Tag: randomized controlled trial

Randomized controlled clinical trials of acupuncture and moxibustion treatment of chronic fatigue syndrome patients

Abstract:

OBJECTIVE: To observe the therapeutic effect of acupuncture and moxibustion interventions in the treatment of chronic fatigue syndrome (CFS).

METHODS: A total of 133 CFS patients were randomized into acupuncture group (47 cases), warm-needling group (44 cases) and non-acupoint group (42 cases). Manual acupuncture (MA) stimulation was applied to Baihui (GV 20), Danzhong (CV 17), Qihai (CV 6), Guanyuan (CV 4), bilateral Zusanli (ST 36), Hegu (LI 4), Taichong (LR 3) and Sanyinjiao (SP 6) for patients in the acupuncture group. For patients in the warm-needling group, moxa-heated needle was applied to Baihui (GV 20), Qihai (CV 6), Guanyuan (CV 4) and bilateral Zusanli (ST 36). Non-acupoints were located about 1-2 cm beside the Baihui (GV 20), Danzhong (CV 17), Qihai (CV 6), Guanyuan (CV 4), Zusanli (ST 36), Taichong (LR 3), Sanyinjiao (SP 6) and Hegu (LI 4). The treatment was given once daily for 20 days. The Chalder Fatigue Scale (14-item fatigue scale) was adopted to evaluate the changes of CFS before and after the treatment.

RESULTS: In comparison with pre-treatment, the scores of Chalder Fatigue Scale including physical and mental fatigue and total score were significantly decreased in both acupuncture and warm-needling groups (P < 0.05, P < 0.01), but not in the non-acupoint group (P > 0.05) except physical score (P < 0.05). The physical, mental and total scores of the acupuncture and warm-needling groups were significantly lower than those of the non-acupoint group (P < 0.05, P < 0.01), while the physical and total scores of the warm-needling group were markedly lower than those of the acupuncture group (P < 0.05). After the treatment, the CFS patients’ satisfactory rates of the acupuncture, warm-needling and non-acupoint groups were 36.2% (17/47), 72.7% (32/44) and 35.7% (15/42), respectively.

CONCLUSION: Both MA and warm-needling interventions have a good therapeutic effect in the treatment of CFS patients, while the latter is obviously better.

 

Source: Lu C, Yang XJ, Hu J. Randomized controlled clinical trials of acupuncture and moxibustion treatment of chronic fatigue syndrome patients. Zhen Ci Yan Jiu. 2014 Aug;39(4):313-7. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/25219128

 

Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial

Abstract:

Background. Anxiety/depressive symptoms are common in patients with chronic fatigue syndrome- (CFS-) like illness. Qigong as a modality of complementary and alternative therapy has been increasingly applied by patients with chronic illnesses, but little is known about the effect of Qigong on anxiety/depressive symptoms of the patients with CFS-like illness.

Purpose. To investigate the effects of Qigong on fatigue, anxiety, and depressive symptoms in patients with CFS-illness.

Methods. One hundred and thirty-seven participants who met the diagnostic criteria for CFS-like illness were randomly assigned to either an intervention group or a waitlist control group. Participants in the intervention group received 10 sessions of Qigong training twice a week for 5 consecutive weeks, followed by home-based practice for 12 weeks. Fatigue, anxiety, and depressive symptoms were assessed at baseline and postintervention.

Results. Total fatigue score [F(1,135) = 13.888, P < 0.001], physical fatigue score [F(1,135) = 20.852, P < 0.001] and depression score [F(1,135) = 9.918, P = 0.002] were significantly improved and mental fatigue score [F(1,135) = 3.902, P = 0.050] was marginally significantly improved in the Qigong group compared to controls. The anxiety score was not significantly improved in the Qigong group.

Conclusion. Qigong may not only reduce the fatigue symptoms, but also has antidepressive effect for patients with CFS-like illness.

Trial registration HKCTR-1200.

 

Source: Chan JS, Ho RT, Wang CW, Yuen LP, Sham JS, Chan CL. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:485341. doi: 10.1155/2013/485341. Epub 2013 Jul 31. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3747479/ (Full article)

 

Chronic fatigue self-management in primary care: a randomized trial

Abstract:

OBJECTIVE: To assess the efficacy of brief fatigue self-management (FSM) for medically unexplained chronic fatigue (UCF) and chronic fatigue syndrome (CFS) in primary care.

METHODS: A randomized controlled design was used wherein 111 patients with UCF or CFS were randomly assigned to two sessions of FSM, two sessions of symptom monitoring support (attention control; AC), or a usual care control condition (UC). Participants were assessed at baseline and at 3 and 12 months after treatment. The primary outcome, the Fatigue Severity Scale, measured fatigue impact on functioning. Analysis was by intention to treat (multiple imputation) and also by per protocol.

RESULTS: A group × time interaction across the 15-month trial showed significantly greater reductions in fatigue impact in the FSM group in comparison with the AC group (p < .023) and the UC group (p < .013). Medium effect sizes for reduced fatigue impact in the FSM group were found in comparison with the AC group (d = 0.46) and the UC group (d = 0.40). The per-protocol analysis revealed large effect sizes for the same comparisons. Clinically significant decreases in fatigue impact were found for 53% of participants in the FSM condition, 14% in the AC condition, and 17% in the UC condition. Dropout rates at the 12-month follow-up were high (42%-53%), perhaps attributable to the burden of monthly telephone calls to assess health care use.

CONCLUSION: A brief self-management intervention for patients with UCF or CFS seemed to be clinically effective for reducing the impact of fatigue on functioning.

Trial Registration clinicaltrials.gov Identifier: NCT00997451.

 

Source: Friedberg F, Napoli A, Coronel J, Adamowicz J, Seva V, Caikauskaite I, Ngan MC, Chang J, Meng H. Chronic fatigue self-management in primary care: a randomized trial. Psychosom Med. 2013 Sep;75(7):650-7. doi: 10.1097/PSY.0b013e31829dbed4. Epub 2013 Aug 6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3785003/ (Full article)

 

Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care

Abstract:

BACKGROUND: Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET) and counselling (COUN) with usual care plus a self-help booklet (BUC) for people presenting with chronic fatigue.

METHODS: A randomised controlled trial was conducted with participants consulting for fatigue of over three months’ duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves.

RESULTS: Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN) had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result.

CONCLUSION: This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC.

Clinical Trial Registration number at ISRCTN register: 72136156.

 

Source: Sabes-Figuera R, McCrone P, Hurley M, King M, Donaldson AN, Ridsdale L. Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care. BMC Health Serv Res. 2012 Aug 20;12:264. doi: 10.1186/1472-6963-12-264. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480915/ (Full article)

 

Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial

Abstract:

BACKGROUND: Cognitive behaviour therapy (CBT) for chronic fatigue syndrome (CFS) is an effective but intensive treatment, requiring trained therapists. A minimal intervention based on CBT for CFS, guided self-instruction, was shown to be an effective treatment when delivered in a tertiary treatment centre. Implementing this intervention in a community-based mental health centre (MHC) will increase the treatment capacity for CFS patients. This study evaluated the effectiveness of guided self-instruction for CFS implemented in an MHC, delivered by nurses.

METHOD: One hundred and twenty-three patients were randomly assigned to either guided self-instruction (n=62) or a waiting list (n=61). Randomization was computer generated, with allocation by numbered sealed envelopes. Group allocation was open to all those involved. Patients fulfilled US Centers for Disease Control and Prevention (CDC) criteria for CFS. Primary outcome variables were fatigue severity and physical and social functioning, measured with the Checklist Individual Strength (CIS) and the Medical Outcomes Survey Short Form-36 (SF-36) respectively.

RESULTS: After 6 months, patients who followed guided self-instruction reported a significantly larger decrease in fatigue compared to the waiting list [mean difference -8.1, 95% confidence interval (CI) -3.8 to -12.4, controlled effect size 0.70]. There was no significant difference in physical and social functioning. However, post-hoc analyses showed a significant decrease in fatigue and physical disabilities following the intervention in a subgroup of patients with physical disabilities at baseline (SF-36 physical functioning ⩽70).

CONCLUSIONS: Implementation of guided self-instruction in a community-based MHC was partially successful. The minimal intervention can be effectively implemented for CFS patients with physical impairments.

 

Source: Tummers M, Knoop H, van Dam A, Bleijenberg G. Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2205-15. doi: 10.1017/S0033291712000232. Epub 2012 Feb 21. https://www.ncbi.nlm.nih.gov/pubmed/22354999

 

Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up

Abstract:

Chronic fatigue syndrome (CFS) produces physical and neurocognitive disability that significantly affects health-related quality of life (HRQL). Multidisciplinary treatment combining graded exercise therapy (GET) cognitive behavioural therapy (CBT) and pharmacological treatment has shown only short-term improvements.

Aim: To compare the effects on HRQL of (1) multidisciplinary treatment combining CBT, GET, and pharmacological treatment, and (2) usual treatment (exercise counselling and pharmacological treatment) at 12 months of follow-up.

Design: Prospective, randomized controlled trial with a follow-up of 12 months after the end of treatment.

Method: Patients consecutively diagnosed with CFS (Fukuda criteria) were randomly assigned to intervention (n = 60) or usual treatment (n = 60) groups. HRQL was assessed at baseline and 12 months by the Medical Outcomes Study Short-Form questionnaire (SF-36). Secondary outcomes included functional capacity for activities of daily living measured by the Stanford Health Assessment Questionnaire (HAQ) and comorbidities.

Results: At baseline, the two groups were similar, except for lower SF-36 emotional role scores in the intervention group. At 12 months, the intervention did not improve HRQL scores, with worse SF-36 physical function and bodily pain scores in the intervention group.

Conclusion: Multidisciplinary treatment was not superior to usual treatment at 12 months in terms of HRQL. The possible benefits of GET as part of multidisciplinary treatment for CFS should be assessed on an individual patient basis.

 

Source: Núñez M, Fernández-Solà J, Nuñez E, Fernández-Huerta JM, Godás-Sieso T, Gomez-Gil E. Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up. Clin Rheumatol. 2011 Mar;30(3):381-9. doi: 10.1007/s10067-010-1677-y. Epub 2011 Jan 15. https://www.ncbi.nlm.nih.gov/pubmed/21234629

For a list of references see: http://link.springer.com/article/10.1007/s10067-010-1677-y

 

Randomized controlled study on acupuncture treatment for chronic fatigue syndrome

Abstract:

OBJECTIVE: To observe the therapeutic effect of acupuncture treatment for chronic fatigue syndrome (CFS).

METHODS: Ninety cases of CFS were randomly divided into an observation group and a control group, 45 cases in each group. The observation group was treated with acupuncture at Renying (ST 9), Fengfu (GV 16), Baihui (GV 20); the control group was treated with 250 mL 5% Glucose injection combined with 20 mL Shenmai injection. Fatigue Scale (FS) was used to compare the scores between the two groups after treatment.

RESULTS: The total scores in the observation group were 9.37 +/- 2.33 and 5.41 +/- 1.96 before and after treatment respectively, and in the control group, they were 9.08 +/- 2.27 and 7.34 +/- 2.03 respectively. FS brainwork integral, physical fatigue integral, and total integral all decreased after treatment in two groups (all P < 0.001), and it decreased much more obviously in the observation group (P < 0.05, P < 0.01).

CONCLUSION: Both of the acupuncture treatment and Shenmai injection are able to decrease fatigue scale score, improve the fatigue symptoms of CFS patients, and the effect of acupuncture treatment is obviously superior to that of Shenmai injection.

 

Source: Chen XH, Li LQ, Zhang W, Yang J, Dai YS, Xu DH, Tang CZ. Randomized controlled study on acupuncture treatment for chronic fatigue syndrome. Zhongguo Zhen Jiu. 2010 Jul;30(7):533-6. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/20862932

 

Effects of an educational video film in fatigued children and adolescents: a randomised controlled trial

Abstract:

BACKGROUND: In many cases standard management for chronic fatigue syndrome (CFS) in children and adolescents is ineffective.

OBJECTIVE: To evaluate the efficacy of a video film intervention in preventing the development of persistent fatigue and significant school absence in fatigued children and adolescents.

DESIGN: Randomised controlled trial.

PARTICIPANTS: 91 patients with fatigue; 50 were randomly assigned to receive the intervention (video film plus usual care) and 41 to usual care only.

INTERVENTION: A video film on CFS and coping behaviour.

MAIN OUTCOME MEASURES: Self-reported fatigue severity, physical activity, motivation, concentration and school absence.

RESULTS: 79 patients had complete data at 12 months (42 in the video film and 37 in the usual care group). Mean fatigue severity and school absenteeism scores did not differ significantly, but in the intervention group the score for reduced motivation was higher (difference 2.9 (CI 0.1 to 5.7), p=0.038). 18% more patients in the intervention compared to the usual care group also had persistent fatigue with significant school absence. The odds of developing persistent fatigue and of missing >50% of school classes was 3.3 times higher in the intervention than in the usual care group (OR 3.3 (CI 1.0 to 11.3), p=0.046).

CONCLUSION:This particular video film intervention plus usual care in children and adolescents with unexplained fatigue did not prevent an unfavourable outcome and possibly had an adverse effect in that it reduced motivation and increased the incidence of persistent fatigue with significant school absence. The use of this particular film is not recommended.

 

Source: Bakker RJ, van de Putte EM, Kuis W, Sinnema G. Effects of an educational video film in fatigued children and adolescents: a randomised controlled trial. Arch Dis Child. 2011 May;96(5):457-60. doi: 10.1136/adc.2009.172072. Epub 2010 Sep 22. https://www.ncbi.nlm.nih.gov/pubmed/20861404

 

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)