Review Article

Comparing Verum and Sham Acupuncture in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis

Table 1

Summary of the included studies.

Study IDSample sizeInterventionOutcomeParticipant’s blinding assessment
Acupuncture group (M : F)Control group (M : F)DurationAcupuncture groupControl group

Included in meta-analysis
Deluze [42]36 (3 : 33)34 (13 : 21)6 sessions over 3 weeksElectroacupuncture: four common points (the first dorsal interosseous muscle of the hand and the anterior tibial muscle on both sides) + 6 other points (according to patient’s symptoms and pattern)Nonacupoint electroacupuncture: 20 mm away from the electroacupuncture points[Pain]: VAS, pain threshold, regional pain score
[Sleep quality]: VAS
[General status]: patient’s appreciation, evaluating physician’s appreciation,
[Others]: VAS of morning stiffness, number of analgesic tablets during the last week
Not reported
Harris et al. [21]29 (0 : 29)(1) 30 (3 : 27)
(2) 28 (4 : 24)
(3) 27 (1:26)
18 sessions over 9 weeksManual acupuncture: GV20, LI11, LI4, GB34, ST36, SP6, LR3, Shenmen manipulation for De Qi (−)(1) Simulated acupuncture: same points as the verum acupuncture group, but the skin was not pierced.
(2) Nonacupoint acupuncture: nonacupoints determined by acupuncturists.
(3) Simulated acupuncture on nonacupoint: combination of 1 and 2
[Pain]: NRS
[Fatigue]: MDFI
[Others]: SF-36
The participants remained blinded at week 4 (Fisher’s exact χ2 = 7.531, P = 0.259)
Martin [43]25 (0 : 25)25 (1 : 24)6 sessions over 2-3 weeksElectroacupuncture: LI4, ST36, LR2, SP6, PC6, HT7, axial paramedian points along the bladder meridian at the cervical or lumbar spine. The sensation of De Qi or needle grab was not elicitedSimulated electroacupuncture: same points as the verum acupuncture group, but the skin was not pierced[Pain]: pain of FIQ, pain of MPI
[Sleep quality]: sleep of FIQ
[Fatigue]: fatigue of FIQ
[General status]: FIQ
[Others]: physical function, well-being, stiffness and anxiety, depression of FIQ, interference, life control, affective distress, and general activity level of MPI
Only 7 were correct in the control group (28%)
Harris [41]10 (0 : 10)10 (0 : 10)18 sessions over 9 weeksManual acupuncture: GV20, LI11, LI4, GB34, SP6, LR3, Shenmen, ST36 manipulation for De Qi (+)Unclassified acupuncture: non-skin-penetrating pricking sensation within similar body locations as the TCM acupuncture points[Pain]: SF-MPQ
[Others]: positron emission tomography
Only 1 was correct in the control group
Stival et al. [31]21 (4 : 17)15 (1 : 14)1 sessionManual acupuncture: LI4, ST36, LR2, SP6, PC6, HT7Nonacupoint acupuncture: 15 mm left away from the TCM acupuncture point[Pain]: VASNot reported
Vas et al. [30]82 (0 : 82)82 (0 : 82)9 sessions over 9 weeksManual acupuncture: 8 common points (LI4, PC6, SP6, LR3, BL18, BL20, SP6, GB34) + other points (according to patient’s symptoms and, pattern) manipulation for De Qi (+)Simulated acupuncture on inappropriate acupoints: acupuncture simulation (through guide tube) on the dorsal and lumbar regions[Pain]: VAS, pressure pain threshold, number of tender points
[General status]: FIQ
[Others]: depression of HAM, physical and mental of SF-12
Over 75% of the participants in both groups were confident that the intervention was real
Ugurlu et al. [33]25 (0 : 25)25 (0 : 25)12 sessions over 8 weeksManual acupuncture: LI4, ST36, LR3, GB41, GB34, GB20, SI3, SI4, BL62, BL10, SP6, HT7, GV20, GV14, KI27, CV6, PC6
Manipulation for De Qi (−)
Simulated acupuncture: park sham devices[Pain]: VAS
[fatigue]: FSS
[general status]: FIQ
[others]: SF-36, BDI
Not reported
Karatay et al. [32]25 (0 : 25)(1) 25 (0 : 25)
(2) 25 (0 : 25)
8 sessions over 4 weeksManual acupuncture: GV14, SI15, LI4, LI11, HT7, PC6, CV6, LR3, ST36, and SP6(1) Simulated acupuncture: blocking by bandage at the same points as TCM acupuncture.
(2) Nonacupoint acupuncture: 10–20 mm away from the TCM acupuncture points
[Pain]: VAS, number of tender points, pain of NHP
[Sleep quality]: sleep of NHP
[General status]: FIQ
[Others]: SF-36, BDI, NHP, serotonin, substance P
Not reported

Excluded from meta-analysis
Assefi et al. [12]25 (3 : 22)(1) 25 (1 : 24)
(2) 24 (0 : 24)
(3) 25 (1 : 24)
24 sessions over 12 weeksManual acupuncture: LI11, SP9, CV12, ST25, K7, TE5, Yintang, BL43, BL44, BL17, BL18, BL20, BL22, KI7(1) Simulated acupuncture: toothpick in the guide tube at identical points as the verum acupuncture group
(2) Nonacupoint acupuncture: body locations not recognized as true acupoints or meridians
(3) Acupuncture on points unrelated to FMS: acupoints for irregular menses or “early menses due to blood heat”
[Pain]: VAS
[fatigue]: VAS
[Sleep quality]: VAS
[Others]: well-being of VAS and physical and mental of SF-36
32% of participants believed they were receiving acupuncture specifically designed for fibromyalgia
Sprott [39]10(1) 10
(2) 10
6 sessions over 2 weeksManual acupuncture: various acupoints according to patient’s symptoms and pattern(1) Simulated laser acupuncture: disconnected laser equipment
(2) Waitlist
[Pain]: number of positive tender points, VAS, pain threshold
[General status]: interview
Not reported

VAS, visual analog scale; NRS, numerical rating scale; MDFI, multidimensional fatigue inventory; SF-36, 36-item short-form survey 36; FIQ, fibromyalgia impact questionnaire; MPI, multidisciplinary pain inventory; SF-MPQ, short form of the McGill pain questionnaire; HAM, Hamilton test score; SF-12, 12-item short-form survey; FSS, fatigue severity scale; BDI, Beck depression scale; HNP, Nottingham health profile; CPF, composite physical function scale.