Einsparung von Diclofenac durch B-Vitamine: Ergebnisse einer randomisierten Doppelblindprüfung mit reduzierten Tagesdosierungen von Diclofenac (75 mg Diclofenac versus 75 mg Diclofenac plus B-Vitamine) bei akuten Lendenwirbelsäulensyndromen

Abstract

Pain syndromes of the lumbar spine are one of the main problems in orthopedic practice. The therapeutic effect of NSAIDs is not subject to doubt in this connection. But considering that the application of NSAIDs is frequently associated with side effects, a reduction of dosage would be to the patient's benefit. Clinical studies have shown that concomitant treatment with vitamins B1, B6, B12 and diclofenac leads to a more efficient pain relief than treatment using diclofenac alone and thus provides the possibility of saving NSAIDs. This clinical trial was carried out in order to determine whether these results can also be achieved when a reduced dosage of diclofenac (75 mg daily) is used. 123 patients with acute pain syndromes of the lumbar spine were treated with either B-vitamins and diclofenac or diclofenac alone for a maximum of 7 days. There was the option to terminate therapy in the trial after 3-4 days in the case of total pain relief. 45 patients could stop the treatment due to remission of symptoms. 30 patients belonged to the combination therapy group, the other 15 took diclofenac alone; this difference is statistically significant (p less than 0.05). All parameters concerning pain relief and movement of the vertebral column showed statistically significant differences in favour of the B-vitamin-diclofenac-combination, too. The results document the positive influence of B-vitamins on painful vertebral syndromes and indicate that B-vitamins contribute to saving of NSAIDs by shortening the treatment time and reducing daily NSAID-dosage.

Analgetische und analgesiepotenzierende Wirkung von B-Vitaminen

“…Die [7,8,40,41,58], oder die Schmerzen mit einer niedrigeren täglichen Dosis von Diclofenac als normalerweise üblich behandelt werden konnten [40,42].…”

Impact of Low Back Pain on Quality of Life: Assessment by Patient Functionality Questionnaire and Treatment Results Using a Combination of Diclofenac plus B Vitamins or Diclofenac Monotherapy

“…The combination of diclofenac with vitamins B 1 , B 6 , and B 12 has been reported to be beneficial in the treatment of painful conditions, including post-operative pain [9], osteoarthritis [10], and especially low back pain. Prior to the publication of the DOLOR trial, encouraging results in clinical studies of low back pain employing the combination of vitamins B 1 , B 6 , and B 12 with diclofenac had been reported in the literature, especially in terms of shortened treatment time to satisfactory analgesia when compared with diclofenac monotherapy [11]- [14]. The results of the DOLOR study confirmed these findings and the results of this post-hoc analysis reinforced the benefit of adding vitamins B 1 , B 6 , and B 12 to diclofenac therapy in terms of shorter treatment time to desired clinical effect.…”

Direct determination of diclofenac in pharmaceutical formulations containing B vitamins by using UV spectrophotometry and partial least squares regression

“…Reported side effects of DCF include gastrointestinal lesions, headache, dizziness, skin rashes, edema and hepatic and renal damage. B vitamins have been reported to potentiate the antinociceptive and analgesic effects of DCF and several papers have documented their contributions to reduce daily DCF dosage and shorten the treatment time [2][3][4]. Although some studies have questioned the antinociceptive efficacy of B vitamins concomitantly administered with DCF [5,6], these compounds have been commercialised together in a number of formulations in different countries in the last decade.…”