Clinical effectiveness of evidence-based guidelines for pain management of terminal cancer patients in Japan

Background: The Japanese Society for Palliative Medicine (JSPM) set guidelines for cancer pain management in 1999. However, the clinical effectiveness of the guidelines has not yet been examined. Methods: Two groups of consecutive patients with cancer admitted to 37 national hospitals (collaborating hospitals for pain management research in Japan) were recruited, one from August to September 1999 (who received the standard treatment in use before the distribution of JSPM guidelines) and the other from July 2000 to May 2001 (who received treatment after the distribution of JSPM guidelines). Demographics, type of cancer and other baseline information were recorded for both groups. In addition, the intensity of pain (evaluated on a 4-level scale of none, mild, moderate, severe; and a visual analog scale of 0 to 100), its duration, source and location were recorded at base line, 1 week and 2 weeks after the start of pain management for two groups and compared by statistical methods. Results: A total of 314 cancer patients received the standard pre-guidelines treatment from August to September 1999 and 106 patients received the post-guidelines treatment from July 2000 to May 2001. No significant differences have been observed between the two groups in terms of baseline characteristics. There were more patients with lung cancer in the pre-guidelines treatment group and more with gastric cancer in the post-guidelines treatment group. More oral opioids (P=0.004) and more adjuvant drugs such as nonsteroidal anti-inflammatory drugs (P=0.001) and hydroxyzine (P=0.001) were used in the post-guidelines treatment group than in the pre-guidelines treatment group and the opposite was true for intravenous (P = 0.022) and suppository (P = 0.041) opioids. More patients in the post-guidelines treatment group became pain free after 2 weeks compared to those in the pre-guidelines treatment group (14.7% vs. 8.8%) (P = 0.036). Moreover, significantly fewer adverse reactions and more recovery from the adverse reactions which did occur were found in the post-guidelines treatment group than in the pre-guidelines treatment group. Conclusion: The implementation of JSPM pain management guidelines for cancer patients was effective in increasing the proportion of patients relieved of pain and in reducing adverse reactions to opioids.