Category: Treatment

Treatment with staphylococcus toxoid in fibromyalgia/chronic fatigue syndrome–a randomised controlled trial

Abstract:

We have previously conducted a small treatment study on staphylococcus toxoid in fibromyalgia (FM) and chronic fatigue syndrome (CFS). The aim of the present study was to further assess the efficacy of the staphylococcus toxoid preparation Staphypan Berna (SB) during 6 months in FM/CFS patients.

One hundred consecutively referred patients fulfilling the ACR criteria for FM and the 1994 CDC criteria for CFS were randomised to receive active drug or placebo. Treatment included weekly injections containing 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml, 0.9 ml, and 1.0 ml SB or coloured sterile water, followed by booster doses given 4-weekly until endpoint.

Main outcome measures were the proportion of responders according to global ratings and the proportion of patients with a symptom reduction of > or =50% on a 15-item subscale derived from the comprehensive psychopathological rating scale (CPRS). The treatment was well tolerated. Intention-to-treat analysis showed 32/49 (65%) responders in the SB group compared to 9/49 (18%) in the placebo group (P<0.001). Sixteen patients (33%) in the SB group reduced their CPRS scores by at least 50% compared to five patients (10%) in the placebo group (P< 0.01). Mean change score on the CPRS (95% confidence interval) was 10.0 (6.7-13.3) in the SB group and 3.9 (1.1-6.6) in the placebo group (P<0.01). An increase in CPRS symptoms at withdrawal was noted in the SB group.

In conclusion, treatment with staphylococcus toxoid injections over 6 months led to significant improvement in patients with FM and CFS. Maintenance treatment is required to prevent relapse.

 

Source: Zachrisson O, Regland B, Jahreskog M, Jonsson M, Kron M, Gottfries CG. Treatment with staphylococcus toxoid in fibromyalgia/chronic fatigue syndrome–a randomised controlled trial. Eur J Pain. 2002;6(6):455-66. http://www.ncbi.nlm.nih.gov/pubmed/12413434

 

Interventions for the treatment and management of chronic fatigue syndrome: a systematic review

Erratum in: JAMA 2002 Mar 20;287(11):1401.

Abstract:

CONTEXT: A variety of interventions have been used in the treatment and management of chronic fatigue syndrome (CFS). Currently, debate exists among health care professionals and patients about appropriate strategies for management.

OBJECTIVE: To assess the effectiveness of all interventions that have been evaluated for use in the treatment or management of CFS in adults or children.

DATA SOURCES: Nineteen specialist databases were searched from inception to either January or July 2000 for published or unpublished studies in any language. The search was updated through October 2000 using PubMed. Other sources included scanning citations, Internet searching, contacting experts, and online requests for articles.

STUDY SELECTION: Controlled trials (randomized or nonrandomized) that evaluated interventions in patients diagnosed as having CFS according to any criteria were included. Study inclusion was assessed independently by 2 reviewers. Of 350 studies initially identified, 44 met inclusion criteria, including 36 randomized controlled trials and 8 controlled trials.

DATA EXTRACTION: Data extraction was conducted by 1 reviewer and checked by a second. Validity assessment was carried out by 2 reviewers with disagreements resolved by consensus. A qualitative synthesis was carried out and studies were grouped according to type of intervention and outcomes assessed.

DATA SYNTHESIS: The number of participants included in each trial ranged from 12 to 326, with a total of 2801 participants included in the 44 trials combined. Across the studies, 38 different outcomes were evaluated using about 130 different scales or types of measurement. Studies were grouped into 6 different categories. In the behavioral category, graded exercise therapy and cognitive behavioral therapy showed positive results and also scored highly on the validity assessment. In the immunological category, both immunoglobulin and hydrocortisone showed some limited effects but, overall, the evidence was inconclusive. There was insufficient evidence about effectiveness in the other 4 categories (pharmacological, supplements, complementary/alternative, and other interventions).

CONCLUSIONS: Overall, the interventions demonstrated mixed results in terms of effectiveness. All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies. Interventions which have shown promising results include cognitive behavioral therapy and graded exercise therapy. Further research into these and other treatments is required using standardized outcome measures.

Comment in:

Measuring the quality of trials of treatments for chronic fatigue syndrome. [JAMA. 2001]

Chronic fatigue syndrome–trials and tribulations. [JAMA. 2001]

Review: behavioural interventions show the most promise for chronic fatigue syndrome. [Evid Based Nurs. 2002]

Review: behavioral interventions show the most promise for the chronic fatigue syndrome. [ACP J Club. 2002]

Review: cognitive behavioural therapy and graded exercise show the most promise for chronic fatigue syndrome. [Evid Based Ment Health. 2002]

 

Source: Whiting P, Bagnall AM, Sowden AJ, Cornell JE, Mulrow CD, Ramírez G. Interventions for the treatment and management of chronic fatigue syndrome: a systematic review. JAMA. 2001 Sep 19;286(11):1360-8. http://www.ncbi.nlm.nih.gov/pubmed/11560542

 

Cortisol deficiency may account for elevated apoptotic cell population in patients with chronic fatigue syndrome

Comment in: Single aetiological agent may not be feasible in CFS patients. [J Intern Med. 1999]

Comment on: Elevated apoptotic cell population in patients with chronic fatigue syndrome: the pivotal role of protein kinase RNA. [J Intern Med. 1997]

 

Dear Sir, Vojdani et al. [1] report that patients with chronic fatigue syndrome (CFS) display an increased apoptotic cell population. This abnormality, according to the authors, is due to the activation of protein kinase RNA pathway, which, in turn, ‘could result from disregulated immune system or chronic viral infection’[1].The latter explanation, however, seems unlikely, because no specific virus has been identified in CFS patients, despite extensive research [2]. Special attention, therefore, should mainly be paid to the immune system of CFS patients, because its repeatedly reported abnormalities may help reveal both the aetiology of CFS and an effective treatment against it.

As Vojdani et al. [1] point out, decreased natural killer (NK) cell activity and altered cytokine production characterize CFS patients. These immunological abnormalities, however, may simply reflect the hypocortisolism of CFS patients [3], because a mere lack of steroid restraint on the immune system may well account for its derangement [3]. In fact, since NK cell activity is directly associated with the circadian rhythm of cortisol [4], the decreased NK cell activity observed in CFS patients may simply be due to their cortisol deficiency [3]. The latter, additionally, may also explain why the release of the cytokines interleukin-lβ, interleukin-6, and tumour necrosis factor-α has been found to be increased in peripheral blood mononuclear cell cultures from patients with CFS [5]. All those cytokines, in fact, have been reported to rise during hypocortisolism [6]. This suggests, therefore, that the cortisol deficiency of CFS patients may play a central role in causing both their immunological abnormalities and, presumably, their elevated apoptotic cells.

In view of the role of hypocortisolism in CFS, Vojdani and coworkers might be interested in determining whether the enhanced apoptosis found in their subjects with CFS could be reduced by giving them small daily doses of hydrocortisone and fludrocortisone. The latter, notably, already has been reported to be of great benefit to CFS patients [7]. The rationale for treating CFS patients with the two steroids that are routinely administered to Addisonian patients [8] lies primarily in the fact that no medical condition, except Addison’s disease, shares 20 features with CFS [3]. Five additional symptoms (dizziness upon standing, orthostatic tachycardia, nausea, diarrhoea, and constipation) can be found in both CFS [9] and Addison’s disease [8, 10, 11]. Rather surprisingly, however, despite the staggering similarities between CFS and Addison’s disease, as yet no published attempt has been made to treat CFS patients with both hydrocortisone and fludrocortisone.

You can read the rest of this comment here: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.1999.00478.x/full

 

Source: Baschetti R. Cortisol deficiency may account for elevated apoptotic cell population in patients with chronic fatigue syndrome. J Intern Med. 1999 Apr;245(4):409-10. http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.1999.00478.x/full

 

Relationship Between Chronic Fatigue Syndrome and Neurally Mediated Hypotension

Abstract:

Chronic fatigue syndrome is a chronic debilitating disease that afflicts 4/1000 of the general population. The pathophysiologic basis for this condition is unknown, and no known consistently effective therapy has been identified. Recent studies have reported a link between the chronic fatigue syndrome and neurally mediated hypotension, a common abnormality of blood pressure regulation. In nonrandomized studies, treatment directed at neurally mediated hypotension has been effective in treating the symptoms of the chronic fatigue syndrome in two-thirds of patients. Prospective randomized trials are now in progress.

 

Source: Calkins H, Rowe PC. Relationship Between Chronic Fatigue Syndrome and Neurally Mediated Hypotension. Cardiol Rev. 1998 May;6(3):125-134. http://www.ncbi.nlm.nih.gov/pubmed/10348934

 

Low-dose hydrocortisone in chronic fatigue syndrome: a randomised crossover trial

Abstract:

BACKGROUND: Reports of mild hypocortisolism in chronic fatigue syndrome led us to postulate that low-dose hydrocortisone therapy may be an effective treatment.

METHODS: In a randomised crossover trial, we screened 218 patients with chronic fatigue. 32 patients met our strict criteria for chronic fatigue syndrome without co-morbid psychiatric disorder. The eligible patients received consecutive treatment with low-dose hydrocortisone (5 mg or 10 mg daily) for 1 month and placebo for 1 month; the order of treatment was randomly assigned. Analysis was by intention to treat.

FINDINGS: None of the patients dropped out. Compared with the baseline self-reported fatigue scores (mean 25.1 points), the score fell by 7.2 points for patients on hydrocortisone and by 3.3 points for those on placebo (paired difference in mean scores 4.5 points [95% CI 1.2-7.7], p=0.009). In nine (28%) of the 32 patients on hydrocortisone, fatigue scores reached a predefined cut-off value similar to the normal population score, compared with three (9%) of the 32 on placebo (Fisher’s exact test p=0.05). The degree of disability was reduced with hydrocortisone treatment, but not with placebo. Insulin stress tests showed that endogenous adrenal function was not suppressed by hydrocortisone. Minor side-effects were reported by three patients after hydrocortisone treatment and by one patient after placebo.

INTERPRETATION: In some patients with chronic fatigue syndrome, low-dose hydrocortisone reduces fatigue levels in the short term. Treatment for a longer time and follow-up studies are needed to find out whether this effect could be clinically useful.

Comment in:

Hydrocortisone and chronic fatigue syndrome. [Lancet. 1999]

Hydrocortisone and chronic fatigue syndrome. [Lancet. 1999]

Chronic fatigue syndrome and functional hypoadrenia–fighting vainly the old ennui. [Lancet. 1999]

Hydrocortisone and chronic fatigue syndrome. [Lancet. 1999]

Hydrocortisone and chronic fatigue syndrome. [Lancet. 1999]

 

Source: Cleare AJ, Heap E, Malhi GS, Wessely S, O’Keane V, Miell J. Low-dose hydrocortisone in chronic fatigue syndrome: a randomised crossover trial. Lancet. 1999 Feb 6;353(9151):455-8. http://www.ncbi.nlm.nih.gov/pubmed/9989716

 

The psychotherapeutic effects of estrogens

Abstract:

The effect of estrogens on the central nervous system, particularly mood and behavior, remains a controversial area which needs clarification, not just for understanding of depression in women but to ensure that such commonplace problems in women have efficient and appropriate therapy.

There is now good evidence that estrogens are rapidly effective in the treatment of depression in many women but this information has not found its way through to those health care personnel, psychiatrists and psychologists who are principally involved in the treatment of depression. There is also strong evidence for the benefits of estrogens on cognitive functioning, not only in preventing the onset of dementia but also in improving the symptoms in the established condition.

Recent work has also suggested a benefit for estrogens on mood in women diagnosed as suffering from chronic fatigue syndrome. This article reviews the effect of endogenous estrogen on the female central nervous system and the ever increasing evidence for the diverse psychotherapeutic effects of exogenous estrogens.

 

Source: Panay N, Studd JW. The psychotherapeutic effects of estrogens. Gynecol Endocrinol. 1998 Oct;12(5):353-65. http://www.ncbi.nlm.nih.gov/pubmed/9859029

 

An evaluation of multidisciplinary intervention for chronic fatigue syndrome with long-term follow-up, and a comparison with untreated controls

Abstract:

Individuals meeting the Fukuda et al definition for chronic fatigue syndrome completed a multidisciplinary assessment that included medical, psychiatric, behavioral, and psychological evaluations. Patients were then offered a comprehensive multidisciplinary intervention that included (1) bringing the patient under optimal medical management; (2) treating any ongoing affective or anxiety disorder pharmacologically; and (3) implementing a comprehensive cognitive-behavioral treatment program. Fifty-one patients proceeded to treatment.

The cognitive-behavioral component was carried out through the use of a therapist working with the patients in their own environments. The program was individually tailored to patients, but included (1) structured physical exercise and activation; (2) sleep management strategies; (3) careful activity management; (4) regulation of stimulant intake and reductions in use of symptomatic medications; (5) cognitive intervention designed to deal with patients’ beliefs concerning the nature of their disorder; (6) participation of patients’ family; and (7) efforts to establish specific vocational and avocational goals. Third parties were encouraged to collaborate cooperatively.

Employers were urged to provide employment opportunities and facilitate a graduated but time-targeted return to work. Disability carriers were encouraged to provide interim financial support in the form of disability benefits, support therapeutic intervention, but also to establish a clear time-frame to access to benefits.

Of 51 treated patients, 31 returned to gainful employment, 14 were functioning at a level equivalent to employment, and 6 remained significantly disabled. Twenty of the original 71 patients were contacted an average of 33 months later. Patients who had been treated showed good maintenance of gains. Untreated patients showed improvement in only a minority of cases.

 

Source: Marlin RG, Anchel H, Gibson JC, Goldberg WM, Swinton M. An evaluation of multidisciplinary intervention for chronic fatigue syndrome with long-term follow-up, and a comparison with untreated controls. Am J Med. 1998 Sep 28;105(3A):110S-114S. http://www.ncbi.nlm.nih.gov/pubmed/9790492

 

Chronic fatigue disorders: an inappropriate response to arginine vasopressin?

Abstract:

Chronic fatigue disorders are characterized by a subjectively defined group of symptoms such as chronic fatigue, mental confusion, exertional malaise, weight changes, and/or diffuse multi-joint pains.

Significant clinical overlap exists between chronic fatigue disorders and the syndrome of serum inappropriate anti-diuretic hormone (SIADH). Both chronic fatigue disorders and SIADH are characterized by lethargy and mental confusion. Both disorders can be induced or exacerbated by viral illnesses, physical exertion, emotional stress and/or hypotension. Both can be treated with salt loading and glucocorticoids.

Therefore, altered water metabolism resulting from inappropriate release and/or response to arginine vasopressin (AVP) is proposed as a pathophysiological basis of certain chronic fatigue disorders. Moreover, these data suggest that salt loading and/or direct inhibition of AVP may be an effective therapeutic approach in individuals with chronic fatigue disorders.

 

Source: Peroutka SJ. Chronic fatigue disorders: an inappropriate response to arginine vasopressin? Med Hypotheses. 1998 Jun;50(6):521-3. http://www.ncbi.nlm.nih.gov/pubmed/9710328

 

Putting the rest cure to rest—again

Go home and rest” is still the advice given to many patients who complain of chronic fatigue. The refrain is echoed in self help books and magazines and adopted by many patients. What are the origins of rest as a treatment, does it work, and what evidence is there on which to base our advice to patients?

Victorian physicians diagnosed them as neurasthenia and routinely prescribed rest. This approach was typified by Silas Weir Mitchell’s “rest cure,” which was so popular as to be described as “the greatest advance of which practical medicine can boast in the last quarter of the century.” Despite such accolades, the popularity of the rest cure was short lived. By the turn of the century the same private clinics that once provided it were changing to more active treatments and to the newer psychotherapies. The years that followed saw the end of the rest cure; Karl Menninger poured scorn on the lack of psychological sophistication shown by its proponents, while Richard Asher drew attention to the “the dangers of going to bed.”

You can read the rest of this article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1112768/

Comment in:

Treating chronic fatigue with exercise. Exercise improves mood and sleep. [BMJ. 1998]

Treating chronic fatigue with exercise. Exercise, and rest, should be tailored to individual needs. [BMJ. 1998]

Treating chronic fatigue with exercise. Results are contradictory for patients meeting different diagnostic criteria. [BMJ. 1998]

 

Source: Sharpe M, Wessely S. Putting the rest cure to rest—again. BMJ. 1998 Mar 14;316(7134):796. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1112768/ (Full article)

 

The history and treatment of chronic fatigue syndrome

Abstract:

This article looks at chronic fatigue syndrome, a common condition affecting 1-2.5% of the population. The criteria for diagnosis are described and the nurse’s role in treatment is discussed.

 

Source: Ross E. The history and treatment of chronic fatigue syndrome.  Nurs Times. 1996 Oct 30-Nov 5;92(44):34-6. http://www.ncbi.nlm.nih.gov/pubmed/8945330