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

pregnancy

I regularly scan the new publications in alternative medicine hoping that I find some good quality research. And sometimes I do! In such happy moments, I write a post and make sure that I stress the high standard of a paper.

Sadly, such events are rare. Usually, my searches locate a multitude of deplorably poor papers. Most of the time, I ignore them. Sometime, I do write about exemplarily bad science, and often I report about articles that are not just bad but dangerous as well. The following paper falls into this category, I fear.

The aim of this systematic review was to assess the efficacy and safety of herbal medicines for the induction of labor (IOL). The researchers considered experimental and non-experimental studies that compared relevant pregnancy outcomes between users and non-user of herbal medicines for IOL.

A total of 1421 papers were identified and 10 studies, including 5 RCTs met the authors’ inclusion criteria. Papers not published in English were not considered. Three trials were conducted in Iran, two in the USA and one each in South Africa, Israel, Thailand, Australia and Italy.

The quality of the included trial, even of the 5 RCTs, was poor. The results suggest, according to the authors of this paper, that users of herbal medicine – raspberry leaf and castor oil – for IOL were significantly more likely to give birth within 24 hours than non-users. No significant difference in the incidence of caesarean section, assisted vaginal delivery, haemorrhage, meconium-stained liquor and admission to nursery was found between users and non-users of herbal medicines for IOL.

The authors concluded that the findings suggest that herbal medicines for IOL are effective, but there is inconclusive evidence of safety due to lack of good quality data. Thus, the use of herbal medicines for IOL should be avoided until safety issues are clarified. More studies are recommended to establish the safety of herbal medicines.

As I stated above, I am not convinced that this review is any good. It included all sorts of study designs and dismissed papers that were not in English. Surely this approach can only generate a distorted or partial picture. The risks of herbal remedies for mother and baby are not well investigated. In view of the fact that even the 5 RCTs were of poor quality, the first sentence of this conclusion seems most inappropriate.

On the basis of the evidence presented, I feel compelled to urge pregnant women NOT to consent to accept herbal remedies for IOL.

And on the basis of the fact that far too many papers on alternative medicine that emerge every day are not just poor quality but also dangerously mislead the public, I urge publishers, editors, peer-reviewers and researchers to pause and remember that they all have a responsibility. This nonsense has been going on for long enough; it is high time to stop it.

We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.

Here is the full and unaltered abstract of the study:

Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.

END OF QUOTE

My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!

My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.

In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.

Placentophagy is the act of eating the placenta after childbirth. It seems to be advocated widely. But why would anyone even think of doing such a weird thing?

According to Wikipedia, the placenta contains high levels of prostaglandin. Prostaglandin stimulates involution (an inward curvature or penetration, or, a shrinking or return to a former size) of the uterus. The placenta also contains small amounts of oxytocin which eases birth stress and causes the smooth muscles around the mammary cells to contract and eject milk.

Wiki also tells us that human placenta has also been an ingredient in some traditional Chinese medicines, including using dried human placenta, known as “Ziheche” (simplified Chinese: 紫河车; traditional Chinese: 紫河車; pinyin: Zǐhéchē), to treat wasting diseases, infertility, impotence and other conditions. Most recently, the Center for Disease Control published a report of a newborn infected with Group B Streptococcus (GBS) bacteria likely after the mother ingested placenta capsules. Consequently, the CDC said that placenta capsule ingestion should be avoided and to educate mothers interested in placenta encapsulation about the potential risks. A recent publication advised that physicians should discourage placentophagy because it is potentially harmful with no documented benefit.

The benefits of placentophagy are, according to many proponents of this therapy, considerable. This website, for instance, claims the following effects:

START OF QUOTE

BALANCE HORMONES
When  a woman births the placenta, she loses the many useful hormones contained in it that were produced during pregnancy.  It can take months for the body to balance these hormones again. Taking placenta pills helps reintroduce these hormones into the mother’s body  in small doses, until her body resumes its natural hormonal balance.

DECREASE THE INCIDENCE OF POSTPARTUM DEPRESSION
Iron-deficiency in postpartum women can lead to fatigue, and may be a contributing factor to depressive symptoms. The placenta is extremely rich in natural iron and can be a valuable and natural resource to replenish the mother’s lost iron supply.  It is also rich in naturally-produced B6 which is often used to combat depression.  Many mothers find the combination of these substances in placenta encapsulation to be helpful in improving their post-birth emotional experience.

INCREASE ENERGY & FACILITATE FASTER HEALING
The placenta contains hormones and nutrients that have been found to increase energy and promote healing.  It is also rich in naturally-produced iron and protein, which can help replenish the mother’s nutrients following childbirth.

LESSEN POSTPARTUM BLEEDING
Historically, midwives have utilized a small portion of the placenta to control postpartum bleeding during and after childbirth.  Placenta pills contain these same hormones and can lessen bleeding and help promote uterine healing.

PROMOTE HEALTHY BREAST MILK PRODUCTION
The  placenta contains Human Placental Lactogen and Prolactin, which help prepare the mammary glands and stimulate milk production.  These are often beneficial in successful breastfeeding of a new infant.

END OF QUOTE

As we all know, bogus claims abound in alternative medicine; the question, as always is: are they true?

There have been no studies of whether placentophagy provides hormonal effects in humans, Wiki claims. But this last statement is no longer true. The first human trial of placentophagy has just been published. The objective of this study was to investigate whether salivary hormone concentrations of women ingesting their own encapsulated placenta during the early postpartum differed from those of women consuming a placebo.

Randomly assigned participants (N=27) were given a supplement containing either their dehydrated and homogenized placenta (n=12), or placebo (n=15). Saliva samples were collected during late pregnancy and early postpartum. Samples of participants’ processed placenta, and the encapsulated placebo, were also collected. Hormone analyses were conducted on all samples utilizing liquid chromatography-tandem mass spectrometry.

The results show that there were no significant differences in salivary hormone concentrations between the placenta and placebo groups post-supplementation that did not exist pre-supplementation. There were, however, significant dose-response relationships between the concentration of all 15 detected hormones in the placenta capsules and corresponding salivary hormone measures in placenta group participants not seen in the placebo group. The higher salivary concentrations of these hormones in the placenta group reflects the higher concentrations of these hormones in the placenta supplements, compared to the placebo.

In a second paper on the same trial, the authors assessed the maternal mood, bonding, and fatigue via validated scales across 4 time points during late pregnancy and early postpartum.

The results show no significant main effects related to maternal mood, bonding, or fatigue between placenta and placebo group participants. However, examination of individual time points suggested that some measures had specific time-related differences between placenta and placebo groups that may warrant future exploration. Though statistical significance should not be interpreted in these cases, the authors did find some evidence of a decrease in depressive symptoms within the placenta group but not the placebo group, and reduced fatigue in placenta group participants at the end of the study compared to the placebo group.

The authors concluded that no robust differences in postpartum maternal mood, bonding, or fatigue were detected between the placenta and placebo groups. This finding may be especially important for women considering maternal placentophagy as a ‘natural’ (i.e., non-pharmacological) means of preventing or treating blues/depression. Given the study limitations, these findings should be interpreted as preliminary. Small, time-related improvements in maternal mood and lower fatigue post-supplementation among placenta group participants may warrant further research.

Will this largely negative evidence stop enthusiasts of placentophagy making therapeutic claims?

I very much doubt it!

 

Perhaps I have a weak spot for fish oil; more likely, however, I just like positive news – and, in alternative medicine, there is not much of it. That’s why I have written about the potential benefits of fish-oil again and again and again and again.

Reduced intake of fish oil, i.e. n−3 long-chain polyunsaturated fatty acids (LCPUFAs), may be a contributing factor to the increasing prevalence of asthma and other wheezing disorders. Yet the evidence is neither clear nor strong. This study was aimed at shedding more light on the issue; specifically, it tested the effect of supplementation with n−3 LCPUFAs in pregnant women on the risk of persistent wheeze and asthma in their offspring.

The investigators randomly assigned 736 pregnant women at 24 weeks of gestation to receive 2.4 g of n−3 LCPUFA (fish oil) or placebo (olive oil) per day. Their children were followed prospectively with extensive clinical phenotyping. Neither the investigators nor the participants were aware of group assignments during follow-up for the first 3 years of the children’s lives, after which there was a 2-year follow-up period during which only the investigators were unaware of group assignments. The primary end point was persistent wheeze or asthma, and the secondary end points included lower respiratory tract infections, asthma exacerbations, eczema, and allergic sensitization.

A total of 695 children were included in the trial, and 95.5% completed the 3-year, double-blind follow-up period. The risk of persistent wheeze or asthma in the treatment group was 16.9%, versus 23.7% in the control group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.97; P=0.035), corresponding to a relative reduction of 30.7%. Prespecified subgroup analyses suggested that the effect was strongest in the children of women whose blood levels of eicosapentaenoic acid and docosahexaenoic acid were in the lowest third of the trial population at randomization: 17.5% versus 34.1% (hazard ratio, 0.46; 95% CI, 0.25 to 0.83; P=0.011). Analyses of secondary end points showed that supplementation with n−3 LCPUFA was associated with a reduced risk of infections of the lower respiratory tract (31.7% vs. 39.1%; hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.033), but there were no statistically significant associations between supplementation and asthma exacerbations, eczema, or allergic sensitization.

The authors concluded that supplementation with n−3 LCPUFA in the third trimester of pregnancy reduced the absolute risk of persistent wheeze or asthma and infections of the lower respiratory tract in offspring by approximately 7 percentage points, or one third.

The authors must be congratulated. This trial is stunning in many ways: it was carefully designed and executed; its results are clear and important; its write-up is excellent. The research was supported by private and public research funds, all of which are listed at www.copsac.com. The Lundbeck Foundation, the Danish Ministry of Health, the Danish Council for Strategic Research, the Danish Council for Independent Research, and the Capital Region Research Foundation provided core support.

It is debatable whether the intake of fish oil falls under the umbrella of alternative medicine. In a way, it reminds me of the famous saying: what do we call alternative medicine that works? We call it medicine. It also holds an important reminder for all who make claims about the benefit of alternative therapies: extraordinary claims require extraordinary evidence.

Can these findings be translated into practical advice to consumers? The NEJM discussed this question in an accompanying article in which the case of a fictional pregnant woman (Ms. Franklin) was considered. Here is what they concluded: …there is benefit and little risk associated with n−3 LCPUFA supplementation. Even though we do not know Ms. Franklin’s EPA and DHA levels, there is likely to be a benefit for her child, at little risk, cost, or inconvenience. She should start taking n−3 LCPUFA supplements.

Despite my soft spot for fish oil, I might add that, while we give advice of this nature, we nevertheless need to insist on independent replications to have certainty.

This randomized, double-blind study evaluated the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. For the homeopathic group (n=62), 9 homeopathic remedies were pre-selected: (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, one was prioritized for administration for each participant. After the first appointment, a re-selection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/day, in the morning and at night, on 4 consecutive days each week, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group (n=72) took placebos. Both groups also received a diet orientation.

Weight change during pregnancy was defined as the difference between the body mass index (BMI) at the initial evaluation and that recorded at the final evaluation, adjusted for 40 weeks of gestation. In addition, the APGAR index in the newborn  (a measure of the health of the baby) was evaluated. The mean variation between baseline BMI and BMI at week 40 of gestation was +4.95 kg/m2 in the control group and +5.05 kg/m2 in the homeopathy group. The difference between the two groups was not significant. APGAR 10 at 5 min (59.6% in the homeopathy group and 36.4% in the control group) was statistically significant (P = .016).

The authors concluded that homeopathy does not appear to prevent excessive body mass gain in pregnant women who are overweight or obese and suspected of having a common mental disorder. Homeopathy did not change the APGAR score to modified clinical attention at delivery room. However, the evidence observed at APGAR 10 at minute 5 suggests that  homeopathy had a modulating effect on the vitality of newborns, warranting further studies designed to investigate it.

I have seen many odd studies in my time, but this must be one of the oddest?

  • What is the rationale for assuming that homeopathy might affect body weight?
  • Why take pregnant women with a weight problem who were suspected of having a common mental disorder?
  • Why try to turn a clearly negative result into a finding that is (at least partly) positive?

The last point seems the most important one to me. The primary outcome measure of this study (weight gain) was clearly defined and was not affected by the therapy. Yet the authors feel it justified to add to their conclusions that homeopathy had a modulating effect on the vitality of newborns (almost certainly nothing but a chance finding).

Are they for real?

I suppose they are: they are real pseudo-scientific promoters of quackery!

Some osteopaths – similar to their chiropractic, naturopathic, homeopathic, etc. colleagues – claim they can treat almost any condition under the sun. Even gynaecological ones? Sure! But is the claim true? Let’s find out.

The aim of this recent review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review.

In total, 24 studies were included. They addressed the following conditions: back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT was considered to be effective for pregnancy related back pain. For all other gynaecological and obstetrical conditions the evidence was considered to be uncertain. Only three studies mentioned adverse events after OMT.

The authors concluded that, although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.

Given the fact that the lead authors of this review come from the “Accademia Italiana Osteopatia Tradizionale, Pescara, Italy, we can probably answer the question in the title of this blog with a straight NO. I see no reason why OMT should work for gynaecological conditions, and I am not in the least surprised to read that there is no clinical evidence for this notion. Sadly, this is unlikely to stop osteopaths to claim otherwise and continue to prey on the desperate and the gullible.

One might thus say that this review is totally unremarkable – but I would beg to differ: it highlights yet again one very important finding, namely the fact that trials of alternative therapies far too often fail to report adverse effects. I have stated this often already, but I will say it again: THIS OMISSION IS A VIOLATION OF RESEARCH ETHICS WHICH GIVES US A FALSE POSITIVE OVERALL PICTURE OF THE RISKS ASSOCIATED WITH ALTERNATIVE MEDICINE.

Lots of people are puzzled how healthcare professionals – some with sound medical training – can become convinced homeopaths. Having done part of this journey myself, I think I know one possible answer to this question. So, let me try to explain it to you in the form of a ‘story’ of a young doctor who goes through this development. As you may have guessed, some elements of this story are autobiographical but others are entirely fictional.

Here is the story:

After he had finished medical school, our young and enthusiastic doctor wanted nothing more than to help and assist needy patients. A chain of coincidences made him take a post in a homeopathic hospital where he worked as a junior clinician alongside 10 experienced homeopaths. What he saw impressed him: despite of what he had learnt at med school, homeopathy seemed to work quite well: patients with all sorts of symptoms improved. This was not his or anybody else’s imagination, it was an undeniable fact.

As his confidence and his ability to think clearly grew, the young physician began to wonder nevertheless: were his patients’ improvements really due to the homeopathic remedies, or were these outcomes caused by the kind and compassionate care he and the other staff provided?

To cut a long story short, when he left the hospital to establish his own practice, he certainly knew how to prescribe homeopathics but he was not what one might call a convinced homeopath. He decided to employ homeopathy in parallel with conventional medicine and it turned out that he made less and less use of homeopathy as the months went by.

One day, a young women consulted him; she had been unsuccessfully trying to have a baby for two years and was now getting very frustrated, even depressed, with her childlessness. All tests on her and her husband had not revealed any abnormalities. A friend had told her that homeopathy might help, and see had therefore made this appointment to consult a doctor who had trained as a homeopath.

Our young physician was not convinced that he could help his patient but, in the end, he was persuaded to give it a try. As he had been taught by his fellow homeopaths, he conducted a full homeopathic history to find the optimal remedy for his patient, gave her an individualised prescription and explained that any effect might take a while. The patient was delighted that someone had given her so much time, felt well-cared for by her homeopaths, and seemed full of optimism.

Months passed and she returned for several further consultations. But sadly she failed to become pregnant. About a year later, when everyone involved had all but given up hope, her periods stopped and the test confirmed: she was expecting!

Everyone was surprised, not least our doctor. This outcome, he reasoned, could not possibly be due to placebo, or the good therapeutic relationship he had been able to establish with his patient. Perhaps it was just a coincidence?

In the small town where they lived, news spread quickly that he was able to treat infertility with homeopathy. Several other women with the same problem liked the idea of having an effective yet risk-free therapy for their infertility problem. The doctor thus treated several infertile women, about 10, during the next months. Amazingly most of them got pregnant within a year or so. The doctor was baffled, such a series of pregnancies could not be a coincidence, he reasoned.

Naturally, the cases that were talked about were the women who had become pregnant. And naturally, these were the patients our doctor liked to remember. Slowly he became convinced that he was indeed able to treat infertility homeopathically – so much so that he published a case series in a homeopathic journal about his successes.

In a way, he had hoped that, perhaps, someone would challenge him and explain where he had gone wrong. But the article was greeted nationally with much applause by his fellow homeopaths, and he was even invited to speak at several conferences. In short, within a few years, he made himself a name for his ability to help infertile women.

Patients now travelled from across the country to see him, and some even came from abroad. Our physician had become a minor celebrity in the realm of homeopathy. He also, one has to admit, had started to make very good money; most of his patients were private patients. Life was good. It almost goes without saying that all his former doubts about the effectiveness of homeopathic remedies gradually vanished into thin air.

Whenever now someone challenged his findings with arguments like ‘homeopathics are just placebos’, he surprised himself by getting quite angry. How do they dare doubt my data, he thought. The babies are there, to deny their existence means calling me a liar!

OUR DOCTOR HAD BECOME AN EVANGELICALLY CONVINCED HOMEOPATH, AND NO RATIONAL ARGUMENT COULD DISSUADE HIM.

And what arguments might that be? Isn’t he entirely correct? Can dozens of pregnancies be the result of a placebo effect, the therapeutic relationship or coincidence?

The answer is NO! The babies are real, very real.

But there are other, even simpler and much more plausible explanations for our doctor’s apparent success rate: otherwise healthy women who don’t get pregnant within months of trying do very often succeed eventually, even without any treatment whatsoever. Our doctor struck lucky when this happened a few times after the first patient had consulted him. Had he prescribed non-homeopathic placebos, his success rate would have been exactly the same.

As a clinician, it is all too easy and extremely tempting not to adequately rationalise such ‘success’. If the ‘success’ then happens repeatedly, one can be in danger of becoming deluded, and then one almost automatically ‘forgets’ one’s failures. Over time, this confirmation bias will create an entirely false impression and often even a deeply felt conviction.

I am sure that this sort of thing happens often, very often. And it happens not just to homeopaths. It happens to all types of quacks. And, I am afraid, it also happens to many conventional doctors.

This is how ineffective treatments survive for often very long periods. This is how blood-letting survived for centuries. This is how millions of patients get harmed following the advice of their trusted physicians to employ a useless or even dangerous therapy.

HOW CAN THIS SORT OF THING BE STOPPED?

The answer to this most important question is very simple: health care professionals need to systematically learn critical thinking early on in their education. The answer may be simple but its realisation is unfortunately not.

Even today, courses in critical thinking are rarely part of the medical curriculum. In my view, they would be as important as anatomy, physiology or any of the other core subjects in medicine.

I thought I had seen everything that is lamentable about homeopathy. When I came across this article, I had to change my opinion. It is a more despicable, unethical and dangerous promotion of falsehoods than I could have imagined.

Strong words? Read for yourself:

There are treatments that can heal vaccine damage, but few physicians in the conventional medical care system know about them, since vaccine injuries are usually denied as the cause of any illness. Some parents with autistic children report that homeopathy has completely reversed their children’s autism and healed other serious health conditions caused by vaccines. This article explains how homeopathic remedies can bring about healing for many types of vaccine injuries.

Homeopathy is not the only treatment that has helped children and adults recover from vaccine damage, but it is the one that is the focus of this article. I will describe how homeopathy can bring about a true cure for the harm that vaccines have caused to children and adults…

It is a tragedy when a normal young child suddenly starts losing the ability to speak sentences or even to speak words after receiving vaccines. The ability to have positive social interactions with other children or adults can disappear in a matter of days after vaccines have been given to children. Intellectual development can be lost and even successful potty training skills can disappear. The ability to sit quietly, listen to a story being read, and the ability to learn can suddenly be replaced with hand flapping, body spinning, head banging, food allergies, asthma, agitation, hyperactivity, learning disabilities, chronic colds and fevers, constant stomach pain, constipation, and a general failure to grow and thrive. There are also serious consequences for adults who use vaccines. Formerly productive adults can lose their independence and become paralyzed, infertile, chronically ill, and even die, because of vaccine damage. It happens every day, yet few people make the connection between their illnesses and vaccine use…

By the time parents fully awaken to the harm that has occurred to their children, many have already resigned themselves to a lifetime of caretaking their disabled children. Some parents will even receive counsel from their physicians to give up their children to the care of the state, because they have no treatments to offer and can offer no hope of recovery. Some physicians will try to convince parents that this is a genetic problem that might be cured someday, but not in the near future. The conventional medical care system leaves parents feeling like helpless victims without any good options. The truth is there are good options for restoring health after vaccine damage, and homeopathy is one of them!…

Homeopathy does not wage war on disease and seek to destroy the symptoms of disease through brute force. It does not bring substances into the body as is done with allopathic drugs, for the purpose of doing hand to hand combat against disease. Instead, homeopathy and its remedies are intended to gently stimulate and strengthen the body so that it can overcome illness through its own vital force and strength. Homeopathic remedies restore the natural ability of the body to defend itself against illness and to heal itself. When this happens, a person is truly cured of what ails him…

Allopathic drugs and treatments do not have a positive effect upon the vital force in the body. They do not improve the strength of a person, and they do not provide for physical, emotional, or mental renewal. Rather, they just suppress symptoms, and add side effects…

You may also wish to ask for a referral from your chiropractor, osteopath, or acupuncturist. Such practitioners are often aware of good homeopaths in the area. Sometimes the person who is responsible for managing supplements and remedies sold at health food stores will be aware of experienced homeopaths as well…

I know, apologists will claim that such extreme idiocy is always the work of a few ‘rotten apples’, even most homeopaths would object to such dangerous and amoral lunacy. But the fact is, they don’t! If you disagree, please show me the protests from homeopaths or other alternative practitioners.

When Wakefield was shown to be a fraud endangering public health with his bogus claims about vaccine damage, there were protests in abundance, and he was ousted by the medical and scientific communities. Where are the protests by the alternative medicine fraternity against this article and the many, many others like it?

NOBODY SHOULD BE ALLOWED TO ENDANGER PUBLIC HEALTH IN THIS WAY.

PS

In case you wonder who wrote the above article, it is John P. Thomas. He is a health writer for Health Impact News. He holds a B.A. in Psychology from the University of Michigan, and a Master of Science in Public Health (M.S.P.H.) from the School of Public Health, Department of Health Administration, at the University of North Carolina at Chapel Hill. John specializes in environmental health, but writes on a variety of issues.

Poor sleep quality during pregnancy is a frequent problem. Drug treatment can be problematic due to possible adverse effects for mother and embryo/foetus. Many pregnant women prefer natural treatments and assume that ‘natural’ equals harmless.

In the present study, the sedative effects of Bryophyllum pinnatum were investigated. This remedy is a phytotherapeutic medication predominantly used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a promising risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnosis.

In this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician’s consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse effects perceived by the patients during the treatment were recorded.

The results show that the number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a reduction in tiredness during the day. There was, however, no evidence for a prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.

From these data, the authors concluded that B. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.

Clinical trials of anthroposophic remedies, i.e. remedies which are based on the school of medicine founded by Rudolf Steiner, are very rare. Therefore this trial could be important.

B. pinnatum is a plant used in traditional Tai medicine against hypertension, and to some extend this makes sense: it contains cardiac glycosides which might help lowering elevated blood pressure. The reason for its use as a hypnotic, however, is not clear.

So, is B pinnatum really a ‘suitable treatment of sleep problems in pregnancy’? I doubt it for the following reasons:

  • the effects documented in this study are far from convincing,
  • we would need much more solid data to issue such a general recommendation,
  • cardiac glycosides can cause very serious adverse effects,
  • the sample size of the study is at least one dimension too small for assuming that it is safe,
  • we know nothing about its potential to cause harm to the foetus.

Personally, I find it irresponsible to draw conclusions such as the ones above on the basis of data which are flimsy to the extreme. I ask myself, to what extend wishful thinking might be a regrettable characteristic for the entire field of anthroposophic medicine.

If you are pregnant, a ‘breech presentation’ is not good news. It occurs when the fetus presents ‘bottom-down’ in the uterus. There are three types:

  • Breech with extended legs (frank) – 85% of cases
  • Breech with fully flexed legs (complete)
  • Footling (incomplete) with one or both thighs extended

The significance of breech presentation is its association with higher perinatal mortality and morbidity when compared to cephalic presentations. This is due both to pre-existing congenital malformation, increased incidence of breech in premature deliveries and increased risk of intrapartum trauma or asphyxia. Caesarean section has been adopted as the ‘normal’ mode of delivery for term breech presentations in Europe and the USA, as the consensus is that this reduces the risk of birth-related complications.

But Caesarian section is also not a desirable procedure. Something far less invasive would be much more preferable, of course. This is where the TCM-practitioners come in. They claim they have the solution: moxibustion, i.e. the stimulation of acupuncture points by heat. But does it really work? Can it turn the fetus into the correct position?

This new study aimed to assess the efficacy of moxibustion (heating of the acupuncture needle with an igniting charcoal moxa stick) with acupuncture for version of breech presentations to reduce their rate at 37 weeks of gestation and at delivery. It was a randomized, placebo-controlled, single-blind trial including 328 pregnant women recruited in a university hospital center between 33 4/7 and 35 4/7 weeks of gestation. Moxibustion with acupuncture or inactivated laser (placebo) treatment was applied to point BL 67 for 6 sessions. The principal endpoint was the percentage of fetuses in breech presentation at 37 2/7 weeks of gestation.

The results show that the percentage of fetuses in breech presentation at 37 2/7 weeks of gestation was not significantly different in both groups (72.0 in the moxibustion with acupuncture group compared with 63.4% in the placebo group).

The authors concluded that treatment by moxibustion with acupuncture was not effective in correcting breech presentation in the third trimester of pregnancy.

You might well ask why on earth anyone expected that stimulating an acupuncture point would turn a fetus in the mother’s uterus into the optimal position that carries the least risk during the process of giving birth. This is what proponents of this technique say about this approach:

During a TCM consultation to turn a breech baby the practitioner will take a comprehensive case history, make a diagnosis and apply the appropriate acupuncture treatment.  They will assess if moxibustion might be helpful. Practitioners will then instruct women on how to locate the appropriate acupuncture points and demonstrate how to safely apply moxa at home. The acupuncture point UB 67 is the primary point selected for use because it is the most dynamic point to activate the uterus.  Its forte is in turning malpositioned babies.  It is located on the outer, lower edge of both little toenails. According to TCM theory, moxa has a tonifying and warming effect which promotes movement and activity.  The nature of heat is also rising.  This warming and raising effect is utilised to encourage the baby to become more active and lift its bottom up in order to gain adequate momentum to summersault into the head down position. This technique can also be used to reposition transverse presentation, a situation where the baby’s has its shoulder or back pointing down, or is lying sideways across the abdomen.

Not convinced? I can’t say I blame you!

Clearly, we need to know what the totality of the most reliable evidence shows; and what better than a Cochrane review to inform us about it? Here is what it tells us:

Moxibustion was not found to reduce the number of non-cephalic presentations at birth compared with no treatment (P = 0.45). Moxibustion resulted in decreased use of oxytocin before or during labour for women who had vaginal deliveries compared with no treatment (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.13 to 0.60). Moxibustion was found to result in fewer non-cephalic presentations at birth compared with acupuncture (RR 0.25, 95% CI 0.09 to 0.72). When combined with acupuncture, moxibustion resulted in fewer non-cephalic presentations at birth (RR 0.73, 95% CI 0.57 to 0.94), and fewer births by caesarean section (RR 0.79, 95% CI 0.64 to 0.98) compared with no treatment. When combined with a postural technique, moxibustion was found to result in fewer non-cephalic presentations at birth compared with the postural technique alone (RR 0.26, 95% CI 0.12 to 0.56).

In other words, there is indeed some encouraging albeit not convincing evidence! How can this be? There is no plausible explanation why this treatment should work!

But there is a highly plausible explanation why the results of many of the relevant trials are false-positive thus rendering a meta-analysis false-positive as well. I have repeatedly pointed out on this blog that practically all Chinese TCM-studies report (false) positive results; and many of the studies included in this review were done in China. The Cochrane review provides a strong hint about the lack of rigor in its ‘plain language summary’:

The included trials were of moderate methodological quality, sample sizes in some of the studies were small, how the treatment was applied differed and reporting was limited. While the results were combined they should be interpreted with caution due to the differences in the included studies. More evidence is needed concerning the benefits and safety of moxibustion.

So, would I recommend moxibustion for breech conversion? I don’t think so!

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