Chronic fatigue treatment trial

People want to learn as much as possible from the PACE trial for chronic fatigue syndrome

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5731 (Published 25 September 2013)
Cite this as: BMJ 2013;347:f5731

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In my previous comments for this section of BMJ I discussed the fact that I had acquired a number of health problems by the age of 25 which were not responding to any form of medication or treatment, so I decided to study them for the purpose of developing some methods of treating them myself.

One of my objectives was to determine the cause or causes, so some of my initial ideas were based on my personal experience with the symptoms.

For example, as a teenager I would occasionally get palpitations when I went to bed and laid back to go to sleep, but I found that it was less likely to start if I sat in the bed, or laid back slowly.

However, I found it difficult to sleep sitting up, so I eventually placed three pillows at the top end of my bed and then laid back and removed them one at a time until there was only one left, and then went to sleep. It was sometimes, but not always effective.

That symptom stopped in my early 20’s.

At about the age of 21, I was transferred to the cash controllers office where all I had to do was sit at a desk and count coins into piles of ten.

After a few weeks I would start work at 9.a.m. and begin getting an ache in my left kidney area in the afternoon. Several more weeks went by when I would begin getting the ache in my left kidney at 2 p.m., and my right kidney by 3 p.m.

Soon after that I was diagnosed with a kidney stone in my left kidney, which was treated effectively by a prescribed drug called Allopurinol.

I was later transferred to another job.

At about the age of 23 I left work at then end of the day, and drove to a hotel where I had a large meal of steak and vegetables, and a glass of beer. I then drove to gym where, ten minutes later, I entered the hall and ran forward, placed my hands on the floor, and flipped over into a hand spring. When my feet hit the floor with a thud I felt a rip in the centre of my upper abdomen.
I considered that I may have injured myself internally and waited for blood to come pouring from my mouth, but nothing happened, so I just continued with gymnastics for the next few hours.

However, a few months later I noticed that I began getting an ache in my upper abdomen when I leaned toward my desk to read or write.

The ache became more of a problem until I found that I would start work at 9.a.m. and begin getting the ache by about 10 a.m., and that it would get gradually worse throughout the day. It would be relieved each time I leaned back.

I would then occasionally become breathless as I leaned forward, and ultimately, on some occasions, I would feel faint when I leaned forward, and those symptoms would also be relieved when I leaned back.

I then began having symptoms of faintness and dizziness during gymnastics, and had problems with other symptoms related to exertion.

By the time I reached the age of 25 my doctor had prescribed many medications to treat those ailments but none of them were effective so I started reading medical books to find the cause myself.

Leaning forward to read and write was one of the problems, so I had to proceed by reading for very short periods of time, perhaps only one sentence or paragraph, and then resting, and thinking about the information.

I also began keeping notes about each symptom and anything which aggravated them.

I noticed that I sometimes, but not always got an upper abdominal pain when I leaned forward to tie up my shoelaces, and that I would occasionally feel abdominal pain, breathlessness, or a sense of faintness each time I leaned toward a desk, or a kitchen sink, or a washing machine.

As I read books of anatomy I could see that leaning forward could compress the stomach to cause stomach pain, the lungs to cause breathlessness, and the kidneys to cause kidney aches etc.

During that time I was summarising my observations and ideas in essays, some of which were published about once each three months in the Australasian Nurses Journal.

However, I couldn’t determine a cause for the faintness and fatigue, and was about to give up in the fourth year when I saw a comment in a medical book about a procedure called Valsalva’s Maneuver, which described it as a way of creating stress in the laboratory.

One of the widely accepted ideas about the cause was psychological stress, so I wanted to know how stress was produced in the lab, and if it was a physical, or psychological method.

I eventually found that it involved pinching the nose, and keeping the mouth shut, and then attempting to breath out forcefully. The air can’t be exhaled through the nose or mouth so air pressure increases in the chest, which compresses all of the blood vessels in that space, and hence slows the flow of blood between the feet and the brain.

The brain has sensors which measure blood pressure and when it is too low, it stimulates the nervous system to send impulses to the blood vessels in the lower half of the body to increase the blood pressure to overcome the pressure in the chest.

The stimulation and activity of the nervous system, and the changes in blood pressure and circulation are the same as those of stress.

I therefore concluded that leaning forward was compressing the air in my chest to cause faintness, and in the longer term, to weaken my circulation and cause problems with exercise and fatigue etc.

I was then able to explain how leaning forward could cause all of my main symptoms, which I referred to as The Posture Theory, and then wrote a summary in an essay called “The Matter of Framework” which was published in the June 1980 edition of the Australasian Nurses Journal.

However, I also had to explain why I had those problems and others didn’t, and I ultimately noticed that I had a forward curvature in my upper spine, sideways curvature of my spine, and a vertical sternum which meant that when I leaned forward there was downward and backward pressure on my chest, whereas that didn’t happen in individuals who had straight spines and deep chests.

Competing interests: None declared

Max Allan Banfield, Publisher

None, Unit 6 No.6 Hartman Ave., Modbury, South Australia, 5092

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By 1975 I was experiencing many health problems which my doctor was unable to explain or treat effectively, so I decided to study them myself. 
I began by purchasing a small Reader’s Digest book which presented the range of diseases in an A-Z format, where I found that my symptoms were only consistent with one ailment which was called Da Costa’s syndrome. 
I later decided to try treating those problems by exercising so I enrolled in an exercise program at a fitness research institute.

While I was training my aerobic capacity was being scientifically measured at the start and at twelve weekly intervals and was found to be abnormally low, and to improve in the first period, and then even out below normal levels. 
I later asked one of the research staff to tell me the formal name of the ailment, and he said that it was “neurocirculatory asthenia”.

I then began using Index Medicus at the Adelaide University library to study research papers on that topic. 
In 1982 the head of that institute invited me to design and co-ordinate a research project for that condition. It revealed that other patients also had a lower aerobic capacity than normal, which explained the fatigue, and established scientific evidence of a physical cause.

A few more years went by when I heard a radio report about a supposedly new illness called “The chronic fatigue syndrome”, but it was just another label for the same ailment.

Since then I have found that it had been given more than 100 different labels during the past 140 years. 
For example, effort syndrome referred to the abnormal response to exertion, anxiety neurosis and anxiety state referred to the ideas of psychological cause, and post-viral syndrome referred to the possibility of a virus being the cause etc. 
When a researcher suggests a new label a lot of old Ideas and evidence are discarded and forgotten, especially if they involve obscure terminology which the average person can’t pronounce or remember. 
However, the new definition then comes under the same sort of criticism where contradiction and confusion continues.

Nevertheless, my symptoms have not changed except for the fact that I have gradually determined what aggravates them and how to control them so that, apart from my limitations, they are no longer a problem. 
I will therefore present a definition which is clear and consistent. If anyone wishes to provide a different one, it won’t change, but will relate to a variation of the ailment, or an entirely different condition.

The Banfield Definition of CFS . . .

The word “chronic” refers to anything which exists and or recurs for a long time, and fatigue has two meanings.

First, tiredness, and second, the exhaustion associated with physical exertion. The word syndrome refers to any ailment which has a set of symptoms, rather than just one. Hence the chronic fatigue syndrome refers to a long term illness which involves several symptoms where abnormal fatigue is the main one.

They include . . .

1 . . . Lower left-sided chest pain which is generally described as a stabbing or lancinating sensation.

It feels as if as if a sewing needle has been stabbed into the left side of the chest between the lower ribs, and proceeds to a depth of about four centimetres and darts out again, all in a fraction of a second. Similar pains can sometimes occur on the opposite side, and in other parts of the chest wall, and occur occasionally, for example, once every few months. There have also been reports of a small area of tenderness at the same location on the left side.

2 . . . Palpitations. This is a more forceful beating of the heart than usual, and occurs occasionally.

3 . . . Breathlessness.This is a very distinct form of breathlessness which involves a sensation of difficulty breathing inwards, as if against an obstruction at the end of inhalation. It can occasionally occur at rest, but becomes more frequent during exercise and as the level of exercise increases. It is associated with an abnormal spasm of the diaphragm which is the main breathing muscle.


4 . . . Abnormal fatigue which includes two types . . .

(a) The first type is related to tiredness, and involves waking several times during the night, waking up tired in the morning, and being tired several times throughout the day. It is probably due to inefficient blood flow to the brain, and is associated with occasional difficulty concentrating.

 (b) The second type of fatigue relates to exertion. Severe cases may involve abnormal responses to low levels of exertion. However, in most cases, if the individual is at rest or exerting at basic levels they may not experience any symptoms, or may only have occasional mild problems.

Nevertheless, as the level of exercise increases the physiological responses increase out of proportion to that increase. The symptoms involve an abnormal pulse rate and a periodic sense of breathlessness with relatively moderate levels of exertion, and more so with higher levels such as sprinting or running.

There may also be limits to aerobic capacity where the symptoms associated with exceeding those limits impels the person to stop and rest, and may result in the after effect of exhaustion accompanied by alertness and delayed recovery. The sense of alertness is comparable to that which occurs after drinking too much coffee. The fatigue also relates to various aspects of lifestyle.

5 . . . Faintness and, or dizziness which occasionally occurs when moving from the laying to the standing position, and when exercising at too high a level, again due to inefficient blood flow.

6 . . . Upper abdominal pain in an area the size of a 20 cent piece just below the tip of the sternum, which is aggravated by mild pressure applied by a finger or knuckle.

Addendum

Other symptoms may include a tendency to sore throats, coughs, and colds, and neck and back aches, headaches, and kidney aches etc.

Furthermore, some individuals report muscular aches and pains, and may have a variation of the ailment, or an entirely different condition, particularly those whose more general responses to physical exertion are normal.

Also, if the individual only has one or two symptoms such as chest pains and palpitations, they may not necessarily have the chronic fatigue syndrome. 
However, if there is a combination of the typical breathlessness, occasional faintness when moving from the laying to the standing position, abnormal tiredness, reduced aerobics capacity, and an abnormal response to exertion, then they probably do, as they are the core aspects which are essential to identifying the ailment, and distinguishing it from others.

Competing interests: None declared

Max Allan Banfield, Publisher

None, Unit 6 No.6 Hartman Ave., Modbury, South Australia, 5092

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In previous comments in this section of BMJ I described how I enrolled in an exercise program at a fitness research institute in 1976 and developed a method of exercising to treat my own chronic fatigue which essentially involved training within my limits.
For example, I found that if I walked at a casual pace I had a minimum of symptoms where I would occasionally need to take an extra deep breath. However, if I increased the pace to brisk walking I would need to take those extra breaths more often, and sometimes stop, bend at the hips, place my hands on my knees, and breath in forcefully to get enough air. Also, if I tried to run or sprint, the symptoms would increase and make it impractical to continue for any more than a few yards, and I would have to stop and rest.
I started training twice per week and increased the frequency to 5-7 times per week until the 10th month when I injured my knee and had to leave the program.
Although I was training at my own pace then and since, there have been occasional circumstances where I exceeded my limits, so I will give some examples.
Example 1
In the seventh month I became involved in a relay race where 50 trainees were lined up in rows of ten, and the first task was to run about thirty yards to the end of the hall and return to tag the next runner. When it was my turn I ran a short distance, and then walked briskly at intervals until I returned to tag the next runner. We then had to run backwards, and then hop the distance which I did at my own slow pace.
In the next sequence we had to squat down and place a heavy medicine ball between our knees, and hop like frogs.
After hopping for about ten paces my heart rate increased, and I felt dizzy and faint and began gasping for breath, so I stopped and leaned forwards onto my hands and knees. People crowded around me to see what was wrong so I told them that I would be okay, but to get out of the way because I needed to move about and get as much air as possible. When I was still, my symptoms seemed worse, so I started crawling until I reached the wall, and kept stopping and starting for several minutes as I crawled around the edge of the hall. I then tried, with great difficulty, to get up onto a chair, and finally, on about the fifth attempt, managed to do it. However, sitting still seemed to make the symptoms worse so I fell to the floor, and kept crawling about for a few more minutes.
I got up onto the chair again, and after a few minutes stood up and walked out of the hall and drove home. My body felt agitated and exhausted at the same time for the next few days. I returned to training about a week later, and resumed at my own pace.
Several years later, in 1982, I was invited to organise a research project to study the effects of exercise on other patients, so I wrote some guidelines for them to train at their own pace and within their own limits, and to stop and slow down if they had any problems.
I have since been exercising regularly myself, mainly by walking, particularly at a brisk pace, and have had the same problems of needing to stop and get extra breath occasionally.
Example 2
About ten years later I was invited to go bushwalking, and as the group of about fifty people set off I was able to stay in the middle as we walked up and down mild hills for about half a mile. When they stopped and turned to go up a steep hill I struggled for few yards and then stopped to rest. I had to keep stopping and starting every few yards as other walkers strode past at a casual rate. I was last to reach the top of the hill where four or five walkers were finishing their cups of tea and sandwiches, and the others had continued to the next part of the journey. When I saw steeper hills in the distance I waited for the remaining walkers to leave, and then turned around and went home.
Example 3
Another ten years went by when, one day, I needed to go to town. The bus stop was fifteen minutes walk away, but I started late, so I walked briskly, and then ran and had to slow down, and continued in that manner intermittently. When I saw the bus passing the cross road ahead I increased my pace and reached the corner to see it at the bus stop about fifty yards away, but I couldn’t run any more, so the bus left without me. I then walked home at my normal pace, and got the next bus later.
Example 4
During the next few years I was walking up and around a local hill for a distance which took about an hour and a half, sometimes three or four times per week. It was just within my limit to do it without too many problems.
One day I met a neighbour in the car park at the start, and he was taking his dog for a walk so we went together. When we were half way up he invited me to go down a side track for the view. When we reached the bottom there was only one way out, and it was up a steep climb. I started and staggered and stopped and rested from rock to tree, gasping for breath as I went, and could hear him up ahead asking if I was okay, and his dog bounded down and back several times. I eventually reached the top, and had a rest, and then continued the remainder of the walk as usual.
I get a lot more exercise than most people, especially those who have sedentary jobs, and who drive their car to the shops, and watch TV in the evenings, but regardless of that fact I still have a limit to the type and amount of exercise I can do.
Since developing that method of exercising it has been used for many other people who have the chronic fatigue syndrome, and has been given the name of “pacing”.

Competing interests: None declared

Max Allan Banfield, Publisher

None, Unit 6, No.6 Hartman Ave., Modbury, South Australia 5092

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When I was a teenager I played a lot of sport, and ran in athletic events such as the hurdles, the mile, and the cross country. I also learnt to swim, and I was involved in gymnastics where a wide range of activities included somersaulting from mats, springboards, or trampolines. I was also an instructor where I needed to take into account the varying abilities of younger gymnasts in relation to their age and experience. I didn’t know anything about medicine, but did occasionally suggest modifying exercise for those who were overweight or had asthma etc. I generally recommended that such individuals do what they could, but not be too concerned about keeping up with other members of the group.

However, by the age of 25 I had gradually become more easily fatigued by relatively minor exercise for other reasons.

My doctor was unable to diagnose the cause, and none of the medications were relieving the symptoms, so I decided to study the problem myself.

I considered the possibility that gradually improving my fitness might improve my health, and about a year later, in 1976, I heard about a medically based fitness research organisation called the South Australian Institute for Fitness Research and Training, so I enrolled in one of their courses.

As part of the training each person was medically examined to determine their aerobic capacity at the start, and at 12 weekly intervals.

The measurement was made by having each person ride a stationary cycle while their pulse rate was being recorded as the brake pressure on the wheel was increased at intervals of three minutes of riding and resting. A graph of load over pulse was then drawn to give the level.
I later found that my initial reading was zero, but when I enquired about how that could be so, I was told that normal measurements were made with straight line graphs, and that a curve would be needed at the low end of the graph, in which case my actual reading would be between zero and 100.

I then trained twice a week for 12 weeks, with each session involving 20 minutes of light exercise, 20 minutes of walking or jogging, and 20 minutes of light games.
I found that when I just walked I had a minimum of symptoms, but when I began to increase my pace I would have to take from one to three extra deep breaths about ever 30 or more yards. Sometimes I could keep walking, but at other times I would actually have to stop and take the extra deep breaths, and then start again. I therefore walked slowly, or briskly, or jogged, and stopped and started my way around a 400 yard track. I was running last, and by the time I was two thirds around the track every other runner had out-lapped me.

My aerobic capacity was measured again after 12 weeks and it was 350 kps.

I therefore increased the frequency of my training to 3 or 4 times per week at the institute venues, and, or local ovals, and was training at a slightly faster pace, but after 24 weeks my aerobic capacity was still 350 kps.

Nevertheless, I continued to train and increased the frequency to 5-7 times per week, until, in the tenth month, I injured my knee and had to stop.

When I discussed the training with others I found that athletes had capacities of 1200-1400 kps, weekend sportsmen who trained for 2 hours on Wednesday and played for 2 hours on Saturday had a capacity of about 900 kps, and a sedentary worker who did no exercise would be 700 kps.

In other words, despite regular training, my capacity was half that of healthy individuals.
I therefore concluded that if I exercised within my limits I would be relatively free of symptoms, and if I reached my limit I would have some trouble with my breathing, and if I exceeded those limits the problem would just get worse. I therefore developed the general policy of exercising within my limits. I also applied that principle to any other aspect of health, by doing things casually instead of hurrying etc.

I also concluded that aerobic testing could be a way of diagnosing the problem, and measuring it’s severity, and that regular exercise could be used as a treatment in some cases.
I continued to study the problem by reading medical books and journals, and some years later found that international researchers were not able to get data on the effects of exercise because the patients could not, or would not train.

I knew that it would be due to the standard exercise programs requiring gradual increases in training to gain improvement, and that as soon as the patients exceeded their limit they would get problems and drop out of the course.

I also found that, in 1980, Russian researchers had measured the aerobic capacity of such patients and found that they were generally below average. In the U.S.A. one of the main names for the ailment was neurocirculatory asthenia. The Russian researchers called it neurocirculatory dystony and placed it in 3 levels for mild, moderate, and severe cases.

Several years later a friend of mine introduced me to the head of the research institute where I had trained.

When I explained how his researchers could solve some of the research problems, he asked them if they would do such a study, but they were busy on other projects, so he asked me to design and co-ordinate a project myself.

I arranged for other patients with similar problems to train in the same manner that I had, and was able to verify that most of them had lower aerobic capacity than normal, and that improvement occurred in the first 12 weeks and began to level out, indicating that they had a limit to their capacity.

The success of the project was reported in newspapers throughout Australia between 1982 and 1983, and although I prepared a research paper and sent it to two medical journals it wasn’t published, so I put it in my filing cabinet where it stayed until recently, when I sent it to BMJ and it was accepted.

References for these comments can be seen in my other responses to the topic in this section of BMJ.

Competing interests: None declared

Max Allan Banfield, Publisher

None, Unit 6, No.6 Hartman Ave., Modbury, South Australia 5092

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In recent correspondence with BMJ I have referred to an exercise program which I designed in 1982 to study the effects of regular exercise on chronic fatigue.

However, although it was reported in local and interstate Australian newspapers, the research paper which I prepared to summarise the findings has not previously been published in a medical journal, therefore, rather than discuss more details, I will present that paper here, as an attachment, for anyone who wishes to read more.

Some minor editing has been made to improve the original text and update the terminology but the description of the methodology is clear and can be readily re-tested and verified.

One of the objectives of the project was to overcome a previous problem where international researchers were not able to determine the physiological effects of regular exercise because the patients could not or would not train for 12 weeks.

In order to achieve that objective those who participated were given instructions to start at a low level, and, for example, to walk, jog, or run at their own pace, and stay within their own limits where symptoms were not a problem, and, to improve in a gradual manner, if and when they could. They were also instructed to slow down if they had any problems, and to stop and rest if necessary, for a few minutes or more, or for however long was required. They could also stop training and leave the project if they wished, or return at whatever time they wanted. They were asked to report any adverse effects if they had any, but none did.

Ultimately 25 attended medicals and had their aerobic capacity measured. Nine completed twelve weeks training, and of those, five continued to complete six months training or more. Their aerobic capacity was re-measured at 12 weekly intervals.

It was therefore possible to determine the physiological effects of regular training, and anyone who used those methods in the future would be able to asses any aspect of physiology that they wished to study.

The 1982 project included other aspects, including phone interviews with 48 of those who participated to determine what they thought was the cause, so a summary of that is also included in the attachment.

Competing interests: None declared

Max Allan Banfield, Publisher

None, Unit 6, No.6 Hartman Ave. Modbury, South Australia, 5092

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The adverse effects of exercise in patients with Chronic Fatigue Syndrome (CFS) are due to the potentially diagnosable and treatable biochemical abnormalities found in the condition. Unfortunately the best tests, including an analysis of red blood cell magnesium levels, are not widely available.

In 1989 John McLaren-Howard demonstrated that a myothermogram reveals smooth muscle contractions when red cell magnesium levels are normal but large irregular spikes in marked magnesium deficiency signalling muscle damage.1

John McLaren-Howard later discovered that about 98% of the CFS patients who have adenosine triphosphate (ATP) profiles have low levels of ATP-related magnesium. Most ATP functions work as complexes with magnesium. Low levels of ATP in CFS indicate the need for specific treatment which he has found is almost always helpful.

A low whole-cell ATP is not exclusive to CFS patients as almost all non-haematological causes of fatigue usually involve lowered ATP levels.

About 40 % of the CFS people with low ATP have some degree of blocking of the translocator sites in the mitochondrial membranes. This has to be addressed as well as trying to improve ATP availability. When ADP to ATP translocation is blocked at the translocator site there is, in effect, a double block because ATP provision to the cytoplasm will also be reduced. The same translocator takes ADP into mitochondria and delivers reformed or de novo synthesised ATP back to the cytoplasm.

Very low magnesium levels can occur without CFS. I know that hard exercise--for example, running five miles every day--may contribute to low red cell magnesium levels. Low cell magnesium cannot only damage muscles but also can affect sperm quality and motility. Repletion of red cell magnesium status is an important part of preconception care for both men and women.

Fatigue, like headache, migraine, or flushing, is a warning symptom which signals perturbations in cell chemistry which can benefit from state of the art investigations. Exercise is easy for those with healthy bodies.

1 Howard J. Muscle action, trace elements and related elements: the myothermogram. In Chazot Gea; ed. Current Trends in Trace Element Research. Smith-Gordon, 1989

2 Myhill S, Booth NE, McLaren-Howard J. Chronic fatigue syndrome and mitochondrial dysfunction. Int J Clin Exp Med. 2009;2:1-16.

3 Booth NE, Myhill S, McLaren-Howard J. Mitochondrial dysfunction and the pathophysiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Int J Clin Exp Med. 2012;5(3):208-20.

4 Myhill S, Booth NE, McLaren-Howard J.
Targeting mitochondrial dysfunction in the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - a clinical audit. Int J Clin Exp Med. 2013;6:1-15.

Competing interests: None declared

Ellen CG Grant, Physician and medical gynaecologist

Retired, Kingston-upon-Thames, KT2 7JU, UK

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In recent BMJ discussions Tom Kindlon has referred to adverse effects in patients who participated in the CFS PACE trials, and Ellen E.C. Grant has questioned the value of exercise methods being used as a form of treatment.

I responded by describing how I developed an exercise regime to treat my own ailment with some beneficial effect in 1976, and was then invited to design a program for other patients at the South Australian Institute for Fitness Research and Training in 1982, with success which was widely reported in local and interstate newspapers.

I have since described that set of guidelines as The Banfield Principles to distinguish them from the standard methods which existed when I first started training, so in this report I will discuss the symptoms, and then explain some of the problems encountered with exercise, and then list some of the principles.

The symptoms

The symptoms which I was attempting to treat included as sub-set which occurred in general, but were particularly notable during any form of exertion, and they consisted of an abnormal increase in pulse rate as the level of exercise increased, and a type of breathlessness which occurred intermittently, after about 30 or more yards, as I walked briskly or jogged. Other symptoms such as faintness, and dizziness could occur, but mainly in the more rapid forms of exertion such as sprinting. Also excessive exertion was sometimes followed by symptoms which required an abnormal period of time to return to normal.

Background information

I didn’t know anything about medicine at the time, but the general view was that the symptoms were part of an abnormal physiological response to exertion which was determined by the exercise combined with anxiety which both affect pulse rate, blood pressure, and breathing, so the fear of exercise had been suggested as a cause.

I had no such fear, so I had determined that regular exercise might be useful on the basis that it was a physical ailment of some sort.

When I was developing the methods I encountered a number of problems which needed to be solved, but then, when I was asked to design a program for other patients I needed to summarise them, so I will first give some information about the problems.

I had experienced various levels of persistent fatigue, so I knew that some people would not be able to start, or benefit from training. I therefore provided the principle that patients should not be forced to train, but should volunteer.

I also knew that the starting level would vary from person to person, so I recommended that they start at a low level and gradually improve at their own rate.

When I started there was some social pressure to keep up with other runners, which I ignored, so when I produced the guidelines I recommended that the patients train in a separate group and be given instructions that each individual should be free to train at their own level.

I knew that my body was responding abnormally to exertion, and that it not only applied to fitness training, but also to daily activities of other sorts which needed to be managed in a similar way, and that such factors would affect the capacity to exercise.

I therefore also knew that the ability to do the exercises on one day did not mean that it would be possible to improve the next day, or the next week etc, so I presented the principle that the exercise level needed to be flexible.

I found that if I ignored the symptoms which occurred with higher levels of exertion, and continued at that level, that they would get worse and I would have to stop, and possibly have after effects, so I presented the guideline of staying within limits.

I also recommended that if the individual over-exercised they should be free to rest and recover and start again any time they wanted, in that session, or the next session a few days, or a week later.

The Banfield Principles for those who participate in the exercise program

1. If rest is necessary then rest may be the best treatment at that time
2. If walking is possible then walking may be the best exercise
3. Any improvement in fitness levels should start at a low level, and improve gradually as determined by the response to exercise.
4. The exercise needs to include light activities rather than strenuous exertion, especially in the early stages.
5. As a general guide sprinting should be avoided.
6. Anaerobic exercises such as weight lifting or forced movement against any form of resistance should be avoided.
7. Each individual should set their own pace and not be concerned with the improvement rates of other people because they may have a different aerobic capacity.
8. Walking or jogging is best on flat ground, especially in the early stages when the person is assessing their aerobic capacity.
9. As a general guide each individual may not be able to walk up moderate slopes, or especially steep hills, until they understand their fitness limits, and then only do so if they think that it is practical and possible, and at a pace determined by their experience.
10. If the person experiences the sense of breathlessness when they are walking or jogging, then they can take two or three slow, but deep breaths in a row, or in any way that suits them, and then should be able to continue, but if they can’t then they can stop and rest for awhile and resume at a lower rate.
11. The objective is to train regularly in a manner that is possible, not in a predetermined way that increases to a degree which makes progress impossible.

Conclusion

It is possible for some chronic fatigue patients to participate in exercise programs and benefit from the training but it needs to be determined on an individual basis.

References . . .
1974: Hurst J.W. et al., The Heart, 3rd edition, McGraw Hill, New York, p.1554 . . . (a quote from a section about the abnormal physiological responses in neurocirculatory asthenia (known by many other names including the Effort Syndrome) . . . ”Attempts by Cohen and his associates to alter these abnormalities by physical training were unsuccessful since the patients could not or would not follow the prescribed training programme”
1982: August 5th, Fitness helps in therapy, The News (Adelaide) p.5.
1983: August 11th, Study lifts fitness levels, The News (Adelaide) p.13.
1983: August 20th Researchers solve mystery, The Courier Mail (Brisbane, Queensland newspaper) p.14.
2013 (4th October) Development of the design principles for safely conducting research into chronic fatigue and exercise at the South Australian Institute for Fitness Research and Training in 1982, British Medical Journal - BMJ 2013;347:f5731
2013 (December 9th), Banfield M.A. Response to Ellen CG Grant's question about why anyone would expect anything of scientific importance from the £5m PACE trial for CFS, British Medical Journal - BMJ 2013;347:f5731

Competing interests: None declared

Max Allan Banfield, publisher

None, Unit 6, No.6 Hartman Ave. Modbury, South Australia, 5092

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I would like to thank the editors of BMJ for publishing my comments about my 1982 research project on chronic fatigue and exercise on their website on 4th October 2013.

I have only recently found that item on 5th December 2013, and would like to add a further response to the letter of Ellen C.G. Grant who asked why anyone would expect to learn anything of scientific importance from the recent five million pound PACE trial. Grant also reports on the importance of studies into mitochondrial dysfunction.

First of all, in 1975 I had been offered many different treatments, mainly medications, for my own ailments, but none of them had any beneficial effects, so I decided to try and find my own solutions.
One of the main symptoms was an abnormal physiological response to exertion.

I began with the objective of joining an exercise class, and gradually improving my fitness until I returned to normal health.

At that time I heard a radio report about an organisation called the South Australian Institute for Fitness Research and Training which invited members of the public to enrol, so I did on the grounds that research doctors might know more than my local GP and specialists.

The institute, as I understand, had some specific studies, and, or, classes for people with such ailments as asthma, high blood pressure, and arthritis, and for those who were overweight, or cigarette smokers etc, but it did not have anything for those who had chronic fatigue.

Consequently, I was placed in a standard group where all kinds of people trained, including sportsmen, and those who were recovering from injuries, and those who just wanted to get fit.
At the outset I was encouraged to ignore my symptoms and try to keep up with the group, but that level of activity was making the symptoms worse instead of better, so I had two choices.

The first was to stop training, and the second was to continue, which I did, by walking or jogging at my own pace.

I started training twice per week, and increased it to six or seven times per week over a period of ten months before injuring my knee, when I had to stop, and during that time my health did improve, although not to the extent that I was aiming for.

I therefore began investigating other aspects and found that international researchers were unable to get scientific information on the effects of regular exercise because patients were not able to complete their training programs for 12 weeks.

Seven years later I had a discussion with Tony Sedgewick who was in charge of the Institute, and I explained how to solve that problem.

However, because his researchers were too busy on other projects he asked me to organise one specifically for fatigue patients.

My objectives were to make it safe for all participants, and to see if the those who trained the same way as I had could continue for twelve weeks or more, and nine did. None of them became significantly worse, three stayed the same or slightly less, and six improved their aerobic capacity, and of the total, five kept training for 24 weeks or more, with one of them apparently on his way back to full recovery, and who, about a year after starting, was still training, and participated in a six mile run.

Consequently, the reason that the project was important, was because I had developed a reliable way of having patients train regularly for 12 weeks or more for the first time, and since then researchers who use that method have been able to get scientific data about any aspect of exercise which they studied.

The exercise method is also important because for some patients it may be the only effective way of improving health when other methods don’t.

Also, since then the name chronic fatigue syndrome has been introduced into official lists of diagnosis, the abnormal physiological response to exertion has become the identifying aspect in the definition, and the method of treatment which I developed has been widely used, and been given the name of PACING.

However, some researchers apparently haven’t been as successful For example, the recent five year study of 650 patients called the PACE trials has been criticised by patients where 51% report that they were worse after, than when they started.

Nevertheless, exercise training can be useful, and should be studied further, to reduce the adverse effects and improve the outcomes.

As for other forms of treatment, I have considered every possibility, and found that at least 100 different labels have reached prominence at some time in the past 150 years, and they all need to be considered in the context that they all have their proponents and potential to help patients.

The concept of mitochondrial dysfunction, as mentioned by Grant, is one of those, and I would encourage the people concerned to pursue that area of study.

However, as I said, it isn’t necessary to discard the exercise methods which have already proven helpful to some patients, and should continue to be available as an option in the future.

Max Banfield

References . . .
1974: J.W. Hurst, The Heart, 3rd edition, McGraw Hill, New York, p.1554 . . . (a quote from a section about the abnormal physiological responses in neurocirculatory asthenia which is often described as having symptoms similar to those of heart disease occurring in the absence of heart disease) . . . ”Attempts by Cohen and his associates to alter these abnormalities by physical training were unsuccessful since the patients could not or would not follow the prescribed training programme” (end of quote).
1982: August, M.A.Banfield - The Australasian Nurses Journal, letter to the editor, p.15 (an invitation for people with the relevant symptoms to enrol in a fitness training course)
1982: August 5th, Fitness helps in therapy, The News (Adelaide) p.5.
1982: December 20th, SA study matches Russian Results, The News (Adelaide) p.18.
1983: August 11th, Study lifts fitness levels, The News (Adelaide) p.13.
1983: August 20th Researchers solve mystery, The Courier Mail (Brisbane, Queensland newspaper) p.14.

Competing interests: I was the designer and co-ordinator of a research project on the effects of regular exercise on chronic fatigue patients at the South Australian Institute for Fitness Research and training between 1982 and 1983.

Max Allan Banfield, publisher

No affiliation, Unit 6, No.6 Hartman Ave. Modbury, South Australia, 5092

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I would like to use this forum to inform BMJ readers that I had a discussion with Tony Sedgewick, head of the South Australian Institute for Fitness Research and Training, in 1982.

I explained that I had completed almost a year of training at his institute in 1978, by making modifications to the standard exercise program to suit my requirements, and that I had since learned that international researchers were finding that chronic fatigue patients "could not or would not train" for sufficient time to gain meaningful scientific data.

He understood clearly, that if I could do it, then so could some other patients so, when his two researchers were too busy to do the study, he asked me to design and co-ordinate the research myself.

The first 12 week program was successful, and the second verified the method, and then I left the project.

However, the exercise principles which I established were a reliable that any researcher could use in the future. It essentially recommended that the person trained at their own rate, within their own limits, and improved very gradually in a specific way, and adjust their daily activities etc. as well.

I prepared a research paper with the details and sent one copy to the Australian Medical Journal, and then another to the New Guinea Medical Journal, but they were not accepted for publication.

Nevertheless, the success of the project was widely reported in local, interstate, and probably international newspapers between 1982 and 1983.

I designed that program so that the people who participated would not be required to do the type of exercise which caused problems.

I then became involved in other activities and projects.

However, in recent years I have seen many modern research projects which use almost exactly the same principles which I developed.

I made that possible by solving the problem by producing the type of exercise regime that some patients could and did follow for the required period of time.

The text and charts for that research paper can be seen by using the Google search engine to navigate to The Posture Theory website, and then by using the drop down menu at the top to locate the specific webpage related to the Chronic Fatigue Syndrome, and then by reading the first few lines to find the link to the paper.

Competing interests: I developed the design principles based on my own experience, for safely conducting research into chronic fatigue and exercise at the South Australian Institute for Fitness Research and Training in 1982

Maxwell Allan Banfield, publisher

No affiliation, Unit 6, No.6 Hartman Ave., Modbury, South Australia

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3 October 2013

People reading the response by White and colleagues could be forgiven for thinking there were inaccuracies in my letter. I said none of the primary outcome measures have been published as in the protocol.1 This is true. The new primary outcome measures do use data from the same questionnaires; however, altering how an outcome is reported by using a different threshold or method of analysis can be considered a significant change.2

It is true that the investigators did alert readers to some changes to outcome measures; however other outcomes e.g. on safety, were also changed without this being highlighted or explained.1,3

Only 0.26% (10/3774) of the adverse events have been reported with both the intervention and details of the event.3 Moreover, patient compliance was considered to be adequate if a participant simply attended (which could be by phone) 10 out of the 15 sessions. For the six-minute walk test, the chief objective measure, there were minimal improvements recorded for graded exercise therapy, and no improvement recorded for cognitive behavioural therapy, so I question we have good data on the safety of dutifully adhering to these graded activity-oriented interventions, given the abnormal response to exertion in the condition.3

Three of the four elements of the recovery definition in the protocol were
changed.1,4 Two of the new thresholds for recovery could be satisfied by participants scoring worse than at baseline.1,4

Minutes from the trial's steering committee, released via an earlier FOI, show that the criteria for a 'positive outcome' (one of the original primary outcome measures) had been made more demanding, involving a SF36 physical functioning score of 75, in order to ensure improvements were "more than trivial" from a baseline score of 65. The post-hoc recovery criteria required a score of just 60, down from 85.4

References:

1. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group.
Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol 2007;7:6.

2. Evans S. When and how can endpoints be changed after initiation of a randomized clinical trial? PLoS Clin Trials 2007;2, e18.

3. Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME 2011;19:59-111.

4. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med 2013; published online 31 Jan.

Competing interests: I work in a voluntary capacity for the Irish ME/CFS Association

Tom Kindlon, Assistant Chairperson

Irish ME/CFS Association, PO Box 3075, Dublin 2, Ireland

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