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Prevalence 2013 Alemani
Prevalence 2013 Alemani
Objective. To evaluate fibromyalgia in the general population with emphasis on prevalence, dimensionality, and somatic
symptom severity.
Methods. We studied 2,445 subjects randomly selected from the German general population in 2012 using the American
College of Rheumatology 2010 preliminary diagnostic criteria for fibromyalgia, as modified for survey research, and the
polysymptomatic distress scale (PSD). Anxiety, depression, and somatic symptom severity were assessed with the Patient
Health Questionnaire (PHQ) series, and measures of symptoms and quality of life were assessed with the European
Organization for Research and Treatment of Cancer questionnaire.
Results. The prevalence of fibromyalgia was 2.1% (95% confidence interval [95% CI] 1.6, 2.7), with 2.4% (95% CI 1.5, 3.2)
in women and 1.8% (95% CI 1.1, 2.6) in men, but the difference was not statistically significant. Prevalence rose with age.
Fibromyalgia subjects had markedly abnormal scores for all covariates. We found smooth, nondisordered relationships
between PSD and all predictors, providing additional evidence against the hypothesis that fibromyalgia is a discrete
disorder and in support of a dimensional or spectrum disorder. There was a strong correlation (r ⴝ 0.790) between the
PSD and the PHQ somatic symptom severity scale; 38.5% of persons with fibromyalgia satisfied the proposed Diagnostic
and Statistical Manual of Mental Disorders, Fifth Edition criteria for a physical symptom disorder.
Conclusion. The modified 2010 diagnostic criteria do not result in high levels of fibromyalgia. PSD and fibromyalgia are
strongly related to somatic symptom severity. There is evidence in support of fibromyalgia as a dimensional or continuum
disorder. This has important ramifications for neurobiologic and epidemiology research, and for clinical diagnosis,
treatment, and ascertainment of disability.
777
778 Wolfe et al
algianess scale or PSD, a measure of physical and psycho- Table 1. The prevalence of fibromyalgia and mean
logical symptom intensity (distress) that can be applied to values of related variables in the general population*
subjects regardless of disease (12). We used the validated
German versions of the FSQ (13). Category Cases N Value (95% CI)
Subjects satisfy the fibromyalgia survey criteria if they
Fibromyalgia prevalence
meet the following 3 conditions: 1) WPI ⱖ7/19 pain sites All 52 2,445 2.1 (1.6, 2.7)
and SS score ⱖ5/12 or WPI between 3– 6/19 and SS score Women 31 1,308 2.4 (1.5, 3.2)
ⱖ9/12; 2) symptoms have been present at a similar level Men 21 1,137 1.8 (1.1, 2.6)
for at least 3 months; and 3) the patient does not have All cases
another disorder that would otherwise sufficiently explain Ages ⬍40 years 6 741 0.8 (0.2, 1.5)
Ages 40–59.9 years 22 895 2.5 (1.4, 3.5)
the pain (2). The conditions 1 and 2 can be assessed by the Ages ⱖ60 years 24 809 3.0 (1.8, 4.1)
FSQ in epidemiologic studies. Women
Ages ⬍40 years 6 392 1.5 (0.3, 2.8)
Patient Health Questionnaire (PHQ). The PHQ Somatic Ages 40–59.9 years 13 491 2.6 (1.2, 4.1)
Symptom Short Form (PHQ-SSS) is the short form of the Ages ⱖ60 years 12 425 2.8 (1.2, 4.4)
Men
PHQ-15 (14) and comprises 8 items (stomach or problems
Ages ⬍40 years 0 349 0.0 (0.0, 0.0)
going to the toilet; pain in the back; pain in the arms, legs, Ages 40–59.9 years 9 404 2.2 (0.8, 3.7)
or joints; headaches; chest pain or getting out of breath; Ages ⱖ60 years 12 384 3.1 (1.4, 4.9)
dizziness; feeling tired or having low energy; trouble PDS
sleeping), with each symptom scored from 1 (“not both- All 2,445 3.0 (2.9, 3.1)
ered at all”) to 5 (“bothered very strongly”) within the last Women 1,308 3.2 (3.0, 3.4)
Men 1,137 2.8 (2.6, 3.0)
7 days (14). The PHQ-15 is best characterized as a measure
All cases
of somatic symptom severity (14). Ages ⬍40 years 741 1.8 (1.6, 2.0)
The PHQ-SSS (not yet validated) had been proposed for Ages 40–59.9 years 895 2.9 (2.7, 3.2)
the research definition of criterion A (somatic symptoms: Ages ⱖ60 years 809 4.2 (3.9, 4.4)
one or more somatic symptoms that are distressing and/or Women
result in significant disruption in daily life) of the physical Ages ⬍40 years 392 2.1 (1.8, 2.4)
Ages 40–59.9 years 491 3.1 (2.8, 3.5)
symptom disorder of the Diagnostic and Statistical Manual Ages ⱖ60 years 425 4.3 (3.9, 4.7)
of Mental Disorders, Fifth Edition (DSM-V). Criterion A is Men
met if a person reports being bothered strongly or very Ages ⬍40 years 349 1.5 (1.2, 1.7)
strongly by a symptom (15). We assumed that criterion B Ages 40–59.9 years 404 2.7 (2.4, 3.0)
(disproportionate and persistent thoughts about the seri- Ages ⱖ60 years 384 4.0 (3.6, 4.4)
WPI
ousness of one’s symptoms) was met if a person reported at
All 2,445 1.3 (1.2, 1.4)
least one severe, continuous, life-disturbing problem in Women 1,308 1.4 (1.3, 1.5)
the 2010 criteria SS score. Men 1,137 1.2 (1.1, 1.4)
The PHQ-4 (16) is an ultra-brief self-report question- All cases
naire that consists of a 2-item depression scale (PHQ-2) Ages ⬍40 years 741 0.5 (0.4, 0.6)
and a 2-item anxiety scale (Generalized Anxiety Disorder). Ages 40–59.9 years 895 1.2 (1.1, 1.4)
Ages ⱖ60 years 809 2.2 (2.0, 2.4)
A score of 3 or greater on the depression subscale repre-
Women
sents a reasonable cut point for identifying potential cases Ages ⬍40 years 392 0.6 (0.4, 0.7)
of major depression or other depressive disorders, and a Ages 40–59.9 years 491 1.3 (1.1, 1.5)
score of 3 or greater on the anxiety subscale represents a Ages ⱖ60 years 425 2.3 (2.0, 2.6)
reasonable cut point for generalized anxiety, panic, social Men
anxiety, and posttraumatic stress disorders in primary care Ages ⬍40 years 349 0.4 (0.3, 0.5)
Ages 40–59.9 years 404 1.1 (0.9, 1.3)
settings and in the general population (17). The PHQ-4 Ages ⱖ60 years 384 2.2 (1.9, 2.4)
total score can serve as a measure for psychological dis- SS score
tress (14). We used the validated German version of the All 2,445 1.7 (1.6, 1.7)
PHQ (17). Women 1,308 1.8 (1.7, 1.9)
Health-related quality of life was assessed by the vali- Men 1,137 1.5 (1.4, 1.6)
All cases
dated German version of the European Organization for
Ages ⬍40 years 741 1.3 (1.2, 1.5)
Research and Treatment of Cancer (EORTC) QLQ-C30, Ages 40–59.9 years 895 1.7 (1.6, 1.8)
version 3.0 (18). The EORTC QLQ-C30 includes 5 func- Ages ⱖ60 years 809 1.9 (1.8, 2.0)
tioning scales, which cover the dimensions physical func- Women
tioning (5 items), role functioning (2 items), emotional Ages ⬍40 years 392 1.5 (1.4, 1.7)
functioning (4 items), cognitive functioning (6 items), and Ages 40–59.9 years 491 1.8 (1.7, 2.0)
Ages ⱖ60 years 425 2.0 (1.8, 2.2)
social functioning (2 items). In addition, the questionnaire
Men
contains a scale for global health status (2 items), and Ages ⬍40 years 349 1.1 (0.9, 1.3)
symptom scales that are relevant to cancer patients (e.g., Ages 40–59.9 years 404 1.6 (1.4, 1.8)
pain, nausea, fatigue, dyspnea). For functional and global Ages ⱖ60 years 384 1.8 (1.6, 2.0)
quality of life scales, higher scores mean a better level of
* 95% CI ⫽ 95% confidence interval; PDS ⫽ polysymptomatic distress
functioning. For symptom-oriented scales, a higher score scale; WPI ⫽ widespread pain index; SS ⫽ symptom severity.
means more severe symptoms (19).
780 Wolfe et al
Table 2. Clinical and demographic variables for full population and fibromyalgia groups*
Age, years (range 18–91 years) 50.2 ⫾ 17.4 59.8 ⫾ 16.4 60.7 ⫾ 16.9 55.7 ⫾ 13.7 0.410
Sex, % male 46.5 39.2 38.1 44.4 0.723
Social class, % lower 8.6 22.0 26.2 0.0 0.087
Depression score (PHQ-2) (range 0–6) 0.7 ⫾ 1.0 3.2 ⫾ 1.4 3.0 ⫾ 1.2 4.0 ⫾ 2.1 0.967
Depression (PHQ ⱖ3), % 6.0 63.5 61.9 77.8 0.366
Anxiety disorder score (GAD-2) (range 0–6) 0.5 ⫾ 0.9 2.6 ⫾ 1.5 2.4 ⫾ 1.4 3.7 ⫾ 1.7 0.015
Anxiety disorder (GAD-2 ⱖ3), % 2.4 50.0 42.9 88.9 0.012
Psychological distress (PHQ-4) (range 0–12) 1.2 ⫾ 1.7 5.8 ⫾ 2.5 5.4 ⫾ 2.1 7.7 ⫾ 3.6 0.014
Somatic symptom (PHQ-SSS) (range 0–26) 3.3 ⫾ 4.0 15.9 ⫾ 5.1 15.3 ⫾ 5.0 18.6 ⫾ 5.1 0.082
EORTC physical function (range 100–0) 92.2 ⫾ 15.0 53.1 ⫾ 25.5 56.3 ⫾ 24.0 37.8 ⫾ 27.9 0.046
EORTC cognitive function (range 100–0) 93.6 ⫾ 14.5 57.0 ⫾ 24.8 59.3 ⫾ 51.8 46.2 ⫾ 27.4 0.154
EORTC quality of life (range 100–0) 75.0 ⫾ 20.4 36.2 ⫾ 19.2 37.2 ⫾ 19.2 31.5 ⫾ 19.4 0.420
EORTC pain (range 0–100) 16.7 ⫾ 24.2 70.9 ⫾ 26.6 69.0 ⫾ 25.6 79.6 ⫾ 30.9 0.284
EORTC sleep status (range 0–100) 12.4 ⫾ 23.3 52.3 ⫾ 35.4 49.2 ⫾ 37.0 66.7 ⫾ 23.6 0.182
EORTC fatigue (range 0–100) 15.5 ⫾ 21.7 71.7 ⫾ 26.3 68.3 ⫾ 26.2 87.7 ⫾ 21.8 0.044
ACR widespread pain index (range 0–19) 1.3 ⫾ 2.3 8.9 ⫾ 3.5 9.6 ⫾ 3.0 4.3 ⫾ 1.3 0.000
ACR symptom severity score (range 0–12) 1.7 ⫾ 1.9 7.4 ⫾ 2.0 6.8 ⫾ 1.6 10.2 ⫾ 1.0 0.000
Polysymptomatic distress (range 0–27) 3.0 ⫾ 3.3 16.4 ⫾ 3.5 16.8 ⫾ 3.6 14.6 ⫾ 1.8 0.077
* Values are the mean ⫾ SD unless otherwise indicated. FM ⫽ fibromyalgia; PHQ-2 ⫽ 2-item Patient Health Questionnaire; GAD-2 ⫽ 2-item
Generalized Anxiety Disorder; PHQ-SSS ⫽ PHQ Somatic Symptom Short Form; EORTC ⫽ European Organization for Research and Treatment of
Cancer; ACR ⫽ American College of Rheumatology.
Statistical methods. We used predicted values from sec- CI 0.17, 0.72) units greater in women than in men. Overall,
ond-degree fractional polynomial (FP) regression (20) to these data show that the prevalence of fibromyalgia and its
describe the PSD and covariate relationships, after first components increases with age, but that sex has a smaller
examining each covariate pair by lowess regression and effect that is not significant for fibromyalgia or WPI, but is
scatter plots to be sure the FP was an accurate and fair significant for SS score and PSD.
representation of the underlying data. Comparisons in
Table 1 used t-tests and chi-square tests, as appropriate. Effect of Type A and B definitions. Of patients satisfy-
Data were analyzed using Stata, version 12.1. ing the modified ACR 2010 criteria, 82.7% satisfied it
using the Type A definition and 17.3% with the Type B
RESULTS definition. As mandated by the Type A and Type B defi-
nitions that required WPI to be lower and SS scores to be
higher, SS scores were significantly higher for Type B
Prevalence of fibromyalgia and component variable
subjects (mean ⫾ SD 10.2 ⫾ 1.0 versus 6.8 ⫾ 1.6) (Table 2),
levels. The study population was representative of the
while WPI scores were greater in Type A subjects (mean ⫾
German population in 2011 in terms of age and sex (21)
SD 9.6 ⫾ 3.0 versus 4.3 ⫾ 1.3). PSD scores were not
(Supplementary Appendix A, available in the online ver-
significantly different (P ⫽ 0.077). In addition, anxiety,
sion of this article at http://onlinelibrary.wiley.com/doi/
general psychological distress, physical function, and fa-
10.1002/acr.21931/abstract). The overall prevalence of fi-
tigue were worse in the Type B group. Figure 1 shows the
bromyalgia was 2.1% (95% confidence interval [95% CI]
distribution of the scores for both groups, with Type B
1.6, 2.7) (Table 1). Fibromyalgia increased with age: 0.8%
(95% CI 0.2, 1.5), 2.5% (95% CI 1.4, 3.5), and 3.0% (95% scores generally spread over the full ranges of fibromyalgia
CI 1.8, 4.1) in those ⬍40, 40 –59.9, and ⱖ60 years of age, patient scores. The 1990 widespread pain criterion was
respectively (P ⫽ 0.004). Fibromyalgia was not statistically noted in 82.7% overall, and in 93.0% of Type A and 33.3%
more common in women than men (2.4% versus 1.8%; of Type B subjects.
P ⫽ 0.372 and 59.6% versus 40.4% among those with
fibromyalgia). We examined the 3 components of fibromy- Continuum hypothesis for fibromyalgia. By definition,
algia shown in Table 1. In regression analyses, the WPI subjects with fibromyalgia (2.1%) had to have a PSD score
increased by 0.45 (95% CI 0.40, 0.50) units per 10-year of at least 12, a level met by 3.4% of all subjects when
increase in age. Adjusted for age, the WPI for women was nonfibromyalgia subjects were included (Figure 2). How-
0.17 (95% CI ⫺0.01, 0.34) units greater than in men (P ⫽ ever, a cut point of 13 better distinguished fibromyalgia
0.062). The SS score increased by 0.14 (95% CI 0.10, 0.19) from nonfibromyalgia patients, for if a score of 12 (or 13)
units per 10-year increase in age. Adjusted for age, the SS were assumed to represent fibromyalgia for research pur-
score was 0.28 (95% CI 0.13, 0.43) units greater in women poses, the respective kappa statistics for agreement would
than in men. The summary PSD score increased by 0.59 be 0.758 (95% CI 0.678, 0.839) and 0.795 (95% CI 0.715,
(95% CI 0.52, 0.67) units per 10 years and was 0.45 (95% 0.875), respectively, indicating full agreement (22) with
Prevalence, Dimensionality, and Somatic Symptom Severity of FM 781
Figure 1. The distribution of fibromyalgia syndrome (FMS) covariate scores for subjects meeting Type A and Type B FMS criteria. PHQ ⫽
Patient Health Questionnaire; GAD ⫽ Generalized Anxiety Disorder.
Figure 3. The relationship between polysymptomatic distress scale (PSD) and relevant covariates. The grey area represents 95%
confidence intervals. The P values for the fractional polynomial regression models were ⬍0.001 for all models. There is no evidence of
discontinuity or important nonlinearity over the relevant ranges. BMI ⫽ body mass index.
anticipated. The Type B criterion was added to capture Definitive evidence to support or refute this view will
those persons who had all of the symptoms of fibromyalgia come from primary care or community samples, not the
but not enough painful areas. Prior to the 1990 ACR crite- study of specialist populations.” Croft et al posed the
ria, the requirement for painful regions and tender points question: “More pain, more tender points: is fibromyalgia
was less strict (26). The 2010 criteria recognized this and just one end of a continuous spectrum?” (31). In a study of
the clinical need to slightly relax requirements imposed by clinical data, Wolfe concluded that “Tender points are
the 1990 criteria. linearly related to fibromyalgia variables and distress, and
The current study noted that the mean level of WPI and there is no discrete enhancement or perturbation of fibro-
the prevalence of fibromyalgia did not differ significantly myalgia or distress variables associated with very high
by sex, although there was a nonsignificant female pre- levels of tender points” (32). The current study provides
dominance (59.6% versus 40.4%) among those with fibro- the type of evidence for fibromyalgia as the continuum that
myalgia (P ⫽ 0.372); for women, fibromyalgia prevalence Wessely and Hotopf stated was necessary.
was 2.4%, compared with 1.8% in men. Other population Although fibromyalgia in clinical practice is treated as
studies have found that rates of widespread pain for the a categorical disorder, the confirmation of fibromyalgia
sexes were similar, and that there was only a modest as a spectrum disorder has important research, clinical,
increase of fibromyalgia in women compared with men and societal connotations: “A study that takes the extreme
(25,27). By contrast, in clinical populations women con- end of the spectrum, represented by selected samples of
stitute as many as 90% of patients. Increased rates in patients referred to rheumatology or pain services, and
clinical populations have been attributed to the use of the compares them with non-fatigued controls, will produce
tender point count and sex differences in health-seeking a . . . categorical solution but for spurious reasons” (6).
behavior. George Ehrlich noted, however, that “No one has Future research, whether clinical or neurobiologic, must
FM until it is diagnosed . . . it has to be named by a doctor account for the continuum nature of fibromyalgia to be
to exist” (28). This observation underscores the difference valid.
between the number of people who satisfy criteria for The ACR 2010 criteria definition of fibromyalgia was
fibromyalgia and the number who actually seek care for constructed based on specialist physicians’ (experts) diag-
symptoms that are cast by physicians or patients as fibro- nosis of fibromyalgia using the ACR 1990 criteria. How-
myalgia. ever, there was no gold standard for patients designated as
We made use of the PSD scale to investigate whether having fibromyalgia in the 1990 criteria study, as the pres-
fibromyalgia was a categorical or dimensional disorder. ence of a fixed high number of tender points was not
The PSD scale arose after the publication of the 2010 required by most previous definitions (33–35), including
criteria, and was formed by adding together the 2 compo- the definition by Yunus et al in their 1981 criteria (26).
nents of the 2010 fibromyalgia diagnosis, the WPI and the Although one might conclude that the 1990 definition
SS score. Persons with fibromyalgia always have mini- of fibromyalgia was reasonable, it was also arbitrary.
mum levels of PSD of at least 12 regardless of whether they With that in mind, it is problematic to sustain the idea that
satisfy the Type A or Type B criterion. This allows fibro- a specific cut point accurately and validly separates dis-
myalgia to be marked as a point on the PSD continuum. ease from nondisease or illness from nonillness, particu-
The PSD scale is linearly correlated with all measures of larly in view of the continuous nature of polysymptomatic
physical and psychological distress over relevant ranges distress.
(Figures 2 and 3). There is considerable uncertainty about the nature of
In deciding whether a disorder should be considered a fibromyalgia. Virtually every type of mental illness has
categorical or a dimensional illness, Kessler indicated that been found to be more common in fibromyalgia (36). Neu-
“The critical test should be whether the predictors are robiologic abnormalities and central sensitization have
consistently related to differences in symptom severity also been suggested as causes of fibromyalgia (37). At the
across the full relevant range of the dimensional distribu- other end of the spectrum, many disbelieve in the idea of
tion. If they are, then analysis of the dimensional version fibromyalgia, citing flaws in the conceptualization of the
of the symptom scale makes most sense . . .” (29). We illness as well as the continuous nature of polysymptom-
found the following strongly supportive of dimensional atic distress (28,38 – 45). One contribution to the nature of
illness. Figure 2 shows that fibromyalgia onset (PSD ⫽ 12) fibromyalgia based on this study, in addition to the dem-
lies at the end of the PSD continuum; 96.6% of all persons onstration of the continuous nature of polysymptomatic
in the general population have values less than 12. PSD is distress, is the exploration of the relationship of somatic
also correlated with dimensional measures of distress in symptom reporting and fibromyalgia. We found that PSD
the current study and in other samples (30). Figure 3, was strongly correlated with the PHQ-SSS (r ⫽ 0.790). In
which examines Kessler’s dictum using fractional polyno- addition, 20 subjects (38.5%) noted at least one severe
mial regression that is sensitive to nonlinearity, demon- problem in the 2010 criteria SS score and ⱖ1 severe so-
strates a smooth relationship between PSD and all relevant matic symptoms on the PHQ-SSS. From these data, it
covariates. would appear that approximately 40% of persons with
In a comprehensive review of fibromyalgia, Wessely and fibromyalgia satisfy the proposed DSM-V criteria for phys-
Hotopf wrote that they were “unaware of any study” that ical symptom disorder. The idea that fibromyalgia is pri-
supported the view that fibromyalgia was a categorical marily a somatic symptom disorder is well accepted in
disorder (6), and wrote that “fatigue and myalgia syn- the pain and psychological literature (46 – 48), but not in
dromes are arbitrarily created syndromes that lie at the the rheumatology community, where the dominant idea is
extreme end of the spectrum of polysymptomatic distress. central sensitization (49).
784 Wolfe et al
An important strength of this study is the high-quality Historical and epidemiological evidence. Baillieres Best Pract
survey in which 56.7% of the requested population agreed Res Clin Rheumatol 1999;13:427–36.
7. Hauser W, Schmutzer G, Brahler E, Glaesmer H. A cluster
to participate. Participation rates that high are difficult to
within the continuum of biopsychosocial distress can be la-
get, and a recent Mayo Clinic epidemiology study that beled “fibromyalgia syndrome”: evidence from a represen-
used the 2010 criteria had 27.7% participation (16.2% in tative German population survey. J Rheumatol 2009;36:
the age group 21–39 years) (50). A potential limitation of 2806 –12.
our study was that we did not exclude subjects whose 8. Benjamin S, Morris S, McBeth J, Macfarlane GJ, Silman AJ.
The association between chronic widespread pain and mental
symptoms were less than 3 months in duration. We made disorder: a population-based study. Arthritis Rheum 2000;43:
this choice in order to be able to consider nonfibromyalgia 561–7.
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10. McBeth J, Macfarlane GJ, Benjamin S, Silman AJ. Features of
alence did not change at the first decimal point by keeping somatization predict the onset of chronic widespread pain:
this subject. Another limitation is that we did not know results of a large population-based study. Arthritis Rheum
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fibromyalgia is a dimensional disorder, not a categorical a new measure for evaluating the severity of somatic symp-
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AUTHOR CONTRIBUTIONS tion and standardization of the Patient Health Questionnaire-
4 (PHQ-4) in the general population. J Affect Disord 2010;122:
All authors were involved in drafting the article or revising it
86 –95.
critically for important intellectual content, and all authors ap-
18. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A,
proved the final version to be published. Dr. Wolfe had full access
Duez NJ, et al. The European Organization for Research and
to all of the data in the study and takes responsibility for the
Treatment of Cancer QLQ-C30: a quality-of-life instrument for
integrity of the data and the accuracy of the data analysis.
use in international clinical trials in oncology. J Natl Cancer
Study conception and design. Brähler, Hinz, Häuser.
Inst 1993;85:365–76.
Acquisition of data. Brähler, Hinz.
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Analysis and interpretation of data. Wolfe, Brähler, Häuser.
Bottomly A, et al. The EORTC QLQ-C30 scoring manual. 3rd
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