Intravenous immunoglobulin (IVIG) is a proposed treatment for chronic fatigue syndrome.
Theory[edit | edit source]
Evidence[edit | edit source]
The American Journal of Medicine published two studies with different conclusions following each other in the November 1990 issue. The two studies were done in different countries and neither report the case definitions used to identify patients. The study with positive results used a dose twice that as the study with negative results. Following are the abstracts.
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Positive results[edit | edit source]
- 1990, A double-blind, placebo-controlled trial of intravenous immunoglobulin therapy in patients with chronic fatigue syndrome. Done by the Department of Infectious Diseases, Prince Henry Hospital, Sydney, Australia. This study found that a low CD4 count at baseline before IVIG treatment commenced was a predictor of which ME/CFS patients would do well on IVIG.
- 1992, Immunological and psychological dysfunction in patients receiving immunotherapy for chronic fatigue syndrome
- 1997, Double-blind randomized controlled trial to assess the efficacy of intravenous gammaglobulin for the management of chronic fatigue syndrome in adolescents
- 1999, Five-Year Follow-Up of Young People with Chronic Fatigue Syndrome Following the Double Blind Randomised Controlled Intravenous Gammaglobulin Trial
- 2003, Successful Intravenous Immunoglobulin Therapy in 3 Cases of Parvovirus B19-Associated Chronic Fatigue Syndrome
- 2008, Tae Park, MD, presented his study about IVIG for ME/CFS patients at the 3rd Invest in ME International ME Conference. He checked the Glomerular filtration rate (GFR) in 125 ME/CFS patients who met the Fukuda criteria by measuring s-creatinine clearance with cockcroft-auld formula. "We found there were significant renal blood flow improvements in 60 patients (50%) with IVIG treatment...the improvement of renal blood flow is between 35% and 60% of previous GFR. These findings of improved renal blood flow may be evidence of improved cerebral blood flow...[and] may explain the improvement of cognitive function and other symptoms of ME/CFS patients with IVIG treatments."
- 2021, Back to the Future? Immunoglobulin Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome - (Full text)
Negative results[edit | edit source]
- 1990, A controlled trial of intravenous immunoglobulin G in chronic fatigue syndrome. Done by the Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.
- 1997, Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome
- 2015, Paradoxical response to intravenous immunoglobulin in a case of Parvovirus B19-associated chronic fatigue syndrome, Attard, Luciano et al.Journal of Clinical Virology , Volume 62 , 54 - 57
Clinicians[edit | edit source]
Dr. Irving Spurr of the UK, "uses immunogloulin treatment extensively and has not done a RCT [randomized controlled trial] because he does not believe it is ethical to not offer it to clients. There are apparently problems with the use of IVIG in the UK and so he used IM."
Risks & safety[edit | edit source]
The risks of IGIV administration must be carefully weighed against potential benefits.
From 1-15% of people receiving IVIG infusions report mild self-limited symptoms, including: fever, chills, headache, myalgia, nausea and/or vomiting, low back pain, increased heart rate, blood pressure changes, shortness of breath and chest tightness. Onset of symptoms range from 30 minutes to several days post-infusion. The cause is thought to be from pathogen die-off and/or a mild allergic reaction. As with any blood product, severe and even fatal anaphylactoid reactions may occur. When using IVIG, the risk is in patients with anti-IgA antibodies of the IgG and IgE isotypes in the patient's serum, though this condition is extremely rare.
Reports of renal failure associated with IVIG occur in less than 1% of cases. Caution is urged for those patients with pre-existing renal insufficiency.
Costs & availability[edit | edit source]
IVIG for ME/CFS is considered an off-use or non-FDA approved treatment. As a result, few physicians prescribe it and insurance companies will not cover it, unless a co-morbid condition that merits IVIG exists. The estimated out of pocket cost in the U.S. for a four dose course of IVIG for a 70 kg/155 lb person at 2 g/kg could cost $25,000-$26,000.
See also[edit | edit source]
Learn more[edit | edit source]
References[edit | edit source]
- Lloyd, A.; Hickie, I.; Wakefield, D.; Boughton, C.; Dwyer, J. (November 1990). "A double-blind, placebo-controlled trial of intravenous immunoglobulin therapy in patients with chronic fatigue syndrome". The American Journal of Medicine. 89 (5): 561–568. ISSN 0002-9343. PMID 2146875.
- Hickie, I.; Lloyd, A.; Wakefield, D. (June 1992). "Immunological and psychological dysfunction in patients receiving immunotherapy for chronic fatigue syndrome". The Australian and New Zealand Journal of Psychiatry. 26 (2): 249–56. PMID 1642616.
- Rowe, K.S. (1997). "Double-blind randomized controlled trial to assess the efficacy of intravenous gammaglobulin for the management of chronic fatigue syndrome in adolescents". Journal of Psychiatric Research. 31 (1): 133–47. PMID 9201655.
- Rowe, K.S. (1999). "Five-Year Follow-Up of Young People with Chronic Fatigue Syndrome Following the Double Blind Randomised Controlled Intravenous Gammaglobulin Trial". Journal of Chronic Fatigue Syndrome. 5 (3–4): 97–107. doi:10.1300/J092v05n03_08.
- Kerr, J. R.; Cunniffe, V. S.; Kelleher, P.; Bernstein, R. M.; Bruce, I. N. (2003). "Successful Intravenous Immunoglobulin Therapy in 3 Cases of Parvovirus B19-Associated Chronic Fatigue Syndrome". Clinical Infectious Diseases. 36 (9): 100–106. doi:10.1086/374666.
- Baken, Don. "3rd Invest in ME International ME Conference 2008 – Report". Invest in ME Research. Retrieved January 16, 2022.
- Brownlie, Helen; Speight, Nigel (November 12, 2021). "Back to the Future? Immunoglobulin Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". Healthcare. 9 (11): 1546. doi:10.3390/healthcare9111546. ISSN 2227-9032. PMC 8623195. PMID 34828592.
- Peterson, P. K.; Shepard, J.; Macres, M.; Schenck, C.; Crosson, J.; Rechtman, D.; Lurie, N. (November 1990). "A controlled trial of intravenous immunoglobulin G in chronic fatigue syndrome". The American Journal of Medicine. 89 (5): 554–560. ISSN 0002-9343. PMID 2239975.
- Vollmer-Conna, U; Hickie, I; Hadzi-Pavlovic, D; Tymms, K; Wakefield, D; Dwyer, J; Lloyd, A (1997). "Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome". American Journal of Medicine. 103: 38–43. doi:10.1016/S0002-9343(97)90045-0.
- Stanford ME/CFS Initiative – Enteroviruses Treatment Options – Physician Perspective: John Chia, MD
- Duhem, C; Dicato, M A; Ries, F (July 1994). "Side-effects of intravenous immune globulins". Clinical and Experimental Immunology. 97 (Suppl 1): 79–83. ISSN 0009-9104. PMID 8033440. Retrieved December 12, 2016.
- American Academy of Allergy, Asthma & Immunology – Work Group Report on the appropriate use of intravenously administered immunoglobulin (IGIV) (pdf)
- Ahsan, N. (June 1998). "Intravenous immunoglobulin induced-nephropathy: a complication of IVIG therapy". Journal of Nephrology. 11 (3): 157–161. ISSN 1121-8428. PMID 9650125.
- Attard, Luciano; Bonvicini, Francesca; Gelsomino, Francesco; Manfredi, Roberto; Cascavilla, Alessandra; Viale, Pierluigi; Varani, Stefania; Gallinella, Giorgio (January 1, 2015). "Paradoxical response to intravenous immunoglobulin in a case of Parvovirus B19-associated chronic fatigue syndrome". Journal of Clinical Virology. 62: 54–57. doi:10.1016/j.jcv.2014.11.021. ISSN 1386-6532. PMID 25542471. Retrieved December 12, 2016.
double blinded trial A clinical trial is double blinded if neither the participants nor the researchers know which treatment group they are allocated to until after the results are interpreted. This reduces bias. (Learn more: www.nottingham.ac.uk)
renal involving, related to or in the area of the kidneys
cerebral blood flow (CBF) - the amount of blood that goes through the arterial tree in the brain in a given amount of time
myalgic encephalomyelitis (M.E.) - A disease often marked by neurological symptoms, but fatigue is sometimes a symptom as well. Some diagnostic criteria distinguish it from chronic fatigue syndrome, while other diagnostic criteria consider it to be a synonym for chronic fatigue syndrome. A defining characteristic of ME is post-exertional malaise (PEM), or post-exertional neuroimmune exhaustion (PENE), which is a notable exacerbation of symptoms brought on by small exertions. PEM can last for days or weeks. Symptoms can include cognitive impairments, muscle pain (myalgia), trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, among others. An estimated 25% of those suffering from ME are housebound or bedbound. The World Health Organization (WHO) classifies ME as a neurological disease.
randomized controlled trial (RCT) - A trial in which participants are randomly assigned to two groups, with one group receiving the treatment being studied and a control or comparison group receiving a sham treatment, placebo, or comparison treatment.
heart rate (HR) - the number of times the heart beats within a certain time period, usually a minute