We learned in the news this week that in the UK around one in four of us are taking prescription medications such as antidepressants, anti anxiety medications, painkillers and sleeping pills. Many people are using the drugs for far too long – they are no longer clinically appropriate.
Professor Paul Cosford, medical director of Public Health England told the BBC that people needed to be helped to find alternatives. Professor Helen Stokes-Lampard of the Royal College of GPs spoke about GPs not wanting to prescribe these drugs but feeling they had no choice. The high level of dependency was a sign of “the severe lack of alternatives”. Alternatives were mentioned in the article – these included talking therapies and social prescribing. It’s great to see the medical profession appreciating how fundamentaly important social connections are to our health and wellbeing. You can read the full article HERE
Personally speaking, as someone who has spent many years working as a therapist, and trying to find ways to research therapeutic alternatives, I think it indicates much more than this. It does not surprise me that CAM (complementary or alternative or complementary medicine/therapies), were not even considered or mentioned by the eminent doctors who were invited to comment on the alarming figures about drug dependency – even those with fairly convincing evidence. I will try to convey the some of the reasons for this in this article.
Sixteen years ago, in 2003, I received a National Institute of Health PhD fellowship award to research acupuncture as a treatment for depression. I knew it ‘worked’ – and literally could see it helping. Seeing a dear friend helped with her depression was what sparked my interest in Chinese medicine in the first place – leading me to study acupuncture instead of clinical psychology. Often people trying CAM therapies come to them because of seeing a friend or relative being helped. They try them and feel better – and wanting to help others go on to study and learn about them. I had seen so many helped in my years of clinical practice. The problem was that acupuncture would never become available on the NHS without an evidence base – enabling people who could not afford to pay privately to benefit from it. So when the opportunity came for me to be involved, and to do a funded PhD, I leapt at the chance. My award was part of a ring fenced funding scheme that came out of the House of Lords report on CAM in 2000 – there was recognition in this report that research capacity was poor and something needed to be done to help therapists like me to develop research careers – to be given the same chances as other health professionals working within the NHS. Depression was what got me into acupuncture in the first place so I couldn’t be more excited and thrilled to be given this opportunity.
In order to design a clinical trial of acupuncture for depression we began by considering a number of potential therapeutic niches for acupuncture within primary care – where most depression is treated. One of these niches was to help people come off antidepressants (1) and at the time I remember feeling quite despairing that the NICE (National Institute for Clinical Excellence), guidelines on depression treatment, amounting to well over 300 pages, had devoted just half a page to coming off medication.
In my practice I saw so many people who were stuck on these drugs – and at this point I had also worked for nearly a decade running a drop in auricular acupuncture service for drug and alcohol users, even helping people to come off heroin. I remember one day, in a clinic where I worked in a deprived area, having five patients in a row, all women, telling me they had been on antidepressants for ten years. If only conventional practitioners and acupuncturists could work together I thought, we could help people move forwards out of prescription drug dependency, which research at that time was showing could have a detrimental impact on a person’s identity and sense of self.
NICE did not prioritise research into interventions or support for patients to come off medication fifteen years ago.
We identified seven patient groups where illness sufferers might value, or wish to use acupuncture, in the stakeholder preparatory research conducted with patients, doctors and acupuncture practitioners:
- using acupuncture as a support to come off medication (helping ameliorate withdrawal symptoms)
- young adults
- pregnant or breastfeeding women/women trying to conceive
- menopausal women
- polypharmacy patients
- helping people who had not responded to medication or preferred not to use it
- helping people with concomitant pain -many if not most depression sufferers experience physical pain of one sort or another, around 60% according to research.
It seems important to say, in the context of the recent findings that over seven million people in the UK are prescribed antidepressants, that patients and doctors were very keen to see alternatives – when my PhD research was conducted 15 years ago.
These patient groups were all rated using the criteria outlined by the Global Forum for Priority Setting in Health Research to make a decision about which group to proceed with. It was hoped that other groups might also be looked at through research later on but we had to make a start with one. We selected patients with concomitant pain for further investigation.
My PhD research also considered what sort of comparisons stakeholders would like to see – these stakeholders wanted to see how acupuncture would stack up compared with psychological therapies and medication. This meant a pragmatic rather than an explanatory trial (with a placebo), was needed and preferred. Many acupuncturists believe that pragmatic trials are the fairest way to evaluate the therapy because it is essentially a complex context driven intervention where treatment is highly individualised, and patients may receive a different treatment at every session depending on their signs and symptoms and what is going on in their life.
The pilot study that we designed, which I undertook for my PhD, in order to inform the full scale trial, was designed to look at pain as a covariable – i.e. to measure both pain and depression outcomes (2).
When I left the project after the pilot study was completed, it was not clear how long a course of acupuncture or counselling should be investigated to allow both interventions a proper and realistic chance to work(3). This is because we were taken by surprise in regards to the depression severity of the self selecting participants who wanted to take part in the pilot study. We had no upper limit on depression severity for this study. We found that 80% had a Becks Depression score of 40 or more, which indicates severe depression, and they were also illness sufferers who had 20 years or more of illness and three or more depression episodes. This is a very difficult group to treat, and a short course of counselling, which most had tried and were reluctant to try again would not be clinically appropriate. There were also not enough CBT therapists working locally to compare acupuncture with CBT at this juncture – and it is more expensive than counselling – we did not have enough money for this comparison, which might have been better as it is considered the gold standard. Practice based evidence, as oppose to evidence based practice, indicated that differences between counselling and CBT in terms of outcome were non existent but CBT seems to have a much better reputation. What actually seems to matter most is the relationship between the patient/client and their therapist or doctor. These ‘effect modifiers’ matter in acupuncture too, so I put in a number of measures of therapeutic relationship into the pilot study to look at relational empathy, patient enablement and the working alliance between therapist/client – comparing these across all types of care provider: GP, acupuncturist and counsellor.
The work I had done was used to secure funding for a full scale trial by the university where I had worked. The team taking the research forwards after my harrowing redundancy, which happened during the introductions week of an adoption placement, chose to evaluate 12 sessions of counselling or acupuncture with both interventions as an adjunct to usual GP care, compared with usual GP care alone. I was concerned enough to write to the chair of the trial steering committee, the British Acupuncture Council and the British Association of Counselling and Psychotherapy because this seemed likely to be too short a course of therapy for a severely depressed person experiencing 20 years of depression and many years of illness. NICE guidance does not recommend a short course of counselling for such patients and there must be good reasons to evaluate care that is so out of kilter with NICE recommendations. I was also worried that a short a course of treatment might privilege acupuncture as it is a body therapy where patients have an immediate response. When people talk about their past, as they do in a talking therapy, there is a chance that there condition might worsen before it improves – which might exaggerate disparities between interventions that work in different ways. There was little interest shown in what I tried to explain.
The findings of the full scale trial in respect of pain comorbidity, which must have cost the best part of £1 million to conduct, showed that acupuncture was every bit as good as counselling but had the added benefit of helping people more effectively with their pain too.
This study, which was meant to be a definitive trial, doesn’t seem to have made much of a difference to service provision or practice. I vaguely remember Ian Hislop laughing about acupuncture for depression on Have I Got News For You when the findings of the full scale trial were reported by the press after the BMJ article. Acupuncturists continue to work outside the NHS, working in professional isolation and often misunderstood by conventional medicine practitioners who generally don’t, in reality, know much about traditional Chinese medicine or the CAM modalities they would gatekeeper if these therapies were to be made available on the NHS. On the positive side of things, the last 15 years has seen an exponential growth in mindfulness based approaches however, which doctors do seem to respect. But most forms of CAM remain out of the NHS with no money for research – yet we are told we need evidence. The need to produce evidence becomes a tyranny when there is no way it can be developed.
As a practitioner of complementary medicine I had so much wanted to be involved in researching the effectiveness of the therapies I practice (I have added Craniosacral Therapy to my repertoire after leaving the university), but found myself confronted with an unsupportive work environment where it was impossible to progress my research career. Research is a collaborative endeavour and I never would have imagined it could be like this and that I would not be protected from people who had little or no respect for my work and clinical knowledge – because it was not part of conventional medicine. It wasn’t personal – although it felt this way because I was personally affected – I was put out of work with nowhere else to go.
When I started at the university it was a centre for complementary medicine research, recieving substantial sums of money from the NHS for research, but within a few years the complementary therapy unit was closed down.
Now, with nearly a quarter of the UK’s population using prescription medications and many struggling to come off, is it time to look at alternatives and reflect on how we are going to find out if they work?
The problem of a lack of research capacity has not been solved and if anything it has worsened. There is no research infrastructure to support practitioners like me to be properly involved in clinical research – especially after PhD level. Is this important? I believe it is. Without people who understand the way an intervention under investigation may work, and what might help it to work better – or stop it being effective – it will be the blinkered and ignorant, often with prejudicial views, who design clinical trials and conduct systematic reviews – and there will be no appreciation or understanding of care quality by people developing the evidence base.
Funding decisions for research, service development and also ethical considerations will all continue to be made by people who have no idea about what is important in CAM therapies. Bias will continue to creep into research but in ways that will not be obvious. A clinical trial or systematic review may privilege one intervention or type of care over another because interventions work in different ways, and none of this will be apparent or understood by people who imagine they can’t work at all.
The placebo effect will also not be understood. What is considered placebo to some, who do not really understand, may be an important aspect of care that is in fact a characteristic feature of the intervention under investigation – see Paterson and Dieppe (2005) for a discussion of this in relation to acupuncture.
Funding and commitment will be needed from government for things to progress and change – when there is no profit to be made for the pharmaceutical industry, who are clearly making £billions now with a quarter of the population taking prescribed drugs for depression, pain, anxiety and sleep problems.
We could achieve so much more by working together and one thing is for sure – no one wants things to get worse.
(1) Schroer, S; MacPherson, H and Adamson, J (2009) Designing a RCT of acupuncture for depression – identifying appropriate patient groups: a qualitative study. Family Practice 2009 Jun;26(3):188-95.
(2) Schroer S and MacPherson, H . (2009) Acupuncture, or non-directive counselling versus usual care for the treatment of depression: a pilot study. Trials 2009 10 (3)
(3) Schroer S, Kanaan M, MacPherson H and Adamson J (2011). Acupuncture for depression: exploring model validity and the related issue of credibility in the context of designing a pragmatic RCT. CNS Neuroscience and Therapeutics