Posted by MERM on 6/21/2008, 11:31 am
This paper focuses on recent evidence of etiopathogenetic links between fibromyalgia and life stress. From an etiologic point of view, studies concerning the role of adverse life events, personality and lifestyle factors, post-traumatic stress, and negative childhood experiences are reviewed. From a pathogenetic point of view, neurobiologic links between stress and fibromyalgia symptoms, notably chronic pain and fatigue are highlighted. Finally, several methodologic issues with regard to stress research on fibromyalgia, as well as the clinical relevance of the stress concept for fibromyalgia are discussed.
A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety and efficacy of controlled-releas
No Authors Listed- GlaxoSmithKline corporate document
This was a proof of concept study, to evaluate the safety and efficacy of ropinirole CR in subjects with fibromyalgia syndrome (FMS). The objective was To evaluate the analgesic efficacy of oral ropinirole controlled release formulation (CR) compared to placebo over a dose range in adult subjects with FMS as measured by the 11-point Pain Intensity Numerical Rating Scale (PI-NRS). A total of 22 centres screened and recruited at least one subject in the following countries: Belgium, Denmark, Finland, France, Germany, Italy, Sweden, The Netherlands and the United Kingdom.
Study medication was provided as: ropinirole CR tablets of 1.0mg, 2.0mg, 4.0mg and 8.0mg, and matching placebo tablets. All tablets were white aqueous film coated capsule shaped tablets, with 'SB' embossed on both sides.
Subjects were randomised to receive once daily doses of ropinirole CR or placebo tablets according to the dose titration regimen until an optimal therapeutic dose was achieved based on efficacy and tolerability as judged by the investigator. No statistically significant differences between placebo and ropinirole CR were observed for the primary efficacy endpoint or the key secondary efficacy endpoints. In the placebo group 73 subjects (80%) reported non-serious adverse events with the most frequently reported being nausea, dizziness and headache
. In the ropinirole CR group 82 subjects (91%) reported non-serious adverse events with the most frequently reported being nausea, dizziness and headache. One subject in the placebo group reported the non-fatal SAE of anaemia. Two subjects in the ropinirole CR group reported a single non-fatal SAE: one subject reported the SAE of unstable angina and one subject reported abdominal pain upper. No fatalities were reported during the study.
2/Restless Legs Syndrome in Patients with Irritable Bowel Syndrome: Response to Small Intestinal Bacterial Overgrowth Therapy
Background: Since restless legs syndrome (RLS) occurs with fibromyalgia, a link between IBS, SIBO, and RLS was studied.
Methods: BS patients with abnormal lactulose breath tests received rifaximin 1,200 mg day(-1) for 10 days, followed by tegaserod 3 mg, long-term, and 1 month of zinc 220 mg day(-1) and once-daily probiotic (N = 11) or rifaximin monotherapy (N = 2). IBS symptom improvement was assessed after rifaximin. RLS symptoms, IBS symptoms, and overall IBS global improvement were assessed at last posttreatment visit: 8/10 patients were followed long-term (mean, 139 days; range, 54-450 days).
Results: Ten of 13 patients exhibited >/=80% improvement from baseline in RLS symptoms. Five maintained complete resolution of RLS symptoms. Global gastrointestinal symptom improvement was great (n = 6), moderate (n = 5), or mild (n = 2).
Conclusion: This study suggests that SIBO associated with IBS may be a factor in some RLS patients and SIBO therapy provides long-term RLS improvement.
3/safety and efficacy of ropinirole CR in subjects w/FM
No Authors Listed- GlaxoSmithKline corporate document
This was a proof of concept study, to evaluate the safety and efficacy of ropinirole CR in subjects with fibromyalgia syndrome (FMS).
The objective was To evaluate the analgesic efficacy of oral ropinirole controlled release formulation (CR) compared to placebo over a dose range in adult subjects with FMS as measured by the 11-point Pain Intensity Numerical Rating Scale (PI-NRS).
A total of 22 centres screened and recruited at least one subject in the following countries: Belgium, Denmark, Finland, France, Germany, Italy, Sweden, The Netherlands and the United Kingdom.
Study medication was provided as: ropinirole CR tablets of 1.0mg, 2.0mg, 4.0mg and 8.0mg, and matching placebo tablets.
All tablets were white aqueous film coated capsule shaped tablets, with 'SB' embossed on both sides. Subjects were randomised to receive once daily doses of ropinirole CR or placebo tablets according to the dose titration regimen until an optimal therapeutic dose was achieved based on efficacy and tolerability as judged by the investigator.
No statistically significant differences between placebo and ropinirole CR were observed for the primary efficacy endpoint or the key secondary efficacy endpoints.
In the placebo group 73 subjects (80%) reported non-serious adverse events with the most frequently reported being nausea, dizziness and headache.
In the ropinirole CR group 82 subjects (91%) reported non-serious adverse events with the most frequently reported being nausea, dizziness and headache.
One subject in the placebo group reported the non-fatal SAE of anaemia.
Two subjects in the ropinirole CR group reported a single non-fatal SAE: one subject reported the SAE of unstable angina and one subject reported abdominal pain upper. No fatalities were reported during the study.wellnesstrain!M!
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