A new clinical study shows that there is a direct correlation between the elevated levels of inflammation present and the symptoms experienced by Fibromyalgia sufferers. Celergen was shown to normalize the elevated levels of inflammation and significantly reduce the associated symptoms.
Fibromyalgia (FM) is characterized by chronic widespread musculoskeletal pain, sleep disturbances, stiffness, fatigue and cognitive dysfunction.
In the largest clinical study ever conducted on Fibromyalgia, subjects between the ages of 18 and 80 (92% women) were chosen after being diagnosed with the disease.
During the first month of the 3 month treatment, 100% of participants experienced at least an 80% reduction of all FM related symptoms which lasted throughout the remainder of the study.
"My wife started taking Celergen for her fibromyalgia and the symptoms disappeared by 80 to 90%, and she has more energy!"
Dr. Robert Barr
Up until now, findings that inflammatory markers were abnormal in the blood levels of patients with fibromyalgia (FM), had been inconclusive. This study however, has concluded that there is a direct correlation between the participants’ abnormally high blood levels of Substance P (SP) and Tumor Necrosis Factor Alpha (TNFa) – which are known to have pro-inflammatory actions – and the FM symptoms suffered by the participants.
Prior to starting Celergen, extensive blood tests were performed on the participants looking for any common abnormalities as compared to the healthy members of a control group without FM.
Substance P and TNFa
All FM participants shared abnormally high levels of the pro-inflammatory markers of Substance P (SP) and Tumor Necrosis Factor Alpha (TNFa) as compared to their counterparts in the control group.
Celergen Effect on SP
Substance P (SP) levels at the beginning of the study for FM sufferers were significantly elevated (0.68 ± 0.31 ng/mL) as compared too healthy controls (0.41 ± 0.31 ng/mL). Remarkably, at the end of the study, the FM participant levels of SP (0.27 ± 0.09 ng/mL) were 35% lower than the healthy controls.
Celergen Effect on TNFa
TNFa levels were also significantly increased (3.34 ± 3.12 pg/mL) in participants with FM at the beginning of the study as compared to healthy controls (0.55 ± 0.41 pg/mL). At the end of the study, FMS participant levels were significantly reduced (1.64 ± 1.24 pg/mL) – well below unhealthy levels.
"This is the first time to our knowledge that any molecule can reduce blood levels of Substance P in any disease..."
Theoharis C. Theoharides, Dept of Integrative Physiology & Pathobiology, Tufts University
Substance P & TNFa In Depth
Some neuroimmune mediators (inflammatory markers) have been reported to be abnormal in individuals with FM. The study above on Celergen’s effect upon FM sufferers confirmed that TNFa is in fact elevated in FM patients, and further showed significantly increased levels of the neuropeptide Substance P (SP), which is known to have proinflammatory actions. SP may be secreted in response to physiological or psychological stress that is known to worsen FM. SP could then stimulate immune cells to secrete TNFa, especially mast, cells which are the only immune cells that store TNFa and can secrete it rapidly.
Mast Cells are involved in allergic conditions, but also inflammatory diseases. This study suggests that mast cells may be involved in FM, and other co-occurring conditions. In this particular clinical study, mast cells were significantly increased in the papillary dermis of FM patients, who also often suffer from chronic urticaria. Activated mast cells secrete numerous nuerosensitizing and pro-inflammatory mediators that could contribute to FMS symptoms. Mast cells are located perivascularly adjacent to neurons both in the skin and in the brain and have been associated with pain.