At the Food & Mood Centre, we are often contacted by the general public asking us questions about a new therapy (device, product, supplement, program, ‘super food’) they have heard about in the news or online. Or perhaps one that they perceive has helped them manage their mental health condition.
Unfortunately, upon investigation, many of these therapies are far from evidence-based. In some instances, they may be in the process of being legitimately tested, but it’s far too early to tell if they work (‘emerging therapies’). Sometimes they may actually cause harm, or the small amounts of evidence that have been produced are poor quality or anecdotal (‘potentially harmful therapies). In some cases, the sole purpose of the therapy is to make other people money (‘scam therapies’).
Often, people without training in medical research do not realise the level, quality and breadth of evidence required for a treatment to be considered evidence-based. The intention of this blog is to arm you with tools that may help you to save your precious time, effort, and money by avoiding non evidence-based approaches to treatment. I finish by providing 5 tips for ‘doing your own research’ and in turn increasing your chances of getting access to the latest advances in mental health research in a safe way.
How do I know if a therapy is evidence-based?
For a therapy to be used by health professionals and subsidised by Government-funded schemes like Medicare, it undergoes years of rigorous evaluation. Clinical trials of new therapies tend to go through four phases:
- A new therapy is tested for the first time in a reasonably small group of people (often fewer than 100). The aim is to test what is a safe level, dose or intensity or treatment, and monitor any side effects.
- Second, the therapy is tested in a larger group (often several hundred) who are randomly allocated to either receive the therapy or a placebo or sham condition, to see if it works as intended. When researchers are measuring the outcomes of the participants before and after the trial, they do not know which therapy each person has received (in some, but not all cases, neither do the participants). This helps to avoid biased conclusions.
- Third, the therapy is again tested by randomly assigning a larger group of participants (hundreds or thousands) to either the therapy or, this time, another established intervention (for example a psychological therapy) to see if it works as intended. This level of evidence is generally required to meet the standards of regulatory bodies like the Therapeutic Goods Administration (TGA) in Australia and the Food & Drug Agency (FDA) in the United States in order for a therapy to be used as part of mainstream health care.
- Finally, studies continue to be run after the therapy is on the market to monitor how it works in the general population and make sure there are no negative effects over the longer term.
The results of the above studies will always be registered on the Australian and New Zealand Clinical Trial Registry (or equivalent in other countries), adhere to national research guidelines, be overseen by a hospital or academic ethics committee, and the results published in a peer-reviewed, scientific journal. To put these phases into perspective, the various Covid-19 vaccinations have been tested in millions of individuals around the world. Few therapies have been tested in so many people. On the other hand, if you read about a therapy on social media, You Tube or on the news or radio that does not meet the above strict criteria, it is unlikely to be a legitimate therapeutic option.
What are emerging therapies?
If a therapy does not meet the above criteria, it may be potentially legitimate and considered an emerging or novel therapy. These are new breakthrough treatments that scientists may have discovered from studies of animals or small human studies (known as pilot studies), such as those in fewer than 100 people. Scientists will never claim that a therapy ‘works’ based on these findings alone. Any trained scientist or clinician is aware that the therapy needs to be re-tested multiple times to ensure that the finding is not a fluke, and then tested as part of the research phases listed in the previous section. If the therapy you read about – whether a new diet or a particular supplement – makes claims that it will improve your mental health because it was tested in 10 patients asking them how they felt before and then after the treatment, that is not a legitimate claim. For context, an undergraduate or high school student would undertake an experiment of this scope. The standard and comprehensiveness of rigorously tested therapies is of a much larger scale.
What are potentially harmful therapies?
If it isn’t difficult enough to keep up with new therapies or work out which are legitimate, it can be even more difficult when it relates to your mental health. This is because psychological and nutritional therapies (e.g counselling, dietary recommendations) do not go through regulatory bodies like the TGA or FDA in the way drugs, vaccines, or medical devices do. Regardless, they are still tested via similar process outlined in the previous section because the same principles apply. Psychologists, counsellors, dietitians, and allied health professionals need to know that their clinical practice is based on the most robust evidence and whether it may have side effects or cause harm. Potentially harmful therapies can be discovered by researchers in the process of conducting a trial. If harm is detected, the trial is stopped to avoid more harm. Unfortunately, due to poor scientific practices (ie those not following the processes outlined earlier), there are instances of potentially harmful therapies being used in clinical practice – as outlined in this article. Examples the authors use include ‘Critical incident stress debriefing’ (a small-group program for people who have very recently witnessed a highly stressful event) or ‘Scared Straight’ (whereby prison inmates attempt to scare adolescents with criminal records out of delinquency using stories about prison). Others can occur because of deliberate scientific misconduct or fraud – this is in no way exclusive to the field of psychology or nutrition but can happen in any field of medical science. Data about the benefits or indeed harms of a therapy may be exaggerated or fabricated to fit with the clinician’s or scientist’s personal beliefs, or to gain public standing and/or financial gain. Think Andrew Wakefield and the falsification of data that linked childhood vaccines to autism. Unfortunately, the devastating effects of this can take years to reverse and create a distrust of medical science.
What are scam therapies?
Belle Gibson. Elizabeth Holmes. ‘Nutritionist’ Influencers. Unfortunately, there are individuals who have ulterior motives in promoting a specific therapy or technology. This might include fame, money, power, and influence. Studying and training to become a health professional who provides a specific therapeutic service can take between 4-10 years, maybe more. They are registered and held to account by an accreditation board and professional standards. Scammers do not have these same responsibilities. There is nothing stopping someone claiming they have skills of an accredited dietitian, for example, describing themselves as a nutritionist or similar on their social media account and providing dietary advice to members of the general public. Unfortunately, this trend has risen with the popularity of social media. To read more about the rise of wellness gurus see this article. This phenomenon is not only highly dangerous but incredibly exploitative, especially when hopes are raised and money is exchanged. Psychiatrist Drew Ramsey MD, provides great tips for how to spot a scam or a therapy that is not evidence based here. This is very useful when it comes to new diets and supplements that claim to work for mental health and other outcomes. There are various reasons why someone may be vulnerable to scam therapies, including a distrust of society, poor treatment response to conventional treatments, feeling unheard by medical professionals and wanting to feel part of a community. All of this is understandable. So, if you decide to pursue your own research outside of the health sector, here are 5 tips to help guide you.
Tips for doing your own research
- If you are reading about a study in the newspaper or hearing about it from a friend or on YouTube, look to see that a therapy has been tested:
– In a study of humans (as opposed to animals like mice)
– In a group of people where half have been randomly allocated to the therapy and the other half to a comparison condition.
– In large numbers of people (see earlier section for a guide of size).
Finally, check who conducted and funded the study. Ideally it will be run by a University, Health Service or Medical Research Institute and funded by an impartial body (e.g a government agency, noting there may be legitimate exceptions to this).
- Talk to a trusted health professional who is accredited in their field about the therapy you are interested in. If they have not heard of it, ask them to investigate it for you. Ideally this is an accredited dietitian, clinical psychologist, allied health professional, general physician, or a specialist doctor like a psychiatrist. They are trained and guided by the rules of ethical conduct, which is so important in ensuring that you are receiving impartial advice. Be sure that they are currently registered in their field. If not, it may be a red flag.
- Appreciate that, as frustrating as it is, nothing in medical research stays the same forever. Science is constantly evolving and there are breakthroughs that quickly advance the field (e.g the development of the Covid-19 vaccines), incremental gains that slowly add to the evidence base, or evidence that refutes previous evidence. For example, scientists did not initially think that Covid-19 was airborne, but that was debunked as the science evolved. This is why so much evidence, from multiple studies, is required to make an assessment about the evidence for one therapy. Seek the assistance of a medical scientist who can help interpret the evidence and explain why things on a specific topic might have changed.
- Get involved in mental health research. Enrolling in a registered clinical trial or study means that you can access new or emerging therapies under safe conditions. You will be closely monitored and not only are you reimbursed for your time, but you may be provided the therapy for free. Some trials will even pay you to participate. If you are interested in nutrition, lifestyle and mental health, sign up to our Food & Mood Centre interest list to hear about the latest opportunities to enrol in our trials. If your interest goes beyond that see https://healthmatch.io/ – a site that has the potential to match you to a suitable opportunity. More generally, medical researchers are always looking to exchange insights and receive advice from people who are or have experienced the condition they are researching. The benefit of this approach is two-fold: researchers develop patient-focussed therapies and you learn about the process of medical research.
- Join a mental health consumer group. There may be a social or peer support component to wanting to support or believe in a non evidence-based therapy. This can make it difficult for people to separate the scientific facts (or lack of) from the benefits of feeling part of a movement or community. Joining a local mental health consumer group can help tap into these networks and this may help you navigate the evidence. In Australia, SANE has an online forum for people with lived experience. Our own Institute has a local community and research group based in Geelong. These opportunities may be a good way of getting support from peers and making new connections.
Professor Adrienne O’Neil is Co-Director of the Food & Mood Centre and leads the centre’s Heart and Mind Research Stream