A randomized controlled trial of dehydroepiandrosterone in postmenopausal women with fibromyalgia

OBJECTIVE: Patients with fibromyalgia (FM) consistently have adrenal hyporesponsiveness and low dehydroepiandrosterone (DHEA) levels. DHEA is promoted for and used by patients with FM. We tested the efficacy and safety of DHEA supplementation in ameliorating the symptoms of FM. METHODS: In a double-blind crossover study, postmenopausal women with FM were randomized to DHEA supplementation (50 mg/day) or placebo for 3 months, with a one-month washout period in between. Patients were assessed monthly for well-being and pain and by medical evaluations at the beginning and the end of each treatment period. The primary outcome was well being; secondary outcomes were pain, fatigue, cognition, sexuality, functional impairment, depression, and anxiety. RESULTS: A total of 52 patients were randomized, 47 patients completed the DHEA treatment period, and 45 the placebo treatment period. After 3 months of treatment with 50 mg of DHEA, median DHEA sulfate blood levels had tripled, but there was no improvement in well-being, pain, fatigue, cognitive dysfunction, functional impairment, depression, or anxiety, nor in objective measurements made by physicians. Androgenic side effects (greasy skin, acne, and increased growth of body hair) were more common during the DHEA treatment period (p = 0.02). CONCLUSION: DHEA does not improve quality of life, pain, fatigue, cognitive function, mood, or functional impairment in FM.     

Efficacy of a multidisciplinary fibromyalgia treatment adapted for women with low educational levels: A randomized controlled trial

Objective

Multidisciplinary treatments of fibromyalgia (FM) have demonstrated efficacy. Nevertheless, they have been criticized for not maintaining their benefits and for not being studied for specific populations. Our objectives were to determine the efficacy of a multidisciplinary treatment for FM adapted for patients with low educational levels and to determine the maintenance of its therapeutic benefits during a long‐term followup period.

Methods

Inclusion criteria consisted of female sex, a diagnosis of FM (using American College of Rheumatology criteria), age between 18 and 60 years, and between 3 and 8 years of schooling. Patients were randomly assigned to 1 of the 2 treatment conditions: conventional pharmacologic treatment or multidisciplinary treatment. Outcome measures were functionality, sleep disturbances, pain intensity, catastrophizing, and psychological distress. Analysis was by intent‐to‐treat and missing data were replaced following the baseline observation carried forward method.

Results

One hundred fifty‐five participants were recruited. No statistically significant differences regarding pretreatment measures were found between the 2 experimental groups. Overall statistics comparison showed a significant difference between the 2 groups in all of the variables studied (P < 0.0001). Mixed linear model analysis demonstrated the superiority of the multidisciplinary treatment in all of the studied variables at posttreatment. The differences were maintained at 12‐month followup in sleep disturbances (P < 0.0001), catastrophizing (P < 0.0001), and psychological distress (P < 0.01).

Conclusion

Multidisciplinary treatment adapted for individuals with low educational levels is effective in reducing key symptoms of FM. Some improvements were maintained 1 year after completing the multidisciplinary treatment.     

The efficacy of mindfulness meditation plus Qigong movement therapy in the treatment of fibromyalgia: a randomized controlled trial

OBJECTIVE: To test the short and longterm benefits of an 8 week mind-body intervention that combined training in mindfulness meditation with Qigong movement therapy for individuals with fibromyalgia syndrome (FM). METHODS: A total of 128 individuals with FM were randomly assigned to the mind-body training program or an education support group that served as the control. Outcome measures were pain, disability (Fibromyalgia Impact Questionnaire), depression, myalgic score (number and severity of tender points), 6 minute walk time, and coping strategies, which were assessed at baseline and at 8, 16, and 24 weeks. RESULTS: Both groups registered statistically significant improvements across time for the Fibromyalgia Impact Questionnaire, Total Myalgic Score, Pain, and Depression, and no improvement in the number of feet traversed in the 6 minute walk. However, there was no difference in either the rate or magnitude of these changes between the mind-body training group and the education control group. Salutary changes occurring by the eighth week (which corresponded to the end of the mind-body and education control group sessions) were largely maintained by both groups throughout the 6 month followup period. CONCLUSION: While both groups showed improvement on a number of outcome variables, there was no evidence that the multimodal mind-body intervention for FM was superior to education and support as a treatment option. Additional randomized controlled trials are needed before interventions of this kind can be recommended for treatment of FM.     

A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia

Sixty-two patients with fibromyalgia were randomly assigned to receive 25 mg of amitriptyline at night, 500 mg of naproxen twice daily, both amitriptyline and naproxen, or placebo in a 6-week, double-blind trial. Amitriptyline was associated with significant improvement in all outcome parameters, including patient and physician global assessments, patient pain, sleep difficulties, fatigue on awakening, and tender point score. Patients taking the combined naproxen-amitriptyline regimen experienced minor, but not significant, improvement in pain when compared with patients who took amitriptyline alone. Amitriptyline, or amitriptyline and naproxen, is an effective therapeutic regimen for patients with fibromyalgia.     

A six-month randomized controlled trial of exercise and pyridostigmine in the treatment of fibromyalgia

OBJECTIVE: A subset of fibromyalgia (FM) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 (IGF-1) axis, as evidenced by low serum levels of IGF-1 and a reduced growth hormone (GH) response to physiologic stimuli. There is evidence that pyridostigmine (PYD) improves the acute response of GH to exercise in FM patients. The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms. METHODS: FM patients were randomized to 1 of the following 4 groups: PYD plus exercise, PYD plus diet recall but no exercise, placebo plus exercise, and placebo plus diet recall but no exercise. The primary outcome measures were the visual analog scale (VAS) score for pain, tender point count, and total myalgic score. Secondary outcome measures were the total score on the Fibromyalgia Impact Questionnaire (FIQ) and FIQ VAS scores for individual symptoms (fatigue, poor sleep, stiffness, and anxiety), as well as quality of life (QOL) and physical fitness (lower body strength/endurance, upper and lower body flexibility, balance, and time on the treadmill). RESULTS: A total of 165 FM patients completed baseline measurements; 154 (93.3%) completed the study. The combination of PYD and exercise did not improve pain scores. PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups. Compared with the nonexercise groups, the 2 exercise groups demonstrated improvement in fatigue and fitness. PYD was generally well tolerated. CONCLUSION: Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms. However, PYD did improve anxiety and sleep, and exercise improved fatigue and fitness. We speculate that PYD may have improved vagal tone, thus benefiting sleep and anxiety; this notion warrants further study.     

Effects of an exercise programme on self-esteem, self-concept and quality of life in women with fibromyalgia: a randomized controlled trial

This study was aimed to investigate the effects of an exercise trial on self-esteem, self-concept and quality of life in patients with fibromyalgia and to evaluate whether improvements in psychological distress were related to changes in physical functioning. Twenty-eight women with a primary diagnosis of fibromyalgia were randomized to a usual care control group or to a 12-week supervised training programme consisting of 3 weekly sessions of aerobic, strengthening and flexibility exercises. Outcomes were physical functioning (Fibromyalgia Impact Questionnaire (FIQ), lower-body strength and flexibility) and psychological functioning (SF-36, Rosenberg self-esteem scale and Erdmann self-concept scale). Outcomes were measured at study entry and at the end of the intervention. Compared to the control group, statistically significant improvements in self-esteem, self-concept, FIQ, physical functioning, role physical, bodily pain, vitality, role emotional, social functioning, mental health, isometric strength, muscular endurance and flexibility were evident in the exercise group at the end of treatment. Self-esteem and self-concept scores were correlated positively with role emotional, mental health and the mental component summary of SF-36 and were negatively correlated to FIQ scores. No significant correlation existed between self-esteem or self-concept and isometric strength, muscular endurance or flexibility. Our results highlight the need for a broader array of physical and mental outcomes and the importance of examining patient’s perceptions in future research therapies.     

Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial

BACKGROUND: Self-management has increasingly been recommended as part of standard care for fibromyalgia, a common, poorly understood condition with limited treatment options. Data that assess popular self-management recommendations are scarce. We evaluated and compared the effectiveness of 4 common self-management treatments on function, symptoms, and self-efficacy in women with fibromyalgia. METHODS: A total of 207 women with confirmed fibromyalgia were recruited from September 16, 2002, through November 30, 2004, and randomly assigned to 16 weeks of (1) aerobic and flexibility exercise (AE); (2) strength training, aerobic, and flexibility exercise (ST); (3) the Fibromyalgia Self-Help Course (FSHC); or (4) a combination of ST and FSHC (ST-FSHC). The primary outcome was change in physical function from baseline to completion of the intervention. Secondary outcomes included social and emotional function, symptoms, and self-efficacy. RESULTS: Improvements in the mean Fibromyalgia Impact Questionnaire score in the 4 groups were -12.7 for the ST-FSHC group, -8.2 for the AE group, -6.6 for the ST group, and -0.3 for the FSHC group. The ST-FSHC group demonstrated greater improvement than the FSHC group (mean difference, -12.4; 95% confidence interval [CI], -23.1 to -1.7). The ST-FSHC (mean difference, 13.6; 95% CI, 2.3 to 24.9) and AE (mean difference, 13.1; 95% CI, 1.6 to 25.6) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey. Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC (14.8), AE (13.2), and ST (5.7) groups. Social function, mental health, fatigue, depression, and self-efficacy also improved. The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months. CONCLUSIONS: Progressive walking, simple strength training movements, and stretching activities improve functional status, key symptoms, and self-efficacy in women with fibromyalgia actively being treated with medication. The benefits of exercise are enhanced when combined with targeted self-management education. Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia.     

A randomized, controlled, trial of controlled release paroxetine in fibromyalgia

Purpose

We investigated the efficacy and tolerability of paroxetine controlled release, a selective serotonin reuptake inhibitor in fibromyalgia.

Methods

After excluding patients with current major depression and anxiety disorders, 116 subjects with fibromyalgia were enrolled in a 12-week, randomized, double-blind, placebo-controlled, trial of paroxetine controlled release (12.5-62.5 mg/day). The primary outcome measure was proportion of responders as defined as a ≥ 25% reduction in scores on the Fibromyalgia Impact Questionnaire (FIQ) from randomization to end of treatment. Secondary outcome measures included changes in FIQ scores, Clinical Global Impression -Improvement (CGI-I) and Severity (CGI-S) scores, Visual Analogue Scale for pain scores, number of tender points, and scores on the Sheehan Disability Scale (SDS).

Results

Significantly more patients in paroxetine controlled release group (57%) showed a ≥ 25% reduction in FIQ compared to placebo (33%) (P=.016). Paroxetine controlled release was significantly superior to placebo in reducing the FIQ total score (P =.015). The CGI-I ratings significantly favored the drug over placebo (P<.005). The improvements on other secondary outcome measures between the 2 groups were not statistically significant. Drowsiness, dry mouth, blurred vision, genital disorders, and anxiety were reported more frequently with paroxetine controlled release. The mean dose of paroxetine controlled release was 39.1 mg/day.

Conclusions

Paroxetine controlled release appears to be well-tolerated and improve the overall symptomatology in patients with fibromyalgia without current mood or anxiety disorders. However, its effect on pain measures seems to be less robust.     

Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: results of a randomized clinical trial

OBJECTIVE: Depressive symptoms are common among patients with fibromyalgia, and behavioral intervention has been recommended as a major treatment component for this illness. The objective of this study was to test the effects of the Mindfulness-Based Stress Reduction (MBSR) intervention on depressive symptoms in patients with fibromyalgia. METHODS: This randomized controlled trial examined effects of the 8-week MBSR intervention on depressive symptoms in 91 women with fibromyalgia who were randomly assigned to treatment (n = 51) or a waiting-list control group (n = 40). Eligible patients were at least 18 years old, willing to participate in a weekly group, and able to provide physician verification of a fibromyalgia diagnosis. Of 166 eligible participants who responded to local television news publicizing, 49 did not appear for a scheduled intake, 24 enrolled but did not provide baseline data, and 2 were excluded due to severe mental illness, leaving 91 participants. The sample averaged 48 years of age and had 14.7 years of education. The typical participant was white, married, and employed. Patients randomly assigned to treatment received MBSR. Eight weekly 2.5-hour sessions were led by a licensed clinical psychologist with mindfulness training. Somatic and cognitive symptoms of depression were assessed using the Beck Depression Inventory administered at baseline, immediately postprogram, and at followup 2 months after the conclusion of the intervention. RESULTS: Change in depressive symptoms was assessed using slopes analyses of intervention effects over time. Depressive symptoms improved significantly in treatment versus control participants over the 3 assessments. CONCLUSION: This meditation-based intervention alleviated depressive symptoms among patients with fibromyalgia.     

The effects of a three-month exercise programme on neuropsychological function in elderly institutionalized women: a randomized controlled trial

This randomized controlled trial examined the effect of a 3-month exercise programme on neuropsychological function in a population of very elderly institutionalized women. Baseline neuropsychological testing was performed, and following 3 months of exercise or control intervention, subjects were retested 3-7 days after the completion of the study period. Apart from the Word Fluency Test, there was no significant improvement in any of the neuropsychological test scores. This study may not have shown any significant improvement in neuropsychological function because our exercise programme was too light to improve aerobic fitness, or because neuropsychological tests were repeated 3-7 days after exercise was completed and any acute effects of exercise may have disappeared by that time.     

Investigation of effectiveness of reformer pilates in individuals with fibromyalgia: A randomized controlled trial

Introduction and objectivesFibromyalgia (FM) is a chronic condition characterized by widespread pain, sleep disorder, fatigue, other somatic symptoms. Clinical pilates method is therapeutic modality that can be used in improving the symptoms. The aim of this study was to investigate the effectiveness of reformer pilates exercises in individuals with FM and to compare with home mat pilates.Material and methodsTwenty-eight women (age mean = 45.61 ± 10.31) diagnosed with FM were included in this study. Participants were randomly divided into two groups as reformer pilates group (n = 14) and home mat pilates group (n = 14). Reformer and home mat pilates exercises were given 2 times a week for 6 weeks. The number of painful regions with Pain Location Inventory (PLI), clinical status with Fibromyalgia Impact Questionnaire (FIQ), lower extremity muscle strength with Chair Stand Test, functional mobility with The Timed Up and Go Test (TUG), biopsychosocial status with Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) and quality of life with Short Form-36 (SF-36) were evaluated. All evaluations were assessed before and after treatment.ResultsThere was a significant difference in FIQ and chair stand test in reformer pilates group, while in PLI, FIQ, BETY-BQ vs. SF-36 Physical Component in home group (p < 0.05) compared with baseline. There were no statistical differences between the groups in terms of delta value (p > 0.05).ConclusionsReformer pilates exercises had positive effects on clinical status and muscle strength while home mat pilates exercises had positive effects on the number of painful regions, clinical status, biopsychosocial status and physical component quality of life.Clinical trial registration number NCT04218630.     

Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial

The efficacy of balneotherapy in fibromyalgia syndrome (FS) has been well demonstrated, while controlled studies using mud packs are lacking. We performed a randomized clinical trial to evaluate the effects and the tolerability of mud-bath treatment in FS patients, who are poor responders to pharmacological therapy. Eighty patients with primary FS, according to ACR criteria, were randomly allocated to two groups: 40 were submitted to a cycle of 12 mud packs and thermal baths, and 40 were considered as controls. At baseline, after thermal treatment and after 16 weeks, patients were evaluated by FIQ, tender points count, VAS for “minor” symptoms, AIMS1 and HAQ. Control patients were assessed at the same time periods. A significant improvement of all evaluation parameters after mud-bath therapy and after 16 weeks was observed. Mud packs were well tolerated and no drop-outs were recorded. Our results suggest the efficacy and the tolerability of mud-bath treatment in primary FS.     

Tilt vibratory exercise and the dynamic balance in fibromyalgia: A randomized controlled trial

Objective

To evaluate the feasibility and efficacy of tilt whole‐body vibration (WBV) for improving dynamic balance in women with fibromyalgia (FM).

Methods

Forty‐one women (ages 41–65 years) were randomly assigned to either a vibration (n = 21) or control (n = 20) group. The vibration intervention consisted of a 30‐minute session of instruction plus 3 sessions of WBV per week over a period of 12 weeks. Each vibration session consisted of 6 repetitions of a 45–60‐second 12.5‐Hz vibration. The posture of the patient was lateral. Dynamic balance was assessed with a balance platform, and the level of stability could be controlled. We performed intent‐to‐treat (ITT) analysis and efficacy analysis in participants who completed the study (vibration, n = 18; control, n = 18).

Results

Based on ITT analysis, the dynamic balance of the vibration group improved by 36% as compared with baseline, whereas that of the control group was unchanged. Differences in the dynamic balance index were predicted (61%; P < 0.001) by the following linear model: (0.027 × body weight) ? (0.800 × dynamic balance at baseline) ? (0.632 × group).

Conclusion

The vibration program was useful and feasible for improving dynamic balance in women with FM. These novel results support further research aimed at the development of physical therapy programs that utilize controlled vibration.

     

Feasibility and effectiveness of an aerobic exercise program in children with fibromyalgia: results of a randomized controlled pilot trial

OBJECTIVE: To determine the feasibility of conducting a randomized controlled trial of a 12-week exercise intervention in children with fibromyalgia (FM) and to explore the effectiveness of aerobic exercise on physical fitness, function, pain, FM symptoms, and quality of life (QOL). METHODS: FM patients ages 8-18 years were randomized to a 12-week exercise intervention of either aerobics or qigong. Both groups participated in 3 weekly training sessions. Program adherence and safety were monitored at each session. Data were collected at 3 testing sessions, 2 prior to and 1 after the intervention, and included FM symptoms, function, pain, QOL, and fitness measures. RESULTS: Thirty patients participated in the trial. Twenty-four patients completed the program; 4 patients dropped out prior to training and 2 dropped out of the aerobics program. Better adherence was reported in the aerobics group than in the qigong group (67% versus 61%). Significant improvements in physical function, functional capacity, QOL, and fatigue were observed in the aerobics group. Anaerobic function, tender point count, pain, and symptom severity improved similarly in both groups. CONCLUSION: It is feasible to conduct an exercise intervention trial in children with FM. Children with FM tolerate moderate-intensity exercise without exacerbation of their disease. Significant improvements in physical function, FM symptoms, QOL, and pain were demonstrated in both exercise groups; the aerobics group performed better in several measures compared with the qigong group. Future studies may need larger sample sizes to confirm clinical improvement and to detect differences in fitness in childhood FM.     

Thalassotherapy for fibromyalgia: a randomized controlled trial comparing aquatic exercises in sea water and water pool

The aim of this study was to evaluate the effectiveness of aerobic exercise in water pool compared with aerobic exercise performed in sea by women with fibromyalgia (FM). A total of 46 patients were randomly allocated into two groups: pool group (23 patients) and sea group (23 patients) that performed the same aerobic exercise program. Patients were evaluated baseline and after 12 weeks using: VAS, number of tender points, FIQ, SF-36, PSQI, and BDI. Both groups improved significantly in post-treatment for all the evaluated variables. There were no significant differences between two groups, except for BDI (F = 2.418, P < 0.0001). Aerobic exercise program performed in water (pool or sea) was effective for patients with FM. However, sea water exercises have been shown to bring more advantages related to emotional aspects. Then, exercise performed sea water (thalassotherapy) is an option for effective treatment with low cost for patients with FM.