MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

addiction

As promised, here is my translation of the article published yesterday in ‘Le Figaro’ arguing in favour of integrating so-called alternative medicine (SCAM) into the French healthcare system [the numbers in square brackets were inserted by me and refer to my comments listed at the bottom].

So-called unconventional healthcare practices (osteopathy, naturopathy, acupuncture, homeopathy and hypnosis, according to the Ministry of Health) are a cause for concern for the health authorities and Miviludes, which in June 2023 set up a committee to support the supervision of unconventional healthcare practices, with the task of informing consumers, patients and professionals about their benefits and risks, both in the community and in hospitals. At the time, various reports, surveys and press articles highlighted the risks associated with NHPs, without pointing to their potential benefits [1] in many indications, provided they are properly supervised. There was panic about the “booming” use of these practices, the “explosion” of aberrations, and the “boost effect” of the pandemic [2].

But what are the real figures? Apart from osteopathy, we lack reliable data in France to confirm a sharp increase in the use of these practices [3]. In Switzerland, where it has been decided to integrate them into university hospitals and to regulate the status of practitioners who are not health professionals, the use of NHPs has increased very slightly [4]. With regard to health-related sectarian aberrations, referrals to Miviludes have been stable since 2017 (around 1,000 per year), but it should be pointed out that they are a poor indicator of the “risk” associated with NHPs (unlike reports). The obvious contrast between the figures and the press reports raises questions [5]. Are we witnessing a drift in communication about the risks of ‘alternative’ therapies? [6] Is this distortion of reality [7] necessary in order to justify altering the informed information and freedom of therapeutic choice of patients, which are ethical and democratic imperatives [8]?

It is the inappropriate use of certain NHPs that constitutes a risk, more than the NHPs themselves! [9] Patients who hope to cure their cancer with acupuncture alone and refuse anti-cancer treatments are clearly using it in a dangerous alternative way [10]. However, acupuncture used to relieve nausea caused by chemotherapy, as a complement to the latter, is recommended by the French Association for Supportive Care [11]. The press is full of the dangers of alternative uses, but they are rare: less than 5% of patients treated for cancer according to a European study [12]. This is still too many. Supervision would reduce this risk even further [13].

Talking about risky use is therefore more relevant than listing “illusory therapies”, vaguely defined as “not scientifically validated” and which are by their very nature “risky” [14]. What’s more, it suggests that conventional treatments are always validated and risk-free [15]. But this is not true! In France, iatrogenic drug use is estimated to cause over 200,000 hospital admissions and 10,000 deaths a year [16]. Yes, some self-medication with phytotherapy or aromatherapy does carry risks… just like any self-medication with conventional medicines [17]. Yes, acupuncture can cause deep organ damage, but these accidents occur in fewer than 5 out of every 100,000 patients [18]. Yes, cervical manipulations by osteopaths can cause serious or even fatal injuries, but these exceptional situations are caused by practitioners who do not comply with the decree governing their practice.[19] Yes, patients can be swindled by charlatans, but there are also therapeutic and financial abuses in conventional medicine, such as those reported in dental and ophthalmology centres. [20]

Are patients really that naive? No. 56% are aware that “natural” remedies can have harmful side-effects, and 70% know that there is a risk of sectarian aberrations or of patients being taken in by a sect [21]. In view of the strong demand from patients, we believe that guaranteeing safe access to certain NHPs is an integral part of their supervision, based on regulation of the training and status of practitioners who are not health professionals, transparent communication, appropriate research, the development of hospital services and outpatient networks of so-called “integrative” medicine combining conventional practices and NHPs, structured care pathways with qualified professionals, precise indications and a safe context for treatment.[22] This pragmatic approach to reducing risky drug use [17] has demonstrated its effectiveness in addictionology [23]. It should inspire decision-makers in the use of NHPs”.

  1. Reports about things going wrong usually do not include benefits. For instance, for a report about rail strikes it would be silly to include a paragraph on the benefits of rail transport. Moreover, it is possible that the benefits were not well documented or even non-existent.
  2. No, there was no panic but some well-deserved criticism and concern.
  3. Would it not be the task of practitioners to provide reliable data of their growth or decline?
  4. The situation in Switzerland is often depicted by enthusiasts as speaking in favour of SCAM; however, the reality is very different.
  5. Even if reports were exaggerated, the fact is that the SCAM community does as good as nothing to prevent abuse.
  6. For decades, these therapies were depicted as gentle and harmless (medicines douces!). As they can cause harm, it is high time that there is a shift in reporting and consumers are informed responsibly.
  7. What seems a ‘distortion of reality’ to enthusiasts might merely be a shift to responsible reporting akin to that in conventional medicine where emerging risks are taken seriously.
  8. Are you saying that informing consumers about risks is not an ethical imperative? I’d argue it is an imperative that outweighs all others.
  9. What if both the inappropriate and the appropriate use involve risks?
  10.  Sadly, there are practitioners who advocate this type of usage.
  11. The recommendation might be outdated; current evidence is far less certain that this treatment might be effective (“the certainty of evidence was generally low or very low“)
  12. The dangers depend on a range of factors, not least the nature of the therapy; in case of spinal manipulation, for instance, about 50% of all patients suffer adverse effects which can be severe, even fatal.
  13. Do you have any evidence showing that supervision would reduce this risk, or is this statement based on wishful thinking?
  14. As my previous comments demonstrate, this statement is erroneous.
  15. No, it does not.
  16. Even if this figure is correct, we need to look at the risk/benefit balance. How many lives were saved by conventional medicine?
  17. Again: please look at the risk/benefit balance.
  18. How can you be confident about these figures in the absence of any post-marketing surveillance system? The answer is, you cannot!
  19. No, they occur even with well-trained practitioners who comply with all the rules and regulations that exist – spoiler: there hardly are any rules and regulations!
  20. Correct! But this is a fallacious argument that has nothing to do with SCAM. Please read up about the ‘tu quoque’ and the strawman’ fallacies.
  21. If true, that is good news. Yet, it is impossible to deny that thousands of websites try to convince the consumer that SCAM is gentle and safe.
  22. Strong demand is not a substitute for reliable evidence. In any case, you stated above that demand is not increasing, didn’t you?
  23. Effectiveness in addictionology? Do you have any evidence for this or is that statement also based on wishful thinking?

My conclusion after analysing this article in detail is that it is poorly argued, based on misunderstandings, errors, and wishful thinking. It cannot possibly convince rational thinkers that SCAM should be integrated into conventional healthcare.

PS

The list of signatories can be found in the original paper.

We have discussed the currently fashionable herbal remedy, ‘kratom‘, before:

Inadequate regulation of Kratom supplements put consumers at risk

News about Kratom: the herb was recently (semi-)legalized in Thailand

Kratom: a ‘herbal drug’ with the potental to do more harm than good

A quick recap:

Kratom is made of the leaves of Mitragyna speciosa, a tree endogenous to parts of Southeast Asia. It has been used traditionally for its stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. By the early 2000s, kratom was increasingly used in the US as a substitute for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There are numerous assessments where people have been unable to stop using kratom and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.

Now it has been reported that the family of a Florida woman who died in 2021 after ingesting kratom has been awarded more than $11m from a distributor of the herbal extract. “There is of course no amount of money that will make up for the pain and suffering that Ms Talavera’s children are enduring because of their mother’s death,” Middlebrooks wrote in court records addressing the sanction against Kratom Distro. “The law nonetheless recognizes that the defendant must pay something, however inadequate.”

The US Drug Enforcement Agency in 2016 had imposed its strictest restrictions on kratom, which is made from the leaves of an evergreen tree and is often used by people to self-treat pain, anxiety, depression, and opioid addiction as well as withdrawal. There was an intense, immediate public backlash to that approach, however, and it prompted the DEA to rescind its prohibition of kratom, which is sold in stores and online.

The US Food and Drug Administration nonetheless has warned consumers over possible safety and addiction risks associated with kratom, and it has spoken in favor of more research aimed at gaining a better understanding of “the substance and its components”.

Friends of Talavera, a resident of the Florida community of Boynton Beach, introduced her to kratom years before her death. Her family said she regarded it as a safe, natural supplement and had taken some after buying it online from the Kratom Distro when her partner and the father of her youngest child – Biagio Vultaggio – found her unconscious in the living room on 20 June 2021. The 39-year-old Talavera was face down on the ground next to an open bag of a kratom derivative marketed as a “space dust”, her family has said. Vultaggio called paramedics, and they took Talavera to a hospital where she was pronounced dead. An autopsy later listed Talavera’s cause of death as acute intoxication from mitragynine, the main kratom component. The local coroner wrote in a report that “at high concentrations, mitragynine produces opioid-like effects, such as respiratory failure”.

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Back to the above lawsuit:

One of the attorneys for Talavera’s family, Tamara Williams, said in a statement that the judgment won by her clients “should be a wakeup call to the kratom industry”. Williams’s law firm had also recently won a $2.5m jury verdict against a kratom manufacturer in Washington state after a separate lawsuit alleging wrongful death. A colleague of Williams called on government officials to take steps “to protect other families from having to deal with unnecessary kratom overdose deaths”.

Alcohol-related hangover symptoms such as nausea, headache, stress and anxiety cause a considerable amount of harm and economic loss. Several so-called alternative medicines (SCAMs) are being recommended to alleviate hangovers. But, according to our systematic review, none has been shown to be convincingly effective:

Objective: To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover.

Data sources: Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted.

Study selection and data extraction: All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality.

Results: Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation.

Conclusion: No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.

However, now we have new data; do they change our conclusion?

The aim of this study is to investigate the effect of the amino acid L-cysteine (an amino acid that is contained in most high-protein foods) on the alcohol/acetaldehyde related aftereffects. Voluntary healthy participants were recruited through advertisements. Volunteers had to have experience of hangover and/or headache. The hangover study was randomized, double-blind and placebo-controlled. Nineteen males randomly swallowed placebo and two differently dosed L-cysteine tablets. The alcohol dose was 1.5 g/kg, which was consumed during 3 h. The study involved 6 drinking sessions on subsequent Friday evenings which all started around 7pm and finished at 10pm.

The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety. For hangover, nausea and headache the results were apparent with the L-cysteine dose of 1200 mg and for stress and anxiety already with the dose of 600 mg.

Men taking L-cysteine also had lower scores for nausea

Men who took the L-cysteine pills (plotted in blue) suffered fewer headaches the morning after drinking. The red plots are the placebo and purple are a mix of L-cysteine and placebo

 

The authors concluded that L-cysteine would reduce the need of drinking the next day with no or less hangover symptoms: nausea, headache, stress and anxiety. Altogether, these effects of L-cysteine are unique and seem to have a future in preventing or alleviating these harmful symptoms as well as reducing the risk of alcohol addiction.

The study was conducted in Finland where excessive drinking is apparently not a rarity. According to the study protocol, an 80kg man would have to drink 15 units of alcohol at 6 weekly occasions. This is an impressive amount, and one might wonder about the ethical implications of such a study.

More crucially, one might wonder whether the sample size was sufficiently large to draw such definitive conclusions. Looking at the graphs, it is easy to see that the average effects were determined by just a few data points. Personally, I would therefore feel uncomfortable with these conclusions and insist on further research before issuing far-reaching recommendations.

My discomfort would increase significantly considering that the sponsor of the study was the manufacturer of the L-cysteine supplement being tested, Catapult Cat Oy.

An article in the ‘Long Island Press’ caught my attention. Here are some excerpts:

A simple painless spinal adjustment by a chiropractor could be the latest breakthrough in the treatment of drug and alcohol addiction… Bridge Back to Life, an outpatient addiction treatment program, has teamed up with New York Chiropractic College (NYCC) … to offer the latest breakthrough therapy for substance use disorder. The first-of-a kind partnership, the brainchild of Bridge Back to Life’s medical director Dr. Russell Surasky, brings doctors from NYCC to evaluate and treat the center’s patients undergoing addiction therapy. Several diagnostic tests are performed at the base of the brainstem to determine if a misalignment exists. If present, the practitioners are taught to incorporate gentle painless, corrective spinal adjustments into the patient’s care plan. This treatment reduces stress on the spinal column and limbic system of the brain…

“Safe, painless adjustments to the upper cervical spinal bones can help normalize the brain’s limbic system by helping with the overall circulation of cerebrospinal fluid of the brain… I truly believe that this agreement with the college will serve as a national model for drug rehabilitation centers throughout the country,” says Surasky, who is triple board certified in neurology, addiction medicine, and preventive medicine. “Not only can spinal adjustments reduce the chronic pain issues that may have led patients into drug addiction in the first place, but now we also have evidence that spinal adjustments actually accelerate the healing of the brain from addiction.”

Surasky points to a study done in 2001 in the journal Nature: Molecular Psychiatry, which looked at the impact of spinal manipulations at an inpatient addiction treatment facility in Miami. The study found that chemically dependent patients who received specific spinal adjustments as part of their treatment reported fewer drug cravings and mental health symptoms. Moreover, 100 percent of the study patients who received chiropractic care completed the inpatient program, while about half of those not receiving treatments dropped out prior to completion. Yet no further studies were performed, and the information languished. Surasky began treating patients with the spinal adjustments at his private practice in Great Neck before bringing the treatment to Bridge Back to Life.

Mary W. came to Surasky’s Great Neck office for help with alcohol addiction nearly one year ago. She received monthly Vivitrol shots and had marked success in curbing her cravings and drastically reducing her drinking. But Mary still had one-day “slips” from time to time. She also complained of insomnia and migraine headaches. She recalled an accident in the past, where she hit her head. Dr. Surasky took X-rays of her upper neck and performed a Tytron scan. He said the digital images showed she had misalignments at the C1 vertebral level, likely putting pressure on the lower brainstem area. In addition to Vivitrol shots, Mary started receiving upper cervical adjustments and has remained sober since. Her migraines have dropped from five per month to one or none and she is sleeping better.

Where to start?

There is much to be concerned about in this short article. Let me mention just a few obvious points:

  1. A treatment that is not backed by solid evidence is hardly a ‘breakthrough’.
  2. The ‘misalignments’ they are looking for do not exist.
  3. Spinal manipulation is not as safe as presented here.
  4. The assumption that it reduces stress on the limbic system is far-fetched.
  5. To suggest this approach as a ‘national model’, is simply ridiculous.
  6. The notion that adjustments increase the circulation of the cerebrospinal fluid is not evidence-based.
  7. What are ‘chronic pain tissues’?
  8. The claim that spinal manipulation accelerates healing of the brain is not evidence-based.
  9. The study in Nature Molecular Psychiatry does not seem to exist (I could not find it, if anyone can, please let me know).
  10. X-ray diagnostics cannot diagnose ‘misalignments’.
  11. Tytron scans are used mostly by chiropractors are not a reliable diagnostic method.
  12. Anecdotes are not evidence.

In short: this article reads like an advertisement for chiropractic as a treatment of addictions. As there is no evidence that chiropractic spinal manipulations are effective for this indication, it is hard to think of anything more irresponsible than that.

And here is the question that I often ask myself:

Are there any bogus, profitable, unethical claims that chiropractors would shy away from?

 

So-called alternative medicine (SCAM) could easily be described as a business that exists mainly because it profits from the flaws of conventional medicine. I know, this is not a good definition, and I don’t want to suggest it as one, but I think it highlights an important aspect of SCAM.

Let me explain.

If we ask ourselves why consumers feel attracted to SCAM, we can identify a range of reasons, and several of them relate to the weaknesses of conventional medicine as it is practised today. For instance:

  1.  People feel the need to have more time with their clinician in order to discuss their problems more fully. This means that their GP does not offer them sufficient time, empathy and compassion they crave.
  2.  Patients are weary of the side-effects of drugs and prefer treatments that are gentle and safe. This shows that they realise that conventional medicine can cause harm and they hope to avoid this risk.
  3.  Patients find it often hard to accept that their symptoms are ‘nothing to worry about’ and does not require any treatment at all. They prefer to hear that the clinician knows exactly what is wrong and can offer a therapy that puts it right.

Conventional medicine and the professionals who administer it have many flaws. Most doctors have such busy schedules that there is little time for building an empathetic therapeutic relationship with their patients. Thus they often palm them off with a prescription and fail to discuss the risks in sufficient detail. Even worse, they sometimes prescribe drugs in situations where none are needed and where a reassuring discussion would be more helpful. It is too easy to excuse such behaviours with work pressures; such flaws are serious and cannot be brushed under the carpet in this way.

Recently, the flawed behaviour of doctors has become the focus of media attention in the form of

  • opioid over-prescribing
  • over-use of anti-biotics.

In both cases, SCAM providers were quick to offer the solution.

  • Acupuncturists and chiropractors claim that their treatments are sensible alternatives to opioids. Yet, there is no good evidence that either acupuncture or chiropractic have analgesic effects that are remotely comparable to those of opioids. They only are seemingly successful in cases where opioids were not needed in the first place.
  • Homeopaths claim that their remedies can easily replace antibiotics. Yet, there is not a jot of evidence that homeopathics have antibiotic activity. They only are seemingly successful in cases where the antibiotic was not needed in the first place.

In both instances, SCAM is trying to profit from the weaknesses of conventional medicine. In both cases, the offered solutions are clearly bogus. Yet, in both cases, scientifically illiterate politicians are seriously considering the alleged solutions. Few seem to be smart enough to take a step backwards and contemplate the only viable solution to these problems. If doctors over-prescribe, they need to be stopped; and the best way to stop them is to give them adequate support, more time with their patients and adequate recognition of the importance of reassuring and talking to patients when they need it.

To put it differently:

The best way to reduce the use of bogus SCAMs is to make conventional medicine less flawed.

One theory as to how acupuncture works is that it increases endorphin levels in the brain. These ‘feel-good’ chemicals could theoretically be helpful for weaning alcohol-dependent people off alcohol. So, for once, we might have a (semi-) plausible mechanism as to how acupuncture could be clinically effective. But a ‘beautiful hypothesis’ does not necessarily mean acupuncture works for alcohol dependence. To answer this question, we need clinical trials or systematic reviews of clinical trials.

A new systematic review assessed the effects and safety of acupuncture for alcohol withdrawal syndrome (AWS). All RCTs of drug plus acupuncture or acupuncture alone for the treatment of AWS were included. Eleven RCTs with a total of 875 participants were included. In the acute phase, two trials reported no difference between drug plus acupuncture and drug plus sham acupuncture in the reduction of craving for alcohol; however, two positive trials reported that drug plus acupuncture was superior to drug alone in the alleviation of psychological symptoms. In the protracted phase, one trial reported acupuncture was superior to sham acupuncture in reducing the craving for alcohol, one trial reported no difference between acupuncture and drug (disulfiram), and one trial reported acupuncture was superior to sham acupuncture for the alleviation of psychological symptoms. Adverse effects were tolerable and not severe.

The authors concluded that there was no significant difference between acupuncture (plus drug) and sham acupuncture (plus drug) with respect to the primary outcome measure of craving for alcohol among participants with AWS, and no difference in completion rates (pooled results). There was limited evidence from individual trials that acupuncture may reduce alcohol craving in the protracted phase and help alleviate psychological symptoms; however, given concerns about the quantity and quality of included studies, further large-scale and well-conducted RCTs are needed.

There is little to add here. Perhaps just two short points:

1. The quality of the trials was poor; only one study of the 11 trials was of acceptable rigor. Here is its abstract:

We report clinical data on the efficacy of acupuncture for alcohol dependence. 503 patients whose primary substance of abuse was alcohol participated in this randomized, single blind, placebo controlled trial. Patients were assigned to either specific acupuncture, nonspecific acupuncture, symptom based acupuncture or convention treatment alone. Alcohol use was assessed, along with depression, anxiety, functional status, and preference for therapy. This article will focus on results pertaining to alcohol use. Significant improvement was shown on nearly all measures. There were few differences associated with treatment assignment and there were no treatment differences on alcohol use measures, although 49% of subjects reported acupuncture reduced their desire for alcohol. The placebo and preference for treatment measures did not materially effect the results. Generally, acupuncture was not found to make a significant contribution over and above that achieved by conventional treatment alone in reduction of alcohol use.

To me, this does not sound all that encouraging.

2.  Of the 11 RCTs, 8 failed to report on adverse effects of acupuncture. In my book, this means these trials were in violation with basic research ethics.

My conclusion of all this: another ugly fact kills a beautiful hypothesis.

Rapidly rising in popularity, kratom is hailed by some as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But kratom also is assailed as a dangerous and unregulated drug that can be purchased on the Internet, a habit-forming substance that authorities say can result in opioid-like abuse and death.

Last week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played.

So, what is kratom, and why might it be dangerous?

A recent review explains that the leaves of Mitragyna speciosa (commonly known as kratom), a tree endogenous to parts of Southeast Asia, have been used traditionally for their stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. Kratom exposure alone has not been causally associated with human fatalities to date. However, further research is needed to clarify the complex mechanism of action of the Mitragyna alkaloids and unlock their full therapeutic potential.

Another review adds that, by the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems. Banning kratom, risks creating public health problems that do not presently exist.

A third review explains that there are no published human pharmacologic, pharmacokinetic, or drug interaction studies on kratom or mitragynine, making it virtually impossible to fully understand kratom‘s therapeutic potential and risks and the populations most likely to benefit or experience harm from its use. Kratom has been used to ameliorate opioid withdrawal symptoms but also induces withdrawal. Human pharmacologic, pharmacokinetic and clinical data are of low quality precluding any firm conclusions regarding safety and efficacy. Kratom does cause a host of adverse effects without clear guidance for how they should be treated. There are numerous assessments where people have been unable to stop using kratom therapy and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.

A systematic review evaluated all studies on kratom use and mental health published between January 1960 and July 2017. Its findings indicate kratom‘s potential as a harm reduction tool, most notably as a substitute for opioids among people who are addicted. Kratom also enhances mood and relieves anxiety among many users. For many, kratom‘s negative mental health effects – primarily withdrawal symptoms – appear to be mild relative to those of opioids. For some users, however, withdrawal is highly uncomfortable and maintaining abstinence becomes difficult.

In Europe, as of 2011, kratom has become a controlled drug in Denmark, Latvia, Lithuania, Poland, Romania and Sweden. In the UK, since 2016, the sale, import, and export of kratom are prohibited.

On balance, my conclusion is that we urgently need more data and meanwhile should avoid this ‘herbal drug’.

 

I was surprised to receive this email yesterday: “Hello Edzard Ernst, You may remember I got in touch last week regarding losing a loved one to the ravages of drugs or alcohol. I just wanted to remind you that Narconon is here to help. For over fifty years Narconon drug and alcohol rehabilitation centres have been successfully reversing the tide of addiction for men and woman from all walks of life. The Narconon programme has saved them from the misery of addiction, and the potential of an early grave. We not only address the cause of the addiction, we resolve them…”

The email was signed by a man from ‘Narconon International’. First I thought someone has been counting the empty bottles in my bin, then I read it again and noticed the word ‘NARCONON’ and remembered that I once wrote about it. A quick search located my article from THE GUARDIAN 2012:

Imagine a therapy that “enables an individual to rid himself of the harmful effects of drugs, toxins and other chemicals that lodge in the body and create a biochemical barrier to spiritual well-being“. If you were told that the treatment was entirely natural and had already “enabled hundreds of thousands to free themselves from the harmful effects of drugs and toxins and so achieve spiritual gains”, wouldn’t you be tempted to try it?

Who doesn’t want a body free of nasty chemicals? And who wouldn’t be delighted at the chance to counter a growing threat to an “advancement in mental … wellbeing”?

These claims are being made for the “Purification Rundown” (“Purif” for short) and the closely related Narconon detox programmes, which mainly consist of regular exercise, sauna and nutrition, with industrial doses of vitamins and minerals added for good measure. Some of the claims are quite specific: the Purif programme is supposed to increase your IQ, reduce the level of cancer-causing agents in your body, and even enable you to lose weight easily and quickly. The Narconon programme is more specifically targeted at drug and alcohol dependency and is claimed to have an impressive success rate of 75%.

Both programmes were developed by L Ron Hubbard (1911-1986) and are currently marketed by the Church of Scientology. The CoS is not generally known to be an organisation that promotes healthcare programmes. Hubbard, the pulp-fiction writer who founded the CoS, portrayed himself somewhat over-optimistically as a pioneer, innovator and nuclear physicist.

He taught his followers that, at their core, humans contain a “thetan”. After creating the universe, thetans accidentally became trapped in physical bodies and, through scientology, we can restore the immortal, omnipotent, god-like powers of the “thetan” within us. Weird stuff that is the preserve of Hollywood eccentrics, you might think, but perhaps the CoS’s detox-ventures are an attempt to conquer new territory?

A typical course of treatment lasts several weeks and consists of many hours of exercise and sauna every day. This regimen is supplemented with megadoses of vitamins and minerals, which can cause problems. Niacin, one vitamin that is given in high doses as part of the regimen, can be particularly dangerous. The US National Institutes of Health warns that at high doses it can cause “liver problems, gout, ulcers of the digestive tract, loss of vision, high blood sugar, irregular heartbeat, and other serious problems.” It should not be taken by people who already have liver damage.

Seven fatalities of people undergoing the Narconon programme are currently being investigated in Oklahoma, although the CoS says these deaths are not connected with the treatment regimen itself.

Whatever the truth regarding these deaths, a review of the evidence about the treatment regimen’s effectiveness – carried out by the Norwegian Knowledge Centre for the Health Services in 2008 – found no good evidence that the Narconon programme works:

There is currently no reliable evidence for the effectiveness of Narconon as a primary or secondary drug prevention program. This is partly due to the insufficient research evidence about Narconon and partly due to the non-experimental nature of the few studies that exist.

The claim that such detox treatments eliminate toxins from the body is, of course, easily testable. All we would need to do is define what toxin we are talking about and measure the change in levels of that toxin compared with a control group of volunteers who did not receive the detox.

But such studies are not available. Why? Do the marketing men believe in their own claims? Maybe they feel that profits and evidence are like fire and water? Or possibly the thetans have an aversion to science?

If you think that the Purif, Narconon or any other form of alternative detox eliminates toxins, you might be mistaken. Most clients have lost some money, many have lost their ability to think straight, some may even have lost their lives. But there is no reliable evidence that they have actually lost any toxins.

END OF MY 2012 ARTICLE

In 2012, I found no evidence to suggest that NARCONON works. Now, I looked again and found this article reporting a non-randomised, controlled study:

“In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. After informed parental consent, approximately 1000 Oklahoma and Hawai’i high school students completed a modified Center for Substance Abuse Prevention (CSAP) Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant reductions measured for alcohol and amphetamines. The program also produced changes in knowledge, attitudes and perception of risk. The eight-module Narconon curriculum has thorough grounding in substance abuse etiology and prevention theory. Incorporating several historically successful prevention strategies this curriculum reduced drug use among youths.”

The question arises: would I send anyone to the NARCONON programme?

My answer is NO!

Not because the trial is lousy (which it is) and not because the programme is too expensive (which it is); I would not send anyone to any institution that has even the slightest links to Scientology.

 

Drug and alcohol dependencies are notoriously difficult to treat effectively. Patients and their families are often desperate and willing to try anything. This seems like an ideal ground for acupuncturists who are, in my experience, experts in putting up smokescreens hiding the true value of their treatment.

The best way to determine the value of any intervention is probably conducting a systematic review of the evidence from rigorous clinical trials. Today we are in the fortunate position to have not just one of those articles; but do they really tell us the truth?

This brand-new systematic review investigated the effects of acupuncture on alcohol-related symptoms and behaviors in patients with this disorder. The PubMed database was searched until 23 August 2016, and reference lists from review studies were also reviewed. The inclusion criteria were the following: (1) being published in a peer-reviewed English-language journal, (2) use of randomized controlled trials (RCTs), (3) assessing the effects of acupuncture on psychological variables in individuals with a primary alcohol problem, and (4) reporting statistics that could be converted to effect sizes.

Seventeen studies were identified for a full-text inspection, and seven (243 patients) of these met our inclusion criteria. The outcomes assessed at the last post-treatment point and any available follow-up data were extracted from each of the studies. Five studies treated patients by inserting a needle into several acupoints in each ear. Two studies stimulated body points with or without ear stimulation. Four studies treated control patients with a placebo needle or under a completely different type of intervention, such as relaxation or transdermal stimulation, whereas the remaining studies inserted needles into nonspecific points. The patients were treated for 2 weeks to 3 months, and the treatment duration per session was 15–45 min. The results of the meta-analysis demonstrated that an acupuncture intervention had a stronger effect on reducing alcohol-related symptoms and behaviours than did the control intervention. A beneficial but weak effect of acupuncture treatment was also found in the follow-up data.

The authors concluded that although our analysis showed a significant difference between acupuncture and the control intervention in patients with alcohol use disorder, this meta-analysis is limited by the small number of studies included. Thus, a larger cohort study is required to provide a firm conclusion.

I am used to reading poor research papers, but this one is like a new dimension. Here are just the most obvious flaws:

  • by searching just one database, the likelihood of missing studies is huge,
  • by excluding non-English papers, the review automatically becomes non-systematic,
  • the included studies differed vastly in many respects and can therefore not be pooled.

As it happens, a further meta-analysis has just been published. Here is its abstract:

Acupuncture has been widely used as a treatment for alcohol dependence. An updated and rigorously conducted systematic review is needed to establish the extent and quality of the evidence on the effectiveness of acupuncture as an intervention for reducing alcohol dependence. This review aimed to ascertain the effectiveness of acupuncture for reducing alcohol dependence as assessed by changes in either craving or withdrawal symptoms.

Methods

In this systematic review, a search strategy was designed to identify randomised controlled trials (RCTs) published in either the English or Chinese literature, with a priori eligibility criteria. The following English language databases were searched from inception until June 2015: AMED, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and PubMed; and the following Chinese language databases were similarly searched: CNKI, Sino-med, VIP, and WanFang. Methodological quality of identified RCTs was assessed using the Jadad Scale and the Cochrane Risk of Bias tool.

Results

Fifteen RCTs were included in this review, comprising 1378 participants. The majority of the RCTs were rated as having poor methodological rigour. A statistically significant effect was found in the two primary analyses: acupuncture reduced alcohol craving compared with all controls (SMD = −1.24, 95% CI = −1.96 to −0.51); and acupuncture reduced alcohol withdrawal symptoms compared with all controls (SMD = −0.50, 95% CI = −0.83 to −0.17). In secondary analyses: acupuncture reduced craving compared with sham acupuncture (SMD = −1.00, 95% CI = −1.79 to −0.21); acupuncture reduced craving compared with controls in RCTs conducted in Western countries (SMD = −1.15, 95% CI = −2.12 to −0.18); and acupuncture reduced craving compared with controls in RCTs with only male participants (SMD = −1.68, 95% CI = −2.62 to −0.75).

Conclusion

This study showed that acupuncture was potentially effective in reducing alcohol craving and withdrawal symptoms and could be considered as an additional treatment choice and/or referral option within national healthcare systems.

This Meta-analysis is only a little better than the first, I am afraid. What its conclusions do not sufficiently reflect, in my view, is the fact that the quality of the primary studies was mostly very poor – too poor to draw conclusions from (other than ‘acupuncture research is usually lousy’; see figure below). Therefore, I fail to see how the authors could draw the relatively firm and positive conclusions cited above. In my view, they should have stated something like this: DUE TO THE RISK OF BIAS IN MANY TRIALS, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.

The authors of the first meta-analysis open the discussion by proudly declaring that “the present study is the first meta-analysis to examine the effect of acupuncture treatment on patients with alcohol use disorder and to provide data on the magnitude of this effect on alcohol-related clinical symptoms and behaviours.” They discretely overlook this meta-analysis from 2009 (and several others which even their rudimentary search would have identified):

Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook.

Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal.

The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues.

One does not need to be an expert in interpreting meta-analyses, I think, to see that this paper is more rigorous than the new ones (which incidentally were published in the very dubious journals). And this is why I trust the conclusions of this last-named meta-analysis more than those of the new one: the efficacy of acupuncture remains unproven. And this means that we should not employ or promote it for routine care.

Several months ago, the Gibraltar Homeopathic Council (GHC) had called for an emergency meeting to discuss the future of Gibraltar. At that meeting, members voiced grave concern over Brexit; the main problem, they predicted, would be that Spain might use the general confusion during the early days of the negotiations to claim back their homeland. It was then that they decided to meet with their patron, Prince Charles. A secret meeting was thus held at High Grove in the presence of leading UK homeopaths, and a cunning plan was devised.

Back in Gibraltar, a team of researchers went to work to develop and test ‘Rock C30’. This novel and innovative remedy is produced by potentising Gibraltar rock according to the ‘like cures like’ principle. Pilot studies were hurriedly arranged, and their results indicated that Rock C30 was indeed a powerful remedy that neutralised all ambitions of individuals wanting to take possession of Gibraltar. Its mechanism of action is as yet unclear, but homeopaths believe it works holistically via stimulating the vital force. The study concluded that Rock C30 added to the water supplies of a small group of Spanish chauvinists proved to totally abolish their desire to consider annexing Gibraltar. The remedy caused no adverse effects and is therefore ready for routine application on a large scale.

The report which has been leaked to the Daily Mail also stated that the development of the new remedy was inspired by the research done on ‘Berlin Wall’, an equally effective solution to potentially difficult situations. Well-informed circles close to the GHC indicate that large supplies of Rock C30 have already been smuggled into Spain and are about to be dropped into the water supplies of its capital.

The president of the GHC apparently stated that ” this is an exciting development which will guarantee the future of Gibraltar as an integral part of the UK.” The patron of the GHC, Prince Charles, is said to have mumbled: “I am pleased not just for the sake of Gibraltar, but also for the sake of homeopathy. Even my cows in Cornwall have been more clever than those despicable homeopathy-deniers; my cows always knew it works.”

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