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D M Simpson
Dr D M Simpson, Mount Sinai Medical Center, New York, NY, USA; david.simpson@mssm.edu
STUDY DESIGN
Design:
randomised controlled trial.
Allocation:
unclear concealment.*
Blinding:
blinded {patients and investigators}†.*
STUDY QUESTION
Setting:
30 centres in the USA.
Patients:
307 patients (mean age 48 y, 93% men) who had ⩾2 months of moderate to severe neuropathic pain in both feet (mean Numeric Pain Rating Scale [NPRS] screening score of 3–9) secondary to HIV-associated distal sensory polyneuropathy or neurotoxic antiretroviral treatment. Treatment dose had to be stable for ⩾8 weeks for current antiretroviral drugs and ⩾21 days for other pain medications. Exclusion criteria included use of topical analgesics; pain other than HIV-associated neuropathy; cardiac, renal, hepatic, or pulmonary function abnormalities; hypersensitivity to capsaicin or opioids; and use of ⩾60 mg morphine-equivalent. …
Footnotes
Source of funding: NeurogesX.