Acupuncture therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials

Figures & data

Figure 1 Review flow diagram.

Abbreviations: ACR, American College of Rheumatology; CBM, Chinese Biomedical Literature Database; CNKI, China National Knowledge Infrastructure; RCT, randomized controlled trial; VIP, Chinese Science and Technology Periodical Database.

Table 1 Characteristics of included studies

Study	Country	Diagnostic criteria	Sample size (AG/CG)	Interventions	Treatment period	Outcomes	Measurement time points (weeks)	Adverse events
Karatay et al 2018^Citation20	Turkey	ACR 1990 criteria	25/25/25 (all female)	AG: real MA CG1: sham acupuncture CG2: simulated acupuncture CG1 was selected as sham acupuncture group	8 sessions for 4 weeks, each session lasting 30 minutes	VAS FIQ	0, 4, 8, 16	NO
Ugurlu et al 2017^Citation19	Turkey	ACR 1990 criteria	25/25 (all female)	AG: real MA CG: sham acupuncture	12 sessions for 8 weeks, each session lasting 30 minutes	VAS FIQ	0, 4, 8	NO
Vas et al 2016^Citation18	Spain	ACR 1990 criteria	80/82 (all female)	AG: real MA CG: sham acupuncture	9 sessions for 9 weeks, each session lasting 20 minutes	VAS FIQ	0, 10, 24, 48	Not serious, mild
Stival et al 2014^Citation26	Brazil	ACR 1990 criteria	21/15 (female: 14/17)	AG: real MA CG: sham acupuncture	1 session for 20 minutes	VAS	Before and immediately after treatment	NR
Harte et al 2013^Citation27	USA	ACR 1990 criteria	22/28 (all female)	AG: real MA CG: sham acupuncture	9 sessions for 4 weeks, each session lasting 30 minutes	VAS SF-MPQ	0, 4	NR
Gong et al 2010^Citation28	China	ACR 1990 criteria	30/30 (female: 21/19)	AG: real MA CG: amitriptyline	AG: 36 sessions for 3 months, each session lasting 30 minutes CG: every day for 3 months	VAS	0, 12, 24	NR
Harris et al 2009^Citation29	USA	ACR 1990 criteria	10/10 (all female)	AG: real MA CG: sham acupuncture	9 sessions for 4 weeks	SF-MPQ	0, 4	NR
Martin et al 2006^Citation30	USA	ACR 1990 criteria	25/25 (female: 25/24)	AG: real EA CG: sham EA	6 sessions for 2–3 weeks	MPI FIQ	0, 3, 7, 31	Not serious, mild
Guo et al 2005^Citation31	China	ACR 1990 criteria	19/19 (female: 16/15)	AG: real MA CG: amitriptyline	AG: 28 sessions for 30 days, each session lasting 30 minutes CG: every morning for 30 days	VAS	0, 4	NR
Harris et al 2005^Citation32	USA	ACR 1990 criteria	29/30/28/27 (female: 29/27/24/26)	AG: traditional site with stimulation CG1: traditional site without stimulation CG2: nontraditional site with stimulation CG3: nontraditional site with no stimulation CG3 was selected as sham acupuncture group	18 sessions for 9 weeks, each session lasting 20 minutes	NRS	0, 3, 4, 8, 9, 10, 13, 15	NR
Assefi et al 2005^Citation33	USA	ACR 1990 criteria	25/25/24/25 (female: 22/24/24/24)	AG: real MA CG1: needling for unrelated condition CG2: sham needling CG3: simulated acupuncture CG2 was selected as sham acupuncture group	24 sessions for 12 weeks, each session lasting 30 minutes	VAS	0, 1, 4, 8, 12, 24, 36	Not serious, mild
Deluze et al 1992^Citation14	Switzerland	ACR 1990 criteria	36/34 (female: 33/21)	AG: real EA CG: sham EA	6 sessions for 3 weeks	VAS	0, 3	Not serious, mild

Abbreviations: ACR, American College of Rheumatology; AG, acupuncture group; CG, control group; EA, electro-acupuncture; FIQ, fibromyalgia impact questionnaire; MA, manual acupuncture; MPI, Multidimensional Pain inventory; NR, not reported; NRS, numeric rating scale; SF-MPQ, short form of McGill Pain Questionnaire.

Figure 2 Risk of bias summary.

Figure 3 Forest plot comparing real acupuncture vs sham acupuncture.

Notes: (A) Outcome: pain changes after treatment (VAS, 0–10 cm scale). (B) Outcome: pain changes after treatment (SF-MPQ). (C) Outcome: FIQ changes after treatment. (D) Outcome: long-term effect of pain changes (VAS, 0–10 cm scale). (E) Outcome: long-term effect of FIQ changes.
Abbreviations: EA, electro-acupuncture; FIQ, fibromyalgia impact questionnaire; MA, manual acupuncture; SF-MPQ, short form of McGill Pain Questionnaire.

Table 2 Effect size and GRADE quality of evidence

Certainty assessment							No. of patients		Effect	Certainty	Importance
No. of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Real acupuncture	Sham acupuncture	Absolute (95% CI)
Pain changes after treatment (VAS, 0–10 cm scale) – real acupuncture vs sham acupuncture
9	Randomized trials	Not seriousa	Seriousb	Not seriousc	Not seriousd	Nonee	266	262	MD 1.04 lower (1.70 lower to 0.38 lower)	⊕⊕⊕◯ Moderate	Critical
Pain changes after treatment (VAS, 0–10 cm scale) – real MA vs sham MA
7	Randomized trials	Not seriousa	Seriousb	Not seriousc	Not seriousd	Nonee	213	211	MD 1.14 lower (2.18 lower to 0.09 lower)	⊕⊕⊕◯ Moderate	Critical
Pain changes after treatment (VAS, 0–10 cm scale) – real EA vs sham EA
2	Randomized trials	Not seriousa	Not seriousf	Not seriousc	Seriousg	Publication bias strongly suspectedh	53	51	MD 0.94 lower (1.17 lower to 0.72 lower)	⊕⊕◯◯ Low	Critical
Pain changes after treatment (SF-MPQ scale) – real MA vs sham MA
2	Randomized trials	Not seriousa	Not seriousf	Not seriousc	Seriousg	Publication bias strongly suspectedh	32	38	MD 1.23 lower (4.74 lower to 2.27 higher)	⊕⊕◯◯ Low	Critical
FIQ changes after treatment – real acupuncture vs sham acupuncture
4	Randomized trials	Not seriousa	Seriousb	Not seriousc	Seriousg	Nonee	152	155	MD 13.39 lower (21.69 lower to 5.1 lower)	⊕⊕◯◯ Low	Critical
FIQ changes after treatment – real MA vs sham MA
3	Randomized trials	Not seriousa	Not seriousf	Not seriousc	Seriousg	Nonee	127	131	MD 16.72 lower (22.51 lower to 10.94 lower)	⊕⊕⊕◯ Moderate	Critical
FIQ changes after treatment – real EA vs sham EA
1	Randomized trials	Not seriousi	Not seriousj	Not seriousc	Seriousg	Publication bias strongly suspectedh	25	24	MD 2.7 lower (9.06 lower to 3.66 higher)	⊕⊕◯◯ Low	Critical
Long-term effect of pain changes (VAS, 0–10 cm scale) – real acupuncture vs sham acupuncture
3	Randomized trials	Not seriousa	Seriousb	Not Seriousc	Seriousg	Nonee	122	129	MD 1.58 lower (2.72 lower to 0.44 lower)	⊕⊕◯◯ Low	Critical
Long-term effect of pain changes (VAS, 0–10 cm scale) – real MA vs sham MA
2	Randomized trials	Not seriousa	Seriousb	Not seriousc	Seriousg	Publication bias strongly suspectedh	97	105	MD 2.06 lower (3.49 lower to 0.63 lower)	⊕◯◯◯ Very low	Critical
Long-term effect of pain changes (VAS, 0–10 cm scale) – real EA vs sham EA
1	Randomized trials	Not seriousi	Not seriousj	Not seriousc	Seriousg	Publication bias strongly suspectedh	25	24	MD 0.6 lower (1.78 lower to 0.58 higher)	⊕⊕◯◯ Low	Critical
Long-term effect of FIQ changes – real acupuncture vs sham acupuncture
3	Randomized trials	Not seriousa	Seriousb	Not seriousc	Seriousg	Nonee	122	129	MD 12.92 lower (24.92 lower to 0.93 lower)	⊕⊕◯◯ Low	Critical
Long-term effect of FIQ changes – real MA vs sham MA
2	Randomized trials	Not seriousa	Not seriousf	Not seriousc	Seriousg	Publication bias strongly suspectedh	97	105	MD 18.96 lower (26.69 lower to 11.23 lower)	⊕⊕◯◯ Low	Critical
Long-term effect of FIQ changes – real EA vs sham EA
1	Randomized trials	Not seriousi	Not seriousj	Not seriousc	Seriousg	Publication bias strongly suspectedh	25	24	MD 3.0 lower (8.98 lower to 2.98 higher)	⊕⊕◯◯ Low	Critical
Pain changes after treatment (VAS, 0–10 cm scale) – real acupuncture vs conventional medication
2	Randomized trials	Seriousk	Not seriousf	Not seriousc	Seriousg	Publication bias strongly suspectedh	49	49	MD 1.81 lower (2.43 lower to 1.18 lower)	⊕◯◯◯ Very low	Critical

Notes:

a <25% of studies had high risk of bias.

b I² is >50%.

c Direct comparison and outcomes.

d Total sample size is >400.

e No clear publication bias was detected.

f I² is <50%.

g Total sample size is <400.

h Only one study or two studies consider potential publication bias.

i The study had low risk of bias.

j Only one study and no inconsistency.

k Two studies had high risk of bias.

Abbreviations: EA, electro-acupuncture; FIQ, fibromyalgia impact questionnaire; MA, manual acupuncture; MD, mean difference; SF-MPQ, short form of McGill Pain Questionnaire.

Figure 4 Forest plot comparing real acupuncture vs conventional medication.

Notes: (A) Outcome: pain changes after treatment (VAS, 0–10 cm scale). (B) Outcome: long-term effect of pain changes (VAS, 0–10 cm scale).

Figure 5 Funnel plot comparing real acupuncture vs sham acupuncture.

Note: Outcome: pain changes after treatment (VAS, 0–10 cm scale).
Abbreviations: EA, electro-acupuncture; MA, manual acupuncture; SE, standard error; MD, mean difference.

Table S1 Reasons for excluded studies

Study	Reason for exclusion
Mist et al, 2018^Citation1	Acupuncture vs education
Ma et al, 2018^Citation2	Article in Chinese; not an RCT
AM et al, 2017^Citation3	Dry needling vs cross tape
Iannuccelli et al, 2017^Citation4	Not an RCT
Zucker et al, 2017^Citation5	Secondary analysis of original article Harris et al, 2005^Citation37
Li et al, 2016^Citation6	Article in Chinese; acupuncture + moxibustion vs Western medicine
Disa et al, 2016^Citation7	Acupuncture vs electro-acupuncture vs moxibustion
Yu et al, 2016^Citation8	Article in Chinese; acupuncture + herbal medicine vs Western medicine
Weber et al, 2015^Citation9	No acupuncture therapy
de Tommaso et al, 2014^Citation10	Cross-over study; only ten patients
Casanueva et al, 2014^Citation11	Dry needling vs medical treatment
Collazo et al, 2014^Citation12	Article in Spanish; acupuncture vs moxibustion vs scalp acupuncture
Shao et al, 2013^Citation13	Article in Chinese; data unusable
Collazo et al, 2013^Citation14	Article in Spanish; acupuncture vs scalp acupuncture
Hadianfard et al, 2012^Citation15	Different treatment period. Acupuncture group received therapy for 2 weeks and control group received fluoxetine orally for 8 weeks
Iannuccelli et al, 2012^Citation16	Not an RCT
Collazo et al, 2012^Citation17	Article in Spanish; acupuncture vs traditional Chinese dietary therapy
Itoh et al, 2010^Citation18	Five acupuncture treatments vs ten acupuncture treatments
Jiang et al, 2010^Citation19	Article in Chinese; acupuncture + cupping + Western medicine vs acupuncture + cupping vs Western medicine
Collazo et al, 2010^Citation20	Article in Spanish; not an RCT
Li et al, 2009^Citation21	Article in Chinese; lower Dan-Tian acupuncture vs conventional acupuncture
Zhao et al, 2009^Citation22	Article in Chinese; moxibustion + Western medicine vs Western medicine
Targino et al, 2008^Citation23	Acupuncture + tricyclic antidepressants + exercise vs tricyclic antidepressants + exercise
Harris et al, 2008^Citation24	Data unusable; only ten patients
Sun, 2008^Citation25	Article in Chinese; not an RCT
Li, 2007^Citation26	Article in Chinese; not an RCT
Li et al, 2006^Citation27	Article in Chinese; acupuncture + cupping + Western medicine vs vs Western medicine
Yao et al, 2006^Citation28	Article in Chinese; not an RCT; data unusable
Harris et al, 2006^Citation29	Secondary analysis of original article Harris et al, 2005^Citation37
Guo et al, 2005^Citation30	Data unusable
Wang et al, 2004^Citation31	Article in Chinese; not an RCT
Wang et al, 2002^Citation32	Article in Chinese; data unusable
Liu et al, 2002^Citation33	Article in Chinese; did not meet ACR criteria
Zhang et al, 2001^Citation34	Article in Chinese; data unusable
Sandberg et al,1999^Citation35	Cross-over study; only ten patients
Sprott et al, 1998^Citation36	Data unusable

Abbreviations: ACR, American College of Rheumatology; RCT, randomized controlled trial.

Table S2 Sensitivity analyses on pain changes after treatment

Real acupuncture vs sham acupuncture	Effect size	Heterogeneity
All studies	MD =−1.04, 95% CI (−1.70, −0.38)	I^2=78%
All studies except Ugurlu et al, 2017^Citation38	MD =−0.83, 95% CI (−1.47, −0.19)	I^2=72%
All studies except Stival et al, 2014^Citation39	MD =−0.90, 95% CI (−1.57, −0.22)	I^2=78%
All studies except Assefi et al, 2014^Citation40	MD =−1.21, 95% CI (−1.89, −0.53)	I^2=77%
All studies except Harris et al, 2005^Citation37	MD =−1.15, 95% CI (−1.84, −0.46)	I^2=80%
The studies with low risk of bias	MD =−0.65, 95% CI (−1.30, −0.01)	I^2=71%

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