Proposed Guidelines Would Exclude Most Headache Patients from Sustained Opioid Therapy

BY JANE SALODOF MACNEIL
Elsevier Global Medical News

SCOTTSDALE, ARIZ. (EGMN) NOV. 11, 2006 - Sustained opioid therapy should only be prescribed for chronic headache patients under stringent new guidelines that would exclude most headache patients, Dr. Joel R. Saper proposed today at an American Headache Society symposium.

Dr. Saper, founder and director of the Michigan Head, Pain and Neurological Institute in Ann Arbor, Michigan, said his group revisited the outcomes of a 5-year observational study of 160 patients on daily opioid therapy for intractable headaches and found even fewer people benefited over time than had been reported in the original published manuscript (Neurology, 2004;62:1687-1694).

Instead of 26% cutting their pain by one-half or more as a result of opioid therapy, Dr. Saper said "no more than 15% of those patients did well." He attributed the over-estimate to "a significant disconnect between objective markers and patient perception."

Patients were less than honest about their analgesia use, he said. Even though the program was tightly controlled, he added, the investigators determined that non-compliance was high and about half the patients had continuing increases in their opioid doses.

Further, a more recent study, he continued, reveals that a majority of patients on opioid therapy have behavioral disturbances.

Dr. Saper and his colleagues reviewed 267 consecutively admitted patients, of whom 76% were discharged with moderate to significant pain control. Opioid use was highest in patients with borderline, narcissistic, and antisocial personality disorders as defined under Axis II, Cluster B of the Diagnostic and Statistical Manual of Mental Disorders IV.

"Headache patients who obtain opioids are different," he said, describing them as being more likely to have Axis II disorders and, in many cases, unwilling or unable to stop taking opioids even if their headaches do not lessen with therapy. Some patients, he added, use the prescribed opioid as a medication for something other than pain, for example, relief of anxiety.

"Opioids make borderline patients angrier and more combative," warned Dr. Saper.

In many cases, he acknowledged, physicians prescribe opioids against their better judgement. "I believe that the behavior of the patient more than the pain itself often drives the doctor to give them opioids, if nothing else, to simply quiet them down," he said.

To help physicians say "no" to such patients, Dr. Saper offered conservative guidelines that he developed in collaboration with Alvin E. Lake, Ph.D. (Headache Currents 2006;3:67-70).

Headache patients would have to meet all four of the following criteria to be eligible for opioid therapy:

1. Older than age 50.
2. Convincing moderate-to-severe pain occurring daily or almost daily with recognizable impairment.
3. Visited the physician at least four times over 3 months to ensure familiarity before the first opioid prescription is written.
4. A history of being compliant and trustworthy in use of medication.

In addition, Dr. Saper said, patients must meet one or more of the following criteria: (1) a history of failing to respond to multiple appropriate treatments, (2) pregnancy threatened by headache, or (3) significant confounding disease or treatment that aggravates headache or limits treatment.

Moreover, he said, chronic headache patients should be disqualified from receiving opioid therapy if they have a moderate-to-severe Axis I diagnosis, past or current addictive disease (with the exception of a "non-drinking rehabilitated alcoholic"), any Axis II, Cluster B personality disorder, or moderate-to-severe somatoform or histrionic features.

Finally, opioid-treated patients must be seen frequently to assure they are not abusing their medication. "If you start them, you had better be willing and able to monitor and stop them," he advised.

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