issue that has many effects on physical, emotional and cognitive functions. An estimated 10-55% of all adults are thought to have chronic pain. Chronic pain is a multifactorial condition, caused by the complex interplay of nociceptive, neuropathic or mixed pathogenic mechanisms. Chronic pain is associated with specific and non-specific medical conditions such as cancer, HIV/AIDS, rheumatoid arthritis, fibromyalgia, osteoarthritis, low back pain or spinal stenosis and is broadly categorized as cancer pain and non-cancer pain. Evaluation of chronic pain requires a clear understanding of the nature of the pain and its underlying pathophysiology. Adequate assessment of pain, using validated tools, is an essential prerequisite of successful pain management. Unidimensional scales are useful for the measurement of pain intensity, while multidimensional scales measure both pain intensity and the extent to which pain interferes with life activity and emotional functioning. Patients should be reassessed and followed up in order to monitor progress and measure improvements in pain.
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http://dx.doi.org/10.2165/11630030-000000000-00000DOI Listing
February 2012

Effects of opioid rotation in chronic pain patients: ORTIBARN study.

Clin Drug Investig 2010 ;30 Suppl 2:39-47

Emergency Care, Critical Care Medicine, Pain Medicine and Anaesthesiology Department at Tor Vergata Polyclinic, University of Rome-Tor Vergata, Rome, Italy.

Background: Opioid rotation is currently the subject of considerable debate for two reasons: firstly as a strategy for pain treatment, and secondly because of the difficulty in determining equianalgesic doses. Switching from one slow-release (SR) opioid analgesic to another raises a number of critical issues, and there are no widespread studies that support a standard protocol. Initiation of opioid therapy must consider gradual dose titration of the drug until the minimum effective and maximum tolerated dosage for each patient is found.

Objective: This study aimed to evaluate the effects of SR opioid rotation after a stabilization period with normal-release (NR) morphine ('start therapy') in patients with cancer or non-cancer pain not controlled with their current SR opioid.

Methods: This is a multicentre, open-label, prospective study. A total of 326 consecutive patients were enrolled who were affected by chronic cancer or non-cancer pain that was not controlled by an SR opioid administered as either monotherapy or in combination with other analgesic drugs. Following start therapy with oral NR morphine at a dosage of 5 mg or 10 mg every 4 hours, rotation to an SR opioid of a different type from that previously administered was carried out.

Results: After about 3 days of start therapy with NR morphine, rotation to an SR opioid allowed a significant decrease of both baseline pain and daily episodes of breakthrough pain. No significant difference was detected between dosages and type of opioid administered, both prior to and after the start therapy period with NR morphine.

Conclusions: Rotation to another opioid preceded by a brief period of opioid receptor resetting by start therapy with NR morphine allows a good level of pain control and avoids rotation to inappropriate opioid dosages or combinations analgesics.
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http://dx.doi.org/10.2165/1158413-S0-000000000-00000DOI Listing
October 2010

Pain biomarkers.

Clin Drug Investig 2009 ;29 Suppl 1:41-6

Department of Anaesthesia and Resuscitation, University of Cagliari, Cagliari, Italy.

The value of biomarkers in aiding early diagnosis of disease and predicting response to pharmacologic interventions is well known. The idea that biomarkers may also be used to identify and quantify pain has been investigated in preclinical and clinical studies. Findings from a preclinical study show that inflammatory pain and neuropathic pain have different biomarkers. Further investigations provided mixed results, on the one hand, cystatin C levels in cerebrospinal fluid appear to be a predictive marker for postherpetic neuralgia in patients with varicella-zoster virus, and a pain marker in women experiencing labour pain, but is not correlated with pain duration or intensity. Investigations into potential biomarkers for chest pain showed that cardiac markers used to aid in diagnosis and prognosis of cardiac disease correlate with tissue damage rather than with pain. Further studies are needed to gain insights into biomarkers for pain to enhance pain management practices.
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http://dx.doi.org/10.2165/0044011-200929001-00006DOI Listing
August 2009

Endocrine consequences of opioid therapy.

Psychoneuroendocrinology 2009 Dec;34 Suppl 1:S162-8

University of Siena, Department of Physiology, Neuroscience and Applied Physiology Section, via Aldo Moro 2, 53100 Siena, Italy.

Gonadal hormones are known to be affected by morphine and other opioids. In this paper, we summarize data collected in recent years which clearly indicate that the opioid-induced effects on steroid hormones depend on the opioid used and in some cases on the sex of the subject. Indeed morphine is able to reduce hormones like testosterone and cortisol in both male and female subjects in just a few hours, probably acting directly on peripheral glands. These depressant effects of morphine on hormones are also present in the treatment of surgical pain and are quickly reversible once opioid administration is suspended. Similar actions were also found to occur in experimental animals and in vitro in glial cells, further confirming the morphine-induced reduction of testosterone cell content. Testosterone and its metabolites are well known substances involved in the development and maintenance of the brain and all body structures. Thus when treating pain with opioids, their effects on hypothalamo-pituitary-gonadal and hypothalamo-pituitary-adrenal-related hormones must be considered and, where possible, hormone replacement therapy should be started.
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http://dx.doi.org/10.1016/j.psyneuen.2009.05.013DOI Listing
December 2009
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