Tramadol is a synthetic, opioid-like analgesic which is known to be a weak inhibitor of serotonin and noradrenaline reuptake and shows very low affinity for the ^-opioid receptors [85]. It has been found to be effective in the treatment of pain in diabetic neuropathy in two double-blind, placebo-controlled, randomized trials and its long-term pain-relieving properties were shown in a 6-month open-label extension study [86-88].

A multicenter randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of tramadol in CPDN consisted of a washout/screening phase, during which all analgesics were discontinued, and a 42-day double-blind treatment phase [86]. A total of 131 patients with CPDN were treated with tramadol four times daily (n = 65) or placebo (n = 66). The primary efficacy analysis compared the mean pain intensity scores in the tra-madol and placebo groups obtained at day 42 of the study or at the time of discontinuation. Tramadol, at an average dosage of 210 mg/day, was significantly (P < 0.001) more effective than placebo for treating the pain of diabetic neuropathy [86]. Patients in the tramadol group scored significantly better in physical (P = 0.02) and social functioning (P = 0.04) ratings than patients in the placebo group. The most frequently occurring adverse events with tramadol were nausea, constipation, headache, and somnolence [86].

In another randomized, double-blind, placebo-controlled and cross-over study, 45 patients (15 of whom had CPDN) were assigned to one of the two treatment sequences [88]. The dose of tramadol slow-release tablets was titrated to at least 200 mg/day and at the highest 400 mg/day. Thirty-four patients completed the study. Their ratings for pain (P = 0.001), paraesthesia (P = 0.001) and touch-evoked pain (P < 0.001) were lower on tramadol than on placebo, as were their ratings of allodynia (P = 0.012) [88].

A NNT of 3.1 has been calculated for the use of tramadol in the setting of CPDN [31].

If opioids are used as adjunctive therapy for neuropathic pain, they should be administered when other more established therapies such as antidepressants or antiepileptic drugs have been tried. Other partially effective treatments should be continued [79, 89, 90]. Regular review, use of opioids for a trial period and a definitive treatment plan are vital to increase the chances of success. Sustained-release opioids are recommended although immediate-release opioids can be used for breakthrough pain [89, 90].

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