Feasibility, safety and preliminary efficacy of a new nutritional supplement for fibromyalgia patients: a pilot study

Abstract

Current treatments for fibromyalgia (a chronic pain disorder) have limited efficacy, posing significant challenges for patients and healthcare providers, and prompting exploration of alternative approaches, such as nutritional supplements. Although limited in the literature, small-scale prospective pilot studies are crucial for assessing the safety and feasibility of these interventions, guiding subsequent research. Here we evaluated the viability and relevance of broader investigations of a new nutritional supplement, combining unique ingredients that are potentially beneficial for addressing the multifaceted nature of fibromyalgia symptoms, based on previous systematic reviews and meta-analyses. Thirty consecutive fibromyalgia patients received an 8-week intervention with the new nutritional supplement. Patients were assessed at baseline, 4 weeks, and 8 weeks to identify primary outcomes for future larger-scale trials, and evaluate safety, challenges, protocol adjustments, and treatment adherence. Treatment adherence was satisfactory, with only two patients experiencing mild adverse effects that did not warrant discontinuation. After the 8-week intervention, we observed moderate improvements in functionality and pain levels, but no significant improvements in fatigue, hemogram, biochemical values, sleep quality, or emotional well-being. Therefore, our results support the safety and tolerability of the new nutritional supplement for fibromyalgia, and indicate the feasibility of an 8-week larger scale trial. A minimum of 43 participants should be recruited in a subsequent trial, with an anticipated 10% dropout rate. Primary outcomes should include functionality, extent of widespread pain, and presence/severity of centralized pain features. Alternative tests should assess fatigue improvement, while changes in blood parameters, sleep, and emotional issues may have lesser significance.