Tag: randomized controlled trial

Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial

Abstract:

OBJECTIVE: To evaluate the effectiveness of home delivered pragmatic rehabilitation-a programme of gradually increasing activity designed collaboratively by the patient and the therapist-and supportive listening-an approach based on non-directive counselling-for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME).

DESIGN: Single blind, randomised, controlled trial.

SETTING: 186 general practices across the north west of England between February 2005 and May 2007.

PARTICIPANTS: 296 patients aged 18 or over with CFS/ME (median illness duration seven years) diagnosed using the Oxford criteria.

INTERVENTIONS: Participants were randomly allocated to pragmatic rehabilitation, supportive listening, or general practitioner treatment as usual. Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months’ training, including supervised practice, in each of the interventions. GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period. Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment compared with GP treatment as usual. Lower fatigue scores and higher physical functioning scores denote better outcomes.

RESULTS: A total of 257 (87%) of the 296 patients who entered the trial were assessed at 70 weeks, the primary outcome point. Analysis was on an intention to treat basis, with robust treatment effects estimated after adjustment for missing data using probability weights. Immediately after treatment (at 20 weeks), patients allocated to pragmatic rehabilitation (n=95) had significantly improved fatigue (effect estimate -1.18, 95% confidence interval -2.18 to -0.18; P=0.021) but not physical functioning (-0.18, 95% CI -5.88 to +5.52; P=0.950) compared with patients allocated to treatment as usual (n=100). At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435). At 20 weeks, patients allocated to supportive listening (n=101) had poorer physical functioning than those allocated to treatment as usual (-7.54, 95% CI -12.76 to -2.33; P=0.005) and no difference in fatigue. At 70 weeks, patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome.

CONCLUSIONS: For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME.

Trial registration International Standard Randomised Controlled Trial Number IRCTN74156610.

Comment in:

Pragmatic rehabilitation for chronic fatigue syndrome. [BMJ. 2010]

Nurse-delivered, home-based pragmatic rehabilitation has a short-term effect on improving fatigue in people with chronic fatigue syndrome compared with usual GP care, but effects were not sustained at 1 year. [Evid Based Nurs. 2010]

 

Source: Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group and 23 Collaborators. Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial. BMJ. 2010 Apr 23;340:c1777. doi: 10.1136/bmj.c1777. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2859122/ (Full article)

 

Making the diagnosis of Chronic Fatigue Syndrome/Myalgic Encephalitis in primary care: a qualitative study

Abstract:

BACKGROUND: NICE guidelines emphasise the role of the primary care team in the management of patients with Chronic Fatigue Syndrome/Myalgic Encephalitis (CFS/ME). A key stage in effective management is making an accurate early diagnosis, supported by appropriate referral.

METHODS: A nested qualitative study within a multi-centre randomised controlled trial which aimed to explore GPs’ views on their role in making the diagnosis of CFS/ME and subsequent management of patients in primary care. Semi-structured interviews with 22 GPs. Interviews were transcribed verbatim and an iterative approach used to develop themes from the dataset.

RESULTS: GPs described difficulties in defining CFS/ME and suggested that their role in making a diagnosis was to exclude physical causes for the patient’s symptoms, but they reported little confidence in positively attributing the label of CFS/ME to a patient and their symptoms. GPs suggested that the label of CFS/ME could be potentially harmful for the patient. The role of referral to secondary care was debated and GPs struggled defining their own role in management of this group of patients.

CONCLUSIONS: Until GPs feel comfortable making the diagnosis of CFS/ME and facilitating initial management, and have appropriate services to refer patients to, there will continue to be delays in confirming the diagnosis and patients presenting in primary care with fatigue may not receive appropriate care.

TRIAL REGISTRATION: ISRCTN 74156610.

 

Source: Chew-Graham C, Dowrick C, Wearden A, Richardson V, Peters S. Making the diagnosis of Chronic Fatigue Syndrome/Myalgic Encephalitis in primary care: a qualitative study. BMC Fam Pract. 2010 Feb 23;11:16. doi: 10.1186/1471-2296-11-16. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2836312/ (Full article)

 

Family-focused cognitive behaviour therapy versus psycho-education for chronic fatigue syndrome in 11- to 18-year-olds: a randomized controlled treatment trial

Abstract:

BACKGROUND: Only one previous randomized controlled trial (RCT) has examined the efficacy of cognitive behaviour therapy (CBT) for chronic fatigue syndrome (CFS) in children. The aim of this study was to compare family-focused CBT with psycho-education for CFS in adolescents.

METHOD: Sixty-three 11- to 18-year-olds (43 girls, 20 boys) with CFS were randomly assigned to either family-focused CBT or psycho-education delivered over 6 months. School attendance was the main outcome, which was assessed at the end of treatment and at 3, 6 and 12 months follow-up.

RESULTS: At the main outcome point (the 6-month follow-up) both groups had improved similarly. However, although those who received family-focused CBT were attending school for longer than those who received psycho-education, at discharge from treatment and at 3 months follow-up, they improved less quickly across the follow-up period.

CONCLUSIONS: Adolescents with CFS get back to school more quickly after family-focused CBT. This is important as they are at a crucial stage of their development. However, the finding that psycho-education was as effective as family-focused CBT at 6 and 12 months follow-up has important implications for health service delivery.

 

Source: Chalder T, Deary V, Husain K, Walwyn R. Family-focused cognitive behaviour therapy versus psycho-education for chronic fatigue syndrome in 11- to 18-year-olds: a randomized controlled treatment trial. Psychol Med. 2010 Aug;40(8):1269-79. doi: 10.1017/S003329170999153X. Epub 2009 Nov 6. https://www.ncbi.nlm.nih.gov/pubmed/19891804

 

Randomized controlled study on influence of acupuncture for life quality of patients with chronic fatigue syndrome

Abstract:

OBJECTIVE: To observe effects of acupuncture on quality of life of patients with chronic fatigue syndrome (CFS).

METHODS: Randomized, controlled and single-blinded study method was used, 70 cases were divided into an observation group and a control group, 35 cases in each group. The observation group was treated with acupuncture at Baihui (GV 20), Danzhong (CV 17), Zhongwan (CV 12), Qihai (CV 6), Guanyuan (CV 4), Hegu (LI 4), Zusanli (ST 36), etc.; the control group was treated with acupuncture at non-meridian points (2 cm to the acupoints), thrice a week. The treatment was given for 14 times. The World Health Organization Quality of Life (WHOQOL-BREF) scale was used to evaluate the patients’ quality of life before and after treatment.

RESULTS: The physiological field, individuals own perception of his health condition and total score were significantly improved after treatment in the observation group (all P<0.05); there were no obvious changes in the psychology, social relationships, environment and subjective feelings about the quality of life (all P>0.05). The score of the environmental field in the control group was significantly decreased compared to that before treatment (P<0.05), and there were no significant changes in the other scores. There were no adverse effects in patients.

CONCLUSION: Acupuncture can improve the quality of life of CFS patients, especially in physiological field and the individual perception to his well being. Acupuncture has high safety, and the acupoints has high specific degree than non-meridian points.

 

Source: Wang JJ, Song YJ, Wu ZC, Chu XO, Wang QM, Wei LN, Wang XJ, Meng H. Randomized controlled study on influence of acupuncture for life quality of patients with chronic fatigue syndrome. Zhongguo Zhen Jiu. 2009 Oct;29(10):780-4. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/19873911

 

Randomized controlled clinical trials of acupuncture treatment of chronic fatigue syndrome

Abstract:

OBJECTIVE: To observe the effect of acupuncture on the fatigue degree in patients with chronic fatigue syndrome (CFS).

METHODS: Seventy CFS patients were equally randomized into control and treatment groups according to randomized block design. Acupuncture was applied to Baihui (GV 20), Danzhong (CV 17), Zhongwan (CV 12), etc., for patients in treatment group, and to non-acupoints (2 cm respectively to the abovementioned acupoints) for those in control group. The treatment was given once every other day, 14 times altogether. The fatigue degree and the therapeutic effect were assessed by Chalder’s fatigue scale (FS).

RESULTS: A total of 64 cases (32/group) were finished in this study. After the treatment, the physical FS (5.0 +/- 2.4 vs 6.8 +/- 1.5), mental FS (1.8 +/-1.8 vs 3.1 +/- 1.5) and the total FS (6.8 +/- 3.8 vs 9.9 +/- 2.5) in treatment group, physical FS (5.0 +/- 2.5 vs 6.4 +/- 1.5) and the total FS (7.5 +/- 3.4 vs 9.6 +/- 2.8) in control group decreased significantly compared with pre-treatment (P < 0.01, P < 0.05). There was no marked change in mental FS (2.5 +/- 11.6 vs 3.2 +/- 11.6) in control group after the treatment (P > 0.05). Comparison between two groups showed no significant differences in the 3 indexes (P > 0.05).

CONCLUSION: Acupuncture can relieve CFS patients’ physical and mental fatigue and the therapeutic effect of acupuncture of acupoints is relatively better than that of non-acupoints in reducing mental fatigue.

 

Source: Wang JJ, Song YJ, Wu ZC, Chu XO, Wang QM, Wang XJ, Wei LN, Meng H, Wang XH. Randomized controlled clinical trials of acupuncture treatment of chronic fatigue syndrome. Zhen Ci Yan Jiu. 2009 Apr;34(2):120-4. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/19685727

 

Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial

Abstract:

A minimal intervention, based on cognitive-behavioural therapy for chronic fatigue syndrome and consisting of self-instructions combined with email contact, was tested in a randomised controlled trial (ISRCTN27293439). A total of 171 patients participated in the trial: 85 were allocated to the intervention condition and 86 to the waiting-list condition. All patients met the Centers for Disease Control and Prevention criteria for chronic fatigue syndrome. An intention-to-treat analysis showed a significant decrease in fatigue and disability after self-instruction. The level of disability was negatively correlated with treatment outcome. Guided self-instructions are an effective treatment for patients with relatively less severe chronic fatigue syndrome.

 

Source: Knoop H, van der Meer JW, Bleijenberg G. Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial. Br J Psychiatry. 2008 Oct;193(4):340-1. doi: 10.1192/bjp.bp.108.051292. http://bjp.rcpsych.org/content/193/4/340.long (Full article)

 

Effectiveness of distant healing for patients with chronic fatigue syndrome: a randomised controlled partially blinded trial (EUHEALS)

Abstract:

BACKGROUND: Distant healing, a form of spiritual healing, is widely used for many conditions but little is known about its effectiveness.

METHODS: In order to evaluate distant healing in patients with a stable chronic condition, we randomised 409 patients with chronic fatigue syndrome (CFS) from 14 private practices for environmental medicine in Germany and Austria in a two by two factorial design to immediate versus deferred (waiting for 6 months) distant healing. Half the patients were blinded and half knew their treatment allocation. Patients were treated for 6 months and allocated to groups of 3 healers from a pool of 462 healers in 21 European countries with different healing traditions. Change in Mental Health Component Summary (MHCS) score (SF-36) was the primary outcome and Physical Health Component Summary score (PHCS) the secondary outcome.

RESULTS: This trial population had very low quality of life and symptom scores at entry. There were no differences over 6 months in post-treatment MHCS scores between the treated and untreated groups. There was a non-significant outcome (p = 0.11) for healing with PHCS (1.11; 95% CI -0.255 to 2.473 at 6 months) and a significant effect (p = 0.027) for blinding; patients who were unblinded became worse during the trial (-1.544; 95% CI -2.913 to -0.176). We found no relevant interaction for blinding among treated patients in MHCS and PHCS. Expectation of treatment and duration of CFS added significantly to the model.

CONCLUSIONS: In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.

Copyright (c) 2008 S. Karger AG, Basel.

 

Source: Walach H, Bosch H, Lewith G, Naumann J, Schwarzer B, Falk S, Kohls N, Haraldsson E, Wiesendanger H, Nordmann A, Tomasson H, Prescott P, Bucher HC. Effectiveness of distant healing for patients with chronic fatigue syndrome: a randomised controlled partially blinded trial (EUHEALS). Psychother Psychosom. 2008;77(3):158-66. doi: 10.1159/000116609. Epub 2008 Feb 14. https://www.ncbi.nlm.nih.gov/pubmed/18277062

 

A randomized controlled graded exercise trial for chronic fatigue syndrome: outcomes and mechanisms of change

Abstract:

The aim of this study was to investigate the potential mechanisms underlying the efficacy of graded exercise therapy for chronic fatigue syndrome (CFS). Forty-nine CFS patients were randomized to a 12-week graded exercise programme or to standard medical care. At the end of treatment the exercise group rated themselves as significantly more improved and less fatigued than the control group. A decrease in symptom focusing rather than an increase in fitness mediated the treatment effect. Graded exercise appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms.

 

Source: Moss-Morris R, Sharon C, Tobin R, Baldi JC. A randomized controlled graded exercise trial for chronic fatigue syndrome: outcomes and mechanisms of change. J Health Psychol. 2005 Mar;10(2):245-59. http://www.ncbi.nlm.nih.gov/pubmed/15723894

 

Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial

Erratum in: BMJ. 2005 Apr 9;330(7495):820.

 

Abstract:

OBJECTIVE: To evaluate the efficacy of cognitive behaviour therapy for adolescents aged 10-17 years with chronic fatigue syndrome.

DESIGN: Randomised controlled trial.

SETTING: Department of child psychology.

PARTICIPANTS: 71 consecutively referred patients with chronic fatigue syndrome; 36 were randomly assigned to immediate cognitive behaviour therapy and 35 to the waiting list for therapy.

INTERVENTION: 10 sessions of therapy over five months. Treatment protocols depended on the type of activity pattern (relatively active or passive). All participants were assessed again after five months.

MAIN OUTCOME MEASURES: Fatigue severity (checklist individual strength), functional impairment (SF-36 physical functioning), and school attendance.

RESULTS: 62 patients had complete data at five months (29 in the immediate therapy group and 33 on the waiting list). Patients in the therapy group reported significantly greater decrease in fatigue severity (difference in decrease on checklist individual strength was 14.5, 95% confidence interval 7.4 to 21.6) and functional impairment (difference in increase on SF-36 physical functioning was 17.3, 6.2 to 28.4) and their attendance at school increased significantly (difference in increase in percentage school attendance was 18.2, 0.8 to 35.5). They also reported a significant reduction in several accompanying symptoms. Self reported improvement was largest in the therapy group.

CONCLUSION: Cognitive behaviour therapy is an effective treatment for chronic fatigue syndrome in adolescents.

Comment in: Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: data are insufficient and conclusion inappropriate. [BMJ. 2005]

 

Source: Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ. 2005 Jan 1;330(7481):14. Epub 2004 Dec 7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC539840/ (Full article)

 

Effect of galantamine hydrobromide in chronic fatigue syndrome: a randomized controlled trial

Abstract:

CONTEXT: There is no established pharmacological treatment for the core symptoms of chronic fatigue syndrome (CFS). Galantamine hydrobromide, an acetyl cholesterone inhibitor, has pharmacological properties that might benefit patients with CFS.

OBJECTIVE: To compare the efficacy and tolerability of galantamine hydrobromide in patients with CFS.

DESIGN, SETTING, AND PATIENTS: Randomized, double-blind trial conducted June 1997 through July 1999 at 35 outpatient centers in the United Kingdom (n = 17), United States (n = 14), the Netherlands (n = 2), Sweden (n = 1), and Belgium (n = 1) involving 434 patients with a clinical diagnosis of CFS (modified US Centers for Disease Control and Prevention criteria).

INTERVENTIONS: A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 91 patients, 7.5 mg; and 86 patients, 10 mg (these patients received medicine in the tablet form 3 times per day); a total of 82 patients received matching placebo tablets 3 times per day.

MAIN OUTCOME MEASURES: The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale, the Fibromyalgia Impact Questionnaire, and the Pittsburgh Sleep Quality Index; changes in quality of life on the Nottingham Health Profile; and assessment of plasma-free cortisol levels and cognitive performance on a computer-based battery of tests.

RESULTS: After 16 weeks, there were no statistically significant differences between any of the galantamine or placebo groups in clinical condition on the Clinician Global Impression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influenced the primary or any secondary outcome measures.

CONCLUSION: This trial did not demonstrate any benefit of galantamine over placebo in the treatment of patients with CFS.

Comment in:

Pharmacotherapy of chronic fatigue syndrome: another gallant attempt. [JAMA. 2004]

Chronic fatigue syndrome and the cholinergic hypothesis. [JAMA. 2004]

 

Source: Blacker CV, Greenwood DT, Wesnes KA, Wilson R, Woodward C, Howe I, Ali T. Effect of galantamine hydrobromide in chronic fatigue syndrome: a randomized controlled trial. JAMA. 2004 Sep 8;292(10):1195-204. http://www.ncbi.nlm.nih.gov/pubmed/15353532