Cymbalta shows modest effect on FIQ scores

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Quick Look

Does treatment with Cymbalta lower FIQ scores?

Science: Yes, treatment with Cymbalta reduced FIQ scores by a statistically significant 5.53 points vs placebo. It did not, however, significantly improve individual scores for pain, fatigue, tiredness on awakening or stiffness.

Conclusion: Cymbalta provides modest but significant benefit in reducing the impact of fibromyalgia.

 

Cymbalta modestly improves total FIQ scores.

Picture of cymbalta medicationJust over 200 subjects were enrolled in a 12 week placebo-controlled trial of Cymbalta (duloxetine.) Just under 90% were female and 38% had a concurrent diagnosis of major depression.

Approximately half the trial participants received a placebo, while the remaining half received duloxetine 60 mg twice a day.

The co-primary outcome measures in this trial (referenced below) were the Fibromyalgia Impact Questionnaire (FIQ) total score and the FIQ pain score.

After 12 weeks the total FIQ score had decreased by just under 13.5 points for those using Cymbalta, and by just under 8 points for those receiving placebo. The difference between those receiving placebo vs those receiving Cymbalta was a statistically significant 5.53 points.

Since the initial average FIQ score for those receiving Cymbalta was 48.7, this represents a net therapeutic benefit of approximately 11.4%.

Cymbalta use did not improve FIQ scores for pain, fatigue, tiredness on awakening, or stiffness.

The Fibromyalgia Impact Questionnaire includes individual questions to assess pain, fatigue, tiredness on awakening and stiffness.

Treatment with Cymbalta for 12 weeks did not result in any significant improvement vs placebo in any of these individual scores.

Of interest, the 12 males enrolled in the active treatment arm showed no significant improvement on Cymbalta.

 

2004

A double-blind, multi-center trial comparing duloxetine (Cymbalta) with placebo in the treatment of fibromyalgia patients with or without major depressive disorder.

Summary of the Abstract

This study was a randomized, double-blind, placebo-controlled trial. A total of 207 subjects meeting the American College of Rheumatology criteria for primary fibromyalgia were enrolled (89% female, 87% white, mean age 49 years, 38% with current major depressive disorder).

Subjects were randomly assigned to receive duloxetine 60 mg twice a day or placebo for 12 weeks. Co-primary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) total score and FIQ pain score.

Duloxetine-treated subjects improved significantly more on the FIQ total score, with a treatment difference of -5.53, but not significantly more on the FIQ pain score.


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