ME/CFS Primer/Education Bulletins 2009 Immunotherapy of Fibromyalgia and Chronic Fatigue Syndrome by a Staphylococcus Toxoid Vaccine
IACFS/ME Bulletin

 

Immunotherapy of Fibromyalgia and Chronic Fatigue Syndrome by a Staphylococcus Toxoid Vaccine

Carl-Gerhard Gottfries* MD, PhD1, Ove Häger RN1, Johan Gottfries PhD2, Olof Zachrisson MD, PhD1

1 Institute of Neuroscience and Physiology at The Sahlgrenska Academy, University of Gothenburg, Sweden. Gottfries Clinic, Krokslätts Torg 5, SE-431 37 Mölndal, Sweden. Tel.: +46 31 343 23 97 Fax.:+46 31 209938 E-Mail cgg@gottfries.se oz@gottfries.se
2 Umeå University, SE 90187 Umeå Sweden. Phone +46 736 266 508

E-Mail johan.gottfries@chem.umu.se

Address for correspondence: Carl-Gerhard Gottfries professor emeritus Gottfries Clinic, Krokslätts Torg 5, SE-431 37 Mölndal, Sweden.


Keywords: Biologic agents; Chronic fatigue syndrome; Fibromyalgia; Immunotherapy; Staphylococcus vaccine

ABSTRACT

Background
In previous clinical double blind investigations a significant effect is recorded in patients with fibromyalgia and/or chronic fatigue syndrome when treated with a staphylococcus vaccine. The aim of this study is to report long-term efficacy and safety of this immunotherapy.

Methods
One hundred and sixty patients with fibromyalgia and chronic fatigue syndrome who had previously participated in vaccine treatment studies were continuously observed during one year in a follow up study. At inclusion mean age was 53±11 years and mean treatment time 22±10 months. In a subgroup of 97 younger patients (48±10 years) with a mean treatment time of 50.4±17.8 months a Principal Components Analysis (PCA) was performed.

The patients were on immunotherapy by a staphylococcus vaccine administered subcutaneously in a dose of 1 mL every 3rd to 4th week. Medically educated and trained staff using the rating scale CPRS-15 evaluated efficacy. Safety was evaluated continuously.

Results
Ratings showed improvement from start of treatment and further improvement was recorded during the follow-up period. The total mean rating CPRS-15 score was reduced by more than 50 %. Five items (Concentration difficulties, Failing memory, Irritability, Sadness and Autonomic disturbances) had mean levels below one at the time of the last rating, indicating that these symptoms on a group level were within the range of normality. The PCA also indicated improvement in the subgroup of 97 middle- agedpatients. Adverse events were few and the adherence to the treatment was surprisingly fine. During the observation period of one year 14% withdrew from treatment.

Conclusions
The result was considered impressive and in view of the lack of effective treatment in fibromyalgia and chronic fatigue syndrome the results are of interest but need to be confirmed.

 


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