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Less opiates does not mean more pain!
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PHOENIX, Arizona — Patients receiving high doses of opioids show no worsening of pain scores or aberrant drug behaviors after significant dose reductions compared with patients who do not have dose reductions, a new study suggests.
"Despite significant reductions in their opioid doses and the fact that doses were often actually increased in the control group, the outcomes in areas of perceived functionality and aberrant behaviors were no different between the 2 groups," said lead author David J. DiBenedetto, MD, an anesthesiologist with the Boston Pain Care Center in Waltham, Massachusetts.
The new findings were presented here at the American Academy of Pain Medicine (AAPM) 35th Annual Meeting.
High-Dose Patients
For the study, Dr. DiBenedetto and his colleagues evaluated 60 high-dose patients undergoing dose reduction treatment at the center over 12 months, between September 2012 and August 2013.
The high-dose patients had starting opioid doses of 200 or more in morphine equivalents (MEQ) per day. The patients were compared with 49 other randomly selected patients who were not undergoing dose reduction.
The average starting opioid dose in the high-dose group was 508 MEQ and the ending dose after 12 months was 305 MEQ, for an average 40% reduction. In the control group, the average starting dose was 105 MEQ and the average ending dose was 203 MEQ, for an average increase of 100%.
In the high-dose group, the functional pain scores according to the Matheson Functional Pain Scale (with scores ranging from 1 to 10) were 6 of 10 at the study's start and 5.4 of 10 at the end; scores in the control group were 6 of 10 at the beginning and 5.3 of 10 at the end.
Dr. David J. DiBenedetto
Perceived functional ability scores, obtained by using the Roland Morris Disability Index, were 9.7 at the beginning and 9.8 at the end in the high-dose group, compared with 12 and 12.6, respectively, in the control group.
The researchers also compared the 10 patients with the highest starting doses in both groups, averaging 1258 MEQ in the high-dose group and 239 MEQ in the control group. They found no significant differences in pain scores or perceived functional ability values at the end of the study.
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"[What's] impressive to me is the fact that these conclusions are drawn not from independent, objective functional observations, which would be more likely to yield negative outcomes regarding benefit from opioid treatment, but rather from the subjective reports obtained from patients taking and by and large wanting to remain on opioid medication treatment," Dr. DiBenedetto toldMedscape Medical News.
Measures of patients' aberrant behaviors, determined with urine drug test screenings, were even lower in the high-dose group (5 of 60 [80%]) than in the control group (7 of 49 [14%]).
With patients sometimes coming in on doses of morphine as high as 3000 mg per day, Dr. DiBenedetto said the pressure is on to reduce their doses, but questions persist regarding how the dose reduction will affect the patient.
"The question we have had is whether the patient will be any worse off with dose reduction in terms of pain, functionality, or wellness," he said.
"But in comparing the patients with others who were just being managed and often times their opioid doses in fact increasing, we found that, consistently, there wasn't any difference between the 2 groups."
"Despite significant reductions in their opioid doses and the fact that doses were often actually increased in the control group, the outcomes in areas of perceived functionality and aberrant behaviors were no different between the 2 groups," said lead author David J. DiBenedetto, MD, an anesthesiologist with the Boston Pain Care Center in Waltham, Massachusetts.
The new findings were presented here at the American Academy of Pain Medicine (AAPM) 35th Annual Meeting.
High-Dose Patients
For the study, Dr. DiBenedetto and his colleagues evaluated 60 high-dose patients undergoing dose reduction treatment at the center over 12 months, between September 2012 and August 2013.
The high-dose patients had starting opioid doses of 200 or more in morphine equivalents (MEQ) per day. The patients were compared with 49 other randomly selected patients who were not undergoing dose reduction.
The average starting opioid dose in the high-dose group was 508 MEQ and the ending dose after 12 months was 305 MEQ, for an average 40% reduction. In the control group, the average starting dose was 105 MEQ and the average ending dose was 203 MEQ, for an average increase of 100%.
In the high-dose group, the functional pain scores according to the Matheson Functional Pain Scale (with scores ranging from 1 to 10) were 6 of 10 at the study's start and 5.4 of 10 at the end; scores in the control group were 6 of 10 at the beginning and 5.3 of 10 at the end.
Dr. David J. DiBenedetto
Perceived functional ability scores, obtained by using the Roland Morris Disability Index, were 9.7 at the beginning and 9.8 at the end in the high-dose group, compared with 12 and 12.6, respectively, in the control group.
The researchers also compared the 10 patients with the highest starting doses in both groups, averaging 1258 MEQ in the high-dose group and 239 MEQ in the control group. They found no significant differences in pain scores or perceived functional ability values at the end of the study.
Relief of opioid-induced constipation (OIC) when laxatives are insufficient
A treatment option for your patients with advanced illness.
View the MOA
REL 13/11
Information from Industry
"[What's] impressive to me is the fact that these conclusions are drawn not from independent, objective functional observations, which would be more likely to yield negative outcomes regarding benefit from opioid treatment, but rather from the subjective reports obtained from patients taking and by and large wanting to remain on opioid medication treatment," Dr. DiBenedetto toldMedscape Medical News.
Measures of patients' aberrant behaviors, determined with urine drug test screenings, were even lower in the high-dose group (5 of 60 [80%]) than in the control group (7 of 49 [14%]).
With patients sometimes coming in on doses of morphine as high as 3000 mg per day, Dr. DiBenedetto said the pressure is on to reduce their doses, but questions persist regarding how the dose reduction will affect the patient.
"The question we have had is whether the patient will be any worse off with dose reduction in terms of pain, functionality, or wellness," he said.
"But in comparing the patients with others who were just being managed and often times their opioid doses in fact increasing, we found that, consistently, there wasn't any difference between the 2 groups."
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"And it was the same with aberrant behaviors — despite the fact that the patients dropped their dose by as much as 200 mg per day, they weren't abusing their medications or taking other people's medications any more frequently than those whose medications increased."
While pain did not significantly improve, other aspects of the patients' lives did change as a result of the dose reduction, Dr. DiBenedetto said.
"They may have been better pain-wise — in fact they usually aren't, but their mood and their motivation to actually do things in life did improve — we see that things like seeking a job and interacting with family and socially vastly improves with dose reduction," he said. "We have yet to see anyone come down and be worse off afterwards."
Dr. DiBenedetto noted that the aim of the line of research isn't necessarily to push for the avoidance of opioids altogether but to better understand when they are most suitable — and necessary.
"I believe that opioid treatment, like many pain related treatments, is helpful in improving both function and quality of life in a subset of pain patients at reasonable doses," he asserted.
"While there is data in the pain literature indicating the characteristics of patients at 'high risk' vs 'low risk' for receiving opioid treatment, less is known about what characteristics, ie, pathophysiology, genetics, functional status, behavioral/ psychological/social features, correlate with a better chance of responding to opioid treatment, and even less is known about what constitutes a 'reasonable' dose of opioid medication."
A Common Observation
In commenting on the study, pain specialist Forest Tennant, MD, from the Veract Intractable Pain Clinic in West Covina, California, said he didn't find the results surprising, and agreed that more data are needed on specific patient characteristics to better determine the true effects of opioid dosing and reduction.
"What they've done is document a common observation, which is always worthwhile," he told Medscape Medical News. "This is not new information, but they've documented it in a nice way."
"The criticism of the study is that the measures are not objective," he added. "Other measures to consider include issues such as serum blood levels, physiological function, sleep length, and how much time was there between flare-ups, so there were a lot of things that weren't measured, aside from the pain scores."
There is an inhumanity to forcing people down — you need to reduce opioids slowly over time.Dr. Forest Tennant
As clinicians grapple to balance effective management of pain with concerns of opioid overuse, it's important that the patient's needs are the bottom line, he emphasized.
"You hate to see anyone on any opioids at all, particularly a long-acting one, because the endocrine complications from being on these are really profound, so you have to try to bring them down from high doses."
"Having said that, there is an inhumanity to forcing people down — you need to reduce opioids slowly over time."
Dr. DiBenedetto and Dr. Tennant have disclosed no relevant financial relationships.
American Academy of Pain Medicine (AAPM) 30th Annual Meeting. Abstract 165. Presented March 8, 2014.
While pain did not significantly improve, other aspects of the patients' lives did change as a result of the dose reduction, Dr. DiBenedetto said.
"They may have been better pain-wise — in fact they usually aren't, but their mood and their motivation to actually do things in life did improve — we see that things like seeking a job and interacting with family and socially vastly improves with dose reduction," he said. "We have yet to see anyone come down and be worse off afterwards."
Dr. DiBenedetto noted that the aim of the line of research isn't necessarily to push for the avoidance of opioids altogether but to better understand when they are most suitable — and necessary.
"I believe that opioid treatment, like many pain related treatments, is helpful in improving both function and quality of life in a subset of pain patients at reasonable doses," he asserted.
"While there is data in the pain literature indicating the characteristics of patients at 'high risk' vs 'low risk' for receiving opioid treatment, less is known about what characteristics, ie, pathophysiology, genetics, functional status, behavioral/ psychological/social features, correlate with a better chance of responding to opioid treatment, and even less is known about what constitutes a 'reasonable' dose of opioid medication."
A Common Observation
In commenting on the study, pain specialist Forest Tennant, MD, from the Veract Intractable Pain Clinic in West Covina, California, said he didn't find the results surprising, and agreed that more data are needed on specific patient characteristics to better determine the true effects of opioid dosing and reduction.
"What they've done is document a common observation, which is always worthwhile," he told Medscape Medical News. "This is not new information, but they've documented it in a nice way."
"The criticism of the study is that the measures are not objective," he added. "Other measures to consider include issues such as serum blood levels, physiological function, sleep length, and how much time was there between flare-ups, so there were a lot of things that weren't measured, aside from the pain scores."
There is an inhumanity to forcing people down — you need to reduce opioids slowly over time.Dr. Forest Tennant
As clinicians grapple to balance effective management of pain with concerns of opioid overuse, it's important that the patient's needs are the bottom line, he emphasized.
"You hate to see anyone on any opioids at all, particularly a long-acting one, because the endocrine complications from being on these are really profound, so you have to try to bring them down from high doses."
"Having said that, there is an inhumanity to forcing people down — you need to reduce opioids slowly over time."
Dr. DiBenedetto and Dr. Tennant have disclosed no relevant financial relationships.
American Academy of Pain Medicine (AAPM) 30th Annual Meeting. Abstract 165. Presented March 8, 2014.
