No benefit from nutrient supplement in fibromyalgia

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Nov 27, 2002

No benefit from nutrient supplement in fibromyalgia

New Orleans, LA - A randomized clinical trial in 99 patients with

fibromyalgia found that a nutrient supplement had no significant effects on

any measure of the disease when compared with placebo [1]. When Dr Liam

(University of Calgary, AB) presented the results at the recent

meeting of the American College of Rheumatology, a fellow clinician in the

audience described the trialthe first of its kind in fibromyalgiaas " a very

courageous study. "

explained that his team was prompted to conduct the study after

several anecdotal reports from patients. He published details of 1 rather

inspiring case report in 1999 [2], and subsequently, 3 further patients with

fibromyalgia reported that they, too, felt greatly improved after taking the

supplement. The product, EM Power, contains 36 ingredients, mostly vitamins

and minerals, plus amino acids and antioxidants [3]. Made by Evince

International Inc, the supplement is distributed by a nonprofit company,

Truehope Nutritional Support Ltd, which promotes its use for bipolar

disorder (manic depression).

Publicity for its beneficial effects in bipolar disorder

Use of EM Power in bipolar disorder has received considerable publicity in

the Canadian lay press, particularly after publication in December 2001 of a

positive study [4], also conducted by researchers from the University of

Calgary, accompanied by a favorable commentary from a Harvard psychiatrist.

The product itself was developed by an animal feed specialist, Hardy,

and is based on a product that is used in farmed pigs when they become

agitated and aggressive and develop an ear-and-tail-biting syndrome. The

idea of trying it in manic depression came to him after hearing from a

friend, Stephan, how the illness was devastating his family. Stephan

had already lost his wife through suicide, and the disorder was now

affecting 2 of his children, who were deteriorating despite treatment with

psychiatric medication. Amazed at the beneficial effect the supplement had

on the children, Hardy and Stephan, both Mormons, created the nonprofit

organization, Truehope, to publicize their " discovery. " They also approached

the medical community and were directed to Calgary University, to Dr Bonnie

Kaplan. A psychologist with a background in nutrition research, Kaplan

headed the bipolar disorder trial and was also involved in the fibromyalgia

study.

However, the 2 trials had quite different results: while the bipolar studyan

open-label trial in 11 patientsyielded remarkably positive results, the

controlled trial in 99 fibromyalgia patients was resoundingly negative.

reported that after 6 months of taking the supplement (24 capsules

daily), patients in the treatment group showed no significant differences

from those in the placebo group on any demographic or illness-related

variable. No significant group differences emerged at any time during the

study for the Fibromyalgia Impact Questionnaire (FIQ), the primary outcome

measure, nor for any of the secondary measures, which included the

Self-Efficacy Scale (SEF), the CES-D Depression Scale, a quality-of-life

measure, or the Illness Intrusiveness Response Scale (IIRS). In addition, no

significant group differences emerged in the number of tender points and the

total myalgic score at preintervention or at 3, 6, and 9 months. Both groups

showed improvement over the course of the trial, told the meeting.

noted that 34 patients dropped out from the trial, primarily due to

gastrointestinal complaints such as loose stools and diarrhea. But there was

no significant difference between the supplement and placebo groups in the

number completing the trial, he added.

Some differences emerged in open-label extension

When the 6-month blinded study was completed, all remaining patients were

invited to participate in an open-label extension for 3 further months, and

50 chose to do so. During this period (ie, between 6 and 9 months), when all

the patients were taking the supplement, a significant difference did emerge

between the 2 groups, reported. The number of tender points for

patients in the active group decreased significantly more than the number

for those in the placebo group. Similarly, there was a significant group

difference for the change in the tender point score from 6 to 9 months, with

the tender point score decreasing significantly more for the active group

than the placebo group.

" The results of this study argue against nutritional deficiencies being a

primary or important cause of fibromyalgia, " concluded. He also

commented that he had asked Truehope to remove from its website the details

of his published case report in a fibromyalgia patient and also his photo,

which had been taken without permission from the university website. There

is now no mention of fibromyalgia on the Truehope website.

Zosia Chustecka

Sources

1. L, Kaplan B, Crawford S , and Kennedee R. A randomized controlled

trial of a nutrient supplement in the treatment of fibromyalgia. American

College of Rheumatology meeting [abstract 1656]. 2002. Available at:

http://www.rheumatology.org.

2. L and Kaplan B. Potential clinical benefit of nutritional

supplements in the management of fibromyalgia. J Musculoskeletal Pain 1999;

7(4):127-128.