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Chronic fatigue syndrome treatment

 
Wikipedia: Chronic fatigue syndrome treatment
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Treatment of chronic fatigue syndrome (CFS) is variable and uncertain, and the condition is primarily managed rather than cured.[1] Only two treatments, cognitive behavioral therapy and graded exercise therapy, have demonstrated reproducible evidence for their efficacy in ambulant (non-severely affected) patients. Other proposed treatments include medications, medical treatments, and complementary and alternative medicine.

Contents

Management techniques

CFS management techniques include behavioral interventions such as cognitive behavioral therapy (CBT, a form of psychological therapy), and graded exercise therapy (GET). Based on evidence from multiple randomized clinical trials (RCTs), a systematic review published in the Journal of the Royal Society of Medicine (October 2006) stated that CBT and GET interventions showed promising results, appearing to reduce symptoms and improve function. The review stated that evidence of effectiveness was inconclusive for most other interventions with some interventions reporting significant adverse effects.[2] A systematic review published in 2004 concluded that depression was the only factor associated with unemployment, and that only cognitive behavior therapy, rehabilitation, and exercise therapy interventions were associated with restoring the ability to work, although for questions of disability and employment in CFS, the limitations inherent in the current literature are extensive.[3]

Cognitive behavioral therapy

According to the cognitive-behavioural model of illness, the patient's interpretation of symptoms plays an important role in perpetuating the illness. CBT aims to help the patient change these negative beliefs with the goal being either to reduce the symptoms, help the patient cope with the illness, or to fully recover.[4]

A systematic review of RCTs found that there is moderate evidence of benefit for CBT in CFS, but that the effectiveness of CBT for CFS outside of specialist settings has been questioned and the quality of the evidence is low.[5] A 2008 Cochrane review of CBT concluded, "CBT is more effective than usual care for reducing fatigue symptoms in adults with CFS, with 40% of participants assigned to CBT showing clinical response at post-treatment, in comparison with 26% assigned to usual care control.", however, it also stated that the benefits of CBT in sustaining clinical response at follow up are inconclusive. The review also concluded that while the quantity and quality of the evidence has grown in recent years "there is a surprising lack of high quality evidence on the effectiveness of CBT alone or in combination with other treatments to inform the development of clinical management programmes for people with CFS".[6] One uncontrolled study with no follow-up found that CBT could facilitate full recovery in some patients, with 69% of the patient cohort no longer meeting the CDC criteria for CFS and "full recovery" occurring in 23% of CFS patients after CBT using the most comprehensive definition of recovery.[7]

Another systematic review on CBT[2] finds that "CBT was associated with a significant positive effect on fatigue, symptoms, physical functioning and school attendance." The reviewers state that the quality of many recent trials on CBT are lower quality randomized controlled trials or trials that did not involve random allocation. The reviewers also state that one recent, good quality trial of CBT in children and adolescence supports the effectiveness of CBT. The reviewers state that reasons for withdrawals typically remain unreported, and that a degree of publication bias seems to be present in CFS/ME literature as a whole. In one study, the effect of CBT has been demonstrated up to five years after therapy.[8]

A 2007 meta-analysis found that the effectiveness of CBT depends on the diagnostic criteria used, with studies using the Oxford criteria having a trend towards significantly higher effect sizes that those using the CDC criteria. The review also notes that CBT for chronic fatigue disorders has about the same efficacy as diverse psychological treatments for a variety of psychological disorders.[9]

According to a 2006 systematic review, "very few studies have assessed the effectiveness of interventions for children and young people and for severely affected patients. The effectiveness of CBT for adolescents is supported by a recent high-quality RCT, although this had only 69 participants." Currently there is no research into the effectiveness of CBT for the severely affected, and these patients may be effectively excluded from trials due to the need to attend a clinic.[2] Some CBT trials suffer from large dropout rates, up to 42% in one study, with a mean dropout rate of 16%. This compares to a 17% dropout rate in a trial of 432 patients receiving CBT for anxiety, "so is not unusually high" according to a 2007 meta-analysis.[9]

CBT has been criticised by patients' organisations because of negative reports from some of their members [10], which have indicated that CBT can sometimes make people worse [11]; one such survey conducted by Action for ME in 2001 found that out of the 285 participants who reported using CBT, 7% reported it to be helpful, 67% reported no change, and 26% reported that it made their condition worse.[12] A subsequent survey in 2008 reported that 50% of patients found CBT helpful, 38% reported no change, and 12% felt that it made their illness worse, though it remained among the lowest-rated treatments in the survey despite the significant increase.[13]

Related treatments

Many CFS patients face the stress of economic and legal problems. CFS sufferers may lose jobs, marriages, and the ability to work at all, causing severe financial loss and distress. A study which included 45 CFS patients found that psychodynamic counselling has comparable effectiveness to cognitive behavioral therapy (CBT) in the treatment of chronic fatigue.[14]

Some CFS patients have comorbid depression and/or anxiety.[15] Children have been successfully treated using antidepressants and therapy.[16]

Graded exercise therapy

Two systematic reviews suggest that some patients may benefit from graded exercise therapy (GET), although there are some limitations with the evidence and the generalizability of the findings.[17][2] The most recent of these reviews (published in 2006) also notes that "no severely affected patients were included in the studies of GET".[2] Patient organisations' surveys commonly report adverse effects.[10][11][12][18]

A New Zealand study suggests that GET may result in self-reported improvement in part by "reducing the degree to which patients focus on their symptoms."[19]

Pacing

Pacing techniques encourage behavioral change while acknowledging patient fluctuations in symptom severity and delayed exercise recovery. Patients are advised to set manageable daily activity/exercise goals and balance their activity and rest to avoid possible over-doing which may worsen their symptoms. Those that are able to function within their individual limits may then start to gradually increase activity and exercise levels (GET) while maintaining pacing methods. The goal is to increase over time the level of routine functioning of the individual.[20] A small randomised controlled trial concluded pacing with GET had statistically better results than relaxation/flexibility therapy.[21][22] A 2008 patient survey by Action for ME found pacing to be the most helpful treatment.[13]

Antiviral Treatments

In subsets of patients, various viruses have been reported as the causative agents of CFS, see Pathophysiology although so far consistent and compelling supportive evidence is still lacking. [23] Others consider that treatment studies of subtypes may reduce the inconsistencies [24] A number of antiviral treatments have been trialled with some benefit.

Ampligen

Nucleic acid (double-stranded RNA) compounds represent a potential new class of pharmaceutical products that are designed to act at the molecular level, it is an inducer of interferon and is considered in other ways to be antiviral and immunomodulatory .

One RCT evaluated Ampligen and found an overall beneficial effect. [25]

In December 2009 the FDA refused to approve Ampligen for treatment of CFS. The FDA concluded that the two RCTs "did not provide credible evidence of efficacy."[26]

Valacyclovir

Nucleosidic class drugs such as acyclovir, valacyclovir and ganicyclovir are inhibitors of viral replication during DNA (for DNA- and retroviruses) or RNA (for RNA viruses) multiplication. [27]

A small RCT compared acyclovir against placebo and found that an equal proportion of patients recovered from placebo and with active treatment. The authors concluded that the improvement of patients reflected either spontaneous remission or the placebo effect. Three people withdrew from acyclovir treatment due to reversible renal failure. [25]

Interferon

A systematic review has found two small RCTs to have evaluated interferon [25]. One of the RCTs found an overall beneficial effect and the other showed some positive effects in relation to immunological outcomes only. The quality of both of these studies was considered poor. [25] A 2007 review of research needs for CFS concluded that trials for interferon beta are now an important priority [28]

IGG

A systematic review found five RCTs to have assessed the effects of immunoglobulin treatment for CFS [25]; of these, 2 RCTs showed an overall beneficial effect and the two RCTs showed some positive results, although in one of the studies this was for physiological effects only. The largest of the RCTs found no effect for the treatment. Another review concluded that "Given the weak evidence of benefit for immunotherapy, the potential harms indicate that it should not be offered as a treatment for CFS."[5]

Pharmacological treatments

No pharmacological treatments have been established as a cure for CFS, but various drugs are used to manage the symptoms of CFS.

Antidepressants

Antidepressants are often prescribed to CFS patients. Their purpose can be to treat secondary depression or mood swings, but low dosage tricyclic antidepressants are sometimes prescribed to improve sleep quality and reduce pain.[29]

Overall, studies into the use of antidepressants in CFS have had mixed results. Some studies have shown a reduction in symptoms with antidepressant use, while others have shown no benefit.[30][31][32]

Hormones

Treatment with steroids such as cortisol and thyroid hormones has been studied.

Hydrocortisone

There have been 7 RCT’s, four trialling hydrocortisone, 2 with fludrocortisone and one with hydrocortisone plus fludrocortisone . Two RCT’s have found overall benefit for hydrocortisone, but it has not been recommended for clinical use.

A 2006 systematic review found one low-quality RCT of hydrocortisone which found a significant difference between groups for fatigue, but two other RCTs found no benefit for steroid treatment.[33].

A randomized, placebo-controlled, double-blind therapeutic trial, conducted between 1992 and 1996 in a tertiary care research institution. 70 patients met the CDC criteria many comorbid with psychiatric diagnosis but who withheld concomitant treatment with other medications. Although hydrocortisone treatment (at a higher dose of 20-30 mg) was associated with some statistical improvement in symptoms of CFS, the authors concluded a degree of adrenal suppression precludes its practical use for CFS. [34]

NADH

A poor quality randomized, double-blind, placebo-controlled crossover study in 26 patients with CFS of reduced nicotinamide adenine dinucleotide NADH reported positive results in 1999. No severe adverse effects were observed related to the study drug. [35]

The RCT had several problems with its methods and a review concluded that there is no good evidence that NADH is of benefit for CFS patients.[5]

Immunotherapy

Staphylococcal toxoid vaccine

There have been 2 RCT’s with staphylococcal toxoid vaccine. A small RCT showed considerable benefit [25] and a large follow up RCT showed overall benefit. However the quality of the follow-up RCT was low and there were relatively high levels of adverse effects. A review concluded that there is insufficient evidence for treatments of this type.[33]

Complementary and alternative medicine

Complementary and alternative medicine usage

People with CFS may use more alternative medicine treatments than people without CFS.[36] In a twin study, 91% of twins with CFS and 71% without CFS used at least one alternative treatment. A large proportion of the study participants said alternative treatments were helpful.[37]

Dietary supplements

Magnesium

Positive results from a trial of magnesium delivered by injection to magnesium-deficient CFS patients were published in 1991,[38] but three subsequent studies did not find magnesium deficiency as a general problem in CFS patients. A 2008 review concluded that there is no good evidence that intramuscular magnesium is of benefit in CFS.[5]

Carnitine

L-Carnitine is an amino acid which includes ALC, a group of natural compounds that have an important role in cellular function. It is required for the transport of fatty acids into the mitochondria during the breakdown of lipids (or fats) for the generation of metabolic energy including in muscles and in the brain. [39]

Two RCTs found benefit from dietary supplementation with L-carnitine or its esters. A 2006 systematic review reported one RCT with overall benefit, although there was no placebo control. [33]

In 2008 a randomised double blind placebo controlled 6 months trial on 96 aged subjects with CFS symptoms administering Acetyl L Carnitine was reported. By the end of the treatment, significant differences between the two groups were found for both physical and mental fatigue and improvements in both the cognitive status and physical functions. [40]

Essential fatty acid treatments

A randomized controlled trial on patients diagnosed with post viral fatigue syndrome (PVFS) and deficient RBC levels, using essential fatty acids comprised of evening primrose oil containing n-6 GLA together with fishoil concentrate containing n-3 EPA and DHA showed significant overall improvement in symptoms and RBC essential fatty acid levels.[41] However a subsequent RCT trying to replicate this study found no significant differences between the treatment and placebo group after treatment, and no significant differences in pre-treatment red-cell membrane lipids between the two groups. [42] The different results may be explained by the patient selection: the first trial tested people with PVFS, whereas the second used the Oxford criteria for CFS. Also, the first trial used paraffin while the second trial used sunflower oil which is better tolerated and less likely to adversely affect the placebo group. [5]

Dietary supplements

A 2006 updated systematic review concluded that the supplements essential fatty acids and magnesium, have shown beneficial effects but only in one or two trials and further rigorous trials of these interventions would be helpful. [33] A 2008 review found insufficient evidence to recommend dietary supplements as a treatment in chronic fatigue syndrome. One RCT compared a polynutrient supplement (containing several vitamins, minerals, and coenzymes, taken twice daily) with a placebo for 10 weeks, but found no difference in fatigue scores.[5]

Placebo response

CFS patients have a low placebo response compared to patients with other diseases, possibly due to the low rate of spontaneous remission in the condition; low patient and provider expectations regarding psychological treatment may explain particularly low placebo responses to psychiatric treatments.[43]

References

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