BACKGROUND: The scheduled update to the German S3 guidelines on fibromyalgia 
syndrome (FMS) by the Association of the Scientific Medical Societies 
("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften", 
AWMF; registration number 041/004) was planned starting in March 2011.
MATERIALS AND METHODS: The development of the guidelines was coordinated by the 
German Interdisciplinary Association for Pain Therapy ("Deutsche 
Interdisziplinären Vereinigung für Schmerztherapie", DIVS), 9 scientific medical 
societies and 2 patient self-help organizations. Eight working groups with a 
total of 50 members were evenly balanced in terms of gender, medical field, 
potential conflicts of interest and hierarchical position in the medical and 
scientific fields. Literature searches were performed using the Medline, 
PsycInfo, Scopus and Cochrane Library databases (until December 2010). The 
grading of the strength of the evidence followed the scheme of the Oxford Centre 
for Evidence-Based Medicine. The recommendations were based on level of 
evidence, efficacy (meta-analysis of the outcomes pain, sleep, fatigue and 
health-related quality of life), acceptability (total dropout rate), risks 
(adverse events) and applicability of treatment modalities in the German health 
care system. The formulation and grading of recommendations was accomplished 
using a multi-step, formal consensus process. The guidelines were reviewed by 
the boards of the participating scientific medical societies.
RESULTS AND CONCLUSION: Amitriptyline and-in case of comorbid depressive 
disorder or generalized anxiety disorder-duloxetine are recommended. Off-label 
use of duloxetine and pregabalin can be considered in case of no comorbid mental 
disorder. Strong opioids are not recommended. The English full-text version of 
this article is available at SpringerLink (under "Supplemental").