tropisetron and Fibromyalgia

Previous studies evaluating the efficacy and tolerance of tropisetron for the treatment of fibromyalgia (FM) used the drug either intravenously or orally, and at different dosage levels ranging from 2 mg to 15 mg daily. The shortest treatment was a single dose and the longest treatment period covered 28 days. A significant reduction of the pain intensity was achieved by using tropisetron 5 mg per day. Apart from the fact that treatment periods were different, the efficacy of oral and intravenous administration did not differ significantly. Tropisetron was well tolerated; but in the 15 mg group in one of the studies, the decrease in pain was less than in the placebo group, however, the frequency of constipation and other gastrointestinal symptoms increased. Furthermore, it was hypothesized that due to the impacts of CYP2D6 activities, a daily dose of tropisetron 2 mg may be efficacious in slow metabolizers only. Although tropisetron proved to be efficacious in a group of fibromyalgia patients, the dose-response curves cannot yet be explained in a fully satisfactory manner, which may encourage research focusing on possible subgroups of FM.

Topics: Analgesia; Dose-Response Relationship, Drug; Fibromyalgia; Humans; Indoles; Serotonin Antagonists; Tropisetron

Modern management of fibromyalgia (FM) requires a holistic approach, which includes nonpharmacologic strategies (both exercise and behavioral strategies) and pharmacologic treatment. Despite only partial effects in some patients, tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal antiinflammatory drugs, analgesics and opioids are in use. The use of antiepileptic drugs and antispasticity agents is mainly supported by anecdotal data. Three other classes of agents are currently thought to have useful potentials. N-methyl-D-aspartate-(NMDA-)mediated neurotransmission may play an important role in mediating wind-up and related phenomena in pain pathways. Recent studies have demonstrated that NMDA receptor antagonists improve pain symptoms in FM. But a poor side effect profile represents a significant problem. Cerebrospinal fluid substance P concentrations are significantly elevated in FM patients, but the analgesic potential of neurokinin-1 (NK1) receptor antagonists did not meet early expectations. Tropisetron, a 5-HT3 receptor antagonist, was tested in a multicenter, double-blind, randomized, placebo-controlled trial including 403 patients. In those receiving 5 mg tropisetron, 39.2% fulfilled the response criterion (pain reduction 35%) as compared to 26.2% in the placebo group (p=0.033). On 10 and 15 mg, the responder rates were smaller and statistically not significant. A total of 78 responders to therapy were followed up for 12 months. After the end of treatment, pain intensity rose within one month in all 4 groups. Patients having received 5 or 10 mg showed a less pronounced increase in pain. In addition, even 12 months after stopping treatment, pain was still markedly below baseline levels in the 5 and 10 mg groups.

Topics: Exercise; Fibromyalgia; Holistic Health; Humans; Indoles; Serotonin Antagonists; Tropisetron

Fibromyalgia syndrome (FMS) frequently presents with autonomic and/or functional symptoms. Tropisetron, a selective serotonin-3 antagonist, is widely used for the treatment of this disease. However, its effects on autonomic function are not well known. In the present study, we evaluated whether tropisetron improved cardiac autonomic symptoms in FMS. Thirty-six patients were treated with physiotherapy and 5 mg tropisetron intravenously for 5 days. An additional 36 patients were treated with physiotherapy alone. Thirty-six volunteers served as healthy controls. The ISAX apparatus was used for spectral analyses of cardiac R-R intervals. High frequencies and mid frequencies were analysed to assess sympathetic and parasympathetic activity. The findings were correlated with pain intensity. ISAX findings were significantly different in FMS patients compared to healthy controls and did not correlate with pain perception. Ten of 12 pathological parameters disappeared during treatment in the tropisetron group. Our results indicate that tropisetron reduced not only pain perception but also had a favourable effect on cardiac dysfunction during treatment.

Topics: Adult; Arrhythmias, Cardiac; Autonomic Nervous System; Combined Modality Therapy; Female; Fibromyalgia; Heart Rate; Humans; Indoles; Middle Aged; Pain Measurement; Physical Therapy Modalities; Serotonin Antagonists; Severity of Illness Index; Tropisetron

To determine the efficacy of a serotonin receptor (5-HT(3)) antagonist in the treatment of fibromyalgia (FM) in a prospective, randomized, double-blind, placebo-controlled, multicentre trial.. Twenty-one female patients (age 21-63 years) with FM according to the American College of Rheumatology classification criteria for FM were assigned randomly to either a placebo group or to receive a daily intravenous bolus injection of 5 mg tropisetron for 5 days.. In patients receiving tropisetron, the visual analogue scale (VAS) score for pain decreased by 28.9 compared with a decrease of 6.8 in the placebo group [probability (p)=0.063; effect size: 0.794]. Similar results were obtained using a body diagram pain score as a secondary efficacy parameter: mean pain reduction was 27.2 in the tropisetron group, versus 2.8 in the placebo group (p=0.038; effect size: 0.902).. 5-HT(3) receptor antagonists provide significant pain relief for a group of FM patients.

Topics: Adult; Double-Blind Method; Female; Fibromyalgia; Humans; Indoles; Middle Aged; Pain; Placebos; Serotonin Antagonists; Tropisetron

Central pain processing is altered in patients with fibromyalgia syndrome (FMS). The serotonin metabolism, especially the 5-HT3 receptor, seems to play an important role.. We investigated the effect of the local injection of the 5-HT3 receptor antagonist tropisetron on the perception and central processing of pain in FMS patients using painful mechanical stimulation and functional magnetic resonance imaging (fMRI) within the framework of a pre-/posttreatment double-blind design.. In the contralateral primary somatosensory cortex, contralateral posterior insula, and anterior cingulate cortex, we found that the activation was significantly reduced after treatment. On average, patients rated the stimulation-induced pain intensity as stronger in the session after treatment compared to before treatment, although the individual data revealed a heterogeneous pattern. All patients showed sensitisation during the painful stimulation, which was not influenced by the treatment.. Both the sensory-discriminative and motivational-affective components of pain as measured by fMRI were altered by tropisetron.

Topics: Brain; Female; Fibromyalgia; Humans; Indoles; Magnetic Resonance Imaging; Middle Aged; Pain; Pain Measurement; Pilot Projects; Receptors, Serotonin; Tropisetron

As described elsewhere the oral administration of 5 mg of the 5-HT3-receptor-antagonist Tropisetron in fibromyalgia exhibited less amelioration of pain in patients with a depression in comparison to patients without depression. Since an intravenous treatment seems to increase the effect of Tropisetron, the question arises whether patients with depression profit from the intravenous therapy. Methods 68 out patients with fibromyalgia according to ACR-criteria were enrolled in the study. The patients filled in a VAS pain and the Beck Depression Inventory (BDI) before and after a bolus i.v. injection of 5 mg Tropisetron for 5 days [Beck AT, Steer Ra. Beck-Depression-Inventory (BDI) In: Hautzinger M (Hrsg der dt. Ausg.). Testhandbuch. 1. Auflage Bern: Verlag Hans Huber, 1994]. In the beginning the patients had to have > or = 40 mm in the VAS pain from 0-100 mm. The patients were divided into three groups: group 1 = patients with a BDI<19 without experience with antidepressive drugs (n=26); group 2=patients with a BDI > or = 19 (n=22) and negative experience with antidepressive substances, and group 3=patients with a BDI > or = 19 and an accompanying antidepressant drug therapy and some benefit under this therapy (n=20). Results Before the therapy there was no significant difference in VAS pain in the groups, but in BDI there was a significant difference between group 1 (BDI mean value 11.5) in comparison to group 2 (BDI mean value 26.1) and group 3 (BDI mean value 24.8). After therapy all three groups had a significant amelioration of pain: group 1: p=0.000023; group 2: p=0.00073; group 3: p=0.0145. There was a significant difference between the group with BDI<19 and the group with antidepressant drug in amelioration of pain (p=0.044). A significant correlation was found in group 2 with Beck > or = 19 between amelioration of pain and BDI after therapy (p=0.008, r=0.666). In this group a pain-reactive depression and in group 3 an endogenous depression must be discussed.

Topics: Adjustment Disorders; Administration, Oral; Adult; Amitriptyline; Depressive Disorder; Drug Therapy, Combination; Female; Fibromyalgia; Fluoxetine; Humans; Indoles; Injections, Intravenous; Middle Aged; Pain Measurement; Personality Inventory; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin Antagonists; Sick Role; Treatment Outcome; Tropisetron

It is well known that the 5-HT3 receptor tropisetron shows a bell-shaped dose-response curve in the treatment of pain associated with fibromyalgia. The best results are achieved with a daily oral dose of 5 mg for 10 days. Dosages of 10 and 15 mg per day have a much weaker effect. If tropisetron is administered by intravenous injection, a regimen of 5 mg per day over 5 days will suffice to reduce pain substantially. An open study of selected cases revealed that 2 mg of tropisetron daily for 5 days also yielded satisfactory pain reduction, whereas this was not observed in a placebo-controlled double-blind study. We therefore investigated which factors might be responsible for the different effects of the drug. Judging from the above-mentioned studies, the effect of a minimum dosage of tropisetron could be assumed to be partly attributable to the different half-life periods. This is supported by the markedly different rates of constipation, a characteristic side effect of the drug, reported by the two studies.

Topics: Adult; Cytochrome P-450 Enzyme System; Female; Fibromyalgia; Half-Life; Humans; Indoles; Injections, Intravenous; Middle Aged; Pilot Projects; Serotonin Antagonists; Treatment Outcome; Tropisetron

The 5-HT3-receptor antagonist tropisetron has a favourable effect on the pain, not only of primary but also of secondary fibromyalgia. In an open study, ten women with clinical and serological evidence of secondary fibromyalgia were treated with tropisetron. Treatment comprised a single daily injection of 5 mg tropisetron on five consecutive days. Prior to, and 7 and 14 days after, treatment, the patients rated their pain on the visual analog pain (VAP) scale.. Nine patients experienced a substantial reduction in pain, with the mean VAP score decreasing from 64.3 initially, to 31.9 on the 7th day. After 14 days, the average score was 33.3, that is, roughly the same as that recorded after 7 days; however, 3 patients indicated the reappearance of substantially greater pain.. On the basis of these preliminary results, it would appear to be worth initiating a double-blind study to investigate the effects of short-term i.v. treatment with tropisetron in a large, clearly defined patient population with secondary fibromyalgia.

Topics: Adult; Aged; Antibodies, Antinuclear; Autoimmune Diseases; Female; Fibromyalgia; Humans; Indoles; Injections, Intravenous; Middle Aged; Pain Measurement; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Treatment Outcome; Tropisetron

A prospective, randomized, placebo-controlled, multicenter, double-blind trial in fibromyalgia patients demonstrated that peroral daily treatment with 5 mg tropisetron for 10 days produced a significant reduction in pain and other symptoms. The aim of the present study was to determine whether intravenous administration of 2 mg tropisetron daily for a limited period of time would produce quicker and more favorable results. In the first cohort 18 fibromyalgia patients received a single intravenous injection of 2 mg tropisetron. In the second cohort 24 fibromyalgia patients were treated with 2 mg intravenous tropisetron daily for 5 days. Pain intensity was measured with the visual analog scale and the pain score. Pain at tender and control points (dolorimeter) as well as 17 ancillary symptoms before and after treatment were evaluated. Pain intensity was followed-up by means of a patient diary until recurrence. Dolorimetry revealed that a single intravenous injection of 2 mg tropisetron significantly reduced pain and enhanced pain threshold. These effects, however, lasted for only a few days. Of 18 patients in the first cohort, only three showed no response to therapy. Of the 24 patients in the second cohort, 23 showed pain reduction when 2 mg tropisetron was administered daily for 5 days. Pain relief lasted for 2 weeks to 2 months in 20 of these patients. Two patients stopped filling in the pain diary. Twelve ancillary symptoms such as sleep disturbances, fatigue, morning stiffness were also significantly improved by the latter treatment. In the global assessment 16 out of 24 patients showed significant improvement and seven showed slight improvement. Only one patient experienced no improvement. Tolerability was good. In conclusion, intravenous injection of 2 mg of the 5-hydroxytryptamine3 receptor antagonist tropisetron once daily for 5 days produced a longer-lasting therapeutic effect on fibromyalgia symptoms than did peroral daily treatment with 5 mg of this drug. The results achieved are currently being evaluated in a randomized, placebo-controlled, double-blind trial.

Topics: Adult; Aged; Double-Blind Method; Female; Fibromyalgia; Humans; Indoles; Injections, Intravenous; Male; Middle Aged; Pain Measurement; Serotonin Antagonists; Treatment Outcome; Tropisetron

We investigated the efficacy and tolerability of short-term treatment with tropisetron, a selective, competitive 5-HT3-receptor antagonist in fibromyalgia. The trial was designed as a prospective, multicenter, double-blind, parallel-group, dose-finding study. We randomly assigned 418 patients suffering from primary fibromyalgia to receive either placebo, 5 mg, 10 mg or 15 mg tropisetron once daily for 10 days. Clinical response was measured by changes in pain score, visual analog scale, tender point count and ancillary symptoms. Responders were prospectively defined as patients showing a 35% or higher reduction in pain score. Treatment with 5 mg tropisetron resulted in a significantly higher response rate (39.2%) than placebo (26.2%) (p < 0.05). In the visual analog scale, the group administered 5 mg tropisetron showed a significant improvement (p < 0.05) and the group administered 10 mg tropisetron showed a nonsignificant clinical benefit. The number of painful tender points was significantly reduced (p = 0.002) in the 5 mg tropisetron group. Regarding ancillary symptoms, the 5 mg tropisetron group showed a significant improvement (p < 0.05) in sleep and dizziness. The patients' overall assessment of efficacy was significantly higher for 5 mg (p = 0.016) and 10 mg (p = 0.002) tropisetron than for placebo. The safety and tolerability of tropisetron was good; gastrointestinal tract symptoms were the most frequently reported adverse events. Short-term treatment of fibromyalgia patients with 5 mg tropisetron for 10 days proved to be efficacious and well tolerated. In this study a bell-shaped dose-response curve was seen.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Female; Fibromyalgia; Half-Life; Humans; Indoles; Male; Middle Aged; Pain Measurement; Prospective Studies; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin Antagonists; Tropisetron

In this pilot study we investigated 10 women suffering from primary fibromyalgia. All patients received 5 mg of tropisetron in the evening, for a period of 4 weeks. Clinical disease variables included the measurement of a pain score, fatigue, sleep disturbances and measurement of the number of tender points. Five of our patients (50%) showed a statistical clinical improvement of all the above parameters starting after the first week of treatment. Two patients did not respond to the therapy and three discontinued the study because of side-effects. We conclude that administration of tropisetron in fibromyalgia patients could be useful in the management of this difficult and incurable syndrome.

Topics: Adult; Female; Fibromyalgia; Humans; Indoles; Middle Aged; Pain Measurement; Pilot Projects; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin Antagonists; Treatment Outcome; Tropisetron

Based on a potential role for serotonin receptors in fibromyalgia, we investigated the efficacy and tolerability of treatment with tropisetron, a highly selective, competitive inhibitor of the 5-HT3 receptor.. In this prospective, multicenter, double-blind, parallel-group, dose-finding study, 418 patients suffering from primary fibromyalgia (ACR criteria) were randomly assigned to receive either placebo, 5 mg, 10 mg or 15 mg tropisetron once daily, respectively. The duration of treatment was 10 days. The clinical response was measured by changes in pain-score, visual analog scale (VAS), and the number of painful tender-points.. Treatment with 5 mg tropisetron resulted in a significantly higher response rate (39.2%) when compared with placebo (26.2%) (p=0.033). The absolute reduction in pain-score was -13.5% for 5 mg tropisetron, -13.0% for 10 mg tropisetron, and -6.3% for placebo (p<0.05). The effects of 15 mg tropisetron were similar to placebo, thus suggesting a bell-shaped dose-response curve. Compared with placebo, treatment with 5 mg tropisetron led to a significant improvement (p<0.05) in VAS, while a clear trend in terms of clinical benefit was seen with 10 mg tropisetron. The number of painful tender-points was also reduced significantly (p=0.002) in the 5 mg tropisetron group. Of interest, during the 12-month follow-up period, pain intensity of responders on 5 mg and 10 mg tropisetron was still markedly below baseline. The treatment was well tolerated, with gastro-intestinal complaints being the most frequently reported side effects, in keeping with the known safety profile for 5-HT3 receptor antagonists.. This study demonstrates the efficacy of short-term treatment with 5 mg tropisetron once daily in primary fibromyalgia. Treatment was well tolerated and prolonged clinical benefits were seen.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Female; Fibromyalgia; Follow-Up Studies; Humans; Indoles; Male; Middle Aged; Pain Measurement; Placebos; Prospective Studies; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin Antagonists; Tropisetron

The 5-HT3 receptor antagonists are a novel therapy for patients suffering from fibromyalgia, although the optimal duration of treatment is still unclear. The objective of this phase II study was to evaluate whether prolonging treatment with tropisetron to 4 weeks is tolerable and correlated with an improved clinical benefit. Thirty female patients with fibromyalgia received oral tropisetron (5 mg) daily for 28 days in an open-label fashion. Treatment resulted in significantly decreased pain as measured by visual analog scale (VAS), with a mean reduction of 59.7% and an absolute median change of -25.0 from baseline to day 28 (p<0.0001). A similar, significant reduction of 55.7% and absolute median change of -31.0 was observed in the painscore (p<0.0001). The response rate with patients showing a > or = 35% reduction in individual pain scores was 72.4% at day 28. The pressure tolerance of tender-points was slightly increased at the end of the treatment period. In addition, significant improvements were observed in the State-Trait-Anxiety-Inventory (STAI), scales of von Zerssen (Bf-S) and Beck Depression Index (BDI). Functional symptoms were compared with the results from a 10-day, randomized, double-blind phase III study of tropisetron in 418 fibromyalgia patients. In both studies several functional symptoms such as sleep disturbances and dizziness improved significantly (p<0.05). In the 28 days study, the number and extent of improvement in functional symptoms was increased compared with the shorter trial. Tolerability and safety of tropisetron was good, and typically for 5-HT3-receptor antagonists, gastrointestinal symptoms and headache were the most frequently reported events. In conclusion, 28 days treatment of fibromyalgia patients with 5 mg tropisetron resulted in significant pain reduction, which was most pronounced after 10 days with a further reduction up to day 28. Psychometric tests showed significant improvements in depression and anxiety state scores, while functional symptoms improved with extended tropisetron treatment.

Topics: Administration, Oral; Anxiety; Depression; Double-Blind Method; Female; Fibromyalgia; Humans; Indoles; Pain Measurement; Placebos; Prospective Studies; Psychometrics; Serotonin Antagonists; Time Factors; Tropisetron

The observed effects on the symptoms of fibromyalgia of daily oral administration of 5 mg of the 5-HT3 receptor antagonist, tropisetron, for 10 days, could be maintained or exceeded with intravenous administration of only 2 mg of the formulation. Following a single i.v. injection of 2 mg tropisetron, a more rapid and profound reduction in pain was achieved than with 5 mg oral tropisetron per day. In individual cases, patients who had previously experienced no reduction in pain from 10 days of 5 mg oral tropisetron daily responded to i.v. therapy. A more favourable and persistent effect on pain, combined with a simultaneous significant improvement in various vegetative and functional symptoms was achieved with five days treatment with 2 mg tropisetron i.v. per day. The results outlined and the possibility for rapid improvements with drug treatment of fibromyalgia should be confirmed in randomised, placebo controlled trials.

Topics: Administration, Oral; Adult; Aged; Dose-Response Relationship, Drug; Female; Fibromyalgia; Humans; Indoles; Injections, Intravenous; Male; Middle Aged; Pain Measurement; Serotonin Antagonists; Tropisetron

To characterize the immune modulatory effects of 5-HT3 receptor antagonist treatment in patients with fibromyalgia, autoimmune disorders, and chronic pain.. Multiplex-assisted cytokine measurements were performed before and during treatment. Whole blood stimulation with TNF-alpha was carried out to determine the proinflammatory response induced by exogenous TNF-alpha.. Five of nine patients clinically responded to treatment, and two had a moderate response. All patients had significantly elevated levels of T-H1 cytokines more prominent than TNF-alpha, IL-1beta, and IL-6. Treatment resulted in transient effects on peripheral monocyte counts in all but one patient, a plasma IL-1beta increase in two responder patients, and decreased T-H1 cytokines in two responder patients. Ex vivo TNF-alpha stimulation was transiently reconstituted in three responder patients to a significant level. Three patients showed a marginal reconstitutive response.. 5-HT3 receptor blockade transiently affects monocyte tissue infiltration, modulates T-H1 cytokines in clinical responders as well as MIP-1beta in moderate responders, and transiently affects the ex vivo response to exogenous TNF-alpha.

Topics: Adult; Aged; Autoimmune Diseases; Chronic Disease; Fibromyalgia; Humans; Immune System; Indoles; Middle Aged; Pain; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Tropisetron

Substance P is found at an elevated level in the cerebrospinal fluid of fibromyalgia (FM) patients. Treatment with tropisetron leads in a subgroup of FM patients to pain reduction. The question arises of whether the substance P level in the serum can be changed by tropisetron treatment.. Twenty patients with FM diagnosed according to the ACR criteria were treated for 5 days with a 5 mg tropisetron intravenous (i.v.) bolus injection daily. Before the first injection, 3 h later, and before and 3 h after the last injection, the serum levels of substance P were determined. The determination of this substance was carried out by means of an immunoassay from Assay Design Biotrend, Cologne. To evaluate the success of the tropisetron treatment, patients made a global assessment as 'clearly better', 'better', 'unchanged', or 'poor'. Patients who answered 'clearly better' and 'better' were regarded as responders.. Of the 20 patients, ten reported a good or very good influence on their pain (responders). In these responders, the means of the serum substance P levels were elevated in comparison with the non-responders, though the difference was not significant. In responders, the 5-HT3 receptor antagonist tropisetron produced a significant decrease in the serum substance P levels, while this did not occur in the non-responders.. It is possible that the responders to tropisetron represent a subgroup of FM patients for whom substance P and 5-HT3 receptors play key roles in the development of the pain symptoms.

Topics: Female; Fibromyalgia; Humans; Indoles; Middle Aged; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Substance P; Time Factors; Tropisetron

Vegetative and functional symptoms are, besides pain and tenderness of tender points, considered as additional information for the diagnosis of fibromyalgia (FM). In clinical trials, vegetative and functional symptoms have been included for selection of patients (e.g. sleep disturbances) and as secondary outcome parameters. Despite the relevance of these symptoms, no validated method is currently available but symptom lists are ad hoc developed by investigators. In this manuscript, data from a published double blind, randomised study are reanalysed which compared oral therapy over 10 days with 5 mg, 10 mg, and 15 mg to placebo in FM patients. This study applied a list of 17 vegetative and functional symptoms, which had to be scored by the patients by use of a 4-point severity scale (0 = none to 3 = severe). Factor analysis of the baseline data from 195 patients suggested to separate 6 sub-scales: Cardiovascular, gastrointestinal, psychiatric (sleep disturbance), nervous, autonomic system, and general disorders. Sleep disturbances, general symptoms (morning stiffness, fatigue) and autonomic symptoms (cold extremities, hyperhidrosis) were most severe in intensity. Analysis of sensitivity for treatment effects made use of differences between placebo and 5 mg tropisetron in changes between baseline and final assessment of the tropisetron trial. While, on the item level, differences in favour of tropisetron could only be demonstrated for sleep disorders, on the sub-scale level, also favourable effects of tropisetron could be shown for cardiovascular and nervous system complaints and, as a tendency, for general symptoms. On the other side, the sub-scale score of gastrointestinal symptoms worsened under tropisetron whilst it improved under placebo which effect was due to side effects of the active treatment. It is concluded that symptom clusters like sub-scales of a list of vegetative and functional symptoms will be more suitable for diagnostic purposes and evaluation of treatment outcome of clinical trials. Further research is urgently required which addresses the development of a FM-specific scale to assess vegetative and functional symptoms.

Topics: Fibromyalgia; Humans; Indoles; Randomized Controlled Trials as Topic; Serotonin Antagonists; Sickness Impact Profile; Tropisetron

In 223 fibromyalgia (FM) patients in a rheumatology practice, a follow-up postal survey was carried out 0.5-2 years after a 5-day intravenous (i.v.) treatment with 5 mg of the 5-HT3 receptor antagonist tropisetron daily on the effect of this treatment. 121 patients returned the completed questionnaire. After subtraction of 22 undeliverable questionnaires, this represented 60.2% of patients contacted for whom an assessment of the tropisetron treatment was possible. A good to very good effect of the treatment on the pain was reported by 45% of the patients, and only 25% reported an unsatisfactory effect. The effect of tropisetron IV lasted between one day and 12 weeks (mean 8.6 +/- 13.6 d). Sleep and general condition were also assessed as good or very good by almost half of the patients. The tolerance of tropisetron was generally good. In comparison with the current treatment and the best treatment with other drugs ever received, tropisetron was rated as more efficacious in almost half of the cases, though an unsatisfactory effect of tropisetron compared to other treatments was reported in 30% of the cases. Considered in comparison to less or at most equally efficacious alternatives, according to this open respective study, IV tropisetron treatment represents a promising option for the treatment of FM even though the study design incorporated many imponderables. Particularly the question of whether the success of treatment can be improved further with a longer lasting treatment or a selection of the patients still needs to be settled.

Topics: Female; Fibromyalgia; Humans; Indoles; Injections, Intravenous; Male; Middle Aged; Pain; Retrospective Studies; Rheumatology; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Surveys and Questionnaires; Tropisetron

Topics: Animals; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Fibromyalgia; Humans; Indoles; Rheumatic Diseases; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Tropisetron

Topics: Animals; Clinical Trials as Topic; Fibromyalgia; Humans; Indoles; Pain Measurement; Pain Threshold; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Rheumatic Diseases; Serotonin; Serotonin Antagonists; Treatment Outcome; Tropisetron

Topics: Female; Fibromyalgia; Humans; Indoles; Injections; Pain Measurement; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin Antagonists; Treatment Outcome; Tropisetron

Topics: Arthritis, Rheumatoid; Clinical Trials as Topic; Fibromyalgia; Humans; Indoles; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin Antagonists; Tropisetron

The aim of the study was to assess the influence of the 5HT3-receptor antagonist tropisetron on circulating catecholamines as biochemical markers of the activity of the sympathoadrenal system in fibromyalgia. Moreover, serum concentrations of serotonin, somatomedin C, oxytocin, calcitonin-gene-related-peptide, calcitonin and cholecystokinin were assayed as putative markers in pain-related disorders like primary fibromyalgia.. In 96 patients, who met the ACR classification criteria for fibromyalgia, and in 20 sex and age matched controls concentrations of dopamine, noradrenaline, adrenaline, serotonin and tropisetron were assayed in serum by HPLC with electrochemical detection. All other transmitters were determined by ELISA.. There was with the exception of tropisetron, calcitonin and dopamine, no correlation between doses of tropisetron 5, 10, 15 mg respectively and significant changes in circulating transmitters or other transmitters as putative biochemicals markers in primary fibromyalgia. Regarding the prediction of pain reduction to tropisetron, patients with elevated dopamine and/or reduced plasma 5-HT concentrations tended to show a higher response rate.. Despite these partly disappointing results another prospective pilot study with selected patients vs. age and sex matched controls, double blind and with comparison of other 5HT3-receptor antagonists e.g. dolasetron and granisetron e.g. after i.v. bolus injection is suggested. Still the data obtained in this preliminary paper provide some evidence regarding the present discussion on subgroups of patients with primary fibromyalgia.

Topics: Analysis of Variance; Biomarkers; Calcitonin; Calcitonin Gene-Related Peptide; Catecholamines; Cholecystokinin; Enzyme-Linked Immunosorbent Assay; Fibromyalgia; Humans; Indoles; Insulin-Like Growth Factor I; Oxytocin; Receptors, Serotonin; Receptors, Serotonin, 5-HT3; Serotonin; Serotonin Antagonists; Tropisetron

Topics: Fibromyalgia; Humans; Indoles; Serotonin Antagonists; Tropisetron