Dataset Information

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.

ABSTRACT:

Background

Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments.

Methods

In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org, number ISRCTN54285094.

Findings

We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p = 0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p = 0·0003), but did not differ for APT (0·7 [-0·9 to 2·3] points lower; p = 0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p = 0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p = 0·0005), but did not differ for APT (3·4 [-1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p = 0·0027; GET p = 0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group.

Interpretation

CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.

Funding

UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.

SUBMITTER: White PD

PROVIDER: S-EPMC3065633 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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Publications

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.

White P D PD Goldsmith K A KA Johnson A L AL Potts L L Walwyn R R DeCesare J C JC Baber H L HL Burgess M M Clark L V LV Cox D L DL Bavinton J J Angus B J BJ Murphy G G Murphy M M O'Dowd H H Wilks D D McCrone P P Chalder T T Sharpe M M

Lancet (London, England) 20110218 9768

<h4>Background</h4>Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments.<h4>Methods</h4>In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six s ...[more]

PMID: 21334061

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Project description:BackgroundChronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is characterized by chronic disabling fatigue and other symptoms, which are not explained by an alternative diagnosis. Previous trials have suggested that graded exercise therapy (GET) is an effective and safe treatment. GET itself is therapist-intensive with limited availability.ObjectiveWhile guided self-help based on cognitive behavior therapy appears helpful to patients, Guided graded Exercise Self-help (GES) is yet to be tested.MethodsThis pragmatic randomized controlled trial is set within 2 specialist CFS/ME services in the South of England. Adults attending secondary care clinics with National Institute for Health and Clinical Excellence (NICE)-defined CFS/ME (N=218) will be randomly allocated to specialist medical care (SMC) or SMC plus GES while on a waiting list for therapist-delivered rehabilitation. GES will consist of a structured booklet describing a 6-step graded exercise program, supported by up to 4 face-to-face/telephone/Skype™ consultations with a GES-trained physiotherapist (no more than 90 minutes in total) over 8 weeks. The primary outcomes at 12-weeks after randomization will be physical function (SF-36 physical functioning subscale) and fatigue (Chalder Fatigue Questionnaire). Secondary outcomes will include healthcare costs, adverse outcomes, and self-rated global impression change scores. We will follow up all participants until 1 year after randomization. We will also undertake qualitative interviews of a sample of participants who received GES, looking at perceptions and experiences of those who improved and worsened.ResultsThe project was funded in 2011 and enrolment was completed in December 2014, with follow-up completed in March 2016. Data analysis is currently underway and the first results are expected to be submitted soon.ConclusionsThis study will indicate whether adding GES to SMC will benefit patients who often spend many months waiting for rehabilitative therapy with little or no improvement being made during that time. The study will indicate whether this type of guided self-management is cost-effective and safe. If this trial shows GES to be acceptable, safe, and comparatively effective, the GES booklet could be made available on the Internet as a practitioner and therapist resource for clinics to recommend, with the caveat that patients also be supported with guidance from a trained physiotherapist. The pragmatic approach in this trial means that GES findings will be generalizable to usual National Health Service (NHS) practice.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRTCTN): 22975026; http://www.isrctn.com/ISRCTN22975026 (Archived by WebCite at http://www.webcitation.org/6gBK00CUX).

Project description:BackgroundRecent studies suggested that the left bundle branch area pacing (LBBAP) has a better efficacy to reduce QRS duration and produce a lower pacing threshold than the conventional right ventricular outflow tract septal pacing (RVOP), which resulted in a better cardiac function and ventricular synchronization. However, whether the LBBAP has a better efficacy in improving left atrial structure, function in pace-dependent patients compared with RVOP has not been well studied.ObjectiveThe purpose of this study was to compare the atrial outcomes of pace-dependent patients who received LBBAP or RVOP procedures.Methods and resultsA total of 72 patients (including II° AVB, high AVB, and III° AVB, excluding atrial fibrillation patients with atrioventricular block) consecutively enrolled in this single-center prospective clinical study and randomly assigned to the RVOP group and the LBBP group with 36 patients. All patients were pace-dependent. The changes in echocardiogram, speckle-tracking echocardiography, brain natriuretic peptide (BNP), and 6-min walking distance were documented and compared between two groups at baseline, 7 days, 1, 3, and 6 months after the implantation. There were no significant differences in baseline characteristics between the two groups. The results of the study were as following: (1) left atrial structure index: Our study indicated that there are no significant differences in left atrial anteroposterior dimension (LAAPD), left atrial superoinferior dimension, and left atrial mediolateral dimension between two groups. While the LAAPD in the LBBAP group was significantly reduced at 6 months after implantation ([38.22 ± 2.17] mm vs. [34.13 ± 1.59] mm, p < .05). (2) Left atrial strain index: We observed that the S% was significantly improved in both groups at 3 and 6 months after implantation but more prominent in the LBBAP group at 6 months (36.94 ± 11.67 vs. 25.87 ± 8.93, p = .01). SRs, SRe were improved in the RVOP group at 6 months after implantation but was further significantly increased in the LBBAP group. Similarly, the SRa in the LBBAP group was significantly better than the RVOP group after 6 months (-2.11 ± 0.75 vs. -2.51 ± 0.70, p = .04). (3) Left atrial ejection index: LAEF% in the LBBAP group was significantly improved compared with the RVOP group (60.02 ± 1.88 vs. 53.65 ± 2.45, p = .047) and baseline (60.02 ± 1.88 vs. 49.68 ± 2.75, p < .05) at 6 months after the surgery. (4) Left ventricular ejection index: The LVEF% in the LBBAP group was significantly increased than the RVOP group after 6 months (69.14 ± 4.99 vs. 64.60 ± 4.84, p = .01) and the BNP level was significantly lower in the LBBAP group compared with the RVOP group at 7 days, 1, 3, and 6 months after implantation (p < .05). (5) 6-min walking distance: the 6-min walking distance was significantly increased at 3 and 6 months after implantation compared with that before (p < .05) in both groups, but was more prominent in LBBAP groups ([483.03 ± 11.02] m vs. [431.09 ± 10.69] m,p < .05).ConclusionCompared with the traditional RVOP, the LBBAP procedure increased left atrial myocardial stress as well as left atrial ejection in pace-dependent patients at follow-up to 6 months.

Project description:IntroductionPersistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments.Methods and analysisWe will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14-18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire).Ethics and disseminationInformed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board-Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians.Trial registration numberClinicalTrials.gov #NCT05365776.

Dataset Information

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.

Background

Methods

Findings

Interpretation

Funding

Publications

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.

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