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Table 1 Characteristics and results of the included reviews

From: An overview of systematic reviews of complementary and alternative therapies for fibromyalgia using both AMSTAR and ROBIS as quality assessment tools

Author
Date
Country
Studies included Intervention group Comparator group Type of included study;
no. of participants
Length of intervention:
no. of sessions:
follow up (range)
Diagnosis Meta-analysis conducted: Y/N main results Subgroup/sensitivity analysis conducted Y/N Risk of bias assessment/methodological quality Safety/
adverse events mentioned
Homoeopathy
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. TAUa
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. TAUa
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
Acupuncture
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 treatmentb
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
Chiropractic
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
Herbal medicine
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
Multiple cam
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
  1. Italics = CAM plus another intervention
  2. aUsual care—one or more of the following physiotherapy, aerobic exercise, anti-inflammatory drugs, antidepressants
  3. bThree sham acupuncture groups combined
  4. cQuasi-experimental
  5. EA electro-acupuncture, TCA Traditional Chinese acupuncture, MA manual acupuncture, TPA trigger point acupuncture, ALI acupoint laser irradiation, AD antidepressants, AI anti-inflammatory, TAU treatment as usual, FU follow up, ACR American College of Rheumatology, IASR International Academy of Soreness Research, Nabilone cannabinoid extract, AEs adverse events, TPC tender point count, WL waitlist, TPP tender point pain, TPS trigger point stimulation, RCT randomised controlled trial, CCT controlled clinical trial, ROB risk of bias, FU follow-up, gp group, diffs differences, sess. sessions, VAS visual analogue scale, FIQ Fibromyalgia Impact Questionnaire, PPT pain pressure threshold, NR not reported, SMD standard mean difference, MD mean difference, MPQ McGill Pain Questionnaire, MPI multi-dimensional pain inventory, TDP specific electromagnetic spectrum treatment, indiv. individualised, RT resistance training