Feelings about being in a placebo-controlled trial
In some trials (especially Phase 1 and Phase 2 trials) everyone taking part will get the treatment. (See ‘Different types of trial’ and ‘Non-randomised trial designs’). However, many trials compare a new treatment with the standard or usual treatment by setting up two groups of people. One group, the experimental group, is given the new treatment. The other group, the control group, is given the standard treatment. (See ‘Feelings about being allocated (randomised) to a treatment group’). If no standard treatment is available, the control group may not be given any specific treatment or may be given a placebo.
A placebo is a treatment with no active ingredient which is designed to appear very like the treatment being tested. By comparing people’s responses to the placebo and to the treatment being tested, researchers can tell whether the treatment is having any real benefit, rather than patients simply feeling better because ‘something is being done’. (See more below about the placebo effect).
The idea of being given a placebo was easy for some people to accept. Comments included, “You’ve got to satisfy the authorities that the drug is capable of doing what it says”, “It was all part of the experiment”, and “That’s how you’ve got to test it”.
Tony is a retired chartered accountant and tax adviser. He is married with 3 grown-up children and 2 step-children. Ethnic background/nationality' White British Jewish.
In the event I realised that I was in fact on the placebo, because there was no possible recognisable benefit derived during the many months on which I was on this trial. And I suppose one can say that the only beneficial side effect is that after the trial per se had finished, all persons who had entered into the trial, whether or not they had been on the original drug or on the placebo, were for several months provided with the actual drug itself, prior to its having come onto the market.
When you started to think you were on the placebo, did you raise that with anybody running the trial?
No. It was totally pointless. There were regular questionnaires which were required to be completed after each session, after each - I forget for how long it went, I forget whether it was a month or two months or what will you. And these questionnaires included whether there was any noticeable effect, what one’s psychological view was, whether one felt - how one felt - whether one felt that one was losing one’s manhood, one’s masculinity, all sorts of things of that nature. They were very interesting psychological questions actually. But it didn’t worry me in any way.
And did they actually confirm to you afterwards that you were on the placebo? Or did you never ask, you just assumed?
It was proven to me when I was given the real drug, because that did have an effect [laughs].
[laugh] Right, yeah, fairly conclusive proof then. When you realised you were on the placebo, did you think about pulling out, withdrawing from the study?
Oh, not at all. If I’m part of a clinical trial I know that it, one has to go ahead with it. One undertakes these things seriously. It’s not a lightly taken decision.
It’s quite important if one is doing a test to see to what extent we know that a particular drug has an impact on the people who are taking it, and you must have a control group who are given a placebo, who are given something other than the drug, against which to compare those results. The fascinating thing of course is the number of times that people on the placebo have satisfied themselves that they have received some beneficial effect.
As Tony explains, he was happy to take part, even though he guessed he was on the placebo. In his case he was offered the active drug at the end of the trial once it had been shown to work. This was also offered to Kate’s husband at the end of a placebo-controlled trial of immunotherapy (grass pollen injections) to reduce hay fever symptoms. Like Tony, he guessed he was in the placebo group, but carried on with the trial, even though it was quite a burden. (See also ‘Thinking about withdrawing from a trial’).
Kate is Operations Director for a charity. She is married with no children. Ethnic background/nationality' White New Zealander.
The main thing with the trial was that we were getting injected with grass pollen or a placebo. So we were randomised to either get the injection with the grass pollen, or get just an injection of nothing, really. And we didn’t know, and the nurse who was running the trial, he didn’t know either. And he had some assistants as well. And so no one knew whether we were on the grass pollen or on the placebo. We had to stay in the hospital for an hour after the administration of the injection, because they explained to us from the outset that one of the possible side effects of an injection of something you’re allergic to is that you go into anaphylactic shock [laughs]. And so they had a doctor always on site and stores of adrenalin. It was a precautionary measure but a quite interesting thought. But it was nice to know that they’d put that level of thought and care into it.
How did you feel about randomisation and the thought that you might be ending up doing all this and be on a placebo?
I think, I kind of thought at the beginning - well, I thought about the odds. Obviously it’s 50'50, either you’re going to get it or you’re not. But I never really thought about not getting it [laughs]. It wasn’t until we were underway and I was clearly getting a local reaction and my husband wasn’t that we thought, you know, that is quite a commitment to make and you’re not actually - well, he wasn’t getting any benefit from it. And they didn’t make it clear at the beginning that they would make the intervention available after, at the end of the trial, if it turned out you were on the placebo. So I think he did quite well to make the commitment the whole way through and follow through on it.
Did your husband eventually take the option of having the intervention?
I think he did - I can’t remember if he did one season or two seasons, but he didn’t do the whole thing. It was just too much of a time commitment. But yeah, he definitely did one, and I think he might have done two seasons. And he did notice a benefit.
Do you think he regrets having been in the placebo arm as a result, or?
I know he was annoyed at the time, because obviously he’d made such a massive commitment to the study and he had hoped he would have got some respite over those summers. But I think he understood the benefit of doing the study, so he was okay with it. And plus there was the benefit anyway of having all these hay fever drugs thrown at you through the summer. So it did actually save us quite a lot of money [laughs].
And how did you both feel when the trial ended?
Probably relief [laughs]. Yeah, it was a big time commitment. It felt good to take part, but it was nice to get our evenings back [laughs].
Kate suggested it might have been better to say at the start of the study that the active treatment – if it was found to work - would be offered to anyone who had had the placebo, as a way of keeping them motivated. This should be stated in the information given to people before they consent to take part, but Kate felt it had not been made clear in their case.
Several people assumed that if they had no change in symptoms they must be taking a placebo. However, this is not necessarily so, as not all drugs work on all patients in the same way.
Sergio is a retired hospital porter. He is divorced. Ethnic background/nationality' White Hispanic.
And they told you, you’d been taking the tablet, not the placebo?
Later on when we finished, when we finished everything.
Did you notice any difference?
Not at all, not at all, not at all.
Do you know what the results of the trial were? Did they--?
Well, they, I suppose they sent us a letter, probably the standard one, quite happy with the results of the trial. And besides thanked us or thanked me, thanked me. They told me, “By the way you have been given a, a proper tablet. You’re one of the, the lucky persons.” Anyway but I can’t say that it was better for my condition, or worse. I never had any difference in my symptoms with this new tablet.
Did they take regular blood tests?
As well, yes. That was part of the trial after – twice, every two, every month we had to go back to the hospital for a blood test. And with a special recommendation, any problem we had to get in touch with the – we were given a telephone number, which - but in my case and I suppose the rest of the other group we didn’t have, in that particular research we didn’t have any problem at all.
But it, presumably they thought it worked for someone if they --
Yes, probably. But in not my case. It was --
And it didn’t make any difference to your blood glucose?
No, no, not at all. No, no, no. No, no, no. So I consider myself, I talked to my GP and he, he said, “Well, probably it’s another tablet, but similar to the one you are taking now.” So probably he, I didn’t ask my GP which kind of tablet was it. But we were given enough information in general from the research. So we accept, because we knew the situation that may happen. We were aware and we were told about that.
Equally, people who are taking a placebo may sometimes experience improvements in their health. This is known as the placebo effect or placebo response. We still do not understand exactly why it happens, but it seems that believing a treatment will help can result in real physical changes. This is why new drugs are often compared against a placebo – if the patients on the drug do significantly better than those taking the placebo, it suggests the new drug really has an effect. If people were only given the new drug, we could not be sure if improvements were simply due to a placebo effect.
Charles is a retired chief engineer. He is married with 5 adult children. Ethnic background/nationality' White British.
One thing that I’d like to go back to is that this was going to be a placebo control trial--
-- and what your thoughts were about being randomised and perhaps ending up in the placebo group - would that have mattered to you?
I thought about it and I think the answer, it didn’t matter to me from the point of view of taking part in the trial. I think it would have been interesting to me to know how I would react in that situation, because they do say that you are - how shall we say - influenced by, you know, your mental state at the time as much as anything else. So I’d be interested to know whether I was one of those people that was influenced or not. So it didn’t concern me, and I did think about it and I made a positive decision to go ahead regardless.
And you wouldn’t have known during the trial whether you were on the placebo. Do you know if they’d have told you at the end?
They would have told me, I think when I asked a question of the doctor at the time, they would let you into it at the end, obviously not during the course of it.
They would have told you. I would like to think I would have been aware [laughs], because I actually asked the question what happens, you know, if things weren’t happening, because, you know, it’s these moments when they come you want to take advantage of them [laughs]. And if it wasn’t working then I’d want to take some other form of help and basically they said you could drop out of the trial at any stage, and so that satisfied me on that particular question.
Age at interview:
David is a full-time student. He is single.
And did you notice any improvement in your asthma during the course of it?
Asthma’s a funny thing because it’s partly self-perpetuating. Because you panic when you’re breathless, it’s sort of cumulative... There may have been a placebo effect on me because I may have wanted to believe that it was having a beneficial effect on me. As I recall, I thought that my symptoms had improved. That may have been because I was working near the coast and I’ve often found that being near the coast the symptoms aren’t as bad. When I was living in New York many years ago, I didn’t have any symptoms at all, and I thought that’s obviously because the sea air is just coming straight off.
And what about the peak flow readings? Did they show any sort of objective change?
I think they did. I mean, I wouldn’t have been the one to know that, because I was simply posting the paperwork off to the doctor at the [specialist hospital]. I think he pointed out to me at the end of the trial that there had been a change, so yeah. And then he told me that I’d been on the lower dose, so that maybe makes sense, yeah.
How do you think you’d have felt if you’d been on the placebo when he told you at the end?
I would have found that very interesting indeed, because with regard to the self-perpetuating element of it, you know, it is partly self-perpetuating, that if the symptoms start you think, “Oh I’m asthmatic.” And then you can sort of, it’s a self-fulfilling prophecy. You can make yourself even more asthmatic than you would otherwise have been. I mean asthma is a bit of a mystery, I think. I think it still is, actually. I don’t think they entirely understand it.
No, I would have been genuinely interested, because I am genuinely interested in the condition and I would’ve been very interested to find out if there was a psychosomatic element to my condition. Yeah, I would have been very interested, very interested indeed, yeah.
And before the trial took part when you were being randomised, what were your thoughts at that point about whether or not you might end up on the placebo? Did it worry you if you were in the placebo arm at that point?
When I started I think I would have been disappointed if I was on the placebo, because I would have thought to myself, “Well, that’s been a bit of a waste of time, and I have just done it for the money.”* And I wouldn’t have found out anything about my condition, although I don’t feel like that now. As I’ve just said, I think I would have been very interested to learn that I was on the placebo, especially if there’d been a change in my peak flow throughout that time, because that would have confirmed the psychosomatic element of it, and that would have been very interesting.
* FOOTNOTE' David was in a trial where every participant was paid a generous fixed sum for expenses. (See also ‘Time commitment, money and other practical issues’).
However, some people we talked to were unhappy with the idea of a placebo-controlled trial, usually because they were concerned that they would be denying themselves the possibility of a treatment which might work for them. (Of course, they might also be avoiding the side effects of a treatment which might not work for them).
Anton is an auditor. He is single. Ethnic background/nationality' Sri Lankan. (You can see more of Anton talking about his experiences of depression on our site on Mental health' ethnic minority experiences, Interview 13).
What kind of trials have you been in, what kind of treatments have they been comparing, can you remember?
Well, what it is normally, it’s some sort of a tablet. They said, “Well, we’ve got this new tablet, so we’ll try it out.” As mine is a mental problem, it’s normally done by a mental hospital, or an organisation like the Institute of Psychiatrists. They’ll advertise and I go along and sit for interview and they will say to me “Well, this is the tablet, these are the side effects.” Some will say, “No, you will be given this tablet.” Some will say, “No, it’s a blind study. You won’t know whether you get the actual tablet or the placebo.” I wasn’t very keen to take the placebo, because already I’m suffering. I don’t want the ruddy placebo. Then I shall tell them quite up front. “No, if you’re giving the real tablet I will take it, but if you’re going to give me the placebo, goodbye.” I’m only volunteering because I’m suffering. I’m not volunteering for the money.
So have you ever taken part in a trial where there’s a placebo?
Oh, whenever they told me I just walked out. I’ve only taken part in trials where they said they’re going to give me the actual medicine.
In a well-designed trial, a treatment should only be compared against a placebo if no-one is being denied a standard treatment known to be helpful. Polly was not opposed to the principle of placebo-controlled trials, but she decided not to take part in one herself because she thought it did not meet this requirement, and was therefore unethical.
Polly is a journalist. She is widowed, with 4 grown-up children. Ethnic background/nationality' White British.
I had a lumpectomy, had the bit taken out, and then I was asked if I would like to go onto a clinical trial. I’m strongly in favour of clinical trials. I think they’re the only way you can ever find out what works and what doesn’t, and I think it’s very important. So in theory I was strongly predisposed to do that, would want to help in any way I could. But when it was explained to me what the trial involved, I had deep doubts about it. The trial, basically I was being asked to be randomly put into a group of people who would not have tamoxifen, which was an anti-breast cancer drug, or into a group that would have tamoxifen, and it would just be random. So if I agreed to go on the trial I might well fetch up in the group that didn’t have it. I’d have a placebo, I’d have a little white sugar pill, and I would never know whether I’d actually had the tamoxifen or not. I knew a bit about tamoxifen and a bit about breast cancer, partly because it had been in my family. And anyway it’s the sort of subject that I was writing about and interested in. So I did a bit of investigation, rang round a few people, talked to a few people. Tamoxifen had already been widely used. There had already been a very large trial in the United States, which had shown that it seemed to have a very strong positive effect. It seemed from this large trial as if it might improve your chances of not recurring, not getting another episode of breast cancer, by about 30 per cent, which is, you know, a very strong positive effect. So I then became very worried at the idea of going into a trial where I might not be given it, and I might never know whether I’d had it or not. So I talked to the doctors about it and they said, “Well, the trouble is, you know, we do need more research. We do need more evidence to be absolutely sure. That was American research. We need British research. We need to find out more details.” But when it came to it, I felt that we already did know pretty much. And every doctor and other people and other sources I looked at, everybody was really positive about tamoxifen.
That particular hospital already had quite a lot of people on it. And I thought to deny myself tamoxifen for the sake of a, you know, just a rather academic study, I thought that the disbenefit to me would be much greater, really, than the extra little bit of knowledge that would be acquired on top of the knowledge they already had. I felt badly about it because, you know, obviously we need more and more knowledge as time goes on about exactly what drugs work and how well they work. But I just felt on this occasion that we already knew a lot.
Age at interview:
Polly is a journalist. She is widowed, with 4 grown-up children. Ethnic background/nationality' White British.
Oh, if tamoxifen had only been available as a clinical trial I would certainly have gone for it in the hope that I might have had it. Of course I probably would have been more nervous, because we also at that early stage wouldn’t have known whether or not it might have other alarming side effects. But I think if the doctor had said, “Well, you know, we have high hopes of this drug” I think I would have gone into it, though I think it does make you uneasy not to know, and never to know, whether you had a drug or not. But certainly if that had been your only chance, I’d have taken it.
I feel that the placebo effect is so well understood now. We all know. We are all easily fooled [laughs]. And, and doctors make us feel better, and being given pills and treatments make us feel better. And whether it’s some homeopathic bit of nonsense or whether it’s a, a genuine drug there is that plus effect. And I accept that about myself. So I would, I wouldn’t be worried about the idea of taking a placebo. I suppose you always feel uneasy about whether you’re missing out on a drug that might do you good. Or alternatively of course [laughs] you might be feeling worried about taking a drug that nobody knows quite yet what its side effects might be. I would want to look into it very carefully. I don’t see anything wrong with the principle of it, but as long as people, patients really, really know what they’re getting into, understand why, and think that the trial is worth it, that the knowledge they’re going to get is worth either giving or denying you the chance of a particular drug. And I think in the end that’s something you have to weigh up carefully. I think I would suggest all patients always try and get a second opinion, go back to their GP, talk to somebody else, these days, you know, look up on the Internet for all of the valid information from responsible sources that they can find. And there is a lot of information around now.
As Polly pointed out, you may still feel uneasy wondering if you were “missing out on something” and this may be harder to live with if you have a life-threatening illness. She commented elsewhere in her interview: “I think I would always have felt uneasy, say [the cancer] had recurred, and I’d never known whether I’d just been taking a sugar pill or whether I’d taken something that might have given me that 30 per cent extra chance.”
The idea of possible regrets and always wondering ‘what if?’ was a common worry about placebo-controlled trials in serious illness. Several people who had willingly volunteered for other types of trial felt differently about placebo-controlled trials.
Judith is an NHS administrator. She is married with 1 adult stepdaughter, and a12-year-old son. Ethnic background/nationality' White British.
What would you think about placebo trials? Would you be willing to even think about it?
Well, my cousin’s husband has got MS and it’s very, very progressed now. But I know he’s been on, he was on a clinical trial and he was on a placebo, and I think he was really miffed about that [laughs].
That’s quite interesting, so that experience in your own family might make you think--
--differently about it?
Yes, it would. It would. I don’t think I’d like it at all, actually.
That’s interesting. Even though you’re, I mean most of the, what you were taking part in research for was to benefit other people really rather than benefiting yourself, apart from the two weeks, obviously.
But there’s something different about a placebo trial for you.
Yes, definitely, definitely. Especially if cancer is involved. I think that, I think that’s an issue as well. If it was to test in-growing toenail creams or something like that then, you know, or something - I mean it’s very painful but, you know, something that wasn’t life threatening. But as soon as somebody says, “Cancer” it changes everything. You just, it’s like having an intruder in your house, you just want it gone and out and finished with, and I just want to get on and not have it. I mean, I’m not in a state of complete panic or anything like that. I have complete confidence that this will sort it out and it’ll be gone. But then again there’s so many different types of cancer, and I know some people are on this ‘watch and wait’, so maybe, maybe that would be different.
Age at interview:
Jenny is a student nurse, divorced, with 1 adult son. Ethnic background/nationality' White British.
If I was experiencing a particular condition, is there anything I wouldn’t want to get involved in? …No, there isn’t. If I’ve got the condition and I want it to be treated... mind you, I’d have to be absolutely convinced, like with an aneurysm, I’d have to be convinced that it was going to treat me. I wouldn’t want to just sort of sign up for it because, you know, it was going to pay me £20, or something stupid like that. I would want to - it’s the quality of the care that I would get that would be vital, and the background knowledge that I was going to be given that would be vital… especially for aneurysm.
So for instance a placebo-controlled trial, how would you feel about being offered that, where you might be randomised to getting a placebo or you might get the treatment?
I wouldn’t want to do that - if it was so vital that I had the treatment. For - I can’t even think in what context I would, it would be okay to have a placebo rather than the actual product, if it was going to work. Because if I, even if I’d scratched myself, I wouldn’t want to have a placebo dressing and then someone else gets, you know, an all -singing all-dancing dressing that heals them in two days, or something like that, so.
I suppose the problem with trials is by definition you don’t know if the intervention is actually going to be any better than the placebo. But there’s something that worries you about…
There is, yeah. Because, I think, of the fact that I’ve had this neurosurgery*, I’m thinking, you know, I wouldn’t want to be involved in anything that was potentially - I mean, okay, fine, if all the products are going to sort me out, or potentially going to sort me out - mind you, placebo might as well, mightn’t it, because it might just sort of, you know, the fact that you’re taking something or you’re sticking something somewhere might just be the thing that you need to get you through. I don’t know.
But for that to work you’ve got to believe it’s something that’s actually an intervention?
Yes, but as well I would - would I know the difference? I probably wouldn’t know the difference, if I wasn’t told it. I’d think, “Oh this, you know, I’ve got to take it tds” [three times a day] or whatever, and that’s it, and I’ll do it. You know, I’m very regular with what I do, you know. I’m very sort of emphatic about times and all this sort of thing, and if I thought it was going to work I’d blooming take it.
* FOOTNOTE' Jenny has recently had surgery for a cerebral aneurysm (an abnormal bulge in an artery in her brain).
However, several people pointed out that we do not know what side effects there might be from taking an active drug. Joanna wondered if most people understood that taking a new treatment might be quite risky, so getting the placebo could be better. There were several mentions of the Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.
This had affected people’s views about the balance of risk, although it is important to note that ‘First-time-in-humans’ studies are done precisely because we need to find out about possible risks and side effects before using the treatment more widely. Most of the people we talked to took part in trials of treatments which had already been tested in humans.
Sergio is a retired hospital porter. He is divorced. Ethnic background/nationality' White Hispanic.
Were you worried about being given the placebo and not getting the real drug?
Not at all, at that, at that time. Later on, one or two years ago, perhaps you know, there was an ex-, a research in London, I think it was in London, and some people, they were affected for some experimental tablet. It was a famous case.* So since then of course I, I was more comprehensive, more aware that I have to be, to be careful if I participate in other, another research. But until that moment I trust completely. I think it was a gen-, a mistake, understandable, whatever the result’s awful. But I suppose it’s part of the research in general, mistakes, everybody can make mistakes.
So in a way that’s made you more worried about the thought that you might get a dangerous drug rather than getting a placebo? Because sometimes people --
-- worry the other way, that they’re not going to get something that might help them.
Yes. I suppose so. And, what can I say? I thought at the beginning when this problem happened with the mistaken, mistaken tablets, medicine they were giving to some people, well, they, I do remember that those people were in hospital for the trial, I think for two or three weeks, some time. But I’ve never been in hospital for a trial, just some couple of hours or whatever. Or only hospitals that’s in particular areas, not to stay for more than four hours, to say. And, and the, the only once, the time that I participated in this research with tablet, I suppose I was completely, I trust. I trust, I trust completely the research. But, as I say, with this other case later on I am, I could be more aware to make sure. But at the same time I’m sure the, the people who make, organise the trial or the research, they have to be more careful because it was a, this situation affected everyone, the people that could participate in the research and the organiser as well. Loss of trust, something like that. So, but in general I do support research, investigation, whatever.
And the idea of being randomised doesn’t worry you?
No, no, no, not at all, no.
*FOOTNOTE' Sergio is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. ‘First-time-in-humans’ studies are carried out precisely because we need to find out about possible risks and side effects before giving the treatment more widely. Most of the people we talked to took part in trials of treatments which had already been tested in humans before. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.
Julian was in a Phase 1 trial, so he was especially conscious of the balance of risks and benefits. However, from his personal experience of seeing how the drug has worked for him, he would find it hard to see how it could ever be compared to a placebo in future.
Julian is a research scientist and author, married, with 3 adult children. Ethnic background/nationality' White English Jewish.
It’s hypothetical and it’s probably difficult to, to answer, but if you were further down the line--
--and this was a phase three trial--
How would you have felt about randomisation and the possibility of being allocated to a group that might not be getting this particular drug?
Well, knowing what I know now [laughs], I would be very uneasy about being randomised to the placebo treatment, because I think there’s strong evidence the drug brings a benefit which you couldn’t achieve any other way.
But, so if I were to be in a… my sister always made the point that for most trials the ideal thing was to be in the placebo branch of a randomised trial, because then you got very close monitoring from good medical staff and you were likely to do well because of that. And most drugs, trial drugs, didn’t do you all that much good and might hurt you, so [laughs]. However, in this case it’s not like that, I think.
*FOOTNOTE' This raises difficult questions about the level of evidence needed before a drug can be said to work. Julian’s personal experience had convinced him the drug was effective in his case. However, although his clinical team felt the drug was promising they also felt there was not yet enough evidence, so they needed to test the drug further in a Phase 2 trial. Sometimes, even when Phase 1 and 2 trials suggest a new drug is promising, when it is compared in Phase 3 trials with the standard treatment in a much wider group of people the results do not show it makes a significant difference. (See ‘Non-randomised trial designs and other research’ and ‘What are clinical trials and why do we need them?’).
This raises difficult questions about the level of evidence needed before a drug can be said to work. Julian’s personal experience had convinced him the drug was effective in his case. However, although his clinical team felt the drug was promising they also felt there was not yet enough evidence, so they needed to test the drug further in a Phase 2 trial. Sometimes, even when Phase 1 and 2 trials suggest a new drug is promising, when it is compared in Phase 3 trials with the standard treatment in a much wider group of people the results do not show it makes a significant difference. (See ‘Non-randomised trial designs and other research’ and ‘What are clinical trials and why do we need them?’)
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