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

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

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.

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

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.

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.