One-year-survey with multicenter data of more than 4,500 patients with degenerative rheumatic diseases treated with therapeutic nuclear magnetic resonance.

BACKGROUND AND OBJECTIVES: Nuclear magnetic resonance (NMR) has been shown to stimulate repair processes and cartilage and to influence pain signalling. It represents an alternative therapy for patients suffering from osteoarthritis (OA). To prove the clinical success of this new therapeutical method, validated measuring parameters are important that are convincing for pain and function in a one-year-follow-up. METHODS: During the course of its application over the last 10 years, over 4,500 protocols of a one-year-follow-up have been collected to record the outcome of NMR therapy. This report reflects the outcome of NMR therapy on patients with the following degenerative rheumatic diseases: OA of the knee (n = 2.770), OA of the hip (n = 673), OA of the ankle joint (n = 420) and chronic low back pain (n = 655). Data were collected at baseline, 6­8 weeks and 6 and 12 months following NMR treatment. RESULTS: Pain was reduced significantly 6 weeks after NMR treatment in the cases of all four examined indications and stayed measurably reduced up to 6 and 12 months. The improvements in all three forms of pain (pain on load, pain on motion, pain at rest) following NMR treatment were around 21­50% on average. CONCLUSIONS: Following therapy with NMR, patients with OA of all four types experienced a distinct improvement in their ability in functional parameters. Overall, the 10 years of a one-year-survey with multicenter data gathered on the effect of NMR therapy on patients verifiably proved its efficacy amongst patients with degenerative rheumatic diseases.

Efficacy and tolerance of an oral enzyme combination in painful osteoarthritis of the hip. A double-blind, randomised study comparing oral enzymes with non-steroidal anti-inflammatory drugs.

OBJECTIVE: The objective of this study was to establish the non-inferiority of an oral enzyme therapy (Phlogenzym-(PE)) as compared to the non-steroidal anti-inflammatory drug (NSAID) diclofenac (DC) in patients with osteoarthritis (OA) of the hip. METHODS: Ninety patients presenting with painful episodes of OA of the hip were treated for 6 weeks in one study centre in a phase III, randomised, double blind, parallel group trial. Altogether, 45 patients were treated in the PE group and 45 patients were treated in the DC group. Primary efficacy criteria were: WOMAC dimensions pain, joint stiffness and function, and Lequesne index as multiple endpoint according to O'Brien. The efficacy criteria were analysed applying the test of non-inferiority with regard to mean changes and frequencies, t-test, U test, ANCOVA and descriptive methods. RESULTS: Within the 6 weeks observation period, the adjusted changes from baseline to endpoint of the target parameters worked out as follows (adjusted differences, mean +/- SEM): WOMAC subscale pain (PE -10.3 +/- 1.2, DC -9.5 +/- 1.2), WOMAC subscale joint stiffness (PE -3.9 +/- 0.5, DC -3.6 +/- 0.5), WOMAC subscale physical function (PE -31.7 +/- 3.5, DC -29.7 +/- 3.5), Lequesne's index (PE -2.89 +/- 0.47, DC -2.27 +/- 0.47). Non-inferiority of PE as compared to DC with regard to the O'Brien's global sum of the standardised adjusted changes from baseline to endpoint in pain, stiffness, physical function, and Lequesne's index was established with p = 0.0025. PE was simultaneously non-inferior as compared to DC with regard to the 4 single endpoints: WOMAC subscale pain (p = 0.0033), WOMAC subscale joint stiffness (p = 0.0061), WOMAC subscale physical function (p = 0.0039), Lequesne's index (p = 0.0008) (closed test procedure). The equivalence tests remained insignificant due to comparatively lower effects of DC. For 71.1% of the PE patients and for 61.4% of the DC patients rates of good or very good global investigator assessments of efficacy were calculated (test of non-inferiority: p = 0.0011). In the majority of patients, tolerability was judged in both drug groups as very good or good. CONCLUSION: This trial showed significant non-inferiority from 6 weeks treatment with PE in patients with OA of the hip with regard to the WOMAC dimensions pain, stiffness and physical function, to Lequesne's index, to the investigator and patients assessments of efficacy, and to the responder rates based on pain, physical function, and patient assessment of efficacy. With regard to drug tolerability some tendencies in favour of PE were detected. However, in this study there was no real difference between PE and DC 100 mg/day, implying an equal benefit-risk relation between the substances. PE may well be recommended for the treatment of patients with osteoarthritis of the hip with signs of inflammation as indicated by a high pain level.

[Results of a multidisciplinary rehabilitation concept in patients with chronic lumbar syndromes]. / Ergebnisse eines multidisziplinären Rehabilitationskonzepts bei Patienten mit chronischen Lumbalsyndromen.

The aim of our pilot study was to evaluate the influence of a multidisciplinary rehabilitation programme on various parameters of pain and function in 88 patients suffering from chronic low back pain caused by disc herniation (46 patients) or after lumbar discectomy (42 patients). We used an exercise-based multidisciplinary programme during a four-week in-patient treatment: active physiotherapy, exercise training and back school, organized in group therapies combined with passive techniques of physiotherapy (heat, massage, electrotherapy, medicated bath) with a daily duration of treatment exceeding three hours. Symptoms and functions improved simultaneously with the reduction of pain. The results of the visual analogue scale improved significantly in both groups (conservatively treated group p < 0.0001, after lumbar discectomy p < 0.005). As for the McGill pain questionnaire, however, only the group with conservatively treated disc herniations changed significantly for the better. We found an improvement in Roland-Morris' disability questionnaire in both groups, which reached statistical significance only in the group after lumbar discectomy. Forward-backward bending (kyphometer measurement as described by Debrunner), ameliorated significantly in both groups. Our results indicate that an exercise based multidisciplinary rehabilitation programme can improve pain and function even in patients suffering from definitely chronic low back pain caused by disc herniation or after lumbar discectomy.

[Reducing pain by oral enzyme therapy in rheumatic diseases]. / Schmerzreduktion durch eine orale Enzymtherapie bei rheumatischen Erkrankungen.

Proteolytic enzymes have analgesic, effects, besides the wellknown antiinflammatory and edema-reducing properties. These analgesic effects are based on the inhibition of inflammation and in addition to that on direct influences on the nociceptors. All that explains the therapeutical effects of such enzymes in degenerative-rheumatic and soft tissue rheumatic diseases in which inflammatory or immunologic processes are not in the forefront. In recent years a significant reduction of pain in various rheumatic diseases, concerning these aspects, was shown in several clinical studies. The clinical trial in patients with periarthritis of shoulder showed statistical equivalence of pain reduction, whether they were treated with phlogenzym or diclofenac. Likewise in the trial of patients suffering from painful osteoarthritis of the knee, there was a statistical equivalence of the pain-scores, comparing diclofenac and enzymes. The study of painful vertebral syndromes again resulted in equivalence of the treatment with NSAIDs compared to therapy with enzymes.