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Background:
The PACE trial (Comparison of adaptive pacing therapy (APT), cognitive behavioural therapy (CBT),
grade exercise therapy (GET), and specialist medical care (SMC) for chronic fatigue syndrome (CFS) : a
randomise trial) is an RCT (randomised controlled trial) that was designed to compare various
treatments for CFS (chronic fatigue syndrome)[1].
Rumusan masalah: CFS is a condition that affects 0.2-2.6% of the world’s population with a poor
prognosis if it is not treated, and therefore it is very important to work out the best way of treating
it. The condition leaves sufferers chronically disabled by an overwhelming sense of fatigue,
which is poorly understood.
Tujuan: So the PACE trial compared SMC (specialist medical care) alone with SMC
supplemented with CBT (cognitive behavioural therapy), GET (graded exercise therapy), or APT
(adaptive pacing therapy).
METHODS.
Question 3: Were all of the patients who entered the trial properly accounted for at its
conclusion? Most of the patients were accounted for; 33 (5%) were lost to follow-up. The
remaining patients were analysed in the groups to which they were randomised.
Question 4: Were the patients, health workers and study personnel ‘blind’ to treatment? No, due to the
nature of the interventions, only the statistician doing the analysis of the results could be blinded,
therefore there is room for bias from the clinicians and patients. The authors performed various
statistical analyses to assess if there was bias in the results from each clinician, however these
analyses showed no bias. We still cannot discount the patients’ bias because most of the
outcome measures were subjective and self-reported by the patients.
Question 5: Were the groups similar at the start of the trial? The groups were similar in age, sex,
body mass index, and many other criteria. However, there was a difference in the duration of
illness between the SMC alone group and the others, with the SMC alone group having a shorter
duration of illness.
Question 6: Aside from the experimental intervention, were the groups treated equally? Largely, it
appears as though the groups were treated equally. However, those allocated to SMC alone did
receive more sessions of SMC compared to the other groups.
Question 8: How precise was the estimate of the treatment effect? This is difficult to say. When
assessing the improvement achieved by each intervention compared to SMC alone, the
confidence intervals did not cross zero for CBT and GET but it did straddle zero in the case of
APT (when the confidence interval includes/straddles zero, then the results are not considered to
be statistically significant). The confidence intervals appear to be fair large for all groups.
Question 10: Were all the clinically important outcomes considered? This paper was very thorough
and many, many outcomes were considered; more than can be listed in this review. Indeed, all
the clinically important outcomes were considered.
Question 11: Are the benefits worth the harms and costs? The trial looked at adverse effects and the
conclusion was that the interventions were safe. Serious adverse effects such as death, hospital
admission, increased severity and persistent disability, self-harm, or life-threatening events
occurred in 1-2% of patients. These serious events were not thought to be related to the
treatments. No mention was made with regards to costs, however it is likely that the benefits are
worth the cost and harms.
Conclusion:
The results show that CBT and GET, when added to SMC, are effective treatments for CFS.
Their effect size is moderate. GET performed better than CBT in the objective test (metres
walked in six minutes), however CBT was better at reducing depression. The results showed that
adding APT to SMC was no better than SMC alone.