deleder2k
Senior Member
- Messages
- 1,129
A new article about the Rituximab study in the Norwegian newspaper Aftenposten today.
Original article in Norwegian: http://www.aftenposten.no/nyheter/i...a-a-lage-middag-til-datteren-min-7865148.html
Original article in Norwegian: http://www.aftenposten.no/nyheter/i...a-a-lage-middag-til-datteren-min-7865148.html
"Before I received treatment, I spent a whole day to cook dinner for my daughter"
Doctors at Haukeland University Hospital has initiated new research to get the final answer about a cancer medicine which can cure chronic fatigue syndrome (CFS). 152 patients participate in the study.
More patients with ME may have been cured after receiving a cancer drug, rituximab. Now cancer doctors Olav Mella and Øystein Fluge want a final answer whether the treatment can cure chronic fatigue syndrome (CFS).
Maria Gjerpe is among patients who have been cured of the treatment.
- Before I got treated, I had to have help to carry firewood, and I spent a whole day to cook dinner for my daughter. Now I can run down and back up from the basement with a large firewood basket between my hands, she says.
The immune system damages the body
Cancer Doctors Olav Mella and Øystein Fluge believe that ME in many patients is a physical, somatic, disease. And they research further on whether the disease is an autoimmune disease where the immune system exerts a harmful effect on the body.
They have now initiated a major study in Norway where 152 patients at five different hospitals will participate. These will receive either rituximab or placebo. First two infusions two weeks apart, then maintenance treatment after 3, 6, 9 and 12 months. The patients will be monitored for two years. Researchers hope this study will provide a clear answer on whether the cancer drug works. The study is national, randomized, double-blind and placebo-controlled study.
Confirm or deny findings
- In this way, one can either confirm things disprove the results of the first studies, says Fluge and Mella.
In the new study there will be conducted some additional studies that may help to shed light on disease mechanisms in ME. They also freeze down a series of blood samples from each patient, which is stored in a bio bank and used for the same purpose, namely to illuminate what ME disease really is.
- Hopefully this will also lead to a shift in the research, an altered attitude to ME patients both in medicine and in society, and eventually a treatment for patients, says Mella and Fluge.
The researchers came across a patient randomly with lymphoma and who had ME for many years. The patient experienced a significant improvement in most ME symptoms from about two months after starting treatment with cancer drugs. Three months after cancer treatment ended, the ME symptoms gradually returned.
The patient made contact
The patient contacted dr. Øystein Fluge and asked what caused the improvement. This prompted Head of the Cancer Department, Fluge, and Professor Olav Mella to ponder what happened to the ME disease after use of the cancer drug rituximab. Later they observed another patient with aggressive lymphoma and severe ME who experienced a significant response to ME symptoms from 4 months after initiation of treatment for lymphoma disease with chemotherapy in combination with rituximab.
Rituximab is an artificially prepared antibody is used in the treatment of lymphomas and in some autoimmune diseases.
The researchers then tried to give the antibody rituximab to two additional patients. These also experienced a significant improvement of symptoms, but as with the first patient, the was improvement temporarily.
This prompted doctors to initiate a small study of 30 ME patients.
- The results were good. Almost 70 percent of those who received rituximab reported minor symptoms and a improvement in quality of life, compared with approximately 15 percent in the control group. The study also showed that it takes at least 2-3 months, and in some more than 6 months before the medication gives effect.
Weaknesses with small studies
Researchers from Bergen says that there are weaknesses in the randomized trial from 2011 and they conducted a new follow-up study with the cancer drug with 29 ME patients, including 9 patients from the placebo group in the first study. This study began in October 2010 and was an open-label phase II study. The patients knew that they received the medication rituximab (unblinded), with repeated infusions.
The open study suggests that the longer you hold down B cells, the longer the symptom response. A weakness of this study is that there is no placebo group.
It is therefore important for researchers to complete the new randomized, double-blind and placebo-controlled study so that one can confirm or disprove results from the first study.
Mella and Fluge’s studies show that there is an accumulation of autoimmune diseases in the patient’s families.
- There is also evidence of increased risk of lymphoma (B-cell lymphoma) in elderly ME patients, which may indicate a chronic activation of B cells in this patient group.
- The years were filled with life
Maria Gjerpe remember well the period she received treatment at Haukeland Hospital, cancer ward, with six infusions of Rituximab.
- It is not possible to forget the moment I understood that I got my life back. In the summer 2012 I knew my health came back in all areas it had previously quarreled. Now, when I am healthy, I never think of the time I was sick. It's almost unreal how sick I was. It is almost impossible to relate yourself to the fact that I was so sick.
Today she helds a 100 percent position at the Norwegian Directorate of Health, helsenorge.no, Department of Digital Healthcare.
- Here I used my skills as both doctor and patient.
Lightning Process
Many patients in Norway have tried Lightning Process. Many claim that they are better with the method. It includes elements of CBT.
- Not proven
Researchers Olav Mella and Øystein Fluge are careful to emphasize that they have not yet proven that ME / CFS is an autoimmune disease. But they believe that what they now see whether the pattern of response and eventually relapse after using Rituximab suggests that such a mechanism may exist.
- ME is basically a physical illness for the group that is discussed in our studies. Nevertheless, psychologic mechanisms may play a role for the patients. Good strategies for coping is important in all chronic diseases, but not particularly important in ME compared to other diseases, they say.
Last edited:
