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In Reply:

Department of Anesthesia and Division of Clinical Care Research, New England Medical Center and Tufts University School of Medicine, Boston, MA

We wish to thank Dr Mercadante for his generous comments regarding our paper.¹ We agree with many of the arguments he made. The first of the papers to which he refers² was an intriguing naturalistic study, which unlike many of the studies in our review, followed patients over a prolonged period of time. By combining an NSAID with an opioid, one should hope to achieve a reduction in the dose of opioid required to control pain, a reduction in adverse effects, or both. Although the study demonstrated a significant reduction in the maximum dose of morphine required to adequately control patients' pain, the combination group suffered a comparable incidence and severity of adverse events, and similar worsening of symptoms. Therefore, it was not possible to ascertain whether the addition of ketorolac actually produced a synergistic combination with morphine. In addition, the authors presented data in a format that did not enable us to calculate average morphine doses for any time period.

Dr Mercadante illustrates contrasting NSAID-prescribing patterns between Europe and the United States. The use of oral ketorolac for prolonged periods of time is restricted in both the United Kingdom and the United States to 7 and 5 days, respectively, because of its adverse-event profile. Although this was not sufficient reason to exclude his study, this limits the generalizability of the papers' findings. The study enrolled sufficient patients to demonstrate a significant difference in morphine requirements, but as was the case with many of the studies in our review, the study might have recruited insufficient numbers to demonstrate significant differences in adverse-event profiles, or to highlight less common but more serious adverse events, such as gastrointestinal bleeding or renal failure.

The second study to which Dr Mercadante referred³ was not a randomized controlled trial, so though its findings on the types of pain which respond favorably to NSAIDs are noteworthy, it did not meet our inclusion criteria.

Both of the valuable studies Dr Mercadante mentioned attempt to address many of the deficiencies of pain studies, in particular, deficiencies of insufficient trial duration and heterogeneity of pain etiology. Larger, randomized trials of similar style, with NSAIDs commonly used for prolonged periods, will hopefully better address the questions that we and Dr Mercadante both wish were answered.

Authors' Disclosures of Potential Conflicts of Interest

The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Employment: Daniel B. Carr, Innovative Drug Delivery Systems Inc. Leadership Position: Daniel B. Carr, QRx Pharma, Accugenics. Consultant: Daniel B. Carr, QRx Pharma. Stock Ownership: Daniel B. Carr, QRx Pharma, Accugenics. Honoraria: Daniel B. Carr, Johnson & Johnson, Eli Lilly, Mallinckrodt, Purdue, Abbott, FNDO, Merck, Pfizer. For a detailed description of these categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section of Information for Contributors found in the front of every issue.

REFERENCES

1. McNicol E, Strassels S, Goudas L, et al: Nonsteroidal anti-inflammatory drugs, alone or combined with opioids, for cancer pain: A systematic review. J Clin Oncol 22:1975-1992, 2004[Abstract/Free Full Text]

2. Mercadante S, Fulfaro F, Casuccio A: A randomized controlled study on the use of anti-inflammatory drugs in patients with cancer pain on morphine therapy: Effects on dose-escalation and a pharmacoeconomic analysis. Eur J Cancer 38:1358-1363, 2002

3. Mercadante S, Casuccio A, Agnello A, et al: Analgesic effects of nonsteroidal anti-inflammatory drugs in cancer pain due to somatic or visceral mechanism. J Pain Symptom Manage 17:351-356, 1999[CrossRef][Medline]

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