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

depression

Neurolinguistic programming (NLP) was developed in the mid-seventies. It is a so-called alternative therapy (SCAM) that is not easy to define. Those who started it and those involved in it use such vague language that NLP means different things to different people. One metaphor keeps recurring: NLP claims to help people change by teaching them to program their brains. We were given brains, we are told, without an instruction manual, and NLP offers a user-manual for the brain. Consciously or unconsciously, NLP is based on the assumptions that:

  • the unconscious mind constantly influences our conscious thoughts and actions;
  • Freud’s theories are correct;
  • hypnotherapy is effective.

Wikipedia is more outspoken about it: Neuro-linguistic programming (NLP) is a pseudoscientific approach to communication, personal development, and psychotherapy…

Despite the fact that NLP is unproven (to say the least), the COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMAIH) is sufficiently impressed by NLP to offer a course for GPs and SCAM practitioners. Here is their announcement:

Neurolinguistic Healthcare in association with the College of Medicine brings you a 2-day Introduction to Hypnosis, Neurolinguistic Programming (NLP) and Neurolinguistic Healthcare (NLH). Dr Wong and Dr Akhtar who lead the course are Trainers in NLP and Hypnosis and GPs who apply their skills in daily practice within the 10-minute consultation. The course is suitable for both medical professionals and complementary therapists. This is a limited training event offered by them to share their years of knowledge and skills with you.

You will learn:

    1. A basic overview of NLP and the most useful aspects to use it to begin making effective changes in how you and the people you treat think and behave
    2. An understanding of the NLH model of the mind so that you understand the concepts of therapy using this mixed hypnosis/ NLP approach in relation to health.
    3. The ability to Hypnotise effectively in a very short period of time with practical experience – the ability to go through all the stages of hypnosis – the induction, deepening, therapy, and emergence, including rapid hypnosis techniques. (Hypnosis courses which are less practical often charge in excess of £2000 for this)
    4. Learn at least 3 therapeutic techniques, including the NLP therapeutic techniques which work much better in trance, so using and applying the skills you will learn in hypnosis
    5. Access to an online mentorship programme with Dr Akhtar or Dr Wong for 6 months and who will provide 3x30mins group webinar meetings after the course to ensure any remaining questions get answered and that you are actually going forth to apply these skills. (worth another £600 in value)
    6. Access to an online learning membership site with educational videos and other content like pain relief techniques, papers with therapeutic scripts, etc

This is an opportunity to learn a different way of helping people from doctors who target the 10-minute consultation with fast, effective formal hypnosis techniques and sleight-of-mouth. It is possible to make change happen in 10-minutes.

Note that attending this course will not make you a certified hypnotherapist, but confer you the skills you will learn to use personally and in the context of guided meditations and relaxations that are commonplace now.

And what evidence do I have for stating that NLP is unproven?

Is there an up-to-date and sound systematic review of NLP?

The answer is yes.

This systematic review of NLP included 10 experimental studies. Five studies were RCTs and five were uncontrolled pre-post studies. Targeted health conditions were anxiety disorders, weight maintenance, morning sickness, substance misuse, and claustrophobia during MRI scanning. NLP interventions were mainly delivered across 4-20 sessions although three were single session. Eighteen outcomes were reported and the RCT sample sizes ranged from 22 to 106. Four RCTs reported no significant between group differences with the fifth finding in favour of NLP. Three RCTs and five pre-post studies reported within group improvements. Risk of bias across all studies was high or uncertain.

The authors concluded that there is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.

Surprised?

I am not!

I did not expect the COMAIH to allow critical thinking to get in the way of quackery-promotion.

This post is dedicated to all who claim that I never discuss anything positive about so-called alternative medicine (SCAM).

Autogenic training is a therapy developed in the 1920s by the German psychiatrist Johannes Heinrich Schultz (1884 – 1970). It is an auto-hypnotic relaxation technique popular in Germany but less so other countries. (The lack of international appreciation of autogenic training might be related to Schultz’ well-documented Nazi past. In 1935, he published an essay which supported compulsory sterilization of men to eliminate hereditary illnesses. Later he was appointed deputy director of the Göring Institute in Berlin. Through this institute, he had an active role in the extermination of mentally handicapped individuals in the framework of the ‘Aktion T4’, the Nazi’s infamous euthanasia programme.)

Autogenic training  consists of mental exercises using instructions directed at different parts of the body to control bodily perceptions, such as ‘my right foot feels warm’ or ‘my left arm feels heavy’. Patients tend to report an intense sense of relaxation during and after autogenic training. Autogenic training is taught in a series of lessons by a qualified instructor.

Autogenic training should be practised regularly and does not require further supervision. It is thus an inexpensive therapy. The technique is claimed to help for a range of (mostly stress-related) conditions. However, the evidence from clinical trials is scarce and, not least due to methodological problems, less than convincing.

This systematic review was conducted to evaluate the effectiveness of autogenic training on stress responses. A total 11 studies were included in a meta-analysis. They showed that autogenic training decreased anxiety and depression, and increased the high frequency of heart rate variability as well as a reduction of anxiety score by 1.37 points (n=85, SMD=-1.37: 95% CI -2.07 to -0.67), in the studies on short-term intervention targeting healthy adults.For depression, a reduction was noted of the symptom score by 0.29 point (n=327, SMD=-0.29: 95% CI -0.50 to -0.07) in the studies on long term intervention targeting the patient group.

The authors concluded that autogenic training is effective for adults’ stress management, and nurses will be able to effectively perform autogenic training programs for workers’ stress relief at the workplace.

I cannot access the full article because it was published in Korean. Nevertheless, I feel that the conclusions are probably correct.

Why?

Because I know (most of) the primary studies and three of the RCTs are my own.

(Yet, some of my critics continue to claim that I never conducted any positive studies of SCAM)

The ‘College of Medicine and Integrated Health’ (CMIH) has been the subject of several previous blog posts (see for instance here, here and here). Recently, they have come up with something new that, in my view, deserves a further comment.

The new ‘SELF CARE TOOL KIT’ began, according to the CMIH, in 2009 with a national multi-centre project commissioned by the UK Department of Health, to consider the best way to integrate self care into family practice. The project involved two large family health centres and two university departments. One output was the Self Care Library (SCL).

The Self Care Library (SCL) is an online patient resource providing free evidence-based information about self-care.  The funding for the SCL did, however, not survive, and the facility was assigned to the CMIH. Thanks to funding from ‘Pukka Herbs Vitamins, Herbal Remedies & Health Supplements‘, the CMIH was able to transfer the content and to begin updating entries. Simon Mills, the coordinator of the original project who is now employed by Pukka, has led this transformation and helped the College set up the new parent portal, Our Health Directory.

The Self Care Toolkit is thus the new SCL. All concerned with this project are experienced in clinical practice and can separate the theory from real life needs. We all have academic lives as well so can be hard-nosed with the evidence base as well.

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The above text is essentially based on the information provided by the CMIH. A few critical remarks and clarifications might therefore be in order:

  • What does ‘separate the theory from real life needs’ mean? Does it mean that the scientific evidence can be interpreted liberally (see below)?
  • Is it a good idea to have a commercial sponsor for such a project?
  • Is it wise that the main person in charge is on the payroll of a manufacturer of dietary supplements?
  • Is there any oversight to minimise undue bias and prevent the public from being misled?
  • Is it really true that all people involved have academic lives? Simon Mills (who once was a member of my team) has no longer an academic appointment, as far as I know.

But, you are right, these are perhaps mere trivialities. Let’s see what the ‘Self Care Tool Kit’ actually delivers. I have chosen the entry on DEPRESSION to check its validity. Here it is:

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It isn’t likely that taking extra vitamins will make much difference to low mood or depression. It is true that many people don’t get quite enough B, C and D vitamins in their food. And it’s also true that the brain and nervous system need these vitamins. Because they don’t get stored in the body, our daily diet has to supply them. Research has shown that people with low blood levels of the B vitamin folic acid are more likely to be depressed and less likely to do well on anti-depressant medicines. So, if you are eating a very poor diet, taking extra vitamins just might help. It’s also worth remembering that alcohol, refined sugars, nicotine and caffeine all take these vitamins out of the body. Yet most people who feel depressed probably won’t benefit from taking vitamins alone. To ensure that you get a good balance of these vitamins, try to eat more whole-foods, fruits, vegetables, nuts and seeds.

Some people say that taking high doses of vitamin C (1-2 g and more a day) helps lift their mood. There is a little research to support this and none showing that high doses of vitamin C actually help clinical depression. Vitamin C levels fall after surgery or inflammatory disease. The body needs more vitamin C when coping with stress, pregnancy and breast feeding. Aspirin, tetracycline and contraceptive pills take vitamin C out of the body. Smokers also need extra vitamin C because nicotine removes it. Fresh fruit and vegetables are the best sources of vitamin C.

Doctors are increasingly concerned about low vitamin D, especially in the Asian community. A lack of vitamin D can lead to depression. Oily fish and dairy products are good sources of vitamin D, and sunlight helps the body make vitamin D. Do you get enough sunshine and eat a good diet? It is estimated that worldwide over 1 billion people get too little vitamin D.

Evidence
Taking supplements of vitamins B and D might help some people, whose diet is poor, but more research is needed.

Safety
Very high doses of vitamins and minerals can upset the body and cause side-effects. Get medical advice if you intend to take large doses. To ensure that you get a good balance of these vitamins, try to eat more whole-foods, fruits, vegetables, nuts and seeds.

Cost
If your diet is poor and you don’t get into the sun, ask your doctor about a vitamin D blood test. If it’s normal, there’s no point in taking vitamin D. If it’s low, your GP will prescribe it for you or you can buy a vitamin D supplement.

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In my view, this text begs several questions:

1) Am I right in thinking that phraseology such as the one below will encourage patients suffering from depression to try the supplements mentioned?

  • people with low blood levels of the B vitamin folic acid are more likely to be depressed and less likely to do well on anti-depressant medicines..
  • Some people say that taking high doses of vitamin C (1-2 g and more a day) helps lift their mood…
  • There is a little research to support this and none showing that high doses of vitamin C actually help clinical depression…
  • A lack of vitamin D can lead to depression.
  • Taking supplements of vitamins B and D might help some people…
  • … your GP will prescribe it for you or you can buy a vitamin D supplement.

2) How does that tally with the latest evidence? For instance:

3) The CMIH state: ‘This site gives you information NOT medical advice.’  But, in view of the actual text above, is this true?

4) Depression is a life-threatening condition. Is there a risk that patients trust the CMHI’s (non-) advice and commit suicide because of its ineffectiveness?

5) Do Pukka, the sponsor of all this, happen to supply most of the self care remedies promoted in the ‘Self Care Tool Kit’?

The answer to the last question, I am afraid, is YES!

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.

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.

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:

  1. Contrary to what the reviewers claim, the trial had no placebo group.
  2. It was a double-dummy equivalence study comparing individualised homeopathy with the antidepressant fluoxetine.
  3. Fluoxetine might have been under-dosed (see below).
  4. 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.
  5. 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.
  6. 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:

  1. 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.
  2. Fluoxetine might have been under-dosed (see below).
  3. 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.

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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.

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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.

I have often cautioned my readers about the ‘evidence’ supporting acupuncture (and other alternative therapies). Rightly so, I think. Here is yet another warning.

This systematic review assessed the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). Nine trials involving 653 women were selected. A meta-analysis demonstrated that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group. Regarding the HAMD and EPDS scores, no difference was found between the two groups. The Chinese authors concluded that acupuncture appears to be effective for postpartum depression with respect to certain outcomes. However, the evidence thus far is inconclusive. Further high-quality RCTs following standardised guidelines with a low risk of bias are needed to confirm the effectiveness of acupuncture for postpartum depression.

What a conclusion!

What a review!

What a journal!

What evidence!

Let’s start with the conclusion: if the authors feel that the evidence is ‘inconclusive’, why do they state that ‘acupuncture appears to be effective for postpartum depression‘. To me this does simply not make sense!

Such oddities are abundant in the review. The abstract does not mention the fact that all trials were from China (published in Chinese which means that people who cannot read Chinese are unable to check any of the reported findings), and their majority was of very poor quality – two good reasons to discard the lot without further ado and conclude that there is no reliable evidence at all.

The authors also tell us very little about the treatments used in the control groups. In the paper, they state that “the control group needed to have received a placebo or any type of herb, drug and psychological intervention”. But was acupuncture better than all or any of these treatments? I could not find sufficient data in the paper to answer this question.

Moreover, only three trials seem to have bothered to mention adverse effects. Thus the majority of the studies were in breach of research ethics. No mention is made of this in the discussion.

In the paper, the authors re-state that “this meta-analysis showed that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group.” This is, I think, highly misleading (see above).

Finally, let’s have a quick look at the journal ‘Acupuncture in Medicine’ (AiM). Even though it is published by the BMJ group (the reason for this phenomenon can be found here: “AiM is owned by the British Medical Acupuncture Society and published by BMJ”; this means that all BMAS-members automatically receive the journal which thus is a resounding commercial success), it is little more than a cult-newsletter. The editorial board is full of acupuncture enthusiasts, and the journal hardly ever publishes anything that is remotely critical of the wonderous myths of acupuncture.

My conclusion considering all this is as follows: we ought to be very careful before accepting any ‘evidence’ that is currently being published about the benefits of acupuncture, even if it superficially looks ok. More often than not, it turns out to be profoundly misleading, utterly useless and potentially harmful pseudo-evidence.


Reference

Acupunct Med. 2018 Jun 15. pii: acupmed-2017-011530. doi: 10.1136/acupmed-2017-011530. [Epub ahead of print]

Effectiveness of acupuncture in postpartum depression: a systematic review and meta-analysis.

Li S, Zhong W, Peng W, Jiang G.

The two German authors start their article (it is in German but has an English abstract to which I refer here) by claiming that “homeopathy is steadily gaining in sympathy in the population.” This is a very odd statement, considering that the sales figures in Germany and elsewhere have, in fact, been declining. Any homeopathy-paper with such an opening is naturally of interest to me.

As I read on, I find further surprises: “the possible effectiveness and the modes of action are currently not scientifically elucidated.” These are two big assumptions which happen to be both untrue:

  1. The effectiveness of homeopathy has now been tested in about 500 clinical trials, and the totality of the reliable evidence from these studies fails to show that highly diluted homeopathic remedies are more than placebos.
  2. The mode of action of homeopathy isn’t “not scientifically elucidated“, but the relevant science tells us that there cannot be a mode of action that is in line with the laws of nature as we understand them today.

And the surprises keep on coming: “there is a whole series of positive evidence for the effects of homeopathic remedies for mental disorders, such as depression, anxiety disorders and addiction.” This statement is not in keeping with the results of a systematic review (which, by the way was authored by ardent homeopaths); here is the abstract:

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OBJECTIVE:

To systematically review placebo-controlled randomized trials of homeopathy for psychiatric conditions.

DATA SOURCES:

Eligible studies were identified using the following databases from database inception to April 2010: PubMed, CINAHL, PsycINFO, Hom-Inform, Cochrane CENTRAL, National Center for Complementary and Alternative Medicine grantee publications database, and ClinicalTrials.gov. Gray literature was also searched using Google, Google Scholar, the European Committee for Homeopathy, inquiries with homeopathic experts and manufacturers, and the bibliographic lists of included published studies and reviews. Search terms were as follows: (homeopath* or homoeopath*) and (placebo or sham) and (anxiety or panic or phobia or post-traumatic stress or PTSD or obsessive-compulsive disorder or fear or depress* or dysthym* or attention deficit hyperactivity or premenstrual syndrome or premenstrual disorder or premenstrual dysphoric disorder or traumatic brain injury or fibromyalgia or chronic fatigue syndrome or myalgic encephalitis or insomnia or sleep disturbance). Searches included only English-language literature that reported randomized controlled trials in humans.

STUDY SELECTION:

Trials were included if they met 7 criteria and were assessed for possible bias using the Scottish Intercollegiate Guidelines Network (SIGN) 50 guidelines. Overall assessments were made using the Grading of Recommendations Assessment, Development and Evaluation procedure. Identified studies were grouped into anxiety or stress, sleep or circadian rhythm complaints, premenstrual problems, attention-deficit/hyperactivity disorder, mild traumatic brain injury, and functional somatic syndromes.

RESULTS:

Twenty-five eligible studies were identified from an initial pool of 1,431. Study quality according to SIGN 50 criteria varied, with 6 assessed as good, 9 as fair, and 10 as poor. Outcome was unrelated to SIGN quality. Effect size could be calculated in 16 studies, and number needed to treat, in 10 studies. Efficacy was found for the functional somatic syndromes group (fibromyalgia and chronic fatigue syndrome), but not for anxiety or stress. For other disorders, homeopathy produced mixed effects. No placebo-controlled studies of depression were identified. Meaningful safety data were lacking in the reports, but the superficial findings suggested good tolerability of homeopathy. A funnel plot in 13 studies did not support publication bias (χ(2)(1) = 1.923, P = .166).

CONCLUSIONS:

The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.

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And specifically for depression, another review (also by proponents of homeopathy) is available; here is its abstract:

OBJECTIVE:

To systematically review the research evidence on the effectiveness of homeopathy for the treatment of depression and depressive disorders.

METHODS:

A comprehensive search of major biomedical databases including MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Library was conducted. Specialist complementary and alternative medicine (CAM) databases including AMED, CISCOM and Hom-Inform were also searched. Additionally, efforts were made to identify unpublished and ongoing research using relevant sources and experts in the field. Relevant research was categorised by study type and appraised according to study design. Clinical commentaries were obtained for studies reporting clinical outcomes.

RESULTS:

Only two randomised controlled trials (RCTs) were identified. One of these, a feasibility study, demonstrated problems with recruitment of patients in primary care. Several uncontrolled and observational studies have reported positive results including high levels of patient satisfaction but because of the lack of a control group, it is difficult to assess the extent to which any response is due to specific effects of homeopathy. Single-case reports/studies were the most frequently encountered clinical study type. We also found surveys, but no relevant qualitative research studies were located.: Adverse effects reported appear limited to ‘remedy reactions’ (‘aggravations’) including temporary worsening of symptoms, symptom shifts and reappearance of old symptoms. These remedy reactions were generally transient but in one study, aggravation of symptoms caused withdrawal of the treatment in one patient.

CONCLUSIONS:

A comprehensive search for published and unpublished studies has demonstrated that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. Further research is required, and should include well-designed controlled studies with sufficient numbers of participants. Qualitative studies aimed at overcoming recruitment and other problems should precede further RCTs. Methodological options include the incorporation of preference arms or uncontrolled observational studies. The highly individualised nature of much homeopathic treatment and the specificity of response may require innovative methods of analysis of individual treatment response.

____________________________________________________________________________________

Back to the new article I started discussing above. Its authors make a vague attempt at being reasonable: “It is clear that homoeopathic remedies can only be used as an add-on and not alone.” I find this statement slightly puzzling. If (as the authors assume) homeopathy is effective for mental disorders, why not on its own? Can a therapy that must not be used as a sole treatment be called effective?

The authors continue with another caveat:  “These remedies belong in the hands of physicians experienced in homeopathic and psychiatric psychopharmacology.” That’s actually quite funny! As the average homeopath has no experience in psychiatric psychopharmacology, they must not use homeopathy for mental conditions. I would agree with the conclusion but not with the reason given for it.

And now to the ‘grand finale’, the conclusion: “It would be advisable to at least try out homeopathy for the well-being of the patient not only in the case of very mild disorders but also in severe chronic cases, since due to the generally good tolerability, no avoidable disadvantage should result.” That sort of conclusion makes me almost speechless. The evidence fails to show that it works, yet it is ADVISABLE to use it in severe chronic cases!

Such articles suggest to me that homeopathy is a cult where logic and reason are irrelevant and need to be supressed. They also indicate that something is amiss with medical publishing. How can it be that, in 2018, ‘Der Nervenarzt’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? ‘Der Nervenarzt‘, by the way, claims to be an internationally recognized journal addressing neurologists and psychiatrists working in clinical or practical environments. Essential findings and current information from neurology, psychiatry as well as neuropathology, neurosurgery up to psychotherapy are presented.

Shiatsu is an alternative therapy that is popular, but has so far attracted almost no research. Therefore, I was excited when I saw a new paper on the subject. Sadly, my excitement waned quickly when I stared reading the abstract.

This single-blind randomized controlled study was aimed to evaluate shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Alzheimer disease (AD) patients with depression were randomly assigned to the “active group” (Shiatsu + physical activity) or the “control group” (physical activity alone).

Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination – MMSE), depressive symptoms (Geriatric Depression Scale – GDS), and functional status (Activity of Daily Living – ADL, Instrumental ADL – IADL) were assessed before and after the intervention.

The researchers found a within-group improvement of MMSE, ADL, and GDS in the Shiatsu group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the Shiatsu group.

The authors concluded that the combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation.

The Journal Complementary Therapies in Medicine also published three ‘Highlights’ of this study:

  • We first evaluated the effect of Shiatsu in depressed patients with Alzheimer’s disease (AD).
  • Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients.
  • Neuroendocrine-mediated effect of Shiatsu may modulate mood and affect neural circuits.

Where to begin?

1 The study is called a ‘pilot’. As such it should not draw conclusions about the effectiveness of Shiatsu.

2 The design of the study was such that there was no accounting for the placebo effect (the often-discussed ‘A+B vs B’ design); therefore, it is impossible to attribute the observed outcome to Shiatsu. The ‘highlight’ – Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients – therefore turns out to be a low-light.

3 As this was a study with a control group, within-group changes are irrelevant and do not even deserve a mention.

4 The last point about the mode of action is pure speculation, and not borne out of the data presented.

5 Accumulating so much nonsense in one research paper is, in my view, unethical.

Research into alternative medicine does not have a good reputation – studies like this one are not inclined to improve it.

This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.

Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.

The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.

WRONG!

This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.

Ethics committees should not accept such protocols.

Researchers should stop running such studies.

Reviewers should not pass them for publication.

Editors should not publish such trials.

THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.

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