Emma - Interview 10

Age at interview: 42

Brief Outline: Emma enrolled her son in a clinical trial for the Ketogenic Diet when he was aged seven years. She says it is the best thing to have happened to him. Matthew is now off his Ketogenic Diet and Emma says it has changed all their lives for the better.

Background: Emma is aged 42 years, divorced, White British and mother of two children. Her son has experienced seizures since the age of nine months and was diagnosed with Dravet Syndrome at the age of 14 years. Emma set up and runs the Charity Matthew's Friends.

More about me...

 Emma aged 42 years is divorced, describes herself as White British and mother of two children ages 15 and 13 years. She gave up her work to take care of her son who has experienced seizures since the age of nine months and was diagnosed with Dravet Syndrome at the age of 14 years. 

 

Emma got involved with a clinical trial because her son’s epilepsy wasn’t being controlled with medication. Life was pretty miserable for him and for them as a family. Emma tried several things to help Matthew’s condition but nothing seemed to work. When Matthew was aged two years she came across the Ketogenic Diet which is a dietary treatment for intractable epilepsy. However, at the time there was little support for the diet and little medical evidence, and as such it was considered that drugs were the best option for Matthew. It wasn’t until Matthew was coming up to his seventh birthday and the ‘cupboard was bare’ as far as other treatments that she began to again explore the Ketogenic Diet. By coincidence, a clinical trial was being conducted at a hospital in London, and Emma jumped at the opportunity that her son might be able to take part. She says it is the best thing to have happened to him. Matthew is now off his medication and Emma says it has changed all their lives. 

 

Emma had previously been involved in clinical trials so had some basic understanding about how they worked, she also realised that as the trial was a randomised controlled trial, that Matthew might be allocated to a control group. However, she was prepared to take this risk and wait for the treatment than continue as they had been doing for nearly seven years. She also knew that being on the trial, Matthew would be closely monitored. So for Emma this was the best option all round. Fortunately, Matthew was in the treatment group, which meant he could start the diet immediately. Emma says that within two weeks Matthew was showing signs of improvement, the number of seizures he was experiencing weekly was markedly reduced. Within eight months of being on the diet, Matthew had been weaned off all his medication.

 

Because of the nature of the diet and the research requirements, Emma said it had made her focus on her son, on the treatment, the difference it was making and as a result actually felt more in control than she had when Matthew was on medication. Although the dietary regime was rigid and took a while to adjust, and required her to be very organised, she felt that it had all been worth it. Her son is now off his medication, is happy and at the age of 15 years continues to live with her and her daughter at home.

 

Emma is now the Chief Executive Officer of the Charity ‘Matthew’s Friends’ that helps to raise money to continue research into the Ketogenic Diet and support other families whose children have epilepsy. She feels it is important to get medical evidence to support the benefits of the diet so that other children can be helped. In terms of advice to other parents who may be thinking of enrolling their child in a clinical trial, Emma recognises that it may depend on the type of clinical trial but he would always consider it because they are very closely monitored and have to adhere to very strict rules. Her only regret is that the Diet wasn’t available when Matthew was younger, but understands that seven years ago the diet may not have been of benefit to Matthew as it has only been through continued research that the diet has improved and more is known about it.

 

More research is needed into diets for children with epilepsy as well as research into the causes...

 I’ve discovered that that the beauty of this trial, this one trial is that we’ve finally got class one evidence for this. There was a lot of anecdotal evidence, there was a lot of, you know, you know reports written. But not this class one evidence that these doctors so desperately want. But now because we’ve got that, never again can a doctor turn around and say there is no clinical evidence. There is, there is clinical evidence this diet works. So that has dispelled that. And it has made a huge difference globally. That trial that [the] Professor led is, has gone around the world, and it has benefitted a lot of, a lot of the families and a lot of the doctors because all of a sudden people are taking notice. So there are sound clinical trials I think, that make a huge difference, and this was one of them. This has changed opinions. There’s still a long way to go. 

 

Emma's son was randomised to receive the diet straight away. Some parents were in the control...

 The clinical trial that Matthew was part of was to test or prove the efficacy of these Ketogenic diets. There are two versions of the Ketogenic diet. There is the classical Ketogenic diet and there is the MCT version, which is the Medium Change Triglyceride diet which is where there, there are different types of fat given. So you’d have long-chain fats more for the classical diet, and then the medium chain. So with these two versions, they were testing which one was better because there was a lot of information out there. They were saying that maybe the MCT diet wasn’t as good.

 

Now in order to prove the efficacy of the diet overall they had a control group for three months. So when you went in on your initial appointment you were randomised, by a computer to either the control group or the diet group. So the control group would have to fill in all the forms, and do all the seizure diaries and everything else, but and they, no treatment would change for three months. And then eventually they would start either one of the diets, and they would be randomised to either the MCT or the classical. Now Matthew wasn’t randomised to the control group so he didn’t have to wait three months to start the diet. And he was randomised by the computer programme that did it. And he was randomised straight to the classical Ketogenic diet.

 

Emma was keen to take part in a trial for dietary changes in children with epilepsy, not only was...

 And my son’s then neurologist turned round to me and said, “Well, funnily enough my colleague has just started doing a clinical trial on using this diet.” So I immediately jumped at it and they tried sort of explaining what the clinical trial was and I was kind of, I didn’t need it explaining to a certain extent because before I’d given up work to have Matthew or when Matthew had started seizing, I was actually a clinical trials monitor, I was, I’d worked in monitoring like medical products so I was aware of how closely monitored people were on clinical trials. So to me, it was a huge benefit because I had an inside knowledge that it was a clinical trial and I knew Matthew would be very closely monitored. So if I was going to do this diet that I’d been told was disgusting and horrible and all the rest of it, then at least I knew he would be very closely monitored by doing it, so I was even more keen. To me it was a big plus factor because it was the treatment I wanted and it was part of a trial. 

Emma understood why some parents would be upset to be in the control group.

 The clinical trial that Matthew was part of was to test or prove the efficacy of these Ketogenic diets. There are two versions of the Ketogenic diet. There is the classical Ketogenic diet and there is the MCT version, which is the Medium Change Triglyceride diet which is where there, there are different types of fat given. So you’d have long-chain fats more for the classical diet, and then the medium chain. So with these two versions, they were testing which one was better because there was a lot of information out there. They were saying that maybe the MCT diet wasn’t as good.

 

Now in order to prove the efficacy of the diet overall they had a control group for three months. So when you went in on your initial appointment you were randomised, by a computer to either the control group or the diet group. So the control group would have to fill in all the forms, and do all the seizure diaries and everything else, but and they, no treatment would change for three months. And then eventually they would start either one of the diets, and they would be randomised to either the MCT or the classical. Now Matthew wasn’t randomised to the control group so he didn’t have to wait three months to start the diet. And he was randomised by the computer programme that did it. And he was randomised straight to the classical Ketogenic diet. 

 

But the families that came along after that were going on the clinical trial; I think they had a more difficult time. They were like, they had to go through things in more detail, and some of them were very disappointed that they went to the control group. And I could understand that, because they’ve got children who are very sick with seizures, that are having a lot, and they don’t want to wait another three months. You know, they’ve got in their heads, “It’s a new treatment we want to start it now.” So that was frustrating for some. And it was kind of coaching them through that. I was quite lucky. 

 

With some of the parents that were frustrated about going into the control group, that, I was quite fortunate because I was able to chat with them on the phone and go, “Listen, this is important because this could affect the results, and this is why. You still will get the diet, but in the meantime prepare yourselves. Prepare,” you know. 

 

And I basically had written up everything that I did before the diet. What I felt useful, what I’d not, and that’s what I put on the site, and that’s what I sort of coached parents through. So I was I was luckier than most because I knew what it would entail. 

 

Yeah because as you say some of the other families I spoke to, they were in the control. And then some weren’t happy with the version of the diet they got. That was the other problem. Because they’d read a lot of literature, or, or the book that had come out from the Americans who don’t use the MCT version of the diet, and only had had bad experiences of it with earlier trials where children had had stomach problems and this kind of thing. But actually when you look closely it was because too much of the MCT was being given, they were giving it in too high a percentage. Whereas part of the trial, they were starting it off at a much lower percentage so you weren’t getting as many problems. Well not nearly as many problems.

 

So some of them had this fixed idea that the classical diet was the best diet, and that’s the one they wanted. So when they got randomised to the MCT version, again some of them got quite disappointed and I have to admit when Matthew got randomised to the classical, I was of that mind set as well and I thought, “Yes, I’ve got the classical, it’s the best one.” It wasn’t necessarily the best one, but it was just the one we knew the most about that had been used in America a lot. And I have to say after three years on the classical diet I changed Matthew over to the MCT diet and it was a doddle. It was really easy to use and Matthew loved it and it wasn’t a problem at all. And now I very much advocate both diets. And the MCT one is great for older kids and teenagers because it actually allows far more carbohydrates because of the different fats that you give, and how it’s metabolised.

Emma's son continued with the diet after the trial had ended. Having a good relationship with her...

 After the trial was up at twelve months I refused to leave our neurologist. I wasn’t going back to the old neurologist because as you can imagine I wasn’t too happy. And I realised the difference of having a good relationship with your neurologist, somebody who would listen and work with you and not just dictate to you. And Professor is very much one of those where “Okay, let’s work together” and I you build that relationship where you go “Yeah I trust what you say now.” And I actually I’ve got to the stage now where I don’t trust anybody else and I will run everything past her before I even sort of think about it. 

 

Yeah. He was, when we took him off the diets two, just over two years ago, the seizures didn’t come back, but we found that the one’s that he had left did increase in length a little bit. So we put a tiny, tiny bit of med in, to just bring those down a little bit. It wasn’t even classed as a therapeutic dose but it seemed to help Matthew and there were no side effects. 

 

That was more difficult than anything else. I felt like we were taking a step back. But when you sort of weigh it up to where he was to where we are now, it was a little, and it was you know Professor was real careful with it, she knew my feelings on it after we’d been so badly burnt beforehand. So it was always mono-therapy, never any more. A tiny bit to start off really small, only go to the level we need. But two years on and I’ve weaned him off that as well because he only seemed to need that for a while. And then he started to get the side effects of the med again. All of a sudden we started seeing a load more mouth ulcers, the drooling came back. And he was a bit spacey. I’m like, “This isn’t him.” So it was wean off again. And he’s not needed it, so now he’s off it all again.

 

Sometimes with these children with these difficult epilepsy syndromes they may just need something to change, or, and maybe that’s just what he needed for a while, until he got used to coming off the diet. Because his metabolism had changed for so long, that coming off was different for him. But he’s as happy as Larry now.

 

She wishes her son had had the diet earlier, but the clinical trial was important to assess...

 I regret not pushing harder for the diet, but I don’t think it was available, and I think it was being done badly anyway from, from families that I’ve spoken to, that were that had tried the diet beforehand, said, “Oh no, we tried that and it didn’t work.” And I’ve said, “Well what did you actually have to do?” When I’ve looked into it closely I’ve realised the diet was done very badly. And that’s why it couldn’t have worked. There was a plethora of drugs on board as well as the diet. 

 

There was like, so I think if I’d got it done earlier it may not have benefitted Matthew, maybe we wouldn’t have had this, I don’t know. It’s very difficult, it’s very difficult. I still would have liked it earlier to be quite honest, because he responded so well. 

 

I’m pleased to say that the results of the trial, there was 149 children enrolled in the trial altogether. And the results of the trial were published in 2008. And it showed no difference between the two diets; both were just as good as one another. And it did show that the diet, it proved the efficacy of the diet for once and for all. It was class one evidence. And it’s equivalent to any new anti-epileptic drug that’s on the market.

 

Even though there were follow-up meetings, parents sometimes still felt a bit abandoned at the...

 The trial, like I say at the end of the twelve months you were supposed to go back to your own local centre and a local dietician was supposed to liaise with the trial centre, but look after and monitor the child. Dieticians around the country wouldn’t touch it. They just went, “Ketogenic Diet – not a chance. I’m not touching this.”

 

So a lot of us were left in the lurch. From my point of view I was happy, because it meant I stayed where I was and with the team I’d got. But a lot of other families were, were stuck or they, in the end the trial centre had to keep the majority of the patients. But just not on a trial basis. So they didn’t have to come in every three months. So then the follow ups went down to every six months, but you could still phone in and get telephone or e-mail support. 

 

But yes there was still regular follow ups afterwards. And if you had any problems you would phone in. But at the end of the trial you would just finish all the paperwork. It was finished with another EEG, and then they would compare that to the beginning one and that kind of thing.

 

Emma didn't mind the hospital appointments and the monitoring; she knew her son was being closely...

 But as far as the clinical trials side of it was concerned there was a lot of paper work involved, obviously consent forms had to be signed, I was more than happy with this, the team explained everything that was going on, they explained that I would have to go up to the hospital and visit and take Matthew in for bloods and EEG’s and all the tests that would be that go along with it. And I was more than happy with this because again I was just happy we’d be so closely monitored. It was it was good in one respect because it really made you focus on your child. For me, it sort of focused on the treatment for Matthew, how he was and the difference it made because I had to fill in seizure diaries and even though I had been doing it before I was now watching absolutely everything and it made me very aware. I felt actually more in control than I had done because it was very it was very rigid, I had to complete this, I had to do that. 

 

So the commitment and the control side of it I liked because it was very organised, it was very you know, strict in how you did it. So it was a very positive experience for me and because it was a dietary therapy as well. So I was very pleased with the way it was done. I was very pleased obviously with the results that it had on Matthew, completely changed all our lives. So I had nothing really but the positives that I gained from our experience within the trial.

 

Publication of results has certainly helped to increase awareness of the assessed diet, but still...

 It's, and some centres are very good in all fairness, and they’ve certainly got better since this trial has been published. They will turn round and say, “Well there is this diet you can have. Unfortunately there’s a long waiting list, or there’s this or that,” but some centres are a hell of a lot better at actually acknowledging there is this treatment now. 

 

There are some centres that really, oh not centres, doctors. This is individual. It’s a whether they like it or not, whether they want to pursue it or not. Whether they feel it’s a valid treatment or not, I don’t know, I still can’t get behind the mentality of that one. As far as I’m concerned it can help a lot of children with intractable epilepsy and normally you will see a result within three months. And three months is not a long period of time, so I can’t understand why this isn’t being used more. Apart from lack of resources, “We need a dietician,” etc, etc. But when you’re putting kids forward for a surgery such as VNS, which is more expensive than a diet, then I, that argument goes out the window as well. There is something to do with charging back on the costs, so do we start treating patients or are we just interested in our budgets, but that’s just something that’s with me.

 

Starting the trial in the school holidays was best for Emma and her son, so they had time to...

 And then after two weeks, two weeks of being enrolled in this trial, I must admit I sort of delayed the start of the diet because it was so involved and because there was the paperwork to go with it and because I really wanted to do it right and I’d fought so long to get it, I kind of delayed starting it for a month until, I waited until Matthew had started the summer holidays because he was six weeks at home with me then and I could monitor him; I could watch him every minute of the day. And I cleared all the decks at home, I literally got, I had ironing piles that I got rid of, just everything and I thought, “Right, if I’m going to do this, I’m going to give it one hundred percent.” And that’s what I did. 

 

The diet was daunting at first when you’re given all this paperwork and all these meal lists and I must admit when I looked at it I was like “Ahh, God you’re going to have to be organised with this.” And then the first few days of the trial I think or the treatment it felt like I was in the kitchen kind of eight hours a day, producing these tiny little meals. “And I can’t live like this” but you soon get into the swing of it and Matthew just; and when you see the difference it makes to your child then it just motivates you even more. 

 

So you know we got to the twelve month, the three months part the follow up appointment and Professor turned round to me and she said “What, do you want to continue him?” and I just looked at her and went “ yeah” and she said “Right now we start drug weaning.” And then like I say then the drugs started to come out and I got this beautiful, beautiful little boy left. But the trouble is he’d suffered so much brain damage because of the seizures he’d had before that he’s got scarring all over his brains so he’s very mentally disabled. But saying that you know after six months I got called “Mum Mum” for the first time and even now still at fifteen if, when I go to get him off the bus I get “Mum Mum” and he comes up for a cuddle and he’s so kissy and he’s so flirty. And we were on the trial for a year and we had a three month follow up and we had a six month follow up where he had to have an EEG and I had to submit papers at every one and I had to chart his progress and I had to fill in seizure diaries and food forms and ketone recordings, all those kind of things and it was great.