MD, PhD, FMedSci, FSB, FRCP, FRCPEd

This is a question which I have asked myself more often than I care to remember. The reason is probably that, in alternative medicine, I feel surrounded by so much dodgy research that I simply cannot avoid asking it.

In particular, the co-called ‘pragmatic’ trials which are so much ‘en vogue’ at present are, in my view, a reason for concern. Take a study of cancer patients, for instance, where one group is randomized to get the usual treatments and care, while the experimental group receives the same and several alternative treatments in addition. These treatments are carefully selected to be agreeable and pleasant; each patient can choose the ones he/she likes best, always had wanted to try, or has heard many good things about. The outcome measure of our fictitious study would, of course, be some subjective parameter such as quality of life.

In this set-up, the patients in our experimental group thus have high expectations, are delighted to get something extra, even more happy to get it for free, receive plenty of attention and lots of empathy, care, time, attention etc. By contrast, our poor patients in the control group would be a bit miffed to have drawn the ‘short straw’ and receive none of this.

What result do we expect?

Will the quality of life after all this be equal in both groups?

Will it be better in the miffed controls?

Or will it be higher in those lucky ones who got all this extra pampering?

I don’t think I need to answer these questions; the answers are too obvious and too trivial.

But the real and relevant question is the following, I think: IS SUCH A TRIAL JUST SILLY AND MEANINGLESS OR IS IT UNETHICAL?

I would argue the latter!

Why?

Because the results of the study are clearly known before the first patient had even been recruited. This means that the trial was not necessary; the money, time and effort has been wasted. Crucially, patients have been misled into thinking that they give their time, co-operation, patience etc. because there is a question of sufficient importance to be answered.

But, in truth, there is no question at all!

Perhaps you believe that nobody in their right mind would design, fund and conduct such a daft trial. If so, you assumed wrongly. Such studies are currently being published by the dozen. Here is the abstract of the most recent one I could find:

The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients. 

The key sentence in this abstract is, of course: complementary medicine intervention improved quality of life of breast cancer patients… It provides the explanation as to why these trials are so popular with alternative medicine researchers: they are not real research but they are quite simply promotion! The next step would be to put a few of those pseudo-scientific trials together and claim that there is solid proof that integrating alternative treatments into conventional health care produces better results. At that stage, few people will bother asking whether this is really due to the treatments in questioning or to the additional attention, pampering etc.

My question is ARE SUCH TRIALS ETHICAL?

I would very much appreciate your opinion.

12 Responses to Where is the line between meaningless and unethical research?

  • Silly, meaningless and unethical. Not just because the two sets of patients are treated differently, but also because such “studies” are intended to deliberately influence public perception of useless treatments

  • It seems that the primary reason for these studies it to justify the introduction of additional profit centers into a practice. They can also be the basis for demanding insurance reimbursement. If insurance companies do not pay the studies can still be used for marketing directly to the patient who is less likely to know that real evidence is not there. When healthcare is a business the free market will find a way to maximise profits. It is the American way which has given us a system second to none (somewhere around 38th). Your current Prime Minister seems to be determined to bring these benefits to the UK. Ethics? I don’t see it listed anywhere on the bottom line. Must not be important.

  • Edzard’s article “Want to legitimise your bogus therapy? Here is how”[1] made it very clear to me that B+C versus C study designs[2] are perhaps the best means to serve an agenda that wishes to legitimise B and hide the fact that B is bogus. This in itself is, I think, not just unethical, it is tantamount to committing (or knowingly participating in) health fraud.

    1. http://edzardernst.com/2014/09/want-to-legitimise-your-bogus-therapy-here-is-how/
    2. Where B is the bogus treatment; and C is the conventional/orthodox treatment.

  • Doesn’t it come down to ‘qui bono’? If a purveyor of quackery funds the study, or a range of visibly branded quackery products and/or ‘services’ are used, then it isn’t a study, it’s a marketing exercise, and therefore unethical.

  • I guess I am more than a little puzzled as to why you, Edzard are so determined not to have patients in extremis feel better, have a positive outlook, and look upon their terrifying condition and their often painful and unpleasant treatments with good heart. Even if creating such an atmosphere is not beyond the natural capabilities of doctors, it seems as if you want it to be.

    • @ank,
      Not at all. No one wants the women to not feel better, all I would like is that they “feel better” because they are “better”, not because of the spurious involvement of some nonsensical witchcraft that is a placebo. What is the point of “feeling better” if your health has not actually improved?

      • Great scott, one’s own perception of it is everything. Otherwise you are just being a bully. No wonder patients sometimes look askance at doctors if these kinds of attitudes inform their care. “It doesn’t matter what you think you feel I’m telling you are in pain.. And I am not going to give you any special attention because you are just deluded about the effects it has..” !!! I guess some of us have a long trudge out of the dark ages still.

        • I guess some of us have a long trudge out of the dark ages still.
          yes perhaps you!
          to improve subjective symptoms, quality of life, well-being etc. we need no quackery, we can do this with legitimate evidence-based therapies and good doctoring too.

        • @ank ank
          “Great scott, one’s own perception of it is everything.”
          Are you seriously saying that a person’s health is only a reflection of their “perception” and not of an objective measure of their health? To extrapolate, if a person is cured of cancer, if they think they still have, then that is all that matters? I am gobsmacked.

          “Otherwise you are just being a bully.”
          This is just silly. It makes no sense and has no foundation. Sure, the “bully” claim is very popular these days but try it where people may fall for it; it won’t cut it here though.

          “No wonder patients sometimes look askance at doctors if these kinds of attitudes inform their care. “It doesn’t matter what you think you feel I’m telling you are in pain.. And I am not going to give you any special attention because you are just deluded about the effects it has..” !!! I guess some of us have a long trudge out of the dark ages still.”
          More silliness.

  • Both groups were allowed to use conventional treatment for breast cancer.

    My question is; what is the point? What did the alt-med actually do? The women had a nice chat with the pleasant person and were given some sugar water and/or a nice rub, or some other nonsense. How do we know a cup of tea, a biscuit and a chat with an equally nice person may have had the same or greater effect?

    Besides, how can anyone think a 5.7 point difference on a “quality of life” scale is significant? Was any consideration given to the effects of the conventional treatments, that is, what health outcomes were experienced by the women?

    This is just spurious nonsense and a waste of time and effort.

  • ank’s comments are beneath contempt, which is presumably why they have been ignored, and why I shall now ignore them to go on to more sensible matters.

    It is not simply the single ‘experiment’ which causes me concern – it is the mounting numbers of such senseless and certainly unethical events. They are most definitely being used, and are targeted at, those who don’t know any better and cannot asess the pointlessness of it. It owuld be bad enough if the only people affected were the poor patients, but the general public is also in danger from the fact that the average politician knows nothing about healthcare matters and doesn’t have the brain power to learn. Or in most cases any incentive to do so. Politicians are used to a scenario where they want to please the maximum number of people for the least effort in the shortest possible time, regardless of long term effects or reality. For this reason they are attracted to CAM because it promises so much and doesn’r need explanations.

    If those within the UK reading this really want to help all of us, they should approach their MP with arguments against such trash as this so-called experiment. This approach is needed because the CAM brigade are using it already and appear to be winning. Suggest your MP reads ‘Trick or Treatment’. Most MPs won’t actually read it but if enough of them are told about it, something may sink in.

  • I too have come across a number of so called “pragmatic” studies regarding alternative therapies and I am also worried about the blurred and misleading results they create. I think one has to be very clear in the formulation of the aim of such studies as well in discussing the results.
    There is a genuine need for pragmatic approach in such cases, where the efficacy of an intervention is well established in proper RCTs, to find out if these interventions are applicable in the routine clinical setting. But if pragmatic studies are used to “investigate” the effectiveness of unproven interventions, they simply are adding nothing to answer the question if the intervention works or not. It is like telling half of the people who go to church, that the priest will pray for them, then asking them if that makes them feel better, and then using the results to “prove” that prayer works.
    This kind of research surely is unethical, if it is the hidden agenda of the researchers to promote unproven interventions by not clearly stating the limited aim and limitation of the results. It also undermines the public trust in science as a whole, because it creates conflicting results that are confusing to lay people (and journalists). The desired narrative will be: “even scientists disagree on whether Therapy X is effective or not”.

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