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Nutritional Supplementation with Chlorella Pyrenoidosa for Fibromyalgia Syndrome: A Double-Blind, Placebo Controlled, Crossover Study

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www.ProHealth.com • January 25, 2002



Authors: Randall E. Merchant, Cynthia A. Andre and Christopher M. Wise.
Journal: J of Musculoskeletal Pain, Vol. 9(4) 2001, pp. 37-54.

Author Affiliations: Randall E. Merchant, PhD, is Professor of Anatomy and Neurosurgery, Cynthia A. Andre, MSc, is Clinical Research Coordinator and Social Worker, and Christopher M. Wise, MD, is Professor of Internal Medicine Rheumatology, Virginia Commonwealth University, Medical College of Virginia, Richmond, VA.

Address correspondence to: Randall E. Merchant, PhD, Virginia Commonwealth University, Medical College of Virginia. Richmond, VA 23298-0709 [E-mail: mailto:rmerchan@hsc.vcu.edu].

This study was supported in part by a contract and grant from Sun Chlorella Corporation of Kyoto, Japan.

ABSTRACT

Objective: To determine if daily dietary supplementation with Chlorella for three months helps normalize body functions, relieve symptoms, and improve quality of life in patients with fibromyalgia syndrome [FMS].

Methods: A total of 43 subjects with FMS were enrolled and randomized such that approximately half consumed 50 Sun Chlorella™ tablets and 100 mL of liquid Chlorella extract known as Wakasa GoId™ each day for three months and the other half consumed 50 placebo tablets and 100 mL of placebo liquid each day for a comparable period. Neither the patient nor the physician conducting the assessments knew which of the dietary supplements the subject was consuming. Following a one month washout period, subjects crossed-over from Chlorella to placebo or vice versa.

Results: Thirty-four subjects completed the entire trial. Six parameters of response were followed while each subject consumed each study diet, subjects answered questions relating to sleep, pain, global well-being, and fatigue while the physician assessed tender point index and global well-being.

Subjects were considered as having a positive response to a diet if they demonstrated a 50 percent or more improvement in at least four parameters. Of the 37 FMS subjects who completed the Chlorella arm, seven [19 percent] were responders versus only 3/34 [9 percent] who completed the placebo arm [P = 0.311].

For the four self-assessment parameters, significantly more 121/37 or 57 percent] subjects who completed the Chlorella arm noted a 50 percent or better improvement in at least two parameters while only 10/34 [29 percent] who completed the placebo arm did [P = 0.0311. Patient self-assessment of functional abilities by the Fibromyalgia Impact Questionnaire [FIQ] showed that when they were consuming Chlorella, there was a steady, statistically significant, drop in the FIQ score while, when taking placebo, levels of improvement varied and were not statistically significant at the end of the three-month period. Comparisons of the FIQ for Chlorella and placebo indicated that the better response of participants in the Chlorella arm of the crossover was nearly statistically significant [P = 0.058].

A questionnaire dealing with issues of pain, anxiety, sleep, and gastrointestinal difficulties indicated that while participants were consuming Chlorella, there were steady, statistically significant improvements [P < 0.001] in scores compared to baseline. Comparing the two arms, there was a statistically significant [P = 0.004] improvement in FMS symptoms while the subjects were taking Chlorella.

Conclusion: Taken together, the results of this randomized, placebo-controlled, double-blind crossover study lead us to conclude that dietary Chlorella supplementation may be useful in relieving symptoms of FMS.


KEYWORDS. Fibromyalgia syndrome, Chlorella, dietary supplement, pain


INTRODUCTION

In the United States it has been estimated that 2-4 percent of the general population suffers from fibromyalgia syndrome [FMS] (1). The major complaint of FMS patients is a generalized achiness but its definitive diagnosis is based on the presence of a minimum of 1 1 tender points in 18 characteristic locations (2). Other symptoms are also often present, particularly fatigue, sleep disturbance, morning stiffness, and headaches.

Most patients with FMS can get some relief of symptoms with nonpharmacologic methods such as increasing the amount of gentle aerobic exercise, getting an adequate amount of sleep, and maintaining a regular sleep schedule. Low doses of amitriptyline are often prescribed to improve deep sleep, but the drug can cause weight gain, dry mouth, and cognitive impairment when given in doses sufficient to keep FMS symptoms under control (3,4).

Also, some tolerance can develop to its sedative effect, necessitating dose increases in order to maintain any benefit. Several other medications have also been shown in controlled studies to help relieve symptoms of FMS, including cyclobenzaprine, fluoxetine, and alprazolam (4-7).

Corticosteroids, as well as nonsteroidal anti-inflammatory drugs, have proven to be of no benefit for FMS in placebo-controlled trials (4) and to date, no "alternative" treatment, food, or herbal preparation has been proven effective in controlled studies.

Recently, we conducted an open-label pilot study which involved 18 subjects with FMS who supplemented their diet with 10 grams [50 Sun Chlorella™ tablets] of Chlorella and 100 mL of the liquid Chlorella extract each day for two months (8). These products are made from Chlorella pyrenoidosa, a unicellular green alga that grows in fresh water. The principal components of Chlorella that have been shown to have certain health benefits are chlorophyll, the organism's cell walls, beta-carotene, and Chlorella growth factor [CGF].

Chlorella pyrenoidosa has the highest content of chlorophyll of any known plant and also contains high concentrations of many vitamins and minerals, as well as dietary fiber, nucleic acids, amino acids, enzymes, and other substances. Chlorella growth factor is a water soluble extract and contains a variety of substances including amino acids, peptides, proteins, vitamins, sugars, and nucleic acids.

A number of scientific reports out of Japan have shown that broken cell wall preparations and extracts of Chlorella pyrenoidosa and other Chlorella species when either given orally or injected promotes growth and healing, stimulates the immune system such that the host is protected from infection, and exerts significant anticancer activity (9-13).

Dietary supplementation with the two Chlorella products led to a mean net decrease of two tender points by the end of the study. The mean tender point index [TPI] which was 32 at baseline fell to 25, representing a statistically significant decrease in the intensity of pain of 22 percent [P = 0.01].

Although these results suggested that there may be a health benefit from Chlorella in the diet for subjects with FMS, it was recognized that these subjects were given open-label Chlorella and that such data were subject to substantial risk of bias on the part of both the subject and the investigator.

Nevertheless, the possibility that subjects with FMS could have their level of pain [as measured by the TPI] significantly decreased by simply adding Chlorella to the diet suggested that a double-blind, placebo-controlled clinical trial of dietary Chlorella supplementation was warranted. Therefore, the objective of the present investigation was to test the hypothesis that FMS subjects benefited by adding Chlorella to their diet.

As we had in the open-label study, we documented each patient's clinical status at strategic intervals using validated, semiobjective and subjective outcome measures and determined the magnitude of any resultant change in clinical symptoms, particularly pain, and other outcome variables.


© 2001 by The Haworth Press, Inc. All rights reserved.



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