Five-Year Follow-Up of Young People with Chronic Fatigue Syndrome Following the Double Blind Randomised Controlled Intravenous Gammaglobulin Trial

1999 ◽  
Vol 5 (3-4) ◽  
pp. 97-107 ◽  
Author(s):  
Katherine S. Rowe
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Young People ◽  
Chronic Fatigue ◽  
Double Blind ◽  
Fatigue Syndrome ◽  
Intravenous Gammaglobulin ◽  
Randomised Controlled

Commentary on: Randomised, double-blind, placebo-controlled trial of fluoxetine and graded exercise for chronic fatigue syndrome†

1998 ◽  
Vol 172 (6) ◽  
pp. 491-492 ◽  
Author(s):  
Alicia Deale ◽  
Trudie Chalder ◽  
Simon Wessely
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Fatigue Syndrome ◽  
Controlled Trial ◽  
Chronic Fatigue ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Fatigue Syndrome ◽  
Graded Exercise ◽  
Randomised Controlled

A variety of treatments for chronic fatigue syndrome (CFS) have been proposed but few have been systematically evaluated. The publication of this well-designed, double-blind, randomised controlled trial is therefore a welcome contribution to the literature.

scholarly journals Results of the feasibility phase of the managed activity graded exercise in teenagers and pre-adolescents (MAGENTA) randomised controlled trial of treatments for chronic fatigue syndrome/myalgic encephalomyelitis

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Amberly Brigden ◽  
Lucy Beasant ◽  
Daisy Gaunt ◽  
William Hollingworth ◽  
Nicola Mills ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Fatigue Syndrome ◽  
Young People ◽  
Controlled Trial ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Fatigue Syndrome ◽  
Graded Exercise ◽  
Activity Management ◽  
Randomised Controlled

Abstract Background Chronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME) is relatively common in young people and causes significant disability. Graded exercise therapy (GET) and activity management are recommended by the National Institute for Health and Care Excellence (NICE) despite a limited evidence-base for either treatment in paediatric CFS/ME. This paper reports on feasibility and acceptability measures from the feasibility phase of the ongoing MAGENTA randomised controlled trial (RCT) investigating GET versus activity management for young people with CFS/ME. Methods Setting: Three specialist secondary care National Health Service (NHS) Paediatric CFS/ME services (Bath, Cambridge and Newcastle). Participants: Young people aged 8–17 years with a diagnosis of mild to moderate CFS/ME. Young people were excluded if they were severely affected, referred to cognitive behavioural therapy (CBT) at initial assessment or unable to attend clinical sessions. Interventions: GET and activity management delivered by physiotherapists, occupational therapists, nurses and psychologists. Families and clinicians decided the number (typically 8–12) and frequency of appointments (typically every 2–6 weeks). Outcome Measures: Recruitment and follow-up statistics. We used integrated qualitative methodology to explore the feasibility and acceptability of the trial processes and the interventions. Results 80/161 (49.7%) of eligible young people were recruited at two sites between September 2015 and August 2016, indicating recruitment to the trial was feasible. Most recruitment (78/80; 97.5%) took place at one centre. Recruitment consultations, online consent and interventions were acceptable, with less than 10% in each arm discontinuing trial treatment. Response rate to the primary outcome (the SF36-PFS at 6 months) was 91.4%. Recruitment, treatment and data collection were not feasible at one centre. The site was withdrawn from the study. In response to data collected, we optimised trial processes including using Skype for recruitment discussions; adapting recruiter training to improve recruitment discussions; amending the accelerometer information leaflets; shortening the resource use questionnaires; and offering interventions via Skype. These amendments have been incorporated into the full trial protocol. Conclusions Conducting an RCT investigating GET versus activity management is feasible and acceptable for young people with CFS/ME. Trial registration ISRCTN23962803 10.1186/ISRCTN23962803, date of registration: 03 September 2015

scholarly journals Effect of Melatonin Plus Zinc Supplementation on Fatigue Perception in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Jesus Castro-Marrero ◽  
Maria-Cleofé Zaragozá ◽  
Irene López-Vílchez ◽  
José Luis Galmés ◽  
Joan Carles Domingo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Fatigue Syndrome ◽  
Sleep Disturbances ◽  
Zinc Supplementation ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Double Blind ◽  
Fatigue Syndrome

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem, and profoundly debilitating condition, probably of multifactorial etiology. No effective approved drugs are currently available for its treatment. Several studies have proposed symptomatic treatment with melatonin and zinc supplementation in chronic illnesses; however, little is known about the synergistic effect of this treatment on fatigue-related symptoms in ME/CFS. The primary endpoint of the study was to assess the effect of oral melatonin plus zinc supplementation on fatigue in ME/CFS. Secondary measures included participants’ sleep disturbances, anxiety/depression, and health-related quality of life. A proof-of-concept, 16-week, randomized, placebo-controlled, double-blind trial was conducted in 50 ME/CFS patients assigned to receive either oral melatonin (1 mg) plus zinc (10 mg) supplementation (n = 24) or matching placebo (n = 26) once daily. Endpoint outcomes were evaluated at baseline and then reassessed at 8 and 16 weeks of treatment and 4 weeks after treatment cessation, using self-reported outcome measures. Treatment was safe and well-tolerated. The most relevant results were the significant reduction in the perception of physical fatigue in the active group at the final follow-up versus placebo (p < 0.05), and the significant improvement in the physical component summary at all follow-up visits in the experimental group. Our findings suggest that oral melatonin plus zinc supplementation for 16 weeks is safe and potentially effective in reducing fatigue and improving the quality of life in ME/CFS. This clinical study was registered on ClinicalTrials.gov (NCT03000777).

A randomised controlled trial of the monoaminergic stabiliser (−)-OSU6162 in treatment of myalgic encephalomyelitis/chronic fatigue syndrome

2017 ◽  
Vol 30 (3) ◽  
pp. 148-157 ◽  
Author(s):  
Marie Karin Lena Nilsson ◽  
Olof Zachrisson ◽  
Carl-Gerhard Gottfries ◽  
Michael Matousek ◽  
Birgitta Peilot ◽  
...  
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Chronic Fatigue ◽  
Mental Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Fatigue Syndrome ◽  
Randomised Controlled ◽  
Global Impression Of Change

ObjectiveThe monoaminergic stabiliser (−)-OSU6162 has in previous studies shown promising effects on mental fatigue after stroke and traumatic brain injury. This study investigated the safety and effectiveness of (−)-OSU6162 in patients with myalgic encephalomyelitis/chronic fatigue syndrome.MethodsA total of 62 patients were randomly assigned to placebo or (−)-OSU6162. Primary outcomes were assessment on the mental fatigue scale (MFS) and the clinical global impression of change (CGI-C) scale. Secondary outcomes were results on the FibroFatigue scale (FF), the Beck Depression Inventory (BDI), the pain visual analogue scale and neuropsychological tests. Assessments were performed at baseline, after 1 and 2 weeks of treatment and at follow-up after 6 weeks.ResultsMFS and CGI-C showed significant improvements for both treatment groups after treatment but not at follow-up; a similar pattern was seen for FF and BDI. However, significant differences between groups could not be demonstrated. On the other hand, correlation analyses showed a significant correlation between (−)-OSU6162 concentration and change in MFS, FF, and BDI score within the concentration interval 0.1–0.7 µM. Exploratory subgroup analyses showed a larger treatment effect with (−)-OSU6162 in improving MFS and FF symptoms in patients on antidepressant therapy compared to those without antidepressant treatment.Conclusion(−)-OSU6162 was found to be safe and well tolerated. When analysing the entire material (−)-OSU6162 was not found to differ significantly from placebo in alleviating fatigue in ME patients but was superior to placebo in counteracting fatigue in a subgroup of ME patients who received concomitant pharmacological treatment for depression.

scholarly journals Effect of Melatonin Plus Zinc Supplementation on Fatigue Perception in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Antioxidants ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 1010
Author(s):  
Jesús Castro-Marrero ◽  
Maria-Cleofé Zaragozá ◽  
Irene López-Vílchez ◽  
José Luis Galmés ◽  
Begoña Cordobilla ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Fatigue Syndrome ◽  
Zinc Supplementation ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Double Blind ◽  
Fatigue Syndrome ◽  
Experimental Group

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem, and profoundly debilitating condition, probably of multifactorial etiology. No effective approved drugs are currently available for its treatment. Several studies have proposed symptomatic treatment with melatonin and zinc supplementation in chronic illnesses; however, little is known about the synergistic effect of this treatment on fatigue-related symptoms in ME/CFS. The primary endpoint of the study was to assess the effect of oral melatonin plus zinc supplementation on fatigue in ME/CFS. Secondary measures included participants’ sleep disturbances, anxiety/depression and health-related quality of life. A proof-of-concept, 16-week, randomized, placebo-controlled, double-blind trial was conducted in 50 ME/CFS patients assigned to receive either oral melatonin (1 mg) plus zinc (10 mg) supplementation (n = 24) or matching placebo (n = 26) once daily. Endpoint outcomes were evaluated at baseline, and then reassessed at 8 and 16 weeks of treatment and 4 weeks after treatment cessation, using self-reported outcome measures. The most relevant results were the significant reduction in the perception of physical fatigue in the Mel-Zinc group at the final treatment follow-up versus placebo (p < 0.05), and the significant improvement in the physical component summary at all follow-up visits in the experimental group. Urinary 6-sulfatoxymelatonin levels were significantly elevated though the treatment in experimental group vs. placebo (p < 0.0001); however, no significantly differences were observed for zinc concentration among participants. Our findings suggest that oral melatonin plus zinc supplementation for 16 weeks is safe and potentially effective in reducing fatigue and improving the quality of life in ME/CFS. This clinical study was registered on ClinicalTrials.gov (NCT03000777).

scholarly journals Efficacy and Safety of Sipjeondaebo-Tang (Shi-Quan-Da-Bu-Tang) for Chronic Fatigue Syndrome: Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Hyunjoo Oh ◽  
Dong-Hyun Nam ◽  
Minwoo Hwang
Keyword(s):  
Informed Consent ◽  
Chronic Fatigue Syndrome ◽  
Controlled Trial ◽  
Chronic Fatigue ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Korean Medicine ◽  
Fatigue Syndrome ◽  
Study Results

Background. Sipjeondaebo-tang (SDT), also known as Shi-Quan-Da-Bu-Tang, is a treatment for both qi and blood deficiency syndromes in traditional Korean medicine. It is also used to treat chronic fatigue syndrome (CFS) in Korea. Herein, we present the protocol for a study to assess the efficacy and safety of SDT for treating CFS. Methods. This will be a multicenter, randomized, double-blind, controlled trial with two parallel-treatment arms: an SDT group and a placebo group. Ninety-six patients with CFS aged between 19 and 65 years will be recruited from two hospitals in Korea. Participants will be randomly allocated at a ratio of 1 : 1 between the two groups. Participants will receive 3 g doses of SDT or placebo thrice daily for 8 weeks. Follow-up evaluations will be performed for 4–6 weeks after the drug administration period. The primary outcome will be the rating of participants’ fatigue symptoms using the Checklist Individual Strength questionnaire. Outcomes will be assessed at baseline, week 4, and week 8, as well as during follow-up. An efficacy evaluation and safety assessment will be performed. This study will be based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. This protocol and informed consent guidelines were reviewed and approved by the institutional review board of Kyung Hee University Korean Medicine Hospital at Gangdong in the Republic of Korea (KHNMCOH 2017-06-004-001). The protocol was registered with the Clinical Research Information Service. Written informed consent will be obtained from all study participants prior to enrollment in the study. Results will be published in a peer-reviewed journal and presented at a scientific conference. Discussion. This study is expected to provide novel, accurate information regarding the 38 efficacy and safety of SDT for CFS in adults. Trial Registration. This trial is registered with https://cris.nih.go.kr; CRIS identifier (KCT0002684) registered on February 9, 2018.

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