After a previous post about aromatherapy, someone recently commented:
I love essential oils and use them daily. Essential oils became a part of my life! I do feel better with it! Why I need clinical trials so?
The answer is probably: you don’t need clinical trials for a little pampering that makes you feel good.
But, if someone claims that aromatherapy (or indeed any other treatment) is effective for this or that medical condition, we need proof in the form of a clinical trial. By proof, we usually mean a clinical trial.
One like this new study, perhaps?
The aim of this study was to evaluate the use of a lavender aromatherapy skin patch on anxiety and vital sign variability during the preoperative period in female patients scheduled for breast surgery. Participants received an aromatherapy patch in addition to standard preoperative care. Anxiety levels were assessed with a 10-cm visual analogue scale (VAS) at baseline and then every 15 minutes after patch placement. Vital sign measurements were recorded at the same interval. There was a statistically significant decrease (P = .03) in the anxiety VAS measurements from baseline to final scores.
The authors concluded that the findings from this study suggest the use of aromatherapy is beneficial in reducing anxiety experienced by females undergoing breast surgery. Further research is needed to address the experience of preoperative anxiety, aromatherapy use, and the challenges of managing preoperative anxiety.
No, not one like this study!
This study – its called it a ‘pilot study’ – tells us nothing of value.
- It was not a pilot study because it did not pilot anything; its aim was to evaluate aromatherapy.
- But it could not evaluate aromatherapy because it had no control group. This means the reduction in anxiety was almost certainly not a specific effect of the therapy, but a non-specific effect due to the extra attention, expectation, etc.
- This means that the conclusion (the use of aromatherapy is beneficial) is not justified.
- In turn, this means that the paper is not helpful in any way. All it can possibly do is to mislead the public.
In summary: another fine example of pseudo-research that, I believe, is worse than no research at all.
Aromatherapy usually involves the application of diluted essential (volatile) oils via a gentle massage of the body surface. The chemist Rene-Maurice Gattefosse (1881-1950) coined the term ‘aromatherapy’ after experiencing that lavender oil helped to cure a severe burn of his hand. In 1937, he published a book on the subject: Aromathérapie: Les Huiles Essentielles, Hormones Végétales. Later, the French surgeon Jean Valnet used essential oils to help heal soldiers’ wounds in World War II.
Aromatherapy is currently one of the most popular of all alternative therapies. The reason for its popularity seems simple: it is an agreeable, luxurious form of pampering. Whether it truly merits to be called a therapy is debatable.
The authors of this systematic review stated that they wanted to critically assess the effect of aromatherapy on the psychological symptoms as noted in the postmenopausal and elderly women. They conducted electronic literature searches and fount 4 trials that met their inclusion criteria. The findings demonstrated that aromatherapy massage significantly improves psychological symptoms in menopausal, elderly women as compared to controls. In one trial, aromatherapy massage was no more effective than the untreated group regarding their experience of symptoms such as nervousness.
The authors concluded that aromatherapy may be beneficial in attenuating the psychological symptoms that these women may experience, such as anxiety and depression, but it is not considered as an effective treatment to manage nervousness symptom among menopausal women. This finding should be observed in light of study limitations.
In the discussion section, the authors state that to the best of our knowledge, this is the first meta-analysis evaluating the effect of aromatherapy on the psychological symptoms. I believe that they might be mistaken. Here are two of my own papers (other researchers have published further reviews) on the subject:
- Aromatherapy is the therapeutic use of essential oil from herbs, flowers, and other plants. The aim of this overview was to provide an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Several SRs of aromatherapy have recently been published. Due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
- Aromatherapy is becoming increasingly popular; however there are few clear indications for its use. To systematically review the literature on aromatherapy in order to discover whether any clinical indication may be recommended for its use, computerised literature searches were performed to retrieve all randomised controlled trials of aromatherapy from the following databases: MEDLINE, EMBASE, British Nursing Index, CISCOM, and AMED. The methodological quality of the trials was assessed using the Jadad score. All trials were evaluated independently by both authors and data were extracted in a pre-defined, standardised fashion. Twelve trials were located: six of them had no independent replication; six related to the relaxing effects of aromatherapy combined with massage. These studies suggest that aromatherapy massage has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
Omitting previous research may be odd, but it is not a fatal flaw. What makes this review truly dismal is the fact that the authors fail to discuss the poor quality of the primary studies. They are of such deplorable rigor that one can really not draw any conclusion at all from them. I therefore find the conclusions of this new paper unacceptable and think that our statement (even though a few years old) is much more accurate: the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
Fish oil (omega-3 PUFA) preparations are today extremely popular and amongst the best-researched dietary supplement. During the 1970s, two Danish scientists, Bang and Dyerberg, remarked that Greenland Eskimos had a baffling lower prevalence of coronary artery disease than mainland Danes. They also noted that their diet contained large amounts of seal and whale blubber and suggested that this ‘Eskimo-diet’ was a key factor in the lower prevalence. Subsequently, a flurry of research stared to investigate the phenomenon, and it was shown that the ‘Eskimo-diet’ contained unusually high concentrations of omega-3 polyunsaturated fatty acids from fish oils (seals and whales feed predominantly on fish).
Initial research also demonstrated that the regular consumption of fish oil has a multitude of cardiovascular and anti-inflammatory effects. This led to the promotion of fish oil supplements for a wide range of conditions. Meanwhile, many of these encouraging findings have been overturned by more rigorous studies, and the enthusiasm for fish oil supplements has somewhat waned. But now, a new paper has come out with surprising findings.
The objective of this meta-analysis was to evaluate the association of anxiety symptoms with omega-3 PUFA treatment compared with controls in varied populations.
A search was performed of clinical trials assessing the anxiolytic effect of omega-3 PUFAs in humans, in either placebo-controlled or non–placebo-controlled designs. Of 104 selected articles, 19 entered the final data extraction stage. Two authors independently extracted the data according to a predetermined list of interests. A random-effects model meta-analysis was performed. Changes in the severity of anxiety symptoms after omega-3 PUFA treatment served as the main endpoint.
In total, 1203 participants with omega-3 PUFA treatment and 1037 participants without omega-3 PUFA treatment showed an association between clinical anxiety symptoms among participants with omega-3 PUFA treatment compared with control arms. Subgroup analysis showed that the association of treatment with reduced anxiety symptoms was significantly greater in subgroups with specific clinical diagnoses than in subgroups without clinical conditions. The anxiolytic effect of omega-3 PUFAs was significantly better than that of controls only in subgroups with a higher dosage (at least 2000 mg/d) and not in subgroups with a lower dosage (<2000 mg/d).
The authors concluded that this review indicates that omega-3 PUFAs might help to reduce the symptoms of clinical anxiety. Further well-designed studies are needed in populations in whom anxiety is the main symptom.
I think this is a fine meta-analysis reporting clear results. I doubt that this paper truly falls under the umbrella of alternative medicine, but fish oil is a popular food supplement and should be mentioned on this blog. Of course, the average effect size is modest, but the findings are nevertheless intriguing.
The two German authors start their article (it is in German but has an English abstract to which I refer here) by claiming that “homeopathy is steadily gaining in sympathy in the population.” This is a very odd statement, considering that the sales figures in Germany and elsewhere have, in fact, been declining. Any homeopathy-paper with such an opening is naturally of interest to me.
As I read on, I find further surprises: “the possible effectiveness and the modes of action are currently not scientifically elucidated.” These are two big assumptions which happen to be both untrue:
- The effectiveness of homeopathy has now been tested in about 500 clinical trials, and the totality of the reliable evidence from these studies fails to show that highly diluted homeopathic remedies are more than placebos.
- The mode of action of homeopathy isn’t “not scientifically elucidated“, but the relevant science tells us that there cannot be a mode of action that is in line with the laws of nature as we understand them today.
And the surprises keep on coming: “there is a whole series of positive evidence for the effects of homeopathic remedies for mental disorders, such as depression, anxiety disorders and addiction.” This statement is not in keeping with the results of a systematic review (which, by the way was authored by ardent homeopaths); here is the abstract:
To systematically review placebo-controlled randomized trials of homeopathy for psychiatric conditions.
Eligible studies were identified using the following databases from database inception to April 2010: PubMed, CINAHL, PsycINFO, Hom-Inform, Cochrane CENTRAL, National Center for Complementary and Alternative Medicine grantee publications database, and ClinicalTrials.gov. Gray literature was also searched using Google, Google Scholar, the European Committee for Homeopathy, inquiries with homeopathic experts and manufacturers, and the bibliographic lists of included published studies and reviews. Search terms were as follows: (homeopath* or homoeopath*) and (placebo or sham) and (anxiety or panic or phobia or post-traumatic stress or PTSD or obsessive-compulsive disorder or fear or depress* or dysthym* or attention deficit hyperactivity or premenstrual syndrome or premenstrual disorder or premenstrual dysphoric disorder or traumatic brain injury or fibromyalgia or chronic fatigue syndrome or myalgic encephalitis or insomnia or sleep disturbance). Searches included only English-language literature that reported randomized controlled trials in humans.
Trials were included if they met 7 criteria and were assessed for possible bias using the Scottish Intercollegiate Guidelines Network (SIGN) 50 guidelines. Overall assessments were made using the Grading of Recommendations Assessment, Development and Evaluation procedure. Identified studies were grouped into anxiety or stress, sleep or circadian rhythm complaints, premenstrual problems, attention-deficit/hyperactivity disorder, mild traumatic brain injury, and functional somatic syndromes.
Twenty-five eligible studies were identified from an initial pool of 1,431. Study quality according to SIGN 50 criteria varied, with 6 assessed as good, 9 as fair, and 10 as poor. Outcome was unrelated to SIGN quality. Effect size could be calculated in 16 studies, and number needed to treat, in 10 studies. Efficacy was found for the functional somatic syndromes group (fibromyalgia and chronic fatigue syndrome), but not for anxiety or stress. For other disorders, homeopathy produced mixed effects. No placebo-controlled studies of depression were identified. Meaningful safety data were lacking in the reports, but the superficial findings suggested good tolerability of homeopathy. A funnel plot in 13 studies did not support publication bias (χ(2)(1) = 1.923, P = .166).
The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.
And specifically for depression, another review (also by proponents of homeopathy) is available; here is its abstract:
To systematically review the research evidence on the effectiveness of homeopathy for the treatment of depression and depressive disorders.
A comprehensive search of major biomedical databases including MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Library was conducted. Specialist complementary and alternative medicine (CAM) databases including AMED, CISCOM and Hom-Inform were also searched. Additionally, efforts were made to identify unpublished and ongoing research using relevant sources and experts in the field. Relevant research was categorised by study type and appraised according to study design. Clinical commentaries were obtained for studies reporting clinical outcomes.
Only two randomised controlled trials (RCTs) were identified. One of these, a feasibility study, demonstrated problems with recruitment of patients in primary care. Several uncontrolled and observational studies have reported positive results including high levels of patient satisfaction but because of the lack of a control group, it is difficult to assess the extent to which any response is due to specific effects of homeopathy. Single-case reports/studies were the most frequently encountered clinical study type. We also found surveys, but no relevant qualitative research studies were located.: Adverse effects reported appear limited to ‘remedy reactions’ (‘aggravations’) including temporary worsening of symptoms, symptom shifts and reappearance of old symptoms. These remedy reactions were generally transient but in one study, aggravation of symptoms caused withdrawal of the treatment in one patient.
A comprehensive search for published and unpublished studies has demonstrated that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. Further research is required, and should include well-designed controlled studies with sufficient numbers of participants. Qualitative studies aimed at overcoming recruitment and other problems should precede further RCTs. Methodological options include the incorporation of preference arms or uncontrolled observational studies. The highly individualised nature of much homeopathic treatment and the specificity of response may require innovative methods of analysis of individual treatment response.
Back to the new article I started discussing above. Its authors make a vague attempt at being reasonable: “It is clear that homoeopathic remedies can only be used as an add-on and not alone.” I find this statement slightly puzzling. If (as the authors assume) homeopathy is effective for mental disorders, why not on its own? Can a therapy that must not be used as a sole treatment be called effective?
The authors continue with another caveat: “These remedies belong in the hands of physicians experienced in homeopathic and psychiatric psychopharmacology.” That’s actually quite funny! As the average homeopath has no experience in psychiatric psychopharmacology, they must not use homeopathy for mental conditions. I would agree with the conclusion but not with the reason given for it.
And now to the ‘grand finale’, the conclusion: “It would be advisable to at least try out homeopathy for the well-being of the patient not only in the case of very mild disorders but also in severe chronic cases, since due to the generally good tolerability, no avoidable disadvantage should result.” That sort of conclusion makes me almost speechless. The evidence fails to show that it works, yet it is ADVISABLE to use it in severe chronic cases!
Such articles suggest to me that homeopathy is a cult where logic and reason are irrelevant and need to be supressed. They also indicate that something is amiss with medical publishing. How can it be that, in 2018, ‘Der Nervenarzt’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? ‘Der Nervenarzt‘, by the way, claims to be an internationally recognized journal addressing neurologists and psychiatrists working in clinical or practical environments. Essential findings and current information from neurology, psychiatry as well as neuropathology, neurosurgery up to psychotherapy are presented.
This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.
Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.
The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.
This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.
Ethics committees should not accept such protocols.
Researchers should stop running such studies.
Reviewers should not pass them for publication.
Editors should not publish such trials.
THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.
The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who
- strictly prescribe conventional medicines (GP-CM),
- regularly prescribe homeopathy in a mixed practice (GP-Mx),
- or are certified homeopathic GPs (GP-Ho).
The investigation was an epidemiological cohort study of general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.
Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group, but not for the GP-Mx group.
The authors concluded that patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.
Aren’t we glad they added the last sentence to their conclusion!!!
Without it, one might have thought that the observed differences were due to the homeopathic remedies. In fact, the finding amounts to a self-fulfilling prophecy: Homeopaths tend to be against prescribing conventional drugs. This means that patients consulting homeopaths are bound to use less drugs than patients who consult conventional doctors. In that sense, the study was like monitoring whether consumers who go to the butchers buy more meat than those shopping in a shop for vegetarians.
The only result that requires a more serious consideration is that homeopathically treated patients experienced more clinical improvement than those treated conventionally. But even this difference is not hard to explain: firstly, the difference was merely marginal; secondly, patients with ADD are bound to respond particularly well to the empathetic and long therapeutic encounter most homeopaths offer. In other words, the difference had nothing to do with the alleged effectiveness of the homeopathic remedies.
The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.
This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.
The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.
The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.
The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.
The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base.
The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:
- the natural history of the conditions that were being treated;
- the conventional therapies the soldiers received;
- the regression to the mean;
- social desirability;
- placebo effects.
In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.
Today is WORLD CANCER DAY.
Yesterday I prepared you for this event by alerting you to a disgusting cancer scam, and today I want to contrast this with more encouraging news from the strange world of alternative medicine. So I searched Medline for a fitting, recent publication showing at least some value of an alternative therapy. Believe me, such papers are few and far between.
But here is one:
The aim of this Cochrane review was to assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment. The authors conducted extensive literature searches and applied no language restrictions. RCTs were eligible, if they (1) compared yoga interventions to no therapy or to any other active therapy in women with a diagnosis of breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances.
Two review authors independently collected data on methods and results. The risk of publication bias was assessed through visual analysis of funnel plot symmetry and heterogeneity between studies. Subgroup analyses were conducted for current treatment status, time since diagnosis, stage of cancer and type of yoga intervention.
Twenty-four studies with a total of 2166 participants were included, 23 of which provided data for meta-analysis. Thirteen studies had low risk of selection bias, five studies reported adequate blinding of outcome assessment and 15 studies had low risk of attrition bias. Seventeen studies that compared yoga versus no therapy provided moderate-quality evidence showing that yoga improved health-related quality of life, reduced fatigue and reduced sleep disturbances in the short term. There was an overall low risk of publication bias.
Yoga did not appear to reduce depression or anxiety in the short term and had no medium-term effects on health-related quality of life or fatigue. Four studies that compared yoga versus psychosocial/educational interventions provided moderate-quality evidence indicating that yoga can reduce depression, anxiety and fatigue in the short term. Very low-quality evidence showed no short-term effects on health-related quality of life or sleep disturbances. Three studies that compared yoga to exercise presented very low-quality evidence showing no short-term effects on health-related quality of life or fatigue. No trial provided safety-related data.
The authors concluded that moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.
As I said, this is most encouraging. Many women are attracted by yoga, and the news that it can improve their symptoms is clearly positive. I have said it often, but I say it again: in supportive and palliative cancer care there might be an important role for several forms of CAM. One has to make sure though that they do not interfere with conventional treatments, and – this is very important – cancer patients must not be misled to believe that they can be used to treat or cure cancer. Finally, patients should not pitch their hopes too high: the effect sizes of alternative treatments in cancer care are invariably small or modest which means that they can help to reduce symptoms but are unlikely to get rid of them completely.
On an even more sober note, I have to reiterate that none of the trials included in the above review reported safety data (yoga is not totally devoid of adverse-effects!). This is an almost stereotypical finding when assessing clinical trials of alternative therapies. It discloses a clear and unacceptable breach of publication ethics. How can we ever get a realistic impression of the risks of alternative medicine, if adverse effects remain unreported? It is high time that researchers, authors, journal editors and reviewers get this message and behave accordingly.
If you want to scientifically investigate this question, it might be a good idea NOT to start with the following sentence: “Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety”. Yet, this is exactly what the authors did in their recent publication.
The aim of this new study was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner. Subsequently they completed three comparable oral anatomy exams with an interval of one month between the exams/interventions.
A licensed acupuncturist with more than five years of experience with this technique applied AA at the acupuncture points MA-IC1 (Lung), MA-TF1 (ear Shenmen), MA-SC (Kidney), MA-AT1 (Subcortex) and MA-TG (Adrenal gland) bilaterally. Indwelling fixed ‘New Pyonex’ needles embedded in a skin-coloured adhesive tape were used for AA. The participants were instructed by the acupuncturist to stimulate the auricular needles for 3–5 minutes, if they felt anxious. For the placebo procedure, ‘New Pyonex’ placebo needles were attached to five sites on the helix of the auricle bilaterally. ‘New Pyonex’ placebo needles have the same appearance as AA needles but consist of self-adhesive tape only. In order to avoid potential physiologic effects of acupressure, the participants were not instructed to stimulate the attached ‘New Pyonex’ placebo needles. AA and placebo needles were left in situ until the next day and were removed out of sight of the participants after the exam by the investigator, who was not involved in acupuncture procedure
Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding.
All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). Moreover, AA was also better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention.
The authors concluded that both auricular acupuncture and placebo procedure were shown to be effective in reducing levels of exam anxiety in medical students. The superiority of verum AA over placebo AA and no intervention is considered to be due to stimulation of cranial nerves, but may have been increased in effect by insufficient participant blinding.
Here are just three of the major concerns I have about this study:
- The trial design seems odd: a crossover study can only work well, if there is a stable baseline. This may not be the case with three consecutive exams; the anxiety experienced by students is bound to get less as time goes by. I think anyone who has passed a series of exams will confirm that there is a large degree of habituation.
- It seems inadequate to employ just one acupuncturist; it means that the trial might end up testing not acupuncture per se but the skills of the therapist.
- The placebo used for this study cannot possibly have fooled anyone into believing that it was real AA; volunteers were not even instructed to ‘stimulate’ the placebo devices. The difference to the ‘real thing’ must have been very clear to all involved. This means that the control for placebo-effects was woefully incomplete. In turn, this means that the observed outcomes are most likely due to residual bias.
In view of these concerns, allow me to re-phrase the authors’ conclusions:
THE RESULTS OF THIS POORLY-DESIGNED STUDY ARE DIFFICULT TO INTERPRET. MOST LIKELY THEY SHOW THAT ACUPUNCTURE IS NOT EFFECTIVE BUT MERELY WORKS THROUGH A PLACEBO-RESPONSE.
A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:
1. Addiction recovery
Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.
2. Helps the body heal itself
The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.
3. Builds a stronger immune system
The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.
4. Eliminate that killer hangover
While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.
5. Mood stabilizer
If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.
6. Chronic stomach problems
Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.
7. Coping with death
Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.
END OF QUOTE
The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:
- There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation. There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
- Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
- Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
- Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
- The same applies to acupuncture to ‘stabilize’ your mood.
- Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
- I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.
So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!
Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!
IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE
- Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
- ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
- Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
- Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
- For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
- The claim of acupuncturists that acupuncture is entirely safe is false.
- Acupuncture studies from China cannot be trusted.