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iCAAD London 2019 - Dr Mike McPhillips -
- 1. What does the future hold for addictions medicine? Dr Mike McPhillips Consultant Psychiatrist Nightingale Hospital, London
- 2. Medical practice in which the treatment decisions are based, where possible, on the results of well-conducted clinical research. Research is well-conducted if it obeys certain criteria aimed at reducing subjectivity (that which we want to be true) and increasing objectivity (that which we can reliably demonstrate to be true). Some types of research are inherently more reliable than others, i.e. Meta-analysis and systematic reviews (studies that analyse all of the published scientific evidence rather than only part on none of of it), and above all, the evidence from randomised, controlled clinical trials. Evidence-based medicine
- 3. Comparison of study designs Randomised controlled trial (RCT) Cohort study Case-control study Time series Case studies, expert opinion Strong design Weak design
- 5. Performance enhancement in the NHS 2001
- 6. Randomised control trial Ideally also has • Independent “blind” observers • Intention to treat analysis • Adequate numbers (n = ‘00’s) • Valid outcome measures • LTFU accounted for
- 7. Case studies and expert opinion “In my clinical experience……” “Time after time, we see…..” “In case after case after case…..”
- 8. Expert opinion “There are as many opinions as there are experts”
- 9. Case studies and expert opinion “In my clinical experience……” “Time after time, we see…..” “In case after case after case…..”
- 10. RTMS “In my clinical experience……” “Time after time, we see…..” “In case after case after case…..”
- 11. RTMS: A pulsed magnetic field induces electrical stimulation in the brain • Medication free treatment • No anaesthetic required • Minimal discomfort • Numerous RCT’s and meta- analyses demonstrate effectiveness for depression, OCD, bipolar depression • Approved by FDA for depression, OCD, and NICE for depression in 2015, but not widely available in NHS • 20-30 x 20 minute applications, outpatient treatment • Becoming less expensive , technology improving Evidence-based medicine RTMS
- 12. • Medication-free treatment for comorbid depression/OCD • Reduces craving for nicotine, alcohol, cocaine • Current trials on food, methamphetamine, opiates, gambling • Increases dopaminergic activity in limbic structures governing mood, sense of well-being, may be useful in rehabilitation RTMS in addictions
- 13. • EC’s are a popular option among people trying to reduce or quit tobacco smoking • They indisputably produce fewer carcinogens than tobacco smoke • They are not known to be free of adverse health effects, because they produce nicotine, formaldehyde and other potentially harmful chemicals • A recent NEJM trial showed 18% 1y quit rate vs 9% for NRT’s, N= 900 Electronic cigarettes in smoking cessation
- 14. There is especial concern about young people experimenting with them, and possible “gateway” effects Electronic cigarettes Controversies
- 15. Electronic cigarettes in smoking cessation
- 16. • Baclofen is a muscle relaxant that has significant effects in making the brain less excitable. • Dr Beaurepaire is a French psychiatrist who treated his own alcohol dependence with baclofen. He went on to treat another 400 of his patients and to write a book about it, plus assorted blogs, websites, videos and interviews. He claimed over a 60% success rate in keeping people sober. • There have been 12 RCT’s of baclofen for alcohol, with over 1200 participants in 8 different countries. • None of the primary or secondary outcomes of the review showed evidence of a difference between baclofen and placebo. Cautionary tales Baclofen for alcohol and gambling disorder?
- 17. Contact details Outpatients Inpatients Dr Mike McPhillips Chelsea Consulting Rooms 2 Lower Sloane Street London SW1W 8BJ T. 020 7245 1199 F. 020 7245 1221 E. info@drmikemcphillips.com www.drmikemcphillips.com Nightingale Hospital 11-19 Lisson Grove Marylebone, London NW1SH T. 020 7535 7700 F. 020 7724 5976 E. patientservices@nightingalehospital.co.uk www.nightingalehospital.co.uk
Editor's Notes
- Dr McPhillips will provide an overview of the design and the statistical meaning of double-blind placebo controlled clinical trials for medical interventions in addictions. He will review the recent arrival of medication and non-medication treatments for abstinence and craving in addictions, including: rTMS for depression, OCD and craving Vaping for smoking Baclofen for alcohol and for gambling Ketamine and Psilocybin for depression
- So let’s imagine that the big circle contains all of the staff of the Nightingale Hospital. The owner of the hospital decides that they would like an increase in productivity, so they devise a performance incentive. Half of all staff receive the incentive and half are managed as per normal. So can I have some audience suggestions about management initiatives that might improve performance?
- I worked in a very entrepreneurial Trust, and borrowing ideas from the private sector to increase productivity in the public sector was very fashionable at the time. There was a lot of debate about performance bonuses (this was before performance bonuses broke the entire World economy in 2008). So my Trust decided to reward all staff with….a ten pound Sainsbury’s voucher. To be honest, it didn’t actually seem to make much difference to work rates, and they gave it to everyone, so there was no proper control group. Anyway, offering people extra money to work harder has now largely been replaced by allowing people to keep their job if they work harder, which seems to be pretty effective.
- Blind observers do not know which intervention the subject had. It would be foolish to ask doctors how good their bedside manner had been. Intention to treat analysis makes sure that everyone who was asked to have a treatment was included in the outcome. This is especially important in addictions treatment, where the treatment is very long, and a lot of refuse to enter it and quite a few more people fail to complete it. Very few addiction studies use solid outcome measures like hair tests, blood tests and breathalysers, so they may overestimate response and recovery rates.
- I am afraid we don’t have time to look at Case Control studies and cohort studies, which are in the middle rank of scientific evidence supporting medical treatments. Speaking as an expert, I just want to show you one slide that summarises the limitations of Expert opinions, when they don’t rely on Evidence Based Medicine: If I have seen once case of an illness in the past, I can say that something is within my clinical experience. After two cases I can reasonably say that I have seen something time after time. After three cases, I can say “in case after case after case”. At best, after a lot of clinical experience, I am an expert in what happens to hundreds of different patients over over time. That does not always make me an expert on what is going to be the outcome for the single patient in front of me.
- For those interested to know more, the free online review article below is a very good primer on the possible benefits of rTMS in addictive disorders: Behav Neurol. 2014; 2014: 815215. Published online 2014 Jan 23. doi: 10.1155/2014/815215 PMCID: PMC4006612 PMID: 24803733 rTMS in the Treatment of Drug Addiction: An Update about Human Studies Elisa Bellamoli, 1 , 2 ,* Paolo Manganotti, 2 Robert P. Schwartz, 3 Claudia Rimondo, 4 Maurizio Gomma, 1 and Giovanni Serpelloni 5 Author information Article notes Copyright and License information Disclaimer
- The trial conducted by Hajek et al of Queen Mary’s University combined NRT’s with expert advice in structured quit smoking interviews. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy Peter Hajek, Ph.D., Anna Phillips-Waller, B.Sc., Dunja Przulj, Ph.D., Francesca Pesola, Ph.D., Katie Myers Smith, D.Psych., Natalie Bisal, M.Sc., Jinshuo Li, M.Phil., Steve Parrott, M.Sc., Peter Sasieni, Ph.D., Lynne Dawkins, Ph.D., Louise Ross, Maciej Goniewicz, Ph.D., Pharm.D., et al. February 14, 2019 N Engl J Med 2019; 380:629-637
- This is 14 year old Mason, a Manchester schoolboy. He was one of the 7% of under-16’s who have a. regular smoking habit (10 cigarettes a day) so his mother bought him an e cigarette for him to use instead. It seemed to work, but unfortunately, he used it at school and it was confiscated, so his aggrieved mother went to the Daily Mail….. The best bit about the story is the Comments section.
- Mother complains after school confiscates her 14-year-old son's e-cigarette - because he was using the device to quit smoking
- This book, despite being published in French, caused a big stir in 2013. A 60% recovery rate for an addictive disorder not only looks too good to be true, it simply IS too good to be true. There seems little doubt that Dr Beaurepaire sincerely believes that he has discovered a revolutionary cure that will transform the outcome for millions of alcoholics. In his eagerness to spread a message of hope, he has overstated the advantages of this treatment, he has completely overlooked the side effects of baclofen (there are a number of them)and he has failed to rigorously evaluate his treatment group and their outcomes. Time without number drug or a psychological treatment that shows promise ion the hands of a persuasive discoverer founder fails to withstand both the test of time, and more importantly, to pass the more discerning test of properly conducted clinical trials. For a more measured account of the usefulness of Baclofen in alcoholism, see the 2018 Cochrane Review https://www.cochrane.org/CD012557/ADDICTN_baclofen-alcohol-use-disorder