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Abstract Objective To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients. Methods A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks. Results There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the “feel good,” “pain,” “do work,” and “fatigue” scores. The placebo group presented significant improvement on the “depression” score after intervention. There were no intolerable adverse effects. Conclusions Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.

Fibromyalgia (FM) is a chronic syndrome of unknown etiology, although many studies point to inflammation, oxidative stress, and altered mitochondrial metabolism as some of the cornerstones of this disease. Despite its socioeconomic importance and due to the difficulties in diagnosis, there are no effective treatments. However, the use of non-drug treatments is increasingly becoming a recommended strategy. In this context, the effects of supplementation of FM patients with an olive (poly)phenol, vitamin C, and vitamin B preparation were investigated in this work, analyzing complete blood count, biochemical, lipid, and coagulation profiles, and inflammation and oxidation status in blood samples. To gain a better understanding of the molecular mechanisms and pathways involved in the etiology of FM, a proteomic study was also performed to investigate the mechanisms of action of the supplement. Our results show that the nutraceutical lowers the lipid profile, namely cholesterol, and improves the oxidative status of patients as well as their quality of life, suggesting that this product could be beneficial in the co-treatment of FM. ClinicalTrials.gov (ID: NCT06348537).

The pathogenesis of fibromyalgia (FM) is currently unknown. Many patients with this condition are not effectively treated, and disorders of the intestinal dysbiosis have been identified in patients with FM. This trial aimed to investigate whether ozonated water enema could alleviate the symptoms of FM by improving intestinal dysbiosis in these patients. This trial aims to evaluate the therapeutic advantages of ozonated water enema therapy for patients suffering from FM. A single-center, double-blind, randomized controlled trial. Department of Pain Management, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China. This is a randomized, double-blind trial conducted on FM patients (n = 66). The selected patients were randomly categorized into the O3 and control groups. The patients in the O3 and control groups received an ozonated and deionized water enema, respectively, at the same dose and frequency. After the treatment, the scores on the numerical rating scale (NRS), widespread pain index (WPI), Hamilton anxiety scale (HAMA), and the Pittsburgh sleep quality index (PSQI) were compared between the 2 groups, as were the doses of duloxetine, to evaluate the treatment effect. Furthermore, the effectiveness of the treatment was assessed by comparing fecal samples from the O3 group collected before and after treatment with 25 healthy individuals from the physical examination department of Shanghai East Hospital. The patients in the O3 group indicated significant relief in pain and reduced NRS, HAMA, PSQI, and WPI scores at each follow-up time point (P < 0.001) when compared to the control group. In addition, the patients in the O3 group used lower doses of duloxetine than did those the control group (P < 0.001). Moreover, FM patients treated with ozonated water indicated improvements to their gut microbiome. The trial's findings might be affected by confounding factors, including medicines, diet, and environmental circumstances. Also, this trial was limited by its sample size, and the symptom severity scores (SSS) of the patients at 3 months after treatment at the given follow-up period were not assessed. This trial confirmed that the symptoms of pain, anxiety, and sleep disorders in FM patients were effectively relieved after treatment with an ozonated water enema. Furthermore, the ozonated water enema was associated with a significant reduction in duloxetine dosage and improved gut microbiome disorder, suggesting that the enema could target disorders related to the gut microbiome and therefore serve as a therapeutic intervention for FM.

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that is seldom reported in China. Recent studies have focused on nondrug treatments, particularly physical therapy, as an alternative to treatments using medication. With the rise of smartphones and mobile communication, mobile health technology has become a significant area of study. This study aims to explore whether using remote network applications to supervise patient exercise, in combination with medication, can improve FM pain. It builds on previous research that focuses on drug treatments and offers insights into individualized exercise therapy for FM.  The study used a prospective, randomized controlled design with 80 participants, who were divided into 2 groups: supervised and unsupervised. Both groups received a drug regimen: oral pregabalin (75-150 mg twice daily) and duloxetine (30-60 mg once daily). The supervised group followed exercise routines with guidance from web-based rehabilitation therapist via a remote network application, while the unsupervised group exercised without supervision. The study was blinded to the participants. Primary outcomes were pain levels over the past 24 hours as measured by the Brief Pain Inventory (BPI). Secondary outcomes included pain relief, sleep improvement, quality of life, and adverse event occurrences. Observations were made at the start of treatment (T0), 1 month after treatment (T1), and 3 months after treatment (T3). We recruited 80 participants, evenly divided into 2 groups, from August 2022 to December 2023 at West China Hospital of Sichuan University. Comparisons of the 2 groups were performed using analysis of variance and Bonferroni post hoc analyses (SPSS version 25 for Windows, P<.05 considered as significant). Compared with T0, the Widespread Pain Index (WPI), symptom severity score (SSS), and BPI (pain on average, least pain in past 24 h, pain right now) scores of the 2 groups of patients with fibromyalgia at T1 were significantly lower. Compared with T0, the WPI, SSS, BPI (pain on average, worst pain in past 24 h, least pain in past 24 h, pain right now), and Fibromyalgia Impact Questionnaire scores of the 2 groups of patients at T3 were significantly lower. The WPI, SSS, BPI (pain on average, worst pain in past 24 h, pain right now), and Pittsburgh Sleep Quality Index scores of the 2 groups at T3 were significantly lower than at T1. However, the significance of some of the data did not exist after Bonferroni correction. The changes in scores from T0 to T1 (T1-T0), from T0 to T3 (T3-T0), and from T1 to T3 (T3-T1) in the supervised group were all less statistically significant compared to the unsupervised group. The study showed that exercise combined with drug therapy can significantly improve the prognosis of FM, including pain relief, better sleep, and better overall quality of life; long-term supervised exercise training is more effective in improving FM symptoms and is safer and more reliable than unsupervised exercise.

Patients suffering from fibromyalgia often report stress and pain, with both often refractory to usual drug treatment. Magnesium supplementation seems to improve fibromyalgia symptoms, but the level of evidence is still poor. This study is a randomized, controlled, double-blind trial in fibromyalgia patients that compared once a day oral magnesium 100 mg (Chronomag®, magnesium chloride technology formula) to placebo, for 1 month. The primary endpoint was the level of stress on the DASS-42 scale, and secondary endpoints were pain, sleep, quality of life, fatigue, catastrophism, social vulnerability, and magnesium blood concentrations. After 1 month of treatment, the DASS-42 score decreased in the magnesium and placebo groups but not significantly (21.8 ± 9.6 vs. 21.6 ± 10.8, respectively, p = 0.930). Magnesium supplementation significantly reduced the mild/moderate stress subgroup (DASS-42 stress score: 22.1 ± 2.8 to 12.3 ± 7.0 in magnesium vs. 21.9 ± 11.9 to 22.9 ± 11.9 in placebo, p = 0.003). Pain severity diminished significantly (p = 0.029) with magnesium while the other parameters were not significantly different between both groups. These findings show, for the first time, that magnesium improves mild/moderate stress and reduces the pain experience in fibromyalgia patients. This suggests that daily magnesium could be a useful treatment to improve the burden of disease of fibromyalgia patients and calls for a larger clinical trial.

Objectives To better investigate neurobiological heterogeneity in fibromyalgia for its symptom diversity and individual differences. Methods We collected structural MRI data and clinical characteristics of Chinese female fibromyalgia patients and healthy controls matched by age and educational level, then invited qualified patients to undergo either Ba‐Duan‐Jin or pregabalin intervention for 12 weeks randomly. Structural MRI was analyzed by CAT12 software, and the regional volume of gray matter (GMV) was calculated according to the Brainnetome atlas. Fibromyalgia patients were clustered using the HYDRA algorithm to detect disease subtypes. Results Two distinct neuroanatomical subtypes were found among 75 patients. Compared to 93 healthy controls, patients in subtype 1 (n = 38, 50.7%) showed widespread GMV increase, especially in some pain‐related brain regions, while no structural changes were observed in subtype 2 (n = 37, 49.3%). At the baseline before treatment, patients in subtype 1 showed a younger age (p = 0.037), longer illness duration (p = 0.042), and a severer psychological stress state evaluated by the Perceived Stress Scale (p = 0.008). After standardized treatment, subtype 1 patients showed less improvement in pain VAS score (p = 0.027) than subtype 2 patients. In addition, GMV of the bilateral dorsal caudate had negative correlations with stress level (Left r = −0.335, p = 0.040; Right r = −0.341, p = 0.036), and GMV of the left rostral temporal thalamus (r = 0.781, p = 0.038) and lateral amygdala (r = 0.761, p = 0.047) were positively related to the improvement of pain severity after treatment in subtype 1 patients. Conclusions These two neuroanatomical subtypes in fibromyalgia emphasize different underlying neuropathological processes and need future studies to optimize individualized treatment. Trial Registration ClinicalTrials.gov identifier: NCT03890133 This study reveals two distinct neuroanatomical subtypes of fibromyalgia. Differences in clinical symptoms and treatment responses between two subtypes validate the subtype classification and highlight variations in the underlying neuropathological processes of fibromyalgia, offering insights for individualized treatment strategies.

Abstract Objective This study explores dose–response relationships when treating fibromyalgia with low-dose naltrexone. Design A single-blinded clinical trial was carried out using the “up-and-down” method. Subjects Subjects included women with a diagnosis of fibromyalgia aged 18–60 years who had been referred to treatment at a public pain clinic at a Danish university hospital. Methods The test doses were in the range 0.75–6 mg, and the dosing interval was 0.75 mg. The method was sequential and allowed predicting the dose effective in 50% (ED50) and 95% (ED95) of the subjects when the dose had shifted direction 10 times, and six pairs of “up-and-down” data were available. Results A total of 27 subjects were included in the study; two subjects were withdrawn. After inclusion of 25 evaluable subjects, the dose estimates were calculated as 3.88 mg for ED50 and 5.40 mg for ED95. As a secondary outcome, the effects on 10 common fibromyalgia symptoms were evaluated. A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone. Conclusions This study is the first to explore dose–response relationships in the treatment of fibromyalgia with low-dose naltrexone. Future placebo-controlled randomized clinical trials are needed, and according to our findings, 4.5 mg, which has previously been used, seems to be a relevant test dose. We recommend that future studies include additional nonpain fibromyalgia symptoms as outcome measures.

Background: Preclinical and clinical studies have suggested that milnacipran, a dual norepinephrine-serotonin reuptake inhibitor, may be efficacious in the treatment of fibromyalgia (FM). Objective: This study was conducted to evaluate the efficacy and tolerability of milnacipran in treating the multiple domains of FM. Methods: This was a multicenter, double-blind, placebo-controlled trial. Adult patients (age 18–70 years) who met 1990 American College of Rheumatology criteria for FM were randomized to receive milnacipran 100 mg/d, milnacipran 200 mg/d, or placebo for 15 weeks. Because this was a pivotal registration trial, the primary end points were chosen to investigate efficacy for 2 potential indications: the treatment of FM and the treatment of FM pain. Thus, the 2 primary efficacy end points were rates of FM composite responders and FM pain composite responders. FM composite responders were defined as patients concurrently experiencing clinically meaningful improvements in the following 3 domain criteria: pain (≥30% improvement, as recorded in an electronic diary); patients' global status (a rating of very much improved or much improved on the Patient Global Impression of Change [PGIC] scale); and physical function (a ≥6-point improvement on the 36-item Short-Form Health Survey [SF-36] Physical Component Summary score). FM pain composite responders were defined as those who met the pain and PGIC criteria. Adverse events reported by patients or observed by investigators were recorded throughout the trial. Results: Of 2270 patients screened, 1196 were randomized to receive milnacipran 100 mg/d (n = 399), milnacipran 200 mg/d (n = 396), or placebo (n = 401). The majority of patients were female (96.2%) and white (93.5%). The population had a mean age of 50.2 years, a mean baseline weight of 180.8 pounds, and a mean baseline body mass index of 30.6 kg/m2. Compared with placebo, significantly greater proportions of milnacipran-treated patients were FM composite responders (100 mg/d: P = 0.01; 200 mg/d: P = 0.02) and FM pain composite responders (100 mg/d: P = 0.03; 200 mg/d: P = 0.004). Milnacipran was associated with significant improvements in pain after 1 week of treatment (100 mg/d: P = 0.004; 200 mg/d: P = 0.04), as well as significant improvements in multiple secondary efficacy end points, including global status (PGIC: P<0.001 for both doses), physical function (SF-36 physical functioning domain—100 mg/d: P < 0.001; 200 mg/d: P = 0.02), and fatigue (Multidimensional Fatigue Inventory— 100 mg/d: P = 0.04). The most commonly reported adverse events with milnacipran were nausea (100 mg/d, 34.3%; 200 mg/d, 37.6%), headache (18.0% and 17.7%, respectively), and constipation (14.3% and 17.9%). Adverse events resulted in premature study discontinuation in 19.5% and 23.7% of those who received milnacipran 100 and 200 mg/d, respectively, compared with 9.5% of placebo recipients. Conclusion: In these adult patients with FM, both doses of milnacipran (100 and 200 mg/d) were associated with significant improvements in pain and other symptoms. Clinical Trials Identification Number: NCT00098124.

Objectives The social pain or invalidation denoting painful feeling following social conflicts or misunderstanding about illness legitimacy has been proposed as a salient disabling symptom besides physical pain or non-pain symptoms in fibromyalgia (FM). We sought to evaluate the effect of 1-month administration of duloxetine or pregabalin on the invalidation dimensions in FM patients with respect to the comparison of these two drugs on this issue. Method This open-label randomized clinical trial study was performed on FM patients whose diagnoses were confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR). Primary outcome measure (Illness Invalidation Inventory (3*I)) and secondary outcome measures (Beck Depression Inventory-II (BDI-II), widespread pain index (WPI), and polysymptomatic distress scale (PSD)) were compared before and after treatment, using paired t test or Wilcoxon signed test. Results Of 81 eligible FM patients, 44 patients in the duloxetine arm and 27 patients in the pregabalin arm completed the study protocol. Overall, no significant improvement was seen in 3*I scores after treatment with either duloxetine or pregabalin, except in the lack of understanding of medical professionals which improved after treatment with pregabalin (2.43 ± 1.38 to 1.79 ± 0.94, p value: 0.01). There were no intragroup and intergroup differences in the effects of duloxetine and pregabalin on 3*I scores when adjusted with the cofounders. Both duloxetine and pregabalin improved WPI, BDI-II, and PSD scores significantly. Conclusions Short-term FM pharmacological treatment had no effect on social pain. This finding was regardless of drug type, improvement of physical pain, and depression. Key Points • Social pain may behave as an independent but influential factor in FM rather than physical pain and depression. • Approved FM medications do not seem to change predictably the invalidation perception, which is a crucial factor in chronicity and maintaining of FM symptoms. • Dedicated approach to social pain seems necessary for the depiction of future successful therapeutic plan in FM.

Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by cognitive deficits such as forgetfulness, concentration difficulties, loss of vocabulary and mental slowness, among others. In recent years, FMS has been associated with altered intestinal microbiota, suggesting that modulating gut microbiota (for example, through probiotics) could be an effective therapeutic treatment. Thus, the aim of the present study was to continue exploring the role of probiotics in cognitive processes in patients with FMS. A pilot randomized controlled trial was conducted in 31 patients diagnosed with FMS to compare the effects of a multispecies probiotic versus a placebo on cognitive variables (memory and attention) after eight weeks. Results showed that treatment with a multispecies probiotic produced an improvement in attention by reducing errors on an attention task, but it had no effect on memory. More specifically, a tendency to reduce errors of omission (Go trials) during the Go/No-Go Task was observed after treatment. These findings, along with our previous results in impulsivity, underline the relevance of using probiotics as a therapeutic option in FMS, although more research with a larger sample size is required.