Efficacy and tolerability of a nutraceutical product (tensiva) in patients with fibromyalgia

Background. Fibromyalgia is a common condition characterized by musculoskeletal pain, fatigue, and defined by the presence of tender points. It is a syndrome of unknown etiology, which mainly affects women with a 9: 1. The aim of this study is to evaluate a nutraceutical product with LTryptophane, Magnesium bisglycinate, Calcium, Potassium, Vit.B2, B6, B12 and D3 (TENSIVA) in the treatment of Fibromyalgia. Tools and methodologies. The sample included 60 women suffering from Fibromyalgia who have been divided into 2 groups by ACR criteria. All of them were asked to complete a test with the Visual Analog Scale (VAS) and Revised Fibromyalgia Impact Questionnaire (R-FIQ). Tests were conducted on days 1, 30 and 60. The first group was taking Paroxetine 20 mg once daily for 60 days, the second was taking TENSIVA 2 sachets per day for 60 days. Results. After 30 days, no patient from the first group was showing any improvement. Therefore, painkillers were administered to all of them. After 60 days, 20 of them were showing improvement in terms of pain. In the second group, after 30 days, 15 patients were getting better in terms of pain. After 60 days, a total of 25 subjects experienced progress in terms of pain and R-FIQ indexes. Conclusions. Fibromyalgia predominantly affects women with myalgia, sleep disorders, asthenia, anxiety and depression. There are not any specific diagnostic tests or therapies, although antidepressants, antiepileptics and analgesics are used associated with physical and cognitive-behavioral therapies. In this study we aimed at evaluating a supplement containing LTryptophane, Magnesium bisglycinate, Calcium, Potassium, Vit.B2, B6, B12 and D3 in the treatment of Fibromyalgia. Results show that TENSIVA appeared to be safe, efficacious and well-tollerated treatment for patients is effective in reducing pain and in improving motor functions, without side effects. Additional studies will confirm its validity