Table 3.

Data Synthesis of the Studies applying Acupuncture in Patients with Fibromyalgia.

Study	Study Design	Sample Characteristics	Objectives	Interventions	Outcomes Assessed	Results	Conclusions
Collazo-Chao et al., 2010 [32]	Quasi-experimental study	n = 42 female patients with fibromyalgia	To evaluate the effectiveness of acupuncture as a combined modality therapy in reducing pain in paired groups (before-after) of patients with fibromyalgia in conditions of clinical practice and to determine the extent to which analgesic consumption is reduced in these patients after a cycle of acupuncture and to identify the adverse reactions due to acupuncture	EG: Acupuncture application (n = 42) 10 sessions	Pain intensity Pain frequency Analgesic intake Disability Sleep quality	After application of an acupuncture cycle, the total pain scale score decreased by 51.5%, intensity by 46.9%, frequency by 41.3%, analgesic intake by 54.3% and disability by 46.2%; sleep improved by 64.4%. Drug intolerance was found in 26.2% of the patients.	Acupuncture is highly effective in the combined treatment of fibromyalgia and consumes scant resources. The reduction in drug intake in patients with fibromyalgia decreases adverse effects and healthcare costs and improves quality of life and user satisfaction.
Collazo-Chao et al., 2012 [33]	Randomized controlled trial	n = 120 female patients with fibromyalgia	To evaluate the effectiveness of acupuncture and traditional Chinese dietary therapy as single therapies in reducing pain and improving quality of life in patients with fibromyalgia versus combined treatment with acupuncture and traditional Chinese dietary therapy	EG1: Acupuncture and dietary therapy (n = 30) EG2: Acupuncture (n = 30) EG3: Dietary therapy (n = 30) CG (n = 30) 10 sessions for 6 months follow-up	VAS of pain FIQ	Treatment with traditional Chinese dietary therapy alone did not improve fibromyalgia symptoms. The combination of traditional Chinese dietary therapy with acupuncture produced significant improvements (p < 0.05). At 6 months, the best results were achieved in the acupuncture group.	The application of TCDT together with acupuncture is an effective measure to improve the therapeutic approach, although acupuncture produced the greatest improvements.
Iannuccelli et al., 2012 [34]	Quasi-experimental study	n = 30 female patients with fibromyalgia	To combine two different acupunctural methods (the somatic and abdominal one) in the treatment of 30 consecutive female patients with fibromyalgia and to evaluate the reduction in pain and the improvement in well-being state	EG1: Somatic acupuncture (n = 15) EG2: Abdominal acupuncture (n = 15) Weekly sessions for 10 weeks	Pain, disability, psychologic health and quality of life by using: VAS of pain FIQ FAS HAQ ZSAS ZSDS	The results showed a statistically significant reduction in the number of tender points and in pain. Moreover, we observed a statistically significant reduction in FIQ, FAS, HAQ, disease activity VAS, ZSAS, ZSDS at the end of the treatment.	The combination of two types of acupuncture could be a useful complementary treatment in FM patients, not only to control pain but also to improve associated symptoms and quality of life. As a result, acupuncture could be very useful to relieve pain in a multidisciplinary setting.
Collazo-Chao et al., 2013 [35]	Randomized controlled trial	n = 62 female patients with fibromyalgia	To assess and compare the effectiveness of acupuncture and scalp acupuncture as exclusive therapies for alleviating pain and improving the quality of life in patients with fibromyalgia	EG1: Acupuncture (n = 31) EG2: Scalp acupuncture (n = 31) 10 sessions for 6 months follow-up	VAS of pain FIQ	The scalp acupuncture group showed significant differences on all variables compared to the acupuncture one, except for sleeping problems.	The scalp acupuncture protocol showed a remarkably higher effectiveness than the acupuncture protocol for treating fibromyalgia.
Collazo-Chao et al., 2014 [37]	Randomized controlled trial	n = 99 female patients with fibromyalgia	To assess the effectiveness of a moxibustion protocol and compare it to that of acupuncture and scalp acupuncture regarding alleviation of pain and improvement in the standard of living in patients with fibromyalgia	EG1: Acupuncture (n = 33) EG2: Moxibustion (n = 33) EG3: Scalp acupuncture (n = 33) 10 sessions for 6 months follow-up	VAS of pain FIQ	The scalp acupuncture group showed significant differences in all variables compared to the other two groups after 6 months; particularly, the pain scale values decreased by 28.23% and those of the VAS by 20%. No differences were found on the FIQ in any of the groups. There were significant differences (p < 0.01) after 6 months in analgesic use, favoring moxibustion over acupuncture.	The scalp acupuncture protocol used showed notably more effectiveness than the moxibustion protocol and acupuncture treatment after syndromic diagnosis in the management of fibromyalgia.
Stival et al., 2014 [38]	Double-blinded randomized controlled trial	n = 36 patients with fibromyalgia 31 women/5 men	To evaluate the efficacy of acupuncture in the treatment of fibromyalgia, considering the immediate response of the VAS of pain as its primary outcome	EG: Acupuncture (n = 21) PG: Sham acupuncture (n = 15)	VAS of pain	The variation between the final and initial VAS values was −4.36 ± 3.23 (p = 0.0001) in the treatment group and −1.70 ± 1.55 in the control group (p = 0.06). The difference in terms of amplitude of variation of VAS (initial—final VAS) among groups favored the actual procedure (p = 0.005). The effect size for the treatment group was d = 1.7, which is considered a large effect. Although small, the statistical power of the sample for these results was very relevant (94.8%).	Acupuncture has proven effective in the immediate pain reduction in patients with fibromyalgia, with a quite significant effect size.
Weber et al., 2015 [39]	Randomized controlled trial	n = 120 female patients with fibromyalgia	To investigate the effect of music combined with vibration on acupuncture points for the treatment of fibromyalgia	EG1: Bach’s music sequence EG2: Vibratory stimuli on a combination of acupuncture points on the skin EG3: Simultaneous and synchronized vibratory stimuli and Bach’s sequence CG: No stimulation 5 sessions on alternate days	FIQ HAQ	All groups showed a significant improvement in FIQ and HAQ scores at the evaluation after the intervention. The complete group exhibited the best result on both the FIQ and HAQ (p < 0.001), and the improvement in HAQ score was significant (p < 0.004).	The placebo effect in FM may be substantial. However, comparison between groups revealed that the complete group had the greatest reduction in both FIQ and HAQ, with a significant improvement in HAQ, suggesting that the combined use of music and vibration exerts a greater effect on FM symptoms.
Dias et al., 2016 [40]	Non-randomized controlled trial	n = 30 female patients with fibromyalgia	To compare three classical traditional Chinese medicine therapies: acupuncture, electroacupuncture and moxibustion in the management of pain and promotion of quality of life in patients with fibromyalgia	EG1: Acupuncture (n = 10) EG2: Electroacupuncture (n = 10) EG3: Moxibustion (n = 10) One session a week for 8 weeks	Pain: PPT WBFPS Quality of life: SF-36	There was no significant improvement in pain or reduction in tender points in any of the groups studied, at the end of the eighth session. Significant improvement in quality of life was perceived in vitality (after acupuncture treatment) and in mental health (after electroacupuncture and moxibustion treatments).	Traditional Chinese medicine therapies promoted an improvement in the quality of life in two areas (vitality and mental health) in women with fibromyalgia.
Vas et al., 2016 [41]	Double-blinded randomized controlled trial	n = 153 female patients with fibromyalgia	To evaluate the efficacy of an individualized acupuncture protocol for patients with fibromyalgia	EG: Acupuncture (n = 73) SG: Sham acupuncture (n = 80) Interventions once a week for 10 weeks	VAS of pain FIQ SF-12 questionnaire HDRS	Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p = 0.001) in the EG group (−41.0%, 95% CI −47.2% to −34.8%) than in the SG group (−27.1%, 95% CI −33.2% to −20.9%). During the follow-up period (6 and 12 months), significant differences (p < 0.01) in favor of the EG group persisted at 12 months (EG: −19.9%, 95% CI −24.6% to −15.1%; vs. SG: −6.2%, 95% CI −11.2% to −1.2%).	Individualized acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualized acupuncture in patients with fibromyalgia is recommended.
Iannuccelli et al., 2017 [43]	Quasi-experimental study	n = 30 patients with fibromyalgia and 20 healthy subjects to compare baseline scores	To assess the effects of an acupuncture cycle on serum NPY levels in patients with FM and identify possible correlations between its serum levels and clinical and clinimetric parameters	Acupuncture (n = 30)	Serum NPY levels NTP VAS of pain	The baseline serum NPY levels of the patients were higher than those of the controls. They had significantly increased by the end of the treatment, when there was also a statistically significant reduction in pain, the number of tender points numbers and the clinimetric scores.	These findings confirm the analgesic properties of acupuncture as a complementary treatment in FM and indicate that NPY could play a role in pain modulation.
Ugurlu et al., 2017 [44]	Randomized controlled trial	n = 50 female patients with fibromyalgia	To determine and to compare the efficacy of real acupuncture with sham acupuncture on fibromyalgia treatment	EG: Acupuncture (n = 25) SG: Sham acupuncture (n = 25) Interventions were 3 sessions in the first week, twice a week for 2 weeks and once a week in the following 5 weeks (total: 12 sessions)	VAS of pain SF-36 questionnaire FIQ BDI FSS	Both groups improved significantly in all parameters 1 month after the first session and this improvement persisted 2 months after the first session (p < 0.05). However, real acupuncture group had better scores than sham acupuncture score in terms of all VAS scores, BDI and FIQ scores either 1 or 2 months after the first session (all p < 0.05).	Acupuncture significantly improved pain and symptoms of fibromyalgia. Although sham effect was important, real acupuncture treatment seems to be effective in treatment of fibromyalgia.
Zucker et al., 2017 [45]	Randomized controlled trial	n = 114 patients with fibromyalgia	To assess the treatment response to verum and sham acupuncture on pressure pain tenderness in fibromyalgia patients	EG: Acupuncture (n = 59) SG: Sham acupuncture (n = 55) Interventions were from once a week to three times a week, increasing in three-week blocks for a total of 18 treatments	VAS of pain Needle sensation	Participants who had higher pain pressure thresholds had greater reduction in clinical pain following verum acupuncture, while participants who had lower pain pressure thresholds showed better analgesic response to sham acupuncture. Moreover, patients with lower pressure pain thresholds had exacerbated clinical pain following verum acupuncture. Similar relationships were observed for sensitivity to acupuncture needling.	Acupuncture efficacy in fibromyalgia may be underestimated, and a more personalized treatment for fibromyalgia may also be possible.
Karatay et al., 2018 [46]	Randomized controlled trial	n = 75 female patients with fibromyalgia	To evaluate the effects of acupuncture treatment on serum levels of serotonin and substance p as well as on clinical parameters in patients with fibromyalgia	EG: Acupuncture (n = 25) SG1: Sham acupuncture (n = 25) SG2: Simulated acupuncture (n = 25) Interventions were semiweekly for 4 weeks	NTP VAS FIQ BDI NHP	Serum serotonin values increased significantly after treatment in EG and SG1 (p < 0.001 and p < 0.01, respectively). The increase in the EG was also different from both of the other groups (p < 0.01). While substance p levels decreased in the EG, they increased in the SG2 (p = 0.001). In the EG, significant improvements were found in almost all clinical outcomes after treatment. These usually continued for three months. In the SG1, there were also significant changes in the NTP, VAS, FIQ and BDI scores after treatment. Improvements in the NTP and FIQ scores lasted for three months. In the SG, significant improvements were found only in the NTP, VAS and BDI scores after treatment.	Acupuncture, rather than sham or placebo acupuncture, may lead to long-term improvements in clinical outcomes and pain neuromediator values. Changes in serum serotonin and substance P levels may be a valuable explanation for acupuncture mechanisms in fibromyalgia treatment.
Mist et al., 2018 [47]	Randomized controlled trial	n = 30 female patients with fibromyalgia	To test the treatment effect of group acupuncture vs. group education in persons with fibromyalgia	EG1: Acupuncture (n = 16) EG2: Group education (n = 14) Twice a week for 10 weeks	Revised FIQ GFI	FIQR total, FIQR pain and Global Fatigue Index all had clinically and statistically significant improvement in the group receiving acupuncture at end of treatment and four weeks post-treatment but not in participants receiving group education between groups.	Compared with education, group acupuncture improved global symptom impact, pain and fatigue. Furthermore, it was a safe and well-tolerated treatment option, improving a broader proportion of patients than current pharmaceutical options.
Yuksel et al., 2019 [48]	Randomized controlled trial	n = 42 patients with fibromyalgia	To evaluate the effects of acupuncture and TENS applications on the quantitative EEG changes and to evaluate their therapeutic effects in patients with fibromyalgia	EG1: Acupuncture (n = 21) EG2: TENS (n = 21)	VAS of pain BDI FIQ Tender points PPT EEG	In the TENS group, after the treatment, an increase was observed in the alpha power of the left anterior region as well as a decrease in pain scores. In the acupuncture group, an increase was determined in the alpha power of the right and left posterior regions as well as a decrease in pain score after the treatment. The power of low- and moderate-frequency waves on resting EEG was decreased in the patients with fibromyalgia. Decreased pain and increased inhibitor activity were found on EEG after TENS and acupuncture applications.	TENS and acupuncture applications seem to be beneficial in fibromyalgia patients.
Ozen et al., 2019 [49]	An experimental effectiveness comparative study	n = 44 female patients with fibromyalgia	To compare the effects of physiotherapy modalities with those of acupuncture on pain, daily function and quality of life in fibromyalgia patients.	EG1: TENS (n = 22) 15 sessions Five consecutive sessions per week EG2: Acupuncture (n = 22) 10 sessions Once every 2 days for 3 weeks	SF-MPQ VAS of pain FIQ	There was a reduction in all SF-MPQ domains and FIQ scores after treatment in both the physical therapy and acupuncture groups. There was no difference in pre- and post-treatment scores between the two groups.	Physical therapy modalities and acupuncture can be effectively used in the treatment of fibromyalgia. Even though one treatment option was not found to be more beneficial than the other, longer post-treatment follow-up may help determine the superior treatment option.
Di Carlo et al., 2020 [51]	Quasi-experimental study	n = 96 patients with fibromyalgia 85 women/11 men	To explore the role of acupuncture, in terms of efficacy on main disease severity measures and pain features, in patients with nonresponsive disease despite optimal drug therapy	EG: Acupuncture (n = 96) Once a week during 8 weeks	FIQ PCS PDQ PHQ	At the end of the eight-week treatment, patients experienced a significant improvement in all evaluated parameters (for FIQ, PDQ and PHQ p < 0.0001; for PCS p = 0.001).	It can be stated that acupuncture can be proposed also in phases of high severity of disease. Intervention with multimodal strategies, including acupuncture, could be of great benefit to patients.
Garrido et al., 2020 [52]	Randomized controlled trial	n = 135 female patients with fibromyalgia	To investigate the effectiveness of a core stability training physiotherapy program vs. acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia	EG1: Core stability physiotherapy program (n = 45) EG2: Acupuncture (n = 45) CG (n = 45) 13 weeks duration	Static Balance Berg Balance Scale Timed up and go test 10 min walk test FHAQ FIQ	The results showed statistically significant improvements in the acupuncture and physiotherapy groups vs. the control group at week 6 regarding Berg Balance Scale (p = 0.00, both groups), timed up and go test (p = 0.00 and p = 0.01, respectively) and 10 m walk test at comfortable speed (p = 0.02 and p = 0.03, respectively). The 10 m walk test at maximum speed showed significance when comparing the physiotherapy and control group (p = 0.03). However, no significant differences were found between the physiotherapy and the acupuncture groups. In relation to functional capacity, the improvements achieved after the treatments were not statistically significant.	Core stability-based physiotherapy and acupuncture improve dynamic balance and postural control in women with fibromyalgia.
Schweiger et al., 2020 [53]	Randomized controlled trial	n = 54 female patients with fibromyalgia	To compare two alternative treatments (nutraceutical and acupuncture) in fibromyalgia patients through a randomized clinical trial.	EG1: Nutritional combination containing coenzyme Q10, vitamin D, Alpha-lipoic acid, magnesium, and tryptophan (n = 21) EG2: Acupuncture (n = 34) 3 months duration	FIQ FSS	EG1 showed a statistically significant reduction in pain 1 month after the start of therapy (T1, p = 0.025), strengthened after 3 months with maintenance of treatment (p = 0.012). The efficacy in reducing pain was apparent in the Acupuncture Group at all post-treatment determinations and at follow-up (T1 and T2 p ≤ 0.001). Regarding quality of life, improvement in FIQ-R and FSS values was revealed in both groups.	The nutritional combination assessed seems to be an effective option to for patients with fibromyalgia. Our experience confirmed also the validity of acupuncture in these patients. Considering the complexity of the management of fibromyalgia patients, our results suggest a cyclical and sequential, or even concurrent, treatment with different approaches to improve the efficacy and the compliance of patients to long-term treatment.
Garrido-Ardila et al., 2021 [54]	Randomized controlled trial	n = 135 female patients with fibromyalgia	To assess the effectiveness of a core stability training physiotherapy program compared to an acupuncture treatment on quality of life, pain, joint stiffness, difficulty to work and depression of women with fibromyalgia	EG1: Core stability physiotherapy program (n = 45) EG2: Acupuncture treatment group CG: No treatment 13 weeks of duration	FIQ Pain intensity Joint Stiffness Difficulty to work Depression	Only the difficulty to work measure in the acupuncture group showed a slight decrease at week 13. In particular, mean (±SD) Spanish Fibromyalgia Impact Questionnaire score at 6 weeks was 62.89 ± 16.91 for the physiotherapy group, 62.5 ± 18.09 for the acupuncture group and 67.45 ± 17.07 for the control group. However, these improvements were not statistically significant.	Core-stability-based physiotherapy and acupuncture showed non-significant improvements in quality of life, pain, joint stiffness, difficulty to work and depression in women with fibromyalgia.