A consensus protocol for the management of medication-overuse headache: Evaluation in a multicentric, multinational study.

INTRODUCTION: The management of medication-overuse headache (MOH) is often difficult and no specific guidelines are available as regards the most practical and effective approaches. In this study we defined and tested a consensus protocol for the management of MOH on a large population of patients distributed in different countries. SUBJECTS AND METHODS: The protocol was based on evidence from the literature and on consolidated expertise of the members of the consensus group. The study was conducted according to a multicentric interventional design with the enrolment of 376 MOH subjects in four centres from Europe and two centres in Latin America. The majority of patients were treated according to an outpatient detoxification programme. The post-detoxification follow-up lasted six months. RESULTS: At the final evaluation, two-thirds of the subjects were no longer overusers and in 46.5% of subjects headache had reverted back to an episodic pattern of headache. When comparing the subjects who underwent out-patient detoxification vs those treated with in-patient detoxification, both regimens proved effective, although the drop-out rate was higher in the out-patient approach. CONCLUSIONS: The present findings support the effectiveness and usability of the proposed consensus protocol in different countries with different health care modalities.

Disability, anxiety and depression associated with medication-overuse headache can be considerably reduced by detoxification and prophylactic treatment. Results from a multicentre, multinational study (COMOESTAS project).

OBJECTIVE: The objective of this article is to investigate whether headache-related disability, depression and anxiety can be reduced by detoxification and prophylactic treatment in patients with medication-overuse headache (MOH). METHODS: Patients with MOH were included from six centres in Europe and Latin America in a seven-month cohort study. Before and six months after treatment, the degree of disability was measured by the Migraine Disability Assessment (MIDAS) questionnaire, while anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS). RESULTS: A total of 694 patients with MOH were included, of whom 492 completed the study. Headache days were reduced by 58.4% from 23.6 to 9.8 days per month at six months ( P < 0.001). The MIDAS score was reduced by 57.1% from baseline 59.9 to 25.7 ( P < 0.001). Number of patients with depression was reduced by 50.7% from 195 to 96 and number of those with anxiety was reduced by 27.1% from 284 to 207 (both P < 0.001). CONCLUSIONS: Disability, depression and anxiety were considerably reduced in patients with MOH by detoxification and prophylactic treatment. This emphasises the urgent need for increased awareness about avoiding overuse of headache medications and demonstrates that not only headache frequency but also disability are remarkably improved by adequate intervention.

Community-based intervention to optimise falls risk management: a randomised controlled trial.

BACKGROUND: falls are the leading causes of accidental death and fragility fractures in older adults. Interventions that assess and reduce falls risk are underutilised. OBJECTIVE: to evaluate the impact of a multifaceted community-based programme aimed at optimising evidence-based management of patients at risk for fall-related fractures. DESIGN: this was a randomised trial performed from 2003 to 2006. SETTING: community-based intervention in Ontario, Canada. PARTICIPANTS: eligible patients were community-dwelling, aged > or =55 years and identified to be at risk for fall-related fractures. A total of 201 patients were allocated to the intervention group or to usual care. INTERVENTION: components of the intervention included assessment of falls risk, functional status and home environment, and patient education. MEASUREMENTS: primary outcome was the implementation of appropriate falls risk assessment at 6 months. Secondary outcomes included falls and fractures at 6 and 12 months. RESULTS: the mean age of participants was 72 years, and 41% had fallen with injury in the previous year. Compared to usual care, the intervention increased the number of referrals made to physiotherapy [21% (21/101) vs 6.0% (6/100); relative risk (RR) 3.47, 95% confidence interval (CI) 1.46-8.22] and occupational therapy [15% (15/101) vs 0%; RR 30.7, 95% CI 1.86 to >500]. At 12 months, the number of falls in the intervention group was greater than in the usual care group [23% (23/101) vs 11% (11/100); RR 2.07, 95% CI 1.07-4.02]. CONCLUSIONS: compared to usual care, a multi-faceted intervention increased referrals to physiotherapy and occupational therapy but did not reduce risk of falls. Similar falls reduction interventions cannot be recommended based on the results of this study.

Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies.

BACKGROUND: Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially underutilized. This paper outlines the protocol for a pragmatic randomised trial of a multifaceted community-based care program aimed at optimizing the evidence-based management of falls and fractures in patients at risk. DESIGN: 6-month randomised controlled study. METHODS: This population-based study was completed in the Algoma District of Ontario, Canada a geographically vast area with Sault Ste Marie (population 78,000) as its main city. Eligible patients were allocated to an immediate intervention protocol (IP) group, or a delayed intervention protocol (DP) group. The DP group received usual care for 6 months and then was crossed over to receive the interventions. Components of the intervention were directed at the physicians and their patients and included patient-specific recommendations for osteoporosis therapy as outlined by the clinical practice guidelines developed by Osteoporosis Canada, and falls risk assessment and treatment. Two primary outcomes were measured including implementation of appropriate osteoporosis and falls risk management. Secondary outcomes included quality of life and the number of falls, fractures, and hospital admissions over a twelve-month period. The patient is the unit of allocation and analysis. Analyses will be performed on an intention to treat basis. DISCUSSION: This paper outlines the protocol for a pragmatic randomised trial of a multi-faceted, community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis. TRIAL REGISTRATION: This trial has been registered with clinicaltrials.gov (ID: NCT00465387).

An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy.

BACKGROUND: A phase 3 study demonstrated that panitumumab, a human monoclonal anti-epidermal growth factor receptor antibody, significantly prolonged progression-free survival versus best supportive care (BSC) in patients with chemorefractory metastatic colorectal cancer. PATIENTS AND METHODS: This open-label extension study evaluated panitumumab monotherapy in BSC patients with radiographically documented disease progression in the phase 3 study. Patients received panitumumab 6 mg/kg every 2 weeks. The primary end point was safety; efficacy was also evaluated. RESULTS: One hundred and seventy-six patients were randomly assigned to the BSC arm of the phase 3 study received >/=1 panitumumab dose in this extension study. Panitumumab was well tolerated. The most frequent treatment-related adverse events were skin toxic effects. Three (2%) patients had a grade 4 treatment-related adverse event. There were no infusion reactions. One (0.6%) patient had a complete response; 19 (11%) patients had a partial response; and 58 (33%) patients had stable disease. Median progression-free survival time was 9.4 [95% confidence interval (CI): 8.0-13.4) weeks. Median overall survival time was 6.3 (95% CI: 5.1-6.8) months. Anti-panitumumab antibodies were detected in 3 (4.2%) of 71 patients with a post-baseline sample. CONCLUSIONS: These findings are comparable to those from the phase 3 study and support panitumumab monotherapy for chemorefractory colorectal cancer.

Epidural hematoma following epidural analgesia in a patient receiving unfractionated heparin for thromboprophylaxis.

BACKGROUND AND OBJECTIVES: The practice of providing postoperative epidural analgesia for patients receiving deep venous thromboprophylaxis with unfractionated heparin is common. This case report is intended to heighten awareness of comorbid risk factors for epidural hematoma and to bring attention to the new ASRA consensus guidelines on the management of neuraxial anesthesia in the presence of standard heparin. CASE REPORT: A 79-year-old woman with apparently normal coagulation and receiving no antiplatelet agents required an abdominoperineal resection for recurrent squamous cell carcinoma of the anus. Approximately 2 hours after her preoperative dose of 5,000 U unfractionated heparin, an epidural catheter was placed on the third attempt. Subcutaneous heparin was subsequently administered every 12 hours. Her international normalized ratio became slightly elevated during surgery while the partial thromboplastin time and platelet count remained normal. The catheter was removed on postoperative day 3, 6 hours after the last dose of heparin. The patient developed signs of an epidural hematoma requiring surgical evacuation on postoperative day 4. The presence of previously undiagnosed spinal stenosis may have contributed to her symptoms. CONCLUSION: Management of postoperative epidural analgesia in the patient receiving thromboprophylaxis with unfractionated heparin requires appropriate timing of epidural insertion and removal, monitoring of coagulation status and vigilance.