A Randomized Controlled Trial of a Nutrient Supplement in the Treatment of Fibromyalgia

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A Randomized Controlled Trial of a Nutrient Supplement in the Treatment of

Fibromyalgia

Category:  11 Soft tissue and regional musculoskeletal disease,

fibromyalgia

Presentation Time: Tuesday, 11:15 a.m. - 11:30 a.m.

Liam , Bonnie Kaplan, Crawford, Rhonda Kennedee

University of Calgary, Calgary, AB, Canada

Presentation Number: 1656

Keywords: Fibromyalgia, Nutrition, Treatment

The beneficial effects of a nutrient supplement called E.M.Power+ in the

management of fibromyalgia (FM) was reported in a recently published case

study ( & Kaplan, 1999). The supplement contains 36 ingredients:

minerals, vitamins, amino acids, and antioxidants. A randomized,

double-blind placebo-controlled trial was conducted to evaluate the

supplementŒs efficacy in the treatment of FM.

In total, 99 patients from the area, diagnosed with FM by ACR criteria,

participated in this clinical trial (7 males, 92 females; average age=51.5

years, SD=11.3). All patients signed an consent form. Exclusion criteria

included any known abnormalities of mineral metabolism, any serious

neurological disorders, and involvement in medico-legal proceedings related

to FM. Patient assessments which were completed pre-intervention, at 3

months, at 6 months and at 9 months into the study included the following:

the number of tender points and total myalgic score ; Fibromyalgia

Impact Questionnaire (FIQ), a Self Efficacy Scale (SEF), the CES-D

Depression Scale, a Quality of Life (QOL) measure, and the Illness

Intrusiveness Response Scale (IIRS). Patients were randomly assigned to

receive the active supplement (N=51) or the placebo (N=48). All patients

took 24 capsules of the supplements daily for 6 months, and were then

invited to participate in an open label extension for 3 more months. Fifty

of the patients continued in the open trial.

Results showed no significant group differences on any demographic or

illness-related variables at the pre-intervention assessment. There were 34

dropouts due primarily to gastrointestinal complaints such as loose stools

and diarrhea. No significant group differences emerged at any time during

the study for the FIQ (primary outcome measure), or for the SEF, CES-D, QOL,

or IIRS. No significant group differences emerged in the number of tender

points and the total myalgic score at pre-intervention, 3 months, 6 months

or 9 months: both groups of patients showed improvement over the course of

the trial. Despite these results, a significant group difference did emerge

for the change in the number of tender points from 6 to 9 months

(t(47)=2.21, p<.05), when both groups were taking the active supplement. The

number of tender points for patients in the active group decreased

significantly more than the number for those in the placebo group between 6

and 9 months. Similarly, there was a significant group difference for the

change in the tender point score from 6 to 9 months (t(47)=3.13, p<.05),

with the tender point score for patients in the active group decreasing

significantly more compared to those in the placebo group.

The results of this study argue against nutritional deficiencies being a

primary or important cause of FM.