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Intrathecal Ziconotide for Chronic Pain—Reply
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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In Reply: In response to Drs Bonicalzi and Canavero, we acknowledge that our short trial cannot be considered the sole method of validating the long-term efficacy of intrathecal ziconotide. Our design, however, provided sufficient time to determine that ziconotide provided effective pain relief with minimal adverse effects and to offer our participants continued pain management using the novel agent in a second, open-label, compassionate trial, during which we continued to collect safety and efficacy data.
Regarding masking, each patient and investigator was blinded on first exposure to the drug. If there was no analgesia the drug (or placebo) was titrated upwards. However, it is true that with the classic double-blinded placebo-controlled trial, astute patients and investigators can sometimes guess if they are in the active treatment group. Future clinical trials may benefit from double-blinded/double-dummy designs with active placebos.
Bonicalzi and Canavero also claim that the risk of infection should have . . . [Full Text of this Article]
Peter S. Staats, MD
pstaats@jhmi.edu
Division of Pain Medicine
Johns Hopkins University School of Medicine
Baltimore, Md
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