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Benecke R.,University of Rostock | Heinze A.,Kiel Headache and Pain Center | Reichel G.,Paracelsus Hospital | Hefter H.,Heinrich Heine University Dusseldorf | Gobel H.,Kiel Headache and Pain Center
Pain Medicine | Year: 2011

Objective. This was a prospective, randomized, double-blind, placebo-controlled, 12-week, multicenter study to evaluate the efficacy and tolerability of fixed location injections of botulinum type A toxin (BoNT-A, Dysport) in predetermined injection sites in patients with myofascial pain syndrome of the upper back. Design. Patients with moderate-to-severe myofascial pain syndrome affecting cervical and/or shoulder muscles (10 trigger points, disease duration 6-24 months) and moderate-to-severe pain intensity were randomized to BoNT-A (N=81) or saline (N=72). Intervention. Patients received treatment into 10 predetermined fixed injection sites in the head, neck, and shoulder (40 units of BoNT-A per site or saline, a total of 400 units of BoNT-A). Outcome Measures. The primary efficacy outcome was the proportion of patients with mild or no pain at week 5 (responders). Secondary outcomes included changes in pain intensity and the number of pain-free days per week. Results. At week 5, 49% (37/76) of BoNT-A patients and 38% (27/72) of placebo patients had responded to treatment (P=0.1873). Duration of daily pain was reduced in the BoNT-A group compared with the placebo group from week 5, with statistically significant differences at weeks 9 and 10 (P=0.04 for both). Treatment was well tolerated. Conclusion. Fixed-location treatment with BoNT-A of patients with upper back myofascial pain syndrome did not lead to a significant improvement of the main target parameter in week 5 after treatment. Only in week 8 were significant differences found. Several secondary parameters, such as physicians' global assessment and patients' global assessment, significantly favored BoNT-A over placebo at weeks 8 and 12. Wiley Periodicals, Inc.

Duschek S.,Ludwig Maximilians University of Munich | Hellmann N.,Ludwig Maximilians University of Munich | Merzoug K.,Paracelsus Hospital | Reyes del Paso G.A.,University of Jaen | Werner N.S.,Ludwig Maximilians University of Munich
Pain Medicine | Year: 2012

Objective. Functional transcranial Doppler sonography (fTCD) enables reliable quantification of cerebral blood flow modulation during neural activation processes. Its high-time resolution, relatively simple technical arrangement, and low costs could make fTCD a useful tool in the investigation of brain activity underlying pain experience in fundamental and clinical research. The present pilot study explored the suitability of this technique to investigate cerebral hemodynamics during the processing of experimental heat pain. Design. In 46 healthy subjects, blood flow velocities in the anterior cerebral arteries (ACA) and middle cerebral arteries (MCA) of both hemispheres were recorded, while heat stimuli of 45 and 47°C were applied to their left forearms (stimulus duration 20seconds). Subjective sensory and affective pain intensities were assessed using visual analog scales. Results. A biphasic right dominant blood flow increase arose in the ACA and MCA with maxima around 5 and 15seconds after stimulus onset. The response was stronger under stimulation with 47°C with respect to 45°C, and the magnitude of the late response component correlated positively with sensory and affective pain intensity under the 45°C condition. Conclusions. The findings suggest that fTCD measurements prove sensitive both to different levels of physical intensity of painful stimuli and to interindividual differences in nociceptive responding. fTCD may be a valuable tool in clinical pain research, for instance, when it comes to quantifying the temporal dynamics of exaggerated nociceptive responses in chronic pain, or evaluating treatment effects on nociceptive processing. © 2012.

Simoes-Wust A.P.,Paracelsus Hospital | Jeschke E.,Havelhoehe Research Institute | Mennet M.,Weleda AG | Schnelle M.,Weleda AG | And 2 more authors.
Forschende Komplementarmedizin | Year: 2012

Background: The use of preparations from Bryophyllum pinnatum for tocolysis (or to arrest labor) is supported by observations obtained mainly at empirical level, but also by preclinical experiments performed with uterus strips and myometrium cell lines. Furthermore, a retrospective matched-pair study revealed good tolerability and effectiveness. In anthroposophic medicine, however, Bryophyllum species are used for a broad spectrum of diagnoses. Here, we characterize the prescribing pattern of Bryophyllum preparations in a network of anthroposophic physicians in Germany. Methods: 38 primary-care physicians in Germany participated in the EvaMed network, a multi-center observational study. They documented anonymized prescriptions, diagnoses and demographic data (age and gender) for each consecutive patient between 01.01.2004 and 01.01.2010. Diagnoses were coded according to the 10th revision of the International Classification of Diseases (ICD-10). In the present analysis, all prescriptions of any Bryophyllum preparation in the resulting data bank were identified and the corresponding diagnoses were analyzed retrospectively. Results: A total of 4,038 prescriptions of Bryophyllum preparations were identified in the EvaMed data bank. A variety of preparations could be found, 77.7% of which were prepared from Bryophyllum plants exclusively and 22.5% were combinations. Bryophyllum preparations were often prescribed to treat 'mental and behavioral disorders' (ICD-10 F00-F99, 35.7%) and 'diseases of the skin and subcutaneous tissue' (L00-L99, 16.0%), followed by 'symptoms, signs, and abnormal clinical and laboratory findings, not elsewhere classified diseases' (R00-R99, 15.2%) and 'diseases of the nervous system' (G00-G99, 9.7%). Conclusion: By revealing the use of Bryophyllum preparations in so many other indications than preterm delivery, our data clearly show the urgent need to conduct additional clinical trials. © 2012 S. Karger AG, Basel.

Wachter R.,University of Zurich | Brenneisen R.,University of Bern | Hamburger M.,University of Basel | Mennet M.,Weleda AG | And 4 more authors.
Phytomedicine | Year: 2011

Aims: The use of preparations from Bryophyllum pinnatum (Lamarck) Oken (Kalanchoe pinnata (Lamarck) Persoon) in tocolysis is supported by clinical evidence. We studied here the effect of B. pinnatum leaf press juice and its chemical fractions on the response of human myometrial strips. No data are available if the influence on myometrial strips of the juice differs from that of its components in the chemical fractions, in order to increase the pharmacological effect. Methodology: In vitro study to test the effect of repeated addition of B. pinnatum leaf press juice (BPJ) and its chemical components in several dilutions (undiluted, 1-10%) on myometrium strips hang up in a myograph chamber. Chemical analysis is including HPLC, MPLC with Sephadex LH-20 and TLC. Results: All test solutions are inhibiting contractility by reducing the amplitude and the area under the curve (AUC) of the contractions. Undiluted BPJ and its undiluted chemical fraction 4 are reducing most effective these two parameters: the amplitude was at 78% of the baseline (95% CI (77-89); p < 0.05) at the second addition of the BPJ and at 70% (95% CI (50-90); p < 0.05) of the first addition of fraction 4; the AUC was at 82% (95% CI (69-95); p < 0.05) of the baseline at the first addition of the press juice and at 51% (95% CI (27-74); p < 0.05) at the first addition of fraction 4. The BPJ decreased amplitude and AUC significantly faster and increased frequency significantly faster than the control. Fractions could be tentatively assigned to bufadienolids, flavonoids and cinnamic acids. Fraction 4, accounted for flavonoids, increased the frequency of the contractions most effectively: 557% of the baseline (95% CI (316-797); p < 0.05) at the first addition. Conclusion: Leaf juice of B. pinnatum and its flavonoid fraction are most effective in relaxing myometrial strips by inducing frequency. © 2011 Elsevier GmbH. All rights reserved.

Simoes-Wust A.P.,Paracelsus Hospital | Graos M.,Biocant Center for Innovation in Biotechnology | Duarte C.B.,Biocant Center for Innovation in Biotechnology | Duarte C.B.,University of Coimbra | And 8 more authors.
Phytomedicine | Year: 2010

The use of preparations from Bryophyllum pinnatum in tocolysis is supported by both clinical (retrospective comparative studies) and experimental (using uterus strips) evidence. We studied here the effect of B. pinnatum juice on the response of cultured human myometrial cells to stimulation by oxytocin, a hormone known to be involved in the control of uterine contractions by increasing the intracellular free calcium concentration ([Ca2+]i).In this work, [Ca2+]i was measured online during stimulation of human myometrial cells (hTERT-C3 and M11) with oxytocin, which had been pre-incubated in the absence or in the presence of B. pinnatum juice. Since no functional voltage-gated Ca2+ channels could be detected in these myometrial cells, the effect of B. pinnatum juice was as well studied in SH-SY5Y neuroblastoma cells, which are known to have such channels and can be depolarised with KCl.B. pinnatum juice prevented the oxytocin-induced increase in [Ca2+]i in hTERT-C3 human myometrial cells in a dose-dependent manner, achieving a ca. 80% inhibition at a 2% concentration. Comparable results were obtained with M11 human primary myometrial cells. In hTERT-C3 cells, prevention of the oxytocin-induced increase in [Ca2+]i was independent of the extracellular Ca2+ concentration and of voltage-dependent Ca2+-channels. B. pinnatum juice delayed, but did not prevent the depolarization-induced increase in [Ca2+]i in SH-SY5Y cells.Taken together, the data suggest a specific and concentration-dependent effect of B. pinnatum juice on the oxytocin signalling pathway, which seems to corroborate its use in tocolysis. Such a specific mechanism would explain the rare and minor side-effects in tocolysis with B. pinnatum as well as its high therapeutic index. © 2010 Elsevier GmbH.

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