homeopathy
Endocrine therapy (ET) is often used to reduce the risk of recurrence in hormone receptor-expressing disease. It is associated with worsening of climacteric symptoms can therefore have a negative impact on the quality of life (QoL) of those affected. Homeopathy is sometimes recommended for management of hot flushes (HF), and a new study aimed to test whether it is effective.
In this multi-centre, double-blind, placebo-controlled RCT, women were included suffering from histologically proven non-metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients scheduled for chemotherapy, or radiotherapy, or those with associated pathology known to induce HF were excluded. After a 2- to 4-week placebo administration, patients were randomly assigned to receiving the homeopathic medicine complex Actheane® (arm A) or placebo (arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. The primary endpoint was the variation between pre- and 4week-HFS. Secondary endpoints included HFS variation between pre- and 8week-HFS. Compliance and tolerance were assessed 8 weeks after randomization, and QoL and satisfaction were assessed at 4- and 8-week post-randomization.
In total, 138 patients were randomized (A, 65; P, 73). Median 4week-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different between the two arms. However, 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4week-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).
The authors concluded that the efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.
At the start of their abstract, the authors state that homeopathy might allow a better management of hot flushes (HF). Frankly, I fail to see the evidence for this statement. The only study I know of (by a known advocate of homeopathy) showed no effect of homeopathy.
Acthéane is a mixture marketed by Boiron of 5 ingredients:
– Actaea racemosa 4 CH : 0,5 mg
– Arnica montana 4 CH : 0,5 mg
– Glonoinum 4 CH : 0,5 mg
– Lachesis mutus 5 CH : 0,5 mg
– Sanguinaria canadensis 4 CH : 0,5 mg
I am not aware of evidence that this remedy might work.
If there is no plausible rationale for conducting a study, does that not mean it is ethically questionable to do it?
Apart from that, the study seems well-designed. It is not very well presented, but the paper is clear enough. Its results are as one would expect from a rigorous trial of homeopathy. The fact that the authors try to squeeze out some positive messages from this squarely negative study is, of course, pathetic. To mention in the abstract that 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients (not the primary outcome measure) in P arm is little more than an embarrassing tribute to the sponsor, in my view.
Boiron Canada state on their website that Acteane® is a homeopathic medicine used for the relief of perimenopause and menopause symptoms such as hot flashes, night sweats, sleep disorders, headache, irritability and mood swings.
The benefits of Acteane, a new solution for women:
• Hormone-free
• Soy-free
• Can be associated with other treatments used during perimenopause
• Non-drowsy
• Chewable tablets
• Does not require water
WILL THEY NOW ADD ‘EFFECT-FREE’ TO THEIR LIST?
The AMERICAN INSTITUTE OF HOMEOPATHY (AIH) is the oldest national medical association in the United States. The AIH’s mission is “to promote the science and art of homeopathic medicine, to safeguard the interests of the homeopathic medical profession, to improve the standards of homeopathic medical education, to educate the medical and scientific communities about the scientific basis for homeopathic medicine, and to increase public knowledge and acceptance of homeopathy as a medical specialty.”
The AIH is about to hold its annual conference. This year’s theme is “Tackling Patients with Severe Pathology”. The announcement reads as follows:
Homeopathy has been found to be effective in the great majority of patients suffering from infectious and autoimmune diseases. The limits of homeopathic treatment are encountered in the treatment of patients with Parkinson’s disease, ALS and late-stage cancers. After finding a way to treat patients with Parkinson’s disease with homeopathy, Dr. Saine began to apply this approach to cancer patients in stages III and IV. In this seminar, he will review case analysis, posology and case management for this cohort of patients.
We are fortunate to have the opportunity to learn from Dr. Saine in this seminar. He is recognized as one of the foremost homeopathic teachers and clinicians in the world, with special expertise in extremely difficult cases of severe and advanced pathology.
Who, for heaven sake, is this foremost homeopathic teachers and clinicians in the world, Dr Saine?, I asked myself after reading this (and even more so after listening to the rather spectacular video provided with the announcement). Here is what I found out about him:
Dr. Saine is a 1982 graduate of the National College of Naturopathic Medicine in Portland, Oregon. He is board-certified in homeopathy (1988) by the Homeopathic Academy of Naturopathic Physicians and has been teaching and lecturing on homeopathy since 1985. He is considered one of the world’s foremost experts on the subject of homeopathy.
And this is what non-doctor* Saine writes about medicine etc.:
The Organon of Medicine is a blueprint on how to practice medicine rationally and wisely through an integration of all the fundamental principles of medicine into a comprehensive whole. Unfortunately, to the detriment of the sick, very few homeopaths have delved, as Hahnemann did, into the practice of lifestyle medicine and the use of complementary care to homeopathy.
With rare exceptions, patients will present with a portion of their disease that ensues from an unhealthy environment or ways of living. The role of the physician is to determine in the equation of disease what is primarily due to an untuned vital force versus a causa occasionalis, as both will have to be addressed in due time.
After reading and listening to all this I am mildly shocked.
It does not seem to me that the AIH is fit for purpose. Neither am I convinced that non-doctor Saine should be let near any patient, let alone one with cancer or another severe pathology.
There should be a law protecting patients from this sort of thing!
[*in the context of healthcare, a doctor is for me someone who has studied medicine]Samuel Hahnemann invented homeopathy about 200 years ago. His placebos were better than (or not as bad as) the ‘heroic’ medicine of his time which frequently was more dangerous than the disease it aimed to cure. Thus, homeopathy took Germany by storm. When, about 100 years ago, medicine finally became scientific and was able to offer more and more effective treatments, the popularity of homeopathy began to wane. Yet, before its natural demise, during the Third Reich, it received a significant boost from Nazi-greats such as Hess and Himmler. After this nightmare was over, German homeopathy went into another slow decline. But when the New Age movement and the current boom in alternative medicine reached Germany, homeopathy seemed to thrive once again.
In the 1990s evidence-based medicine (EBM) grew into one of the central concepts of medicine. In Germany, however, EBM had a relatively hard time to get established. This might be one of the reasons why homeopathy continued to prosper, despite the arrival of ever clearer evidence that highly diluted homeopathic remedies are pure placebos. While, in the UK, we had an increasingly lively debate about the uselessness of homeopathy, Germany remained the promised land of homeopathy. Sales figures of homeopathics continued to increase steadily and reached a level of about half a billion Euros per annum.
The golden age of German homeopathy had dawned:
- The media, often sponsored by homeopathic interest groups, kept on promoting homeopathy largely unopposed.
- The mighty Carstens Stiftung worked tirelessly to promote it.
- Homeopathy became established in many medical schools.
- Homeopathy was available and often advertised in almost all pharmacies.
- The public was convinced that homeopathy worked.
- The Heilpraktiker adopted homeopathy fully.
- The medical and other conventional healthcare professions embraced it to a large degree.
- The adult education institutes (Volkshochschulen) offered courses.
- Politicians were squarely on the side of homeopathy,
- Health insurances, paid for it.
Of course, there were also some (and always had been) opposing voiced and organisations, such as the GWUP (the German sceptic organisation), for example. But somehow, they remained relatively low-key. When, every now and then, courageous journalists dared to think of a critical take on homeopathy, they had to search far and wide to find a German-speaking expert who was willing or able to tell them the truth: that homeopathy is neither biologically plausible nor evidence-based and therefore an expensive, potentially harmful waste of money that makes a mockery of EBM. During this period, journalists (far too) often asked me for some critical comments. I hardly ever published my research in German, but they nevertheless would find me via my Medline-listed papers. I often felt like a very lone voice in a German desert.
For the German homeopathic industry, I evidently was more than just a lone voice. Unbeknown to me, they clubbed together and financed a PR-man/journalist (at the tune of Euro 30 000/year) to write as many defamatory articles about me as he could muster. First, I was bewildered by his activity, then I tried to communicate with him (only to get mis-quoted), and eventually I ignored his writings. Yet, a German investigative journalist found Fritzsche’s one-sided activities offensive and started investigating. His research and subsequent article disclosed the fact that he was being paid by the homeopathic industry. Once I learn about this scandal, I wrote to some of the financiers directly and asked for an explanation. As a result, they discontinued their sponsorship. Shortly afterwards, Fritzsche committed suicide.
At heart, I have always been an optimist and strongly believe that in medicine the truth, in this case the evidence, will always prevail, no matter what obstacles others might put in its way. Recent developments seem to suggest that I might be right.
In the last few years, several individuals in Germany have, from entirely different angles, taken a fresh look at the evidence on homeopathy and found it to be desperately wanting. Independent of each other, they published articles and books about their research and insights. Here are 5 examples:
Die Homöopathie-Lüge: So gefährlich ist die Lehre von den weißen Kügelchen, Christian Weymayr, Nicole Heißmann, 2012
In Sachen Homöopathie: Eine Beweisaufnahme, Norbert Aust, 2013
Homöopathie neu gedacht: Was Patienten wirklich hilft, Natalie Grams, 2015
Der Glaube an die Globuli: Die Verheißungen der Homöopathie, Norbert Schmacke, Bernd Hontschik, 2015
Der wahrscheinlich teuerste Zucker der Welt: Was Sie über Homöopathie und Alternativmedizin wissen sollten, Oliver Grunau, 2017
Inevitably, these individuals came into contact with each other and subsequently founded several working-groups to discuss their concerns and coordinate their activities. Thus the INH and the Muensteraner Kreis were born. So, now we have at least three overlapping groups of enthusiastic, multidisciplinary experts who voluntarily work towards informing the German public that paying for homeopathy out of public funds is unethical, nonsensical and not in the interest of progress:
- the GWUP,
- the INH
- and the Muensteraner Kreis.
No wonder then, that the German homeopathic industry and other interested parties got worried. When they realised that (presumably due to the work of these altruistic enthusiasts) the sales figures of homeopathics in Germany had, for the first time since many years, started declining, they panicked.
Their reaction was, as far as I can see, similar to their previous response to criticism: they started a media campaign in an attempt to sway public opinion. And just like before, they have taken to employing PR-people who currently spend their time defaming all individuals voicing criticism of homeopathy in Germany. Their prime targets are those experts who are most exposed to activities of responsibly informing the public about homeopathy via lectures, publications social media, etc. All of us currently receive floods of attack, insults and libellous defamations. As before (innovation does not seem to be a hallmark of homeopathy), these attacks relate to claims that:
- we are incompetent,
- we do not care about the welfare of patients,
- we are habitual liars,
- we are on the payroll of the pharmaceutical industry,
- we aim at limiting patient choice,
- we do what we do because we crave the limelight.
So, what is going to happen?
I cannot read tea leaves but am nevertheless sure of a few things:
- The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
- They will not argue on the basis of science or evidence, because they know that neither are in their favour.
- They will fight dirty and try to defame everyone who stands in their way.
- They will use their political influence and their considerable financial power.
AND YET THEY WILL LOSE!
Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.
The UK Royal Pharmaceutical Society have published a quick reference guide on homeopathy. In it, they make the following 5 ‘key points’:
- The Royal Pharmaceutical Society (RPS) does not endorse homeopathy as a form of treatment because there is no scientific basis for homeopathy nor any evidence to support the clinical efficacy of homeopathic products beyond a placebo effect.
- The RPS does not support the prescribing of homeopathic products on the NHS.
- Pharmacists should ensure, wherever possible, that patients do not stop taking their prescribed conventional medication, if they are taking or are considering taking a homeopathic product.
- Pharmacists must be aware that patients requesting homeopathic products may have serious underlying undiagnosed medical conditions which may require referral to another healthcare professional.
- Pharmacists must advise patients considering a homeopathic product about their lack of efficacy beyond that of a placebo.
This publication is a few months old, but I only saw it recently. It could not be clearer and it is much more to the point than the General Pharmaceutical Council’s ‘Standards for Pharmacy Professionals‘ which state:
People receive safe and effective care when pharmacy professionals reflect on the application of their knowledge and skills and keep them up-to-date, including using evidence in their decision making. A pharmacy professional’s knowledge and skills must develop over the course of their career to reflect the changing nature of healthcare, the population they provide care to and the roles they carry out. There are a number of ways to meet this standard and below are examples of the attitudes and behaviours expected.
People receive safe and effective care when pharmacy professionals:
- recognise and work within the limits of their knowledge and skills, and refer to others when needed
- use their skills and knowledge, including up-to-date evidence, to deliver care and improve the quality of care they provide
- carry out a range of continuing professional development (CPD) activities relevant to their practice
- record their development activities to demonstrate that their knowledge and skills are up to date
- use a variety of methods to regularly monitor and reflect on their practice, skills and knowledge
The two statements together should suffice to finally get some sense into UK pharmacies when it comes to the sale of homeopathic remedies. What is needed now, I think, is an (under-cover?) investigation to see how many UK community pharmacists abide by this guidance.
If anyone has the means to conduct it, I would be delighted to advise them on the best methodology.
Some homeopaths claim that there is anecdotal support for the use of the homeopathic medicine Arsenicum album in preventing post-vaccination fever. As far as I know, the claim has not been tested in clinical trials. This study was aimed at evaluating the efficacy of this approach in preventing febrile episodes following vaccination.
In the community medicine out-patient of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, a double-blind, randomized, placebo-controlled trial was conducted on 120 children. All of them presented for the 2nd and 3rd dose of DPT-HepB-Polio vaccination and reported febrile episodes following the 1st dose. They were treated with Arsenicum album 30cH 6 doses or placebo (indistinguishable from verum), thrice daily for two subsequent days. Parents were advised to report any event of febrile attacks within 48h of vaccination.
The groups were comparable at baseline. Children reporting fever after the 2nd dose was 29.8% and 30.4% respectively for the homeopathy group and control group respectively [Relative Risk (RR)=1.008] with no significant difference (P=0.951) between groups. After the 3rd dose, children reporting fever were 31.5% and 28.3% respectively for the homeopathy group and control group respectively (RR=0.956) with no significant difference (P=0.719) between groups.
The authors concluded that empirically selected Arsenicum album 30cH could not produce differentiable effect from placebo in preventing febrile episodes following DPT-HepB-Polio vaccination.
I can hear it now, the chorus of homeopaths:
- this is part of a conspiracy against homeopathy,
- the authors of this study display an anti-homeopathy bias,
- this study did not closely follow the principles of homeopathy,
- it lacked the input by experience homeopaths,
- no homeopath worth his money would use Arsenicum album 30cH for this purpose,
- no homeopath in his right mind would employ 6 doses thrice daily for two subsequent days,
- etc., etc.
Well guys, I have to disappoint you: the authors of this paper have the following affiliations:
- Dept. of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
- Dept. of Community Medicine, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
- Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal
- National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India
- Central Council of Homoeopathy, Vill, Champsara
So, perhaps it’s true: highly diluted homeopathic remedies are pure placebos.
It has been reported that the faculty of medicine of Lille unversity in France has suspended its degree in homeopathy for the 2018-19 academic year. The university announced its decision on Twitter, and the faculty of medicine’s dean, Didier Gosset, confirmed it to the AFP news agency: “It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial,” he explained. “Continuing to teach it would be to endorse it.”
The decision is, of course, long overdue and must be welcomed. Personally, however, I wonder why defenders of reason like Prof Gosset often employ such unclear lines of argument. Would it not be clearer to make (some of) these simple points?
- The assumptions on which homeopathy is based are obsolete and implausible.
- It is not that we do not understand homeopathy’s mode of action, but we understand that there cannot be one that does not fly in the face of science.
- The clinical evidence fails to show that highly diluted homeopathic remedies are more than placebos.
- Homeopathy can cause significant harm, e. g. through neglect.
- Homeopathy costs millions which would be much better used for evidence-based treatments.
- The practice of homeopathy hinders progress and does not provide benefit for the public.
- Teaching homeopathy at university-level is unscientific, unethical and nonsensical.
The French are among the world’s largest consumers of homeopathic remedies. The French social security system does normally reimburse homeopathic therapy. A group of doctors challenged this situation in an open letter in Le Figaro newspaper in March 2018. They called practitioners of homeopathy and other alternative medicines “charlatans”, pointing to a 2017 report by the European Academies Science Advisory Council that stressed, like a plethora of previous reports, the “absence of proof of homeopathy’s efficacy”. They challenged the French medical council to stop allowing doctors to practice homeopathy and asked the social security system to stop paying for it. Subsequently, a group of French homeopaths filed a formal complaint with the medical council against the signatories of this letter.
France’s health ministry has asked France’s National Health Authority to prepare and publish a report on whether homeopathy works and should be paid for by the public purse. It is due to be delivered in February 2019.
WATCH THIS SPACE
Medline is the biggest electronic databank for articles published in medicine and related fields. It is therefore the most important source of information in this area. I use it regularly to monitor what new papers have been published in the various fields of alternative medicine.
As the number of Medline-listed papers dated 2018 on homeopathy has just reached 100, I thought it might be the moment to run a quick analysis on this material. The first thing to note is that it took until August for 100 articles dated 2018 to emerge. To explain how embarrassing this is, we need a few comparative figures. At the same moment (6/9/18), we have, for instance:
- 126576 articles for surgery
- 5001 articles or physiotherapy
- 30215 articles for psychiatry
- 60161 articles for pharmacology
Even compared to other types of alternative medicine, homeopathy is being dwarfed. Currently the figures are, for instance:
- 2232 for herbal medicine
- 1949 for dietary supplements
- 1222 for acupuncture
This does not look as though homeopathy is a frightfully active area of research, if I may say so. Looking at the type of articles (yes, I did look at all the 100 papers and categorised them the best I could) published in homeopathy, things get even worse:
- 29 were comments, letters, editorials, etc.
- 16 were basic and pre-clinical papers,
- 12 were non-systematic reviews,
- 10 were surveys,
- 7 were case-reports,
- 5 were pilot or feasibility studies,
- 5 were systematic reviews,
- 5 were controlled clinical trials,
- 2 were case series,
- the rest of the articles was not on homeopathy at all.
I find this pretty depressing. Most of the 100 papers turn out to be no real research at all. Crucial topics are not being covered. There was, for example, not a single paper on the risks of homeopathy (no, don’t tell me it is harmless; it can and does regularly cost the lives of patients who trust the bogus claims of homeopaths). There was no article investigating the important question whether the practice of homeopathy does not violate the rules of medical ethics (think of informed consent or the imperative to do more harm than good). And a mere 5 clinical trials is just a dismal amount, in my view.
In a previous post, I have already shown that, in 2015, homeopathy research was deplorable. My new analysis suggests that the situation has become much worse. One might even go as far as asking whether 2018 might turn out to be the year when homeopathy research finally died a natural death.
PROGRESS AT LAST!!!
This systematic review included 18 studies assessing homeopathy in depression. Two double-blind placebo-controlled trials of homeopathic medicinal products (HMPs) for depression were assessed. The first trial (N = 91) with high risk of bias found HMPs were non-inferior to fluoxetine at 4 (p = 0.654) and 8 weeks (p = 0.965); whereas the second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine (p = 0.082) and superior to placebo (p < 0.005) at 6 weeks.
The remaining research had unclear/high risk of bias. A non-placebo-controlled RCT found standardised treatment by homeopaths comparable to fluvoxamine; a cohort study of patients receiving treatment provided by GPs practising homeopathy reported significantly lower consumption of psychotropic drugs and improved depression; and patient-reported outcomes showed at least moderate improvement in 10 of 12 uncontrolled studies. Fourteen trials provided safety data. All adverse events were mild or moderate, and transient. No evidence suggested treatment was unsafe.
The authors concluded that limited evidence from two placebo-controlled double-blinded trials suggests HMPs might be comparable to antidepressants and superior to placebo in depression, and patients treated by homeopaths report improvement in depression. Overall, the evidence gives a potentially promising risk benefit ratio. There is a need for additional high quality studies.
It is worth having a look at these two studies, I think.
The 1st (2011) study is from Brazil
Here is its abstract:
Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.
There are many important points to make about this trial:
- Contrary to what the reviewers claim, the trial had no placebo group.
- It was a double-dummy equivalence study comparing individualised homeopathy with the antidepressant fluoxetine.
- Fluoxetine might have been under-dosed (see below).
- Equivalence studies require large sample sizes, and with just 91 patients (only 55 of whom finished the study), this trial was underpowered which means the finding of equivalence is false positive.
- The authors noted that a higher percentage of troublesome adverse effects reported by patients receiving fluoxetine. This means that the trial was not double-blind; patients were able to tell by their side-effects which group they were in.
- The authors also state that more patients randomized to homeopathy than to fluoxetine were excluded due to worsening of their depressive symptoms. I think this confirms that homeopathy was ineffective.
The 2nd (2015) study is from Mexico
Here is its abstract:
Background: Perimenopausal period refers to the interval when women’s menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.
Methods/Design: A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).
Results: After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.
Conclusion: Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.
And here are my critical remarks about this trial:
- The aim of a small study like this cannot be to assess or draw conclusions about the safety of the interventions used; for this purpose, we need sample sizes that are at least one dimension bigger.
- Fluoxetine might have been under-dosed (see below).
- The blinding of patients might have been jeopardized by patients experiencing the specific side-effects of fluoxetine. The authors reported adverse effects in all three groups. However, the characteristic and most common side-effects of fluoxetine (such as hives, itching, skin rash, restlessness, inability to sit still) were not included.
________________________________________________
Usual Adult Dose for Depression
Immediate-release oral formulations:
Initial dose: 20 mg orally once a day in the morning, increased after several weeks if sufficient clinical improvement is not observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day
Delayed release oral capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.
_________________________________________________
Considering all this, I feel that the conclusions of the above review are far too optimistic and not justified. In fact, I find them misleading, dangerous, unethical and depressing.
On 4 September 2018, during the FIP (78th FIP World Congress of Pharmacy and Pharmaceutical Sciences), a meeting took place intended to give an opportunity to practising pharmacists to voice their opinions on the question whether pharmacies should stop selling homeopathic products. Attendees were provided with voting materials to allow them to express their views in a spontaneous and powerful manner, and for FIP to ascertain genuine opinions about this important matter. The debate and subsequent voting is likely to influence FIP policymaking and statement formulation. Here is the outline of the meeting:
The Great Debate – The motion “Pharmacists should not sell or dispense homeopathic products”
12:30 – 12:34 Introduction by the chairs
- 12:34 – 12:57 For the motion
Geoff Tucker (University of Sheffield, UK) - 12:57 – 13:20 Against the motion
Christine Glover (Glover’s Integrated Healthcare, UK) - 13:20 – 13:25 Ethical considerations related to homeopathy
Betty Chaar (The University of Sydney, Australia) - 13:25 – 13:35 Responses and summary
Facilitator: Andy Gray (University of KwaZulu Natal, South Africa)- Against the motion
Christine Glover (Glover’s Integrated Healthcare, UK) - For the motion
Geoff Tucker (University of Sheffield, UK)
- Against the motion
- 13:35 -14:00 Open forum – Questions from the audience with speakers and chairs as panel/ Vote and concluding comments
The German ‘Pharmazeutische Zeitung‘ just published a report about the outcome of the meeting:
“Bei der Abstimmung im Anschluss sprachen sich fast zwei Drittel der im Auditorium anwesenden Pharmazeuten gegen eine Distribution von homöopathischen Produkten durch Apotheken aus. Mehr als ein Drittel stimmte für den Erhalt der Produkte in den Apotheken. Das Ergebnis habe keine bindende Wirkung für den Entscheidungsprozess des FIP, machte der Moderator der Sitzung, Andy Gray von der Universität KwaZulu Natal in Südafrika, deutlich. Es gebe aber einen Hinweis, in welche Richtung sich die Organisation orientieren sollte. (ch).”
In plain English: two thirds voted for the motion and against homeopathic products remaining on sale in pharmacies. The vote has, however, no binding effect on FIP policy. It is nevertheless likely to determine the direction in which FIP will decide.
I think this is long-overdue (I have been trying to persuade pharmacists to do something like this since ~15 years). I now applaud the FIP for raising the issue. Bravo!
What next?
The vote needs to be translated into policy.
Other healthcare professionals – not least doctors – must follow suit.
Just when I thought I had seen all homeopathy has to offer, here comes this:
THE BRISTOL STOOL CHART AND CORRESPONDING HOMEOPATHIC REMEDIES!
“With mere examination of stool appearance, Homoeopathic remedy can easily be selected….”
The chart was, according to Wikipedia, developed and proposed for the first time by Dr. Stephen Lewis and Dr. Ken Heaton at the University Department of Medicine, Bristol Royal Infirmary, it was suggested by the authors as a clinical assessment tool in 1997 in the journal Scandinavian Journal of Gastroenterology after a previous prospective study, conducted in 1992 on a sample of the population (838 men and 1,059 women), had shown an unexpected prevalence of defecation disorders related to the shape and type of stool. The authors of the former paper concluded that the form of the stool is a useful surrogate measure of colon transit time. That conclusion has since been challenged as having limited validity for Types 1 and 2; however, it remains in use as a research tool to evaluate the effectiveness of treatments for various diseases of the bowel, as well as a clinical communication aid.
Nobody had meant this chart to get in any way related to homeopathy. I congratulate Dr Sharma to have spotted the connection. Thanks to him, we all can now easily find which homeopathic remedies are the ones we need. The writing is not on the wall, it is in the loo! I think someone should inform the Karolinska Institute in Stockholm – this surely is Nobel Prize material!!!
