randomized controlled trial – Page 4 – American ME and CFS Society

Randomized controlled trial of Siberian ginseng for chronic fatigue

Abstract:

BACKGROUND: Chronic fatigue greatly affects quality of life and is a common reason for consulting a physician. Since conventional therapy is often of limited help, fatigued patients may use herbal treatments. This randomized controlled trial evaluated the effectiveness of Siberian ginseng.

METHOD: Subjects were recruited from advertisements in Iowa (82%) and members of chronic fatigue syndrome support groups (18%). Potential subjects were required to have substantial fatigue > or = 6 months with no identifiable cause. The mean change in a fatigue measure was compared for placebo and Siberian ginseng at 1 and 2 months. Comparisons were for all subjects and for subjects with characteristics previously identified in the literature as important for categorizing chronic fatigue.

RESULTS: Ninety-six subjects were randomized to treatment groups, and 76 provided information at 2 months of follow-up. Fatigue among subjects assigned to either placebo or Siberian ginseng was substantially reduced during the study, but differences between treatment groups were not statistically significant in the full sample. Fatigue severity and duration had a statistically significant interaction with response to Siberian ginseng at the P < 0.05 level. Treatment was effective at 2 months for 45 subjects with less severe fatigue (P = 0.04 unadjusted for multiple comparisons) and for 41 subjects with fatigue for > or = 5 years (P = 0.09 unadjusted for multiple comparisons).

CONCLUSION: Overall efficacy was not demonstrated. However, the findings of possible efficacy for patients with moderate fatigue suggests that further research may be of value.

Source: Hartz AJ, Bentler S, Noyes R, Hoehns J, Logemann C, Sinift S, Butani Y, Wang W, Brake K, Ernst M, Kautzman H. Randomized controlled trial of Siberian ginseng for chronic fatigue. Psychol Med. 2004 Jan;34(1):51-61. http://www.ncbi.nlm.nih.gov/pubmed/14971626

Patient education to encourage graded exercise in chronic fatigue syndrome. 2-year follow-up of randomised controlled trial

Abstract:

BACKGROUND: An earlier trial demonstrated good outcomes after 1 year for patients with chronic fatigue syndrome (CFS) who received an educational intervention designed to encourage graded activity.

AIMS: To determine 2-year outcomes for the same treated patients and the response to treatment of patients formerly in the control condition.

METHOD: Patients in the treatment groups (n=114) were followed up at 2 years; 32 patients from the control group were offered the intervention after 1 year and were assessed 1 year later. Assessments were the self-rated measures used in the original trial.

RESULTS: At 2 years 63 of the treated patients (55%) no longer fulfilled trial criteria for CFS compared with 64 patients (56%) at 1 year. Fourteen of 30 crossover patients (47%) achieved a good outcome at 1 year and seven (23%) no longer fulfilled criteria for CFS.

CONCLUSIONS: Benefits of the intervention were maintained at 2 years. Delaying treatment is associated with reduced efficacy and required more intensive therapy.

Source: Powell P, Bentall RP, Nye FJ, Edwards RH. Patient education to encourage graded exercise in chronic fatigue syndrome. 2-year follow-up of randomised controlled trial. Br J Psychiatry. 2004 Feb;184:142-6. http://www.ncbi.nlm.nih.gov/pubmed/14754826

A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome

Abstract:

This study determined whether dexamphetamine improved symptoms and quality of life in patients with chronic fatigue syndrome. The setting was a specialized clinic within a tertiary referral hospital. This was a 6-week parallel-group, placebo-controlled trial with random allocation. There was a 2-week dose-adjustment phase and a 4-week stable treatment period. Outcome measures were the Fatigue Severity Scale, the Medical Outcomes Study 36-item Short-Form Health Survey, and two patient-determined outcomes. Ten patients were randomly assigned to dexamphetamine, and 10 were assigned to placebo. Fatigue Severity Scale scores improved in nine of 10 dexamphetamine and four of 10 placebo patients. The change in mean score was statistically significant. There were large but statistically nonsignificant changes in scores for the Short-Form Health Survey domains vitality and physical functioning. Dexamphetamine may be useful in the management of chronic fatigue syndrome; a larger and longer trial is justified by these results.

Source: Olson LG, Ambrogetti A, Sutherland DC. A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome. Psychosomatics. 2003 Jan-Feb;44(1):38-43. http://www.ncbi.nlm.nih.gov/pubmed/12515836

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

Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial

Abstract:

BACKGROUND: Cognitive behaviour therapy (CBT) seems a promising treatment for chronic fatigue syndrome (CFS), but the applicability of this treatment outside specialised settings has been questioned. We compared CBT with guided support groups and the natural course in a randomised trial at three centres.

METHODS: Of 476 patients diagnosed with CFS, 278 were eligible and willing to take part. 93 were randomly assigned CBT (administered by 13 therapists recently trained in this technique for CFS), 94 were assigned the support-group approach, and 91 the control natural course. Multidimensional assessments were done at baseline, 8 months, and 14 months. The primary outcome variables were fatigue severity (on the checklist individual strength) and functional impairment (on the sickness impact profile) at 8 and 14 months. Data were analysed by intention to treat.

FINDINGS: 241 patients had complete data (83 CBT, 80 support groups, 78 natural course) at 8 months. At 14 months CBT was significantly more effective than both control conditions for fatigue severity (CBT vs support groups 5.8 [2.2-9.4]; CBT vs natural course 5.6 [2.1-9.0]) and for functional impairment (CBT vs support groups 263 [38-488]; CBT vs natural course 222 [3-441]). Support groups were not more effective for CFS patients than the natural course. Among the CBT group, clinically significant improvement was seen in fatigue severity for 20 of 58 (35%), in Karnofsky performance status for 28 of 57 (49%), and self-rated improvement for 29 of 58 (50%). Prognostic factors for outcome after CBT were a higher sense of control predicting more improvement, and a passive activity pattern and focusing on bodily symptoms predicting less improvement.

INTERPRETATION: CBT was more effective than guided support groups and the natural course in a multicentre trial with many therapists. Our study showed a lower proportion of patients with improvement than CBT trials with a few highly skilled therapists.

Comment in:

Cognitive behaviour therapy for chronic fatigue syndrome. [Lancet. 2001]

ACP J Club. 2001 Sep-Oct;135(2):47.

Cognitive behaviour therapy for chronic fatigue syndrome. [Lancet. 2001]

Source: Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM, Severens JL, van der Wilt GJ, Spinhoven P, van der Meer JW. Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet. 2001 Mar 17;357(9259):841-7. http://www.ncbi.nlm.nih.gov/pubmed/11265953

Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome

Abstract:

OBJECTIVE: To assess the efficacy of an educational intervention explaining symptoms to encourage graded exercise in patients with chronic fatigue syndrome.

DESIGN: Randomised controlled trial.

SETTING: Chronic fatigue clinic and infectious diseases outpatient clinic.

SUBJECTS: 148 consecutively referred patients fulfilling Oxford criteria for chronic fatigue syndrome.

INTERVENTIONS: Patients randomised to the control group received standardised medical care. Patients randomised to intervention received two individual treatment sessions and two telephone follow up calls, supported by a comprehensive educational pack, describing the role of disrupted physiological regulation in fatigue symptoms and encouraging home based graded exercise. The minimum intervention group had no further treatment, but the telephone intervention group received an additional seven follow up calls and the maximum intervention group an additional seven face to face sessions over four months.

MAIN OUTCOME MEASURE: A score of >/=25 or an increase of >/=10 on the SF-36 physical functioning subscale (range 10 to 30) 12 months after randomisation.

RESULTS: 21 patients dropped out, mainly from the intervention groups. Intention to treat analysis showed 79 (69%) of patients in the intervention groups achieved a satisfactory outcome in physical functioning compared with two (6%) of controls, who received standardised medical care (P<0.0001). Similar improvements were observed in fatigue, sleep, disability, and mood. No significant differences were found between the three intervention groups.

CONCLUSIONS: Treatment incorporating evidence based physiological explanations for symptoms was effective in encouraging self managed graded exercise. This resulted in substantial improvement compared with standardised medical care.

Comment in:

Patient education to encourage graded exercise in chronic fatigue syndrome. Trial has too many shortcomings. [BMJ. 2001]

ACP J Club. 2001 Sep-Oct;135(2):46.

Source: Powell P, Bentall RP, Nye FJ, Edwards RH. Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome. BMJ. 2001 Feb 17;322(7283):387-90. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC26565/ (Full article)

Illness beliefs and treatment outcome in chronic fatigue syndrome

Abstract:

Longitudinal studies have shown that physical illness attributions are associated with poor prognosis in chronic fatigue syndrome (CFS). Speculation exists over whether such attributions influence treatment outcome. This study reports the effect of illness beliefs on outcome in a randomized controlled trial of cognitive-behavior therapy versus relaxation.

Causal attributions and beliefs about exercise, activity, and rest were recorded before and after treatment in 60 CFS patients recruited to the trial. Physical illness attributions were widespread, did not change with treatment, and were not associated with poor outcome in either the cognitive-behavior therapy group or the control group.

Beliefs about avoidance of exercise and activity changed in the cognitive behavior therapy group, but not in the control group. This change was associated with improved outcome. These findings suggest that physical illness attributions are less important in determining outcome (at least in treatment studies) than has been previously thought. In this study, good outcome is associated with change in avoidance behavior, and related beliefs, rather than causal attributions.

Source: Deale A, Chalder T, Wessely S. Illness beliefs and treatment outcome in chronic fatigue syndrome. J Psychosom Res. 1998 Jul;45(1):77-83. http://www.ncbi.nlm.nih.gov/pubmed/9720857

Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome

Abstract:

OBJECTIVE: To test the efficacy of a graded aerobic exercise programme in the chronic fatigue syndrome.

DESIGN: Randomised controlled trial with control treatment crossover after the first follow up examination.

SETTING: Chronic fatigue clinic in a general hospital department of psychiatry.

SUBJECTS: 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance.

INTERVENTIONS: Random allocation to 12 weeks of either graded aerobic exercise or flexibility exercises and relaxation therapy. Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards.

MAIN OUTCOME MEASURE: The self rated clinical global impression change score, “very much better” or “much better” being considered as clinically important.

RESULTS: Four patients receiving exercise and three receiving flexibility treatment dropped out before completion. 15 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment. Analysis by intention to treat gave similar results (17/33 v 9/33 patients better). Fatigue, functional capacity, and fitness were significantly better after exercise than after flexibility treatment. 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment.

CONCLUSION: These findings support the use of appropriately prescribed graded aerobic exercise in the management of patients with the chronic fatigue syndrome.

Comment in:

Graded exercise in chronic fatigue syndrome. Including patients who rated themselves as a little better would have altered results. [BMJ. 1997]

Managing chronic fatigue syndrome in children. [BMJ. 1997]

Graded exercise in chronic fatigue syndrome. Chronic fatigue syndrome is heterogeneous condition. [BMJ. 1997]

Graded exercise in chronic fatigue syndrome. Patients should have initial period of rest before gradual increase in activity. [BMJ. 1997]

Graded exercise in chronic fatigue syndrome. Patients were selected group. [BMJ. 1997]

Source: Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. BMJ. 1997 Jun 7;314(7095):1647-52. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2126868/ (Full article)

Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial

Abstract:

OBJECTIVE: Cognitive behavior therapy for chronic fatigue syndrome was compared with relaxation in a randomized controlled trial.

METHODS: Sixty patients with chronic fatigue syndrome were randomly assigned to 13 sessions of either cognitive behavior therapy (graded activity and cognitive restructuring) or relaxation. Outcome was evaluated by using measures of functional impairment, fatigue, mood, and global improvement.

RESULTS: Treatment was completed by 53 patients. Functional impairment and fatigue improved more in the group that received cognitive behavior therapy. At final follow-up, 70% of the completers in the cognitive behavior therapy group achieved good outcomes (substantial improvement in physical functioning) compared with 19% of those in the relaxation group who completed treatment.

CONCLUSIONS: Cognitive behavior therapy was more effective than a relaxation control in the management of patients with chronic fatigue syndrome. Improvements were sustained over 6 months of follow-up.

Comment in: Cognitive behavior therapy for chronic fatigue syndrome. [Am J Psychiatry. 1998]

Source: Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997 Mar;154(3):408-14. http://www.ncbi.nlm.nih.gov/pubmed/9054791

Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial

Abstract:

OBJECTIVE: To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with thechronic fatigue syndrome.

DESIGN: Randomised controlled trial with final assessment at 12 months.

SETTING: An infectious diseases outpatient clinic.

SUBJECTS: 60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome.

INTERVENTIONS: Medical care comprised assessment, advice, and follow up in general practice. Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care.

MAIN OUTCOME MEASURES: The proportions of patients (a) who achieved normal daily functioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 points or more) by 12 months after randomisation.

RESULTS: Only two eligible patients refused to participate. All randomised patients completed treatment. An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27% (8/30) of patients who were given only medical care (difference 47 percentage points; 95% confidence interval 24 to 69). Similar differences were observed in subsidiary outcome measures. The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy. Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone.

CONCLUSION: Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment.

Comment in:

Cognitive behaviour therapy for the chronic fatigue syndrome. Good general care may offer as much benefit as cognitive behaviour therapy. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Patients were not representative of all patients with the syndrome. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Cognitive behavior therapy should be compared with placebo treatments. [BMJ. 1996]

ACP J Club. 1996 May-Jun;124(3):71.

Cognitive behaviour therapy for the chronic fatigue syndrome. Use an interdisciplinary approach. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Patients’ beliefs about their illness were probably not a major factor. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Evening primrose oil and magnesium have been shown to be effective. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Essential elements of the treatment must be identified. [BMJ. 1996]

Source: Sharpe M, Hawton K, Simkin S, Surawy C, Hackmann A, Klimes I, Peto T, Warrell D, Seagroatt V. Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial. BMJ. 1996 Jan 6;312(7022):22-6. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2349693/

Note: You can read the full article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2349693/pdf/bmj00523-0026.pdf