Using a Chinese herbal medicine to reduce excessive drinking

This post was written by Natasha Clarke, an MSc student at the University of Liverpool.

Many current drinkers report drinking to excess, therefore it is important to identify treatments which can reduce these drinking levels, even if the reductions are modest. Medicines derived from natural products that have few side effects and low toxicity are desirable. Kudzu extract, a Chinese herbal medicine, has long been used to treat alcoholism and reduce hangover symptoms in Asian cultures. A previous study reported that treatment with kudzu extract led to significant reductions in alcohol consumption in heavy drinkers over the course of a week (Lukas et al, 2005).

This randomised, double-blind, placebo controlled study was designed to see if treatment with kudzu extract (NPI-031) over a longer period of 4 weeks would reduce alcohol consumption. It was conducted in Boston and published in Psychopharmacology. Authors found a modest reduction in alcohol consumption, and the kudzu extract was well-tolerated with minimal side effects.

Methods

The study recruited 21 male heavy drinkers aged 21-33 years, of whom 17 completed the study. Only males could take part because kudzu extract may interfere with oestrogen activity.

The study had a 2-week baseline period, 4 weeks of medication (or placebo) and a 2-week follow up. Participants were assigned to receive either kudzu extract or a placebo, and they attended the laboratory twice per week for the first 6 weeks and once per week in the follow-up fortnight. Alcohol and other drug use were monitored with self-report measures which were validated with breath, urine and blood samples. Safety of the kudzu extract was monitored by assessments of vital signs, daily reports, weekly assessments of adverse events, blood sample testing and an ECG at the end of the study.

Results

•   During the 4 weeks when participants received medication (or placebo), participants who received kudzu extract reported significant reductions in drinking compared to baseline. Participants in the placebo group also reported reductions in drinking compared to baseline, although these reductions were not statistically significant. However, differences between the kudzu extract and placebo groups were only statistically significant during the third week of receiving medication. Overall, the interaction between medication group and study week was statistically significant (p=0.034, ηPartiall²= 0.146), which reflects the reduction in drinking compared to baseline in the kudzu extract group only.  However, it seems that the study was underpowered to detect differences between kudzu extract and placebo.

•   There were also differences between the kudzu-treated and placebo groups in terms of the number of days per week that they drank heavily, as revealed by main effects of time (p<0.005, ηPartiall²= 0.197) and drug (p=0.008, ηPartiall²= 0.386). Relative to baseline, the kudzu group showed a reduction in heavy drinking days on the first, third and fourth treatment weeks (but not the second week). Differences between kudzu and placebo were only statistically significant on week 4, which again seems down to low statistical power.

•   Importantly, these reductions in drinking in the kudzu extract group (compared to baseline) were maintained during the two-week follow-up period, after they had stopped taking the medication.

•   The medication also influenced the number of days that participants remained abstinent from alcohol during the treatment phase. Nine out of 10 participants in the kudzu extract group achieved three or more consecutive days of abstinence, compared to only three out of seven participants in the placebo group. This difference was statistically significant, although we have to again note the small sample size and the fact that 3 of 10 participants originally assigned to the placebo group did not complete the study, as opposed to only one of the 11 participants assigned to the kudzu group.

•   There were no indications that kudzu extract altered desire for alcohol.

•   Medication adherence was excellent.

•   There were no adverse events and changes in vital signs, blood chemistry and renal or liver function.

Conclusions

The researchers stressed that their most important finding was that 4 weeks treatment with the kudzu extract led to a reduction in self-reported alcohol consumption in heavy drinkers who were not seeking treatment. It also increased the number of consecutive days that participants did not drink alcohol.

Overall, it seems that kudzu extract could be a useful add-on to other treatments for problem drinking. However, the sample size in this study was very small and differences between kudzu extract and placebo were not consistent across time, so a much larger randomised controlled trial (RCT) is needed.

 

This study suggests that kudzu extract can result in a desirable reduction in drinking (compared to baseline), with no adverse side effects, and it may be beneficial when combined with a comprehensive treatment program. However, this study only tested this effect in Males, and for safety reasons they could not test the drug in Females. Which is a shame!

Link to paper

Lukas SE, Pentair D, Su Z, Geaghan T, Maywalkt M, Tracy M, Rodolico J, Palmer C, Ma Z, Lee DY-W. A standardized kudzu extract (NPI-031) reduces alcohol consumption in nontreatment-seeking male heavy drinkers. Psychopharmacology 2013, 226: 65-73.

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Cost-effectiveness of internet-based interventions for harmful drinking

This post was written by Andy Jones for the Mental Elf website, you can find the original here.

The World Health Organisation (WHO) considers harmful drinking as the third largest contributor to the Global Burden of Disease, an index of disability, poor health and mortality. The majority of people who suffer from alcohol use disorders do not receive any treatment, due in part to lack of access. One way of increasing the availability of treatment is to administer it via the internet. Overall, internet-based interventions do seem to lead to reductions in harmful drinking.

The authors of the current study, published in the Journal of Medical Internet Research, compared the efficacy and cost effectiveness of two types of internet-based interventions: Internet-based self-help and Internet-based therapy (the Mental Elf previously discussed the efficacy of these interventions here). Both are based on cognitive behaviour therapy and motivational interviewing, but there are a few major differences. Internet-based self-help provides information and introduces heavy drinkers to exercises that help them to resist craving and peer pressure, and deal with drinking ‘lapses’. Whereas internet-based therapy is driven by online chat sessions with a qualified therapist and has specific aims including self-control, goal setting, and relapse prevention. Despite being significantly more costly (€283 compared to €12 for the self-help sessions), the authors discovered that Internet-based therapy may be a more cost effective intervention than Internet-based self-help.

Methods

The research was conducted alongside a randomised controlled trial comparing the two types of interventions and a waiting list control (data from the waiting list control were not analysed, and we assume that ‘waiting’ doesn’t cost anything). Participants were recruited through the website of a substance abuse treatment centre based in the Netherlands and in order to take part they had to be between 18-65 years old, drink alcohol at levels that are harmful to health (indicated by a score of 8 or above on the Alcohol Use Disorders Identification Test) and have internet access (obviously!). Overall, 136 participants were included in the analyses (68 in each treatment condition). Participants were followed up three months after the intervention, and again at six months.

At follow-up, the researchers counted the number of ‘treatment responders’ in each group. A treatment responder was defined as somebody who had reduced their alcohol consumption to ‘safe’ levels (based on recommendations from the British Medication Association: no more than 14 standard units for women, or 21 units for men, per week)), along with no substantial deterioration in scores on the AUDIT, Quality of Life Scale or Brief Symptom Inventory.

The researchers also calculated Quality Adjusted Life Years (QALYs; more information on this measure can be found here), and the Incremental Cost Effectiveness Ratio (ICER; more information here) in order to quantify the cost effectiveness of any additional benefits caused by internet based therapy, when compared to internet based self-help.

Results

This is what they found:

• Internet-based therapy was much more effective at reducing drinking than internet based self-help at 6 month follow-up. In the Internet-based therapy group 36 (53%) participants responded favourably, whereas in the Internet-based self-help group only 20 (36%) participants showed a reduction in their drinking. 
• The Internet-based therapy intervention also led to improved QALYs compared to Internet-based self-help (0.89 vs. 0.78 years). 
• Despite being considerably more expensive than self-help (recall that internet-based therapy cost €283 per session as opposed to €12 per session for internet-based self-help), Internet-based therapy had a 60% likelihood of being a more cost-effective treatment, with an Incremental Cost Effectiveness Ratio of €14,710. 

Conclusions

The paper set out to answer the question of whether the beneficial effects of Internet-based therapy (IT) would outweigh its significantly greater cost compared to the much cheaper (but also effective) internet-based self-help (IS).

The authors concluded that:

‘IT offers outcomes for money equal to or better than those obtained with IS, and might therefore be considered as a possible treatment option’.

The results suggest that an internet intervention comprising interaction with a therapist via online chat was significantly more effective than a self-help internet intervention, and the additional cost of this intervention was money well spent in terms of improvement in Quality Adjusted Life Years (QALYs). However, participants were only followed up for six months, so we need to evaluate the efficacy and cost-effectiveness of this treatment in the long-term. Furthermore, a 60% likelihood of increased cost effectiveness for Internet-based therapy is relatively small. Therefore, because of the larger costs involved in Internet-based therapy (it was over 20 times more expensive than comparable ‘self-help’) the authors suggested a stepped care approach. This would mean referring individuals for internet self-help first, and then moving them on to the more expensive Internet-based therapy if they did not reduce their drinking in response to the self-help.

Links:

Target Paper:

Blankers, M., Nabitz, U., Smit. F., Koeter, M.W.J., Schippers, G.M. (2012). Economic Evaluation of Internet-Based Interventions for Harmful Alcohol Use Alongside a Pragmatic Randomized Controlled Trial. J Med Internet Res, 14, e134 (free PDF).

More information:

Bambha, K., Kim, W.R. (2004). Cost-effectiveness analysis and incremental cost-effectiveness ratios: uses and pitfalls. Eur J Gastroenterol Hepatol, 16(6):519-26.

National Institute for Health and Clinical Excellence. Briefing paper for the Methods Working Party on the Cost Effectiveness Threshold.

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Tailored primary care intervention for heavy drinking may be counterproductive

This post was written by Matt Field for the Mental Elf website, you can find the original here.

Approximately 15% of adults in Europe drink alcohol to excess, at levels that are likely to affect their health. Most of these people are not alcohol dependent and do not require intensive treatment such as detox and aftercare, but many of them would benefit from a ‘nudge’ to reduce their drinking to safer levels.  Screening and Brief Interventions for hazardous drinking are a useful and cost-effective way of doing this. Indeed the Lifestyle Elf has recently written about screening and brief interventions in primary care and for general hospital patients.

This Randomised Controlled Trial, published in the Journal of the American Board of Family Medicine, describes an evaluation of an intervention that was delivered through 70 GP practices in the Netherlands. The headline result is that the group of patients who received the intervention did show a significant reduction in hazardous drinking when assessed at two-year follow-up. However, this was no cause for celebration because a control group of patients also showed a significant reduction in hazardous drinking at follow-up, and to a greater extent than the group that received the intervention! Therefore, it seems that this particular intervention was, unfortunately, counterproductive.

Methods

The research team invited 2758 general practices to participate, of which 82 practices (3%) agreed to take part. Five practices dropped out subsequently, and another seven were eliminated because they did not identify any patients who met the criteria for ‘hazardous drinking’ (defined as a score of 8 or above on the Alcohol Use Disorders Identification Test; AUDIT). The final sample comprised 712 patients, who all scored at least 8 on the AUDIT, recruited from a total of 70 GP practices. Each practice was then randomly assigned to either the intervention group (346 patients from 36 practices), or the control group (366 patients from 34 practices). The GP practices in the intervention group received the following:

·      Professional-directed interventions such as drinking guidelines, reminder cards, and training sessions about hazardous drinking provided to the GPs themselves.

·      Organization-directed interventions including feedback from the researchers about their patients’ drinking characteristics, introductions to local addiction treatment services, and provision of training in the alcohol intervention by a trained facilitator

·      Patient-delivered interventions including a poster in the waiting room, personalised feedback on their alcohol consumption, and leaflets on alcohol consumption and harmful drinking.

The control group were mailed the leaflets about alcohol consumption and harmful drinking (described above), but did not receive any personalised feedback on their drinking or any of the other interventions described above. The primary outcome measure was the proportion of patients in each group who still met the criteria for hazardous drinking, which the researchers obtained by mailing the AUDIT to all of the participants two years after they had originally enrolled in the study.

Results

This is what they found:

·      35.5% of patients from the intervention group had reduced their alcohol consumption to low-risk levels (a score of 7 or below on the AUDIT) after two years.

·      47% of patients from the control group had reduced their alcohol consumption to low-risk levels after two years.

·      This difference between groups was statistically significant (Odds Ratio: 0.62, 95% CI: 0.43-0.90).

·      They also found that, across both groups, females, older participants and non-smokers were more likely to shift to low-risk drinking across the follow-up period. Other variables, including beliefs about the effects of alcohol and intentions to reduce drinking, also predicted outcome. 

Conclusions

The authors concluded that their intervention was counterproductive: although some patients who received the intervention did reduce their drinking to ‘low risk’ levels, the proportion that did so was actually significantly lower than the proportion in the control group, who only received leaflets about alcohol in the post! The research team discussed several possible explanations for their findings. Firstly, the participation rate was low (only 3% of practices that were invited actually took part). Perhaps most importantly, the researchers noted that:

‘our program did not result in improvements in rates of screening and giving of advice’

 In other words, compliance with the intervention among the GPs was low.

Overall, it is not such a mystery that patients in both the control and intervention conditions showed a reduction in hazardous drinking, because factors such as regression to the mean and ‘non-specific effects’ are common with these types of brief interventions, as the Lifestyle Elf discussed in regards to a different study here. But it is unusual to demonstrate that a control condition produces better results than a brief intervention, and the authors were not really able to explain this in their paper. I cannot explain it either.

Link to paper:

Hilbink M, Voerman G, van Beurden I, Penninx B, Laurant M. A randomized controlled trial of a tailored primary care program to reverse excessive alcohol consumption. J Am Board Fam Med. 2012 Sep-Oct;25(5):712-22. doi: 10.3122/jabfm.2012.05.120070.

Matt Field

mfield@liv.ac.uk

Follow @field_matt

A teetotaller’s view on life as an alcohol researcher

Whenever I go out to a pub or bar and decline a drink, people generally think it’s quite strange. What's more, when we talk about jobs and interests it gets worse. When I tell them I conduct research into alcohol and problem drinking they either think I am joking, begin to shuffle nervously and assume I am silently judging them, or perhaps more surprisingly they become generally interested in what I do and start picking my brain.

When I say I study alcohol, I’m only really at the beginning of my research career (well, I hope I am not near the end of it). I recently finished a PhD in at the University of Liverpool investigating disinhibition and cognitive biases in heavy drinkers (you can read some of my published, peer-reviewed research here, here, here and here. Having finished, I decided that research was the job for me, and signed up to three more years as a post-doc on an MRC-funded project that will examine the issues from my PhD in more detail.  When I tell people I don’t drink they assume that my research interests have contributed to my choice, when in fact this isn’t the case.

I’m still not entirely sure what drives my abstinence. I did the usual heavy drinking in my teens. Heading into the city centre tanked up on cheap vodka and someone else’s ID, I had some of the best times (as far as I can remember!).  At the same time, not all of my experiences with alcohol were positive. When I did drink, it wasn’t in moderation and I do not like vomiting! Drinking to get drunk is a strategy adopted by many young people: they drink huge amounts of alcohol not for the taste, but for the effects. Regardless, I think my experiences fit in with the well-established roles for both positive and negative experiences and expectations as determinants of individual differences in alcohol consumption. The idea that something can be pleasurable but can also have negative consequences, and the ambivalence this causes, is what made me interested in studying addiction in the first place. 

So, how does teetotalism affect me and my work? It has its pros and cons. I have to rely on purely objective accounts of the effects of drug and alcohol use. This is perhaps both good and bad. My discipline (experimental psychology) is defined by its objectivity, and as noted in a previous post here, scientists shouldn’t infer much from their own experiences. Besides, my subjective experiences of the effects of alcohol are now a distant memory. However, maybe to truly understand something you have to experience it (think Freud and cocaine or Hofmann and LSD)?  I can honestly say that sometimes, particularly during the early stages of my PhD, I did not feel as qualified or knowledgeable as my peers who went to the pub regularly. I assumed they held a greater understanding at least partly because of their personal experiences!

Aside from the obvious health related benefits, a major ‘pro’ is that I always have a clear head for work; there are no hangovers for me! I have never experienced a hangover but they sound pretty unpleasant. This means my productivity doesn’t suffer due to hangover. Something that was highlighted by the government recently is the cost to the economy of hangovers whilst at work. Over 200000 people go to work with a hangover every day. However, I’d like to think I am not a robot purely focused on my work and that the most understandable ‘con’ of my total abstinence is that occasionally I think I am missing out on something. Alcohol plays an important role in British culture (including at Universities!):  socialising, celebrations, commiserations and everything in-between.  When I decided I did not want to drink any more, the hardest part in the beginning was the peer-pressure; my friends didn’t understand (some still don’t) why I would choose to do such a foolish thing.  I find that there is no pressure from my friends now. Maybe they have accepted I am a ‘lost cause’, but what I have noticed is that they themselves are starting to reduce their alcohol consumption. I am now in my mid twenties, so my peers and I are at an age now where heavy drinking is not compatible with our responsibilities. Have I produced this healthy change in my friends, or are they ‘maturing out’ of heavy drinking, as the evidence suggests they should?

Anyway, I am not advocating abstinence for all: moderation is a sensible goal for most people, and is likely to lead to fewer suspicious glances when you go to the pub. However, I do think my choices give me a different insight into the topic that I study for my day job, and I wanted to share those with you here. Thanks for reading.

Andy Jones (or: Dr Andrew Jones)

Twitter: @ajj_1988

Some reflections on ‘Dry January’ - personal and professional

February 1^st has arrived, and I have not consumed any alcohol since New Year’s Eve. Which means that I managed to stay off the sauce for a whole month, a target I set when I signed up for Dry January, a campaign run by Alcohol Concern (not be be confused with Dryathlon, a similar campaign from Cancer Research UK).

I found the experience both interesting and – dare I say it – enjoyable. I slept better and generally felt healthier. I was particularly interested in this because of my day job – I’m a Professor of Psychology at the University of Liverpool, and I conduct research into addiction, particularly alcohol problems and the psychology of self-control. Personally, I wouldn’t say that I had an alcohol problem (not the whisky on cornflakes kind, anyway), but I probably drink a little more than the Government recommends (3-4 units per day for men, 2-3 units per day for women).

So, how did I cope? Overall, I was never seriously tempted to break my resolution. I made a big deal of telling everyone who would listen that I was doing it, and fortunately my social calendar was pretty light for the whole month. I went out for dinner and to the pub a few times, but deliberately avoided anything that had the potential to turn into a Big Night Out. I was happy to be the designated driver for a posh meal out in the Lancashire countryside for a friend’s birthday. Fortunately my girlfriend doesn’t drink much, and when she does she sticks to pink wine (which I think is vile), so that helped. Stress levels at work were about average – about 7 out of 10, I would say – and although sometimes I had a bad day and was tempted to open some wine when I got home, I found it surprisingly easy to stay on track. If anything, it got easier as the month progressed.

I noticed a few things which resonate with some of the research that my colleagues and I have conducted over the years. Firstly, we have studied how the perception of the availability of alcohol has a very powerful influence on craving and other psychological processes. If people are told that alcohol is available imminently, their desire to drink rockets, they get more distracted by alcohol-related ‘cues’ in their environment, and their self-control plummets. This concept of ‘availability’ is a strange one. Alcohol is all around (including at my home) and I could easily get some at a moment’s notice. But because I had told everyone that I would not be drinking, this made it ‘unavailable’ as far as I was concerned. In my experience, it was this feeling that meant that I was rarely tempted to drink, and on the handful of times when I was tempted, this soon passed.

It also got me thinking about ‘self control’. At the beginning of the month, I thought it would get much harder as the month progressed. But actually, despite a tough first weekend, it got easier. Now, there are at least three different ideas about the psychology of self-control. One is that each person has a fairly fixed capacity for self-control: they can’t do anything about to improve it, although if they use alcohol or other drugs for a long period of time it might cause a permanent reduction in self-control. Another idea is that self-control is like a muscle, which gets tired whenever we have to exert self-control but (maybe) it can be strengthened by repeatedly practicing self-control. Based on this idea, we might expect that I would have found it difficult earlier on in the month (as my self-control ‘muscle’ became weak), but after that it should have become easier (as that ‘muscle’ got stronger). A competing idea is that self-control is ‘all in the mind’: people don’t have a fixed capacity for self-control, but rather they have beliefs (or an identity) about how much self-control they have, and they act accordingly. So if someone believes that their self-control is rubbish, they may crack at the first sign of temptation. Unfortunately, my own experience doesn’t really help me to tell which of these theories is true: did I find it difficult at first, but then easier, because I had strengthened my self-control muscle, or because I had learned that my self-control was actually better than I thought it was, so my identity had changed? Perhaps it is a bit of both? Or neither?  I’m a scientist, so I know that I cannot infer that much from my own experiences, but it has given me some extra insight – not to mention some ideas for new research projects!

Overall, I found it a useful (and sobering) experience. If you think you drink too much, I would encourage you to think about doing Dry February (or maybe just start with a ‘Dry Week’). I have certainly seen opportunities for me to cut down my drinking when life returns to normal, and take account of recommendations from the British Liver Trust to have 2-3 dry days per week. Finally, I should say that, despite some concerns about Dry January and Dryathlon, I do NOT intend to go on a mad binge in February. However, there is a beer festival down the road from my house tonight, and I would be fibbing if I said that I wasn’t looking forward to a pint or two of ale……

Matt Field

mfield@liv.ac.uk, or on twitter at @field_matt