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Stage-dependent analgesia of electro-acupuncture in a mouse model of cutaneous cancer pain.
Mao-Ying QL, Cui KM, Liu Q, Dong ZQ, Wang W, Wang J, Sha H, Wu GC, Wang YQ.
Department of Integrative Medicine and Neurobiology, Institute of Acupuncture Research, Shanghai Medical College, Fudan University, Post Box 291, 138 Yi Xue Yuan Road, Shanghai 200032, China.
Acupuncture is one of the most effective alternative medical treatments in pain management with the advantages of simple application, low cost and minimal side effects. However its scientific evidence and laws of action are not very clear in cancer pain relieving. The aim of this study was to examine the immediate and therapeutic anti-hyperalgesic effect of electro-acupuncture (EA) on a mouse model of cutaneous cancer pain. B16-BL6 melanoma cells were inoculated into the plantar region of unilateral hind paw and the thermal hyperalgesia was measured by using radiant heat test and hot plate test. C57BL/6 mice showed moderate and marked hyperalgesia during days 8-12 and from day 14 after the orthotopic inoculation of B16-BL6 melanoma cells into the hind paw. Single EA on day 8 after inoculation showed significant analgesic effect immediately after the treatment, the analgesic effect reached its maximum within 15-30min and declined to its minimum at 50min after EA treatment. Single EA treatment on day 20 showed no significant analgesic effect; Repeated EA treatments (started from day 8, once every other day) showed therapeutic analgesic effect, while it showed no therapeutic effect when started from day 16, a relatively late stage of this cancer pain model. The results demonstrated that EA had anti-hyperalgesic effect on early stage of cutaneous cancer pain but not on late stage. These results indicated a tight correlation of EA anti-hyperalgesic effects with the time window of cancer pain.
PMID: 16376128 [PubMed - as supplied by publisher]
Managing persistent neuropathic pain in the elderly.
McCarberg BH.
PMID: 16382568 [PubMed - indexed for MEDLINE]
Pharmacotherapeutic options in pain management.
Argoff CE.
PMID: 16382567 [PubMed - indexed for MEDLINE]
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Measuring Pain Intensity in Nursing Home Residents.
Jones KR, Fink R, Hutt E, Vojir C, Pepper GA, Scott-Cawiezell J, Mellis BK.
Yale University School of Nursing (K.R.J.), New Haven, Connecticut; University of Colorado Hospital/Health Sciences Center (R.F.), Denver, Colorado; VAMC-Denver TREP (E.H.); School of Nursing (C.V., B.K.M.), University of Colorado Health Sciences Center, Denver, Colorado; College of Nursing (G.A.P.), University of Utah, Salt Lake City, Utah; and Sinclair School of Nursing (J.S.-C.), University of Missouri at Columbia, Columbia, Missouri, USA.
Assessing pain intensity in nursing home residents remains a challenge. As part of a multifaceted intervention study to improve pain practices in nursing homes, quarterly pain assessments were conducted in 12 Colorado nursing homes. Residents who reported pain or discomfort of any kind in the past 24 hours were asked to choose one of three pain intensity scales to quantify their current and highest level of pain intensity. They were also observed for pain behaviors using Feldt's Checklist of Nonverbal Pain Indicators. Residents preferred the Verbal Descriptor Scale almost 2:1 over the 11-point Verbal Numeric Rating Scale and the Faces Pain Scale. Sex and ethnicity were associated with differences in scale preference. More than one-half of residents reporting pain had an observable pain indicator. There was a monotonic relationship between reported pain intensity and number of observed pain indicators. To improve pain assessment and management in nursing homes, residents should be given a choice of pain intensity scales and observed for possible pain behaviors.
PMID: 16376738 [PubMed - as supplied by publisher]
Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes.
Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators.
Duke University Medical Center, Duke Clinical Research Institute, Durham, NC 27715, USA. karen.alexander@duke.edu
CONTEXT: Effective medical care assumes delivery of evidence-based medicines to appropriate patients with doses comparable to those studied. OBJECTIVE: To investigate dosing of unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and glycoprotein IIb/IIIa inhibitors, and the association between dosing and major outcomes. DESIGN, SETTING, AND PARTICIPANTS: A prospective observational analysis in 387 US academic and nonacademic hospitals of 30,136 patients from the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines) National Quality Improvement Initiative Registry who had non-ST-segment elevation acute coronary syndromes (NSTE ACS) with chest pain and either positive electrocardiograms or cardiac biomarkers between January 1 and September 30, 2004. MAIN OUTCOME MEASURES: Excessive dosing of UFH, LMWH, and glycoprotein IIb/IIIa inhibitors and major clinical outcomes, including bleeding, in-hospital mortality, and length of stay. RESULTS: A total of 3354 patients (42%) with NSTE ACS who were administered antithrombotic agents received at least 1 initial dose outside the recommended range. An excess dose was administered to 2934 patients (32.8%) treated with UFH, 1378 (13.8%) treated with LMWH, and 2784 (26.8%) treated with glycoprotein IIb/IIIa inhibitors. Factors associated with excess dosing included older age, as well as female sex, renal insufficiency, low body weight, diabetes mellitus, and congestive heart failure. Relative to those patients not administered excess dosages, patients with excess dosages of UFH, LMWH, and glycoprotein IIb/IIIa inhibitors either tended toward or had higher risks for major bleeding (adjusted odds ratio [OR], 1.08; 95% confidence interval [CI], 0.94-1.26; OR, 1.39; 95% CI, 1.11-1.74; and OR, 1.36; 95% CI, 1.10-1.68; respectively). Bleeding increased relative to the degree of excess dose and to the number of agents administered in excess (6.6% [237/3590] if neither heparin nor glycoprotein IIb/IIIa excess vs 22.2% [93/419] if both excess). Mortality and length of stay were also higher among those patients administered excess dosing. We estimated that 15% (400/2766) of major bleeding in this population may be attributable to excess dosing. CONCLUSIONS: Patients with NSTE ACS treated in the community often receive excess doses of antithrombotic therapy. Dosing errors occur more often in vulnerable populations and predict an increased risk of major bleeding.
Publication Types:
PMID: 16380591 [PubMed - indexed for MEDLINE]
Comment on:
Management of acute coronary syndromes.
Spaulding C, Varenne O, Weber S.
Publication Types:
PMID: 16379088 [PubMed - indexed for MEDLINE]
Comment on:
Management of acute coronary syndromes.
Ionescu A, Garg A.
Publication Types:
PMID: 16379087 [PubMed - indexed for MEDLINE]
Comment on:
Management of acute coronary syndromes.
Costantino G, Raggi F, Montano N.
Publication Types:
PMID: 16379086 [PubMed - indexed for MEDLINE]
Comment on:
Management of acute coronary syndromes.
Newby DE, Fox KA.
Publication Types:
PMID: 16379085 [PubMed - indexed for MEDLINE]
Comment on:
Management of acute coronary syndromes.
Garcia-Pavia P, Aguiar-Souto P, Silva-Melchor L.
Publication Types:
PMID: 16379084 [PubMed - indexed for MEDLINE]
Comment on:
Management of acute coronary syndromes.
Tarantini G, Ramondo A, Iliceto S.
Publication Types:
PMID: 16371640 [PubMed - indexed for MEDLINE]
Afterword: five steps to increase the payoff of chronic pain trials.
Max MB.
lisam23961@aol.com
PMID: 16385108 [PubMed - in process]
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Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain.
Dworkin RH, Katz J, Gitlin MJ.
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA. robert_dworkin@urmc.rochester.edu
This article reviews studies of the placebo response in antidepressant clinical trials, describes methods that have been attempted to decrease it, and discusses implications of the placebo response in depression for research on treatments for neuropathic pain. Literature reviews and research studies examining the placebo response in clinical trials of treatments for depression were reviewed. Existing data suggest that the placebo response in antidepressant clinical trials is substantial and that a high placebo response in a clinical trial is associated with a reduced likelihood of demonstrating the statistical superiority of antidepressant treatment vs. placebo. Attempts to decrease the placebo response in antidepressant clinical trials have generally not been effective. In addition, there is little evidence that decreasing the placebo response rate makes it more likely that superiority of active vs. placebo treatment will be demonstrated. Analyses of neuropathic pain clinical trial databases should be conducted to examine factors associated with trial outcomes. Aspects of neuropathic pain clinical trials that require further consideration or investigation include the following: (a) exclusion of patients with mild pain severity; (b) exclusion of patients with short episode duration; (c) maximizing reliability, validity, and responsiveness of outcome measures; (d) minimizing extraneous contact with investigative staff and other sources of nonspecific therapeutic effects; (e) trial duration; (f) minimizing the number of treatment groups; (g) flexible vs. fixed dose designs; (h) strategies for identifying patients and accelerating enrollment; (i) identification of run-in periods that reduce the placebo response rate; and (j) registration of clinical trials and publication of negative studies.
PMID: 16385107 [PubMed - in process]
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Mechanisms of neuropathic pain and their implications for the design of clinical trials.
Rowbotham MC.
The UCSF Pain Clinical Research Center, Department of Neurology, University of California, San Francisco, California, USA. mcrwind@itsa.ucsf.edu
A mechanism-based approach to treatment is alluring, but numerous practical problems impede its implementation. Although many new therapies have entered clinical trials, and randomized controlled trials have become larger and more sophisticated, pre-trial testing of underlying pain mechanisms is almost never performed for reasons of cost, risk to subjects, time required, and validation of the techniques used. Most registration clinical trials are performed in patients with post-herpetic neuralgia and painful diabetic neuropathy, but without more information on pain mechanisms, it remains uncertain how fully results in those two disorders can be generalized to patients with other types of chronic neuropathic pain. Examples of study designs and potential solutions are presented.
PMID: 16385106 [PubMed - in process]
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Ethical aspects of placebo groups in pain trials: lessons from psychiatry.
Nagasako EM, Kalauokalani DA.
Washington University School of Medicine, St. Louis, MO 63110, USA. nagasake@msnotes.wustl.edu
Placebo control use in clinical research is contentious in areas where effective treatments already exist. Determination of appropriate standards for placebo use is especially difficult in areas such as pain treatment and psychiatry, in which substantial placebo responses can occur. Debates are characterized by three common themes: (a) whether the state of existing treatments forbids placebo use, (b) whether the nature of the condition being treated and the level of additional risk permit placebo control use, and (c) whether methodological concerns are sufficient to justify placebo use. A review of these themes in the psychiatric research literature suggests possible strategies for analysis of this issue in the area of pain research.
PMID: 16385105 [PubMed - in process]
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Clinical trials of acute treatments for migraine including multiple attack studies of pain, disability, and health-related quality of life.
Lipton RB, Bigal ME, Stewart WF.
Department of Neurology, Albert Einstein College of Medicine, Bronx, NY 10461, USA. Rlipton@aecom.yu.edu.
Because migraine has features in common with episodic monophasic pain disorders (such as postoperative or posttraumatic pain) and with chronic pain disorders (such as osteoarthritis or painful neuropathy), it is often considered an episodic-chronic disorder. In clinical practice, the chronic aspects of migraine are addressed using preventive treatment strategies, while the episodic attacks are addressed by acute treatment strategies. Acute treatment strategies have generally been supported by clinical trial designs that focus on single attacks, whereas preventive treatment strategies evaluate multiple attacks over a period of time. Recently, long-term acute treatment clinical designs have emerged that may inform the design of clinical trials for other episodic-chronic disorders. After reviewing traditional acute treatment clinical trials, we focus here on study methods designed to evaluate treatment and management strategies for migraine over multiple attacks, including outcomes that assess the chronic-episodic nature of migraine (such as headache recurrence and consistency of relief), rather than relief from single attacks. We also discuss end points that reflect the treatment needs of patients, such as disability and health-related quality of life. The traditional randomized controlled trial designed to assess treatment efficacy for a single attack is insufficient to address the broader set of issues that arise in clinical practice. We consider clinical trials strategies designed to address the more complex clinical and policy requirements for meeting the needs of those with migraine.
PMID: 16385104 [PubMed - in process]
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Methodological issues in clinical trials of opioids for chronic pain.
Katz N.
Tufts University School of Medicine, Boston, MA, USA. NatPaulKatz@aol.com
Clinical trials of opioid analgesics for chronic pain are recognized to frequently fail to distinguish the analgesic effect from placebo, despite known efficacy of the drug. This paper reviews the methodologic features of such trials that may be associated with risk of failure. A literature search yielded 23 randomized placebo-controlled studies of opioids with at least one week of continuous treatment; contacting pharmaceutical companies yielded six additional studies. A classification system and standard terminology were developed for describing the methodologic features of these trials. The methodologic features that appeared to augur well for success of the trials were slow titration of medications, flexible dosing, minimizing concomitant and rescue analgesics, homogeneous samples, particularly in terms of opioid use upon entry, fewer study sites (for the same sample size), and including as much data as possible in statistical analyses. Study designs that lead to high dropout rates lack internal validity, unless dropout is the intended endpoint of the trial. Opioid analgesics should be studied in a manner that is clinically relevant, and that supports internal validity. More systematic attention is needed to clinical research methodology.
PMID: 16385103 [PubMed - in process]
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Research design issues in pain clinical trials.
Dworkin RH, Farrar JT.
University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 604, Rochester, NY 14642. robert_dworkin@urmc.rochester.edu.
PMID: 16385100 [PubMed - as supplied by publisher]
Effect of a low-allergen maternal diet on colic among breastfed infants: a randomized, controlled trial.
Hill DJ, Roy N, Heine RG, Hosking CS, Francis DE, Brown J, Speirs B, Sadowsky J, Carlin JB.
Department of Allergy, Royal Children's Hospital, Melbourne, Australia. allergy.clinic@rch.org.au
BACKGROUND: There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants. METHODS: A randomized, controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic. In the active arm, mothers excluded cow's milk, eggs, peanuts, tree nuts, wheat, soy, and fish from their diet; mothers in the control group continued to consume these foods. Outcomes were assessed after 7 days, as the change in cry/fuss duration over 48 hours, with validated charts. The primary end point was a reduction in cry/fuss duration of > or =25% from baseline. Mothers also assessed the responses to diet with categorical and visual analog scales. RESULTS: Of 107 infants, 90 completed the trial (mean age: 5.7 weeks; range: 2.9-8.6 weeks; 54 male infants). Infants in both groups presented with significant distress (geometric mean: low-allergen group: 690 minutes per 48 hours; control group: 631 minutes per 48 hours). In follow-up assessments on days 8 and 9, there were significantly more responders in the low-allergen group (74% vs 37%), ie, an absolute risk reduction of 37% (95% confidence interval: 18-56%). Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group; the adjusted geometric mean ratio was 0.79 (95% confidence interval: 0.63-0.97), ie, an average reduction of 21% (95% confidence interval: 3-37%). Mothers' subjective assessments of the responses to diet indicated little difference between the groups. CONCLUSION: Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life.
Publication Types:
PMID: 16263986 [PubMed - indexed for MEDLINE]
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New and lingering controversies in pediatric end-of-life care.
Solomon MZ, Sellers DE, Heller KS, Dokken DL, Levetown M, Rushton C, Truog RD, Fleischman AR.
Center for Applied Ethics and Professional Practice, Education Development Center, Newton, MA 02458, USA. msolomon@edc.org
OBJECTIVES: Professional societies, ethics institutes, and the courts have recommended principles to guide the care of children with life-threatening conditions; however, little is known about the degree to which pediatric care providers are aware of or in agreement with these guidelines. The study's objectives were to determine the extent to which physicians and nurses in critical care, hematology/oncology, and other subspecialties are in agreement with one another and with widely published ethical recommendations regarding the withholding and withdrawing of life support, the provision of adequate analgesia, and the role of parents in end-of-life decision-making. METHODS: Three children's hospitals and 4 general hospitals with PICUs in eastern, southwestern, and southern parts of the United States were surveyed. This population-based sample was composed of attending physicians, house officers, and nurses who cared for children (age: 1 month to 18 years) with life-threatening conditions in PICUs or in medical, surgical, or hematology/oncology units, floors, or departments. Main outcome measures included concerns of conscience, knowledge and beliefs, awareness of published guidelines, and agreement or disagreement with guidelines. RESULTS: A total of 781 clinicians were sampled, including 209 attending physicians, 116 house officers, and 456 nurses. The overall response rate was 64%. Fifty-four percent of house officers and substantial proportions of attending physicians and nurses reported, "At times, I have acted against my conscience in providing treatment to children in my care." For example, 38% of critical care attending physicians and 25% of hematology/oncology attending physicians expressed these concerns, whereas 48% of critical care nurses and 38% of hematology/oncology nurses did so. Across specialties, approximately 20 times as many nurses, 15 times as many house officers, and 10 times as many attending physicians agreed with the statement, "Sometimes I feel we are saving children who should not be saved," as agreed with the statement, "Sometimes I feel we give up on children too soon." However, hematology/oncology attending physicians (31%) were less likely than critical care (56%) and other subspecialty (66%) attending physicians to report, "Sometimes I feel the treatments I offer children are overly burdensome." Many respondents held views that diverged widely from published recommendations. Despite a lack of awareness of key guidelines, across subspecialties the vast majority of attending physicians (range: 92-98%, depending on specialty) and nurses (range: 83-85%) rated themselves as somewhat to very knowledgeable regarding ethical issues. CONCLUSIONS: There is a need for more hospital-based ethics education and more interdisciplinary and cross-subspecialty discussion of inherently complex and stressful pediatric end-of-life cases. Education should focus on establishing appropriate goals of care, as well as on pain management, medically supplied nutrition and hydration, and the appropriate use of paralytic agents. More research is needed on clinicians' regard for the dead-donor rule.
PMID: 16199696 [PubMed - indexed for MEDLINE]
Incidence and course of low back pain episodes in the general population.
Cassidy JD, Cote P, Carroll LJ, Kristman V.
Division of Outcomes and Population Health, Toronto Western Hospital Research Institute, University Health Network, Toronto, Ontario, Canada. dcassidy@uhnres.utoronto.ca
STUDY DESIGN: Population-based, prospective cohort. OBJECTIVES: To estimate incidence and course of severity-graded low back pain (LBP) episodes in adults. SUMMARY OF BACKGROUND DATA: Past studies report variable estimates that do not differentiate LBP severity. METHODS: An incidence cohort of 318 subjects free of LBP and a course cohort of 792 prevalent cases was formed from respondents to a mailed survey. Incident, recurrent, persistent, aggravated, improved, and resolved episodes were defined by the Chronic Pain Questionnaire. The follow-up at 6 and 12 months was 74% and 62%, respectfully. Annual estimates were age and sex standardized. RESULTS: The cumulative incidence was 18.6% (95% confidence interval [CI], 14.2%-23.0%). Most LBP episodes were mild. Only 1.0% (95% CI, 0.0%-2.2%) developed intense and 0.4% (95% CI, 0.0%-1.0%) developed disabling LBP. Resolution occurred in 26.8% (95% CI, 23.7%-30.0%), and 40.2% (95% CI, 36.7%-43.8%) of episodes persisted. The severity of LBP increased for 14.2% (95% CI, 11.5%-16.8%) and improved for 36.1% (95% CI, 29.7%-42.2%). Of those that recovered, 28.7% (95% CI, 21.2%-36.2%)had a recurrence within 6months,and 82.4% of it was mild LBP. Younger subjects were less likely to have persistent LBP (incidence rate ratio, 0.88; 95% CI, 0.80-0.97) and more likely to have resolution (incidence rate ratio, 1.26; 95% CI, 1.02-1.56). CONCLUSIONS: Most new and recurrent LBP episodes are mild. Less than one third of cases resolve annually, and more than 20% recur within 6 months. LBP episodes are more recurrent and persistent in older adults.
PMID: 16371911 [PubMed - in process]
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Predictors and modifiers of treatment effect influencing sick leave in subacute low back pain patients.
Hagen EM, Svensen E, Eriksen HR.
Spine Clinic, Sykehuset Innlandet HF, Ottestad, Norway. emhagen@online.no
STUDY DESIGN: Modifying effects in multivariate analyses of a randomized controlled trial. OBJECTIVES: To identify prognostic factors for the effect of a brief intervention ("modifiers") at a spine clinic on return to work in patients with subacute low back pain. SUMMARY OF BACKGROUND DATA: A previous study of a brief intervention showed significant reduction of sick leave, compared with usual primary healthcare treatment. Randomized controlled trials give data only on the group as an average. Identifying prognostic factors that interact with the treatment ("modifiers") may identify specific groups requiring this or other types of treatment. METHODS: A total of 457 patients who had been sick-listed 8 to 12 weeks for low back pain were randomized into an intervention group (spine clinic with medical examination, information, reassurance, encouragement to engage in physical activity, n = 237), and a control group (primary health care, n = 220). All subjects filled out questionnaires. Logistic regression and tests for interaction were used to identify prognostic factors and modifiers for return to work in the two groups, at 3 and 12 months of follow-up. RESULTS: At 3 months of follow-up, the strongest modifying effect on return to work was the perception of constant back strain when working and beliefs about reduced ability to work. At 12 months, gastrointestinal complaints were the strongest modifier for the effect of the intervention. CONCLUSION: The spine clinic intervention seems to have a main effect on work absenteeism via interacting with the concerns of being unable to work.
PMID: 16371893 [PubMed - in process]
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