Primary studies included in this broad synthesis

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A pilot randomized placebo-controlled study of pirlindole in the treatment of primary fibromyalgia

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Journal Journal of Musculoskeletal Pain
Year 1998
Links DOI http://dx.doi.org/10.1300/J094v06n02_02

This article is included in 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVES: The objective of this study was to evaluate the efficacy and safety of pirlindole [75 mg b.i.d.], a reversible and selective inhibitor of monoamine oxidase A [RIMA] in the treatment of primary fibromyalgia syndrome [FMS]. METHODS: One hundred patients were included in a four-week double-blind placebo-controlled study. The safety analysis was based on 89 patients [45 pirlindole and 44 placebo] and the efficacy analysis on 61 patients [33 pirlindole and 28 placebo]. The evaluation of the outcome of therapy was based on the results obtained on eight characteristic parameters [pain, morning stiffness, tender pain score, psychological evaluation using the Symptom Checklist-90-Revised, fatigue, sleep disturbance, global evaluation by the patient, global evaluation by the investigator]. RESULTS: When compared with baseline evaluation a significant improvement [P < 0.05] was noticed for all the parameters with pirlindole whereas three parameters only [tender point score, psychological score, global evaluation by the patient; P < 0.05] were significantly improved by the placebo. Moreover, at the end of the four-week treatment period, pirlindole appeared to be significantly superior to placebo on four parameters [pain, tender point score, global evaluation by the patient and the investigator]. Side-effects were observed in 40% of the pirlindole-treated patients and 3 6.4% of the placebo-treated patients leading to 13.3% and 6.8% drop-outs, respectively. These differences were not statistically significant [P > 0.05]. CONCLUSION: This four-week double-blind placebo-controlled trial suggests that pirlindole [75 mg b.i.d.] might be a well-tolerated and beneficial treatment for FMS patients.

Primary study

Unclassified

A placebo controlled crossover trial of subcutaneous salmon calcitonin in the treatment of patients with fibromyalgia.

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Journal Scandinavian journal of rheumatology
Year 1998
Links Pubmed DOI

This article is included in 1 Broad synthesis Broad syntheses (1 reference)

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The objective of this study was to evaluate the relative efficacy and tolerability of subcutaneously (s.c.) administered salmon calcitonin (sCT) in the treatment of patients with fibromyalgia. Eleven patients who fulfilled the American College of Rheumatology classification criteria for fibromyalgia were studied in a double-blind, crossover trial in which they alternatively received salmon calcitonin (100 IU s.c.) and isotonic saline (1 cc s.c.) for four weeks, with a four weeks wash-out period between the treatments. None of the 11 outcomes measures (seven analog scales, dolorimetry score, and three SIP scores) showed a significant improvement with sCT. The principal side effect observed with sCT was nausea in ten patients and erythema in four patients. These data suggest that sCT given at a dose of 100 IU daily for one month is not effective in the treatment of fibromyalgia.

Primary study

Unclassified

A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia.

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Authors Bennett RM , Clark SC , Walczyk J
Journal The American journal of medicine
Year 1998
Links Pubmed DOI

This article is included in 1 Broad synthesis Broad syntheses (1 reference)

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PURPOSE: The cause of fibromyalgia (FM) is not known. Low levels of insulin-like growth factor 1 (IGF-1), a surrogate marker for low growth hormone (GH) secretion, occur in about one third of patients who have many clinical features of growth hormone deficiency, such as diminished energy, dysphoria, impaired cognition, poor general health, reduced exercise capacity, muscle weakness, and cold intolerance. To determine whether suboptimal growth hormone production could be relevant to the symptomatology of fibromyalgia, we assessed the clinical effects of treatment with growth hormone. METHODS: Fifty women with fibromyalgia and low IGF-1 levels were enrolled in a randomized, placebo-controlled, double-blind study of 9 months' duration. They gave themselves daily subcutaneous injections of growth hormone or placebo. Two outcome measures--the Fibromyalgia Impact Questionnaire and the number of fibromyalgia tender points-were evaluated at 3-monthly intervals by a blinded investigator. An unblinded investigator reviewed the IGF-1 results monthly and adjusted the growth hormone dose to achieve an IGF-1 level of about 250 ng/mL. RESULTS: Daily growth hormone injections resulted in a prompt and sustained increase in IGF-1 levels. The treatment (n=22) group showed a significant improvement over the placebo group (n=23) at 9 months in both the Fibromyalgia Impact Questionnaire score (P <0.04) and the tender point score (P <0.03). Fifteen subjects in the growth hormone group and 6 subjects in the control group experienced a global improvement (P <0.02). There was a delayed response to therapy, with most patients experiencing improvement at the 6-month mark. After discontinuing growth hormone, patients experienced a worsening of symptoms. Carpal tunnel symptoms were more prevalent in the growth hormone group (7 versus 1); no other adverse events were more common in this group. CONCLUSIONS: Women with fibromyalgia and low IGF-1 levels experienced an improvement in their overall symptomatology and number of tender points after 9 months of daily growth hormone therapy. This suggests that a secondary growth hormone deficiency may be responsible for some of the symptoms of fibromyalgia.

Primary study

Unclassified

Double-blind, placebo-controlled cross-over study of intravenous S-adenosyl-L-methionine in patients with fibromyalgia.

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Journal Scandinavian journal of rheumatology
Year 1997
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial. There was no significant difference in improvement in the primary outcome: tender point change between the two treatment groups. There was a tendency towards statistical significance in favour of SAMe on subjective perception of pain at rest (p = 0.08), pain on movement (p = 0.11), and overall well-being (p = 0.17) and slight improvement only on fatigue, quality of sleep, morning stiffness, and on the Fibromyalgia Impact Questionnaire for pain. No effect could be observed on isokinetic muscle strength, Zerrsen self-assessment questionnaire, and the face scale. No effect of SAMe in patients with FM was found in this short term study.

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Lowe J

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Primary study

Unclassified

Comparison of the analgesic efficacy and tolerability of tramadol 100 mg sustained-release tablets and tramadol 50 mg capsules for the treatment of chronic low back pain

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Authors Sorge, Dr J. , Stadler, Th
Journal Clinical Drug Investigation
Year 1997
Links DOI Google Scholar

This article is included in 2 Broad syntheses Broad syntheses (2 references) 1 Systematic review Systematic reviews (1 reference)

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This multicentre, randomised, double-blind, parallel-group study was designed to examine the analgesic efficacy and tolerability of a newly developed tramadol slow-release (SR) tablet in comparison with immediate-release tramadol capsules in patients with chronic low back pain which had persisted despite intervention with other pharmacological and/or nonpharmacological measures. 103 patients were treated with tramadol SR tablets twice daily (2 x 100 mg/day) and 102 patients with capsules 4 times daily (4 x 50 mg/day) over a period of 3 weeks. The medication in both groups (verum/placebo) was administered 4 times daily to ensure the double-blind character of the study ('double-dummy technique'). In case of insufficient pain relief the patients received 2 x 200 mg SR/day as an escape medication (open design). Daily pain intensity was assessed by patients on a 4-step verbal rating scale. At the end of the study retrograde assessment of analgesia was done by the patient using a 5-step classification. Sufficient pain relief could be achieved in approximately 60% of the patients (116 patients) who completed the 3-week treatment period. There was no difference in pain relief (SR 59% and capsules 59%) and in course of pain intensity between both groups. Furthermore, 30 patients (15.3%) were satisfactorily treated with the escape medication. Adverse events were reported at a similar rate in both groups (54.4% with the SR tablet formulation and 52.9% with the capsules). The main adverse events were nausea (l6.6%), dizziness (14.1%), vomiting (9.8%), tiredness (7.8%), diaphoresis (6.3%), headache (6.3%), constipation (6.3%) and dry mouth (6.3%). With the exception of diaphoresis, constipation and dry mouth, adverse events decreased in incidence during the study. The results confirmed the equivalence with regard to efficacy and tolerability of twice-daily administration of tramadol SR tablets compared with 4-times-daily administration of tramadol capsules.

Primary study

Unclassified

An evaluation of antidepressants in rheumatic pain conditions.

Journal Anesthesia and analgesia
Year 1996
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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In a randomized, double-blind, parallel study, fluoxetine and amitriptyline were compared with placebo in the treatment of chronic rheumatic pain. A total of 59 patients were evaluated during 4 wk of treatment and received 20 mg fluoxetine, 25 mg amitriptyline, or placebo daily. Pain intensity, pain relief, vital variables, and global evaluation were used to assess efficacy. To evaluate safety variables, the incidence of side effects was noted. Both amitriptyline and fluoxetine significantly reduced pain intensity compared with placebo. Similarly, pain relief was greater with both amitriptyline and fluoxetine than with placebo. At the end of the fourth week, fluoxetine was superior in efficacy to amitriptyline. The incidence of adverse effects was significantly greater with amitriptyline; dryness of the mouth was the most predominant side effect. We conclude that fluoxetine is an effective analgesic with fewer side effects.

Primary study

Unclassified

A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia.

Journal Arthritis and rheumatism
Year 1996
Links Pubmed DOI

This article is included in 12 Systematic reviews Systematic reviews (12 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVE: To study the effect of fluoxetine (FL) and amitriptyline (AM), alone and in combination, in patients with fibromyalgia (FM). METHODS: Nineteen patients with FM completed a randomized, double-blind crossover study, which consisted of 4 6-week trials of FL (20 mg), AM (25 mg), a combination of FL and AM, or placebo. Patients were evaluated on the first and last day of each trial period. Outcome measures included a tender point score, the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI) scale, and visual analog scales (VAS) for global well-being (1 completed by the physician and 1 by the patient), pain, sleep trouble, fatigue, and feeling refreshed upon awakening. RESULTS: Both FL and AM were associated with significantly improved scores on the FIQ and on the VAS for pain, global well-being, and sleep disturbances. When combined, the 2 treatments worked better than either medication alone. Similar, but nonsignificant, improvement occurred in the BDI scale, the physician global VAS, and the VAS for fatigue and feeling refreshed upon awakening. Trends were less clear for the tender point score. CONCLUSION: Both FL and AM are effective treatments for FM, and they work better in combination than either medication alone.

Primary study

Unclassified

The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo controlled, modified crossover study.

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Journal The Journal of rheumatology
Year 1996
Links Pubmed

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVE: This dose ranging, double blind, placebo controlled, modified crossover study examined whether zolpidem would improve the disturbed sleep, fatigue, mood and pain symptoms in patients with fibromyalgia (FM). METHODS: All symptoms were rated over 4 nights and 4 conditions for 16 consecutive nights during which 19 patients (mean age 42 years) randomly received placebo or zolpidem 5 mg, 10 mg, or 15 mg at bedtime. RESULTS: The 16 patients who completed the study reported no significant differences in ratings of pain, number of tender points, mood, sleep quality, morning fatigue, morning sleepiness or ability to concentrate. Compared to the placebo group, patients treated with zolpidem recorded significantly reduced time to fall asleep, increased sleep time, reduced awakenings, overall improvement in sleep and daytime energy, but a lower rating for evening energy. Zolpidem at the 10 mg dose was rated most acceptable for sleep. Adverse incidence rates were highest in the placebo group and lowest in the zolpidem 10 mg group. One person withdrew because of migraine while taking zolpidem 10 mg. CONCLUSION: Short term treatment with zolpidem (5 to 15 mg) does not affect the pain of FM, but is useful for sleep and daytime energy in this patient population.