Tramadol in post-herpetic neuralgia: a randomized, double-blind, placebo-controlled trial

Abstract

The efficacy and safety of sustained-release tramadol compared to placebo in the treatment of post-herpetic neuralgia were evaluated in a multicenter, randomized, double-blind, parallel-group study in 127 outpatients. Treatment was administrated for 6 weeks. The dose of tramadol could be increased from 100 mg/day to 400 mg/day (300 mg/day in patients more than 75 years old). Groups were compared on changes in pain intensity on a Visual Analogue Scale (VAS) between inclusion and the 6th week of treatment (covariance analysis as main analysis and repeated measures analysis as complementary analysis) in the per protocol (PP) population. The randomized population comprised 127 patients aged 35-85 years, mostly females (72.4%). Groups were comparable at inclusion both in the intent to treat (ITT) population (63 patients in the tramadol group and 62 patients in the placebo group) and in the PP population (53 patients in the tramadol group and 55 patients in the placebo group). Mean pain intensity on day 43 adjusted on day 1 (covariance analysis) was significantly lower in the tramadol group than in the placebo group in both the PP (P=0.0499), and the ITT (P=0.031) populations. The two groups significantly differed on change in pain intensity over time (repeated measures analysis) in the ITT population (P=0.012). The percentage of pain relief over the 6th week was significantly higher in the tramadol group than in the placebo group (P=0.017). During the 6th week, patients in the tramadol group required less rescue medication than patients in the placebo group (P=0.022). No significant difference was found between groups either in pain intensity on a 5-point Verbal Scale (VRS) or in quality of life measurements. Tramadol was administered at an average dosage of 275.5 (89.7) mg/day after a 1-week dose-adaptation period. Tramadol was well tolerated. No notable difference appeared between groups either in the percentage of patients with treatment-associated adverse events (TAAE) (29.7% in the tramadol group and 31.8% in the placebo group) or in the total number of TAAE (31 in the tramadol group and 28 in the placebo group).

Practice Parameter: Treatment of postherpetic neuralgia: [RETIRED]

“…25 A greater than 50% reduction in pain was reported for 49/63 subjects on tramadol compared to 35/62 on placebo. (NNT ϭ 4.7, 95% CI 2.9 to 19.…”

“…Five of 12 articles on use of opioids in postherpetic neuralgia met inclusion criteria. Of these, one class I 13 and two class II 17,25 are discussed further. A 50% decrease in the VAS was reported for 22 of 38 subjects who completed a double-blind, placebo-controlled, two way crossover study of controlled release oxycodone (class II, ARR ϭ 65%, NNT ϭ 2.5, 95% CI 1.7 to 5.1).…”

Zoster-Associated Pain and Post Herpetic Neuralgia

“…A recent randomized placebo-controlled trial compared the effectiveness of oxycodone and gabapentin in reducing acute pain, showing that oxycodone provided a greater pain relief (Dworkin et al, 2009). Tramadol, however, is effective in the treatment of PHN, but its efficacy in the treatment of acute herpetic pain has not been evaluated (Boureau et al, 2003).…”

Postherpetic Neuralgia: From Preclinical Models to the Clinic

“…105 A RCT of tramadol indicated that 6 weeks of sustained release resulted in reduced pain and improved quality of life. 106 Overall, the evidence indicates that PHN pain may respond to opioid therapy, with titration of the dose required to achieve optimum efficacy and to minimize adverse effects. Constipation, nausea, and sedation are among the common adverse effects associated with opioid therapy; prophylactic treatment of nausea or constipation is often necessary, and can improve patient compliance.…”