The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).
Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.
At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.
Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.
The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.
Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:
- Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
- Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
- MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?
Considering all this, I ask myself: should we trust this study and its findings?
What do you think?
8 Responses to Homeopathy for sleep bruxism? In your dreams!
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Unfortunately again the paper (like all Elsevier publications) is hidden behind a paywall, so I don’t have access to vital information from the full paper. Nevertheless…
This seems a very strange trial design. With 52 subjects and four-way randomisation, there can only have been 13 in each group. The investigators try to get round this by using a crossover design, whereby each subject has all four treatments in succession, including the placebo. Since one of the treatments involves two homeopathic preparations, I am assuming that there was some way of ensuring that this looked the same as the others (both in one pill, or 1 – 2 placebo pills for the other phases?).
So… How were the different treatment phases analysed? Were they lumped together, say, so that MO as first treatment was grouped with placebo then MO, MO+PD then placebo then MO and PD then MO+PD then placebo then MO (I don’t know the actual order the treatments were given in)?
What about changes with time regardless of which arm the subjects were in. Each one would have had about five months of treatment, which is a long time at this age, and I would have expected spontaneous changes in their symptoms over that period.
It seems to me that with so many variables and so few subjects, if we assume the null hypothesis, the results are going to depend very much on how the data are analysed, and you might well expect a few “significant” differences purely by chance.
The primary outcome measure was the parents’ assessment of how their child was sleeping on a visual analogue scale at the end of each treatment phase. I’m not even sure how you would begin to place sleep patterns on such a scale, nor measure changes, and in any case such an assessment is going to be very subjective, particularly as, in order to complete it, the parents would have to remember how the sleep had been over the previous 30 days and how it had changed over this time. In my experience patients have difficulty reporting changes in symptoms from memory over much shorter periods (e.g. pain – they will tell you how their pain is now, not how it was the day before or even a couple of hours ago). Hence the importance of diaries.
We are told that the parents did keep a sleep diary, and that “the sleep diary results… were not influenced by any of the treatments”.
The other, slightly more objective assessment, was the TAS, administered by questionnaire. Again this showed no difference between the arms.
So to conclude that anything assessed in this trial gives promising results might be what I would expect from the advertising and PR industry (or perhaps from a spin-doctor or politician), but certainly not from serious medical investigators. I don’t think this reflects very well on the School of Dentistry at the Federal Uuniversity of Rio de Janeiro.
Julian
Nothing to do with the post (although I’d ask a few questions about the design as well) but I received this message on Twitter today
“Hi Lenny
I came across your profile while I was searching for Dr Julian Money-Kyrle on Twitter as I wanted to write to him, and was very sad to learn he had retired from medicine due to ill health.
He treated me as a 17 year old nearly 15 years ago and I would very much like to write to him, and wondered whether you had any contact details for him. I hope you don’t feel this is an intrusion.
He was such a fantastic doctor to me and my family thought him the most wonderful man during my treatment. It was awful to learn of his illness and I would like to tell I am thinking of him. The blog posts you’ve linked to are the most beautiful, eloquent testaments to the power and truth of science and I’ve spent most of the morning reading them.
Thank you again.
With very best wishes
(Name deleted)
I’ve suggested he contact you via your website.
Dr Julian – just reading Lenny’s post, I looked to see if you had a website, but could only see listings under your hospital.
Do you blog, aside from this one, about your immunotherapy treatment?
I have a friend starting this treatment shortly, and thought it may be helpful to read of your experiences, especially with your medical professional background. I wish you well.
Hi Angela,
No, I don’t blog, though Ii have thought about it. However, I would probably cover other things that I am interested in, such as music and photography and the strangeness of the world and everything in it.
Immunotherapy is a blanket category covering a number of different treatments – the immune system itself is very complex so there are many ways to affect it.
Dr Julian – if you ever decide to blog about your many interests it would be a worthwhile read for many people.
For example I didn’t know immunotherapy covers a number of different treatments.
When I looked to see if you had a website to help a friend, I noticed your link to a hospital, which is my local one. Many friends and family have benefited from the first class care of the medical professionals there: we are fortunate to have such expertise.
I wish you well.
Hi Lenny,
Thank-you for your email.
He has managed to get hold of my email address – it seems that a friend of his knows my cousin! The world is a smaller place than you might think, and with a name like mine I am forever coming across people who know my relatives, even though there are only about forty of us.
With Best Wishes,
Julian
LIke so many studies that pretend to study homeopathy, this is not a trial of homeopathy, it is a trial of homeopathicaly prepared medicines used in an allopathic way. One can palliate or suppress symptoms with homeopathic remedies also, just like conventional medicines do. The study does show that homeopathicaly prepared medicines have effects beyond placebo. Anyone can do a properly conducted proving of homeopathic remedies and experience that as well.
But Homeopathy is not a “medicine”, it is a process. A truly homeopathic remedy must match the constellation of symptoms, mental, physical and emotional of the patient. Matching only a single symptom like bruxism is not enough to cure but it could palliate. A cross-over study in this case might be valid because a remedy that is only palliating at such a low potency (12C) would likely wear off quickly.
Recently a researcher published a meta-analysis of homeopathic studies which purportedly showed homeopathy didnt work. I asked him if he had ruled out studies that didnt follow good homeopathic procedure. He said it didnt matter because he knew that homeopathic remedies were worthless. A Lancet meta-analysis of homeopathic studies relied on just 8 studies of the hundreds that have been published. Those few studies met their standards “well-conducted” studies , but didnt meet homeopath’s standards for homeopathic procedure.
MO wouldnt necessarily cause sleeplessness and anxiety if there was no susceptibility to it.
“The study does show that homeopathicaly prepared medicines have effects beyond placebo.”
No it doesn’t, for the reasons I pointed out in my previous post.