Posted by MERM on 1/26/2009, 9:25 am
EFFICACY OF TRAMADOL IN TREATMENT OF PAIN IN FIBROMYALGIA.
I. Jon Russell, Marc Kamin, Robert Bennett, Thomas Schnitzer, Jerry Green, Warren Katz.
An outpatient, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of tramadol in the treatment of the pain of fibromyalgia syndrome.
One hundred patients with fibromyalgia syndrome, (1990 American College of Rheumatology criteria) were enrolled into an open-label phase and treated with tramadol 50-400 mg/day.
Patients who tolerated tramadol and perceived benefit were randomized to treatment with tramadol or placebo in the double-blind phase. The primary efficacy outcome measurement was the time (days) to exit from the double-blind phase because of inadequate pain relief, which was reported as the cumulative probability of discontinuing treatment because of inadequate pain relief.
One hundred patients entered the open-label phase; 69% tolerated and achieved benefit with tramadol. These patients were then randomized to continue tramadol (n=35) or convert to a placebo (n=34) during a 6-week, double-blind treatment period.
The Kaplan-Meier estimate of cumulative probability of discontinuing the double blind period because of inadequate pain relief was significantly lower in the tramadol group compared with the placebo (p=0.0001). Twenty (57.1%) patients in the tramadol group successfully completed the entire double-blind phase compared with nine (27%) in the placebo group (p=0.15).
These results support the efficacy of tramadol over a period of 6-weeks in a double blind study for
the treatment of pain of fibromyalgia in a group of patients who had been determined to tolerate it and perceive benefit. Reference: Journal of Clinical Rheumatology 2000;6:250-257
OPIOID ANALGESICS IN FIBROMYALGIA-FOLLOW-UP STUDY OF EFFICACY AND PREDICTORS OF OUTCOMES.
Kip L. Kemple, Northwest Rehabilitation Network; Gregory T. Smith, Progressive Rehabilitation Association; Julia Wong-Ngan, Oregon Health Sciences University.
Theme: Arthritis and Rheumatic Pain While opioid analgesics have gained acceptance in the management of non-cancer pain, indications for their use in Fibromyalgia (FM) have not been defined. We have completed baseline and 12-24 month follow-up evaluations of 43 patients with FM enrolled in an opioid treatment protocol. Our goal was to study therapy selection patterns, efficacy and to evaluate whether specific pain or psychological profiles predict outcome.
Methods: All patients met ACR criteria for FM. Most patients were on low (#22) or moderate (#13) dose opioids at enrollment. They were allowed to adjust Rx according to pain severity, balanced with review of risks.
Evaluations included: pain scores (VAS), FIQ, MMPI, Beck or Zung Depression Index, McGill Pain Questionnaire, SF-36 and diagnostic interview including review of abuse history.
Results: Initial FM morbidity levels were high (SF-36 scores low and FIQs high). Opioid doses increased in 31 patients, decreased in 3 and were unchanged in 9. Mean dose at FU was 52 mg Morphine equiv/24 hr with mean increase of 26 mg Meq/24. Benefit was rated as "good" by 26 patients; "fair" by 16; and "poor" by 1. Measures of pain, fatigue, function and depression all improved modestly but changes were not significant. Since outcome changes were small, correlations with other predictive measures were difficult to assess. MMPI profiles did not correlate with pain or function, but improvement in function (FIQ) was significant (p<.05) in patients with abuse history. Affective and sensory pain descriptors (McGill) correlated with greater pain severity, higher FIQs, higher opioid doses and with less benefit (p<.05).
Conclusion: Pain in FM is complex. Response to opioids is variable. Evaluation of affective and sensory pain domains may help predict outcome. Disclosure: This project was supported in part by Purdue Pharma.
Addiction? Tolerance? Dependency? New stance on using pain drugs.
Three major medical societies, The American Academy of Pain Medicine (AAPM), the American Pain Society (APS), and the American Society of
Addiction Medicine (ASAM) have issued a joint consensus paper which clearly defines the frequently misunderstood terms addiction, tolerance,and physical dependence, and discusses their definitions in the context of opioid use in the treatment of pain.
"The addiction community was concerned because of inaccurate diagnosis. The pain community was concerned about over-diagnosis of addiction when it didn't exist, and how this misdiagnosis interfered with treatment with opioids," said Edward Covington, MD, Director of the Chronic Pain
Rehabilitation Program at the Cleveland Clinic and past president of AAPM, who was one of the paper's authors. "Also we needed agreement about what is and what is not an addictive disorder."
Dr. Covington noted that addiction a primary, chronic, neurobiologicdisease can be identified by the three "Cs" Craving or Compulsive use,loss of Control, and use despite adverse Consequences.
Other behaviors that signal addiction include "drug seeking" behavior, taking multiple doses of medications, and an inability to take them on
schedule, "doctor shopping," frequent reports of lost or stolen prescriptions, isolation from friends and family members, and taking pain
medications for sedation, increased energy, or to get "high."
Physical dependence and tolerance are often confused with addiction.
According to the consensus paper definitions, both of these are normalresponses to regular use of some prescribed medications, including opioids,and are not in themselves evidence of an addictive disorder.
"Unlike tolerance and physical dependence, addiction is not a predictable effect of [taking] a drug but an adverse reaction in biologically and psychosocially vulnerable individuals."
It is also important for healthcare professionals to recognize the difference between true addiction and "pseudoaddiction," notes Albert Ray, MD, President of AAPM.
With pseudoaddiction, patients whose pain is undertreated appear to behave "like addicts" to get the pain relief they need. They may focus on getting more medication, for example, and appear to be engaging in drug-seeking behavior. But unlike a person with a true addictive disorder, however, once their pain is properly managed, these behaviors stop immediately." (The Pain Connection. Spring 2001; 1-4.)wellnesstrainresearch
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