Table 1 Characteristics and results of the included reviews

Perry [28]

2010

UK

1. Fisher [35]

2. Fisher [36]

3. Bell [37]

4. Relton [38]

1. Arnica, Bryonia, rhus tox

2. Rhus tox

3. Indiv. homoeopathy

4. Indiv. homoeopathy + TAU ^a

1. Placebo pill

2. Placebo pill

3. Placebo pill

4. TAU^a

RCTs

(1 crossover—assessed to first point only)

N = 163

1. 2× a day for 3 months

2. 3× a day up to crossover at 1 month

3. Daily dose up to crossover at 3 months

4. Daily dose for 22 weeks

No criteria reported

No:

1. Diff. found when remedy is well indicated

2. No diff. found (re-analysis of data)

3. Improvement in TPC and TPP on completers

4. No diff. in FIQ pain scores. In completers, sample greater reduction in MPQ scores (P < 0.05)

No

Jadad score plus additional assessment from Cochrane ROB

NR

Boehm [29]

2014

Germany

1. Fisher [35]

2. Fisher [36]

3. Bell [37]

4. Relton [38]

5. Egocheaga [40] CCT

1. Arnica, Bryonia, rhus tox

2. Rhus tox

3. Indiv. homoeopathy

4. Indiv. homoeopathy + TAU ^a

5. Antihomotoxic injection

1. Placebo pill

2. Placebo pill

3. Placebo pill

4. TAU^a

5. Placebo injection

4 RCTs, 1 CCT (plus 13 other types of study NR here)

N = 183

1. 2× a day for 3 months

2. 3× a day up to crossover at 1 month

3. Daily dose up to crossover at 3 months

4. Daily dose for 22 weeks

5. Injections 2× a week for 8 weeks

ACR criteria

Yes:

meta-analysis of 3 RCTs (n = 139): effects of homoeopathy on TPC (SMD = −0.42; 95% CI −0.78, −0.05; P = 0.03), I ² = 0%, compared to placebo

Meta-analysis of 2 RCTs and 1 CCT (n = 97): effects of homoeopathy on pain intensity (SMD = −0.54; 95% CI −0.97,−0.10; P = 0.02 I ² = 42%), compared to placebo

Homoeopathy had no effect on MPQ scores (2 RCTs)

Yes: (indiv. homoeopathy)

no longer an effect on pain intensity P = 0.15.

Heterogeneity reduced to I ² = 13% (P = 0.28)

Cochrane ROB

NR

Mayhew [43] 2007

UK

1. Martin [52]

2. Assefi [54]

3. Guo [53]^c

4. Sprott [50]

5. Deluze [51]

1. EA

2. TCA

3. (i) EA; (ii) DE

4. TCA

5. EA

1. Sham TCA

2. (i) Unrelated TCA for FM;

(ii) not acupuncture points;

(iii) Sham needling

3. AD, vit. B, oryzanol

4. Sham needling

5. Sham EA

4 RCTs, 1 quasi-RCT

N = 316

1. 6 sess. over 3 weeks, FU 1, 7 months

2. 24 sess., FU 3, 6 months

3. 28 sess. over 30 days, FU 6 months

4. 6 sess. over 3 weeks, FU 2 months

5. 6 sess. over 3 weeks

ACR criteria

No:

1. FIQ score improved more in TCA gp during study period (P = 0.01), at 1 month (P = 0.007) but not after 7 months (P = 0.24)

2. No diff. between TCA and pooled sham gp

3. Diff. between acupuncture gps and control

4. Number of TP decreased in TCA gp. This was not maintained at 2 months

5. Pain threshold improved by 70% in EA gp v 4%. Pain on VAS also improved more in EA gp

No

Jadad score

Yes

Daya [49]

2007

UK

1. Martin [52]

2. Assefi [54]

3. Singh [96]^c

4. Sandberg [97]

1. EA

2. TCA

3. TCA

4. TCA

1. Sham TCA

2. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) Sham needling

3.NR—no control arm

4. Crossover

3 RCTs (1 crossover), 1 quasi-RCT

N = 58 completed

1. 6 sess. over 3 weeks, FU 1, 7 months

2. 24 sess., FU 3, 6 months

3. NR

4. 10–14 sess. over 2–3 months

ACR criteria

No:

1. FIQ P = 0.007, 7 months, FU NS (P = 0.24)

2. No dif. between TCA and pooled sham gp for pain (P > 0.2) or number of pain meds used during active treatment^b

3. Pre-post data only

4. TPC = P = 0.03; medication intake P = 0.03; pain intensity P = 0.01

No

van Tulder

Yes

Langhorst [44] 2009

Germany

1. Assefi [54]

2. Deluze [51]

3. Harris [55]

4. Harris [56]

5. Lautensclauger [57]

6. Martin [52]

7. Sprott [50]

1. TCA

2. EA

3. TCA

4. TCA

5. TCA

6. EA

7. TCA

1. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) sham needling

2. Sham EA

3. Sham needling

4. Not acupuncture points

5. Sham needling

6. Sham EA

7. Sham needling

7 RCTs

N = 385

1. 24 sess., FU 3, 6 months

2. 6 sess. over 3 weeks

3. 18 sess. over 13 weeks

4. 9 sess. over 4 weeks

5. 6 sess. over 2 weeks

6. 6 sess. over 3 weeks, FU 1, 7 months

7. 6 sess. over 3 weeks, FU 2 months

6 used ACR

1 used criteria of generalised tendo-myapthia

Yes:

pooled analysis of 7 studies (n = 242) indicate strong evidence for the reduction of pain (SMD −0.25; 95% CI −0.49 to −0.02; P = 0.04, I ² = 1%) at post-treatment compared to sham/simulated acupuncture

Yes

Cochrane ROB

and van Tulden score

Yes

Martin-Sanchez [45]

2009

Spain

1. Lautenschlauger [57]

2. Deluze [51]

3. Sprott [50]

4. Assefi [54]

5. Harris [55]

6. Martin [52]

1. EA

2. EA

3. TCA

4. TCA

5. TCA

6. EA

1. Sham needling

2. Sham EA

3. Sham needling

4. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) sham needling

5. Not acupuncture points

6. Sham EA

6 RCTs

N = 323

1. 6 sess. over 2 weeks

2. 6 sess. over 3 weeks

3. 6 sess. over 3 weeks, FU 2 months

4. 24 sess., FU 3, 6 months

5. 18 sess. over 13 weeks

6. 6 sess. over 3 weeks, FU 1, 7 months

ACR criteria

Yes:

Pain intensity—pooled analysis of 4 studies (n = 257) indicated no diff. between gps from baseline: SMD 0.02 (95% CI −0.24 to 0.28). Considerable intra-study homogeneity was in evidence P = 0.41, I ² = 0%

No

NR

NR

Cao [47]

2013

China

1. Assefi [54]

2. Cao [98]

3. Deluze [51]

4. Gong [61]

5. Hadianfard [62]

6. Harris [55]

7. Harris [59]

8. Jiang [64]

9. Lautensclager [57]

10. Liu [99]

11. Liu [60]

12. Martin [52]

13. Ruan [61]

14. Sprott [50]

15. Targino [65]

16. Yao [63]

1. TCA

2. TA + cupping + AD

3. EA

4. TA

5. TA

6. TA

7. TA

8. (i) EA + cupping; (ii) EA + cupping + AD

9. TA

10. TA

11. (i) TA; (ii) TA + Vit B12

12. EA

13. Moxibustion

14. EA + basic therapy

15. TA + usual care

16. TA

1. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) sham needling

2. Seroxat (AD)

3. Sham needling

4. Amitriptyline (AD)

5. Fluoxetine (AD)

6. (i) Sham needling; (ii) unrelated TCA; (iii) sham needling in unrelated sites

7. Sham needling

8. Amitriptyline (AD)

9. Sham needling

10. Painkiller (ibuprofen)

11. Amitriptyline (AD)

12. Sham EA

13. Amitriptyline (AD)

14. Sham EA

15. AD + exercise (=usual care)

16. Amitriptyline (AD)

16 RCTs (12 in meta-analysis)

N = 1081

1. 24 sess., FU 3, 6 months

2. 9 sess. over 4 weeks

3. 6 sess. over 3 weeks

4. Once daily to 2× wkly for 12 weeks

5. 32 sess. over 8 weeks

6. 18 sess. over 13 weeks

7. 9 sess. over 4 weeks

8 (i) 12 sess. over 4 weeks; (ii) every day for 4 weeks

9. 6 sess. over 2 weeks

10. Every day for 2 weeks

11. Every day for 4 weeks

12. 6 sess. over 3 weeks, FU 1, 7 months

13. Every day for 4 weeks

14.4–8 sess. over 2–4 weeks, FU 2 months

15. 20 sess., FU 3, 6, 12, and 24 months

16. Every day for 4 weeks

15 used ACR

1 used IASR criterion

Yes:

Change in VAS pain score: no diff. between acupuncture and sham on reducing pain shown in pooled analysis of 7 arms: SMD −0.09 (95% CI −0.32, 0.14) P = 0.44 I ² = 2% or at post-treatment SMD −0.22, (95% CI −0.51 to 0.07) P = 0.13, I ² = 26%

Pooled analysis of 4 trials showed acupuncture was better than ADs in VAS pain scores: SMD −0.60 (95% CI −0.93 to −0.27, P = 0.0004, I ² = 22%

Yes

Cochrane ROB

Yes

Deare [48]

(Cochrane review)

2013

Australia

1. Assefi [54]

2. Deluze [51]

3. Guo [66]^c

4. Harris [55]

5. Harris [59]

6. Harris [59]

7. Itoh [67]

8. Martin [52]

9. Targino [65]

Restricted to acupuncture that penetrated the skin:

1. TCA

2. EA

3. TCA

4. TCA

5. TA

6. TA

7. EA or TPA

8. EA

9. TA + usual care

1. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) sham needling

2. Sham EA

3. Amitriptyline

4. (i) Sham needling; (ii) unrelated TCA; (iii) sham needling in unrelated sites

5. Sham needling

6. Sham needling

7. Less acupuncture

8. Sham EA

9. AD + exercise (usual care)

8 RCTs

1 quasi-RCT

N = 395

1. 24 sess., FU 3, 6 months

2. 6 sess. over 3 weeks

3. 28 sess. over 30 days, FU 6 months

4. 18 sess. over 13 weeks

5. 9 sess. over 4 weeks

6. 9 sess. over 4 weeks

7. 10 sess. over 5 weeks (after 5 weeks)

8. 6 sess. over 3 weeks, FU 1, 7 months

9. 20 sess., FU 3, 6, 12, and 24 months

ACR criteria

Yes:

Pain severity using VAS (100-mm NRS, MPI, and MPQ.

6 studies: no diff. between MA/EA and sham in reducing pain: SMD −0.14; 95% CI −0.53 to 0.24, P = 0.48. I ² = 54%.

Reduction in pain (VAS) for those treated with acupuncture compared with no acupuncture at the end of treatment. 1 study: mean diff. (MD) −22.40 points on a 100-point scale; 95% CI −40.98 to −3.82, P = 0.02)

Short-term benefit of acupuncture over ADs

1 study VAS = −17.3 on a 100-point scale; 95% CI −24.1 to −10.5

Yes

Cochrane ROB

Yes

Yang [46] 2013

China

1. Deluze [51]

2. Martin [52]

3. Harris [55]

4. Wang [100]

5. Guo [66] CCT

6. Guo [101] CCT

7. Wang [102]

8. Guo [53] CCT

9. Targino [65]

1. EA

2. EA

3. TCA

4. TCA + ALI

5. TCA

6. EA with TDP

7. TCA

8. (i) DE; (ii) EA

9. TCA + usual care

1. Sham EA

2. Sham EA

3. (i) Unrelated TCA; (ii) sham needling in unrelated sites

4. Amitriptyline

5. Amitriptyline

6. Fluoxetine

7. Amitryptaline + oryzanol + vit B1

8. (i) Amitriptyline; (ii) amitriptyline

9. AD + exercise (usual care)

6 RCTs + 3 CCTs

N = 592

1. 6 sess. over 3 weeks

2. 6 sess. over 3 weeks, FU 1, 7 months

3. 18 sess. over 13 weeks

4.20 days

5. 28 sess. over 30 days, FU 6 months

6. 4 weeks

7. 4 weeks

8. 45 days

9. 20 sess, FU 3, 6, 12, and 24 months

ACR criteria

Acupuncture V sham acupuncture: inaccurate meta-analyses—used control group from Harris (2005) twice

Acupuncture V AD at 45 days: inaccurate meta-analyses—used control group from Guo (2010) twice

Single studies used for the remaining meta-analyses

Yes: sub group analyses were completed but the meta-analyses were not conducted appropriately

Cochrane ROB

Yes

Ernst [73]

2009

UK

1. Blunt [69]

2. Tyers [72]^c

3. Wise [70]

4. Panton [71]

1. Chiropractic care

2. Chiropractic treatment + CES + rugs

3. Chiropractic adjustments + soft tissue therapy

4. Chiropractic + RT

1. WL

2. CES + drugs

3. Ultrasound or no treatment

4. RT only

3 RCTs + 1 quasi-RCT

N = unclear due to missing information

1. 4 weeks

2. 3× wk for 3 weeks

3. NR

4. 2× a week for 16 weeks

No criteria reported

No:

1. No diffs. on any outcomes

2. 34% pain reduction on VAS v 26% reduction in control, no statistical analysis provided

3. NR

4. No between group diffs. found but no analysis presented

No

Jadad score

No

de Souza Nascimento [75]

2013

Brazil

1. Casanueva [76]

2. McCarty [77]

3. Ware [78]

4. Skrabek [79]

5. Rutledge [80]

6. Ko [81]

7. Lister [82]^c

8. Lukaczer [83]^c

1. Capsaicin (T)

2. Capsaicin (T)

3. Nabilone (O)

4. Nabilone (O)

5. Oil24 (T) + exercise

6. Oil24 (T)

7. Coenzyme Q10 and ginko (O)

8. Meta050 (O)

1. TAU

2. TAU

3. Amitriptyline (AD)

4. Placebo

5. Peppermint oil + exercise

6. Peppermint oil

7. No control gp

8. No control gp

6 RCTs (1 crossover) + 2 observational studies

N = 475

1. 0.075% 3× a day for 6 weeks, FU at 6 weeks

2. 0.0025% 4× a day for 4 weeks

3. 0.5 to 1 mg for 2 weeks

4. 0.5 to 1 mg over 4 weeks, FU at 8 weeks

5. 3× a week for 12 weeks

6. 1 month

7. 12 weeks

8. 440 mg 3× day for 4 weeks then 880 mg 2× a day for 4 weeks

ACR criteria

No:

Capsicum:

1. Improvement in myalgic score, PPT, FSS, FIQ

2. Improvement in sensitivity and pain

Nabilone:

3. Similar to amitriptyline on pain rating

4. Decrease in pain in nabilone group

024 oil :

5. Pain score NR

6. Improvements noted on VAS for night pain rating

Meta 050:

7. No control gp so no relevant analysis

Coe10 and ginko:

8. No control gp so no relevant analysis

No

Jadad and Cochrane ROB

Yes

Holdcroft [30] 2003

USA

1. Deluze [51]

2. Feldman [103]

3. Fisher [36]

4. Blunt [69]

Multiple CAM (4 relevant):

1. EA

2. EA + amitryptaline (AD)

3. Rhus tox

4. Chiropractic

1. Sham needling

2. Sham needling and amitriptyline (AD)

3. Placebo pill

4. TAU (WL control)

4 relevant RCTs

N = 179

1. 6 sess. over 3 weeks

2. 16 weeks

3. 3× a day up to crossover at 1 month

4. 4 weeks

No formal diagnosis of FMS reported

No:

1. Pain threshold improved by 70 V 4% in the sham acupuncture group.

2. Pain differed between acupuncture and sham group

3 mean number of TP reduced by 25% and pain on VAS improved compared to placebo

4. P > 0.05 for chiropractic

No

Consort 22

Yes

Baronowsky [31] 2009

Germany

1. Assefi [54]

2. Deluze [51]

3. Martin [52]

4. Sprott [50]

5. Bell [37]

6. Blunt [69]

7. Gamber [74]

Multiple CAM (7 relevant):

1. TCA

2. EA

3. EA

4. EA + basic therapy

5. Indiv. homoeopathy

6. Chiropractic

7. Osteopathy

1. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) sham needling

2. Sham EA

3. Sham EA

4. Sham needling

5. Placebo pill

6. TAU (WL control)

7. (i) TAU; (ii) moist heat treatment

7 relevant RCTs

N = 357

1. 24 sess., FU 3, 6 months

2. 6 sess. over 3 weeks

3. 6 sess. over 3 weeks, FU 1, 7 months

4. 6 sess. over 3 weeks, FU 2 months

5. Daily dose up to crossover at 3 months

6. 4 weeks

7. Every week for 6 months

1. No diff. between gps

2. Improvement in treatment group in pain threshold

3. Improvement in FIQ (P = 0.01) and MPI (P = 0.03) up to 1 month

4. Decrease in TPC compared to usual care but not sham

5. Improvement in TPC and TP pain on palpation compared to placebo

6. No diffs. were found

7. Osteopathy gp better than control in pain threshold in 3 TP (plus some subcategories of various pain scales)

No

Yes: non-standardised quality scale (16 formal criteria)

No

De Silva [32]

2010

UK

1. Fisher [35]

2. Fisher [36]

3. Bell [37]

4. McCarty [77]

Multiple CAM (4 relevant):

1. Arnica, Bryonia, rhus tox

2. Rhus tox

3. Indiv. homoeopathy

4. Capsicum (T)

1. Placebo pill

2. Placebo pill

3. Placebo pill

4. TAU

4 relevant RCTs

N = 161

1. 2× a day for 3 months

2. 3× a day up to crossover at 1 month

3. Daily dose up to crossover at 3 months

4. 0.0025% 4× a day for 4 weeks

‘Recognised criteria for FM’

No:

Homoeopathy:

1. Rhus tox—improvement in TPC (P < 0.005)

2. Improved pain VAS P < 0.05

3. Improvement in TP pain, TPC compared with placebo

Capsicum:

4. Improvement in tenderness

No

Jadad score

Yes

Terhorst [33, 34]

2011, 2012

USA

1. Bell [37]

2. Fisher [36]

3. Relton [38]

4. Blunt [69]

5. Gamber [74]

6. Panton [71]

7. Assefi [54]

8. Deluze [51]

9. Harris [55]

10. Itoh [67]

11. Martin [52]

12. Jiang [64]

13. Targino [65]

Multiple CAM (13 relevant):

1. Indiv. homoeopathy

2. Rhus tox

3. Indiv. homoeopathy + usual care ^a

4. Chiropractic

5. Osteopathy

6. Chiropractic + RT

7 TCA

8. EA

9. TCA

10. EA or TPA

11. EA

12. (i) EA + cupping; (ii) EA + cupping + AD

13. TCA + usual care

1. Placebo pill

2. Placebo pill

3. TAU

4. TAU (WL control)

5. (i) TAU; (ii) moist heat treatment

6. RT only

7. (i) Unrelated TCA for FM; (ii) not acupuncture points; (iii) sham needling

8. Sham EA

9. Sham TCA

10. Less acupuncture

11. Sham EA

12. Amitriptyline (AD)

13. AD + exercise (usual care)

13 relevant RCTs

Acupuncture = 329

Manipulation = 52

Homoeopathy = 131

1. daily dose up to crossover at 3 months

2. 3× a day up to crossover at 1 month

3. Daily dose for 22 weeks

4. 4 weeks

5. Every week for 6 months

6. 4 weeks

7. 24 sess., FU 3, 6 months

8. 6 sess. over 3 weeks

9. 18 sess. over 13 weeks

10. 10 sess. over 5 weeks (after 5 weeks)

11. 6 sess. over 3 weeks, FU 1, 7 months

12. (i) 12 sess. over 4 weeks; (ii) every day for 4 weeks

13. 20 sess., FU 3, 6, 12, 24 months

ACR, Yunus or Smythe criteria

Acupuncture (6/7 studies)

A modest treatment effect in favour of acupuncture

Spinal manipulation (2/3 studies)

Both studies had effect sizes that were in the direction of the treatment group. No overall effect size was given because of the limited number of studies with very small sample sizes.

Homoeopathy (2/3 studies)

One homoeopathic study favoured the treatment group

No

GRADE

No