Effect of Acupuncture on Pain, Fatigue, Sleep, Physical Function, Stiffness, Well-Being, and Safety in Fibromyalgia: A Systematic Review and Meta-Analysis

Figures & data

Figure 1 Flow chart for research selection strategy based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement.

Notes: PRISMA figure adapted from Moher D, Liberati A, Altman D, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Journal of clinical epidemiology. 2009;62(10). Creative Commons.⁴³

Table 1 Characteristics of Included Studies

Source	Setting	Sample Size	Intervention	Treatment Duration	Outcome Measures	Time Point	Adverse Effects
Deluze et al, 1992	Switzerland	28/27	AG: EA (individually adapted); CG: Sham EA	6 sessions, 3 weeks	Pain: VAS (1–100 mm) sleep: VAS (10 is best) stiffness: minutes	Before and after treatment	Increase in symptoms, unpleasantness of needle insertion, ankle oedema, and hospitalized for unrelated condition
Sprott, 1998	Germany	10/10/10	AG: MA (individually adapted); CG1: simulated acupuncture CG2: no treatment	6 sessions, 2 sessions/week	Pain: VAS	Before and after treatment, 2 months after the treatment	NR
Assefi et al, 2005	USA	25/25/24/25	AG: MA (standardized) CG1: needling for unrelated condition CG2: sham needling CG3: simulated acupuncture	12 weeks, 2 sessions/week (24 sessions)	Pain: VAS (10 is worst pain); fatigue: VAS (10 is worst); sleep quality: VAS (10 is best); physical function: SF-36; well-being: VAS (10 is best)	Baseline, 1, 4, 8, and 12 weeks of treatment, and 3 and 6 months after treatment	Bruising, nausea, faint, discomfort.
Harris et al, 2005	USA	29/30/28/27	AG: MA (individually adapted) CG1: traditional site without stimulation CG2: nontraditional site with stimulation CG3: nontraditional site with no stimulation	18 sessions	Pain: VAS (0–100) fatigue: Multi-dimensional Fatigue Inventory physical function: SF-36	0, 3, 4, 8, 9, 13, 15 weeks	NR
Martin et al, 2006	USA	25/24	AG: EA (standardized) CG: simulated acupuncture	6 sessions for 2–3 weeks	Pain: FIQ; fatigue: FIQ; sleep: FIQ; physical function: FIQ; stiffness: FIQ; well-being: FIQ	Before and after treatment, at 1 month and 7 months after treatment	AG: mild vasovagal symptoms, mild bruising and soreness CG: pulmonary embolism
Harris et al, 2009	USA	10/10	AG: MA (individually adapted) CG: sham acupuncture	9 treatments, 4 weeks	Pain: SF-MPQ	0, 4 weeks	NR
Harte et al, 2013	USA	22/28	AG: MA (standardized) CG: sham acupuncture	9 sessions for 4 weeks	Pain: SF-MPQ	Before and after treatment	NR
Stival et al, 2014	Brasil	21/15	AG: MA (standardized) CG: sham acupuncture	1 session for 20 minutes	Pain: VAS	Before and after the proposed procedure	NR
Vas et al, 2016	Spain	80/82	AG: MA (individually adapted) CG: sham acupuncture	1 session/week, 9 sessions	Pain: VAS (0–100 mm); fatigue, sleep, stiffness, and well-being: FIQ; physical function: SF-12;	Baseline and at 10 weeks, 6 months, and 12 months after the 1st session	AG: post-acupuncture pain, post-acupuncture bruising, and post-acupuncture vagal symptoms
Uğurlu et al, 2017	Turkey	25/25	AG: MA (standardized) CG: sham acupuncture	12 sessions	Pain: VAS (0–10); fatigue: FSS; physical function: SF-36; well-being: FIQ	Baseline, 1 month and 2 months after the 1st session	NO
Zucker et al, 2017	USA	59/55	AG: MA (standardized) CG: sham acupuncture	18 sessions	Pain: VAS (0–100)	Before and after treatment	NR
Karatay et al, 2018	Turkey	24/25/23	AG: MA (standardized) CG1: sham acupuncture CG2: simulated acupuncture	8 sessions	Pain: VAS; sleep: NHP; physical function: NHP; well-being: FIQ	Baseline, after the last treatment, and 1 and 3 months after treatment	NO
Mawla al., 2021	USA	35/37	AG: EA (standardized) CG: mock laser acupuncture	8 weeks, 2 sessions/week	Pain: BPI	Before and after treatment	NR

Abbreviations: NA, not availability; NR, not reported; AG, acupuncture group; CG, control group; EA, electroacupuncture; MA, manual group; VAS, visual analogue scale; SF-36, short form-36; SF-12, short form-12; FIQ, fibromyalgia impact questionnaire; SF-MPQ, short form of McGill pain questionnaire; FSS, fatigue severity scale; BPI, brief pain inventory.

Figure 2 Bias risk assessment for included studies.

Table 2 Effect Sizes of Acupuncture Group Compared with Control Group on Selected Outcome Variables

Outcome Title	Number of Studies	Number of Patients	Effect Size SMD (95% CI)	Test for Overall Effect P-value	Heterogeneity I^2
Post-treatment
1.Pain	12	715	−0.42 [−0.66, −0.17]	0.0009	58%
2.Fatigue	4	251	−0.03 [−0.42, 0.35]	0.87	54%
3.Sleep	2	151	−0.38 [−0.78, 0.02]	0.06	0%
4.Physical function	3	268	0.14 [−0.51, 0.79]	0.67	83%
5.Stiffness	2	104	−0.38 [−0.77, 0.01]	0.06	27%
6.Well-being	4	357	−0.86 [−1.49, −0.24]	0.007	85%
Latest follow-up
1.Pain	4	356	−0.40 [−0.77, −0.03]	0.03	60%
2.Fatigue	2	145	0.04 [−0.52, 0.59]	0.90	58%
3.Sleep	2	98	−0.64 [−1.77, 0.49]	0.27	86%
4.Physical function	2	98	−0.25 [−0.91, 0.41]	0.46	63%
5.Well-being	3	307	−0.58 [−0.82, −0.35]	<0.00001	0%

Note: Bold text indicates that the P-value is less than 0.05.

Abbreviations: SMD, standardized mean difference; CI, confidence interval.

Figure 3 Forest plots of the analgesic effect of acupuncture in the post-treatment. (A) Subgroup analysis: manual acupuncture vs electroacupuncture. (B) Subgroup analysis: individual adapted acupuncture vs standardized acupuncture. (C) Subgroup analysis: less than 10 sessions vs more than 10 sessions.

Figure 4 The forest plot of adverse events.

Figure 5 Publication bias funnel plots of standard errors and effect sizes of the included studies.

Moher D, Liberati A, Altman D, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1–34.

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