Ergebnisse einer Doppelblindprüfung Diclofenac+Vitamin B₁, B₆, B₁₂ versus Diclofenac bei Patienten mit akuten Beschwerden im Lendenwirbelsäulenbereich

Summary

Several clinical trials have shown that the duration of treatment of painful vertebral syndromes can be shortened by using a combination of vitamins B₁, B₆, B₁₂ and diclofenac instead of diclofenac. In addition, a more efficient pain relief could be achieved by the combination therapy.

In order to confirm these results, we compared the clinical efficacy of diclofenac (25 mg) and a combination preparation with diclofenac (25 mg) plus vitamins B₁ (thiamine nitrate 50 mg), B₆ (pyridoxine hydrochloride 50 mg) and B₁₂ (cyanocobalamin 0.25 mg) in a multicentric randomized double-blind study including 418 patients. All patients received 3×2 capsules daily for a maximum of 2 weeks. In case of total pain relief, therapy should be discontinued after one week.

Data of 376 patients could be evaluated. 53 out of 184 patients receiving the combination and 48 out of 192 patients treated with diclofenac alone could stop therapy due to sufficient pain relief after one week.

The evaluation of the “Hoppe Pain Questionnaire” and the data concerning pain intensity also revealed better results for the combination preparation. The differences in favour of the B-vitamin-diclofenac-combination were statistically significant in patients with severe pain at the beginning of therapy.

Considering undesirable side-effects (symptoms in 70 out of 418 patients) there were no significant differences between the two medications.

This clinical trial provides further evidence that the combination therapy with diclofenac plus B-vitamins is more effective than diclofenac alone for the treatment of painful vertebral syndroms.