REUMASPIS

An Open-Label, Pilot Trial of HRG80™ Red Ginseng in Chronic Fatigue Syndrome, Fibromyalgia, and Post-Viral Fatigue

Jacob Teitelbaum and Sarah Goudie

Abstract

Chronic fatigue syndrome and fibromyalgia (CFS/FMS) affect 2.1% of the world’s population and ~10–25% of people who have had COVID-19. Previous clinical data suggested that a unique Panax ginseng (C.A. Meyer, family Araliaceae) root extract (HRG80™ Red Ginseng) often resulted in marked improvement. We aimed to study this hydroponic form of red ginseng root, containing high levels of rare ginsenosides, for improving energy, cognition, and stamina. This open-label prospective study included participants with severe CFS/FMS who took a daily supplement of HRG80 capsules (200–400 mg) or tablets (100–200 mg) for one month. A total of 188 subject patients completed the one-month treatment trial. Of these, 60.1% rated themselves as improved, with 13.3% rating themselves as being much better. In this group, the mean composite score improved from 11.9 to 18.8 (p < 0.001), with a 67% average increase in energy, 44% average increase in overall well-being, 48% average improvement in mental clarity, 58% average composite improvement in the previous three measurements (primary outcome measure), 46% average improvement in sleep, 33% average decrease in pain, and 72% average increase in stamina. Our study showed that HRG80 red ginseng root powder resulted in a marked improvement in people with CFS and fibromyalgia. This included the subgroup with post-viral CFS/FMS.

Pharmaceuticals 2022, 15, 43. https://doi.org/10.3390/ph15010043

Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial

Mansoor Shakiba et al.

Abstract

Objective: Saffron was found to be efficient and safe in treatment of  neuropsychiatric disorders, in particular depression. We compared the efficacy of saffron with duloxetine in treatment of patients with fibromyalgia.

Materials and Methods: In this double-blind parallel-group clinical trial, outpatients with fibromyalgia were randomized to receive either saffron 15 mg or duloxetine 30 mg starting with 1 capsule per day in the first week followed by 2 capsules per day  from week 2 until the end of week 8. Participants were men and = Rheumatology 2010 criteria who also had a pain score ≥40 based on visual analogue scale. Participants were excluded in case they had rheumatologic diseases, inflammatory/infectious/autoimmune arthritis, comorbid neuropsychiatric disorders except depressive disorders, pain due to traumatic injuries, drug history of duloxetine or saffron use, current use of psychoactive medications, recent use of muscle relaxants, steroids, opioid analgesics, benzodiazepines, anti-epileptics, or injective analgesics. Primary outcomes included differences in mean score changes from baseline to endpoint between the treatment arms for Hamilton Rating Scale for Depression, Fibromyalgia Impact Questionnaire, and Brief Pain Inventory.

Results: Socio-demographic characteristics and baseline scores were similarly distributed between the two treatment arms (2n=46).  No significant difference was detected for any of the scales neither in terms of score changes from baseline to endpoint between the two treatment arms (Mean score changes: -4.26 to 2.37; p-values: 0.182- 0.900) nor in terms of time treatment interactions (p-values: 0.209- 0.964).

Conclusions: Saffron and duloxetine demonstrated comparable efficacy in treatment of fibromyalgia symptoms.

Avicenna J Phytomed, 2018; 8(6): 513-523. Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial – PMC

The Role of Oxidants/Antioxidants, Mitochondrial Dysfunction, and Autophagy in Fibromyalgia

Alejandra Guillermina Miranda-Díaz and Simón Quetzalcóatl Rodríguez-Lara

Abstract

Fibromyalgia (FM) is a syndrome that presents primarily in women and is characterized by generalized pain, muscle rigidity, poor quality of sleep, fatigue, cognitive dysfunction, anxiety, episodes of depression, overall sensitivity, and deterioration in the performance of day-to-day activities. In the pathophysiology of fibromyalgia neuroendocrine factors, anomalies of the autonomous nervous system, genetic characteristics, and environmental and psychosocial factors are implicated. Alterations to the cells of the central nervous system that are present in fibromyalgia are due to the toxic effects of free radicals by the high concentrations of polyunsaturated fatty acids of the membranes that are easily oxidized and the low level of protective antioxidant enzymes. In FM, defects are produced in any part of the cycle in the generation of adenosine-5′-triphosphate (ATP) by the mitochondria, which can alter energy production by the mitochondria and cause the characteristic symptoms of FM. The degradation of the mitochondria dependent on autophagy or mitophagy is an important process for maintaining the critical integrity of the mitochondria and limiting the production of reactive oxygen species (ROS). Therefore, the deregulation of autophagy and mitochondrial dysfunction could represent key aspects in the pathophysiology of FM. Management with antioxidants, vitamins, coenzyme Q10, and melatonin, in addition to the antidepressants and structural analogs of the gamma-aminobutyric acid, could modify the florid symptomatology that patients with FM have.

InTech. doi: 10.5772/intechopen.70695

Short-Term Magnesium Therapy Alleviates Moderate Stress in Patients with Fibromyalgia: A Randomized Double-Blind Clinical Trial

Nicolas Macian et al.

Abstract

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.

Nutrients 2022, 14(10), 2088; https://doi.org/10.3390/nu14102088

Effect of  vitamin B12 on  the symptom severity and  psychological profile of  fibromyalgia patients; a prospective pre-post study

Faeze Gharibpoor et al.

Abstract

Background: Fibromyalgia (FM) as a prototypical nociplastic pain condition displays a difficult therapeutic situation in many cases. Given the promising data on the efect of vitamin B12 in improving pain and cognitive functions in various nociplastic pain conditions, we aimed to determine the efcacy of 1000 mcg daily dose of oral vitamin B12 on the symptom severity and psychological profile of FM patients.

Methods: This open-label, pre-post study was performed on FM patients whose diagnoses were confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR). Patients were instructed to take a daily dose of 1000mcg vitamin B12 for fifty days. Outcome measures including the Revised Fibromyalgia Impact Questionnaire (FIQR), Hospital Anxiety and Depression Scale (HADS), 12-item Short-Form health survey (SF-12), and pain Visual Analog Scale (pain-VAS) were fulfilled by patients before and after the treatment.

Results: Of 30 eligible patients, 28 patients completed the study protocol. Patients were female with a mean age  of 47.50±8.47 years. FIQR scores in all domains improved significantly after treatment (total FIQR: 49.8±21.86 vs 40.00±18.36, p value<0.01; function: 13.17±7.33 vs 10.30±5.84, p value: 0.01; overall: 10.32±6.22 vs 8.25±6.22, p-value: 0.03; symptoms: 26.30±10.39 vs 21.44±8.58, p value<0.01). Vitamin B12 also improved anxiety scores from  9.33±4.30 to 7.70±3.60, p value: 0.01. Depression, pain-VAS, and SF-12 didn’t improve following the treatment. The Generalized estimating equations (GEE) analysis showed the improvement in total FIQR score is not confounded by the improvement of anxiety and patients’ baseline characteristics.

Conclusions: This study showed a short course of sublingual vitamin B12, 1000 mcg daily, significantly improves the severity of FM and anxiety score. We postulate that vitamin B12 has a strong potential to consider, at least, as adjunctive therapy of FM.

Gharibpoor et al. BMC Rheumatology (2022) 6:51 https://doi.org/10.1186/s41927-022-00282-y

 

The Role of Vitamin D in the Management of Chronic Pain in Fibromyalgia: A Narrative Review

Hannah W. Haddad, BS et al.

Introduction: Fibromyalgia (FM) is a complex disorder characterized primarily by chronic, widespread musculoskeletal pain. Currently, the Food and Drug Administration (FDA) has approved the use of three medications to treat FM: pregabalin, duloxetine, and milnacipran. The pharmaceutical intervention has lacked consistent pain relief among all patients. Therefore, the investigation into alternative treatment options has grown in interest. This narrative review aims to evaluate the evidence regarding vitamin D for the treatment of FM.

Methods: Narrative review.

Results: Low serum vitamin D has been linked to various chronic pain states. An association between vitamin D deficiency and FM has been reported but is controversial in the literature. Some studies have documented the beneficial effects of vitamin D supplementation on reducing pain symptoms and improving the overall quality of life in those with FM. Despite these positive findings, many of the studies regarding this topic lack adequate power to make substantial conclusions about the effects of vitamin D on FM.  

Conclusion: Existing studies provide promising results. However, additional high-quality data on vitamin D supplementation is needed before recommendations for pain management can be made. Vitamin D supplementation is inexpensive, has minimal side effects, and can benefit FM patients regardless of its efficacy in pain control. Additionally, high-quality studies are warranted to fully elucidate the potential of vitamin D to manage chronic pain in FM.

Health Psychology Research. 2021;9(1). doi:10.52965/001c.25208