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

methodology

1 3 4 5 6 7 16

Homeopathy for depression? A previous review concluded that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. But that was 13 years ago. Perhaps the evidence has changed?

A new review aimed to assess the efficacy, effectiveness and safety of homeopathy in depression. Eighteen studies assessing homeopathy in depression were included. 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 and 8 weeks.
  • The second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine and superior to placebo 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.

I beg to differ!

What these data really show amounts to far less than the authors imply:

  • The two ‘double-blind’ trials are next to meaningless. As equivalence studies they were far too small to produce meaningful results. Any decent review should discuss this fact in full detail. Moreover, these studies cannot have been double-blind, because the typical adverse-effects of anti-depressants would have ‘de-blinded’ the trial participants. Therefore, these results are almost certainly false-positive.
  • The other studies are even less rigorous and therefore do also not allow positive conclusions.

This review was authored by known proponents of homeopathy. It is, in my view, an exercise in promotion rather than a piece of research. I very much doubt that a decent journal with a responsible peer-review system would have ever published such a biased paper – it had to appear in the infamous EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE.

So what?

Who cares? No harm done!

Again, I beg to differ.

Why?

The conclusion that homeopathy has a ‘promising risk/benefit profile’ is frightfully dangerous and irresponsible. If seriously depressed patients follow it, many lives might be lost.

Yet again, we see that poor research has the potential to kill vulnerable individuals.

This study was aimed at evaluating group-level and individual-level change in health-related quality of life among persons with chronic low back pain or neck pain receiving chiropractic care in the United States.

A 3-month longitudinal study was conducted of 2,024 patients with chronic low back pain or neck pain receiving care from 125 chiropractic clinics at 6 locations throughout the US. Ninety-one percent of the sample completed the baseline and 3-month follow-up survey (n = 1,835). Average age was 49, 74% females, and most of the sample had a college degree, were non-Hispanic White, worked full-time, and had an annual income of $60,000 or more. Group-level and individual-level changes on the Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 profile measure were evaluated: 6 multi-item scales (physical functioning, pain, fatigue, sleep disturbance, social health, emotional distress) and physical and mental health summary scores.

Within group t-tests indicated significant group-level change for all scores except for emotional distress, and these changes represented small improvements in health. From 13% (physical functioning) to 30% (PROMIS-29 Mental Health Summary Score) got better from baseline to 3 months later.

The authors concluded that chiropractic care was associated with significant group-level improvement in health-related quality of life over time, especially in pain. But only a minority of the individuals in the sample got significantly better (“responders”). This study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.

These conclusions are worded carefully to avoid any statement of cause and effect. But I nevertheless feel that the authors strongly imply that chiropractic caused the observed outcomes. This is perhaps most obvious when they state that this study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.

To me, it is obvious that this is wrong. The data are just as consistent with the opposite conclusion. There was no control group. It is therefore conceivable that the patients would have improved more and/or faster, if they had never consulted a chiropractor. The devil’s advocate therefore concludes this: the results of this study suggest that chiropractic has significant detrimental effects on functioning and well-being of patients with low back pain or neck pain.

Try to prove me wrong!

PS

I am concerned that a leading journal (Spine) publishes such rubbish.

The ‘Schwaebische Tageblatt’ is not on my regular reading list. But this article of yesterday (16/10/2018) did catch my attention. For those who read German, I will copy it below, and for those who don’t I will provide a brief summary and comment thereafter:

Die grün-schwarze Landesregierung lässt 2019 den ersten Lehrstuhl für Naturheilkunde und Integrative Medizin in Baden-Württemberg einrichten. Lehrstuhl für Naturheilkunde und Integrative Medizin

Ihren Schwerpunkt soll die Professur im Bereich Onkologie haben. Strömungen wie Homöopathie oder Anthroposophie sollen nicht gelehrt, aber innerhalb der Lehre beleuchtet werden, sagte Ingo Autenrieth, Dekan der Medizinischen Fakultät in Tübingen am Dienstag der Deutschen Presse-Agentur. «Ideologien und alles, was nichts mit Wissenschaft zu tun hat, sortieren wir aus.»

Die Professur soll sich demnach mit Themen wie Ernährung, Probiotika und Akupunktur beschäftigten. Geplant ist laut Wissenschaftsministerium, die Lehre in Tübingen anzusiedeln; die Erforschung der komplementären Therapien soll vorwiegend am Centrum für Tumorerkrankungen des Robert-Bosch-Krankenhauses in Stuttgart stattfinden. Die Robert-Bosch-Stiftung finanziert die Professur in den ersten fünf Jahren mit insgesamt 1,84 Millionen Euro, danach soll das Land die Mittel dafür bereitstellen.

«Naturheilkunde und komplementäre Behandlungsmethoden werden von vielen Menschen ganz selbstverständlich genutzt, beispielsweise zur Ergänzung konventioneller Therapieangebote», begründete Wissenschaftsministerin Theresia Bauer (Grüne) das Engagement. Sogenannte sanfte oder natürliche Methoden könnten schwere Krankheiten wie etwa Krebs alleine nicht heilen, heißt es in einer Mitteilung des Ministeriums. Wissenschaftliche Ergebnisse zeigten aber, dass sie häufig zu Therapieerfolgen beitragen könnten, da sie den Patienten helfen, schulmedizinische Therapien gut zu überstehen – etwa die schweren Nebenwirkungen von Chemotherapien mindern.

Im Gegensatz zur Schulmedizin gebe es bisher aber kaum kontrollierte klinische Studien zur Wirksamkeit solcher Therapien, ergänzte Ingo Autenrieth. Ihre Erforschung am neuen Lehrstuhl solle Patienten Sicherheit bringen und ermöglichen, dass die gesetzlichen Krankenkassen die Kosten dafür übernehmen.

Hersteller alternativer Arzneimittel loben den Schritt der Politik. «Baden-Württemberg nimmt damit eine Vorreiterrolle in Deutschland und in Europa ein», heißt es beim Unternehmen Wala Heilmittel GmbH in Bad Boll. Die Landesregierung trage mit der Entscheidung dem Wunsch vieler Patienten und Ärzte nach umfassenden Behandlungskonzepten Rechnung.

Auch hoffen die Unternehmen, dass Licht in die oft kritische Debatte um Homöopathie gebracht wird. «Wir sehen mit Erstaunen und Befremden, dass eine bewährte Therapierichtung wie die Homöopathie, die Teil der Vielfalt des therapeutischen Angebots in Deutschland ist, diskreditiert werden soll», sagte ein Sprecher des Herstellers Weleda AG mit Sitz in Schwäbisch Gmünd der Deutschen Presse-Agentur. Deshalb begrüße man den Lehrstuhl: «Es ist gut, dass Forschung und Lehre ausgebaut werden, da eine Mehrheit der Bevölkerung Komplementärmedizin wünscht und nachfragt. Es braucht Ärzte, die in diesen Bereichen auch universitär ausgebildet werden.»

Laut Koalitionsvertrag will Baden-Württemberg künftig eine Vorreiterrolle in der Erforschung der Komplementärmedizin einnehmen. Bisher gab es im Südwesten mit dem Akademischen Zentrum für Komplementäre und Integrative Medizin (AZKIM) zwar einen Verbund der Unikliniken Tübingen, Freiburg, Ulm und Heidelberg, aber keinen eigenen Lehrstuhl. Bundesweit existieren nach Angaben der Hufelandgesellschaft, dem Dachverband der Ärztegesellschaften für Naturheilkunde und Komplementärmedizin, Lehrstühle für Naturheilkunde noch an den Universitäten Duisburg-Essen, Rostock und Witten/Herdecke sowie drei Stiftungsprofessuren an der Berliner Charité.

END OF QUOTE

And here is my English summary:

The black/green government of Baden-Wuerttemberg has decided to create a ‘chair of naturopathy and integrated medicine’ at the university of Tuebingen in 2019. The chair will focus in the area of oncology. Treatments such as homeopathy and anthroposophical medicine will not be taught but merely mentioned in lectures. Ideologies and everything that is not science will be omitted.

The chair will thus deal with nutrition, acupuncture and probiotics. The teaching activities will be in the medical faculty at Tuebingen, while the research will be located at the Robert-Bosch Hospital in Stuttgart. The funds for the first 5 years – 1.84 million Euro – will come from the Robert-Bosch Foundation; thereafter they will be provided by the government of the county.

So-called gentle or natural therapies cannot cure serious diseases on their own, but as adjuvant treatments they can be helful, for instance, in alleviating the adverse effects of chemotherapy. There are only few studies on this, and the new chair will increase patient safety and facilitate the reimbursement of these treatments by health insurances.

Local anthroposophy manufacturers like Wala welcomed the move stating it would be in accordance with the wishes of many patients and doctors. They also hope that the move will bring light in the current critical debate about homeopathy. A spokesperson of Weleda added that they ‘note with surprise that time-tested therapies like homeopathy are being discredited. Therefore, it is laudable that research and education in this realm will be extended. The majority of the public want complementary medicine and need doctors who are also university-trained.’

Baden-Wurttemberg aims for a leading role in researching complementary medicine. Thus far, chairs of complementary medicine existed only at the universities of Duisburg-Essen, Rostock und Witten/Herdecke as well as three professorships at the Charité in Berlin.

END OF MY SUMMARY

As I have occupied a chair of complementary medicine for 19 years, I am tempted to add a few points here.

  • In principle, a new chair can be a good thing.
  • The name of the chair is odd, to say the least.
  • As the dean of the Tuebingen medical school pointed out, it has to be based on science. But how do they define science?
  • Where exactly does the sponsor, the Robert-Bosch Stiftung, stand on alternative medicine. Do they have a track-record of being impractical and scientific?
  • In order to prevent this becoming a unrealistic prospect, it is essential that the new chair needs to fall into the hands of a scientist with a proven track record of critical thinking.
  • Rigorous scientist with a proven track record of critical thinking are very rare in the realm of alternative medicine.
  • The ridiculous comments by Wala and Weleda, both local firms with considerable local influence, sound ominous and let me suspect that proponents of alternative medicine aim to exert their influence on the new chair.
  • The above-voiced notion that the new chair is to facilitate the reimbursement of alternative treatments by the health insurances seems even more ominous. Proper research has to be objective and could, depending on its findings, have the opposite effect. To direct it in this way seems to determine its results before the research has started.
  • I miss a firm commitment to medical ethics, to the principles of EBM, and to protecting the independence of the new chair.

Thus, I do harbour significant anxieties about this new chair. It is in danger of becoming a chair of promoting pseudoscience. I hope the dean of the Tuebingen medical school might read these lines.

I herewith offer him all the help I can muster in keeping pseudoscience out of this initiative, in defining the remit of the chair and, crucially, in finding the right individual for doing the job.

Often referred to as “Psychological acupressure”, the emotional freedom technique (EFT) works by releasing blockages within the energy system which are the source of emotional intensity and discomfort. These blockages in our energy system, in addition to challenging us emotionally, often lead to limiting beliefs and behaviours and an inability to live life harmoniously. Resulting symptoms are either emotional and/ or physical and include lack of confidence and self esteem, feeling stuck anxious or depressed, or the emergence of compulsive and addictive behaviours. It is also now finally widely accepted that emotional disharmony is a key factor in physical symptoms and dis-ease and for this reason these techniques are being extensively used on physical issues, including chronic illness with often astounding results. As such these techniques are being accepted more and more in medical and psychiatric circles as well as in the range of psychotherapies and healing disciplines.

An EFT treatment involves the use of fingertips rather than needles to tap on the end points of energy meridians that are situated just beneath the surface of the skin. The treatment is non-invasive and works on the ethos of making change as simple and as pain free as possible.

EFT is a common sense approach that draws its power from Eastern discoveries that have been around for over 5,000 years. In fact Albert Einstein also told us back in the 1920’s that everything (including our bodies) is composed of energy. These ideas have been largely ignored by Western Healing Practices and as they are unveiled in our current times, human process is reopening itself to the forgotten truth that everything is Energy and the potential that this offers us.

END OF QUOTE

If you ask me, this sounds as though EFT combines pseudo-psychological with acupuncture-BS.

But I may be wrong.

What does the evidence tell us?

A systematic review included 14 RCTs of EFT with a total of 658 patients.  The pre-post effect size for the EFT treatment group was 1.23 (95% confidence interval, 0.82-1.64; p < 0.001), whereas the effect size for combined controls was 0.41 (95% confidence interval, 0.17-0.67; p = 0.001). Emotional freedom technique treatment demonstrated a significant decrease in anxiety scores, even when accounting for the effect size of control treatment. However, there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioural therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.  Meta-analyses indicate large effect sizes for posttraumatic stress disorder, depression, and anxiety; however, treatment effects may be due to components EFT shares with other therapies.

Another, more recent analysis reviewed whether EFTs acupressure component was an active ingredient. Six studies of adults with diagnosed or self-identified psychological or physical symptoms were compared (n = 403), and three (n = 102) were identified. Pretest vs. posttest EFT treatment showed a large effect size, Cohen’s d = 1.28 (95% confidence interval [CI], 0.56 to 2.00) and Hedges’ g = 1.25 (95% CI, 0.54 to 1.96). Acupressure groups demonstrated moderately stronger outcomes than controls, with weighted posttreatment effect sizes of d = -0.47 (95% CI, -0.94 to 0.0) and g = -0.45 (95% CI, -0.91 to 0.0). Meta-analysis indicated that the acupressure component was an active ingredient and outcomes were not due solely to placebo, nonspecific effects of any therapy, or non-acupressure components.

From these and other reviews, one could easily get the impression that my above-mentioned suspicion is erroneous and EFT is an effective therapy. But I still do have my doubts.

Why?

These reviews conveniently forget to mention that the primary studies tend to be of poor or even very poor quality. The most common flaws include tiny sample sizes, wrong statistical approach, lack of blinding, lack of control of placebo and other nonspecific effects. Reviews of such studies thus turn out to be a confirmation of the ‘rubbish in, rubbish out’ principle: any summary of flawed studies are likely to produce a flawed result.

Until I have good quality trials to convince me otherwise, EFT is in my view:

  1. implausible and
  2. not of proven effectiveness for any condition.

Really?

For dogs?

Yes, one (of many) website explains that dogs benefit from acupuncture in 5 different ways:

1. Pain management is one of the most common uses for acupuncture, often in conjunction with a more traditional treatment plan. Strong medical treatments like chemo, which can cause discomfort, are often paired with acupuncture to help make a pet more comfortable and able to fight the illness.

2. Musculoskeletal problems such as arthritis, hip dysplasia, or nerve injuries can respond to acupuncture. It is often employed during rehabilitation after an injury. Carefully monitoring a healing pet is important; without the feeling of pain, a dog can re-injure him or herself with over-activity.

3. Skin problems like allergic dermatitis, granulomas, or hot spots may respond well to acupuncture treatment because increased circulation can improve healing, while pain reduction will reduce a dog’s overgrooming or itching responses.

4. Gastrointestinal problems like nausea and diarrhea can be aided by the increased blood flow from acupuncture. It may also help normalize digestive activity by stimulating digestive secretions.

5. Respiratory problems like asthma and allergies can benefit from the immune-calming, anti-inflammatory capabilities of acupuncture.

But all of this is based on ‘experience’ (or probably more accurately, the wishful thinking of those who earn money by sticking needles into animals), not evidence!

So, what does the evidence tell us about acupuncture for dogs?

The answer is: next to nothing; there are almost no studies. And this is why this recent paper could be important.

This new study was aimed at quantifying changes in gastric and intestinal emptying times in the conscious dog following gastrointestinal acupoint stimulation.

In a randomised, blinded crossover study, six dogs were fed 30×1.5 mm barium-impregnated polyethylene spheres and underwent: (1) no acupuncture (Control); (2) stimulation of target points PC6 and ST36 (Target) and (3) stimulation of non-target points LU7 and BL55 (Sham). Abdominal radiographs were assessed immediately after feeding the spheres and every hour for 12 hours and their number in the stomach and large intestines was counted.

The number of barium-impregnated polyethylene spheres found distal to the stomach was less in the Target group compared to the Control and Sham groups between hours 2 and 4, but no differences between groups were seen for the remainder of the treatment period. The number of spheres found within the colon/rectum was less in the Target group compared to the Control and Sham groups between hours 4 and 6, and compared to the Sham group only at hour 7 but no differences between groups were seen after hour 8.

The authors concluded that acupuncture targeted at the gastrointestinal tract of dogs was associated briefly with slowed gastric emptying and gastrointestinal transit time. This foundational study lays the groundwork for additional studies of acupuncture effects associated with altered physiologic states.

There you have it: the proof has been presented that acupuncture works in dogs; and if it works in animals, it cannot be a placebo!

Hold on, not so quick!

This was a tiny study, and the effects are small, only temporary and of questionable relevance. It is possible (I’d say even likely) that the finding was entirely coincidental.

I think, I wait until we have more and better data.

After a previous post about aromatherapy, someone recently commented:

I love essential oils and use them daily. Essential oils became a part of my life! I do feel better with it! Why I need clinical trials so?

The answer is probably: you don’t need clinical trials for a little pampering that makes you feel good.

But, if someone claims that aromatherapy (or indeed any other treatment) is effective for this or that medical condition, we need proof in the form of a clinical trial. By proof, we usually mean a clinical trial.

One like this new study, perhaps?

The aim of this study was to evaluate the use of a lavender aromatherapy skin patch on anxiety and vital sign variability during the preoperative period in female patients scheduled for breast surgery. Participants received an aromatherapy patch in addition to standard preoperative care. Anxiety levels were assessed with a 10-cm visual analogue scale (VAS) at baseline and then every 15 minutes after patch placement. Vital sign measurements were recorded at the same interval. There was a statistically significant decrease (P = .03) in the anxiety VAS measurements from baseline to final scores.

The authors concluded that the findings from this study suggest the use of aromatherapy is beneficial in reducing anxiety experienced by females undergoing breast surgery. Further research is needed to address the experience of preoperative anxiety, aromatherapy use, and the challenges of managing preoperative anxiety.

No, not one like this study!

This study – its called it a ‘pilot study’ – tells us nothing of value.

Why?

  1. It was not a pilot study because it did not pilot anything; its aim was to evaluate aromatherapy.
  2. But it could not evaluate aromatherapy because it had no control group. This means the reduction in anxiety was almost certainly not a specific effect of the therapy, but a non-specific effect due to the extra attention, expectation, etc.
  3. This means that the conclusion (the use of aromatherapy is beneficial) is not justified.
  4. In turn, this means that the paper is not helpful in any way. All it can possibly do is to mislead the public.

In summary: another fine example of pseudo-research that, I believe, is worse than no research at all.

On Twitter and elsewhere, homeopaths have been celebrating: FINALLY A PROOF OF HOMEOPATHY HAS BEEN PUBLISHED IN A TOP SCIENCE JOURNAL!!!

Here is just one example:

#homeopathy under threat because of lack of peer reviewed studies in respectable journals? Think again. Study published in the most prestigious journal Nature shows efficacy of rhus tox in pain control in rats.

But what exactly does this study show (btw, it was not published in ‘Nature’)?

The authors of the paper in question evaluated antinociceptive efficacy of Rhus Tox in the neuropathic pain and delineated its underlying mechanism. Initially, in-vitro assay using LPS-mediated ROS-induced U-87 glioblastoma cells was performed to study the effect of Rhus Tox on reactive oxygen species (ROS), anti-oxidant status and cytokine profile. Rhus Tox decreased oxidative stress and cytokine release with restoration of anti-oxidant systems. Chronic treatment with Rhus Tox ultra dilutions for 14 days ameliorated neuropathic pain revealed as inhibition of cold, warm and mechanical allodynia along with improved motor nerve conduction velocity (MNCV) in constricted nerve. Rhus Tox decreased the oxidative and nitrosative stress by reducing malondialdehyde (MDA) and nitric oxide (NO) content, respectively along with up regulated glutathione (GSH), superoxide dismutase (SOD) and catalase activity in sciatic nerve of rats. Notably, Rhus Tox treatment caused significant reductions in the levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6) and interleukin-1β (IL-1β) as compared with CCI-control group. Protective effect of Rhus Tox against CCI-induced sciatic nerve injury in histopathology study was exhibited through maintenance of normal nerve architecture and inhibition of inflammatory changes. Overall, neuroprotective effect of Rhus Tox in CCI-induced neuropathic pain suggests the involvement of anti-oxidative and anti-inflammatory mechanisms.

END OF QUOTE

I am utterly under-whelmed by in-vitro experiments (which are prone to artefacts) and animal studies (especially those with a sample size of 8!) of homeopathy. I think they have very little relevance to the question whether homeopathy works.

But there is more, much more!

It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud. It has been noted that the study used duplicated data figures that claimed to show different experimental results, inconsistently reported data and results for various treatment dilutions in the text and figures, contained suspiciously identical data points throughout a series of figures that were reported to represent different experimental results, and hinged on subjective, non-blinded data from a pain experiment involving just eight rats.

Lastly, others pointed out that even if the data is somehow accurate, the experiment is unconvincing. The fast timing differences of paw withdraw is subjective. It’s also prone to bias because the researchers were not blinded to the rats’ treatments (meaning they could have known which animals were given the control drug or the homeopathic dilution). Moreover, eight animals in each group is not a large enough number from which to draw firm conclusions, they argue.

As one consequence of these suspicions, the journal has recently added the following footnote to the publication:

10/1/2018 Editors’ Note: Readers are alerted that the conclusions of this paper are subject to criticisms that are being considered by the editors. Appropriate editorial action will be taken once this matter is resolved.

WATCH THIS SPACE!

Aromatherapy usually involves the application of diluted essential (volatile) oils via a gentle massage of the body surface. The chemist Rene-Maurice Gattefosse (1881-1950) coined the term ‘aromatherapy’ after experiencing that lavender oil helped to cure a severe burn of his hand. In 1937, he published a book on the subject: Aromathérapie: Les Huiles Essentielles, Hormones Végétales. Later, the French surgeon Jean Valnet used essential oils to help heal soldiers’ wounds in World War II.

Aromatherapy is currently one of the most popular of all alternative therapies. The reason for its popularity seems simple: it is an agreeable, luxurious form of pampering. Whether it truly merits to be called a therapy is debatable.

The authors of this systematic review stated that they wanted to critically assess the effect of aromatherapy on the psychological symptoms as noted in the postmenopausal and elderly women. They conducted electronic literature searches and fount 4 trials that met their inclusion criteria. The findings demonstrated that aromatherapy massage significantly improves psychological symptoms in menopausal, elderly women as compared to controls. In one trial, aromatherapy massage was no more effective than the untreated group regarding their experience of symptoms such as nervousness.

The authors concluded that aromatherapy may be beneficial in attenuating the psychological symptoms that these women may experience, such as anxiety and depression, but it is not considered as an effective treatment to manage nervousness symptom among menopausal women. This finding should be observed in light of study limitations.

In the discussion section, the authors state that to the best of our knowledge, this is the first meta-analysis evaluating the effect of aromatherapy on the psychological symptoms. I believe that they might be mistaken. Here are two of my own papers (other researchers have published further reviews) on the subject:

  1. Aromatherapy is the therapeutic use of essential oil from herbs, flowers, and other plants. The aim of this overview was to provide an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Several SRs of aromatherapy have recently been published. Due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
  2. Aromatherapy is becoming increasingly popular; however there are few clear indications for its use. To systematically review the literature on aromatherapy in order to discover whether any clinical indication may be recommended for its use, computerised literature searches were performed to retrieve all randomised controlled trials of aromatherapy from the following databases: MEDLINE, EMBASE, British Nursing Index, CISCOM, and AMED. The methodological quality of the trials was assessed using the Jadad score. All trials were evaluated independently by both authors and data were extracted in a pre-defined, standardised fashion. Twelve trials were located: six of them had no independent replication; six related to the relaxing effects of aromatherapy combined with massage. These studies suggest that aromatherapy massage has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.

Omitting previous research may be odd, but it is not a fatal flaw. What makes this review truly dismal is the fact that the authors fail to discuss the poor quality of the primary studies. They are of such deplorable rigor that one can really not draw any conclusion at all from them. I therefore find the conclusions of this new paper unacceptable and think that our statement (even though a few years old) is much more accurate: the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.

Evening primrose oil (EPO) is amongst the best-selling herbal remedies of all times. It is marketed in most countries as a dietary supplement. It is being promoted for eczema, rheumatoid arthritis, premenstrual syndrome, breast pain, menopause symptoms, and many other conditions. EPO seems to be a prime example for the fact that, in alternative medicine, the commercial success of a remedy is not necessarily determined by the strength of the evidence but by the intensity and cleverness of the marketing activities.

Evening primrose oil has been extensively tested in clinical trials for a wide range of conditions, including eczema (atopic dermatitis), postmenopausal symptoms, asthma, psoriasis, cellulite, hyperactivity, multiple sclerosis, schizophrenia, obesity, chronic fatigue syndrome, rheumatoid arthritis, and mastalgia. As I have reported previously, these data were burdened with mischief and scientific misconduct, and it is therefore not easy to differentiate between science, pseudoscience and fraud. The results of the more reliable investigations fail to show that it is effective for any condition.  A Cochrane review of 2013, for instance, concluded that supplements of evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials.

But now, a new study has emerged that casts doubt on this conclusion. The aim of this double-blinded, placebo-controlled RCT is to evaluate the efficacy and safety of EPO in Korean patients with atopic dermatitis (AD).

Fifty mild AD patients with an Eczema Area Severity Index (EASI) score of 10 or less were randomly divided into two groups. The first group received an oval unmarked capsule containing 450 mg of EPO (40 mg of GLA) per capsule, while placebo capsules identical in appearance and containing 450 mg of soybean oil were given to the other group. Treatment continued for a period of 4 months. EASI scores, transepidermal water loss (TEWL), and skin hydration were evaluated in all the AD patients at the baseline, and in months 1, 2, 3, and 4 of the study.

At the end of month 4, the patients of the EPO group showed a significant improvement in the EASI score, whereas the patients of the placebo group did not. There was a significant difference in the EASI score between the EPO and placebo groups. Although not statistically significant, the TEWL and skin hydration also slightly improved in the EPO patients group. Adverse effect were not found in neither the experimental group nor the control group during the study period.

The authors concluded by suggesting that EPO is a safe and effective medicine for Korean patients with mild AD.

I find this study odd for several reasons:

  • One cannot possibly draw conclusions based on such a small sample.
  • The authors state that a total of 69 mild AD patients were enrolled and randomized into either the control group (14 males and 17 females) or the EPO group (20 males and 18 females). Six patients in the control group and 13 patients in the EPO group dropped out due to follow up loss. No patient dropped out because the disease worsened. Should this not have necessitated an intention-to-treat analysis? And, if 19 patients were lost to follow-up, how do the authors know that their disease did not worsen?
  • The graph shows impressively the lack of a placebo-response. I don’t understand why there was none.
  • The authors state that there were no adverse effects at all. I find this implausible; we know that even taking placebos will prompt patients to report adverse effects.

So, what to make out of this?

I am not at all sure, but one thing is certain: this study does not alter my verdict on EPO; as far as I am concerned, the effectiveness of EPO for AD is unproven.

The aim of this RCT was to investigate the effects of an osteopathic manipulative treatment (OMT) which includes a diaphragm intervention compared to the same OMT with a sham diaphragm intervention in chronic non-specific low back pain (NS-CLBP).

Participants (N=66) with a diagnosis of NS-CLBP lasting at least 3 months were randomized to receive either an OMT protocol including specific diaphragm techniques (n=33) or the same OMT protocol with a sham diaphragm intervention (n=33), conducted in 5 sessions provided during 4 weeks.

The primary outcomes were pain (evaluated with the Short-Form McGill Pain Questionnaire [SF-MPQ] and the visual analog scale [VAS]) and disability (assessed with the Roland-Morris Questionnaire [RMQ] and the Oswestry Disability Index [ODI]). Secondary outcomes were fear-avoidance beliefs, level of anxiety and depression, and pain catastrophization. All outcome measures were evaluated at baseline, at week 4, and at week 12.

A statistically significant reduction was observed in the experimental group compared to the sham group in all variables assessed at week 4 and at week 12. Moreover, improvements in pain and disability were clinically relevant.

The authors concluded that an OMT protocol that includes diaphragm techniques produces significant and clinically relevant improvements in pain and disability in patients with NS-CLBP compared to the same OMT protocol using sham diaphragm techniques.

This seems to be a rigorous study. The authors describe in detail their well-standardised interventions in the full text of their paper. This, of course, will be essential, if someone wants to repeat the trial.

I have but a few points to add:

  1. What I fail to understand is this: why the authors call the interventions osteopathic? The therapist was a physiotherapist and the techniques employed are, if I am not mistaken, as much physiotherapeutic as osteopathic.
  2. The findings of this trial are encouraging but almost seem a little too good to be true. They need, of course, to be independently replicated in a larger study.
  3. If that is done, I would suggest to check whether the blinding of the patient was successful. If not, there is a suspicion that the diaphragm technique works partly or mostly via a placebo effect.
  4. I would also try to make sure that the therapist cannot influence the results in any way, for instance, by verbal or non-verbal suggestions.
  5. Finally, I suggest to employ more than one therapist to increase generalisability.

Once all these hurdles are taken, we might indeed have made some significant progress in the manual therapy of NS-CLBP.

1 3 4 5 6 7 16
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Categories