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From the Townsend Letter
October 2006


Recent Progress in Clinical Applications
and Research in Fibromyalgia

by Robert W. Bradford, Professor of Medicine, D. Sc. NMD, and Henry W. Allen, Director of Clinical Biochemistry, BRI

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Continued. . . 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Fibromyalgia patients (25 women, four men), as defined by the American College of Rheumatology criteria, with a mean age of 48.2 years and a mean disease duration of 6.1 years, participated in the acupuncture study. During the therapy, no analgesic medication was allowed. Pain levels and positive tender points were assessed using the visual analogue scale (VAS, range 0-100).

Following therapy, the VAS scores decreased from 64.0 mm to 34.5 mm (p< .001). The number of tender points decreased from 16.0 to 11.8 (p< .01). Serotonin levels decreased from 715.8 micrograms/1012 platelets to 352.4 micrograms/1012 platelets (p< .01). Substance P levels in serum increased from 134.0 ng/ml to 66.9 ng/ml (p< .01).

Acupuncture treatment of patients with fibromyalgia was associated with decreased pain levels and fewer positive tender points as measured by VAS. These results suggest that acupuncture therapy is associated with changes in the concentrations of pain-modulating substances in serum.30

Branched-Chain Amino Acid Supplementation
Patients with fibromyalgia have been found to have significantly lower plasma concentrations of the three branched-chain amino acids (BCAA – valine, leucine, and isoleucine – than normal controls. It is hypothesized that the deficiency of BCAAs may play a role in the pathophysiology of fibromyalgia, since BCAAs supply energy to the muscle and regulate protein synthesis in the muscles. The amino acid phenylalanine, though not a BCAA, was also deficient in fibromyalgia patients. Supplementation with branched-chain amino acids may benefit fibromyalgia patients.31

Melatonin Supplementation
Since disturbed sleep is one symptom of fibromyalgia patients, and since melatonin is known to be effective in promoting sleep, a four-week study was conducted with 21 fibromyalgia patients and 20 age- and sex-matched controls. Patients were evaluated before and after treatment (3 mg melatonin at bedtime) for tender point count, pain score in four predesignated areas, and pain severity on a 10 cm visual analogue scale (VAS). At day 30, median values for the tender point count and severity of pain at selected points and VAS for sleep were significantly improved with melatonin treatment.32

Chlorella Supplementation
Eighteen fibromyalgia patients having a tender point index (TPI) of at least 22 were given daily dietary supplements of both 10 g of "Sun Chlorella" tablets and 100 ml of liquid "Wakasa Gold" for a period of two months. The average TPI for the group, 32 at the beginning, decreased to a mean of 25 after two months. This decrease was statistically significant (p = .01), representing a 22% decrease in pain intensity. Seven patients felt that the dietary supplementation had improved their symptoms, while six thought they had experienced no change. Five patients believed their symptoms had worsened over the time period of the study. Dietary Chlorella supplementation may help relieve the symptoms of fibromyalgia in some patients.33

Serotonin Receptor Antagonists
Serotonin receptor antagonists are potent and highly selective inhibitors of the serotonin receptor with negligible affinity for other receptors. They are rapidly absorbed and penetrate the blood-brain barrier easily. Half-lives in healthy persons vary from three-to-four hours (ondansetron, granisetron) to seven-to-ten hours (tropisetron, hydrodolasetron). Drugs of this category diminish serotonin-induced release of substance P and prevent unmasking of these receptors in the presence of serotonin.34

In a study comparing the effectiveness of ondansetron and paracetamol, a marked improvement in pain intensity measured by VAS (p< .005), pain score, tender points, average pain threshold (p< .01), and a lower pain threshold was obtained with ondansetron, whereas no improvement was seen with paracetamol. Ondansetron appears to be an effective drug in about 50% of patients with fibromyalgia.35

Three classes of antidepressants were evaluated: tricycles (nine trials), selective serotonin reuptake inhibitors (three trials), and S-adenosylmethionine (two trials). When the effects on individual symptoms were combined, antidepressants improved sleep, fatigue, pain, and well-being, but not trigger points. Antidepressants are efficacious in treating many symptoms of fibromyalgia.36

A randomized, double-blind, crossover trial of fluoxetine (FL) and amitriptyline (AM) was conducted in the treatment of 19 fibromyalgia patients, consisting of four six-week trials of FL (20 mg), AM (25 mg), a combination of FL and AM, or placebo. Both FL and AM were associated with significantly improved scores on the Fibromyalgia Impact Questionnaire (FIQ) and on the VAS for pain, global well-being, and sleep disturbances. When combined, the two medications worked better together than either medication alone. (a synergistic response).37

Serotonin reuptake inhibitors alone seem to be of little value. Moclobemide, a reversible inhibitor of monoamine oxidase, seems to be inferior to amitriptyline as an inhibitor of pain. Although only one-third of the patients respond, amitriptyline remains the first choice in the conventional medication treatment of fibromyalgia.38

Venlafaxine is a medication available by prescription in the U S, both in an immediate release form as well as an extended release formulation. Preclinical studies indicate it has the effect of potently blocking the serotonin transporter. Venlafaxine has been approved by the FDA for the treatment of major depressive disorders and anxiety. Suggestive evidence also indicates efficacy in fibromyalgia.39

5-Hydroxytryptophan (5-HTP) is the intermediate metabolite of the essential amino acid L-tryptophan in the biosynthesis of serotonin. 5-HTP is well absorbed from an oral dose, with about 70% absorption into the bloodstream. It easily crosses the blood-brain barrier and effectively increases CNS synthesis of serotonin. In the CNS, serotonin levels have been implicated in the regulation of sleep, depression, anxiety, and pain sensation. Therapeutic administration of 5-HTP has been shown to be effective in treating a wide variety of conditions, including depression and fibromyalgia.40

Oral treatment of fibromyalgia with 5 mg oral tropisetron, a 5-hydroxytryptamine (serotonin) receptor antagonist, resulted in significantly decreased pain as measured by VAS, with a mean reduction of 59.7% (p< .0001).41 In another study, the reduction in pain score was –13.5% for 5 mg/day of tropisetron, -13% for 10 mg/day (p< .05). The number of painful tender points was also reduced significantly (p< .002) in the 5 mg/day group.42 Following a single I.V. injection of 2 mg, a more rapid and profound reduction in pain was achieved than with 5 mg/day oral tropisetron.43 See Charts 10 and 11.

Chart 10: Fibromyalgia Therapy

  • Stabilized Alkanylated Sulfur Compound (Lowers Pain antifungal)
  • Stabilized Active Oxygen Carrier (Inactivates Virus, Bacteria)
  • Aerobic Exercise
  • Acupuncture
  • Branched-Chain Amino Acids (Valine, Leucine, Isoleucine, Benefit to Muscles)
  • Melatonin (Improves Sleep)
  • Chlorella
  • Serotonin Receptor Antagonists (Ondansetron, Granisetron, Tropisetron, Hydrodolasetron)
  • Antidepressants (S-Adenoxylmethionine, Fluoxetine {PROZAC}, Amitriptyline, Moclobemide, Venlafaxine, Tropisetron)
  • 5-Hydroxytryptophan (Precursor of Tryptophan, Serotonin)

Chart 11: Ingles Integrative Hospital Antimicrobial Protocol Dosage and Administration

IV Push Benadryl 10 - 20 mg (push)- (1 - 2 cc)
Or PO (25 - 50 mg)

Infusion 1:
25 grams Vitamin C
1.42 grams Taurine (20 cc.)
42 mg. Stabilized Glycyrrhizic Acid (5 cc)
500 mg. Glutathione (5 cc.)
1 gram Magnesium Chloride (10 cc.)
200 cc. Normal Saline

Infusion 2:
15 cc. Stabilized Active Oxygen Carrier (25K-ppm)
100 cc. Normal Saline

Infusion 3:
Stabilized Alkanylated Sulfur Compound 200 cc.
(15% pre-mixed alkanylated sulfur compound infusion)

Continued. . . 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

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