All of our cells depend on cellular membranes to enclose cells and compartments within cells and provide cells with the ability to make and assemble proteins and enzymes and the components that generate cellular energy (the mitochondria). They also maintain the organization of our genetic information (the nucleus). Mitochondria are the little batteries inside our cells that produce 90% of the energy needed for cellular activities and synthesis of cellular molecules. However, mitochondria are particularly sensitive to membrane damage that occurs during aging and disease. When their membranes are damaged, such as during disease, mitochondria cannot provide the energy necessary for natural cellular functions. The membrane lipids of mitochondria, called phospholipids, are particularly sensitive to this type of damage, and they must be repaired to return mitochondria and cells to normal function and maintain general health.

Membrane Lipid Replacement (MLR) is the oral supplementation of membrane phospholipids, along with protective molecules and antioxidants to provide membrane replacement molecules for those that are damaged during chronic illnesses, cancer and aging [1,2]. Replacement membrane phospholipids are important for a variety of cellular and tissue functions. They repair damage to mitochondrial membranes, and are also an important energy storage reservoir and provide precursors for bioactive molecules that function in cellular signaling and molecular recognition pathways. Thus MLR lipids are considered essential for general health [1-5].

We have used MLR with oral phospholipid supplements to successfully reduce fatigue in Chronic Fatigue Syndrome (CFS) and Fibromyalgia patients [1,2]. More recently we have found in uncontrolled preliminary studies that the MLR phospholipids (4 g per day) can reduce pain as well as gastrointestinal symptoms in a few self-reporting Fibromyalgia patients (6). These results, those from several published trials and other preliminary observations on a few Fibromyalgia patients form the basis for this clinical study to use special phospholipid wafers to assess their ability to reduce pain, fatigue and gastrointestinal symptoms and improve Quality of Life (QOL) indicators in Fibromyalgia patients.

The Clinical Study
The goals of this clinical study are to test the ability of the membrane phospholipids to reduce pain, fatigue and gastrointestinal symptoms while improving indicators for quality of life in adult male and female Fibromyalgia patients. Using a randomized, double-blinded, placebo-controlled, cross-over clinical trial format we will test the outcome (symptoms and QOL) in Fibromyalgia patients taking oral membrane phospholipid (test supplement) wafers over 6 week periods of test supplement and placebo (control wafers that look and taste the same but without the active ingredient phospholipids). A randomized, double-blinded, placebo-controlled study means that patients will be placed randomly into two groups and neither the patients or the investigators will know which group. One group will first take the phospholipid wafers for approximately 6 weeks, stop for two weeks, and then take placebo wafers for approximately 6 weeks. The other group will start with the placebo wafers, stop for two weeks, and then take the test phospholipid wafers for 6 weeks. At various times, patients will be asked to evaluate their symptoms using a Combined Symptoms Survey Form that will document their symptom severities at different times. In this type of study every patient will receive the same test and placebo supplements, but at different times unknown to them and to the trial investigators. In this way the severity of symptoms can be directly linked to the test supplement and not due to a random feeling that the test supplement is working to reduce symptom severity. The entire study will take approximately 3 months to complete.

Significance of the Clinical Study
The most characteristic feature of Fibromyalgia is widespread chronic pain, and this has resulted in the increased use of various methods of pain control, mainly opioids and other pharmaceuticals [7, 8]. Recently the long-term use of opioids for pain control in Fibromyalgia patients has been questioned. Evidence from several sources, including controlled clinical trials, indicates that there is only a weak connection between opioids and their ability to reduce pain during long-term treatment in Fibromyalgia [9].

Similarly, long-term use of pharmaceuticals to control fatigue in Chronic Fatigue Syndrome and other conditions have also been questioned. The use of natural supplements, including MLR with oral phospholipid supplements, to provide mitochondrial support has also been reviewed with some positive results noted by investigators [10]. Thus there is evidence to support the use of a new approach in the treatment of pain, fatigue, gastrointestinal and other symptoms in Fibromyalgia patients.

Safety of the Test Phospholipid Supplement
Preclinical and clinical studies on the phospholipid test supplement have not shown any evidence of toxicity, including high dose effects on adults, effects on unborn or newly born and older children as well as the ability to cause cancers [1,2]. Thus there has been no indication that would indicate any possible risk in ingesting the phospholipid supplements. None of the preclinical studies, which were mostly conducted in laboratory animals (mice, rats and rabbits), have demonstrated any acute or chronic toxic effects of phospholipids given by oral, subcutaneous or intravenous administration [1]. In addition, multiple studies on toxic or lethal doses could not establish in laboratory animals any toxic or lethal dose levels of MLR supplements. Over 40 million doses of the test phospholipid supplement have been consumed by adults and children without any evidence of adverse effects.


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2. Nicolson GL. Membrane Lipid Replacement: clinical studies using a natural medicine approach to restoring membrane function and improving health. Intern. J. Clin. Med. 2016; 7: 133-143.

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6. Nicolson GL, Breeding PC. Membrane Lipid Replacement with glycerolphospholipids to restore mitochondrial function and reduce fatigue and pain in CFS/Me and Fibromyalgia patients. Fibromyalgia 2016. Abstract.
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8. Provenzano DA, Viscusi ER. Rethinking the role of opioids in the outpatient management of chronic nonmalignant pain. Curr. Med. Res. Opin. 2014; 30: 2051-2062.

9. Goldenberg DL, Clauw DJ, Palmer RE, Clair AG. Opioid use in Fibromyalgia: a cautionary tale. Mayo Clin. Proc. 2016; 91(5): 640-648.

10. Nicolson GL. Mitochondrial dysfunction and chronic disease: treatment with natural supplements. Altern. Therap. Health Med. 2014; 20(suppl 1): 18-25.