Clinical Trial: Biological Against Disc Prolapse is Effective

August 30, 2007

Applied Clinical Trials

Study shows: New therapy against disc prolapse is effectiveOrthokine therapy alleviates severe back pain for six months

DÜSSELDORF, GERMANY, August 30, 2007-The treatment of disc-related back pain with the body’s own anti-inflammatory proteins is effective and safe. This is the conclusion of a randomised, prospective, double-blinded trial published in the current issue of the medical journal Spine. The goal of the clinical trial was to investigate the effect of the endogenous protective proteins, produced using the Orthokine procedure, and to compare it to the standard therapy cortisone. The result: over a six-month period, better results could be obtained with the biological than with the cortisone treatment.

Eighty-four patients suffering from nerve root disorders of the lumbar spine took part in the randomised, prospective, double-blinded clinical trial. In the trial, authorised by the ethics committee of the University of Bochum, 32 patients were treated with the Orthokine therapy, 27 patients received 5 mg cortisone, and a further 25 participants received 10 mg cortisone. All three drugs were injected into the affected nerve root, with the patients receiving three injections once a week. The participants were medically supervised over a period of six months. Check ups were made 6, 10, and 22 weeks after the first injection. Four weeks after the treatment, all patients demonstrated a statistically significant reduction in symptoms. As the trial progressed the pain level of the Orthokine-treated patients was further reduced, whereas the pain level of the cortisone-treated patients fluctuated. In total, the reduction of pain was greater with the Orthokine therapy than with the standard treatment.

“This study has confirmed our results and shown for the first time that there is an effective, well tolerated alternative to cortisone treatment,” said Wehling. The widespread standard therapy using cortisone is effective, but is however, associated with possible side effects. If cortisone treatment is repeated too often, in some cases it can lead to serious side effects, such as a weakening of the immune system, osteoporosis, oedema, or metabolic disorders. The treatment of patients with agents from their own body can therefore be recommended to every patient who wishes a natural and effective treatment that has few side effects.

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