Effectiveness and Economy of Harpagophytum Extract in the Treatment of Acute Low Back Pain - First Results of a Therapeutic Cohort Study

Author(s): Schmidt, A., Junck, H., Pfisterer, M.

Abstract: Objective: Does a post-marketing surveillance including two different therapies provide sufficient information on the criteria effectiveness and economy? Study Design: In an open prospective study patients receiving natural or conventional treatments were observed. Patients: 102 patients suffering from acute local (non-pseudoradiating) low back pain that was not attributable to identifiable causes were included. All patients had to suffer from chronic low back pain for more than 6 months. Interventions: Patients received from naturopathically orientated physicians 1,800 mg Harpagophytum extract with 30 mg harpagoside per day as single or co-treatment (group J) or from conventionally treating physicians a conventional therapy (group K). Main Outcome Measures: The validated Arhus low back pain index was evaluated prior to treatment and 4 and 6 weeks after start of treatment. Furthermore, in agreement with the AOK/Heidelberg the relative costs of treatment were calculated. In order to guarantee careful documentation, the authors, who did not interfere in the treatment, investigated the patients in their physicians' consulting rooms. Results: Patients receiving the Harpagophytum treatment (group J, n = 51) were not favoured, they were older, multimorbid and suffered longer from low back pain than patients receiving conventional treatment (group K, n = 51). The duration of acute local low back pain and the Arhus low back pain index, however, were comparable in the two groups prior to treatment. Conventional treatment consisted mostly of oral nonsteroidal antiinflammatory drugs (p<0.001), physical exercises (p<0.001) or paravertebral injections (p<0.001). The number of pain-free patients after 4 and 6 weeks of treatment was similar (group J: n = 16 and 20; group K: n = 12 and 23), respectively (n. s.). After the six-week therapy the Arhus low back pain index improved in both groups by about 20%. The relative change of the single components pain, invalidity and physical impairment did not differ between the groups. However, in the course of treatment the pain index decreased significantly from the 4th to the 6th week of treatment (groups J and K, p<0.05), in group K also the invalidity index (p<0.001) and the Arhus index (p<0.02) improved. The subgroup of patients receiving Harpagophytum extract as monotherapy showed a similar therapy outcome as group J. During the Harpagophytum treatment only minor adverse effects occured, that did not necessitate discontinuation of treatment. The relative costs of treatment were significantly lower under the Harpagophytum therapy both for members of sickness insurance schemes (p<0.002) and tot privately insured patients (p<0.001). Conclusion: Due to its efficacy and economy the oral administration of Harpagophytum extract should gain more importance in the treatment of acute local low back pain. An equivalence study, however, has to be performed to confirm these results.

Keyword(s): Harpagophytum-Extrakt (Wirksamkeit, Wirschaftlichkeit

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