Journal of IiME Volume 6 Issue 1 (June 2012) Significant changes were recorded in the group on active treatment while no change was seen in the controls. Treatment led to an increase in the capacity of serum to neutralize alpha-toxin (p< 0.001) and led to a significant increase in serum IgG to alpha-toxin (p< 0.01) and lipase (p< 0.01). Furthermore, the increase in the serum parameters paralleled the improvement in clinical out-come. Thus, the greater the serological response, the greater was the clinical effect. This relationship could indicate a working mechanism of the vaccine. Long term treatment In long-term studies the safety of the treatment were found good and the adherence to the treatment were impressive (Gottfries et al. 2006). In one followup study, 160 patients with FM and ME/CFS were continuously observed during another year of treatment. The patients had previously participated in controlled vaccine studies and were continuing on vaccine treatment with 1 ml Staphypan every 3rd to 4th week. At inclusion the mean treatment period with Staphypan was 22±10 months. The mean age of the patients was 53±11 years. The rating scale CPRS-15, handled by medically educated and trained staff, was used to evaluate efficacy. Ratings at inclusion showed improvement compared to start of treatment. Repeated ratings during the one year follow-up period showed further improvement. The total mean rating CPRS15 score was reduced by more than 50 % compared to start of treatment. Five items (Concentration difficulties, Failing memory, Irritability, Sadness and Autonomic disturbances) had mean levels below one (range of scores 0-6) at the time of the last rating, indicating that these symptoms on a group level were within the range of normality. In a somewhat younger subgroup of 97 patients (age 48±10 years) with a mean treatment time of 50.4±17.8 months (variance 30Invest in ME (Charity Nr. 1114035) 120), nine CPRS-15 core items were rated before as well as during treatment with the vaccine. They were analyzed with Principal Components Analysis (PCA) and a model was created using the clinical rating data at patient inclusion together with the assumed healthy profiles (Gottfries et al. 2009). The patient profiles after start of treatment were predicted by the PCA model and overlaid for comparison. The predicted values show loadings (black triangles in Figure), which have changed clearly in direction towards the normal group indicating improvement. The data show that this subgroup of middle-aged women after four to five years’ treatment still has an impressive beneficial effect. FIGURE Scatter plot indicating PCA scores for the model. Red boxes indicate assumed healthy objects. Blue points for untreated patients as rated at inclusion. Black triangles for treated patients. Each patient was re-assessed with last rating 50.4±17.8 months after study start (n=97) and his or her individual ratings predicted by the PCA model. The distribution after treatment with vaccine (black triangles) showed a shift of patient scores towards symptom relief. Adverse events during long-term treatment Safety was evaluated continuously. Adverse events were few and the adherence to the www.investinme.org Page 21 of 108
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