[Study of codeine-paracetamol combination treatment compared with tramadol-paracetamol in the control of moderate-to-severe low back pain]. / Associazione codeina-paracetamolo e tramadolo-paracetamolo nel controllo del dolore lombare moderato-severo.

AIM: The objective of this study was to compare the analgesic efficacy and tolerability of tramadol hydrochloride compared with codeine phosphate in combination with paracetamol in patients with moderate-to-severe low back pain caused by osteoarthritis. In fact, while paracetamol is the analgesic of choice for this disease, in cases where this treatment may be ineffective, the therapeutic choice involves the addition of weak opioids. Due to the chronic nature of the disease, these drugs represent a safer alternative compared to anti-inflammatory drugs (NSAIDs) and selective inhibitors of cyclooxygenase 2 (COX-2). METHODS: In the present study two combination treatments were considered: codeine-paracetamol (respectively 30 mg and 500 mg) and tramadol-paracetamol (respectively 37.5 mg and 325 mg). The study duration was 4 weeks and involved 38 patients (mean age 64.7 years). The effectiveness of the two treatments was assessed in terms of analgesic efficacy, tolerability and safety. RESULTS: The results recorded after a week of treatment and at the end of the study showed a difference in favour of codeine-paracetamol association which showed slightly higher values ​​in pain improvement and, above all, was better tolerated in terms of adverse events and drop out. CONCLUSION: The study, although conducted on a limited number of patients and for a relatively short time, demonstrates the greater efficacy and tolerability of the association codeine-paracetamol compared to tramadol-paracetamol.