93201
document
Mexiletine for HIV-infected patients with painful peripheral neuropathy : a double-blind , placebo-controlled , crossover treatment trial . Although mexiletine , an antiarrhythmic with local anesthetic properties , has been reported to relieve discomfort in diabetic neuropathy , its usefulness in the treatment of HIV-related painful peripheral neuropathy ( PPN ) has not been determined . The tolerance and effectiveness of mexiletine in HIV-related PPN were assessed in 22 patients who were randomized to receive mexiletine ( maximum dose , 600 mg/day ) or placebo for 6 weeks , followed by the alternative intervention for 6 weeks after a 1-week washout period . The daily pain response was assessed using a visual analogue scale card in 19 patients who received at least 2 weeks of the drug , 16 of whom were crossed-over to receive the alternate agent . No statistically significant difference was found between the mean daily pain scores for patients receiving mexiletine versus placebo , irrespective of the order in which the agents were received . Comparing the mean individual daily pain scores for each phase of study , 5 patients ( 31 % ) had significantly less pain while receiving mexiletine compared with their response to placebo , 5 patients ( 31 % ) had significantly less pain while receiving placebo , and no difference was noted in 6 patients ( 38 % ) . Crossover and multivariate analyses for repeated measures showed no apparent difference in the response to mexiletine versus placebo . Dose-limiting adverse events occurred in 39 % of those receiving mexiletine , but only 1 patient ( 5 % ) discontinued placebo . Mexiletine was only modestly well tolerated despite its relatively brief period of administration , and no evidence was found to support its benefit in HIV-related PPN . Although a first-drug effect was not demonstrated , a powerful placebo effect was seen in some patients .
93202
Intervention_Pharmacological
Mexiletine
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Intervention_Pharmacological
mexiletine
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Intervention_Pharmacological
mexiletine
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Intervention_Pharmacological
mexiletine ( maximum dose , 600 mg/day )
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Intervention_Control
placebo
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Intervention_Pharmacological
followed by the alternative intervention
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Intervention_Pharmacological
mexiletine
93209
Intervention_Pharmacological
mexiletine
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Intervention_Pharmacological
placebo
93211
Intervention_Pharmacological
placebo
93212
Intervention_Pharmacological
mexiletine
93213
Intervention_Pharmacological
placebo
93214
Intervention_Pharmacological
mexiletine
93215
Intervention_Pharmacological
placebo
93216
Intervention_Pharmacological
Mexiletine
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Outcome_Other
tolerance and effectiveness
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Outcome_Physical
daily pain response was assessed using a visual analogue scale card
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Outcome_Pain
mean daily pain scores
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Outcome_Pain
mean individual daily pain scores
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Outcome_Other
Crossover and multivariate analyses
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Outcome_Adverse-effects
Dose-limiting adverse events
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Participant_Condition
HIV-infected
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Participant_Condition
painful peripheral neuropathy
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Participant_Condition
HIV-related painful peripheral neuropathy ( PPN
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Participant_Sample-size
22
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Participant_Sample-size
19
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Participant_Sample-size
16