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Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.

Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study.

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1
Centro Universit√°rio Serra dos Org√£os (UNIFESO), Rio de Janeiro, Brazil.

Abstract

OBJECTIVES:

To assess the influence of vitamins B1, B6 and B12 on the analgesia success achieved by diclofenac in subjects with acute lumbago.

RESEARCH DESIGN AND METHODS:

A randomised, double blind controlled clinical study in parallel groups, in which subjects received twice-daily oral administration of either the combination therapy, Group DB (50 mg diclofenac plus 50 mg thiamine, 50 mg pyridoxine and 1 mg cyanocobalamin) or diclofenac monotherapy, Group D (50mg diclofenac). The study period lasted a maximum of 7 days. If sufficient pain reduction was achieved (defined as Visual Analogue Scale <20 mm and patient's satisfaction), subjects could withdraw from the treatment after 3 or 5 days. All subjects gave written informed consent to participate in the study.

MAIN OUTCOME MEASURES:

The primary confirmatory study objective was to determine the number of patients with sufficient pain reduction after 3 days of treatment.

RESULTS:

Three hundred and seventy-two subjects were allocated at random to either treatment group: Group DB - 187 subjects and Group D - 185 subjects. After 3 days of treatment, a statistically significant higher proportion of subjects in Group DB (n = 87; 46.5%) than in Group D (n = 55; 29%) terminated the study due to treatment success (chi(2): 12.06; p = 0.0005). Furthermore, the combination therapy yielded superior results in pain reduction, improvement of mobility and functionality. Drug safety monitoring profile throughout the trial was within the expected safety profile of diclofenac.

CONCLUSIONS:

The combination of diclofenac with B vitamins was superior to diclofenac monotherapy in lumbago relief after 3 days of treatment. As a study drawback, daily VAS measurements were only recorded until subject withdrawal from treatment, whether after 3, 5, or 7 days. There were no differences in safety profile between the two study groups.

PMID:
19731994
DOI:
10.3111/13696990903246911
[Indexed for MEDLINE]

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