Gulf War Veterans Treating Symptoms and Syndromes (2001) / Chapter Skim
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5. Effective Treatments
5. Effective Treatments
Pages 51-122
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From page 51... ...
Randomized controlled trials were given greatest weight in making recommendations about specific treatments; other types of published studies were evaluated using the levels-of-evidence concepts described in Chapter 3. The following material is organized by condition studied.
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From page 52... ...
The best currently available evidence for potential effectiveness in a population of Gulf War veterans, therefore, is strong evidence of efficacy through RCTs. CHRONIC FATIGUE SYNDROME Introduction Chronic fatigue syndrome (CFS)
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From page 53... ...
This group developed diagnostic criteria for CFS (see Table 5-1~. TABLE 5-1 Diagnostic Criteria for Chronic Fatigue Syndrome A person must meet both of the following criteria in order to be diagnosed with CFS: 1.
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From page 54... ...
Any past or current major depressive disorder with psychotic or melancholic features, including bipolar affective disorders, schizophrenia, delusional disorders, dementias, anorexia nervosa, or bulimia nervosa; 4. Alcohol or other substance abuse within two years before the onset of chronic fatigue and at any time afterward.
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From page 55... ...
Mechanisms, as examined in the literature, have tended to focus on a single explanatory model (e.g., infections, psychiatric disorders) , a perspective unlikely to be useful in the vast majority of cases.
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From page 56... ...
Nonetheless, if carefully selected, some currently available measures are adequate for clinical trials. These are primarily self-report measures such as the Short Form-36.
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From page 57... ...
Benefits. Two recent controlled trials found that approximately 70% of patients receiving several months of weekly CBT versus only 20% of the placebo group (who received visits or relaxation therapy)
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From page 58... ...
Two randomized controlled trials have compared exercise with and without fluoxetine to appointments or flexibility training. CFS patients appear to experience short- and long-term subjective and objective functional benefits from a graded aerobic exercise program.
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From page 59... ...
There have been several clinical trials of dietary supplements, including magnesium (one study) and evening primrose oil (two studies)
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From page 60... ...
Antiviral Therapy Benefits. One double-blinded placebo-controlled trial has been performed of acyclovir, and it did not demonstrate a positive treatment effect.
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From page 61... ...
Recommendations For Gulf War veterans who meet the criteria for diagnosis of CFS, the committee recommends: · use of cognitive-behavioral therapy and exercise therapies because they are likely to be beneficial; · monitoring the results of studies of the efficacy and effectiveness of NADH, dietary supplements, corticosteroids, and antidepressants other than SSRIs; · because immunotherapy and prolonged rest are unlikely to be beneficial, they should not be used as treatments; · SSRIs are unlikely to be beneficial and are not recommended unless they are used as treatment for persons with concurrent major depression; and · treatments effective for CFS should be evaluated in Gulf War veterans who meet the criteria for CFS. DEPRESSION Introduction Depression is one of the most common complaints among persons with psychological distress.
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From page 62... ...
, may be chronic, and may occur intermittently upon a base of a less severe yet chronic variant of depression, dysthymia. Virtually all studies of treatment efficacy of depression, however, especially of efficacy using randomized clinical trials, have concentrated on major depression (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 63... ...
It is sufficient to note that the clinical trials of therapies for major depression have not only substantiated the value of certain therapies for major depression but have also led to these therapies being used frequently for less severe forms of depression, often with anecdotal evidence that the therapies are effective. Beneficial Therapies · Tricyclic and heterocyclic antidepressants · MOAIs · SSRIs and related compounds · Cognitive-behavioral therapy · Interpersonal psychotherapy · Electroconvulsive therapy (in severe/treatment-resistant depression)
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From page 64... ...
IPT has become the most frequent psychotherapy for depression studied in randomized clinical trials. The therapy is basically an educational/behavioral therapy with an emphasis on improving interpersonal relations rather than evaluating cognitions associated with depression (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 65... ...
Behavioral therapy for depression is rarely used in isolation for the treatment of major depression, yet elements of behavioral therapy are frequently combined with cognitive therapy, IPT, and marital/family therapy (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Goodle 2000~. Marital/Family Therapy Benefits.
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From page 66... ...
Comments. Though evidence for the effectiveness of groups is much less than for individual IPT and cognitive-behavioral therapy, the economy of group sessions coupled with the unique potential benefit of peer support and advice renders groups a potentially valuable form of therapy for major depression (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 67... ...
For major depression, the efficacy of the TCAs is at least equivalent to these newer agents. TCAs are much less expensive (as virtually all are now manufactured as generic compounds; Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 68... ...
BZPs should never be used as first-line therapy for major depression (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 69... ...
Though further large trials are needed to demonstrate the effectiveness of various medications and the combination of psychotherapy and pharmacotherapy in preventing recurrence of depressive episodes, most psychiatrists now recommend continuation of pharmacotherapy for at least six to nine months following response to the medication. A history of multiple or particulary debilitating episodes of depression suggests longer-term maintenance prophylaxis with ongoing antidepressant therapy (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 70... ...
Comment. The type of exercise prescribed and the motivation of the patient to maintain an exercise regime are critical aspects of the use of exercise in the treatment of depression (Depression Guideline Panel 1993; Work Group on Major Depressive Disorder 1993; Godlee 2000~.
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From page 71... ...
We have concentrated in this report on major depression for there are very few clinical trials that focus on other depressive diagnoses. Nevertheless, many depressive symptoms of clinical significance that present to practicing physicians do not meet the criteria for major depression as noted earlier in this chapter.
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From page 72... ...
Uniform implementation of these therapies would vastly improve the treatment of Gulf War veterans diagnosed with major depression (Work Group on Major Depressive Disorder 1993~. Nevertheless, Gulf War veterans who experience comorbid major depression and other conditions reviewed in this report clearly may experience improvement in depressive symptoms from therapies such as exercise.
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From page 73... ...
Although dolorimetry may be useful in clinical trials as a method to assess exact pain threshold, digital palpation and manual palpation are sufficiently accurate diagnostic approaches for use in the routine clinical setting (Wolfe et al.
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From page 74... ...
In a review of these studies, the focus is on RCTs. The ability to attribute benefits to any specific treatment is attenuated by a 15 to 30% placebo response in fibromyalgia clinical trials.
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From page 75... ...
, hypnotherapy, and biofeedback. While cognitive and behavioral therapies appear efficacious in chronic fatigue syndrome, the literature does not support clear efficacy in fibromyalgia.
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From page 76... ...
Results of open-label and controlled clinical trials offluoxetine have been equivocal at best (Geller et al. 1989; Finestone and Ober 1990; Cortet et al.
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From page 77... ...
selective NSAIDs have a significantly lower gastrointestinal and bleeding toxicity profile but maintain the other NSAID risks. Glucocorticoid toxicity is myriad and includes osteoporosis, weight gain, hypertension, blood sugar elevations, and eye problems.
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From page 78... ...
Fifty women with fibromyalgia and low insulin-like growth factor 1 levels had significant improvements on the fibromyalgia impact questionnaire and tender point score in comparison to placebo when given growth hormone (GH) (Bennett et al.
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From page 79... ...
After a larger, partially favorable experience in an uncontrolled study, a very small RCT suggested that EMG biofeedback significantly improved most variables, compared with sham biofeedback (Ferraccioli et al.
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From page 80... ...
disorder chronic fatigue syndrome found CBT superior to other treatment approaches (Price and Couper 2000) , nearly all CBT studies in fibromyalgia have been uncontrolled or quasi-experimental.
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From page 81... ...
Recommendation The committee recommends that: · Gulf War veterans who meet criteria for fibromyalgia not receive treatment with opioid analgesics or glucocorticoids and · In the absence of therapies of generally proven benefit, results of treatment studies of physical training, tricyclic antidepressants, and acupuncture should be further monitored in Gulf War veterans who meet the criteria for fibromyalgia.
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From page 82... ...
The consortium developed practice guidelines for use in the primary practice setting for the management of primary headaches, particularly migraine. Explicitly excluded were new-onset headaches or headaches secondary to identifiable pathology (mass lesions, infections, intracerebral bleeds, etc)
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From page 83... ...
History, physical, and neurological examinations do not suggest headaches secondary to identifiable pathology (e.g., mass lesions, infections, intracerebral bleeds, etc.)
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From page 84... ...
The U.S. Headache Consortium achieved consensus on the therapy in the absence of relevant randomized controlled trials.
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From page 85... ...
. Migraine and Normal Neurological Examination Meta-analysis of studies of patients with migraine and a normal neurological examination found a rate of significant intracranial lesions of 0.18% (2/1000; previously reported rates of finding intracranial lesions with CT and MRI ranged from 0.3 to 0.4%~.
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From page 86... ...
Occasional to frequent Infrequent to occasional Infrequent to occasional Occasional to frequent Frequent Occasional IM/IV B ++ Frequent Triptans (serotonin 1B/1D receptor agonists) PO A +++ Infrequent to occasional Nasal, SQ A +++ Occasional Isometheptene B + Occasional Corticosteroids C ++ Infrequent The clinical effect of each drug is indicated on a five-point scale: 0, no evidence of benefit, +/-, equivocal evidence; +, somewhat beneficial; ++, beneficial; +++, highly beneficial.
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From page 87... ...
respond to these or simple dietary or environmental changes can be treated as indicated. In general, primary headaches can be expected to affect individuals for many years, and this must be taken into consideration in recommending treatment modalities that have potential side effects.
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From page 88... ...
88 Lr 5°V o V H H ~ O ~ 5bC V U ·bC o o U U ~ ._' U IS o 5 · c ~ ~ ~ ~ E C ~ 5 in, U U ~ U ~ ·_1 .
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From page 90... ...
The committee is aware of no major adverse effects of these modalities. Relaxation training, thermal biofeedback combined with relaxation training, EMG biofeedback, and cognitive-behavioral therapy are all somewhat effective in preventing migraine when compared with controls.
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From page 91... ...
thermal biofeedback plus relaxation plus cognitive-behavioral therapy, (2) thermal biofeedback plus relaxation, and (3)
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From page 92... ...
Recommendations For Gulf War veterans with chronic headache not associated with underlying pathology (e.g., tumors, vascular abnormalities) , the committee recommends the following treatments: · pharmacological management of acute episodes, using agents listed in Table 5-6, taking into consideration the clinical effectiveness and potential side effects, as listed; · prophylactic pharmacological management for headaches that occur frequently or are disruptive to the patient's functioning, as listed in Tables 5-7 and 5-8, taking into consideration the clinical effectiveness and potential side effects, as listed; · use of behavioral and physical treatments, including relaxation training, thermal biofeedback combined with relaxation training, EMG biofeedback and cognitive-behavioral therapy, or behavioral therapy combined with preventive drug therapy.
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From page 93... ...
Performing extensive laboratory, radiological, or endoscopic procedures does not establish a diagnosis of IBS; it is often unnecessary and may be harmful (Functional GI Disorders 2000~. TABLE 5-9 Rome II Diagnostic Criteria for Irritable Bowel Syndrome Abdominal discomfort or pain that has two of these features: · Relief with defecation · Onset associated with change in stool frequency · Onset associated with change in form (appearance of stool)
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From page 94... ...
, PsycINFO (1967 to 1999) , and the Cochrane controlled trials registry was undertaken to identify randomized, double-blind, placebo-controlled, parallel, or cross-over trials of a pharmacological intervention for adult patients who reported outcomes of improvement in global or irritable bowel-specific symptoms in order to evaluate the efficacy of pharmacological agents for IBS (lailwala et al.
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From page 96... ...
A positive response is associated with patients who relate symptom exacerbations to stressors and have a waxing and waning of symptoms rather than chronic pain. There are no comparative data to determine which treatments are superior, and additional studies are needed to determine the relative efficacy of psychological treatments for various subgroups of patients" (Drossman et al.
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From page 97... ...
A randomized controlled trial supporting the efficacy of psychodynamic psychotherapy appeared in the literature (Guthrie et al.1993) , as did controlled studies generally supportive of cognitive-behavioral therapy (Blanchard et al.
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From page 98... ...
of the intervention and provide relief for patients suffering from this still mysterious debilitating disorder." Recommendations For Gulf War veterans who meet the diagnostic criteria for IBS, the committee recommends that:
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From page 99... ...
12. Chills or hot flushes SOURCE: Reprinted with permission from the Diagnostic and Statistical Manual of Mental Disorders, 1994, Fourth Edition, Text Revision, copyright 2000, American Psychiatric Association, p.
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From page 100... ...
Panic attacks vary in frequency and intensity (American Psychiatric Association 1998~. They generally have a sudden onset, peak within minutes, and last 5 to 30 minutes.
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From page 101... ...
Evaluation of Therapies The care of patients with panic disorder involves a comprehensive array of approaches designed to reduce the frequency and severity of panic attacks, reduce morbidity, and improve patient functioning (American Psychiatric Association 1998~. For most patients, treatment is conducted on an outpatient basis.
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From page 102... ...
Randomized controlled trials of CBT for panic disorder have been conducted with treatment length varying from 4 to 16 weeks. In a summary of 12 studies, the response rate using an intent-to-treat analysis was 66% (American Psychiatric Association 1998~.
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From page 103... ...
RCTs show that each is effective in treating panic disorder (American Psychiatric Association
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From page 104... ...
Benefits. TCAs are effective in treating panic and have been used for nearly 40 years for that purpose (American Psychiatric Association 1998~.
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From page 105... ...
BZPs are effective in reducing the intensity and frequency of panic attacks and anticipatory anxiety (Davidson 1997; American Psychiatric Association 1998~. Alprazolam has been studied more extensively than the other BZPs and is FDA approved for the treatment of panic disorder.
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From page 106... ...
RCTs have found that continuing antidepressant drug treatment for patients with panic disorder reduces the risk of relapse (American Psychiatric Association 1998~.
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From page 107... ...
Recommendation For Gulf War veterans who meet the criteria for panic disorder, the committee recommends treatment with antidepressant medication and cognitive-behavioral therapy. POSTTRAUMATIC STRESS DISORDER Introduction Posttraumatic stress disorder (PTSD)
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From page 108... ...
Symptoms fluctuate but typically worsen during stressful periods. Rapid onset of symptoms, good premorbid functioning, strong social support, and the absence of psychiatric or medical comorbidity are factors associated with a good outcome (Choy and de Bosset 1992; Davidson and Conner 1999; American Psychiatric Association 2000~.
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From page 109... ...
The disturbance causes clinically significant distress or impairment in social, occuptional, or other important areas of functioning. Specify if: Acute: If duration of symptoms is less than three months Chronic: If duration of symptoms is three months or more Specify if: With delayed onset: If onset of symptoms is at least six months after the stressor SOURCE: Reprinted with permission from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, copyright 2000, American Psychiatric Association, pp.
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From page 110... ...
Beneficial Therapies · SSSRIs · CBT Likely to Be Beneficial · TCAs · MAOIs · BZPs · Group therapy · Maintenance therapy to prevent reoccurrence Unknown Effectiveness · Psychodynamic psychotherapy · Marital/family therapy
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From page 111... ...
Psychodynamic psychotherapy and related therapies by their very nature are not amenable to clinical trials to assess efficacy.
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From page 112... ...
1 Harms. Adverse effects of TCAs include dry mouth, constipation, urinary hesitancy, sweating, sleep disturbance, orthostatic hypotension, fatigue
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From page 113... ...
Harms. The adverse effects of BZPs include sedation, fatigue, ataxia, slurred speech, memory impairment, and weakness.
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From page 114... ...
and with no contraindications, the committee recommends treatment with antidepressant medication and cognitive-behavioral therapy. MEDICALLY UNEXPLAINED PHYSICAL SYMPTOMS Introduction As described in Chapter 2, many Gulf War veterans experience symptoms that correspond closely to symptoms experienced by people in other populations that have recognized diagnoses of unknown etiology, such as chronic fatigue syndrome.
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From page 115... ...
argue, that the existence of specific syndromes such as chronic fatigue syndrome, fibromyalgia, and irritable bowel syndrome is largely an artifact of medical specialization and that similarities between these syndromes outweigh the differences. They suggest, instead, a dimensional classification.
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From page 116... ...
These medications and narcotic analgesics usually do more harm than good, since they typically slow cognition, cause sedation, and reduce overall functioning and levels of physical activity. In contrast, antidepressants may reduce MUPS among patients with chronic pain, panic disorder, dysthymic disorder, and major depressive disorder and can result in improved activity levels among depressed or anxious patients.
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From page 117... ...
Productive goalsetting areas include occupational, household, or social tasks, physical activation, sleep hygiene, or medication adherence. Clinicians should shift the responsibility for change to the patient but avoid blaming the patient for his or her predicament.
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From page 118... ...
appointments at regular, time-contingent intervals of about every four to six weeks; 3. a brief physical examination at each visit to address new physical concerns; and 4.
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From page 119... ...
In retrospect, the intensity of the intervention was low, perhaps serving notice that MUPS involve many complex factors that are not responsive to a brief one-time intervention that targets mainly psychiatric disorders. Prescription practices were marginally better for the intervention group, but subsequent antidepressant regimen adherence was generally poor for patients in both groups.
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From page 120... ...
Elements that targeted the process of care were extensive and manualized. These included behavioral therapy conducted in the primary care setting and aimed at teaching patients depression self-management skills, improving medication regimen adherence, and preventing future relapses.
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From page 121... ...
compared this collaborative interdisciplinary intervention to usual care for depressed primary care patients using a randomized controlled design. As long as four months after completion of the intervention, intervention patients with major depression reported greater satisfaction with care, adherence to the medication regimen, and improvement in depressive symptoms than major depression patients receiving usual care.
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From page 122... ...
Therefore, for Gulf War veterans with unexplained symptoms, the committee recommends that: · for the purposes of treatment efficacy and effectiveness studies, explicit criteria for medically unexplained physical symptoms (apart from chronic fatigue syndrome, fibromyalgia, and irritable bowel syndrome) be developed and used uniformly in treatment studies and · treatment studies of antidepressant medications, cognitive-behavioral therapy, and a stepped intensity-of-care program be implemented for MUPS.
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