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Sempere-Rubio et al. | Journal of Clinical and Translational Research 2023; 9(6): 369-380   375
        intensity variable in favor of HEIs. In addition, Suso-Martí   a  significant  improvement  in  pain  intensity  variable  (n = 8).
        et al. [23] found that PNE showed statistically significant   Finally, Saracoglu  et al. [22] also found that adding PNE to a
        differences  reducing  post-intervention  pain  intensity  with   multicomponent  approach  resulted  in  a  statistically  significant
        a moderate clinical effect (n  =  7,  SMD  =  −0.76;  95%  CI:   decrease in pain intensity with a moderate clinical effect (n = 3,
        −1.33 – −0.19, P < 0.05, I  = 92%) but not at 3 months of   standardized mean differences (SMD) = −1.05; 95% confidence
                               2
        follow-up  (n  =  7,  SMD  =  −0.42;  95%  CI:  −0.93  –  0.08,   interval (CI): −1.4 – −0.69, P < 0.001, I =37.7%).
                                                                                                2
        P > 0.05, I  = 89%).
                 2
                                                                3.5.2.2. Quality of life
        3.5.1.2. Quality of life
                                                                   A total of four SRs offered at least one outcome for the quality of
          A total of two SRs offered at least one outcome for the quality   life variable [19-22]. Antunes et al. [19] found in one primary study
        of life variable [20,23]. Elizagaray-García et al. [20] found strong   that HEI plus multicomponent approach significantly improved
        evidence (n = 5) of HEI, in isolation, did not show significant   quality of life. Elizagaray-García et al. [20] found strong evidence
        improvements in improving quality of life in the short, medium,   (n = 4) of HEI plus therapeutic exercise significantly improved
        or long term. Finally, Suso-Martí et al. [23] found that PNE did   quality of life in the short, medium, and long term. García-Ríos
        not show statistically significant post-intervention improvements   et al. [21] reported that the best results in improving quality of
        in quality of life (n = 8, SMD = −0.37; 95% CI: −0.85 – 0.11,   life were found when a multicomponent approach was added to
        P > 0.05, I  =  91%). However, Suso-Martí  et  al. [23] found   HEIs. Finally, Saracoglu et al. [22] found that adding PNE to a
                  2
        statistically significant improvements in quality of life at 3 months   multicomponent  approach  resulted  in  a  statistically  significant
        of follow-up with a small clinical effect (n = 8, SMD = −0.44;   improve in quality of life with a moderate clinical effect (n = 4,
                                                                                                         2
        95% CI: −0.73 – −0.14, P < 0.05, I  = 89%).             SMD = −1.05; 95% CI: −1.3 – −0.79, P < 0.001, I  = 86%).
                                    2
        3.5.1.3. Functionality                                  3.5.2.3. Functionality
          One  SR  offered  at  least  one  outcome  for  the  functionality   A  total  of  two  SRs  offered  at  least  one  outcome  for  the
        variable  [20]. Elizagaray-García  et al. [20] found controversial   functionality  variable  [20,21]. Elizagaray-García  et al. [20]
        evidence (n = 3) of HEI, in isolation, did not show significant   found strong evidence (n = 3) of HEI plus therapeutic exercise
        improvements in improving functionality in the short term.  significantly improved functionality in the short and the medium
                                                                term. Finally, García-Ríos et al. [21] found that adding HEI to
        3.5.1.4. Anxiety                                        a multicomponent approach resulted in a statistically significant

          One SR offered at least one outcome for the anxiety variable [23].   improve in functionality (n = 3).
        Suso-Martí et al. [23] found no statistically significant differences in   3.5.2.4. Anxiety
        anxiety improvement either at post-intervention (n = 5, SMD = −0.06;
        95% CI: −0.67 − 0.55, P > 0.05, I  = 85%) or at 3-month follow-up   A total of two SRs offered at least one outcome for the anxiety
                                  2
        (n = 5, SMD = −0.07; 95% CI: −0.69 to 0.82, p>0.05, I =85%).  variable [21,22]. García-Ríos et al. [21] found that adding HEI to
                                                  2
                                                                a multicomponent approach resulted in a statistically significant
        3.5.1.5. Pain catastrophizing                           improve in anxiety (n = 4). Finally, Saracoglu et al. [22] found
                                                                that  adding  PNE  to  a  multicomponent  approach  resulted  in  a
          One SR offered at least one outcome for pain catastrophizing
        variable  [23]. Suso-Martí  et  al. [23] found  no statistically   statistically significant improve in anxiety with a moderate clinical
                                                                effect (n = 4, SMD = −0.711; 95% CI: −0.86 – −0.55, P < 0.001,
        significant differences in pain catastrophizing improvement either   I = 51.6%).
                                                                 2
        at post-intervention (n = 8, SMD = −0.10; 95% CI: −0.52 – 0.32,
        P > 0.05, I  = 89%) or at 3-month follow-up (n = 8, SMD = −0.16;   3.5.2.5. Pain catastrophizing
                2
        95% CI: −0.52 – 0.19, P > 0.05, I  = 86%).
                                  2
                                                                   A  total  of  two  SRs  offered  at  least  one  outcome  for  pain
        3.5.2. HEI (in combination with other interventions)    catastrophizing variable [21,22]. García-Ríos et al. [21] showed
                                                                contradictory  results with regard to the improvement  of pain
        3.5.2.1. Pain intensity                                 catastrophizing  variable  (n = 2). Finally, Saracoglu  et  al. [22]
          A  total  of  four  SR  offered  at  least  one  outcome  for  the   found that adding PNE to a multicomponent approach resulted
        pain intensity  variable  [19-22]. Antunes  et al. [19] found in   in  a  statistically  significant  improve  in  pain  catastrophizing
        one  primary  study  that  HEI plus  multicomponent  approach   with  a  moderate  clinical  effect  (n  =  3,  SMD  =  −0.89;  95%
                                                                                         2
        significantly reduced pain intensity. Elizagaray-García et al. [20]   CI: −1.43 – −0.34, P = 0.001, I  = 70.5%).
        found moderate evidence (n = 2) of HEI plus therapeutic exercise   4. Discussion
        showed  significant  improvements  in  reducing  pain  intensity  in
        the medium term although mixed results were found in the short   The main aim of this review was to assess the effectiveness
        term. García-Ríos  et al. [21] found that studies analyzing  the   of HEI in patients  with FMS.  We divided  the  results into  two
        impact  of HEI, in  combination  with other  approaches,  showed   groups:  When  HEI  were  evaluated  in  isolation  and  when  HEI
                                          DOI: http://dx.doi.org/10.18053/jctres.09.202306.23-00108
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