Kathrin Bernardy

Efficacy of multicomponent treatment in fibromyalgia syndrome: a meta-analysis of randomized controlled clinical trials

OBJECTIVE To systematically review the efficacy of multicomponent treatment of fibromyalgia syndrome (FMS). METHODS We screened Medline, PsychINFO, Scopus, and the Cochrane Library (through December 2007), as well as reference sections of original studies, reviews, and evidence-based guidelines. Randomized controlled trials (RCTs) on the multicomponent treatment (at least 1 educational or other psychological therapy with at least 1 exercise therapy) of FMS were analyzed. RESULTS We included 9 (of 14) RCTs with 1,119 subjects (median treatment time 24 hours) in the meta-analysis. Effects were summarized using standardized mean differences (SMDs) or weighted mean differences (WMDs). There was strong evidence that multicomponent treatment reduces pain (SMD -0.37; 95% confidence interval [95% CI] -0.62, -0.13), fatigue (WMD -0.85; 95% CI -1.50, -0.20), depressive symptoms (SMD -0.67; 95% CI -1.08, -0.26), and limitations to health-related quality of life (HRQOL) (SMD -0.59; 95% CI -0.90, -0.27) and improves self-efficacy pain (SMD 0.54; 95% CI 0.26, 0.82) and physical fitness (SMD 0.30; 95% CI 0.02, 0.57) at posttreatment. There was no evidence of its efficacy on pain, fatigue, sleep disturbances, depressive symptoms, HRQOL, or self-efficacy pain in the long term. There was strong evidence that positive effects on physical fitness (SMD 0.30; 95% CI 0.09, 0.51) can be maintained in the long term (median followup 7 months). CONCLUSIONS There is strong evidence that multicomponent treatment has beneficial short-term effects on the key symptoms of FMS. Strategies to maintain the benefits of multicomponent treatment in the long term need to be developed.

Efficacy of Cognitive-Behavioral Therapies in Fibromyalgia Syndrome — A Systematic Review and Metaanalysis of Randomized Controlled Trials

Objective. We performed the first systematic review with metaanalysis of the efficacy of cognitive-behavioral therapies (CBT) in fibromyalgia syndrome (FM). Methods. We screened Cochrane Library, Medline, PsychINFO, and Scopus (through June 2009) and the reference sections of original studies and systematic reviews for CBT in FM. Randomized controlled trials (RCT) comparing CBT to controls were analyzed. Primary outcomes were pain, sleep, fatigue, and health-related quality of life (HRQOL). Secondary outcomes were depressed mood, self-efficacy pain, and healthcare-seeking behavior. Effects were summarized using standardized mean differences (SMD). Results. A total of 14 out of 27 RCT with 910 subjects with a median treatment time of 27 hours (range 6–75) over a median of 9 weeks (range 5–15) were included. CBT reduced depressed mood (SMD −0.24, 95% CI −0.40, −0.08; p = 0.004) at posttreatment. Sensitivity analyses showed that the positive effect on depressed mood could not be distinguished from some risks of bias. There was no significant effect on pain, fatigue, sleep, and HRQOL at posttreatment and at followup. There was a significant effect on self-efficacy pain posttreatment (SMD 0.85, 95% CI 0.25, 1.46; p = 0.006) and at followup (SMD 0.90, 95% CI 0.14, 1.66; p = 0.02). Operant behavioral therapy significantly reduced the number of physician visits at followup (SMD −1.57, 95% CI −2.00, −1.14; p < 0.001). Conclusion. CBT can be considered to improve coping with pain and to reduce depressed mood and healthcare-seeking behavior in FM.

Treatment of fibromyalgia syndrome with gabapentin and pregabalin--a meta-analysis of randomized controlled trials.

ABSTRACT The efficacy of gabapentin (GPT) and pregabalin (PGB) in the treatment of fibromyalgia syndrome (FMS) was assessed. We screened MEDLINE, PsycINFO, SCOPUS, www.clinicaltrials.org, the Cochrane Library (through October 2008), and the reference sections of original studies on GPT/PGB in FMS. Randomized controlled trials (RCTs) on the treatment of FMS with GPT and PGB were analyzed. Six out of 127 RCTs studying 2422 subjects on treatment with GPT (one study) or PGB (five studies) and 1056 subjects on placebo with a median treatment duration of 11 weeks were included into the systematic review. Five studies were suitable for meta‐analysis. Effects were summarized using standardized mean differences (SMD). There was strong evidence for a reduction of pain (SMD ‐0.28, 95% CI −0.36, −0.20; p < 0.001), improved sleep (SMD −0.39, 95% CI −0.48, −0.39; p < 0.001), and improved health‐related quality of life (HRQOL) (SMD −0.30, 95% CI −0.46, −0.15; p < 0.001), but not for depressed mood (SMD −0.12, 95% CI −0.30, 0.06; p = 0.18). There was strong evidence for a non‐substantial reduction of fatigue (SMD −0.16, 95% CI −0.23, −0.09, p < 0.001) and of anxiety (SMD −0.18, 95% CI −0.27, −0.10; p < 0.001). The external validity of the studies was limited because patients with severe somatic and mental disorders were excluded.

Comparative efficacy of pharmacological and non-pharmacological interventions in fibromyalgia syndrome: network meta-analysis

Objectives To synthesise the available evidence on pharmacological and non-pharmacological interventions recommended for fibromyalgia syndrome (FMS). Methods Electronic databases including MEDLINE, PsycINFO, Scopus, the Cochrane Controlled Trials Registry and the Cochrane Library were searched for randomised controlled trials comparing any therapeutic approach as recommended in FMS guidelines (except complementary and alternative medicine) with control interventions in patients with FMS. Primary outcomes were pain and quality of life. Data extraction was done using standardised forms. Results 102 trials in 14 982 patients and eight active interventions (tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors (SNRIs), the gamma-amino butyric acid analogue pregabalin, aerobic exercise, balneotherapy, cognitive behavioural therapy (CBT), multicomponent therapy) were included. Most of the trials were small and hampered by methodological quality, introducing heterogeneity and inconsistency in the network. When restricted to large trials with ≥100 patients per group, heterogeneity was low and benefits for SNRIs and pregabalin compared with placebo were statistically significant, but small and not clinically relevant. For non-pharmacological interventions, only one large trial of CBT was available. In medium-sized trials with ≥50 patients per group, multicomponent therapy showed small to moderate benefits over placebo, followed by aerobic exercise and CBT. Conclusions Benefits of pharmacological treatments in FMS are of questionable clinical relevance and evidence for benefits of non-pharmacological interventions is limited. A combination of pregabalin or SNRIs as pharmacological interventions and multicomponent therapy, aerobic exercise and CBT as non-pharmacological interventions seems most promising for the management of FMS.

Efficacy and safety of meditative movement therapies in fibromyalgia syndrome: a systematic review and meta-analysis of randomized controlled trials

A systematic review with meta-analysis of the efficacy and safety of meditative movement therapies (Qigong, Tai Chi and Yoga) in fibromyalgia syndrome (FMS) was carried out. We screened Clinicaltrials.Gov, Cochrane Library, PsycINFO, PubMed and Scopus (through December 2010) and the reference sections of original studies for meditative movement therapies (MMT) in FMS. Randomized controlled trials (RCT) comparing MMT to controls were analysed. Outcomes of efficacy were pain, sleep, fatigue, depression and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD [95% confidence interval]). Outcomes of safety were drop out because of adverse events and serious adverse events. A total of 7 out of 117 studies with 362 subjects and a median of 12 sessions (range 8–24) were included. MMT reduced sleep disturbances (−0.61 [−0.95, −0.27]; 0.0004), fatigue (−0.66 [−0.99, −0.34]; <0.0001), depression (−0.49 [−0.76, −0.22]; 0.0004) and limitations of HRQOL (−0.59 [−0.93, −0.24]; 0.0009), but not pain (−0.35 [−0.80, 0.11]; 0.14) compared to controls at final treatment. The significant effects on sleep disturbances (−0.52 [−0.97, −0.07]; 0.02) and HRQOL (−0.66 [−1.31, −0.01]; 0.05) could be maintained after a median of 4.5 (range 3–6) months. In subgroup analyses, only Yoga yielded significant effects on pain, fatigue, depression and HRQOL at final treatment. Drop out rate because of adverse events was 3.1%. No serious adverse events were reported. MMT are safe. Yoga had short-term beneficial effects on some key domains of FMS. There is a need for high-quality studies with larger sample sizes to confirm the results.

Efficacy of hypnosis/guided imagery in fibromyalgia syndrome--a systematic review and meta-analysis of controlled trials.

BackgroundRecent systematic reviews on psychological therapies of fibromyalgia syndrome (FMS) did not consider hypnosis/guided imagery (H/GI). Therefore we performed a systematic review with meta-analysis of the efficacy of H/GI in FMS.MethodsWe screened http://ClinicalTrials.gov, Cochrane Library, MEDLINE, PsycINFO and SCOPUS (through December 2010). (Quasi-) randomized controlled trials (CTs) comparing H/GI with controls were analyzed. Outcomes were pain, sleep, fatigue, depressed mood and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD).ResultsSix CTs with 239 subjects with a median of 9 (range 7-12) H/GI-sessions were analysed. The median number of patients in the H/GI groups was 20 (range 8-26). Three studies performed follow-ups. H/GI reduced pain compared to controls at final treatment (SMD -1.17 [95% CI -2.21, -0.13]; p = 0.03). H/GI did not reduce limitations of HRQOL at final treatment (SMD -0.90 [95% CI -2.55, 0.76]; p = 0.29) compared to controls. Effect sizes on fatigue, sleep and depressed mood at final treatment and follow-up and on pain and HRQOL at follow-up were not calculated because of limited data available. The significant effect on pain at final treatment was associated with low methodological and low treatment quality.ConclusionFurther studies with better treatment quality and adequate methodological quality assessing all key domains of FMS are necessary to clarify the efficacy of H/GI in FMS.

Efficacy of EMG- and EEG-Biofeedback in Fibromyalgia Syndrome: A Meta-Analysis and a Systematic Review of Randomized Controlled Trials

Objectives. Biofeedback (BFB) is an established intervention in the rehabilitation of headache and other pain disorders. Little is known about this treatment option for fibromyalgia syndrome (FMS). The aim of the present review is to integrate and critically evaluate the evidence regarding the efficacy of biofeedback for FMS. Methods. We conducted a literature search using Pubmed, clinicaltrials.gov (National Institute of Health), Cochrane Central Register of Controlled Trials, PsycINFO, SCOPUS, and manual searches. The effect size estimates were calculated using a random-effects model. Results. The literature search produced 123 unique citations. One hundred sixteen records were excluded. The meta-analysis included seven studies (321 patients) on EEG-Biofeedback and EMG-Biofeedback. In comparison to control groups, biofeedback (BFB) significantly reduced pain intensity with a large effect size (g = 0.79; 95% CI: 0.22–1.36). Subgroup analyses revealed that only EMG-BFB and not EEG-BFB significantly reduced pain intensity in comparison to control groups (g = 0.86; 95% CI: 0.11–1.62). BFB did not reduce sleep problems, depression, fatigue, or health-related quality of life in comparison to a control group. Discussion. The interpretation of the results is limited because of a lack of studies on the long-term effects of EMG-BFB in FMS. Further research should focus on the long-term efficacy of BFB in fibromyalgia and on the identification of predictors of treatment response.

Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial

This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference −12.4; 95% CI: −18.9; −5.9, p < 0.001) but not compared to sham (difference −3.0; 95% CI: −9.9, 3.9, p = 0.396). Further effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time.

Fibromyalgia, Facial Expression and Emotional Experience

Background: The present study aims at analyzing the nonverbal affective behavior of female fibromyalgia (FM) inpatients in comparison to healthy women. Methods: Videotaped psychodynamic interviews of each of 15 female FM inpatients and healthy women were analyzed. Afterwards the analyses of facial expression were related to gazing behavior and emotional experience. Results: FM patients exhibited neither a reduction in total activity of facial expression nor in absolute frequency of primary affects in comparison to healthy women, who, however, (also in eye contact) also exhibited a significantly higher proportion of ‘genuine joy’ and a lower one of ‘contempt’. No congruence between the patient’s emotional experience and affective expression was found. Conclusions: The absence of reduced total activity of facial expression is in contrast to the elaborate descriptions of complaints provided by the patients. Nevertheless, our detailed analysis shows a lack of elements that stabilize the relationship and the presence of dissociating elements in the interactions.