P S O R I A M E D
Contents
1. fcM 2 Figure 1 The IFC equipment Evaluation procedures Based on the clinical features of the PASI psoriasis area and severity index score 9 we developed a clinical study score to allow for the measurement of PP severity The overall score is the sum of the following separately recor ded features erythema scaling induration fissures and pustules 0 absent 1 mild 2 moderate 3 severe 4 extremely severe The maximum possible value was 20 for pustular psoriasis and 16 for PP without pustules In addition to these criteria each patient was asked to eva luate pruritus pain and success of the therapy by himself These criteria were assessed every four weeks In addition photographs were taken For inclusion into the study a minimum score of 6 resp 8 for pustular PP was required before therapy Outcome criteria The primary outcome criteria was the clinical response documented in a decrease of the overall score by more than 2 points An early stopping of treatment without complete disappearance of PP was defined as non res ponse The secondary outcome criteria were the subjective criteria as documented by the patient and were used only to validate the primary criteria Statistical analysis and stopping rules As outlined in the introduction a control group could not be formed in this study For this group a response rate of 18 spontaneous remission rate would be expected Without a con2. PSORIAMED LE CONCEPT D APPAREIL INNOVATEUR POUR UNE THERAPIE EFFICACE DU PSORIASIS PHYSIOMED FLEKTROMEDIZIN TECHNOLOGY FOR THERAPY Ecran ordre clair avec images de traitement TECHNOLOGY FOR PSORIAMED est un appareil cliniquement test bas sur les exigences d une th rapie action rapide mais facile utilisation car n cessitant l application de courants de stimulation Sans irriter les zones affect es les courants d interf rence IFS traversent en douceur les barri res de r sistance de la peau et agissent ainsi sur les zones pr sentant cette dysfonction L effet antipsoriasique de l IFS est bas sur la normalisation des processus de division cellulaire ainsi que sur une action anti inflammatoire et anti oed mateuse Gr ce la transmission d informations appropri es stimulant ainsi le m ta bolisme cellulaire le temps de traitement avec PSORIAMED est de courte dur e d une intensit faible et agr able L efficacit de ce traitement dont l inocuit est totale est une alternative et ou un adjuvant au traitement du psoriasis Pour obtenir des bons r sultats le traitement doit tre r alis deux fois par jour le matin et le soir On peut appliquer les courants de stimulation soit dans un bain d eau soit a l aide d lectrodes sp ciales Pour le traitement le menu de l appareil offre des propositions de th rapie pr programm es ainsi que des graphiques Grace son cran
3. confidence interval 62 99 These results arc highly encouraging and should focus attention on this new therapy modality which in contrast to other treatments is not A Philipp B Rzany E G Jung Uni versit ts Hautklinik Klinikum gGmbH Universit tsklinikum Fakult t f r kli nische Medizin Mannheim der Univer sitat Heidelberg Theodor Kutzer Ufer D 68135Mannheim Germany G K Wolf Klinisches Forschungsinsti tut Neuenheimer Landstrasse 38 2 D 69120 Heidelberg Germany H Dertinger Forschungszcntrum Karls ruhe Institut f r Toxikologie Postfach 3640 D 76021 Karlsruhe Germany associated with side effects and discomfort Key words psoriasis interfe rential current clinical trial shifted null hypothesis is very difficult to treat 1 It is usually resistant to most of the available therapeutic modalities like topical glucocorticosteroids vitamin D derivates and pho totherapy 2 few effective therapies exist such as coal tar 3 but are hampered by e g displeasing odour or other side effects Thus there is an urgent need to find new the rapeutic strategies Here we report the results of a clinical study on a comple tely new therapy for palmar psoriasis PP which involves the application of interferential current IFC This wave form is a well known tool in physiotherapy and other fields 4 51 Recent in vitro studies revealed details of its mode of action at the cellular level see Discuss
4. effective in cases where other therapies failed Moreover the time course of the score profile suggests that the total treatment time could eventually be reduced to 2 months 2 No discom fort and side effects are associated with IFC treatment Thus additional therapy cycles can be initiated if neces sary 3 A decrease of pruritus was reported by the patients Possible therapeutic mechanisms of IFC might involve activation of second messenger dependent cell signalling processes Specifically it has been found that the messen ger cyclic AMP is upregulated in cells exposed to IFC at 10 and 100 Hz modulation 111 12 Also the ratio cAMP cGMP is increased at these frequencies 12 As shown earlier cAMP and cAMP cGMP both involved in control of proliferation are reduced in cells from psoriatic areas 13 14 In addition antipsoriatic effects of dibuty ryl cAMP have been reported 3 This suggests that repeated stimulation of cAMP or of cAMP cGMP towards the normal skin values during the therapy sessions might remove psoriatic hyperproliferation Whether or not this may explain the antipsoriatic action of IFC will depend on the results of further investigations addressing other possible effective mechanisms like immunological processes but also supportive effects of IFC such as the stimulation of microcirculation which may influence the therapeutic result For the future we plan to replicate the present results on palmar psor
5. senior der matologist The patients had been treated by other modali ties before but without success Topical therapies were stopped two weeks and systemic therapies including UV treatment 4 weeks before the start of IFC treatment During the treatment phase no other therapy was allowed except an ointment and lotion containing urea e g Urea pura 10 in Ungt leniens and Excipial U Lipolotio Treatment modalities The patients were treated with a commercially available IFC device operated in the bi po3ar mode Each patient recel ved his own IFC equipment and was instructed to treat his PP twice a day for 6 minutes with a modulation frequency of 100 Hz in the morning and of 10 Hz in the evening Both sessions were separated by at least 8 hours No oint ment or lotion were allowed one hour prior to treatment The duration of the whole therapy cycle was 12 weeks All patients received a standard training on the usage of the equipment For IFC treatment each hand was immer sed in a small water filled plastic tub At the bottom of each tub a 24 x 15 cm rubber electrode was placed A cellulose cotton tissue between the electrode and the hand avoided direct electrode contact IFC amperage was slowly upregulated by an assisting person slightly above the thre shold where prickling sensation occurred which corres ponded to a typical effective current density of as low as 100u A cm M tater Ei beer 2e LR
6. 11 patients had in addition to the palmar involvement typical psoriatic lesions on the trunk All patients reported the onset of their disease more than one year ago ss 5 ZOOP ROIS Fo 1D 1 amp b n ID2 i s my il A ID3 o e D 1D4 8 D IDS o ID 6 B O ID 7 Sa 4 ID 9 o ID 10 2 O ID 11 Rome Se A ID 12 i ae oF Median day 0 day 28 day 56 day 86 Se Figure 2 Overall score and median course AD HS vol IQ Aprl Mua ATM Figure 3a and b Patient 3 before and after 12 weeks of IFC treatment Clinical response At the end of the IFC treatment period the overall score decreased from 7 5 day 0 to 3 0 day 84 We found a decrease of the median score for erythema as well as for scaling from 3 0 points day 0 to point day 84 The median score for induration was reduced from 2 0 points day 0 to 1 0 point day 84 The one patient with pustular psoriasis also showed a decrease of pustules from 3 0 day 0 to 1 0 day 84 11 of 12 patients were cured or markedly improved and were considered to have demonstrated a clinical response to the therapy Since the interim analysis indicated a signi ficant result p 0 003 the trial was terminated thereaf ter Estimated response rate was 90 with a 95 confi dence interval of 62 to 99 The subjective criteria correlated well with the objective criteria The median of pruritus decreased from 2 0 points day 0 to 0 po
7. e la Directive 93 42 CEE Mil THERAPY Commande au pied optionnel Pour op ration s re et confor table pendant le traitement PHYSIOMED ELEKTROMEDIZIN AG Hutweide 10 91220 Schnaittach Laipersdorf Germany C n Q Qualit tssicherung ISO 9001 MADE IN GERMANY 08 2006 Sp cifications et design susceptibles d tre modifi s sans avertissement pr liminaire 49 0 91 26 25 87 0 49 0 91 26 25 87 25 info physiomed de www physiomed de el est le mode d action de PSORIAMED tude de cas pratique Le traitement cellulaire agit sp cifiquement sur les cellules qui pr sentent Diagnostic Psoriasis sur la paume depuis environ 2 ans une anomalie fonctionnelle On sait depuis longtemps que le taux Traitement Arr t du traitement pr c dent 14 jours avant le traitement d ad nosine monophosphate cyclique AMP cyclique un messager par PSORIAMED deux s ances quotidiennes de 5 minutes de notre organisme est consid rablement plus faible dans les cellules matin et soir U ne nouvelle solution cutan es psoriasiques que dans des cellules normales DERTINGER et ses collaborateurs ont pu montrer dans des tudes de biologie cellulaire que ce messager cellulaire peut tre stimule de fa on cibl e par l application de courants de stimulation fr quence moyenne pour le psoriasis PSORIAMED Traitement efficace par l application de courants de stimulation Des fen tre
8. e not able to healing the disease permanently The need for new treatments to reduce clinical symptoms of the chronic disease to avoid or diminish adverse effects of conventional protocols and to improve quality of life of the patients fosters the research on innovative non traditional clinical approaches including physiotherapeutic ones We present here a clinically successful approach to the therapy of psoriasis with Interferential Currents IFC a wave form traditionally applied in physiotherapy This method is based on the bipolar application of current in specific bands A safe pleasant and effective treatment protocol has been developed with application of extremely low intensity IFC approx 50 A cm either through electrodes covered with water containing gel or using electrodes placed in water baths The procedure was performed regularly twice a day mornings 10 Hz and evenings 100 Hz modulation with brief sessions of 5 minutes each Highly positive and durable clinical effect was achieved after 8 to 12 weeks of the IFC treatment There were no undesirable side effects and the patients compliance was excellent The clinical study Philipp et al Eur J Dermatol 2000 performed on 12 patients with therapy resistant palmar plantar form of psoriasis receiving local IFC treatment during a 12 weeks period showed a 90 positive response of the patients in terms of complete remission or significant improvement of the disease A more r
9. ecent study on psoriatric arthritis Walker et al Rheumatol Int 2006 on 9 patients treated for 16 weeks at affected joints hands and feet has demonstrated a consistent analgesic effect of the treatment as demonstrated by the improvement of SF 36 body pain index morning stiffness tender joint counts and a physician assessed disease activity The mechanisms of action at the molecular and cellular levels are currently obscure However our recent data allowed us to suggest that IFC modulated production of pro inflammatory cytokines IL 18 TNF a and IL 10 through activation of cyclic AMP metabolic pathway affecting intracellular Ca transporting systems The proliferative capacity of Th1 in response to mitogenic stimulus was substantially suppressed by IFC which could also contribute to its anti inflammatory effects in psoriasis
10. ent is effective in palmar psoriasis an open prospective trial Armin PHILIPP Gerhard K WOLF Berthold RZANY Hermann DERTINGER Interferential current IFC has been shown to improve psoriasis in a small Ernst G JUNG case series So far no formal clinical trial had been conducted As IFC is associated with slight prickling sensations a blinded study design was not feasible Therefore an open type prospective study was conducted with the assumption of 18 spontaneous remission rate A response rate of 50 or less was judged as indicating no effect hypothetical control while 80 or more was considered as success alternative hypothesis In this quasi controlled study 12 patients with therapy resistant palmar psoriasis recei ved local treatment with IFC during a 12 week period Treatment was per formed at low current density in two daily sessions each of 6 minutes duration Erythema scaling induration fissures and pustules were recorded in separate scores every 4 weeks Response of a patient was judged positive when the total score of these criteria was reduced at least by two points at the end of treatment After 12 weeks of treatment 11 of 12 patients were cured or showed marked remission with the median overall score reduced by 4 points An interim analysis was performed in order to decide whether the results had already reached significance a lt 0 05 The analysis revea led a statistically significant response rate of 90 95
11. es pieds les coudes les bras et la t te cette m thode peut galement tre utilis e sur toutes les autres parties du corps grace aux lectrodes flexibles qui s appliquent l aide d un ruban auto agrippant Psoriasis tete matin Psoriasis tronc matin Psoriasis pieds matin PSORIAMED est effica Traitement efficace par l application de courants de stimulation s Pourquoi applic th rapeutique d velopp au centre de recherche de Karlsruhe en Allemagne sous la direction du professeur Hermann DERTINGER et il repose galement largement sur des preuves scientifiques Des tudes cliniques ont montr l efficacit lev e de ce traitement m me dans les cas de patients jusque la r sistants toute forme th rapeutique environ 90 des patients r agissent ce traitement non agressif et sans effets secondaires L application de courants lectriques est consid r e comme un mode de traitement efficace et prouv Elle conna t actuellement un regain de po pularit grace son absence d effets secondaires n est pas rare que des patients chroniques o des patients ayant en vain suivi tous les traitements existants d veloppent un nouvel int r t pour cette option th rapeutique Dans le traitement du psoriasis aussi les courants de stimulation pr sentent des r sultats excellents et rapides Ce traitement se fonde sur un concept Therapy Eur J Dermatol 2000 10 195 8 Interferential curr
12. graphique clair et sa modulation l aide d un seul potentiom tre PPORIAMED est un appareil extr mement facile utiliser Pour les applications dans des bains d eau l appareil est pourvu d un interrupteur p dale pour r gler sans probl me l intensit du courant Le fonctionnement avec une batterie rechargeable garantit la s curit d utilisation de l appareil et permet de s en servir lors de d placements ER Oar Ti i DONN ES TECHNIQUES Puissance d sortie maxi 100 mA 500 Ohm Puissance 25 VA Tension nominale 100 240 V Classe de protection 1 type BF Dimensions Lx H x P 315 x 104 x 285 mm Poids 3 1 kg ACCESSOIRES STANDARD 2 Coupes de traitement 2 Electrodes flexo EF 400 2 Sachets en viscose EF 400 10 Grilles distance 2 Rubans textiles lastiques 10 x 125 cm 1 C ble de patient bipolaire 1 C ble d alimentation 1 Mallette de transport 1 Mode d emploi 1 Dossier th rapeutique Psoriasis ACCESSOIRES SUPPLEMENTAIRES Commande au pied Electrode sp ciale bras Electrode sp ciale t te Cable de liaison avec serre fermoir jeu de 2 Electrode flexo EF 200 jeu de 2 Sachet en viscose EF 200 Chariot Universal II Tous les appareils PHYSIOMED se confor ment aux derni res normes de s curit et de fabrication en vigueur Ils sont fabriqu s selon les normes standard d assurance qua lit et passent les tests type leur permettant d obtenir le marquage CE obligatoire d
13. iasis for other locations of psoriasis In addi tion the combination of IFC with antipsoriatic treatments like topical vitamin D derivates or vitamin A will be investigated Article accepted on 5 12 99 Acknowledgements The study was funded by the Manfred and Ursula M ller Stiftung from the Stifterverband fur die Deutsche Wissenschaft We thank the Hans Karrer GmbH D 86330 K nigsbrunn for providing Excipial U Lipolotio References 1 Eriksson M Hagforsen E Lundin Palmoplantar pustulosis a clinical and immunohistological study Br J Dermatol 1998 138 390 8 2 Derancourt C Van Landuyt Laurent R Le Psoriasis Palmo Plantaire diagnostic et strategie therapeutique Ann Dermatol Venereol 1998 125 220 5 3 Kumar B Kumar A Kaur Coal tar therapy in palmoplantar psoriasis old wine in an old bottle ntJ Dermatol 1 997 36 309 12 4 Wolf SM Interferenzstrom Therapie Elektromedizin 1956 1 77 80 5 Nikolova L Treatment with Interferential current Churchill Livingstone Edinburgh London Melbourne New York 1987 6 Ward AR Fields and Waves in Therapy Science Press 1980 Fitzroy and Chapel Streets Marrikville NSW 2204 Australia 7 Wolf 6 Dertinger H Wolf G Die Wirkung von Interferenzstrom auf Psoriasis vulgaris Akt Dermatol 1996 22 94 7 ms 198 8 Altmeyer PJ Matthes U Pawlak F et at Antipsoriatic effect of fumaric acid derivatives J Am Acad Dermatol 1994 30 977 81 9 Fredriksso
14. ints day 84 Discussion We have chosen this specific study design because it allows a quasi controlled study when blinding is not pos sible It requires however existing data on the healing rate without intervention based on previous studies on the natural history of the disease or on randomized clinical trials with a placebo group The reader should be aware EJD n 3 vol M April May 2000 that this is a design suitable only for special conditions It should not be done whenever a randomised clinical trial is possible Besides that the planned adaptive interim analysis allows us providing a large treatment effect exists to control the therapy results with only a small number of patients This was important for us for practical reasons because only 12 IFC devices were available for this study The results we have found reveal a high therapeutic poten tial of IFC in palmar psoriasis Clinical and statistical significance was reached in an interim analysis after treat ment of only 12 patients In the study protocol the res ponse of a patient was judged positive when the total score was reduced at least by two points after 12 weeks of treat ment leading to a response rate of 90 Even when using the criterion of a 4 points reduction of the overall score as suggested by the median course the response rate is still about 70 The clinical significance of these results is further empha sised by the following facts 1 IFC is
15. ion IFC is the most simple type of an amplitude modulated alternating current It is usually generated by superposition interference of two sinewave currents with slightly dif ferent frequencies mostly near 4 kHz 6 Due to the low skin impedance in the kHz region IFC causes no damage like burning or cauterization Previous clinical results based on a small case series point to 100 Hz as the most potent IFC modulation frequency for treating psoriatic plaques 17 Meanwhile 10 Hz also proved as therapeutically effective A Philipp unpubli shed results Therefore both frequencies were incorpora ted into the treatment concept of this study Since IFC application is associated with slight prickling sensations of the skin it was not possible to use a blinded study design Therefore we conducted an open prospective P almoplantar psoriasis is a disabling condition which EID n 3 vel 10 April May 2000 study based on the hypothesis of an at least 50 response rate Assuming a spontaneous remission rate of 18 8 we allowed for a sufficiently large cordon sanitaire bet ween expected and required rate for statistical analysis Patients and methods Patients All consecutive patients visiting our in or outpatient department older than 18 years with PP affecting at least 10 of the surface of both hands were eligible Patients with pacemakers and patients with other general systemic diseases were excluded PP was diagnosed by a
16. n T Pettersson U Severe psoriasis oral therapy with a new retinoid Dermatologica 1978 157 238 44 10 Bauer P K hne K Evaluation of experiments with adaptive interim analyses Biometrics 1994 50 1029 41 Correction in Biometrics 1996 52 380 11 Knedlitschek G Noszvai Nagy M Meyer Waarden H et al Cyclic AMP response in cells exposed to electric fields of different frequencies and intensities Radiat Environ Biophys 1994 33 141 7 12 Sontag W Dertinger H Response of cytosolic calcium cyclic AMP and cyclic GMP in DMSO differentiated HL 60 cells to modulated low fre quency electric currents Bioelectromagnetics 1998 in press 13 Voorhees JJ Duell EA Imbalanced cyclic AMP cyclic AMP levels in psoriasis In Advances in Cyclic Nucleotide Research Vol 5 GI Drum mond P Greengard GA Robinson Eds 1975 Raven Press New York 735 58 14 Royer E Chaintreul J Meynadier J et al Cyclic AMP and cyclic GMP productionin normal and psoriatic epidermis Dermatologica 1982 165 533 43 EID n vel 10 April May 28800 CLINICAL EFFICACY OF LOW DOSE INTERFERENTIAL CURRENTS IN THE TREATMENT OF PSORIASIS Chiara de Luca Liudmila Korkina Hermann Dertinger Laboratory of Tissue Engineering amp Cutaneous Physiopathology Istituto Dermopatico dell Immacolata Rome Italy e mail c deluca idi it Institute for Biological Interfaces Research Centre Karlsruhe Germany To date all anti psoriasis therapeutic regimens ar
17. s de fr quences pr cises ont r v l une efficacit optimale dans les tests cliniques Ces tudes ont non seulement mis jour une l vation du taux d AMP cyclique mais galement une augmentation de la synth se de l interleukine 10 une cytokine anti inflammatoire L efficacit antipsoriasique lev e de ce traitement s explique aussi bien par la normalisation de la division cellulaire des keratinocytes que par une action anti inflammatoire et anti cedemateuse Le concept th rapeutique PSORIAMED est galement disponible en location traitement non agressif PHYSIOMED ELEKTROMEDIZIN www soulager le psoriasis fr sans Cai Se eo medics test cliniquement Vous souffrez de psoriasis Dans 90 des cas le traitement par PSORIAMED contribue a une remission totale ou a une nette amelioration des sympt mes Erreurs r serv es Sp cific oncept th rapeutique PSORIAMED PSORIAMED est un concept th rapeutique tr s facile utiliser Les options pr programm es assurent la rapidit des s ances de traitement Apres avoir choisi la zone traiter il vous suffit de r gler l intensit et le traitement commence Le traitement doit tre suivi tous les jours par deux s ances de 5 minutes matin et soir Pour le traitement des zones les plus couramment touch es on utilise des bains d eau et diff rentes lectrodes sp cialement con us En plus de ces traitements sp ciaux pour les mains l
18. trol group a sufficient distance of safety to this null hypothesis has to be kept Under the assumption that only a response of at least 50 would justify the application of the new therapy it is reasonable to take a response of Po 50 as null hypothesis thus creating quasi controlled conditions A binomial test against this shifted null hypothesis was used In order to allow for a sufficiently high treatment efficiency the alternative hypo thesis was PI 80 The planned adaptive interim analysis 10 was performed at the time when 12 patients had been treated for twelve weeks If p gt 0 2 the trial would have to be stopped and the conclusion of no effect would be taken In order to arrive at an overall significance level of a 0 05 the significance level for the interim analysis was a 0 0348 Then the trial would have to be terminated and the results be judged as a significant outcome power 0 56 The power for not accepting the null hypothesis in the interim analysis was gt 0 90 If 0 0348 lt p lt 0 20 a new sample size would have to be defined in order to arrive at a statis tically significant result Results Patient and disease characteristics Between October 1997 and March 1998 a total of 12 patients were included 8 men and 4 women The mean age was 48 36 60 years 11 patients suffered from typical psoriasis vulgaris three of them with deep fissures One patient was diagnosed with pustular psoriasis
Download Pdf Manuals
Related Search