Effects of prolonged-release oxycodone/naloxone on pain control, bowel function and quality of life: A prospective observational study

2014 ◽  
Vol 5 (2) ◽  
pp. 75-81 ◽  
Author(s):  
Sabine Hesselbarth ◽  
Oliver Löwenstein ◽  
Thomas Cegla

AbstractBackground and aimStrong opioids including oxycodone are amongst the most effective analgesics to combat moderate to severe pain of various aetiologies, but opioid-induced bowel dysfunction (OIBD) represents a relevant problem. The rationale for development of a prolonged-release (PR) fixed combination of oxycodone and naloxone was to counteract OIBD. Due to its negligible oral bioavailability, the μ-opioid receptor antagonist naloxone is able to selectively displace opioids from local μ-receptors in the gastrointestinal tract without affecting central opioid binding sites. Pivotal trials of PR oxycodone/naloxone not only demonstrated improved bowel function but also equivalent analgesic efficacy compared to PR oxycodone alone. Controlled clinical trials comparing PR oxycodone/naloxone with strong opioids other than oxycodone are not available. The present study is the first data set aimed at comparing pain control, bowel function, and quality of life (QoL) in patients newly treated with or switched to PR oxycodone/naloxone or other strong opioids during routine clinical practice.MethodsIn this three-arm, prospective observational study, 588 patients with moderate to severe pain of varying aetiologies received either PR oxycodone/naloxone (OXN group and OXN 40/20 group with indicated use of the 40 mg/20 mg dose strength at baseline) or other strong opioids (control group), dosed according to pain severity, for 4–6 weeks. Data documented include pain intensity (NRS), bowel function (Bowel Function Index, BFI), pain-related functional impairment (BPI-SF), QoL (EuroQol EQ-5D-3L), and a global assessment of treatment.ResultsPatients receiving PR oxycodone/naloxone experienced a clinically important reduction in pain intensity and pain-related functional impairment of approximately 40%. The reductions of pain intensity (−2.9 ± 2.3) and pain-related functional impairment (−2.4 ± 2.3) in the OXN group were significantly more pronounced than in the control group (−2.1 ± 2.1 and −1.8 ± 1.7). In the control group, mean reductions in pain intensity did not reach the threshold of ≥30% for at least moderate clinically important differences, although patients were prescribed higher doses of morphine equivalents than OXN group patients. Improvements in bowel function (OXN: −16.0 ± 27.6; control: 3.1 ± 24.4) and QoL (OXN: 20.8 ± 24.2; control: 13.2 ± 23.1) were also significantly more pronounced in the OXN group, with BFI scores reduced to a level that reflects normal bowel function. Results for the OXN 40/20 group receiving higher doses of PR oxycodone/naloxone were in line with those for the OXN group. In the control group, more frequent gastrointestinal adverse events and less favourable ratings of tolerability resulted in a higher rate of treatment discontinuations due to adverse events.ConclusionsIn patients receiving PR oxycodone/naloxone, more favourable outcomes compared with other strong opioids regarding pain control, bowel function, and QoL were observed.ImplicationsThe present findings underline the value of PR oxycodone/naloxone in the management of patients with moderate to severe chronic pain. The data set further adds to our understanding of the benefits and risks of opioid treatment in routine clinical practice.

2004 ◽  
Vol 22 (24) ◽  
pp. 4918-4925 ◽  
Author(s):  
Karen O. Anderson ◽  
Tito R. Mendoza ◽  
Richard Payne ◽  
Vicente Valero ◽  
Guadalupe R. Palos ◽  
...  

Purpose Previous studies found that African American and Hispanic cancer patients are at risk for undertreatment of pain. We evaluated the efficacy of a pain education intervention for underserved minority patients. Patients and Methods Ninety-seven underserved African American and Hispanic outpatients with cancer-related pain were enrolled onto a randomized clinical trial of pain management education. The patients in the education group received a culture-specific video and booklet on pain management. The control group received a video and booklet on nutrition. A research nurse met with each patient to review the materials. We measured changes in pain intensity and pain-related interference 2 to 10 weeks after the intervention, as well as changes in quality of life, perceived pain control, functional status, analgesics, and physician pain assessments. Results Physicians underestimated baseline pain intensity and provided inadequate analgesics for more than 50% of the sample. Although the ratings for pain intensity and pain interference decreased over time for both groups, there was no statistically significant difference between groups. Pain education did not affect quality of life, perceived pain control, or functional status. African American patients in the education but not the control group reported a significant decrease in pain worst ratings from baseline to first follow-up (P < .01), although this decrease was not maintained at subsequent assessments. Conclusion Brief education had limited impact on pain outcomes for underserved minority patients, suggesting that more intensive education for patients and interventions for physicians are needed.


2015 ◽  
Vol 20 (6) ◽  
pp. 293-299 ◽  
Author(s):  
Eun-Kee Song ◽  
Hyunjeong Shim ◽  
Hye-Suk Han ◽  
DerSheng Sun ◽  
Soon-Il Lee ◽  
...  

BACKGROUND: Osmotic release oral system (OROS®) hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients.OBJECTIVES: A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain.METHODS: OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg/day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients’ and investigators’ global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID).RESULTS: A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment.CONCLUSIONS: OROS hydromorphone provided effective pain relief and improved quality of life in opioid-naive cancer patients. As a single and front-line treatment, OROS hydromorphone delivered rapid pain control.


2020 ◽  
Vol 50 (5) ◽  
pp. 581-585
Author(s):  
Yehuan Liu ◽  
Beibei Lin

Abstract Context Pain is one of the most common and intolerable symptoms in cancer patients. But cancer pain control is still negative in China. Objectives This paper explores the application of quality control circle in the treatment of cancer pain in inpatients to improve the quality of life of patients with cancer pain. Method Established a quality control circle group to analyze the current status of cancer pain control in inpatients with moderate cancer pain, set goals, formulate corresponding countermeasures and implement and review them in stages. The plan-do-check-act method was cyclically applied. The Brief Pain Inventory was used to evaluate the cancer pain status of patients with cancer pain hospitalized before (January to April 2016) and after (September to December 2016) the implementation of quality control circle activities. Results The pain control effect of the observation group was significantly better than that of the control group. The mean (standard deviation) of pain severity and pain interference in the observation group were significantly lower than those in the control group (6.21 [2.86] vs 4.31 [2.25], 10.54 [4.10] vs 7.25 [3.77]). There was significant difference after the implementation of quality control circle (P &lt; 0.01). Conclusion Quality control circle activities are used to manage patients with cancer pain, to improve the situation of pain control and to improve the quality of life of patients. This management tool and method is worthy of clinical promotion and application.


2011 ◽  
Vol 26 (S2) ◽  
pp. 643-643
Author(s):  
K. Sokolowska ◽  
E. Gorniak ◽  
A. Kowalska ◽  
K. Wydra ◽  
K. Krysta ◽  
...  

IntroductionAlexithymia appears as an inhibition of recognizing and describing the mental conditions. It is often connected with psychosomatic illness or depression.AimsThe aim of this study was to compare depressive patients with healthy persons in terms of the prevelence and level of the alexithymia and pain feeling.MethodsThe examined group (E) consists of 16 patients with diagnosed depression (11 women, 44,6±11,6 year old).The control group (C) consists of 14 randomly chosen persons (10 women, 40,0+/-15,3 year old) who achieved < 11 points in the Beck's Depression Inventory (BDI).The alexithymia level was examined with TAS - 26 questionnaire (difficulty of recognizing the feelings and somatic senses (ODR), concrete thinking (MK), difficulty of expressing the feelings (TRW) and the lack of imagination (U)). The intensity of pain was examined with the questionnaire SF-MPQ. The scale BPCQ was used to examine beliefs about pain control.ResultsNo statistical differences about age, sex, the U feature in TAS-26 scale and the results of BPCQ test were shown. The differences beetween groups E and C appeared in the alexithymia intensity range (75,3 ± 14,4 v.62,4 ± 8,2pts, p = 007), the ODR feature (23,7 ± 6,7 v. 13,0 ± 4,1pts, p< 0,001), MK (18,9 ± 4 v.23,1 ± 5,3pts, p = 0,036) and TRW (13,4 ± 2,6 v. 9,6 ± 2,8pts, p = 0,001). The E group featured significantly higher pain intensity(p = 0,012).ConclusionsThe patients with depression suffer from alexithymia very often. The prevalence of upper difficulties and great intensity of pain could suggest a psychotomatic component of pain affections.


2015 ◽  
Vol 8 (4) ◽  
pp. 142 ◽  
Author(s):  
Nour Mohammad Bakhshani ◽  
Ahmadreza Amirani ◽  
Hamed Amirifard ◽  
Mahnaz Shahrakipoor

<p>The aim of this study was to determine the effectiveness of Mindfulness-Based Stress reduction (MBSR) on perceived pain intensity and quality of life in patients with chronic headache. Thus, forty patients based on the diagnosis of a neurologist and diagnostic criteria of the International Headache Society (IHS) for migraine and chronic tension-type headache were selected and randomly assigned to the intervention group and control group, respectively. The participants completed the Pain and quality of life (SF-36) questionnaire. The intervention group enrolled in an eight-week MBSR program that incorporated meditation and daily home practice, per week, session of 90-minutes. Results of covariance analysis with the elimination of the pre-test showed significantly improvement of pain and quality of life in the intervention group compared with the control group. The findings from this study revealed that MBSR can be used non-pharmacological intervention for improvement the quality of life and development of strategies to cope with pain in patients with chronic headache. And can be used in combination with other therapies such as pharmacotherapy.</p>


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Christoph Arneitz ◽  
Jana Windhaber ◽  
Christina Flucher ◽  
Paolo Gasparella ◽  
Eva Amerstorfer ◽  
...  

AbstractThe aim of this study was to assess whether adolescents following anorectal malformation repair have a decreased cardiorespiratory performance capacity and impaired motor skills. All eligible children treated for ARMs between 2000 and 2014 were invited to participate in a prospective study consisting of a clinical examination, evaluation of Bowel function and Quality of Life, spirometry, spiroergometry and assessment of the motor activity. The results were compared to a healthy age- and sex-matched control group. There was no statistically significant difference in height, weight, BMI, muscle mass or body fat percentage between the study and the control group. Nine out of 18 patients (50%) had an excellent functional outcome with a normal Bowel Function Score. Spirometry revealed no significant differences between ARM patients and controls, four patients showed a ventilation disorder. Spiroergometry revealed a significantly lower relative performance capacity and the overall rating of the motor activity test showed significantly decreased grades in ARM patients. ARM patients were affected by an impaired cardiopulmonary function and decreased motor abilities. Long-term examinations consisting of routine locomotor function evaluation and spiroergometry are advisable to detect impaired cardiopulmonary function and to prevent a progression of associated complications and related impaired quality of life.


2020 ◽  
Vol 31 ◽  
pp. S1356
Author(s):  
S.H. Ahmedzai ◽  
A. Covarrubias-Gómez ◽  
G. De Simone ◽  
M. Green ◽  
L. Langenhoven ◽  
...  

2021 ◽  
Vol 11 (4) ◽  
pp. 4280-4293

The study's objective was to determine the changes in oxidative stability of m. Longissimus dorsi, m. Semimembranosus and perirenal adipose tissue from lambs fed a diet supplemented by 7.5 mg dihydroquercetin/kg life wight/d or 545 mg dry distilled rose petals (DDRP)/kg life wight/d.The experiments were performed with 30 male lambs aged 65 days. They were divided into three groups of 10 animals fed 50 days ad libitum: the control group (with ground alfalfa + granulated compound feed) and two experimental ones (with the same diet + phytonutrients). Samples stored 7 days at 0-4°C were examined. After 7 d of storage in both muscles, the addition of 545 mg DDRP/kg life wight/d contributed to the reduction of α-aminoacidic nitrogen with approximately 0.5 mg Leu/g and the FFA with 0.5-2%. The addition of 7.5 mg dihydroquercetin contributed to the reduction of TBARS with 0.14-0.21 mg MDA/kg, the total color difference, and a slight increase in the share of the MUFA more pronounced in m. Longissimus dorsi. The reduction of aerobic plate count and total yeasts and molds count were determined too. Further studies with higher doses of phytonutrient’s supplementation are needed to determine if it will provoke a more pronounced oxidative stability.


2018 ◽  
Vol 5 (3) ◽  
pp. 145 ◽  
Author(s):  
Peter Holzer, PhD ◽  
Sam H. Ahmedzai, BSc, MBChB, FRCP ◽  
Norbert Niederle, MD ◽  
Petra Leyendecker, PhD ◽  
Michael Hopp, MD ◽  
...  

Opioids are the mainstay of management for patients with cancer-related pain. Although the analgesic efficacy of opioid therapy is well documented, the recent European Pain in Cancer survey demonstrated that the management of moderate-to-severe pain in patients with cancer is far from optimal. Bowel dysfunction, and importantly constipation, is a common side effect and has a significant impact on the patient’s morbidity and quality of life. Nonpharmacological strategies and laxatives are often not effective in the management of opioid-induced constipation (OIC), making it necessary to search for new strategies for the treatment of opioid-induced bowel dysfunction. One promising strategy is the prevention of OIC with peripherally acting opioid antagonists that specifically target the underlying cause of this condition, without affecting centrally mediated analgesia. In recent studies, the novel combination of prolonged-release oral oxycodone and prolonged-release oral naloxone provided effective analgesia with improved bowel function in patients suffering from severe cancer-related and noncancer-related pain. The combination has the potential to improve the quality of pain management significantly in these patients.


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