placebo
he German press reported yesterday that the country’s Health Minister Karl Lauterbach plans to remove homeopathic treatments from the benefits catalog of statutory health insurance companies. “Services that have no medically verifiable benefit should not be financed from contribution funds,” states a recommendation paper by the minister. “For this reason, we will remove the option for health insurance companies to include homeopathic and anthroposophic services in their statutes, thereby avoiding unnecessary expenditure by health insurance companies.” However, private supplementary insurance should still be possible.
Lauterbach had already announced last year that he would review the funding of homeopathic treatments. “Although homeopathy is not significant in terms of expenditure, it has no place in a science-based healthcare policy,” the SPD politician told “Der Spiegel” last October. The measure would save merely a maximum of ten million Euros. This is because firstly not all health insurance companies offer the option to reimburse homeopathy, and secondly, because not that many Germans use homeopathy.
____________________________
Before I was joined about a decade ago by a group of excellent and effective skeptics, I seemed to be a lone, lost voice in Germany cautioning against the misunderstanding that homeopathy and anthroposophical medicine were backed by evidence. Thus, you probably think that I am rejoicing at this spectacular success. At first glance, it does indeed seem to be great news for those who support evidence-based medicine. But sadly, I also have second thoughts.
We should, I think, be concerned that Lauterbach intends to leave homeopathic and anthroposophical remedies reimbursible via private supplementary insurance. Most Germans have such insurance which means that, despite Lauterbach’s grand announcement, very little will probably change. Homeopathy and anthroposophic medicine, both pure placebo therapies, will still be able to pretend to be real medicine.
Moreover, we should be concerned about Lauterbach’s reasoning. It is, of course, laudable to point out that homeopathic and anthroposophic remedies are not demonstrably effective. But clearly, this is only half of the truth. The full truth is that they are based on totally ridiculous assumptions, that, in other words, they fly in the face of science. Only if we manage to get this message across, will we inform the public responsibly, in my view.
A total ban then? No, personally, I don’t want to ban homeopathic or anthroposophical remedies. If someone loves esoteric nonsense or placebos, he/she should, in my view, be able to buy them. But he/she should use their own money for the purchase. We should remember that wasting notoriously scarce public funds from either statutory or private health insurances is not just uneconomical but foremost unethical.
This systematic review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included. Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. The findings reveal:
- High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p=0.004).
- There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p=0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p=0.11).
- Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p=0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p=0.008) at the endpoint intervention.
- There was no evidence indicating the association between pain reduction and different types of cupping (p=0.2).
- Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p=0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p=0.78) at the endpoint intervention.
- Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p<0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p=0.29).
- A potential association between pain reduction and different cupping locations (p=0.05) was found.
- Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n=8; d=1.8 [95% CI: 1.22 – 2.39], p<0.001) and usual care (n=5; d=1.07 [95% CI: 0.21- 1.93], p=0.01).
- Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 hours, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p<0.001).
- Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p=0.03).
- There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p=0.39).
- A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The real therapeutic effects of cupping could be confirmed using a sham device or objective outcome measurements. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
Confused?
No need, it’s really quite simple: cupping can, according to this review, be shown to have some short-lasting effect, provided the study is flawed and does not control for placebo effects.
Surprised?
No need! There is hardly a form of so-called alternative medicine (SCAM) that does not have a similarly small effect of back pain, if tested in equally dodgy studies. This is particularly true for those treatments that can act as a theatrical placebo, e.g. acupuncture or chiropractic.
So, should a back pain sufferer try cupping?
If he/she insists, why not? But please don’t use wet cupping (which can do quite a bit of harm). Dry cupping (without injuring the skin) is arguably better (less risk, less expense, possibility of home treatment by your partner) than chiropractic, osteopathy, acupuncture, or many other SCAMs.
My conclusions – as mentioned many times previously – are as follows:
- Most SCAMs help a little with back pain (and similar conditions) because they can have a powerful placebo effect.
- Conventional medicine is also not convincingly effective for back pain.
- If you insist on SCAM, it is best to use one that is relatively harmless and inexpensive.
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.
This study investigated the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.
The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care.
Outcome parameters were evaluated after 8, 16 and 24 wk. They included:
- neurological scores, such as an 11-point numeric rating scale (NRS) for hypesthesia,
- neuropathic pain symptom inventory (NPSI),
- neuropathy deficit score (NDS),
- neuropathy symptom score (NSS);
- nerve conduction studies (NCS) as assessed with a handheld point-of-care device.
Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.
The authors concluded that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.
That “acupuncture may be beneficial” has been known before and presumably was the starting point of the present study. So, why conduct an open, under-powered trial with non-blind assessors and without defining a primary outcome measure?
Could the motivation be to add yet another false-positive study to the literature of acupuncture?
False-positive, you ask?
Yes, let me explain by having a look at the outcome measures:
- NRS = a subjective endpoint.
- NPSI = a subjective endpoint.
- NDS = a subjective endpoint.
- NSS = a subjective endpoint.
- NCS = the only objective endpoint.
And what is remarkable about that?
- Subjective endpoints are likely to respond to placebo effects.
- Objective endpoints are not likely to respond to placebo effects.
In other words, what the authors of this study have, in fact, confirmed with their study is this:
acupuncture is a theatrical placebo!
Some articles are just too remarkable for me to alter them in any way. This one impresses already by its title: “Ameliorative effects of homeopathic medicines in the management of different cancers“. By way of a ‘Christmas treat’, here its summary:
Homeopathy is a commonly used complementary and alternative system of medicine for the treatment of various sorts of ailments throughout the world. Homeopathic medicines are made up of potential therapeutic natural products that are primarily acknowledged for their low doses as well as extended patient survival results. Homeopathic medicines are derived from plants such as arnica (mountain herb), red onion, poison ivy, stinging nettle, and belladonna (deadly nightshade); minerals including white arsenic as well as from animals such as crushed whole bees. Homeopathic medicines are synthesized as sugar pellets to be placed under the tongue and may also be used in the form of gels, ointments, drops, tablets, and creams. Homeopathic medicines can be used to treat various disorders including migraine, depression, gastrointestinal diseases, joint pain, inflammation, different sorts of injuries, flu, arthritis as well as sciatica.
Cancer is the 2nd major reason behind global mortalities. It is revealed that developing countries around the world shoulder most of the cancer burden. According to a survey conducted in 2020, low- and middle-income countries face 70% of the total mortalities worldwide which accounts for approximately 10 million people of these countries. Homeopathic medicines ensure low-cost cancer treatment with little or no side effects on the bodies of humans and animals. Besides, it is applied as a supportive and palliative therapy in a broad range of cancer patients to enhance the body’s fight against cancer, alleviate discomfort resulting from disease or conventional treatments as well as improve the general well-being of the patients. In this chapter, our primary focus will be on the anti-cancerous effects of homeopathic medicines against different cancerous conditions in the body along with their mechanism of action.
Let me just mention a few fairly obvious points:
- Homeopathic medicines are made up of potential therapeutic natural products … REALLY? Have a look at those remedies, for instance:
- Blue (colour)
- Eclipse Totality
- Electricitas (Electricity – 80,000 volts)
- Electricitas (High Voltage Pylon)
- Green (colour)
- Halogen light
- Indigo (colour)
- Laser – red (Diode Laser Red)
- Laser Beam (2940 nm)
- LED (white) (White L(ight) E(mitting) D(iode) Light)
- LIGHT (ENERGY SAVING BULB)
- Luna (Moonlight)
- Microwave 750 MHz
- Milky Way (Essence)
- Mobile phone (Eising)
- Mobile Phone 1800MHz
- Mobile Phone 900Mhz
- Mobile Phone Mast G3
- Polaris (North star)
- Purple (Colour)
- Radiation Combination (Guild Radiation Combination)
- Rainbow (Spectrum)
- Red (colour)
- Red ( A. Wauters)
- Sol Africana
- Sol Australis (Sunlight – Australia)
- Sol Britannic (Sunlight British)
- Stonehenge (Emanation)
- Sunlight Blue (Prismatic blue from sunlight)
- Sunlight Green (Prismatic green from sunlight)
- Sunlight Orange (Prismatic orange from sunlight)
- Sunlight Purple (Prismatic purple from sunlight)
- Sunlight Red (Prismatic Red from Sunlight)
- Sunlight Yellow (Prismatic yellow from sunlight)
- Ultrasound (General)
- Ultrasound (Vaginal)
- Ultraviolet Light
- Vacuum
- Wind (South-West)
- X-ray
- Homeopathic medicines are derived from plants such as arnica (mountain herb), red onion, poison ivy, stinging nettle, and belladonna (deadly nightshade); minerals including white arsenic as well as from animals such as crushed whole bees. REALLY? Consider these remedies, for example:
- Aqua Aurum (Gold and sea water)
- Aqua Fida Vetusta (Old Faithful Water)
- Aqua Hochstein (Spring Source water from the Bavarian Forest)
- Aqua marina (Sea Water)
- Aqua nova
- Aqua Odilien
- Aqua Pura Bottled Water
- Aqua Schuasta
- Aqua Sulis (Water from Bath, Roman Spa)
- Aqua Victoria Falls
- Aqua XwMuthkwium (Musqueam Creek Water)
- Chalice Well Water
- Dead Sea Water
- Double Helix Water
- Ganga water (water from the River Ganges)
- Ganga Water (Gaumuk)
- Ganga Water (Varanasi)
- Gastein (Gastein Aqua)
- Geum Rivale (Water Avens)
- Halltal Spring Water (Water from Solbadhall in Tirol)
- Levico water (from lake in N Italy)
- Lourdes Water
- Nadana Water
- Nigari (Concentrated Japanese seawater)
- Nordenau water
- Seven Spring Head Water
- Severn Water (Source)
- Water (Guild)
- Wiesbaden Aqua (Wiesbaden Water)
- Winchelsea Water
- Zamzam aqua (Zamzam spring water [Mecca])
- Homeopathic medicines are synthesized… No, they are manufactured.
- Homeopathic medicines can be used to treat various disorders… albeit without any effect beyond placebo!
- Homeopathic medicines ensure low-cost cancer treatment with little or no side effects… and no therapeutic effect beyond placebo!
- Besides, it is applied as a supportive and palliative therapy in a broad range of cancer patients to enhance the body’s fight against cancer, alleviate discomfort resulting from disease or conventional treatments as well as improve the general well-being of the patients. This, I’m afraid, is a dangerous lie.
- …the anti-cancerous effects of homeopathic medicines… do not exist.
My conclusion:
Those who advocate homeopathy don’t know what it is, while those who know what it is, don’t advocate it.
I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):
Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].
Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:
- I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
- Successful concepts? Really?
- So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
- I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
- No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
- I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
- The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
- Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
- Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.
Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.
On the occasion of a talk that I recently gave in Italy, I was interviewed by VANITY FAIR ITALY. I gave it in English and it was published in Italian. As I don’t expect many readers to be fluent in Italian and since it was a good interview, in my view, I thought I give you here the English original:
1.How can we exactly define «alternative medicine»?
There is much confusion and a plethora of definitions, none of which is fully satisfactory. In fact, the term “alternative medicine” itself is nonsensical: if a therapy works, it belongs to evidence-based medicine; and if it doesn’t work, it cannot possibly be an alternative. I therefore have long been calling it “so-called alternative medicine” (SCAM). The definition I use for SCAM with lay audiences is simple: SCAM is an umbrella term for a diverse range of therapeutic and diagnostic methods that have little in common, other than being excluded from mainstream medicine.
2.Who uses it and why?
Predominantly women! Statistics say about 30-70% of the general population use SCAM. And with patient populations, the percentage can be close to 100%. They use it because they are told over and over again that SCAM is natural and thus safe, as well as effective for all sorts of conditions.
3.Focusing on terminology, is there a difference between «complementary» and «alternative» medicine?
Theoretically, there is a big difference between «complementary» and «alternative» medicine. The former is supposed to be used as an add-on to, while the latter is a replacement of mainstream medicine. In practice, this dividing line is very blurred; most SCAMs are used in both ways, depending on the actual situation and circumstance.
4.Are users different from non-users?
Yes, there has been much research on this and my reading of it is that SCAM users tend to be less intelligent, more religious, more superstitious, less trusting in science, and more prone to conspiracy theories, for instance.
5.Which forms of alternative medicine are the most popular?
There are certain national differences, but in most European countries herbal medicine, acupuncture, chiropractic, osteopathy, homeopathy, aromatherapy, and reflexology are amongst the most popular SCAMs.
6.Does it work?
With such a wide range – someone once counted over 400 modalities and my last book evaluated 202 of them (Alternative Medicine: A Critical Assessment of 202 Modalities (Copernicus Books): Amazon.co.uk: Ernst, Edzard: 9783031107092: Books) – it is impossible to answer with yes or no. In addition we need to consider the conditions that are being treated. Acupuncture, for example, is touted as a panacea, but might just work for pain. If you take all this into account, I estimate that less than 3% of the therapeutic claims that are being made for SCAM are supported by sound evidence.
Is it safe?
Again, impossible to say. Some treatments are outright dangerous; for instance, chiropractic neck manipulations can injure an artery and the patient suffers a stroke of which she can even die. Other treatments are assumed to be entirely harmless; for example homeopathy. But even that is untrue: if a cancer patient relies exclusively on homeopathy for a cure, she might easily hasten her death. Sadly, such things happen not even rarely.
Do its benefits outweigh its risks?
That depends very much on the treatment, the disease, and the precise situation. Generally speaking, there are very few SCAMs that fulfill this condition.
You said that these were the research questions that occupied all your life in Exeter. Did you find the answers?
We published more on SCAM than any other research group, and we found mostly disappointing answers. But still, I am proud of having found at least some of the most pressing answers. Even negative answers can make an important contribution to our knowledge.
7.What is the problem with the placebo effect?
All therapies can prompt a placebo effect. Thus an ineffective treatment can easily appear to be effective through generating a placebo effect. This is why we need to rely on properly conducted, if possible placebo-controlled trials, if we want to know what works and what not.
8.Is it true that some alternative medicines can cause significant harm?
see above
9.What about herbal remedies? What do studies show about them?
Many of our modern drugs originate from plants, Therefore, it is not surprising that we find herbal remedies that are effective. But careful! This also means that plants can kill you – think of hemlock, for instance. In addition herbal medicine can interact powerfully with synthetic drugs. So, it is wise to be cautious and get responsible advice.
10.Which alternative therapies are overrated and why?
In my view, almost all SCAMs are over-rated. If you go on the Internet, you find ~5 000 000 websites on SCAM. 99% of them try to sell you something and are unreliable or even dangerous. We need to be aware of the fact that SCAM has grown into a huge business and many entrepreneurs are out to get your money based on bogus claims.
11.On the contrary, which therapies could be seen as an integration in routine care?
The best evidence can be found in the realm of herbal medicine, for instance St John’s Wort. Some mind-body interventions can be helpful; also a few massage techniques might be worth a try. Not a lot, I’m afraid.
12.Would you tell us what happened in 2005 with Prince Charles?
He complained about my actions via his private secretary to my University. A 13 month investigation followed. At the end, I was found not guilty but my funding, my team, my infrastructure had been dismantled. So, in effect, Charles managed to close down what was the only research group that looked critically and systematically into SCAM. A sad story – not so much for me but for progress and science, I think.
3.Why is alternative medicine still a controversial subject?
Mainly because the gap between the claims and the evidence is so very wide – and getting wider all the time.
14.Would you suggest the «right way» to approach it?
I often recommend this: if it sounds too good to be true, it probably is! I might add that, if you want reliable advice, don’t listen to those who profit from giving it.
This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.
A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.
The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.
As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:
- regression towards the mean;
- natural history of the condition;
- success of patient blinding;
- social desirability.
To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.
In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.
This study evaluated the effect of ear acupressure (auriculotherapy) on the weight-gaining pattern of overweight women during pregnancy. It was a single-blinded randomized clinical trial conducted between January and September 2022 and took place in health centers of Qom University of Medical Sciences in Iran.
One-hundred thirty overweight pregnant women were selected by a purposeful sampling method and then divided into two groups by block randomization method. In the intervention group, two seeds were placed in the left ear on the metabolism and stomach points, while two seeds were placed in the right ear on the mouth and appetite points. Participants in the intervention group were instructed to press the seeds six times a day, 20 minutes before a meal for five weeks. For the placebo group, the Vaccaria seedless label was placed at the same points as the intervention group.
A digital scale with an accuracy of 0.1 kg was used to weigh the pregnant women during each visit. Descriptive statistics, independent T-test, chi-square, and repeated measure ANOVA (analysis of variance) test were used to check the research objectives.
There was a statistically significant difference between the auriculotherapy and placebo groups immediately after completing the study (1120.68 ± 425.83 vs. 2704.09 ± 344.96 (g); = 0.018), respectively. Also, there was a substantial difference in the weight gain of women two weeks (793.10 ± 278.38 vs. 1090.32 ± 330.31 (g); < 0.001) and four weeks after the intervention (729.31 ± 241.52 vs. 964.51 ± 348.35 (g); < 0.001) between the auriculotherapy and placebo groups.
The authors concluded that the results of the present study indicated the effectiveness of auriculotherapy in controlling the weight gain of overweight pregnant women. This treatment could be used as a safe method, with easy access, and low cost in low-risk pregnancies.
In order to understand these findings, it is worth reading the methods section of the paper. It explains what actually happened with the two groups:
After providing explanations to familiarize the participants with the working method and answering their questions, the participants were requested to be comfortable. The first author who has an auriculotherapy certificate did the intervention. The intervention began by disinfecting both ears with a 70% alcohol solution. After determining the location of metabolism and stomach points in the left ear and mouth and appetite points in the right ear related to weight and appetite control, the researcher placed the seeds on the desired points… The intervention lasted for a total of 5 weeks. The seeds were changed twice a week (once every three days) by the researcher. The participants in the intervention group were taught to press the seeds 6 times a day for one minute each time. The pressure method was to use moderate stimulation with continuous pressure. In the first session, the researcher fully taught the participants the amount of pressure and the duration of it in a practical way and asked them to do this once in her presence to ensure that it was correct. Participants were recommended to do this preferably 20 minutes before eating. The researcher reminded the participants in the intervention group of their daily interventions by phone or text message. Each night, they were asked to check if they had followed the instructions and completed the daily registration checklist. In each seed replacement session, which was performed every three days, the checklist of the previous session was viewed and checked, and a checklist was received every week at the same time as the participants were weighed. Subjects were also emphasized in case of any symptoms of allergies or infections and pain as soon as possible through the contact number provided to them to discuss the issue with the researcher to remove the seeds.
In the placebo group, instead of real seeds, a label without Vaccaria seed (waterproof fabric adhesive) was placed by the researcher at the desired points in both ears, and the participants did not receive training to compress the points. They also did not receive the list of daily pressing points. All follow-ups and replacement of labels were performed in the same way as the intervention group in the placebo group. Finally, all participants were requested to notify the researcher if any seeds or labels were removed for any reason. It should be noted that pregnant mothers were unaware of the nature of the group to which they belonged.
It seems clear, therefore, that the patients were NOT blinded and that the verum patients received different care and more attention/encouragement than the placebo group. This means firstly that the trial was NOT single-blind, as the authors claim. Secondly, it means that the outcomes were most likely NOT due to ear acupressure at all – they were caused by the non-specific effects of expectation, extra attention, etc. which, in turn, motivated the women to better control their weight. Consequently, the conclusions of this study should be re-phrased:
The results of the present study fail to indicate the effectiveness of auriculotherapy in controlling the weight gain of overweight pregnant women.
In addition, I feel that the researchers, supervisors, peer-reviewers, editors should all bow their heads in shame for trying to mislead us.
This case report aims to describe the effects of craniosacral therapy and acupuncture in a patient with chronic migraine.
A 33-year-old man with chronic migraine was treated with 20 sessions of craniosacral therapy and acupuncture for 8 weeks. The number of migraine and headache days were monitored every month. The pain intensity of headache was measured on the visual analog scale (VAS). Korean Headache Impact Test-6 (HIT-6) and Migraine Specific Quality of Life (MSQoL) were also used.
The number of headache days per month reduced from 28 to 7 after 8 weeks of treatment and to 3 after 3 months of treatment. The pain intensity of headache based on VAS reduced from 7.5 to 3 after 8 weeks and further to < 1 after 3 months of treatment. Furthermore, the patient’s HIT-6 and MSQoL scores improved during the treatment period, which was maintained or further improved at the 3 month follow-up. No side effects were observed during or after the treatment.
The authors concluded that this case indicates that craniosacral therapy and acupuncture could be effective treatments for chronic
migraine. Further studies are required to validate the efficacy of craniosacral therapy for chronic migraine.
So, was the treatment period 8 weeks long or was it 3 months?
No, I am not discussing this article merely for making a fairly petty point. The reason I mention it is diffteren. I think it is time to discuss the relevance of case reports.
What is the purpose of a case report in medicine/healthcare. Here is the abstract of an article entitled “The Importance of Writing and Publishing Case Reports During Medical Training“:
Case reports are valuable resources of unusual information that may lead to new research and advances in clinical practice. Many journals and medical databases recognize the time-honored importance of case reports as a valuable source of new ideas and information in clinical medicine. There are published editorials available on the continued importance of open-access case reports in our modern information-flowing world. Writing case reports is an academic duty with an artistic element.
An article in the BMJ is, I think, more informative:
It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.
It usually falls to the junior to write up the case, so here are a few simple tips to get you started.
First steps
Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.
Getting consent
Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.
Information gathering
Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.
Writing up
Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.
Coming up with a title
Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.
Background research
Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.
How your case is different
Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.
Conclusion
Finish by explaining why your case report adds to the medical literature and highlight any learning points.
Writing an abstract
The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.
What next
Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!
Both papers agree that case reports can be important. They may provide valuable resources of unusual information that may lead to new research and advances in clinical practice and should offer an interesting case with an unusual presentation or a surprise twist.
I agree!
But perhaps it is more constructive to consider what a case report cannot do.
It cannot provide evidence about the effectiveness of a therapy. To publish something like:
- I had a patient with the common condition xy;
- I treated her with therapy yz;
- this was followed by patient feeling better;
is totally bonkers – even more so if the outcome was subjective and the therapy consisted of more than one intervention, as in the article above. We have no means of telling whether it was treatment A, or treatment B, or a placebo effect, or the regression towards the mean, or the natural history of the condition that caused the outcome. The authors might just as well just have reported:
WE RECENTLY TREATED A PATIENT WHO GOT BETTER
full stop.
Sadly – and this is the reason why I spend some time on this subject – this sort of thing happens very often in the realm of SCAM.
Case reports are particularly valuable if they enable and stimulate others to do more research on a defined and under-researched issue (e.g. an adverse effect of a therapy). Case reports like the one above do not do this. They are a waste of space and tend to be abused as some sort of indication that the treatments in question might be valuable.
The US ‘Public Citizen‘ is an American non-profit, progressive consumer rights advocacy group, and think tank based in Washington, D.C. They recently published an article entitled “FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure“. Here are a few excerpts:
In December 2022, the U.S. Food and Drug Administration (FDA) issued new guidance on homeopathic drug products. The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”
Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:
- products with reports of injury that, after evaluation, raise potential safety concerns
- products containing or purportedly containing ingredients associated with potentially significant safety concerns (for example, infectious agents or controlled substances)
- products that are not administered orally or topically (for example, injectable drug products and ophthalmic drug products)
- products intended to be used to prevent or treat serious or life-threatening diseases
- products for vulnerable populations, such as immunocompromised individuals, infants and the elderly
- products with significant quality issues (for example, products that are contaminated with foreign materials or objectionable microorganisms)
But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications. However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality…
… there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.
The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
_____________________
I fully agree with these sentiments. The harm caused by homeopathy is considerable and multi-facetted. Many previous posts have discudded these problems, e.g.:
- Nine cases of severe homeopathy-induced liver injuries
- Another death by homeopathy
- HOMEOPATHY – “It is not just irresponsible, it’s downright dangerous.”
- Adverse effects of homeopathy and aggravations at NAFKAM
- Homeopathy: it’s time to stop the double standards
- Homeopathy can cause serious harm – and finally, the NHS England has realised it
- Vidatox, homeopathy’s answer to cancer or outright fraud?
- Another child has died because of homeopathy
- Doctor homeopaths violate fundamental rules of ethics when practising homeopathy
- ‘Best homeopathy doctor in Delhi’ offers treatment for HIV/AIDS
- DIY-Homeopathy: how to kill your entire family
- The risks of homeopathy?
- The FDA has warned 4 manufacturers of unapproved injectable homeopathic drugs
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19
- The FDA has sent more warning letters to homeopathic manufacturers
- Walmart is being sued for selling homeopathic products
- Homoeopathic remedies may be safe, but do all homeopaths merit this attribute?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- FDA: homeopathic teething remedies were toxic
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.”
- A truly dangerous homeopath
- The scandalous attitude of some homeopaths and their supporters towards immunisations
- Oh yes, let’s have homeopaths as primary care practitioners! But only in a parallel universe,please.
Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.
