The main objective of this multicentric study was to compare the effects of two posologic schemes on the safety profile of slow-release tramadol in patients with non-oncological chronic pain. One hundred, eighty nine patients aged between 14 and 75 years were enrolled and divided in two groups at random : group A, with 96 and group B with 93 patients which received the study medication for 15 days. Group A received an initial dose of slow release tramadol of 50mg twice a day for 3 to 7 days, and then using 100mg twice a day until day 15. Group B received a standard dose of slow release tramadol 100mg bid during the study period. The parameters analised were: type of non-oncological chronic pain, intensity of pain assessed by means of a Visual Analogue Scale, the compliance to the prescribed treatment, requirement of rescue medication, adverse events, global assessment of efficacy by the investigators and patients as well as global assessment of tolerability by the investigators and patients. Musculoeskeletal pain, defined as muscular pain and its bone insertions, was the most frequent type in group A ( 45.8%) while osteoarticular pain was the most observed in group B ( 47.3%). A significant relief of the intensity of pain was shown within both groups and when compared with each other ( 67% decrease). The treatment prescribed was followed by 77.1% of the patients in Group A and by 75.3% of the patients in group B, showing that there was no significant statistical difference between groups. Both groups were similar regarding rescue medication required, whereas only 9.7% of the group A patients and 15.1% in group B needed it. Both groups had similar frequency of adverse events: 30.2% in group A and 36.6% in group B. Patients which received a daily dose of 200mg at the end of the study had their global efficacy assessed as good and excellent by the investigators in 86.7% in group A and 78.8% in group B. In group A, 88.9% of the patients considered the global assessment of efficacy as good and excellent and in group B, 78.8% of them did. Tolerability of the drug was considered good and excellent by the patients in group A in 86% and in group B the result was of 77,2%. In conclusion, both treatment groups were statistically similar regarding all assessed parameters, except for pain intensity, which was formerly higher in group B, and becoming equivalent in both groups at the end of the study. There was a favorable tendency, however non-significant, towards the titration dose group.
Chronicpain; Opiates; Tramadol
