Neuropathic Pain

 
 
 
 
The study by Gilron et al (2005) looked at neuropathic pain in patients with painful diabetic neuropathy and those with postherpetic neuralgia. They looked at the effects of gabapentin, morphine and a gabapentin-morphine combination compared to a placebo consisting of lorazepam, which does not cause pharmacological analgesia but mimics the adverse effects of the active treatments. The study used a randomized, double-blind, active placebo-controlled, four-period crossover trial, with patients receiving daily doses of active placebo, sustained-release morphine, gabapentin, or a combination of gabapentin and morphine, each given orally for five weeks.

The outcome measured was the mean daily pain intensity in patients while they were receiving the maximal tolerated dose of the drugs. Secondary outcomes measured were pain rated on the Short-Form McGill Pain Questionnaire, adverse effects of the drugs, maximal tolerated doses of each drug, mood changes, and quality of life estimates. A pharmacist prepared a concealed allocation schedule randomly assigning the four sequences, in blocks of four, to a consecutive series of numbers, and each consecutive patient was assigned the next consecutive number and their corresponding series of medications for the study were dispensed to them when they enrolled in the study.

To maintain the double-blind conditions of the study, the medications were placed in blue or gray gelatin capsules, with patients receiving identical blue and g


     
 
 
 
    

 

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ion Inventory on a scale of 0 to 63; health status using Medical Outcomes Study 36-Item Short-Form General Health Survey on a scale of 0 to 100; mental status using the Mini-Mental State Examination on a scale of 0 to 30; global pain relief assessed by the research nurse using the scale pain worse, no relief, slight relief, moderate relief, a lot of relief, and complete relief; and adverse effects of the drugs. The study found no significant main effects of either sequence or treatment period, but the effects of drug treatment (P<0.001) and carryover (P=0.04) were statistically significant. An analysis of all differences in pairwise carryover effects showed only that the effects of morphine are more likely to carry over more than those of placebo. Pain treated with the gabapentin-morphine combination was lower than that treated with morphine (P=0.04), gabapentin (P<0.001) or placebo (P<0.001). The combination gave a 20.4 percent greater pain reduction (P=0.03) than placebo. Mood interference was less with combination treatment than placebo (P<0.001) or morphine (P=0.03), and pain interference with social life was less with any treatment than with placebo. Combination treatment resulted in higher vitality (P=0.007) and socia

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