It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”
Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.
Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.
They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.
Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.
Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…
“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.
When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!
I suspect and hope that our recent initiative might have something to do with it.
Let’s hope that the pharmacists of other countries follow the German example.
A “null field” is a scientific field where there is nothing to discover and where observed associations are thus expected to simply reflect the magnitude of bias.
This analysis aimed to characterize a null field using a known example, homeopathy (a pseudoscientific medical approach based on using highly diluted substances), as a prototype. The researchers identified 50 randomized placebo-controlled trials of homeopathy interventions from highly cited meta-analyses. The primary outcome variable was the observed effect size in the studies. Variables related to study quality or impact were also extracted.
The mean effect size for homeopathy was 0.36 standard deviations (Hedges’ g; 95% confidence interval: 0.21, 0.51) better than placebo, which corresponds to an odds ratio of 1.94 (95% CI: 1.69, 2.23) in favor of homeopathy. 80% of studies had positive effect sizes (favoring homeopathy). The effect size was significantly correlated with citation counts from journals in the directory of open-access journals and CiteWatch. We identified common statistical errors in 25 studies.
The authors concluded that a null field like homeopathy can exhibit large effect sizes, high rates of favorable results, and high citation impact in the published scientific literature. Null fields may represent a useful negative control for the scientific process.
The paper is perhaps not the easiest to comprehend but once you got the idea, you will agree with me that it is BRILLIANT. I warmly recommend it to all fans of homeopathy – in fact, if I could I’d offer it to King Charles as a present for the coronation.
Its authors are among the most prominent medical epidemiologist of our time with affiliations that speak for themselves:
- Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
- 2Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA.
- 3Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA; Department of Statistics, Stanford University, Stanford, CA, USA.
It is, of course, a pity that the article is behind a paywall – but fortunately, the senior author, John Ioannidis, published his email address together with the abstract: [email protected]. So, if you have trouble understanding the point of the analysis, I suggest you ask for a reprint to get your head around it. I promise it’s worth it.
At first, I thought this was an ‘April fools’ joke. Then I looked at it a bit closer and realized that it seemed for real: Amazon is selling a placebo tablet. Here is how it is advertised:
- Honest Placebo Tablets by Zeebo Effect, inert ingredients, halal & kosher
- Focus on symptom relief, concentration, clarity, energy, calm, sleep
- Ze logo on each tablet, the original honest placebo brand trusted since 2014
- Randomized Controlled Trials with Zeebo Published in Journal for Pain, Nature, American Family Physician
- Each bottle is sealed with a transparent, tamper-proof neckband
Zeebo Tablets – Honest placebo tablets (white, round, 250mg each) are designed to help you create a safe placebo experience. Zeebo comes with the Ze logo on each tablet. Zeebo is made from an inert, natural fiber. Vegan, free of sugar or dyes. When it comes to Zeebo, You are the active ingredient. Users of Zeebo Tablets know they are taking a placebo containing only inert ingredients. Zeebo Tablets are taken intentionally obtain stress and pain relief, to release tension, irritability and nervousness, to help with calm and sleep serving as a sleep aid. Some of our customers take Zeebo Tablets to solicit placebo effects for increased mental focus, clarity, concentration, test performance and to sustain higher energy levels during physical exercise. Zeebo tablets are pure placebo, they are non-drowsy, non-homeopathic. There are no known interactions between Zeebo Placebo Tablets and other medications or supplements. Do not use Zeebo to delay or replace medical treatment. Visit zeeboeffect.com to learn about Zeebo. Look for the ebook The Placebo Cure to find out more about how to create your own Honest Placebo experience.
Take as needed. You may or may not respond to placebo. Do not use Zeebo to replace or delay medical treatment. Use Zeebo without deceit.*
* These statements have not been evaluated by the FDA. This product is not intended to diagnose, cure, treat, or prevent any disease.
Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.
Zeebo Tablets are an ethical placebo. People take it knowing it is a placebo. Take it without self-deceit. Zeebo is not made to look like any other ingestible. In fact, we think that the Zeebo branding can help enhance the experience. Have a look into ethical placebo or honest placebo studies. You will find a lot of research there, published in the journals Nature, Pain, for example. No need to trick yourself.
After reading all this, I am again not entirely sure whether this is a hoax. If it is, I failed to get the fun of it. If it isn’t, there might be reasons for concern. When a placebo was marketed, a few years ago, THE GUARDIAN published opinions about the idea:
Jennifer Buettner, whose company Efficacy is marketing the placebo, says it can stimulate “the body’s ability to repair itself and the miracle power of the brain”. She said the company planned to distribute the pills, which cost £3 for 50, in the UK. “When drugs are not needed and the patient still thinks that medicine would help, we believe that the placebo effect can work,” she said.
But Dr Clare Gerada, vice-chair of the Royal College of GPs, described the pill as “medicalising love”, adding: “This placebo disempowers parents. It is telling them that unless you give your children this pill there’s nothing else.” Douglas Kamerow, associate editor of the British Medical Journal, said giving placebos to children was a “deeply bad idea”. Writing in the latest edition of the journal, he said: “The problems are numerous. Firstly, whom are we treating here, children or their parents?” He added that if parents used placebos to comfort their children they were teaching them that tablets are the answer for all life’s aches and pains.
As we have seen previously, the evidence on ‘open placebos’ is less impressive than many think. It makes me wonder whether the sale of placebo tablets is a good idea.
WHAT DO YOU THINK?
‘Agoro’ is a German (all texts are my translations from German) website that claims this:
“We specialize in alternative methods of treatment from the field of natural medicine. Our mission is to ensure that the ancient wisdom of our grandparents and ancestors is not forgotten.”
Unsurprisingly, this subject interests me. In particular, I was fascinated by an article entitled
Nux Vomica in homeopathy
Nux vomica is (after arnica) amongst the most popular remedies in homeopathy. Therefore, we should all be keen to learn all about it.
Here is the translation of this article:
Nux vomica is one of the homeopathic remedies that you can get in all pharmacies. It can help you with various diseases, such as stomach pain. You can also use this homeopathic remedy for nausea and heartburn. You can buy it in the city pharmacies, but you can also make it easy for yourself and use the online pharmacy for globules. Here you will be well advised on the dosage of homeopathic remedies. Similarly, you can also contact the homeopath or naturopath for good advice.
Nux vomica is a remedy derived from the medicinal plant nux vomica. You can use the homeopathic remedy in the potencies D6 and D12. In some cases, it can be recommended to you also in C6, C12, or C30.
You can use the homeopathic remedy in many ways, including for constipation or exhaustion. You will find out which dosage you can take if you consult a professional. In this way, you will be recommended the appropriate potency to experience help from it.
It is crucial that you always seek advice before taking the remedy. As already mentioned, you can use several contact points for this. Whether it is the pharmacy, the naturopath, or the homeopath. In addition, there are many family doctors who now also use homeopathy and could recommend you the appropriate dosage. The consultation is important in any case because the homeopathy must be adapted to your complaints. Otherwise, the remedy will not work or will not work properly.
If you want to use the remedy for yourself, you always need patience. Homeopathic remedies need a little time to work, that is their only disadvantage. How long this always depends on the person and the remedy. Sometimes it takes only a few hours, sometimes a few days or weeks. You can also get advice on this.
Indications for nux vomica
Stomach and intestinal problems
You can use the remedy for you in case of abdominal pain, mild biliousness, and various stomach and intestinal problems. The remedy can also be of great help for nausea, flatulence, nausea, and constipation.
Headaches and migraines
The remedy Nux vomica can help you if you suffer from headaches that are located just above the eye. It can also help you with migraines. Even with a hangover, the remedy could help.
If you suffer from autumn depression or are often easily frustrated, you can use the remedy.
Yes, I do get easily frustrated with texts like this!
But I doubt that nux vomica can help me with this or any other problem.
Some might say that doubting is not good enough, evidence is needed!
I agree but was unable to find sound evidence to show that homeopathic nux vomica was better than a placebo for any condition (in case any of our regular defenders of homeopathy know more, please let me know). On the contrary, I only found studies that suggested its ineffectiveness. Here is an example:
In a monocenter prospective randomized double-blind clinical trial the efficacy of homeopathic treatment was investigated on children with adenoid vegetations justifying an operation. Patients were treated with either homeopathic remedies such as Nux vomica D200, Okoubaka D3, Tuberculinum D200, Barium jodatum D4 and Barium jodatum D6 or with placebo. The duration of the study for each patient was 3 months. Examination of the ears using a microscope, rhinoscopy, stomatoscopy and pharyngoscopy, as well as tympanometry and audiometry were performed after 4, 8 and 12 weeks. Out of a total of 97 children studied between the ages of 4 to 10 years 82 could be analyzed. At the end of the study no operation was required in 70.7% of the placebo-treated children and in 78.1% of the children treated with homeopathic preparations. These results show no statistical significance.
So, where does that leave us in relation to the “ancient wisdom of our grandparents and ancestors“? I fear, that this story shows yet again that, when it comes to homeopathy, the scrutiny of ancient wisdom quickly turns it into old bullshit.
Acupuncture is a panacea, we are often told.
But is it true?
Of course not!
This study was aimed at evaluating the effect of acupuncture on myelosuppression and quality of life in women with breast cancer during treatment with anthracyclines (ANT).
Women with an indication for ANT chemotherapy were randomized into two groups:
- the acupuncture group (AG) was submitted to an acupuncture intervention, starting before the first chemotherapy infusion, and continuing throughout the treatment;
- the control group (CG) received no acupuncture.
A quality of life questionnaire (FACT-G) and peripheral blood levels of the participants were evaluated before and at the end of treatment.
A total of 26 women were randomized into 2 groups: AG (10) and CG (16). Of these, 26.9% had a dense dose indication according to the service’s protocol for the administration of granulocyte-stimulating factor (G-CSF) from the first cycle, not participating in the analysis. The need for secondary prophylaxis with G-CSF occurred in 72.7% in the control group versus 12% in the acupuncture group. Regarding quality of life (QoL), it was observed that the groups did not initially differ from each other. At the end of the treatment, there was a significant difference in the AG for the physical (GP) (p-value=0.011), social/family (GS) (p-value=0.018), and functional (GF) (p-value=0.010) domains, regarding the initial and final FACT-G showed a difference between the groups, where the GA average at the end rose from 80.68 to 90.12 (p-value = 0.004) and in the CG the average dropped from 81.95 to 70.59 (p-value=0.003).
The authors concluded that acupuncture was efficient in the secondary prophylaxis of myelosuppression during chemotherapy and the quality of life of women during treatment has increased.
My interpretation of these results is quite different from that of the authors.
Please let me explain.
The improvement of the quality of life can easily be explained via a placebo effect; acupuncture itself has not necessarily any part in it. But what about the effect on the bone marrow? Might it too be due to a placebo response, or the additional attention? Probably not.
Does that mean that this study proves a definite positive effect of acupuncture?
Because firstly the study was far too small for allowing such a far-reaching conclusion, and secondly one would need independent confirmation before accepting such a far-reaching conclusion.
This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of Chinese herbal medicine (CHM) combined with Western medicine (WM) in comparison with WM in reducing systolic and diastolic blood pressure for patients with primary hypertension (PHTN).
Various literature searches located a total of 29 studies that included 2623 patients. The results showed that the clinical effectiveness in the treatment of hypertension with CHM+WM was considerably higher than that with WM alone, clinical effective (RR 1.23, 95% CI [1.17, 1.30], P < 0.00001), and markedly effective (ME) in the patients (RR 1.66, 95% CI [1.52, 1.80], and P < 0.00001). Random effect in SBP (MD 7.91 mmHg,[6.00, 983], P < 0.00001) and DBP (MD 5.46 mmHg, [3.88, 6.43], P < 0.00001), a subgroup analysis was carried out based on the type of intervention, duration of treatment, and CHM formulas that showed significance. Furthermore, no severe side effects were reported, and no patients stopped treatment or withdrawal due to any severe adverse events.
The authors concluded that compared to WM alone, the therapeutic effectiveness of CHM combined with WM is significantly improved in the treatment of hypertension. Additionally, CHM with WM may safely and efficiently lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in individuals with PHTN. However, rigorous randomized controlled trials with a large sample, high quality, long duration of treatment, and follow-up are recommended to strengthen this clinical evidence.
The authors can boast of an impressive list of affiliations:
- 1Heilongjiang University of Chinese Medicine, Harbin, 150040, Heilongjiang, China; School of Pharmacy, Lebanese International University, 18644, Sana’a, Yemen.
- 2Heilongjiang University of Chinese Medicine, Harbin, 150040, Heilongjiang, China.
- 3Key Laboratory of Chinese Materia Medica, Ministry of Education of Heilongjiang University of Chinese Medicine, Harbin, 150040, Heilongjiang, China.
- 4Department of Urology, Affiliated Hospital of Qingdao Binhai University, Qingdao, Shandong, China.
- 5Department of Respiratory Diseases, Shandong Second Provincial General Hospital, Shandong University, Shandong, China.
- 6Heilongjiang University of Chinese Medicine, Harbin, 150040, Heilongjiang, China. Electronic address: [email protected].
Impressive in the sense of being impressively prone to bias, particularly knowing that ~80% of Chinese research findings have been shown to be fabricated and considering that Chinese authors as good as never publish anything negative about TCM.
But perhaps you still believe that the results reported here are 100% true? In this case, I might even agree with you. The reason is that the authors demonstrate in exemplary fashion what I have been saying so often before:
Blood pressure is one of the many endpoints that are highly prone to placebo effects. Therefore, even the addition of an ineffective CHM to WM would lower blood pressure more effectively than WM alone.
But there is a third way of explaining the findings of this review: some herbal remedies might actually have a hypotensive effect. The trouble is that this review does come not even close to telling us which.
I recently came across a truly baffling article. As it is in German, I translated it for you:
Supply shortages have kept pharmacies on tenterhooks for months, with more than 400 common medicines missing. The German Central Association of Homeopathic Doctors (DZVhÄ) suggests switching to alternative medicine as a solution: “We have homeopathic medicines that have been tried and tested in practice for more than 200 years and can replace many medicines that are currently not available,” says the president of the DZVhÄ , Dr Michaela Geiger.
The DZVhÄ is convinced that homeopathic medical practices can replace fever-reducing medicines, but in many cases also antibiotics and much more. However, Geiger qualifies: “Due to our medical training, we also know that cancer drugs such as the often cited Tamoxifen cannot be replaced by homeopathy”.
The homeopathic doctors respond directly to the sharpest argument of their critics: “But let’s assume that homeopathy only works via the placebo effect, as is being rumored, even then it would be an option, especially if other options are lacking,” says DZVhÄ vice-president Dr. Ulf Riker. Since homeopathically trained doctors can judge the general course of a disease, they can also distinguish a placebo effect from a medicinal effect.
If fever medication for children is lacking, parents should not be deprived of another “therapy option”, Riker said. “If you do not get your conventional fever medication in the coming weeks, visit a specialist pharmacy for naturopathy and homeopathy. If you are due for a medical consultation, experienced homeopathic doctors can prescribe a suitable homeopathic medicine for you,” he says.
Why do I find this so intriguing?
Essentially, what we have learned from the article is the following:
- “Tried and tested in practice for more than 200 years” is ‘homeopathy speak’ for “effective”, even if the evidence tells us otherwise.
- Homeopathic remedies can replace many evidence-based conventional medications such as fever-reducing medicines, antibiotics, and much more, even if the evidence tells us otherwise.
- Homeopaths know that cancer drugs cannot be replaced by homeopathy – except for those homeopaths who seem to have forgotten this simple lesson.
- Homeopathic placebos are a realistic option when there is a supply problem with effective drugs, even if the evidence tells us otherwise.
- Homeopathically trained doctors can distinguish a placebo effect from a medicinal effect, even if there is no evidence that any clinician can reliably do this.
- Homeopathic doctors prescribe suitable homeopathic medicine. Suitable for whom? As it is ineffective, it is unsuitable for the patient. Therefore, Riker is probably talking about the homeopath.
So, what have we really learned from this article? I don’t know about you, but I got the impression that the president and the vice president of the DZVhÄ do not seem to mind putting patients in danger, as long as they can promote homeopathy.
Is acupuncture more than a theatrical placebo? Acupuncture fans are convinced that the answer to this question is YES. Perhaps this paper will make them think again.
A new analysis mapped the systematic reviews, conclusions, and certainty or quality of evidence for outcomes of acupuncture as a treatment for adult health conditions. Computerized search of PubMed and 4 other databases from 2013 to 2021. Systematic reviews of acupuncture (whole body, auricular, or electroacupuncture) for adult health conditions that formally rated the certainty, quality, or strength of evidence for conclusions. Studies of acupressure, fire acupuncture, laser acupuncture, or traditional Chinese medicine without mention of acupuncture were excluded. Health condition, number of included studies, type of acupuncture, type of comparison group, conclusions, and certainty or quality of evidence. Reviews with at least 1 conclusion rated as high-certainty evidence, reviews with at least 1 conclusion rated as moderate-certainty evidence and reviews with all conclusions rated as low- or very low-certainty evidence; full list of all conclusions and certainty of evidence.
A total of 434 systematic reviews of acupuncture for adult health conditions were found; of these, 127 reviews used a formal method to rate the certainty or quality of evidence of their conclusions, and 82 reviews were mapped, covering 56 health conditions. Across these, there were 4 conclusions that were rated as high-certainty evidence and 31 conclusions that were rated as moderate-certainty evidence. All remaining conclusions (>60) were rated as low- or very low-certainty evidence. Approximately 10% of conclusions rated as high or moderate-certainty were that acupuncture was no better than the comparator treatment, and approximately 75% of high- or moderate-certainty evidence conclusions were about acupuncture compared with a sham or no treatment.
Three evidence maps (pain, mental conditions, and other conditions) are shown below
The authors concluded that despite a vast number of randomized trials, systematic reviews of acupuncture for adult health conditions have rated only a minority of conclusions as high- or moderate-certainty evidence, and most of these were about comparisons with sham treatment or had conclusions of no benefit of acupuncture. Conclusions with moderate or high-certainty evidence that acupuncture is superior to other active therapies were rare.
These findings are sobering for those who had hoped that acupuncture might be effective for a range of conditions. Despite the fact that, during recent years, there have been numerous systematic reviews, the evidence remains negative or flimsy. As 34 reviews originate from China, and as we know about the notorious unreliability of Chinese acupuncture research, this overall result is probably even more negative than the authors make it out to be.
Considering such findings, some people (including the authors of this analysis) feel that we now need more and better acupuncture trials. Yet I wonder whether this is the right approach. Would it not be better to call it a day, concede that acupuncture generates no or only relatively minor effects, and focus our efforts on more promising subjects?
This double-blind, randomized study assessed the effectiveness of physiotherapy instrument mobilization (PIM) in patients with low back pain (LBP) and compared it with the effectiveness of manual mobilization.
Thirty-two participants with LBP were randomly assigned to one of two groups:
- The PIM group received lumbar mobilization using an activator instrument, stabilization exercises, and education.
- The manual group received lumbar mobilization using a pisiform grip, stabilization exercises, and education.
- Numeric Pain Rating Scale (NPRS),
- Oswestry Disability Index (ODI) scale,
- Pressure pain threshold (PPT),
- lumbar spine range of motion (ROM),
- lumbar multifidus muscle activation.
There were no differences between the PIM and manual groups in any outcome measures. However, over the period of study, there were improvements in both groups in NPRS (PIM: 3.23, Manual: 3.64 points), ODI (PIM: 17.34%, Manual: 14.23%), PPT (PIM: ⩽ 1.25, Manual: ⩽ 0.85 kg.cm2), lumbar spine ROM (PIM: ⩽ 9.49∘, Manual: ⩽ 0.88∘), and/or lumbar multifidus muscle activation (percentage thickness change: PIM: ⩽ 4.71, Manual: ⩽ 4.74 cm; activation ratio: PIM: ⩽ 1.17, Manual: ⩽ 1.15 cm).
The authors concluded that both methods of lumbar spine mobilization demonstrated comparable improvements in pain and disability in patients with LBP, with neither method exhibiting superiority over the other.
If this conclusion is meant to tell us that both treatments were equally effective, I beg to differ. The improvements documented here are consistent with improvements caused by the natural history of the condition, regression towards the mean, and placebo effects. The data do not prove that they are due to the treatments. On the contrary, they seem to imply that patients get better no matter what therapy is used. Thus, I feel that the results are entirely in keeping with the hypothesis that spinal mobilization is a placebo treatment.
So, allow me to re-phrase the authors’ conclusion as follows:
Lumbar mobilizations do not seem to have specific therapeutic effects and might therefore be considered to be ineffective for LBP.
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.
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.
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of aacupuncture 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.
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!