A shared decision-making communication training program for physicians treating fibromyalgia patients: Effects of a randomized controlled trial

By Christiane Bieber, Knut Georg Mqller, Klaus Blumenstiel, Achim Hochlehnert, Stefanie Wilke, Mechthild Hartmann, Wolfgang Eich

Journal of Psychosomatic Research 64 (2008) 13 – 20

Department of Psychosomatic and General Internal Medicine, Medical Hospital, University of Heidelberg, Im Neuenheimer Feld 410, D-69120 Heidelberg, Germany. Tel.: +49 6221 56 38657; fax: +49 6221/56 5988. E-mail address: christiane.bieber@med.uni-heidelberg.de (C. Bieber).

Objective: Fibromyalgia syndrome (FMS) is a condition of chronic widespread pain that is difficult to control and is associated with strains in physician–patient interaction. Shared decision making (SDM) can be a potential solution to improve interaction. We evaluated the effects of an SDM intervention, including an SDM communication training program for physicians, in a randomized controlled trial with FMS patients. The main objective was to assess whether SDM improves the quality of physician–patient interaction from patients’ perspective.

Methods: Patients were randomized to either an SDM group or an information-only group. The SDM group was treated by physicians trained in SDM communication and had access to a computer-based information package; the information-only group received only the information package and was treated by standard physicians. All patients were offered the same evidence-based treatment options for FMS. Patients were assessed with questionnaires on physician–patient interaction (main outcome criteria) and decisional processes. Physicians filled out a questionnaire on interaction difficulties. Assessment took place immediately after the initial consultation.

Results: Data from 85 FMS patients (44 in the SDM group and 41 in the information-only group) were analyzed. The mean age was 49.9 years (S.D.=10.2), and 91.8% of patients were female. The quality of physician–patient interaction was significantly higher in the SDM group than in the information-only group ( Pb.001). We found no differences in secondary outcome measures. Conclusions: SDM with FMS patients might be a possible means to achieve a positive quality of physician–patient interaction. A specific SDM communication training program teaches physicians to perform SDM and reduces frustration in patients.

 

Read the Full Study

 

The Effect of Cranial Electrotherapy Stimulation (CES) on Pain Associated with Fibromyalgia.

By Cork RC, Wood PB, Ming N, Shepherd C, Eddy J, Price L.

The Internet Journal of Anesthesiology. 2004; 8(2)

Subjective pain intensity was the primary measured variable in a double-blind crossover study examining the effect of cranial electrotherapy stimulation (CES) on the pain associated with fibromyalgia. Initially, 39 patients were randomly allocated to CES and 35 patients were allocated to a sham group. Measurements taken at baseline and after three weeks included pain intensity, McGill Pain Score, tenderpoint score, profile of mood states, and Oswestry Score. Three weeks after crossover, measurements were repeated. Significant CES effects were identified, revealing an improvement in pain intensity, McGill Score, tenderpoint score, and profile of mood states (p<0.05). However, no significant effect was observed on Oswestry Score, which is a score identifying functional effects of pain.

This study reveals that CES could play a significant role in the treatment of pain associated with fibromyalgia; however, the long-term effects on disability remain to be studied.

 

The effect of melatonin in patients with fibromyalgia: a pilot study.

By Citera G, Arias MA, Maldonado-Cocco JA, Lázaro MA, Rosemffet MG, Brusco LI, Scheines EJ, Cardinalli DP.

Clin Rheumatol. 2000;19(1):9-13.

The aim of the study was to determine the possible effect of melatonin treatment on disturbed sleep, fatigue and pain symptoms observed in fibromyalgia (FM) patients.

Twenty-one consecutive patients with FMwere included in an open 4-week-duration pilot study. Before and after treatment with melatonin 3 mg at bedtime, patients were evaluated using tender point count by palpation of 18 classic anatomical regions, pain score in four predesignated areas, pain severity on a 10 cm visual analogue scale (VAS), sleep disturbances, fatigue, depression, anxiety, and patient and physician global assessments, also by a VAS. Urine 6-sulphatoxymela-tonin levels (aMT-6S) were measured in the patients and 20 age- and sex-matched controls.

Nineteen patients completed the study. One patient withdrew because of migraine and another was lost to follow-up. At day 30, median values for the tender point count and severity of pain at selected points, patient and physician global assessments and VAS for sleep significantly improved with melatonin treatment. Other variables improved but did not reach statistical significance. Adverse events were mild and transient. Lower levels of aMT-6S were found in FMpatients compared with normal median controls (+/-SD, 9.16 +/- 7.9 microg/24 h vs 16.8 +/- 12.8 microg/24 h) (p = 0.06).
Although this is an open study, our preliminary results suggest that melatonin can be an alternative and safe treatment for patients with FM. Double-blind placebo controlled studies are needed.

 

Treatment of cervical myelopathy in patients with the fibromyalgia syndrome: outcomes and implications.

By Heffez DS, Ross RE, Shade-Zeldow Y, Kostas K, Morrissey M, Elias DA, Shepard A.

Eur Spine J. 2007 Apr 11; [Epub ahead of print]

Some patients with fibromyalgia also exhibit the neurological signs of cervical myelopathy. We sought to determine if treatment of cervical myelopathy in patients with fibromyalgia improves the symptoms of fibromyalgia and the patients’ quality of life.

Anon-randomized, prospective, case control study comparing the outcome of surgical (n = 40) versus non-surgical (n = 31) treatment of cervical myelopathy in patients with fibromyalgia was conducted. Outcomes were compared using SF-36, screening test for somatization, HADS, MMPI-2 scale 1 (Hypochondriasis), and self reported severity of symptoms 1 year after treatment. There was no significant difference in initial clinical presentation or demographic characteristics between the patients treated by surgical decompression and those treated by non-surgical means.

There was a striking and statistically significant improvement in all symptoms attributed to the fibromyalgia syndrome in the surgical patients but not in the non-surgical patients at 1 year following the treatment of cervical myelopathy (P ≤ 0.018–0.001, Chi-square or Fisher’s exact test). At the 1 year follow-up, there was a statistically significant improvement in both physical and mental quality of life as measured by the SF-36 score for the surgical group as compared to the non-surgical group (Repeated Measures ANOVA P < 0.01). There was a statistically significant improvement in the scores from Scale 1 of the MMPI-2 and the screening test for somatization disorder, and the anxiety and depression scores exclusively in the surgical patients (Wilcoxon signed rank, P < 0.001). The surgical treatment of cervical myelopathy due to spinal cord or caudal brainstem compression in patients carrying the diagnosis of fibromyalgia can result in a significant improvement in a wide array of symptoms usually attributed to fibromyalgia with attendant measurable improvements in the quality of life. We recommend detailed neurological and neuroradiological evaluation of patients with fibromyalgia in order to exclude compressive cervical myelopathy, a potentially treatable condition.

 

The treatment of fibromyalgia with cranial electrotherapy stimulation.

By Lichtbroun AS, Raicer MM, Smith RB.

J Clin Rheumatol. 2001 Apr;7(2):72-8.

In cranial electrotherapy stimulation (CES), microcurrent levels of electrical stimulation are passed across the head via electrodes clipped to the ear lobes. After successful clinical use of CES with fibromyalgia patients in our clinic, it was decided to test these results with a double-blind, placebo-controlled study in which 60 randomly assigned patients were given 3 weeks of 1-hour-daily CES treatments, sham CES treatments, or were held as wait-in-line controls for any placebo effect in the sham-treated patients.

Treated patients showed a 28% improvement in tender point scores, and a 27% improvement in self-rated scores of general pain level. The number of subjects rating their quality of sleep as poor dropped from 60% at the beginning of the study to 5%. In addition, there were significant gains in the self-rated feelings of well-being and quality of life, plus gains in six stress-related psychological test measures. No placebo effect was found among the sham-treated controls. Atheoretical role of CES in affecting the brain’s pain message mechanisms and/or neurohor-monal control systems is discussed.

It is concluded that CES is as effective as the drug therapies in several trials, with no negative side effects, and deserves further consideration as an additional agent for the treatment of fibromyalgia.

 

Double-blind, multicenter trial comparing acetyl l-carnitine with placebo in the treatment of fibromyalgia patients.

By Rossini M, Di Munno O, Valentini G, Bianchi G, Biasi G, Cacace E, Malesci D, La Montagna G, Viapiana O, Adami S.

Clin Exp Rheumatol. 2007 Mar-Apr;25(2):182-8.

OBJECTIVE: Fibromyalgia (FMS) is a chronic syndrome characterized by widespread pain, troubled sleep, disturbed mood, and fatigue. Several analgesic strategies have been evaluated but the results are moderate and inconsistent. Antidepressant agents are now considered the treatment of choice in most patients. It has been recently suggested that FMS may be associated with metabolic alterations including a deficit of carnitine. In this multicenter randomized clinical trial we evaluated the efficacy of acetyl L-carnitine (LAC) in patients with overt FMS.

METHODS: One hundred and two patients meeting the American College of Rheumatology criteria for FMS were randomized into the study. The treatment consisted of 2 capsules/day of 500 mg LAC or placebo plus one intramuscular (i.m.) injection of either 500 mg LAC or placebo for 2 weeks. During the following 8 weeks the patients took 3 capsules daily containing either 500 mg LAC or placebo. The patients were seen during treatment after 2 (visit 3), 6 (visit 4) and 10 weeks (visit 5). The patients were also visited 4 weeks after treatment discontinuation (follow-up visit). Outcome measures included the number of positive tender points, the sum of pain threshold (kg/cm2 or “total myalgic score”), the Short Form 36 (SF36), a 100 mm visual analog scale (VAS) for self-perceived stiffness, fatigue, tiredness on awakening, sleep, work status, depression, and muscular-skeletal pain, and the Hamilton depression scale.

RESULTS: The “total myalgic score” and the number of positive tender points declined significantly and equally in both groups until the 6th week of treatment. At the 10th week both parameters remained unchanged in the placebo group but they continued to improve in the LAC group with a statistically significant between-group difference. Most VAS scores significantly
improved in both groups. Astatistically significant between-group difference was observed for depression and musculo-skeletal pain. Significantly larger improvements in SF36 questionnaire were observed in LAC than in placebo group for most parameters. Treatment was well-tolerated.

CONCLUSION: Although this experience deserves further studies, these results indicate that LAC may be of benefit in patients with FMS, providing improvement in pain as well as the general and mental health of these patients.

 

Venlafaxine treatment of fibromyalgia.

By Sayar K, Aksu G, Ak I, Tosun M.

Ann Pharmacother. 2003 Nov;37(11):1561-5.

BACKGROUND: Although the pathophysiology of fibromyalgia is unknown, central monoaminergic transmission may play a role. Antidepressants have proved to be successful in alleviating symptoms of fibromyalgia. Medications that act on multiple neurotransmitters may be more effective in symptom management.

OBJECTIVE: To assess the efficacy of venlafaxine, a potent inhibitor of both norepinephrine and serotonin reuptake, in the treatment of patients with fibromyalgia.

METHODS: Fifteen patients with fibromyalgia were assessed prior to and after treatment with fixed-dose venlafaxine 75 mg/d. Before initiation of pharmacotherapy, patients were interviewed
with the Structured Clinical Interview for Axis Idisorders in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition. The study lasted for 12 weeks, and patients were evaluated in weeks 6 and 12. The primary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) total score and pain score. The anxiety and depression levels of the patients were measured with the Beck Depression, the Beck Anxiety, the Hamilton Anxiety, and the Hamilton Depression scales.

RESULTS: There was a significant improvement in the mean intensity of pain (F = 14.3; p = 0.0001) and in the disability caused by fibromyalgia (F = 42.7; p = 0.0001) from baseline to week 12 of treatment. The depression and anxiety scores also decreased significantly from baseline to week 12. The improvement in the FIQ scores did not correlate with the decrease of scores in both patient- and physician-rated depression and anxiety inventories. Change in pain scores also was not correlated with the change in depression and anxiety scores.

CONCLUSIONS: Venlafaxine was quite promising in alleviating the pain and disability associated with fibromyalgia. This effect seems to be independent of its anxiolytic and antidepressant properties. Blockade of both norepinephrine and serotonin reuptake might be more effective than blockade of either neurotransmitter alone in the treatment of fibromyalgia.

 

A combination of 6 months of treatment with pyridostigmine and triweekly exercise fails to improve insulin-like growth factor-Ilevels in fibromyalgia, despite improvement in the acute growth hormone response to exercise.

By Jones KD, Deodhar AA, Burckhardt CS, Perrin NA, Hanson GC, Bennett RM.

J Rheumatol. 2007 May;34(5):1103-11.

OBJECTIVE: People with fibromyalgia (FM) often have low insulin-like growth factor-I(IGF-I) levels and a suboptimal growth hormone (GH) response to acute exercise. As previous work had demonstrated a normalization of the acute GH response to exercise with the use of pyri-dostigmine (PYD), we tested the hypothesis that 6 months of PYD therapy plus supervised exercise would increase IGF-Ilevels.

METHODS: Subjects with primary FMwere randomized into 4 groups: (1) PYD/exercise; (2) PYD/diet recall; (3) placebo/exercise; and (4) placebo/diet recall. The dosing of PYD was 60 mg tid for 6 months. Resting IGF-Ilevels were measured at baseline and after 6 months of treatment. In addition the acute GH response to exercise at VO2 max was measured at baseline and after treatment.

RESULTS: Atotal of 165 FMsubjects (mean age 49.5 yrs, 5 male) were entered and 154 (93.3%) completed the study. Six months of therapy (PYD plus exercise or exercise alone) failed to improve the IGF-Ilevels. The use of PYD 1 hour prior to exercise improved the acute GH response (4.54 ng/dl) compared to placebo (1.74 ng/dl) (p = 0.001) at the end of the 6-month trial. The acute GH response to exercise at baseline did not correlate with IGF-I, age, depression, medications, estrogen status, or obesity.

CONCLUSION: Acombination of triweekly supervised exercise plus the daily use of PYD for 6 months failed to increase IGF-Ilevels in patients with FM, despite the confirmation that PYD normalizes the acute GH response to strenuous aerobic exercise.

 

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

By Bennett RM, Clark SC, Walczyk J.

Am J Med. 1998 Mar;104(3):227-31.

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 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.

 

Treatment of fibromyalgia with cyclobenzaprine: A meta-analysis.

By Tofferi JK, Jackson JL, O’Malley PG.

Arthritis Rheum. 2004 Feb 15;51(1):9-13.

OBJECTIVE: To systematically review the effectiveness of cyclobenzaprine in the treatment of fibromyalgia.

METHODS: Articles describing randomized, placebo-controlled trials of cyclobenzaprine in people with fibromyalgia were obtained from Medline, EMBase, Psyclit, the Cochrane Library, and Federal Research in Progress Database. Unpublished literature and bibliographies were also

reviewed. Outcomes, including global improvement, treatment effects on pain, fatigue, sleep, and tender points over time, were abstracted.

RESULTS: Five randomized, placebo-controlled trials were identified. The odds ratio for global improvement with therapy was 3.0 (95% confidence interval [95% CI] 1.6-5.6) with a pooled risk difference of 0.21 (95% CI0.09-0.34), which calculates to 4.8 (95% CI3.0-11) individuals needing treatment for 1 patient to experience symptom improvement. Pain improved early on, but there was no improvement in fatigue or tender points at any time.

CONCLUSION: Cyclobenzaprine-treated patients were 3 times as likely to report overall improvement and to report moderate reductions in individual symptoms, particularly sleep.