Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Fibromyalgia (FM) with a Staphylococcus Vaccine Olof Zachrisson MD, PhD Institute of Neuroscience and Physiology, University of Gothenburg, Sweden Gottfries Clinic, Krokslätts Torg 5 SE 431 37 Mölndal SWEDEN oz@gottfries.se Background The general scientific strategy evolved from a seminal observation made by professor Gottfries in 1958. He then noticed an increasing number of patients in his clinical psychiatric practice presenting a fatigue condition similar to the syndrome that in the 1990ies was named chronic fatigue syndrome or myalgic encephalomyelitis (ME/CFS). The patients continued to have a status indicating ongoing mild infection long after they had recovered from the Asian flu, an influenza which was epidemic in Sweden in 1958. This observation led to attempts of treatment with vaccine compounds in order to modulate/stimulate the immune system and thereby improve the status of the patients. Clinical benefit was noted in some individuals after repeated treatment with a staphylococcus toxoid vaccine (Gottfries, 1999). Based on this uncontrolled experience, the vaccine treatment was reuptake in the 1990ies, when the diagnoses of ME/CFS and also the Fibromyalgia syndrome (FM) were established within medicine. The vaccine used in the clinical research, Staphypan®, contained a mixture of staphylococcal vaccine and toxoid. It was manufactured by the Swiss Serum and Vaccine Institute Berne until 2005 and used for the prophylaxis of staphylococcal infections, especially before surgery. Controlled clinical studies The first controlled double blind study was conducted in 1997 and included 28 patients (Andersson et al. 1998). The study drug, Staphypan or coloured sterile water as placebo, was administered subcutaneously on weekly basis. The start dose of 0.1 ml was increased by 0.1 ml every week up to 1.0 ml. Endpoint ratings were performed at week 12. Observer-based rating scales (CPRS-15) were used for the primary assessment of outcome. Significant beneficial Invest in ME (Charity Nr. 1114035) effect was seen in favour of active treatment and the drop-out rate was low. Encouraged by the positive results a second extended trial was performed. This was a 6-month randomised controlled study, including 100 women fulfilling the criteria of combined ME/CFS and FM (Zachrisson et al. 2002). The study drug (Staphypan/coloured sterile water) was administered subcutaneously in doses of 0.1 to 1.0 ml at weekly intervals for eight weeks and then in booster doses of 1.0 ml every 4th week. End-point ratings were performed at week 26. Main outcome measures were proportion of responders on global ratings and proportion of “good responders”, defined as patients with a symptom reduction of ≥50% from baseline in ratings on an observer-based rating scale (CPRS15). Blind ratings were repeated at week 32 for evaluation of withdrawal effects. The treatment was well tolerated (drop-out rate 8%) and 65% responded to active treatment. The placebo response was 18% (p < 0.001). Patients on active treatment were significantly more often “good responders”. At withdrawal, deterioration was seen in the Staphypan group only, indicating the need of long-term treatment in order to maintain the effect. The majority of participant wanted to restart the treatment after the study. Working mechanism The clinical positive response to vaccine treatment was found related to the response of the patient’s immune system. In corporation with Professor Roland Möllby, the Karolinska Institute, the antibody status during treatment was evaluated (Zachrisson et al. 2004). In 14 patients receiving active vaccine treatment and 14 receiving placebo, the serological antibody status against extracellular toxins/enzymes, cellwall components, and enterotoxins was evaluated at baseline and after six months of treatment. www.investinme.org Page 20 of 108
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