Reprinted with the kind permission of Cort Johnson and Health Rising
By Cort Johnson
The Lancet — one of the most highly regarded journals in the world — is back on the chronic fatigue syndrome (ME/CFS) community’s front page. That’s probably enough to either elicit curses from ME/CFS patients or to produce a strong desire to hide under one’s bed. Lancet’s ME/CFS offerings of late have been dominated by the PACE CBT trials and their controversies. Lancet’s refusal to retract that study is bad enough; it’s unwillingness to allow skeptics to publish a letter stating their concerns (after Lancet asked the PACE authors whether they should) was just plain weird. It’s editor, Richard Horton, can hardly control himself when talking about the ME/CFS community.
Lancet is back with another ME/CFS behavioral study…
Now Lancet is back with guess what? Another behavioral chronic fatigue syndrome trial. To make sure EVERYONE can read it, they put it in their free article section. Lancet has occasionally allowed dissenters to publish letters but there’s no doubt as to the journals pro-behavioral orientation to this disease. What’s more doubtful is whether the studies they’re publishing are helping their case.
Clark, LV, Pesola, F, Thomas, JM, Vergara-Williamson, M, Beynon, M, and White, PD. Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial. (published online June 22.) Lancet. 2017
As usual in UK-funded CBT/GET trials the trial was very large (n=211), far larger than non-CBT/GET trials in ME/CFS. in size. That size differential alone gives CBT/GET an advantage because it gives researchers more ability to tease out less subtle effects.
Another advantage — crappy entry criteria. The patients had to meet the NICE guidelines — a slightly more restrictive version of the much derided and now officially debunked (see the AHRQ report) Oxford criteria. Since most of the patients chose walking as their exercise activity of choice we can assume that not many of the really ill were included.
- 4 months of clinically evaluated, unexplained, persistent or relapsing fatigue with a definite onset resulting in a substantial reduction in activity that is characterized by post-exertional malaise or fatigue, or both.
- One of the following symptoms: difficulty sleeping, headaches, cognitive dysfunction, general malaise or flu-like symptoms, painful lymph nodes, sore throat, physical or mental exertion making symptoms worse, dizziness or nausea, palpitations, or multi-site muscle or joint pain without evidence of inflammation.
One wonders when the U.K. and the Netherlands are going to say enough is enough with CBT/GET. How much more, after all, can one say about a therapy’s effectiveness after dozens of studies have been published? They’re certainly not giving up yet.
This study’s twist is that it employed a graded exercise self-help component it’s proponents could be administered cheaply. The participants met with a physiotherapist up to four times to ensure that they were doing the program correctly, but otherwise worked off a GET handbook containing a six-step graded exercise program that took about 12 weeks to complete.
The participants (half were in the GET program and half were in normal care) were assessed at baseline, four weeks after the trial ended, and 12 months after the start of the trial. The Chalder Fatigue scale and Physical Functioning subscale of the SF-36 tests were used to assess results. Another questionnaire asked the patients how much better their health was after the trial.
As in the PACE trial, some changes were made in the study protocol but I’ll leave it to David Tuller, Julie Rehmeyer, Tom Kindlon, Graham and other patient statistical experts to parse out if they might have affected the study.
The Graded Exercise Therapy Program
The Graded Exercise Therapy Booklet (find it here
) is humble in many of its promises. It does not promise that ME/CFS patients will be cured or that they will be able to do all the activities they did in the past. It also does not delegitimize problems with exercise or suggest that ME/CFS is all in one’s mind; instead it suggests that prior exercise attempts may have failed because they were too rigorous.
Ignoring the fact that the program has not been tested in more severely ill ME/CFS patients, the booklet states:
A GET programme will help you gradually improve your ability to undertake some of the physical activities that you have been unable to do since becoming unwell.
The short theory section unmasks the limitations of GET and the program. GET, it turns out, is primarily designed to address two factors: deconditioning and the boom/bust cycle.
It’s clear that deconditioning is present in some ME/CFS patients; in fact, it’s unavoidable. Any disease that so severely limits functioning is going to cause some deconditioning — a physiological state of inactivity which produces a horde of negative effects.(Hold your breath)
Deconditioning results in decreased muscle strength, structural changes to the nerves and muscles, reduced co-ordination and balance, connective tissue thickening and muscle shortening that affects movement (hence the stretching exercises), reduced blood volume, increased inflammation, bone demineralization, stroke volume (heart), thickened blood, orthostatic intolerance, decreased gut motility, constipation, increased risk of diabetes, cognitive problems, sleep disturbances, irritability and depression. (!)
Unfortunately it’s really hard to determine how much bedrest is needed to cause deconditioning or how much activity is needed to stave it off. (One website did say that even by short periods of upright activity can stave off some effects of deconditioning.) It’s clear, though, that deconditioning process can begin within days of being bedbound. Ten days of bed rest in healthy adults resulted in significantly reduced maximum aerobic capacity. Muscle wasting and problems with orthostatic intolerance can occur within days.
Unfortunately for the purveyors of GET and their emphasis on deconditioning, while deconditioning is surely present in some ME/CFS patients, there’s no evidence that deconditioning plays a major role in producing ME/CFS. Systrom’s fascinating invasive CPET study of ME/CFS and other patients with idiopathic or unexplained exercise issues uncovered a heart filling pattern that is opposite to that found in deconditioning. The results of other exercise studies argue against deconditioning being a core element of ME/CFS. Deconditioned people, after all, should improve on a second exercise study; many people with ME/CFS do worse. Even Wyller’s studies (Wyller is a strong proponent of CBT/GET) find no evidence that deconditioning contributes to the core issues in ME/CFS.
If deconditioning is present in some ME/CFS patients, but is not causing ME/CFS, a program like GET should have some positive effects but not many. It should help people around the edges but not significantly affect their core issues. That’s exactly what happened in this study.
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The Boom-Bust Cycles
The booklet indirectly acknowledges the major role post-exertional malaise plays in ME/CFS by emphasizing that getting enough rest and avoiding overdoing activities that result in a crash or relapse is critical to the success of the program.
(Note the unusual blend of “treatments” in this program: one is designed to slowly increase activity; another to limit it and ensure that ample rest is present.)
The Six Step GETSET Program
The GETSET program consists of the following steps:
- Stabilize activity levels: Use a diary to stabilize one’s activity levels and avoid boom-bust cycles for a week or so.
- Begin a stretching program: See booklet for numerous stretching exercises.
- Decide on an enjoyable, regular activity goal
- Add one activity/exercise: About 2 to 3 weeks in, add an activity you can do without making you worse — even on a bad day. Do not do more than your planned activity, even if you feel up to it. Take a short rest after the activity/exercise in a sitting position.
- Increase exercise duration: Increase the amount of exercise by 20% a week. If you only increase exercise (and keep your baseline activity intact), the booklet says “your body will adapt”. The program shows a person starting out at 10 mins a day, ending up with 30 mins a day after 12 weeks.
- Increase exercise intensity: Once you’re able to walk 30 minutes a day, five days a week, increase the intensity (e.g. by walking faster) very slowly over several months.
Notes from the booklet: Maintain as much physical activity as you can, even if it is uncomfortable. If you have to take a break, get back to your exercises program as soon as possible. An increase in symptoms does not necessarily mean that harm is being done.
The results of the 200-plus study were decidedly underwhelming. Yes, a higher percentage of patients using the remote form of GET improved than those receiving normal care, but not by much. On a scale of 0-33, with 0 meaning no fatigue is present, the GET patients’ fatigue improved by just 4 points, or about 12%. GET moved the needle on physical functioning — an arguably more important measure — by even less (just 6 points out of a hundred). That outcome was similar to a Cochrane Review which found that GET produced “little or no difference in physical functioning, depression, anxiety and sleep”.
When asked to rate their overall health following the trial, the good news for GET proponents was that a much higher percentage of GET participants reported feeling much better than did those receiving normal care. The bad news was that the percentage of those really benefiting from the program was small, indeed, with just 1 out of 5 reporting feeling “much better” or “very much better”.
More good news for the GET proponents included the low dropout and low serious adverse events rates. The bad news was that only about 40% of the participants (42%) adhered to the protocol “well” or “very well”. That suggested that either some stopped before an adverse event could occur or that the protocol was simply too difficult to manage for many. An easily manageable protocol is a key goal in therapeutic trials; treatments are worth little if they’re too difficult to adhere to.
The elephant in the room was (once again) the missing activity or actometer measurements. Since GET is specifically designed to increase activity levels measuring that increase — easily done with an actometer — having one seems like a no-brainer, yet once again actometers were not included.
In the end the improvement was similar to what one might have expected in a population in which some deconditioning was present. It’s possible that the remote GET program may have improved some patients’ deconditioning (the worse off patients did better) but failed to move the bar in a major way in the disease itself. Physical functioning was barely touched and most in the study (80%) reported that their health was not much or very much better after doing the remote GET protocol.
There’s nothing the matter with — and everything right with — an appropriate exercise program. The problem is the outsize influence CBT/GET studies have had on how ME/CFS is viewed and treated. The GET SET program’s detailed (diary-based) approach to managing activity levels seems encouraging but it was surely optimistic in its projection that activity levels would climb over time. It’s assertion that symptom exacerbation doesn’t reflect harm was questionable as well. (Symptom exacerbation (muscle soreness, fatigue), of course, occurs with any increase in exercise but is brief and the exerciser is left stronger not weaker.) Staci Stevens’ and Dr. Klimas’ heart-rate based activity management programs — specific exercises with rest times — provides a more sophisticated approach for people with ME/CFS.
Check out a report
of a patient who significantly increased her activity levels and fitness and even cardiovascular measures using Staci Stevens’ heart-rate approach, which required that she keep her heart rate below a certain level.
The Lancet Effect
Lancet, not surprisingly, filled its comment age with CBT/GET proponents who lauded the study findings — demonstrating again what a low bar for success exists in these studies. Daniel Clauw, M.D. — a fibromyalgia, not an ME/CFS specialist — lead the applause stating, “The finding that graded exercise therapy is effective even when exercise is not being witnessed and directly guided by a physiotherapist is a substantial advance”.
But effective for whom? The study’s own findings indicated that most ME/CFS patients in the trial (66%) were not significantly improved and less than 20% rated their health as much better at the trial’s end. (This is in a study put together using a definition not that dissimilar from the Oxford one, a lax criterion).
The results were decidedly underwhelming and the lead author’s statement, read carefully, reflected that: remote GET, she said, helped “some” patients “manage” their symptoms.
“We found that a self-help approach to a graded exercise programme, guided by a therapist, was safe and also helped to reduce fatigue for some people with chronic fatigue syndrome, suggesting that it might be useful as an initial treatment for patients to help manage symptoms of chronic fatigue syndrome. ~Dr. Lucy Clark
Symptom management is fine, but effective symptom management should affect more than a minority of participants. Even better, of course, would be a cure. One wonders when the U.K. is going to give up its decades long obsession with CBT/GET and actually try to get at the cause of this disease. Results like these should help U.K. administrators make that switch.
We pretty much know what behavioral therapies can do: they can help with fatigue for a few but do little to improve physical functioning. Neither come close to curing this disease and few, if anyone anymore, are suggesting that they can. The results from both the PACE trial (even in its original version), and this study suggests it’ time for the U.K. and others to get off the behavioral bandwagon and spend some money trying to really help ME/CFS patients.
About the Author: Cort Johnson has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, Cort has contributed hundreds of blogs on myalgic encephalomyelitis, chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort's and other bloggers' work at Health Rising.