The results of a double-blind, randomized, therapeutical trial with SER282, an antidiencephalon immune serum (Serolab, Lausanne, Switzerland), in 36 women, aged 24-56 years, with primary fibromyalgia are presented. Treatment was ambulatory and consisted of either SER282 (20 mg/ml) or amitryptiline (AMI, 50 mg) or placebo (PL) over an 8-week treatment course. Clinical and sleep EEG polygraphic data were obtained at baseline and after 4 and/or 8 weeks of therapy. Compared to an important PL response and moderate analgesia with AMI, pain and associated symptoms improved moderately with SER282. In contrast, polysomnographic recordings showed that SER282 tended to promote stage 4 sleep, while AMI and PL had few--if any--effect on sleep. These results are discussed together with the clinical characteristics of the patients and the relations between pain, associated symptoms, and sleep parameters in our patient population.
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"Several clinical studies failed to report tolerability and/or safety outcomes. Two placebo-controlled studies [40,41] did not report the percentage of patients who experienced adverse events or dropout rates due to adverse events. Two placebocontrolled studies [38,43] only reported dropout rates due to adverse events without referring to the percentage of patients who reported adverse events. "
[Show abstract][Hide abstract]ABSTRACT: Fibromyalgia is characterized by chronic generalized pain accompanied by a wide range of clinical manifestations. Most clinical practice guidelines recommend multidisciplinary treatment using a combination of pharmacological and non-pharmacological therapies. The tricyclic antidepressant amitriptyline has been most thoroughly studied in fibromyalgia. Amitriptyline has been evaluated in placebo-controlled studies, and it has served as an active comparator to other therapeutic interventions in the treatment of fibromyalgia. In addition, several systematic reviews and meta-analyses have evaluated its efficacy and safety for the treatment of fibromyalgia. Data from individual studies as well as from systematic reviews indicate that low doses (10-75 mg/day) of amitriptyline are effective for the treatment of fibromyalgia and, despite the limited quality of the data, they do not seem to be associated with relevant tolerability or safety issues. Consistent with some clinical guidelines, we believe amitriptyline in low doses should be considered a first-line drug for the treatment of fibromyalgia.
"A third meta-analysis of antidepressants in the treatment of fibromyalgia  evaluated 13 trials of antidepressants, most of which studied the cyclic drugs amitriptyline [17-20,26,29-32], clomipramine , and maprotiline . The meta-analysis also included trials of the selective serotonin reuptake inhibitors (SSRIs) fluoxetine [20,33] and citalopram , as well as a reversible inhibitor of the monoamine oxidase-A enzyme, moclobemide , and the dietary supplement S-adenosylmethionine [35,36]. "
[Show abstract][Hide abstract]ABSTRACT: Fibromyalgia is a chronic, musculoskeletal pain condition that predominately affects women. Although fibromyalgia is common and associated with substantial morbidity and disability, there are no US Food and Drug Administration-approved treatments. However, progress has been made in identifying pharmacological and non-pharmacological treatments for fibromyalgia. Recent pharmacological treatment studies have focused on selective serotonin and norepinephrine reuptake inhibitors, which enhance serotonin and norepinephrine neurotransmission in the descending pain pathways and lack many of the adverse side effects associated with tricyclic medications. Promising results have also been reported for medications that bind to the alpha2delta subunit of voltage-gated calcium channels, resulting in decreased calcium influx at nerve terminals and subsequent reduction in the release of several neurotransmitters thought to play a role in pain processing. There is also evidence to support exercise, cognitive behavioral therapy, education, and social support in the management of fibromyalgia. It is likely that many patients would benefit from combinations of pharmacological and non-pharmacological treatments, but more study is needed.
Preview · Article · Feb 2006 · Arthritis research & therapy
"Animal's polyclonal hyperimmune antibodies against human thymic lymphocytes induce a profound immunosuppression of cellular immune responses and are used by daily doses from 1.5 to 30 mg/kg for 14 to 28 days to prevent acute organ graft rejection. In contrast, tissue antisera repeated low-doses have been shown sufficient to improve the outcome of some inflammatory disorders [8, 9, 10, 11]. The daily dose administered by rectal route is of 20 mg of sera proteins. "
[Show abstract][Hide abstract]ABSTRACT: Background A retrospective study was carried out in 42 outpatients with age-related macular degeneration to assess the effectiveness and tolerance of tissue antisera "OEil" and tissue antisera "Neurovasculaire".