pregnancy
Guest post by Udo Endruscheit
Two years ago, in a guest post on this blog, I described the long and winding history of homeopathy in Switzerland — a story marked by political expectations, institutional entanglements, and repeated attempts to reconcile a lack of evidence with a desire for legitimacy. I ended that article with the hope that the country would not embark on yet another “honour lap” around the same unresolved questions.
In 2024, however, Switzerland initiated a new evaluation of homeopathy — a renewed attempt to clarify its role within the national health insurance system. It was, in many ways, the beginning of yet another loop in the same story.
Now, in 2026, that loop has come to an unexpected end. The evaluation was halted.
Not postponed, not softened, not watered down — simply stopped.
And this stop is not merely a political gesture. It marks the structural endpoint of a system that has exhausted its internal possibilities.
A system designed to avoid the evidence question
To understand why Switzerland has arrived at this point, one must look beyond the political headlines and examine the institutional landscape that has shaped the country’s approach to homeopathy for more than a decade.
Three elements are central:
- The political mandate created by the 2009 referendum, which placed homeopathy and other CAM modalities into the basic health insurance package.
- The professional environment, in which thousands of Swiss physicians hold CAM qualifications and the national medical association (FMH) views integrative medicine positively.
- The academic anchor, the Institute for Complementary and Integrative Medicine (IKIM) at the University of Bern, which provides an appearance of scientific legitimacy without producing evidence capable of resolving the core question of efficacy.
This combination created a system in which homeopathy became institutionally normalised — not because of evidence, but because of political and professional expectations.
The HTA as a detour — and the beginning of the dead end
When the Federal Office of Public Health (BAG) was tasked with evaluating homeopathy after the referendum, it faced an impossible dilemma:
- The clinical evidence was weak to non‑existent.
- The political expectation was strong.
- A direct assessment of the evidence would have produced a negative result.
The solution was a detour: a Health Technology Assessment (HTA). But HTAs are not designed to determine efficacy. They assume efficacy has already been established through robust clinical research. Their purpose is to assess cost‑effectiveness, safety, and system impact.
The Swiss HTA did the opposite. In its conclusion, it stated:
“The effectiveness of homeopathy can be considered as proven when internal and external validity criteria are taken into account.”
This is a remarkable inversion of the HTA principle. The report asserted efficacy — without the evidence required to do so — while simultaneously admitting that the actual HTA questions (such as cost‑effectiveness) could not be answered reliably.
In retrospect, this HTA was not the beginning of a solution. It was the beginning of a dead end. A system that asserts efficacy without evidence cannot move forward. It can only circle around itself.
The IKIM: an academic structure without academic function
The IKIM at the University of Bern has played a central role in stabilising this circular logic. Its research output is broad in appearance but narrow in substance. It avoids the central question of efficacy and instead focuses on:
- sociological aspects,
- patient satisfaction,
- model validity,
- and experimental approaches that are not independently reproducible.
The IKIM does not produce evidence. It produces normality — the impression that homeopathy is a legitimate academic field simply because it is housed within a university.
This normality has been crucial for maintaining the political and professional acceptance of homeopathy in Switzerland. But it has also contributed to the structural dead end: an academic institution that cannot resolve the evidence question because it is not designed to ask it.
The 2026 decision: not a surprise, but a consequence
Against this background, the 2026 decision to halt the renewed evaluation of homeopathy is not really surprising. It is the logical endpoint of a system that has exhausted its internal possibilities.
- The evidence has not improved.
- The HTA detour has failed to provide a foundation.
- The institutional structures have stabilised expectations but not knowledge.
- The political mandate cannot be fulfilled without contradicting scientific standards.
The result is a dead end. Not because anyone wanted it, but because the system was built in such a way that no other outcome was possible.
A lesson beyond Switzerland
The Swiss case is often cited by proponents of homeopathy as a model of political and professional acceptance. But the 2026 decision reveals a different lesson:
A system that tries to reconcile political expectations with a lack of evidence will eventually reach a point where it can neither move forward nor turn back.
Switzerland has reached that point. The “endless story” of homeopathy in the Swiss health system has not been resolved — but it has reached its structural conclusion.
And unfortunately that conclusion is not a triumph of evidence. It is the recognition that evidence cannot be replaced by institutional normality. But one thing it certainly isn’t: an endorsement of homeopathy, even if its advocates will once again try to interpret it that way.
It’s hard to believe: my very 1st paper was published exactly 50 years ago. I remember it like it was yesterdy! It was a busy time with lots of distractions: at the time, I was preparing for my finals at the medical school, playing in jazz clubs 2-4 times per week, and having a rather tumultous love-life. On top of all that, I had to finish the work on my doctorate which then produced the said article.
The experimental work on the doctorate did not at all progress as hoped. I needed blood samples from the poor women who were admitted with septic abortion, a very serious condition. More often than not, the poor patient was dead before I could get a blood sample. When finally the sample was complete and the results were in, I had to calculate the stats on my little HP pocket calculator. Once this was done, I had to draw graphs by hand and write up my thesis. 
The article for publication was then written mostly by my supervisor, Dr. Henner Graeff, who later became Professor and head of gynaecology at the TMU, Munich. He was a good supervisor, excellent scientict, and a very kind man. Sadly, he died in 2011; I owe him a lot.
For what it’s worth, here is the Medline-listed abstract of out paper:
Soluble fibrin monomer complexes (SFMC) were determined in patients with septic abortion (body temperatures of more than 39 degree C and/or chills without apparent signs of endotoxic shock), with infected abortion, with non-infected abortion and with normal pregnancies. Quantitative gel filtration (4% agarose) of beta-alanine precipitated plasma samples yielded the relative (percent of total fibrinogen content) and absolute (mg/100 ml plasma) amount of SFMC. The relative (5.5+/-1.4%, mean+/-SD) and absolute (21.5+/-8.6 mg/100 ml) amount of SFMC was significantly increased in patients with septic abortion compared to patients with normal pregnancies or non-infected abortion (p less than 0.001). Patients with infected abortion (p less than 0.001). Patients with infected abortion already revealed increased levels of SFMC (4.3+/-1.2%, 14.2+/-6.8 mg/100 ml) though their platelet count was still unaltered (infected abortion: 221+/-47 X 10(3) platelets/mm3; septic abortion; 99+/-36 X 10(3) platelets/mm3). The use of heparin in patients with septic abortion resulted in a decrease in SFMC. Chain characterization of SFMC frequently revealed a slight degradation of the alpha-chains probably due to fibrinolytic activity in vivo; gamma-gamma dimers representing intermolecular covalent bindings were not observed. The findings are in agreement with our former assumption that patients with septic abortion have a pronounced state of hypercoagulability.
PIP: The effect of septic abortion on plasma levels of soluble fibrin monomer complexes (SFMC) was studied by quantitative gel filtration (4% agarose) of beta-alanine precipitated plasma samples. Pregnant patients and those with infected or noninfected abortions were also studied. The relative and absolute amounts of SFMC were significantly (p less than .001) increased in cases of septic abortion compared with cases of normal pregnancy or uninfected abortion. Patients with infected abortion showed increased absolute and relative levels of SFMC, though not to the extent of septic abortion cases. However, unlike septic abortion cases, platelet count was not reduced. When heparin was used in septic abortion cases, SFMC decreased. A slight degradation of the alpha-chains of SFMC probably due to in vivo fibrinolytic activity was observed. The findings confirm that patients with septic abortion have a marked degree of hypercoagulability.
When I think back to all this, I am tempted to say that today’s medical students have it relatively easy – but, of course, that’s precisely what the old relics of every generation have always said.
The attitude of Robert F. Kennedy Jr. (RFKJr.) on science and evidence-based medicine has long been a source for concern, particularly if we consider his total lack of expertise combined with his immense power to influence public health of the US and beyond. Here are several key quotes and recurring themes that define his perspective:
- “The CDC is a subsidiary of the pharmaceutical industry. The agency’s advisory committee is essentially a front for the vaccine manufacturers.”
- “Tony Fauci’s career has been a long-running effort to prioritize the interests of Big Pharma over public health.”
- “The FDA, the NIH, the CDC—all these agencies have become the sock puppets of the industries they are supposed to regulate.”
- “The scientists who are supposed to be the guardians of our children’s health are instead taking money from the companies that are poisoning them.”
- “We are living in an era where ‘evidence-based medicine’ has been replaced by ‘reimbursement-based medicine.’ The data is cooked to favour the product.”
- “I am not anti-vaccine. I am pro-science and pro-safety. I want the same kind of rigorous, double-blind, placebo-controlled testing for vaccines that we require for every other medication.”
- “When people say ‘follow the science,’ they usually mean ‘follow the decree of the person in power.’ Science is a process of constant questioning, not a set of holy commandments.”
- “Consensus is the enemy of science. Science is about dissent; it’s about looking at the outliers and the data that doesn’t fit the narrative.”
- “The minute you say ‘the science is settled,’ you are no longer talking about science; you are talking about religion and totalitarianism.”
- “Public health policy is no longer based on the best available evidence; it’s based on the best available lobbyists.”
- “I don’t necessarily believe all the scientists, because I can read science myself. That’s what I do for a living. I read science critically.”
- “I spent 40 years cross-examining experts… I know how to tell when someone is lying to me about the data.”
- “I am pro-science. I’ve spent my life fighting for science-based policies. What I am against is ‘captured’ science that serves a corporate bottom line.”
- “I advise parents: do your own research… don’t take my word for it, and don’t take the government’s word for it.”
- “I don’t think people should be taking medical advice from me… I think what we’re going to try to do is to lay out the pros and cons… with replicable studies.”
- “People should be skeptical of any medical advice. They need to look at the primary sources, not the summaries provided by the pharmaceutical industry.”
- “Trusting the experts is not a feature of democracy and it’s not a feature of science. It’s a feature of religion and totalitarianism.”
- “We train physicians to wield the latest surgical tools, but not to guide patients on how to stay out of the operating room in the first place.”
- “The science [on nutrition] is indisputable, and the void [in medical training] is clear… future physicians must graduate prepared to prevent disease.”
- “I’m not scared of a germ. I used to snort cocaine off of toilet seats.”
- “One of the worst parts of addiction was my total incapacity to keep contracts with myself. I didn’t want to be someone who woke up every morning thinking about drugs.”
- “All of us have kind of a God-sized hole in us that we’re trying to fill. And addicts… try to fill that hole inside of you with things that change the way you feel about yourself.”
- “You can’t live off the laurels of the spiritual awakening. You have to renew it every day. You have to wake up every day and say ‘reporting for duty sir,’ and give up control every day.”
- “I had a dark spot on my brain scans… doctors concluded I had a tumor. I was scheduled for an operation by the same surgeon who operated on my uncle.”
- “The abnormality was caused by a worm that got into my brain and ate a portion of it and then died.”
- “I probably got it in South Asia… I was traveling in a lot of places where you can get those kinds of parasites.”
- “I have cognitive problems, clearly. I have short-term memory loss, and I have longer-term memory loss that affects me.”
- “It didn’t require treatment. The worm died on its own, and the symptoms cleared up over time.”
- “I recovered from the memory loss and mental fogginess… I have no aftereffects from the parasite.”
- “Questioning my health is a hilarious suggestion, given the competition.”
RFKJr., as U.S. HHS Secretary since early 2025, was tasked by Trump with restoring trust in healthcare agencies. However, polls show trust has further eroded under his leadership, with KFF data indicating widespread disapproval – nearly 60% of adults – and drops in confidence for CDC, FDA, and vaccine info sources. His tenure involved firing CDC vaccine advisors, slashing HHS staff by 25%, revising childhood vaccine schedules (e.g., dropping hep B at birth), and canceling research grants, sparking measles outbreaks and expert backlash. Public health leaders cite these as science-defying moves worsening distrust across parties. Only 37% trust RFK Jr. as a health info source (KFF Jan 2026). Major health organizations, like the WHO and the American Academy of Pediatrics, point to decades of peer-reviewed, large-scale epidemiological studies that contradict the plethora of demonstrably wrong assertions of RFKJr.
One could almost pity RFKJr. for his naive stupidity – I say ‘almost’ because his stance is not just pitiful and embarrassing, it is evidently dangerous. If a chap having a beer in your local pub came out with such nonsense, you would laugh; if RFKJr. does it and then – horror of horrors – tries to act on it, it gets frightfully dangerous for us all.
Conclusion:
Even Trump cannot be as mean as to allow RFKJr. continue the destruction of public health!
He must be replaced before it is too late!
The aim of this randomized, triple-blind, placebo-controlled clinical trial was to analyze the effect of using Bach’s emergency compound, Five-Flower essence, on the stress level of mothers with premature newborns.
The study was conducted with 117 postpartum women. They were divided into intervention (with five-flower) and control groups. Their children were admitted to a Maternity Hospital in São Paulo, Brazil, from June 2019 to May 2021. The use of the Five-Flower essence was proposed during hospitalization (4 drops every 15 min four times a day) and at home (16 drops a day at pre-determined times) in the ten days after the first intervention. The pre-and post-intervention parameters were evaluated using the Instrument Parental Stress Scale: Neonatal Intensive Care Unit and cortisol analysis. Student’s T, Mann-Whitney, Chi-square, Fisher’s exact tests, and Generalized Estimating Equation models were used to analyze the data. The 5 % significance level was considered in statistical tests.
The groups were homogeneous regarding sociodemographic, obstetric, and neonatal characteristics (p > 0.05). Mean stress scores were calculated for the control (3.75) and intervention (3.82) groups before intervention and a range was observed for the control (2.75-3.44) and intervention (2.55-3.54) groups after the intervention; the difference between groups was statistically significant (p < 0.05). Mean cortisol levels were calculated for the control (3.53) and intervention (3.45) groups before intervention and a range was observed for the control (3.38-2.75) and intervention (2.32-2.86) groups after intervention, showing distinct declines in the groups but without statistical difference (p > 0.05).
The authors concluded that the use of the Five-Flower essence as a non-pharmacological therapy is effective in reducing the stress and cortisol levels in mothers of premature newborns admitted to neonatal and semi-intensive care units.
This is odd!
The remedy does not contain relevant doese of pharmacologically active molecules (other than alcohol). This means that, in this study, the authors tested one placebo against another one. Why then is there a differnce in the outcome?
I read the paper carefully in an attempt to find out. Here is what might have happened (the article does not disclose all the relevant details, so I can only guess):
- The placebo which the authors fail to describe was a water solution or a solution that tasted different than the verum.
- The authors do, however, state this: “Regarding blinding, the manufacturer of the flower essences previously identified the bottles as A and B, one of which was the intervention and the other the placebo.”
- It is possible that the patients were de-blinded, meaning one or two knew how the Bach remedy should taste and communicated this to the several other patients.
- In this case, the expectation of patients affected the results accordingly. In other words, the results are due to a placebo effect.
In any case, the conclusion (even if the ‘Five-Flower essence’ did work exactly as described) is far too optimistic. Before anyone might accept the results, we need an INDEPENDENT replication of this dubious study.
Qigong, a traditional Chinese mind–body exercise, is believed to promote physical and mental well-being during pregnancy. This multicenter randomized controlled clinical trial aimed to investigate the effects of qigong on anxiety, stress, and exercise self-efficacy in pregnant women. It included pregnant women in their second trimester attending prenatal education classes at Baskent University and Alaaddin Keykubat University. Women in the first or third trimester with uncontrolled systemic diseases, high-risk pregnancies, or irregular attendance were excluded. Participants were randomly assigned via Randomizer.org to either the Qigong group or the control group. The Qigong group performed Baduanjin qigong exercises for 30–45 minutes, three times a week, in addition to standard prenatal counseling. The control group received standard prenatal counseling only. Demographic data were recorded. All participants completed the Pregnancy-Related Anxiety Scale (PrAS), Pregnancy Stress Rating Scale (PSRS), and Pregnancy Exercise Self-Efficacy Scale (P-ESES).
A total of 102 pregnant women were analyzed (qigong group: 52; control group: 50). The mean age was 27.95±3.66 years, and the mean gestational week was 26.94±2.12. The qigong group showed significantly lower systolic and diastolic blood pressure increases compared to the control group (p < 0.05). Exercise self-efficacy scores increased significantly in the qigong group (p < 0.05). Pregnancy-related anxiety and stress scores, including all subscales, showed significant improvement in the qigong group (p < 0.05), with no significant changes in the control group (p > 0.05).
The authors concluded that Baduanjin qigong was effective in reducing anxiety and stress levels and improving exercise self-efficacy in pregnant women. This non-pharmacological intervention may offer a safe, supportive approach to mental well-being during pregnancy.
I beg to differ and claim that qigong has no effects per se, and that the observed outcomes are entirely due to placebo effects.
In case you think this is an unsubstantiated claim, let me tell you that it is much more solidly based on evidence than the conclusion of the authors:
- Firstly, there are no compelling reasons to believe that qigong has meaningful health effects.
- Secondly, as the study does not control for placebo effects and qigong is likely to generate such responses, my claim seems much more plausible.
My conclusion: lousy study designs must generate unreliable results.
PS
In case you have doubts, please read up about the ‘A versus A+B’ study design, so often discussed and explained on this blog.
Consider the case of a women who is 3 months pregnant and develops a high and persistent fever (by no means a rare event). Her doctor diagnoses a strep throat and treats her with antibiotics. For lowering her temperature, he would normally have advised paracetamol (acetaminophen). After this was pronounced prohibitively dangerous, he has 3 options:
- Give no medicine for the fever.
- Give Aspirin.
- Give ibuprofen.
What are the risks involved in these three options?
1. Give no medicine for the fever
High or sustained fever, especially in the first trimester (which the patient is nearing the end of or just finished), has been associated with an increased risk of certain birth defects, including neural tube defects, heart defects, and cleft lip/palate.
2. Give Aspirin
The use of Aspirin during pregnancy, especially at higher doses (not the low dose often used for preeclampsia prevention), carries the following risks:
- Higher doses of aspirin during early pregnancy raise the risk of pregnancy loss and congenital defects.
- Higher doses of aspirin are also associated with premature closure of the ductus arteriosus (a fetal heart vessel), fetal kidney problems, and increased bleeding risk for both mother and baby.
Low-dose aspirin is considered safe but may not affect the fever.
3. Give Ibuprofen
- Some studies suggest an increased risk of miscarriage, if taken around conception or over a long period, though evidence is conflicting.
- Ibuprofen is contraindicated in the third trimester (after 28 weeks) due to the risk of fetal renal dysfunction, premature closure of the ductus arteriosus or inhibition of uterine contractions.
What are the consequences?
One can extrapolate that an adherence to a “no paracetamol” policy to treat fever in pregnancy would likely have the following effects in the US:
- Over a thousand additional severe birth defects per year that might have been prevented by safely treating a high fever, especially in the first trimester.
- Many thousands of additional cases of preterm labor/delivery caused by untreated maternal fever later in pregnancy.
- A significant increase in the use of the riskier medicines such as ibuprofen or Aspirin which are associated with fetal risks, leading to hundreds of new cases of fetal kidney and cardiac issues.
In other words, persuading pregnant women to forgo the safest, most effective fever reducer would cause thousands of severe, preventable fetal adverse outcomes per year. This would far outweigh the unproven or even disproven risk of autism from short-term, appropriate paracetamol use.
The US Health Secretary Robert F Kennedy (JFKJr) famously claimed that vitamin A could work “as a prophylaxis” of measles infection. That claim is not just wrong, it also is dangerous. Overuse of vitamin A can have serious health consequences. As a result of JFKJr yet again promoting dangerous nonsense, doctors treating patients during the measles outbreak in Texas and New Mexico are now facing the problem of vitamin A toxicity.
At Covenant Children’s Hospital in Lubbock, near the outbreak’s epicenter, several patients have been found to have abnormal liver function on routine lab tests, a probable sign that they’ve taken too much of the vitamin, according to Dr. Lara Johnson, pediatric hospitalist and chief medical officer for Covenant Health-Lubbock Service Area.
Vitamin A is fat-soluble. It therefore accumulate in organs like the liver when over-doesed. Excess vitamin A can cause dry skin and eyes, blurry vision, bone thinning, skin irritation, liver damage and other serious issues. In pregnant women, it can even lead to birth defects. Recovery for patients with acute toxicity is normally rapid, if the vitamin is discontinued. But the more serious problems with vitamin A toxicity are not always reversible.
The Council for Responsible Nutrition, a trade association for dietary supplement and functional food manufacturers, issued a statement warning parents against using high doses of vitamin A to try to keep their children from getting measles. “While vitamin A plays an important role in supporting overall immune function, research hasn’t established its effectiveness in preventing measles infection. CRN is concerned about reports of high-dose vitamin A being used inappropriately, especially in children,” the statement says.
JFKJr made his remarks in an interview with Fox News medical correspondent Dr. Marc Siegel. Snippets of the interview were featured in four Fox News or Fox Business segments airing on March 4. “They have treated most of the patients, actually, over 108 patients in the last 48 hours. And they’re getting very, very good results, they report from budesonide, which is a steroid, it’s a 30-year-old steroid,” Kennedy said in the longest of the segments. “And clarithromycin [an antibiotic] and also cod liver oil, which has high concentrations of vitamin A and vitamin D. We need to look at those therapies and other therapies,” he said in another segment. “We need to really do a good job of talking to the front-line doctors and see what is working on the ground, because those therapeutics have really been ignored by the agency for a long, long time.”
Local doctors are increasingly concerned about the growing popularity of unproven remedies for preventing and treating measles. They fear that they are causing people to delay critical medical treatment and to reject vaccination, the only proven way to prevent a measles infection.
The measles outbreak has now affected at least 379 people across Texas, New Mexico and Oklahoma. Kansas has reported 23 measles cases, and officials said that they may also be linked to the outbreak. The best measure to get to grips with the outbreak, I think, would be to make JFKJr shut up and let those who understans the issues get on with it.
Probiotics are live microorganisms promoted claimed to provide health benefits when consumed, generally by improving or restoring the gut microbiota. Prebiotics are compounds in food that foster growth or activity of beneficial microorganisms such as bacteria and fungi. Both are sold as dietary supplements, and there is hardly a human disease or symptom for which these supplements are not said to be effective.
One such claim is that the ingestion of prebiotics during pregnancy and lactation has immunomodulatory benefits for the developing fetal and infant immune system and provide a potential dietary strategy to reduce the risk of allergic diseases.
This study sought to determine whether maternal supplementation with dietary prebiotics reduces the risk of allergic outcomes in infants with hereditary risk.
A double-blind randomized controlled trial was conducted in which pregnant women were allocated to consume prebiotics (14.2 g daily of galacto-oligosaccharides and fructo-oligosaccharides in the ratio 9:1) or placebo (8.7 g daily of maltodextrin) powder. The treatment lasted from less than 21 weeks’ gestation until 6 months postnatal during lactation. All eligible women had infants with a first-degree relative with a history of medically diagnosed allergic disease. The primary outcome was medically diagnosed infant eczema by age 1 year, and secondary outcomes included allergen sensitization, food allergy, and recurrent wheeze by age 1 year.
A total of 652 women were randomized between June 2016 and November 2021 (329 in the prebiotics group and 323 in the placebo group). There was no significant difference between groups in the percentage of infants with medically diagnosed eczema by age 1 year (prebiotics 31.5% [103 of 327 infants] vs placebo 32.6% [105 of 322 infants]; adjusted relative risk, 0.98; 95% CI, 0.77-1.23; P = .84). Secondary outcomes and safety measures also did not significantly differ between groups.
The authors concluded that they found little evidence that maternal prebiotics supplementation during pregnancy and lactation reduces the risk of medically diagnosed infant eczema by age 1 year in infants who are at hereditary risk of allergic disease.
It is rare that we come across a well-planned, well-conducted and well-reported study of pro/prebiotics. When we do, it often casts doubts on the numerous claims made for these products.
Here we have such a study.
I congratulate the Australian authors for conducting it.
Two years ago, I reported about an acupuncture review that was, in my view, a fairly clear case of scientific misconduct. To remind you, here is my from 22/11/22 about it:
Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.
The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.
Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture
- relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
- improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
- improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).
There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).
The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.
What should we make of this paper?
In case you are in a hurry: NOT A LOT!
In case you need more, here are a few points:
- many trials were of poor quality;
- there was evidence of publication bias;
- there was considerable heterogeneity within the studies.
The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.
Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.
Dishonest researchers?
Biased reviewers?
Incompetent editors?
Truly unbelievable!!!
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.
PS
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!
_________________________
Now – 2 years later! – the journal (BMJ-Open) has retracted the article and posted the following notice about the decision:
BMJ Open has retracted this article.1 After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.
I am delighted that this misleading paper is now officially discredited. Yet, I do have some concerns:
WHY DOES IT TAKE 2 YEARS TO IDENTIFY SOMETHING AS FRAUDULENT RUBBISH, WHEN IT TOOK ME ALL OF ~30 MINUTES?
Instead of just insisting on a triumphant ‘I TOLD YOU SO’, let me provide some constructive advice to reviewers and journal editors.
- Many journal editors are to lazy to find reviewers themselves and ask the submitting author to name a few. Having myself published in the BMJ Open (the journal that published the paper in question) I fear that this might have been the case in the present instance. This habit invites poor reviews, e.g. reviews from colleagues who owe a favour to the submitting authors. It does not promote objective reviews and should be abandonned.
- Papers on acupuncture originating from China (as the one in question) are very likely to be biased (or worse), as we have so often discussed on this blog. Editors should be extra careful with such submissions.
- Reviewers who have in the past overlooked obvious flaws in a paper should be banned from further reviewing in future.
- Editors should understand the reviewers’ comments only as guidelines and still have an obligation to check the actual submissions themselves. the responsibility for publishing an article lies with them alone.
- Editors who repeatedly make such mistakes should be dismissed.
I think that adhering to these suggestions might improve the quality of published research … and, by Jove, this would be badly needed in the realm of so-called alternative medicine!!!
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.
