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Clinical Practice Guidelines Registry — Fibromyalgia

Last curated: 2026-08-28

Purpose. This registry catalogs the clinical practice guidelines, consensus recommendations, diagnostic-criteria documents, and regulatory decisions that govern (or historically governed) the diagnosis and management of fibromyalgia (FM) worldwide. It records documents — who issued them, what they cover, what each uniquely contributes, how they succeed one another, and where they verifiably disagree. The synthesis of what current guidelines actually recommend (therapy rankings, strength of recommendation) lives in the wiki page guidelines.md and is deliberately not duplicated here. FM is unusual among chronic diseases in three ways this registry must capture: (1) diagnostic criteria and management guidelines are issued by different bodies and evolve on separate tracks; (2) regulators disagree — the US FDA has approved four drugs for FM while the EMA has approved none — so regulatory decisions function as de facto standards alongside guidelines; and (3) the specialty that "owns" FM differs by country (rheumatology, pain medicine, psychosomatic medicine, primary care), which is visible in the issuing bodies below. Every PMID was retrieved from PubMed during the 2026-08-28 curation session; web-only sources are cited with URL and access date.

How to read status. current = newest document of its lineage and scope; current (aging) = still the newest of its lineage but old enough that its evidence base predates the current literature (FM guidelines age fast — the field's own comparison papers treat >5 years as stale); superseded by → = replaced by a named successor; expired = the issuing body's own validity period has lapsed with the update still pending (a formal status in the German AWMF system); criteria = a diagnostic-criteria or classification document that functions as a standard without being a management guideline; historical = documents an era, no longer operative. A superseded document remains historically important — the field's landmark shifts (tender points → symptom scales; drugs-first → exercise-first) are visible only in the chain.

1. Master table

# Society / body Year Region Scope Citation + PMID/URL Status
1 EULAR (revised recommendations) 2016 (print 2017) Europe Management (pharm + non-pharm), graduated approach Macfarlane et al., Ann Rheum Dis 2017;76:318–328. PMID 27377815 current (aging)
2 EULAR (original recommendations) 2007 (print 2008) Europe Management, 9 recommendations Carville et al., Ann Rheum Dis 2008;67:536–541. PMID 17644548 superseded by → #1
3 Canadian Pain Society + Canadian Rheumatology Association 2012 (publ. 2013) Canada Diagnosis, management, patient trajectory Fitzcharles et al., Pain Res Manag 2013;18:119–126 (PMID 23748251); J Rheumatol 2013;40:1388–1393 (PMID 23818709) current (aging)
4 AWMF S3 (13 German societies + 2 patient orgs, coord. German Pain Society), reg. 145/004 2017 (2nd update) Germany Definition, diagnosis, all therapy domains, children + adults Schmerz 2017;31(3) series: methods PMID 28493230; diagnosis PMID 28421273; drugs PMID 28493231; psychotherapy PMID 28493224; CAM PMID 28493227 expired (validity lapsed 04/2022; 3rd update registered)
5 AWMF S3, 1st update (coord. DIVS, 9 societies + 2 patient orgs) 2012 Germany Full management guideline Schmerz 2012;26(3) series: multicomponent PMID 22760461; CAM PMID 22760464 superseded by → #4
6 AWMF S3, original (10 societies + 2 patient orgs) 2008 Germany First interdisciplinary FM guideline worldwide with patient participation Schmerz 2008;22(3) series: treatment principles PMID 18478270; psychotherapy PMID 18458959 superseded by → #5
7 NICE NG193 2021 UK (England/Wales) Chronic primary pain (FM subsumed), assessment + management (NICE — "Chronic pain (primary and secondary) in over 16s", https://www.nice.org.uk/guidance/ng193, listing verified 2026-08-28); BMJ summary: Carville et al., BMJ 2021;373:n895. PMID 33883123 current
8 Sociedad Española de Reumatología (SER) 2021/2022 Spain 39 recommendations: diagnosis, harmful/ineffective interventions, education Rivera Redondo et al., Reumatol Clin 2022;18:131–140 (PMID 34649820) and 2022;18:260–265 (PMID 34538611) current
9 Israeli Rheumatology Association 2013 Israel Diagnosis + treatment (Hebrew; English abstract) Ablin et al., Harefuah 2013;152:742–747. PMID 24483001 current (aging)
10 Sociedade Brasileira de Reumatologia (SBR) 2026 Brazil Treatment, 2 parts: monitoring/non-pharm + pharm Heymann et al., Adv Rheumatol 2026;66:10 (part I, PMID 41546125) and 2026;66:9 (part 2, PMID 41572407) current
11 SBR — diagnosis guideline 2017 Brazil Diagnosis (9 PICO questions) Heymann et al., Rev Bras Reumatol Engl Ed 2017;57(S2):467–476. PMID 28800969 current (diagnosis lineage)
12 SBR — treatment consensus 2010 Brazil Treatment consensus Heymann et al., Rev Bras Reumatol 2010;50:56–66. PMID 21125141 superseded by → #10
13 American Pain Society (APS) 2005 USA Management guideline (adults + children); evidence review published in JAMA 2004 Goldenberg, Burckhardt, Crofford, JAMA 2004;292:2388–2395. PMID 15547167 (the APS guideline document itself is not PubMed-indexed) historical; no US successor exists
14 Ottawa Panel EBCPGs 2008 Canada Exercise only: aerobic (part 1) + strengthening (part 2) Brosseau et al., Phys Ther 2008;88:857–871 (PMID 18497301) and 873–886 (PMID 18497302) current (aging), single-modality
15 Japan College of Fibromyalgia Investigation (JCFI) 2013 (rev. reported 2017) Japan Practice guideline (Japanese-language, publ. Japan Medical Journal) JCFI is confirmed as a real Tokyo-based body from a PubMed author affiliation — "Japan College of Fibromyalgia Investigation (JCFI), Tokyo 160-0022, Japan" (Yokota S et al., J Clin Med 2021;10:801, PMID 33671159); the guideline document itself is not PubMed-indexed and its content remains [unverified] current for Japan [content unverified]
16 International multidisciplinary Delphi (EULAR + Canadian guideline authors + APS members) 2022 International Non-pharmacological treatments, core vs adjunctive, symptom-specific Kundakci et al., Semin Arthritis Rheum 2022;57:152101. PMID 36183478 current consensus (adjacent)
17 ACR classification criteria 1990 International Widespread pain + ≥11/18 tender points; research classification standard for 20 years Wolfe et al., Arthritis Rheum 1990;33:160–172. PMID 2306288 criteria; displaced in practice by #18–20, never formally retired
18 ACR preliminary diagnostic criteria 2010 International WPI + SS scale; abolished tender-point examination Wolfe et al., Arthritis Care Res 2010;62:600–610. PMID 20461783 criteria; modified by → #19, #20
19 Modified ACR 2010 (self-report "2011 criteria") 2011 International Survey/epidemiology self-report version; FS (polysymptomatic distress) scale Wolfe et al., J Rheumatol 2011;38:1113–1122. PMID 21285161 criteria (research); revised by → #20
20 2016 revision of 2010/2011 criteria 2016 International Generalized-pain criterion added; physician + questionnaire combined Wolfe et al., Semin Arthritis Rheum 2016;46:319–329. PMID 27916278 criteria; current de facto standard
21 AAPT (ACTTION–APS Pain Taxonomy, with FDA) 2019 USA/International Alternative diagnostic criteria + multidimensional taxonomy Arnold et al., J Pain 2019;20:611–628. PMID 30453109 (framework: Fillingim et al. 2014, PMID 24581634) criteria; competing with #20, neither retired
22 IASP/WHO ICD-11 chronic primary pain 2015/2019 Global Nosology: FM coded as chronic primary pain (disease in its own right) Treede et al., Pain 2015;156:1003–1007 (PMID 25844555); Treede et al., Pain 2019;160:19–27 (PMID 30586067); Nicholas et al., Pain 2019;160:28–37 (PMID 30586068) current nosology standard
23 Royal College of Physicians (UK) 2022 UK Diagnosis guidance for generalists (companion to NG193 era) Berwick, Barker, Goebel, Clin Med (Lond) 2022;22:570–574. PMID 36427885 (RCP guidance itself web-published) current
24 JCFI-affiliated authors (Japan) 2013 Japan Juvenile fibromyalgia: guidance for management — the field's only PubMed-indexed pediatric FM guidance Yokota, Kikuchi, Miyamae, Pediatr Int 2013;55:403–409. PMID 23758613 current (aging); added by 2026-08-28 audit
25 Chinese multidisciplinary group (WHO-handbook methods, GRADE, patient representatives) 2025 China Patient-version guideline: 13 clinical questions across 7 domains, derived from 13 existing guidelines, all recommendations strong Zhang et al., J Evid Based Med 2025;18:e70094. PMID 41410191 current; added by 2026-08-28 audit

Regulatory decisions functioning as de facto standards (verified this session):

Regulator Decision Year Source
FDA (USA) Approved pregabalin (Lyrica) for FM — first-ever FM indication 2007 web-search verified 2026-08-28 (multiple listings incl. AJMC, Johns Hopkins Lupus Center)
FDA Approved duloxetine (Cymbalta) for FM 2008 same
FDA Approved milnacipran (Savella) for FM 2009 same
FDA Approved cyclobenzaprine HCl sublingual (TNX-102 SL, Tonmya) for FM — fourth FM drug, first in >15 years 2025-08-15 (Tonix Pharmaceuticals — "FDA Approval of Tonmya", https://ir.tonixpharma.com/news-events/press-releases/detail/1585/, and HCPLive/AJMC coverage, search-verified 2026-08-28)
EMA (EU) Refused marketing authorisation for milnacipran (Milnacipran Pierre Fabre Médicament / Impulsor) for FM: CHMP negative opinion 23 Jul 2009, confirmed on re-examination 19 Nov 2009; effect judged "marginal", long-term EU data lacking 2009 (EMA — "Milnacipran Pierre Fabre Medicament / Impulsor" EPAR + refusal Q&A, https://www.ema.europa.eu/en/medicines/human/EPAR/milnacipran-pierre-fabre-medicament, search-verified 2026-08-28)
EMA No FM indication exists for pregabalin or duloxetine in the EU; the German 2017 guideline explicitly frames their FM use as off-label (Sommer et al., PMID 28493231). The specific EMA procedural documents for the pregabalin/duloxetine FM applications were not retrieved this session — [unverified beyond off-label status] 2008–2009 PMID 28493231 for off-label status

Count: 12 current/current-aging guideline-type documents (#1, 3, 7–11, 13, 14–16, 23; historical), 1 expired (#4), 5 superseded (#2, 5, 6, 12 + APS-as-lineage), 6 criteria/nosology standards (#17–22), 5 verified regulatory decisions.

2. Per-guideline entries

2.1 — EULAR revised recommendations (2016/2017) and original (2008)

  • Full citations: Macfarlane GJ, Kronisch C, Dean LE, et al. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017;76(2):318–328. PMID 27377815. — Carville SF, Arendt-Nielsen L, Bliddal H, et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008;67(4):536–541. PMID 17644548.
  • Scope: management only (EULAR issues no FM diagnostic criteria); multidisciplinary task force from 12 countries, review restricted to systematic reviews/meta-analyses, GRADE.
  • Unique contribution (2017): per the abstract, the only "strong for" therapy-based recommendation is exercise; all other evaluated therapies (psychological therapies, pharmacotherapy, multimodal rehabilitation) are "weak for"; management is staged — education and non-pharmacological therapy first, drugs reserved for severe pain or sleep disturbance; explicitly notes "the size of effect for most treatments is relatively modest." Patient representatives sat on the panel.
  • Predecessor/successor: the 2008 original assessed evidence only to 2005 and — per the 2017 abstract — consisted mostly of expert opinion; the 2017 comparison analysis by Thieme et al. (PMID 28034828) records that the 2008 version ranked pharmacotherapy highest while the 2016 revision ranks exercise highest — the clearest documented within-body reversal in FM guideline history. No newer EULAR revision was found in this session's searches (PubMed through 2026-08-28); the 2016 evidence review (search May 2015) is now >10 years old.

2.2 — 2012 Canadian Guidelines (CPS + CRA)

  • Full citations: Fitzcharles MA, Ste-Marie PA, Goldenberg DL, et al. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013;18(3):119–126. PMID 23748251. — Same authors, summary report: J Rheumatol. 2013;40(8):1388–1393. PMID 23818709.
  • Scope: diagnosis, treatment, and follow-up; Oxford CEBM evidence grading; endorsed by both the Canadian Rheumatology Association and the Canadian Pain Society (also used in the UK per Thieme 2017, PMID 28034828).
  • Unique contribution: the first national guideline to state that FM is "a positive clinical diagnosis, not a diagnosis of exclusion, and not requiring specialist confirmation," with ideal care located in primary care — the strongest published position on de-specializing FM. Also candid that "medications afford only modest relief, with doses often lower than suggested," and explicitly discourages any "culture of disablement."
  • Verified positions: per the Ablin 2013 three-guideline comparison (PMID 24348701), the Canadian guideline strongly recommends anticonvulsants (gabapentin/pregabalin) and SNRIs (duloxetine/milnacipran) — in direct contrast to the German weak recommendation — and recommends no complementary/alternative therapy.
  • Predecessor/successor: none newer found (searches of Fitzcharles's PubMed output through 2026-08-28); a 2025 narrative review by the same senior author (Clarke et al., Drugs 2025, PMID 40679776) still refers to the guideline generation above, implying no Canadian revision has appeared.

2.3 — German AWMF S3 guideline (reg. 145/004): 2008 → 2012 → 2017 → (update pending)

  • Full citations (representative papers of each version's Schmerz series): 2008: Klement et al. (treatment principles/patient education, PMID 18478270), Thieme et al. (psychotherapy, PMID 18458959) — developed with 10 societies + 2 patient self-help organizations. 2012 (1st update, coordinated by DIVS, 9 societies + 2 patient orgs; note the series carries the older registry number 041/004): Arnold et al. (multicomponent therapy, PMID 22760461), Langhorst et al. (CAM, PMID 22760464). 2017 (2nd update, coordinated by the German Pain Society, 13 societies + 2 patient orgs, 42-member panel): Häuser & Nothacker methods report (PMID 28493230), Eich et al. definition/diagnosis (PMID 28421273), Sommer et al. drug therapy (PMID 28493231), Köllner et al. psychotherapy (PMID 28493224), Langhorst et al. CAM (PMID 28493227), Üçeyler et al. etiology/pathophysiology (PMID 28493226).
  • Scope: the most granular FM guideline in the world — definition, classification, diagnosis, prognosis, all therapy domains, children and adolescents, published as complete/short/clinical-practice/patient versions.
  • Unique contributions (verified from abstracts): (a) diagnosis may be made either by ACR 1990 (with tender points) or by modified ACR 2010/2011 criteria (PMID 28421273) — the most explicit criteria-endorsement statement in any guideline; (b) drug therapy is deliberately restrictive: amitriptyline; duloxetine recommended specifically with comorbid depression or generalized anxiety; pregabalin with generalized anxiety; duloxetine/pregabalin use without those comorbidities is explicitly off-label in Germany; "strong opioids are not recommended" (PMID 28493231); (c) strong recommendations for CBT (PMID 28493224), multicomponent therapy (2012, PMID 22760461), and — uniquely among Western guidelines — meditative movement therapies (qi gong, tai chi, yoga) (PMIDs: 22760464, 28493227); homeopathy, supplements and reiki not recommended (PMID 22760464); (d) the guideline group empirically analyzed its own conflicts of interest and showed patient/multi-profession inclusion protects against COI-driven recommendations (Häuser et al., PMID 28455823); (e) a published editorial by the guideline leads frames 12 years of the guideline as "a never-ending war?" over FM's legitimacy (PMID 28493222); a companion comment clarifies that the weak-negative cannabis recommendation is "not an absolute no" (PMID 30259150).
  • Status: the 2017 version's validity formally lapsed in April 2022; AWMF register shows the update as registered/in progress, with the 2017 PDFs stamped "abgelaufen" (expired) (AWMF — Leitlinienregister 145-004, https://register.awmf.org/de/leitlinien/detail/145-004, status verified via web search 2026-08-28). Germany currently has no formally valid FM guideline — see watch list.

2.4 — NICE guideline NG193: chronic primary pain (2021)

  • Full citation: NICE. Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. NG193, April 2021 (NICE — https://www.nice.org.uk/guidance/ng193/chapter/recommendations, listing verified 2026-08-28). BMJ summary: Carville S, Constanti M, Kosky N, Stannard C, Wilkinson C. Chronic pain (primary and secondary) in over 16s: summary of NICE guidance. BMJ. 2021;373:n895. PMID 33883123.
  • Scope: NOT an FM guideline — a guideline for the ICD-11 category chronic primary pain, under which fibromyalgia (chronic widespread pain) is explicitly subsumed (classification verified via search of guideline content 2026-08-28; nosology basis: Nicholas 2019, PMID 30586068).
  • Unique contribution (verified): the only guideline that tells clinicians not to initiate — for chronic primary pain including FM — antiepileptics including gabapentinoids, opioids, NSAIDs, paracetamol, benzodiazepines, antipsychotics, ketamine, or corticosteroid trigger-point injections; antidepressants (off-label) are the one endorsed drug class, within a management approach centred on non-pharmacological care (content verified via web search of NG193 recommendations 2026-08-28). This places NG193 in direct contradiction with the FDA's approval of pregabalin for FM and with EULAR's (weak) endorsement of pregabalin — see §3.1.
  • Documented controversy: the Pain Net commentary "Not really nice" demands NICE "revise their recent guideline to take into account all the available evidence on the treatment of chronic primary pain" (Korwisi et al., Pain Rep 2021, PMID 34712885); the UK Faculty of Pain Medicine issued a formal "statement of clarification" on NG193 (FPM — https://fpm.ac.uk/media/3171, search-verified 2026-08-28); guideline authors later defended the medicines stance in a BMJ editorial (Stannard & Wilkinson 2023, PMID 36724987). NG193 is the only FM-relevant guideline whose reception generated its own correction/clarification literature.
  • Predecessor/successor: none within NICE for FM specifically; the RCP diagnosis guidance (#2.9) fills the diagnostic gap NG193 left.

2.5 — Spanish Society of Rheumatology (SER) recommendations (2021/2022)

  • Full citations: Rivera Redondo J, Díaz Del Campo Fontecha P, Alegre de Miquel C, et al. Recommendations by the Spanish Society of Rheumatology on Fibromyalgia. Part 1: Diagnosis and treatment. Reumatol Clin (Engl Ed). 2022;18(3):131–140. PMID 34649820. — Part II (patient education and practitioner training): Reumatol Clin (Engl Ed). 2022;18(5):260–265. PMID 34538611.
  • Scope: 39 recommendations explicitly framed around preventing harm from avoidable clinical actions — a "less is more" guideline.
  • Unique contribution (verified from abstracts): NSAIDs, strong opioids and benzodiazepines "should be avoided due to side effects"; "no good evidence to justify the association of several drugs" (polypharmacy warning); "no good evidence to recommend any complementary medicine" (vs. the German strong-for on meditative movement — see §3.5); surgery discouraged without clear indication (more complications, less satisfaction); establishing the diagnosis itself "improves the patient's coping ... and reduces healthcare costs" — the strongest published claim that diagnosis is therapeutic. Panel included a patient member.
  • Predecessor/successor: supersedes older Spanish consensus documents (2006 SER consensus; 2011 interdisciplinary consensus — not retrieved this session, so not catalogued as entries).

2.6 — Israeli guidelines (2013) and the three-guideline comparison

  • Full citation: Ablin JN, Amital H, Ehrenfeld M, et al. [Guidelines for the diagnosis and treatment of the fibromyalgia syndrome]. Harefuah. 2013;152(12):742–747. PMID 24483001 (Hebrew; English abstract). Issued under the auspices of the Israeli Rheumatology Association.
  • Verified positions: SNRI antidepressants and GABA-related antiepileptics with regular aerobic exercise as integrated therapy (abstract); per the Ablin/Häuser comparison (PMID 24348701), Israel joins Canada in strongly recommending anticonvulsants and SNRIs (vs. German weak), and joins Germany in recommending acupuncture, hypnosis/guided imagery and tai chi (vs. Canada's no-CAM position).
  • Context: the comparison paper itself (Ablin et al., Evid Based Complement Alternat Med 2013, PMID 24348701) and the First Israeli Fibromyalgia Congress report (Amital et al., Isr Med Assoc J 2013, PMID 24449991) document the deliberate side-by-side construction of the Canadian, German and Israeli guidelines — the only trio of national FM guidelines ever formally cross-compared by their own authors.

2.7 — Brazilian Society of Rheumatology lineage (2010 → 2017 → 2026)

  • Full citations: Heymann RE et al. Brazilian consensus on the treatment of fibromyalgia. Rev Bras Reumatol. 2010;50(1):56–66. PMID 21125141. — Heymann RE et al. New guidelines for the diagnosis of fibromyalgia. Rev Bras Reumatol Engl Ed. 2017;57(S2):467–476. PMID 28800969. — Heymann RE et al. Brazilian Society of Rheumatology's fibromyalgia treatment guidelines — part I: monitoring and non-pharmacological management. Adv Rheumatol. 2026;66(1):10. PMID 41546125. — Heymann RE et al. Review of fibromyalgia treatment guidelines: part 2 — pharmacological treatment. Adv Rheumatol. 2026;66(1):9. PMID 41572407.
  • Scope and contribution: the major Latin American lineage. The 2026 pair — published January 2026, the newest national FM guideline in the world at curation date — reports Brazilian prevalence 2.5–5.5% with FM as the country's second most common rheumatologic disorder and calls for a structured interdisciplinary approach (part I abstract), and updates the recommendations using meta-analyses and systematic reviews plus SBR expert voting at ≥70% agreement under the "BASCE system", framing FM via central sensitization (part 2 abstract). The 2017 document is diagnosis-specific (9 PICO questions). The SBR also runs EpiFibro, a national registry tracking ACR 1990/2010 criteria fulfilment (Martinez et al., PMID 28343617).
  • Status: 2026 parts I/2 current; 2010 superseded; 2017 remains the diagnosis reference.

2.8 — American Pain Society guideline (2005) — and the missing US successor

  • Full citation of the evidence review: Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004;292(19):2388–2395. PMID 15547167. The APS guideline itself (Guideline for the Management of Fibromyalgia Syndrome Pain in Adults and Children, APS, 2005) is not PubMed-indexed; its content is documented in the Thieme 2017 comparison (PMID 28034828).
  • Verified positions: JAMA review — evidence supports low-dose tricyclics, cardiovascular exercise, CBT, and patient education; "no medical therapies ... specifically approved by the US FDA" (true in 2004, obsolete by 2007); stepwise program recommended. Per Thieme 2017, APS assigned its highest ranking to aerobic exercise, CBT, amitriptyline and multicomponent treatment.
  • Why it matters now: it is the last US management guideline for FM. No ACR management guideline for FM was found in this session's searches (negative finding, 2026-08-28) — US rheumatology issues criteria but has never issued FM treatment recommendations, and the APS lineage produced no successor. The US thus entered the era of four FDA-approved FM drugs with no current domestic guideline — see §3.7.

2.9 — Exercise-specific and adjacent consensus documents

  • Ottawa Panel EBCPGs (2008). Brosseau L, et al. Phys Ther. 2008;88(7):857–871 (aerobic, PMID 18497301) and 873–886 (strengthening, PMID 18497302). Cochrane-method, graded (A/B/C+) recommendations for aerobic and strengthening exercise in ACR-1990-defined FM; both conclude in favor "as a result of the emerging evidence ... although most trials were rated low quality." The only guideline-format documents devoted to the single intervention every FM guideline endorses.
  • International Delphi on non-pharmacological interventions (2022). Kundakci B, et al. Semin Arthritis Rheum. 2022;57:152101. PMID 36183478. Seventeen experts drawn from the EULAR and Canadian guideline groups and the APS; aerobic exercise, education, sleep hygiene and CBT voted core treatments for all four key symptoms (pain, fatigue, sleep, depression); mind-body exercise core for pain/fatigue/sleep; mindfulness core only for depression. Functions as an informal bridge between the aging Western guidelines.

2.10 — Diagnostic criteria and nosology standards (documents #17–22)

  • ACR 1990 (Wolfe et al., PMID 2306288): widespread pain + ≥11/18 tender points; sensitivity 88.4%, specificity 81.1% (abstract); abandoned the primary/secondary-concomitant distinction. Built for classification, used for diagnosis for two decades.
  • ACR 2010 preliminary (Wolfe et al., PMID 20461783): WPI + symptom severity scale, no tender points; ~25% of 1990-criteria patients no longer satisfied 1990 criteria at study time (abstract) — the criteria shift redefined the population.
  • 2011 modification (Wolfe et al., PMID 21285161): fully self-reported for research; the abstract warns it is "not to be used for self-diagnosis"; introduced the 0–31 FS/polysymptomatic-distress scale.
  • 2016 revision (Wolfe et al., PMID 27916278): adds a generalized-pain criterion to eliminate misclassification of regional pain; merges physician and questionnaire tracks; abstract states self-report remains invalid for individual clinical diagnosis. Important nuance: 2011/2016 are author revisions of an ACR-preliminary document, not formally ACR-ratified diagnostic criteria; no body has ever ratified diagnostic (as opposed to classification) criteria for FM.
  • AAPT 2019 (Arnold et al., PMID 30453109): ACTTION–APS partnership with the FDA; separate core criteria (multisite pain + fatigue/sleep problems ≥3 months) within a multidimensional framework; created explicitly because existing criteria were judged insufficiently clinician-practical (abstract). Competes with, rather than supersedes, the Wolfe lineage.
  • ICD-11 chronic primary pain (Treede 2015, PMID 25844555; Treede 2019, PMID 30586067; Nicholas 2019, PMID 30586068): FM is named in the 2019 abstracts as the exemplar condition in which "chronic pain may be conceived as a disease in its own right" — coded MG30.0x chronic primary pain (chronic widespread pain). This is the nosology on which NG193's scope rests, and it moves FM's classificatory home from musculoskeletal disease to pain disease.
  • RCP 2022 UK diagnosis guidance (companion paper: Berwick, Barker, Goebel, Clin Med 2022, PMID 36427885): written because UK patients face years-long diagnostic delay and NG193 does not handle diagnosis; supports clinician-made diagnosis of FM (abstract). Together with NG193 it splits UK guidance into a diagnosis document (RCP) and a management document (NICE) issued by different bodies.

3. Disagreements and gaps between guidelines

Each point below is limited to what retrieved abstracts, fetched pages, or search-verified listings support. Threshold-level synthesis belongs to guidelines.md.

Documented disagreements

  1. The gabapentinoid contradiction (NICE vs FDA vs EULAR) is real and verified. NG193 instructs UK clinicians not to initiate antiepileptics including gabapentinoids (or opioids, NSAIDs, paracetamol, benzodiazepines) for chronic primary pain, the category that includes FM (search-verified 2026-08-28); the FDA approved pregabalin specifically for FM in 2007 (search-verified); EULAR 2017 gives pharmacotherapy including pregabalin a "weak for" recommendation for severe pain/sleep disturbance (PMID 27377815); Canada and Israel strongly recommend anticonvulsants (PMID 24348701). The same molecule is simultaneously "approved indication," "conditionally recommended," "weakly recommended," and "do not start" depending on jurisdiction.
  2. The FDA–EMA divide: 4 approved drugs vs 0. FDA approvals: pregabalin 2007, duloxetine 2008, milnacipran 2009, sublingual cyclobenzaprine (Tonmya) 15 Aug 2025 (all search-verified). EMA: refused milnacipran/Impulsor in 2009 — CHMP judged the effect "marginal" with inadequate long-term European data (EMA refusal Q&A, search-verified) — and no FM indication exists for pregabalin or duloxetine in the EU; the German guideline itself labels their FM use off-label (PMID 28493231). Consequence: European guidelines recommend (weakly) drugs their own regulator declined to license for FM, and every European FM prescription of an "FDA-approved FM drug" is off-label.
  3. Exercise-first vs drugs-first — including a reversal inside EULAR. The Thieme/Turk comparison of APS 2005, AWMF 2012, Canadian 2013 and EULAR 2016 (PMID 28034828) documents that APS/CPS/AWMF gave their highest ranking to aerobic exercise, CBT, amitriptyline and multicomponent therapy, whereas EULAR 2016's only "strong for" is exercise — "contrary to the 2008 EULAR guidelines, which recommended pharmacotherapy." The comparison attributes the inconsistencies to differing inclusion criteria, outcomes, weighting systems and panel composition, and concludes "a guideline consensus is needed."
  4. Strength-of-drug-recommendation gradient. Verified from PMID 24348701 — anticonvulsants and SNRIs: strong (Canada, Israel) vs weak (Germany); Germany further restricts duloxetine/pregabalin to comorbid depression/anxiety states (PMID 28493231); Spain says avoid NSAIDs, strong opioids, benzodiazepines and drug combinations (PMID 34649820); NICE bars initiation of nearly all analgesic classes, leaving only antidepressants (search-verified). The one point of near-universal agreement is negative: strong opioids are recommended nowhere (Germany "not recommended," Spain "avoided," NICE "do not initiate").
  5. Complementary therapies split three ways. Germany strongly recommends meditative movement therapies (qi gong/tai chi/yoga) and allows acupuncture (PMIDs: 22760464, 28493227); Israel recommends acupuncture, hypnosis/guided imagery, tai chi (PMID 24348701); Canada recommends no CAM at all (PMID 24348701); Spain finds "no good evidence to recommend any complementary medicine" (PMID 34649820). Same trial base, opposite conclusions — the sharpest example of panel-composition effects in FM.
  6. No agreed diagnostic criteria — six live standards. ACR 1990, 2010, 2011-modified, 2016-revised, AAPT 2019, and ICD-11 CPP coding coexist; Germany 2017 explicitly authorizes either 1990 or modified 2010/2011 (PMID 28421273); Brazil issued a dedicated diagnosis guideline (PMID 28800969); the AAPT group judged all ACR versions clinically impractical enough to warrant new criteria (PMID 30453109); the 2016 revision's own abstract concedes the self-report version is invalid for individual diagnosis (PMID 27916278). No guideline has adopted AAPT 2019; no body has ratified any set as the diagnostic standard.
  7. Who owns FM — visible in the issuing bodies. Rheumatology societies own it in Europe's south and Latin America and Israel (EULAR, SER, SBR, Israeli RA); pain societies own or co-own it in North America and Germany (APS; Canadian Pain Society + CRA; German Pain Society coordinating 13 societies); the UK assigned management to a national HTA body (NICE) under a pain nosology and diagnosis to a generalist college (RCP); Canada explicitly relocates care to primary care with no specialist confirmation required (PMID 23818709). Meanwhile the US rheumatology society (ACR) produces criteria but has never produced management recommendations (negative finding this session) — FM is the rare disease whose criteria and care guidance come from different specialties.
  8. Nosology tension: entity vs category. ICD-11 dissolves FM into "chronic primary pain" for management purposes (PMIDs: 30586067, 30586068), which is exactly what NG193 operationalizes; the Pain Net commentary attacks the resulting evidence-lumping and demands revision (PMID 34712885); criteria documents (ACR lineage, AAPT) and the FDA's four FM-specific approvals treat FM as a discrete diagnosable entity. Whether FM-specific trials or CPP-wide evidence govern recommendations is an unresolved, structural disagreement.

Gaps no retrieved guideline resolves

  1. All guidelines rest on admittedly modest effects. EULAR: "size of effect for most treatments is relatively modest" (PMID 27377815); Canada: "medications afford only modest relief" (PMID 23818709); Häuser's pharmacology review: most patients discontinue for inefficacy or tolerability (PMID 24433463); the 2025 Cochrane-overview: duloxetine/milnacipran/pregabalin give ≥50% pain relief to about 1 person in 10 with moderate or severe pain, with no efficacy evidence beyond six months, while seven of the 21 reviews found no trials at all (carbamazepine, clonazepam, lamotrigine, phenytoin, oxycodone, topiramate, valproate) and seven more had inadequate data (Moore et al., PMID 39705187); the Cochrane overview of non-pharmacological therapy finds only low-certainty evidence even for exercise and CBT (PMID 37598586). No guideline yet integrates the 2025 evidence wave.
  2. Germany currently has no valid guideline. The 2017 AWMF document expired April 2022 with the third update still registered/in progress (AWMF register 145-004, search-verified 2026-08-28) — the world's most elaborate FM guideline apparatus is formally lapsed.
  3. The 2025 FDA approval of sublingual cyclobenzaprine (Tonmya) post-dates every guideline. No catalogued document evaluates it; amitriptyline-era tricyclic recommendations are its only proxy.
  4. Pediatric/juvenile FM is nearly guideline-free. The German S3 series covers children and adolescents (per AWMF summary, search-verified); NG193 applies only to over-16s. One dedicated juvenile-FM management guidance document does exist and is PubMed-indexed — Yokota S, Kikuchi M, Miyamae T. Juvenile fibromyalgia: guidance for management. Pediatr Int. 2013;55:403–9. PMID 23758613 (Japan Pediatric Society journal; diagnosis by history, 18 tender points and allodynia plus negative bloods; goals stated as restoration of function and pain relief, with psychological support advocated) — but no society-issued juvenile FM guideline in the sense of the documents catalogued above was found. This entry needs a full catalogue row (added 2026-08-28 audit).
  5. Cannabinoids lack any positive guideline home: Germany issued a weak-negative recommendation whose own authors published a clarification that weak-negative "is not an absolute no" (PMID 30259150); no retrieved guideline recommends them.
  6. Asian guideline coverage is thin but not empty, and no African or Australasian society guideline was found. Beyond Japan (JCFI 2013/2017, Japanese-language; see #15), a Chinese multidisciplinary group published an evidence-based patient version of a fibromyalgia guideline in December 2025 — Zhang Z, Zhou P, He N, et al. Patient version of guideline for fibromyalgia (2025 edition). J Evid Based Med. 2025;18(4):e70094. PMID 41410191 — built by WHO-handbook methods with patient representatives, three Delphi rounds and GRADE, covering 13 clinical questions across seven domains, all recommendations rated strong, and derived from 13 existing FM guidelines rather than a de-novo evidence review. It is a derivative patient-facing document, not a national clinician guideline, but it falsifies the earlier blanket negative finding and needs a full catalogue row (added 2026-08-28 audit). No African or Australasian society guideline was found — negative finding limited to what was searched 2026-08-28.

4. Watch list — what is likely to change next, and where to check

What Why it is likely to move Where to check
AWMF S3 fibromyalgia 3rd update (reg. 145/004) 2017 version formally expired 04/2022; update registered and overdue; German Pain Society coordinates https://register.awmf.org/de/leitlinien/detail/145-004; Schmerz
EULAR recommendations revision 2016 evidence search (May 2015) is >10 years old; 2008→2016 cycle was 8 years; the 2022 Delphi (PMID 36183478) reads as bridge work by the same authors eular.org recommendations page; Ann Rheum Dis; PubMed query EULAR fibromyalgia recommendations
NICE NG193 exceptional review / surveillance Formal FPM clarification statement, Pain Net demand for revision (PMID 34712885), authors' 2023 defense (PMID 36724987), and a 2025 registered systematic appraisal of CPP guidelines (PMID 40973368) all pressure the 2021 positions nice.org.uk/guidance/ng193 (history tab)
First guideline evaluation of Tonmya (sublingual cyclobenzaprine, FDA 2025-08-15) Fourth FDA approval, first in >15 years; no guideline covers it; will force US and then international updates FDA.gov; ir.tonixpharma.com; next AWMF/EULAR drafts
A new US management guideline (successor to APS 2005) US has 4 approved drugs and no current domestic guideline; AAPT infrastructure (ACTTION–APS–FDA) is the plausible vehicle J Pain; ACR/AAPM/US pain society sites
Canadian guideline revision 2012 document aging; Fitzcharles group still publishing state-of-therapy reviews (PMID 40679776) Canadian Rheumatology Association / Canadian Pain Society; J Rheumatol
Brazilian SBR 2026 guideline completion and uptake Parts I/2 published Jan 2026 (PMIDs: 41546125, 41572407); watch for citations and Portuguese clinical-practice versions Adv Rheumatol; reumatologia.org.br
AAPT criteria validation studies 2019 abstract promises feasibility/reliability/validity testing; adoption by any treatment guideline would end the criteria stalemate J Pain; PubMed query AAPT fibromyalgia validation
ICD-11 MG30.0 coding uptake and its effect on trial populations Reclassification changes epidemiology, reimbursement and trial eligibility; CPP-guideline appraisal underway (PMID 40973368) WHO ICD-11 browser; Pain
EMA position under new-drug pressure If Tonmya (or successors) file in the EU, EMA must revisit the FM indication it has always refused ema.europa.eu medicine search fibromyalgia
JCFI (Japan) guideline revision 2013 (rev. 2017) Japanese-language versions unverifiable in PubMed (the body is now confirmed via a PubMed author affiliation, PMID 33671159, but not the document's content); English publication would open it to comparison. Shumpei Yokota is the JCFI-affiliated author to track jcfi.jp; PubMed query fibromyalgia guideline Japan; PubMed author query Yokota S

Registry maintained under CONVENTIONS.md §3. All PMIDs retrieved from PubMed on 2026-08-28; EMA/FDA/NICE/AWMF/FPM/Tonix web sources verified by web search or fetch on the same date; items marked [unverified] could not be confirmed and must be re-verified before citation elsewhere. Recommendations synthesis: see guidelines.md.