[Structure of pain management facilities in Germany : Classification of medical and psychological pain treatment services-Consensus of the Joint Commission of the Professional Societies and Organizations for Quality in Pain Medicine]. / Struktur der schmerzmedizinischen Versorgung in Deutschland : Klassifikation schmerzmedizinischer Einrichtungen - Konsens der Gemeinsamen Kommission der Fachgesellschaften und Verbände für Qualität in der Schmerzmedizin.

On behalf of the Medical/Psychological Pain Associations, Pain Patients Alliance and the Professional Association of Pain Physicians and Psychologists, the Joint Commission of Professional Societies and Organizations for Quality in Pain Medicine, working in close collaboration with the respective presidents, has developed verifiable structural and process-related criteria for the classification of medical and psychological pain treatment facilities in Germany. Based on the established system of graded care in Germany and on existing qualifications, these criteria also argue for the introduction of a basic qualification in pain medicine. In addition to the first-ever comprehensive description of psychological pain facilities, the criteria presented can be used to classify five different levels of pain facilities, from basic pain management facilities, to specialized institutions, to the Centre for Interdisciplinary Pain Medicine. The recommendations offer binding and verifiable criteria for quality assurance in pain medicine and improved pain treatment.

[Long-term treatment of chronic pain with low-dose 7-day buprenorphine transdermal patch. Observational data from elderly patients of pain relief and quality of life]. / Langzeitbehandlung chronischer Schmerzen mit niedrig dosiertem 7-Tagetransdermalem-Buprenorphinpflaster. Beobachtungsdaten bei älteren Patienten zu Schmerzintensität und Lebensqualität.

BACKGROUND: Six-months analysis of non-interventionally collected observation data of effectiveness of long-term treatment with low-dose 7-day buprenorphine transdermal patch in elderly patients with chronic pain. METHODS: Analysis of data regarding pain intensity, pain-related impairments of daily life and quality of life documented by 321 pain patients in German primary care (age 72.4 +/- 13.8 years; 67.3% female; musculoskeletal pain 85.4%; mean pain intensity 6.1 +/- 1.2, for 90% > or = 5 NRS11) using standardised self-report instruments (German Pain Questionnaire/German Pain Diary). RESULTS: After initiation with 5/10 microg/h buprenorphine (89.7%/10.3%), treatment was maintained in 57.1/39.1/3.8% patients with stable doses of 5/10/20 microg/h after 6 months. The average pain intensity decreased by 5.1 +/- 1.0 (absolute) to 1.0 +/- 1.0 NRS11 (83.5%), pain-related impairments and burden of pain were reduced by 86.0% and 87.9%, respectively, and pain-related quality of life improved by 97.3% to nearly normalvalues. CONCLUSIONS: Pain treatment of elderly persons with 7-day low-dose transdermal buprenorphine patch on a stable dose regimen resulted in fast, effective and sustained pain relief accompanied by marked improvements in daily life participation and quality of life.

[2-week efficacy and tolerability of flupirtine MR and diclofenac in patients with acute low/back pain--results of a post-hoc subgroup analysis of patient-level data from four non-interventional studies]. / 2-Wochen-Wirksamkeit und -Verträglichkeit von Flupirtin MR und Diclofenac bei akuten Kreuz-/Rückenschmerzen. Ergebnisse einer Post-hoc-Subgruppenanalyse individueller Patientendaten von vier nichtinterventionellen Studien.

BACKGROUND: Current restrictions in use of flupirtine-containing medicines for a maximum of 14 days endorsed by the European Medicines Agency were followed by uncertainty/ambiguity of its analgesic efficacy for the treatment of acute low/back pain. METHODS: Post-hoc selection of patient-level data from non-interventional studies with flupirtine MR and diclofenac with respect to patient age (> or = 18 years), duration of treatment (14 +/- 2 days), indication (acute/subacute low/back pain) and first-line use. Primary endpoint: average 24-hr. pain intensity; secondary endpoints: pain-related disabilities in daily life, 30/50/70% response with respect to pain and pain-related restrictions, frequency of untoward side effects/treatment emergent adverse events. RESULTS: 318/31 patients treated with flupirtine MR/diclofenac fulfilled the inclusion criteria for this subgroup analysis. Starting from comparable demographic and baseline characteristics both treatments were followed by significant effects (p < 0.001). Subgroup comparisons revealed superior effects for flupirtine MR vs. diclofenac for pain relief (p = 0.001), improvement of pain-related restrictions in daily life (p = 0.023), and gastrointestinal/overall tolerability (p < 0.001). CONCLUSIONS: Even for short-term use in patients suffering from muscle-related acute low/back pain, flupirtine MR is superior effective and tolerated compared with the nsaid diclofenac.

Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial*.

OBJECTIVE: To assess the efficacy and tolerability of flupirtine in comparison with tramadol for the treatment of moderate to severe subacute low back pain (LBP). DESIGN AND METHODS: In this randomised, double-blind, parallel-group trial, 209 LBP patients, aged 18-65 years, were orally treated with flupirtine 100 mg (n = 105) vs. tramadol 50 mg (n = 104), both three times daily for 5-7 days. MAIN OUTCOME MEASURES: Patient assessment of pain intensity after 5-7 days (primary); physicians' global assessment of improvement in pain and functional capacity; adverse events. RESULTS: Flupirtine showed an overall pain-relieving efficacy comparable to tramadol. Mean LBP intensity after end of treatment dropped from 6.8 (95% CI: 6.5-7.0) to 2.8 (95% CI: 2.3-3.1) for flupirtine and from 6.9 (95% CI: 6.6-7.1) to 3.0 (95% CI: 2.6-3.4) for tramadol, corresponding to pain relief rates of 57% (95% CI: 51-63%) and 56% (95% CI: 50-62%) respectively (p = 0.796), indicating non-inferiority of flupirtine. All other efficacy endpoints supported equivalent efficacy. Adverse events (AEs) occurred significantly less in patients after flupirtine (33%) vs. tramadol (49%) (p = 0.02) and both the respective severity grading and the AE-related dropout rates were significantly lower after flupirtine than after tramadol (1% vs. 15%, p < 0.001). CONCLUSION: Flupirtine 100 mg three times daily was associated with a reduction in pain and improvements in functional capacity equivalent to that observed with tramadol 50 mg three times daily, and was better tolerated, when administered to patients with subacute back pain for one week. The limitations of this study were the lack of a placebo control and the short (7-day) duration of the study.

[Analgesic and muscle tonus normalizing effect of flupirtine retard in chronic back pain. Results of a standardized therapeutic evaluation applying objective methods for measuring pain pressure threshold, pain pressure tolerance and muscle tension]. / Analgetische und muskeltonus- normalisierende Wirkungvon Flupirtin retard bei chronischen Rückenschmerzen. Ergebnisse einer standardisierten Therapieevaluation unter Verwendung objektiver Verfahren zur Messungvon Druckschmerzschwelle, Druckschmerztoleranz und Muskelspannung.

BACKGROUND: Chronic back pain is mainly caused by painful tension in the back muscles. Thus, analgesics with muscle tone decreasing effects that apparently normalize increased muscle tonus through specific modes of action without disturbing normal muscular movement are an important therapeutic option. Flupirtine retard (Katadolon S long) has provided such an option since 2006. OBJECTIVES: To impartially evaluate the muscle tonus normalizing effects of flupirtine retard by applying specific, objective test methods in patients with chronic musculoskeletal pain under routine practice conditions. METHODS: Prospective standardized evaluation of a treatment with flupirtine retard in 30 patients with continuous chronic, therapy refractory back pain. Measurement of general pain intensity, pain pressure threshold and pain pressure tolerance for trigger-point related pain and muscle tension in the affected back muscles before and during flupirtine retard treatment were performed in a standardized manner. RESULTS: In comparison to the reproducible, constant initial values, the two-week treatment with flupirtine retard led to a significant improvement in all measured muscle-specific indicators: pain pressure threshold (+48%), pain pressure tolerance (+27%) and depth of penetration in the muscle (+18%) (all values p < 0.001). These were also correlated with a clinically observable and statistically significant pain relief from an initial level of 7.0 +/- 1.3 to 3.0 +/- 1.4. CONCLUSION: Flupirtine retard was shown to be a useful, effective and very tolerable therapeutic option for patients with chronic back pain. The improvement of muscle disturbances which are responsible for the pain in addition to pain relief was shown firstly by objective measure methods.

Effectiveness of lamotrigine in children with paroxysmal kinesigenic choreoathetosis.

Paroxysmal kinesigenic choreoathetosis (PKC) is a rare movement disorder, characterized by recurrent, brief involuntary dystonic attacks that are provoked by sudden movements. Pathophysiology is uncertain, but a channelopathy is discussed. Treatment recommendations favour antiepileptic drugs (AEDs) acting on voltage-gated neuronal ion channels. This report summarizes the history of three children (6, 8, and 10 years of age) with idiopathic PKC successfully treated with low doses of lamotrigine, an AED acting primarily via neuronal voltage-sensitive sodium channels.

[Therapy of headaches in childhood and adolescence]. / Kopfschmerztherapie im Kindes- und Jugendalter.

BACKGROUND: Headaches are one of the most common health problems of children and adolescents, afflicting between 50-90% of the pediatric population in some form sometimes during their first two decades of life. Due to changing prevalence rates, more or less complex classification systems, inconsistent therapy responses with great inter- and intraindividual variabilities and high placebo response rates, pediatric headache syndromes are frequently thought to be too difficult for the outpatient evaluation and treatment in clinical practice. THERAPY AND PROGNOSIS: However, with the introduction of the International Headache Society classification system, the continuously expanding knowledge about the pathophysiology of different headache syndromes and the development of new symptomatic as well as causative treatment options - covering both: pharmacologic and non-pharmacologic approaches - a pragmatic diagnostic work up and the development of specific treatment schedules for pediatric headache patients is now possible.

Severe adverse events in a comparative efficacy trial in Germany in infants receiving either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine. The Pertussis Vaccine Study Group.

Severe adverse events were evaluated in a comparative efficacy trial in Germany in infants who received either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine. Vaccinees received four doses (at three, four-and-a half, six and 15-18 months of age) of either DTP or DTaP vaccine or three doses at three, four-and-a half and 15-18 months of age) of DT vaccine. The analysis included 4,273 DTaP recipients, 4,259 DTP recipients and 1,739 DT vaccinees. Convulsions within three days of vaccination occurred in 1/15,912 doses in DTaP recipients and 1/3,926 doses in DTP vaccinees (p = 0.22). Persistent inconsolable crying was more common in DTP vaccinees (1/113 doses) compared with DTaP (1/497 doses, p < 0.001) and DT (1/359 doses, p < 0.001) recipients. High fever (< or = 40.5 degrees C) was less frequent in DTaP vaccinees (1/16,239 doses) compared with DTP (1/5,359) and DT recipients (1/4,665). One hypotonic-hyporesponsive episode was observed.

Minor adverse events in a comparative efficacy trial in Germany in infants receiving either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine. The Pertussis Vaccine Study Group.

Minor adverse events were evaluated in a comparative efficacy trial in Germany in infants who received either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine. Vaccinees received four doses (at three, four-and-a half, six and 15-18 months of age) of either DTP or DTaP vaccine or three doses (at three, four-and-a half and 15-18 months of age) of DT vaccine. The reactogenicity analysis included 4,273 DTaP, 4,259 DTP and 1739 DT vaccinees. Local reactions (erythema and induration) and systemic events (fever, fretfulness, drowsiness and anorexia) were more common after each dose of DTP vaccine than after the DTaP and DT vaccine doses. Erythema, induration and fever increased in frequency in DTaP and DT recipients with increasing series number. Erythema, induration and fever after the first two doses of vaccine were more frequent in DT recipients than DTaP vaccinees. Antipyretics were more commonly used in DTP recipients than in DTaP vaccinees.