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Abstract Number: 1362

Isymind Significantly Reduces MTX-Induced Nausea In a Pilot Trial

Eva Ostermeier1, Hans Ulrich Koetter2, Hans-Peter Tony3 and Ruth Pfister2, 1Rheumatology, University of Würzburg, Würzburg, Germany, 2iSyMind Institut, Giessen, Germany, 3Rheumatology/Clinical Immunology, University of Würzburg, Würzburg, Germany

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Drug toxicity and methotrexate (MTX)

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Session Information

Session Title: Rheumatoid Arthritis - Clinical Aspects II: Predictors of Disease Course in Rheumatoid Arthritis - Treatment Approaches

Session Type: Abstract Submissions (ACR)

Background/Purpose:  MTX is the standard DMARD for treating rheumatoid arthritis and the most important partner for biological DMARDs. However MTX often induces heavy nausea accompanied by disgust and phobic fear concerning drug application leading to premature discontinuation of treatment. Therefore we analyzed the effectiveness of Neurointrinsic Mind Modulation and Synchronization(iSyMind), a neuropsychological method to reduce or eliminate the reported MTX side-effects in a clinical pilot study.

Methods:  4 patients with strong side-effects were screened using Visual Analog Scale (VAS; 0-100) for Intensity of Problem (IoP), Ability to Cope (AtC), Wish to Discontinue (WtD), Disgust (D), Anxiety (A). Each Patient was treated in a one-session group treatment with iSyMind 2×30 min in combination with psychoeducation concerning the development of disgust and phobia. All parameters were examined pre and post treatment and after 7, 28 and 90 days.

Results:   After iSyMind treatment patients were able to receive MTX  s.c. or p.o. with a highly improved tolerance. In 3 patients all 6 parameters (VAS) showed clinically significant reduction between day 1 and day 90: IoP from 91 to 24, AtC from 80 to 13, WtD from 59 to 12, D 87 from to 26, A 88 from to 26. The treatment satisfaction index via Visual Analoge Scale  (0= not at all satisfied, 100 = very satisfied) at day 90 was .81. The positive effect was ongoing in 3 of 4 patients till day 90 while one patient showed a fast relapse probably because of underlying moderate depression. Due to large standard deviation, inflicted by 1 patient, the statistical significances scored between p < .002 and p < .09.

Conclusion:  This pilot trial suggests that iSyMind significantly reduces MTX induced nausea, disgust and phobic fear with a response rate of about 75% enabling continuation of medication. The results indicate that the studied MTX related side-effects  concerning drug application are primarily neuropsychological results of an intrinsic learning process which can be resolved. Further studies are necessary for statistical validation.


Disclosure:

E. Ostermeier,
None;

H. U. Koetter,
None;

H. P. Tony,
None;

R. Pfister,
None.

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