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نقش دارودرمانی ترکیبی در مدیریت و درمان فیبرومیالژیا در بزرگسالان

Appendices

Appendix 1. Search strategies

Cochrane Central Register of Controlled Trials (CENTRAL) (via the Cochrane LIbrary)

#1 MeSH descriptor: [Fibromyalgia] this term only

#2 MeSH descriptor: [Myofascial Pain Syndromes] explode all trees

#3 (fibromyalgia* or fibrositi* or myofascial pain):ti,ab,kw (Word variations have been searched)

#4 #1 or #2 or #3

#5 MeSH descriptor: [Drug Therapy, Combination] explode all trees

#6 (combin* or cotreat* or co‐treat* or coadministr* or co‐administr* or synerg* or isobol* or "add on*" or polytherapy):ti,ab,kw (Word variations have been searched)

#7 #5 or #6

#8 #4 and #7

MEDLINE (OVID)

1 Fibromyalgia/

2 exp Myofascial Pain Syndromes/

3 (fibromyalgia$ or fibrositi$ or myofascial pain).tw.

4 or/1‐3

5 exp Drug Therapy, Combination/

6 (combin$ or cotreat$ or co‐treat$ or coadministr$ or co‐administr$ or synerg$ or isobol$ or "add on$" or polytherapy).tw.

7 or/5‐6

8 4 and 7

9 randomized controlled trial.pt.

10 controlled clinical trial.pt.

11 randomized.ab.

12 placebo.ab.

13 drug therapy.fs.

14 randomly.ab.

15 trial.ab.

16 or/9‐15

17 exp animals/ not humans.sh.

18 16 not 17

19 8 and 18

Embase (OVID)

1 Fibromyalgia/

2 Myofascial pain syndromes/

3 (fibromyalgia$ or fibrositi$ or myofascial pain).tw.

4 or/1‐3

5 exp Drug Therapy, Combination/

6 (combin$ or cotreat$ or co‐treat$ or coadministr$ or co‐administr$ or synerg$ or isobol$ or "add on$" or polytherapy).tw.

7 or/5‐6

8 4 and 7

9 random$.tw.

10 factorial$.tw.

11 crossover$.tw.

12 cross over$.tw.

13 cross‐over$.tw.

14 placebo$.tw.

15 (doubl$ adj blind$).tw.

16 (singl$ adj blind$).tw.

17 assign$.tw.

18 allocat$.tw.

19 volunteer$.tw.

20 Crossover Procedure/

21 double‐blind procedure.tw.

22 Randomized Controlled Trial/

23 Single Blind Procedure/

24 or/9‐23

25 (animal/ or nonhuman/) not human/

26 24 not 25

27 8 and 26

Appendix 2. GRADE: criteria for assigning grade of evidence

The GRADE system uses the following criteria for assigning a quality level to a body of evidence (Schünemann 2011b).

  • High: randomised trials; or double‐upgraded observational studies.

  • Moderate: downgraded randomised trials; or upgraded observational studies.

  • Low: double‐downgraded randomised trials; or observational studies.

  • Very low: triple‐downgraded randomised trials; or downgraded observational studies; or case series/case reports.

Factors that may decrease the quality level of a body of evidence are:

  • limitations in the design and implementation of available studies suggesting high likelihood of bias;

  • indirectness of evidence (indirect population, intervention, control, outcomes);

  • unexplained heterogeneity or inconsistency of results (including problems with subgroup analyses);

  • imprecision of results (wide confidence intervals);

  • high probability of publication bias.

Factors that may increase the quality level of a body of evidence are:

  • large magnitude of effect;

  • all plausible confounding would reduce a demonstrated effect or suggest a spurious effect when results show no effect;

  • dose‐response gradient.

Flow diagram

Figures and Tables -
Figure 1

Flow diagram

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Figures and Tables -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Summary of findings 1. Any combination of two or more drugs compared with placebo or other comparators, or both, for fibromyalgia

Any combination of two or more drugs compared with placebo or other comparators, or both, for fibromyalgia

Patient or population: adults with fibromyalgia

Settings: community

Intervention: any combination of two or more drugs (note: our searches found nine combinations of drugs)

Comparison: placebo and/or other comparators

Outcome

Result

GRADE

Patient‐reported pain relief of 30% or greater

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

Patient‐reported pain relief of 50% or greater

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

Patient‐reported global impression of clinical change much or very much improved (moderate improvement)

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

Any pain‐related outcome indicating some improvement

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

Participants experiencing any adverse event

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

Participants experiencing any serious adverse event

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

Withdrawals due to adverse events

No or insufficient data for analysis for any combination of drugs

Very low quality, as no data for analysis

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

Figures and Tables -
Summary of findings 1. Any combination of two or more drugs compared with placebo or other comparators, or both, for fibromyalgia
Table 1. Methodology of included trials

First author, year

Trial comparisons

Placebo‐controlled

Combination vs. only 1 component

Combination vs. both components

Combination vs. other

Albertoni Giraldes 2016

+

+

Bennett 2003

+

de Zanette 2014

+

Gilron 2016

+

+

Goldenberg 1986

+

+

Goldenberg 1996

+

+

Hussain 2011

+

Kravitz 1994

+

+

Nicolodi 1996

+

+a

Pridgen 2017

+

+

Quijada‐Carrera 1996

+

+

Russell 1991

+

+

Russell 1995

+

Vaeroy 1989

+

Vlainich 2010

+

Zucker 2006

+

aNicolodi 1996 compared a monoamine oxidase inhibitor, 5‐hydroxytryptophan, their combination, and amitriptyline.

Figures and Tables -
Table 1. Methodology of included trials