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

anxiety

Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.

This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.

Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.

Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.

The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.

I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.

It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:

In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.

But why is this not so with the above-mentioned study?

Why is, in this instance, A even more that A+B?

There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.

But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).

My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.

It has been pointed out to me that my recent posts on the thorny subject of Donald Trump have angered many of his devoted fans. I am so sorry! Now that Trump is (almost) history, these poor, disappointed people need our help; they urgently need some effective anger management before they start firing those weapons they have been amassing.

This is why, in the spirit of building bridges and in the interest of peace, I have made an effort and put together a list of so-called alternative medicines (SCAMs) that might be useful.

Various pharmaceutical medications are available for treating anxiety, stress and anger problems:

Anxiolytics e.g. Alprazolam, Diazepam,
Antidepressants e.g. Paroxetine, Fluoxetine,
Antipsychotics e.g. Paliperidone, Risperidone,
Mood regulators e.g. Lithium, Valproate.

Oh, sorry! I have angered you again! I forgot, you are SCAM only. Let me have a look into my own book and find something that works for your problems.

ANXIETY

  • Massage
  • Music therapy
  • Various relaxation techniques

DEPRESSION

  • St John’s wort

Yes, these are the only SCAMs that are listed as being supported by sound evidence.

What, you say, you care a f**k about evidence? Of course, I should have known!

But my book offers nothing for delusional disorders, sorry.

Not good enough, you say? Alright, alright, keep your gun where it is. I better look elsewhere.

Found something. Thanks heavens for homeopathy! One can always rely on homeopaths to offer help, and they certainly know a thing or two about delusions! One website has this long list of remedies for delusional disorders:

Stramonium

Vision of animals, black dogs etc. (It also cured pneumonia on these symptoms). Thinks himself double, tall and a part missing and objects around him small. Cannot bear solitude and darkness; must have light and company. Sees ghosts, hears voices and talks with spirits. Feeling as if a long trail of bedbugs is pursuing her, and after them a procession of beetles and then comes crawling over her a host of cockroaches. Sees horrifying images at his side than in front of him. Sings amorous songs and utters obscene speeches. Hallucination and delirium. Attempts to stab and bite. Calls things by wrong names, his boots the logs of wood; his bedroom the stable. Has communication from God, delivers sermons, prophecies.

Lactuca Virosa

As if swimming in the air or walking above the ground.

Chloralum

Night terrors. Sees visions of arches. Hears voices when in the dark or when eyes are shut.

Lac Can

Delusions about snakes. Imagines he is surrounded by them. Afraid of closing the eyes for fear of being bitten by a snake. Feels to be walking in air. Tormenting thoughts. No reality in things; thinks that everything she says is a lie; she is not herself; her properties not her own; wears someone else’s nose.

Sabadilla

Erroneous impressions as to the state of her body e.g. that she is pregnant when she is merely swollen with flatus.

Platinum

Pride or over-estimate of one-self. Thinks she is superior to all others. Thinks her body is longer than those of others. Arrogant and haughty.

Camphor

Everything that moves is a ghost and inanimate things in the room become alive and terrify him. Extreme nervousness. Fear of strangers and of the dark.

Calcarea Carb

Sees and talks to persons who are not present. Imagines as if she is surrounded by dogs. Aversion to do any business. She is sad and melan­choly. Full of fear, weary of life.

Ailanthus

Feels as if a rat or something small is crawling up the limb and over the body.

Anacardium

The patient finds himself to be between good and evil will. His external will wants him to do some­thing evil, but his internal will stops him from doing this.

Indecisive

One moment he thinks it is so and the next moment has enough reason left that it is not so. Low spirited, disheartened, fears he is pursued by someone; looks for thieves, expects enemies, fears everything and everybody. He is pursuaded by his evil will to do acts of violence and injustice, but is withheld and restrained by his good will. (See also Hyosc, Bell., and Stram.) Hears voices of sister and mother who are far away.

Helleborus Nig

Stupefaction and sluggishness of the body and mind. Stupor from which he can be aroused with” difficulty and when so aroused he will talk about spirits or say that he sees devils with horns and tails. Hallucination.

Causticum

Conscience stricken as if she had committed a crime.

Ferrum Iod:

As if body had grown 30 feet high.

Baptisia T:

Feels as if body scattered into pieces.

Chamomilla

Hearing voices of absent persons which disturb his sleep.

Zincum Met

Voices from within him speaking in abusive and filthy language.

Belladonna

Sees frightful faces and monsters. Bites and strikes. Patient will not injure himself or others unless he thinks he is acting in self-defence. He will attack the person who is “acting against the patient’s will.

Spigelia

For apprehensive and nervous persons. Will not use razor, as something is constantly urging him to cut throat with it. Urge to commit suicide with fork when at dining table and so on. Afraid of sharp and pointed instruments.

Thuja

Sensation as though a living child were in the abdomen. Feels body thin and delicate, frail, easily breakable as if made of glass.

Cannabis Ind

Errors of perception as to space and as to time. The patient feels as if he had not taken any food for the last six months, although he had just finished his meals. A mile distance looks as if it were a hundred miles. Mind is full of unfinished ideas. Delusion of rhinoceros and elephants following him up. Imagines he hears sweet music, shuts his eyes and is lost in most delicious thoughts and dreams. Imagines someone calling him. Imagines as if he exists without form throughout a vast extent of space. His body seems to expand and the arch of his skull to be broader than the vault of heaven. All seem unreal. Feels himself unreal. All impressions extremely exaggerated. Hears voices and most sublime music; sees vision of beauty and glory, only to be equalled in paradise.

Arsenic Alb

Imagines house full of thieves. Runs through the house in search of them or hides himself in the house on account of fear.

Cicuta Virosa

Feels as if he were in a strange place and not living in ordinary conditions; everything appeared strange and almost frightful. Contempt of mankind. Runs away from his friends on account of disgust with their follies.

Viscum Alb

Delusion as if upper part of the body is floating in the air.

Coculus

Delusion as if something is rolling on walls, chairs, floor or elsewhere and will also roll on him.

Hyoscyamus

Talks to imaginary people as if they are sitting by his side. Talking to dead wife, sister or husband as if they were here again on earth. Imagines the things are worms, vermin, rats, cats, and mice. Feels as if his hands and fingers are too large.

Cocaine

Thinks he hears unpleasant remarks about himself; hallucination of hearing. Cannot sleep for hours after retiring. Sees and feels bugs and worms in his room and bed. Moral sense blunted.

Alumina

When he says anything, he feels as if another person has said it. Similarly if he sees anything, he feels as if another person had seen it, or as if he could transfer himself into another person and then only he could see. Confusion of personal identity.

Glonoine

Chin feels elongated to knees. Touching the chin repeatedly to be sure that it was not so.

Carboneum Sul

Hears voices and believes he has committed robbery.

Lachesis

When she sees anyone in whispering conversation, she thinks they are talking about her to her detriment. She thinks herself under superhuman control whose commands (partly in dream) she must obey. Fears that she is pursued by enemies; the medicine is a poison; that there are robbers in the house and she wants to jump out of window.

Melilotus

Delusion; thinks everyone is looking at her; fears to talk aloud; wants to run away.

Agnus C

Delusion of smell as of herring (kind of fish) or musk.

Coca

Delusion; of worms on the skin or clothing.

Aethusa

Delusion; sees cats and dogs; wants to jump out of bed or window.

Asarum Europ

As if hovering in the air. Vertigo as if drunk.

Baryta Carb

As if everything rocks with him, as in a ship.

Crocus

As if something alive is in abdomen. Imaginary pregnancy. Alternating mood.

Morphinum

As if room filled with babies. Man at foot of bed. Cannot describe symptoms.  Sobs at trifles.

Medorrhinum

Feels as if things done today were done a week ago; as if someone is whispering behind her, faces appearing from behind the furniture and look at her and say, “come”. Feels life unreal like a dream. Had committed unpardonable sin, and was going to hell. Not caring whether she goes to hell or heaven. Impatient, very selfish.

Mercurius

Feels as if worm rising in throat; apple-core stuck in throat; ice hi ear; cold water running from ears.

Palladium

Feels that she has been neglected. Wounded pride.

Petroleum

Imagines that another person or a child is in bed with her. Dreams that she is two or more. That her limbs are double.

Psorinum

Feels as if brain separated from the body; as if there is not enough room in forehead; as if he heard with ears not his own.

Cyclamen

Thinks herself impure and wants to take bath every time she touches somebody or something. Every thing seems double. As if person lying in bed. Ailments from duty not done or bad act committed.

Staphisagria

When he walks he feels as if someone were following him. This causes anxiety and fear and he cannot look behind.

Sulphur

Everything turns into beauty. Old rag and old stick looks to be a beautiful piece of workmanship. Every thing looks pretty which the patient takes fancy to. Wishing to touch everything.

Cannabis Sat

Hears hissing whisper to kill himself. This is an order from the Most High Command.

Cuprum Aceticum

Delusion that a policeman has come to seize him. Hallucinations of all kinds of figures and premises, especially in the evening, when shutting eyes or when going to sleep.

Oleander

Washes herself and her clothes after touching anything or any person, as she believes she has touched a dirty thing as a result of which she must wash.

Pyrogenium

Hallucination that he is very wealthy and has a large sum of money in the bank.

Nux Moschata

Seems as if he is two persons and watches his other self playing. He seems lost, and when spoken to would come to himself confused. Feels as if she has two heads.

________________________________

Did you find something that fits?

No?

Then let me help you: Pride or over-estimate of one-self. Thinks she is superior to all others. Arrogant and haughty. Yes, that must be for you; PLATINUM it is!!!

Hope you get better soon.

And, if I may, I suggest PYROGENIUM for your idol.

____________________________

 

 

PS

A personal note: during the last 4 years, I have turned down all invitations for lectures in the US and argued that I do not travel to counties with fascistoid leaders. Once the pandemic is under control, I’d be happy to reconsider.

Reflexology (originally called ‘zone therapy’ by its inventor) is a manual technique where pressure is applied to the sole of the patient’s foot. Reflexology is said to have its roots in ancient cultures. Its current popularity goes back to the US doctor William Fitzgerald (1872-1942) who did some research in the early 1900s and thought to have discovered that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists thus drew maps of the sole of the foot where all the body’s organs are depicted. Numerous such maps have been published and, embarrassingly, they do not all agree with each other as to the location of our organs on the sole of our feet. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs.

So, does reflexology do more good than harm?

The aim of this review was to conduct a systematic review, meta-analysis, and metaregression to determine the current best available evidence of the efficacy and safety of foot reflexology for adult depression, anxiety, and sleep quality.

Twenty-six studies could be included. The meta-analyses showed that foot reflexology intervention significantly improved adult depression, anxiety, and sleep quality. Metaregression revealed that an increase in total foot reflexology time and duration can significantly improve sleep quality.

The authors concluded that foot reflexology may provide additional nonpharmacotherapy intervention for adults suffering from depression, anxiety, or sleep disturbance. However, high quality and rigorous design RCTs in specific population, along with an increase in participants, and a long-term follow-up are recommended in the future.

Sounds good!

Finally a so-called alternative medicine (SCAM) that is backed by soild evidence!

Or perhaps not?

Here are a few concerns that lead me to doubt these conclusions:

  • Most of the primary studies were of poor methodological quality.
  • Most studies failed to mention adverse effects.
  • Very few studies controlled for placebo effects.
  • There was evidence of publication bias (negative studies tended to remain unpublished).
  • Studies published in languages other than English were not considered.
  • The authors fail to point out that a foot massage is, of course, agreeable (and thus may relieve a range of symptoms), but reflexology with all its weird assumptions is less than plausible.
  • Many of the studies located by the authors were excluded for reasons that are less than clear.

The last point seems particularly puzzling. Our own trial, for instance, was excluded because, according to the review authors, it did not include relevant outcomes. However, our method secion makes it clear that the primary focus for this study was the subscores for anxiety and depression, which comprise four and seven items, respectively. As it happens, our study was negative.

Also cuirous is the fact that the authors did not mention our own 2011 systematic review of reflexology:

Reflexology is a popular form of complementary and alternative medicine (CAM). The aim of this update is to critically evaluate the evidence for or against the effectiveness of reflexology in patients with any type of medical condition. Six electronic databases were searched to identify all relevant randomised clinical trials (RCTs). Their methodological quality was assessed independently by the two reviewers using the Jadad score. Overall, 23 studies met all inclusion criteria. They related to a wide range of medical conditions. The methodological quality of the RCTs was often poor. Nine high quality RCTs generated negative findings; and five generated positive findings. Eight RCTs suggested that reflexology is effective for the following conditions: diabetes, premenstrual syndrome, cancer patients, multiple sclerosis, symptomatic idiopathic detrusor over-activity and dementia yet important caveats remain. It is concluded that the best clinical evidence does not demonstrate convincingly reflexology to be an effective treatment for any medical condition.

I wonder why!

This recent Cochrane review assessed the effects of so-called alternative medicine (SCAM) for post-caesarean pain. Randomised clinical trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing SCAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain were included.

A total of 37 studies (3076 women) investigating 8 different SCAM therapies for post-CS pain relief were found. There was substantial heterogeneity among the trials. The primary outcome measures were pain and adverse effects. Secondary outcome measures included vital signs, rescue analgesic requirement at 6 weeks after discharge; all of which were poorly reported or not reported at all.

Acupuncture/acupressure

The quality of the RCTs was low. Whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) have any effect on pain. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) have any effect on the risk of adverse effects.

Aromatherapy

Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). The authors were uncertain whether aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia.

Electromagnetic therapy

Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence).

Massage

There were 6 RCTs (651 women), 5 of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty.

Music therapy

Music therapy plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I2 = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music therapy plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low.

Reiki

The investigators were uncertain whether Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).

Transcutaneous electrical nerve stimulation (TENS)

TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). The authors were uncertain whether TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).

The authors concluded that some SCAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of SCAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed in this review, and use validated scales.

I feel that the Cochrane Collaboration does itself no favours by publishing such poor reviews. This one is both poorly conceived and badly reported. In fact, I see little reason to deal with pain after CS differently than with post-operative pain in general. Some of the modalities discussed are not truly SCAM. Most of the secondary endpoints are irrelevant. The inclusion of adverse effects as a primary endpoint seems nonsensical considering that SCAM studies are notoriously bad at reporting them. Many of the allegedly positive findings rely on trial designs that cannot control for placebo effects (e.g A+B versus B); therefore they tell us nothing about the effectiveness of the therapy.

Most importantly, the conclusions are not helpful. I would have simply stated that none of the SCAM modalities are supported by convincing evidence as treatments for pain control after CS.

This Cochrane review assessed the efficacy and safety of aromatherapy for people with dementia. The researchers  included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.

The investigators included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were:

  • lavender (eight studies);
  • lemon balm (four studies);
  • lavender and lemon balm,
  • lavender and orange,
  • cedar extracts (one study each).

For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66). The primary outcomes were:

  • agitation,
  • overall behavioural,
  • psychological symptoms,
  • adverse effects.

Ten trials assessed agitation using various scales. Among the 5 trials for which the confidence in the results was moderate or low, 4 trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other 5 trials either reported no useable data or the confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and there was moderate or low confidence in the results of 5 of them. Of these, 4 reported significant benefit from aromatherapy and one reported no significant effect.

Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. There was no evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. The confidence in the results of these studies was low.

The authors reached the following conclusions: We have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.

This is a thorough review. It makes many of the points that I so often make regarding SCAM research:

  • too many of the primary studies are badly designed;
  • too many of the primary studies are too small;
  • too many of the primary studies are poorly reported;
  • too many of the primary studies fail to mention adverse effects thus violating research ethics;
  • too many of the primary studies are done by pseudo-scientists who use research for promotion rather than testing hypotheses.

It is time that SCAM researchers, ethic review boards, funders, editors and journal reviewers take these points into serious consideration – if only to avoid clinical research getting a bad reputation and losing the support of patients without which it cannot exist.

Mindfulness is one of the 150 so-called alternative medicines (SCAMs) that I have evaluated in my recent book ‘Alternative Medicine: A Critical Assessment of 150 Modalities‘. Here is an excerpt from my text:

Mindfulness is a form of meditation which involves bringing one’s attention to experiences occurring in the present moment while sitting silently and paying attention to thoughts, sounds, the sensations of breathing or parts of the body.

    1. Many experts do not consider mindfulness to be an alternative therapy but see it as a set of psychological methods that have long become well-accepted, conventional treatments.
    2. There are several forms of mindfulness meditation; one of the best-known and most thoroughly researched is Mindfulness-Based Stress Reduction developed by Jon Kabat-Zinn (1944- ). It uses a combination of mindfulness meditation, body awareness, and yoga to help people become more mindful.
    3. Mindfulness programs are currently popular and have been widely adopted in schools, hospitals, and other settings. They are also being applied to initiatives such as for healthy aging, weight management, athletic performance enhancement, for children with special needs, and as a help during the perinatal period.
    4. Novices are advised to start with short periods of about 10 minutes of meditation practice per day. With regular practice, it becomes easier to keep the attention focused and the length of time spent practising can be extended.
    5. There has been much research interest in mindfulness, and many studies are now available. However, the quality of these trials is often poor which is one reason why the evidence is less clear than one would hope.
    6. Several systematic reviews have assessed mindfulness for various medical conditions, e. g.:Image result for mindfulness meditation
    • A systematic review of mindfulness for chronic headaches concluded that, due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.[1]
    • A systematic review of mindfulness for addictions found support for the effectiveness of the mindfulness-based interventions.[2]
    • An overview included 26 reviews and found a substantially consistent picture… Improvements in depressive disorders, particularly recurrent major depression, were strongly supported. Evidence for other psychological conditions was limited by lack of data. In populations with physical conditions, the evidence for significant improvements in psychological well-being was clear, regardless of population or specific mindfulness intervention. Changes in physical health measures were inconclusive; however, pain acceptance and coping were improved.[3]
    1. Some reports have linked mindfulness to increasing fear and anxiety panic or “meltdowns” after treatments. However, these seem to be rare events; in general, mindfulness is considered to be a safe therapy.

[1] https://www.ncbi.nlm.nih.gov/pubmed/29863407

[2] https://www.ncbi.nlm.nih.gov/pubmed/29651257

[3] https://www.ncbi.nlm.nih.gov/pubmed/29306938

Now there is new evidence regarding the safety of Mindfulness, including an estimate of the incidence of adverse effects. An article in the NEW SCIENTIST warned that about one in 12 people who try meditation experience an unwanted negative effect, usually a worsening in depression or anxiety, or even the onset of these conditions for the first time, according to the first systematic review of the evidence. “For most people it works fine but it has undoubtedly been overhyped and it’s not universally benevolent,” says Miguel Farias at Coventry University in the UK, one of the researchers behind a paper which as yet is not available on-line.

Farias’s team combed through medical journals and found 55 relevant studies. Once the researchers had excluded those that had deliberately set out to find negative effects, they worked out the prevalence of people who experienced harms within each study and then calculated the average, adjusted for the study size, a common method in this kind of analysis. They found that about 8 per cent people who try meditation experience an unwanted effect. “People have experienced anything from an increase in anxiety up to panic attacks,” says Farias. They also found instances of psychosis or thoughts of suicide.

I will add a link to the original paper, once it has been published

 

In my never-ending search for novel so-called alternative medicines (SCAMs) I came across WATSU. If you had never heard of WATSU, you are in good company (for instance mine). WATSU (water and shiatsu) is a form of passive hydrotherapy in chest-deep thermoneutral water. It was created in the early 1980s by the California-based Shiatsu teacher Harold Dull and combines elements of myofascial stretching, joint mobilization, massage, and shiatsu and is used to address physical and mental issues.

To me, this sounds as though an old physiotherapeutic approach has been re-vamped in order to seem more attractive to the affluent sections of the SCAM brigade. My suspicion seems to be confirmed by SCAM ueber-guru Dr Andrew Weil’s comments:

Dr. Weil has received the therapy many times and often recommends it.

While other bodywork modalities are based on touch in a stationary, two-dimensional world, Watsu offers a different experience. A three-dimensional environment, nearly free from gravity, within a warm and comforting fluid-space and the opportunity to connect with another person all have obvious therapeutic potential.

Achieving states of deep relaxation combined with the therapeutic benefits of good massage therapy can be of great benefit in controlling pain, relieving stress, and recovering from emotional and physical trauma.

But never mind the one-dimensional Dr Weil. The question is: does WATSU work? According to a recent paper, it is effective for a wide range of conditions.

The objective of this systematic review and meta-analyses was to assess the applications, indications, and the effects of WATSU to form a basis for further studies.

Literature searches for “WATSU OR watershiatsu OR (water AND shiatsu)” were conducted without any restrictions in 32 databases. Peer reviewed original articles addressing WATSU as a stand-alone hydrotherapy were assessed for risk of bias. Quantitative data of effects on pain, physical function, and mental issues were processed in random model meta-analyses with subgroup analyses by study design.

Of 1,906 unique citations, 27 articles regardless of study design were assessed for risk of bias. WATSU has been applied to individuals of all ages. Indications covered acute (e.g. pregnancy related low back pain) and chronic conditions (e.g. cerebral palsy) with beneficial effects of WATSU regarding e.g. relaxation or sleep quality. Meta-analyses suggest beneficial effect sizes of WATSU on pain, physical function, and mental issues.

The authors concluded that various applications, indications and beneficial effects of WATSU were identified. The grade of this evidence is estimated to be low to moderate at the best. To strengthen the findings of this study, high-quality RCTs are needed.

Of the 27 studies included in this review, most were case-reports or case series, and only 5 were RCTs. Of these RCTs, none was robust. Some, for instance compared WATSU against no treatment at all, thus not controlling for placebo effects. All of these RCTs had small sample sizes, and all had been published in odd journals of dubious repute.

So, is it justified to categorically conclude that beneficial effects of WATSU were identified?

No, I don’t think so.

That physiotherapy in water can have positive effects on some symptoms would hardly be surprising. But, to convince people who think more critically than Dr Weil, better evidence would be needed.

Aromatherapy is currently one of the most popular of all alternative therapies. It consists of the use of essential oils for medicinal purposes. Aromatherapy usually involves the application of diluted essential oils via a gentle massage of the body surface. Less frequently, the essential oils are applied via inhalation. The chemist Rene-Maurice Gattefosse (1881-1950) coined the term ‘aromatherapy’ after experiencing that lavender oil helped to cure a serious burn. 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.

This Iranian study aimed to investigate the effect of inhalation aromatherapy with damask rose essence on pain and anxiety in burn patients. This three group clinical trial was conducted on 120 patients with burns less than 30% of total body surface area (TBSA). The patients were randomly allocated into three groups, aromatherapy damask rose essence, placebo, and control. The pain intensity was assessed using visual analogue scale prior to intervention, immediately before, and 15 min after dressing. Anxiety was measured using Spielberger Inventory at before intervention and 15 min after dressing, also the prolonged effect of intervention on pain was assessed by number of the analgesics drugs received for four hours after dressing change. The intervention included inhalation of 6 drops of 40% damask rose essential oil in the damask group, and six drops of distilled water in placebo group one hour before dressing change. The control group received no additional intervention. All groups also received standard care.

Baseline state-trait anxiety and pain intensity were similar in these three groups. A significant reduction was found in pain intensity immediately before and after dressing and state anxiety after dressing in the damask group compared to the placebo and control groups. The researchers found no significant difference between the placebo and control groups in terms of these variables at these times. No significant difference was noted among the three groups in frequency of analgesics drugs and trait anxiety after intervention.

The authors concluded that inhaled aromatherapy with Damask rose essence reduces subjective pain intensity and state anxiety in burned patients. Therefore, it is recommended considering use of damask rose essence, as an easy and affordable method along with other treatments.

These are interesting findings for sure. Aromatherapy is far less implausible than many other so-called alternative medicines (SCAMs). It furthermore has the advantages of being safe and inexpensive.

I have no reason to doubt the validity of the study. Yet, I nevertheless think it is prudent to insist on an independent replication before issuing a general recommendation.

The aim of this systematic review was to assess the efficacy of homeopathic remedies (HRs) in the treatment of mental disorders.

Italian psychiatrists performed a Medline/Embase search for studies written in English and published from any date to October 23, 2018. All randomized controlled trials enrolling patients with any psychiatric disorder and comparing HR with placebo, no treatment, or other psychotropic drugs were included.

A total of 212 studies were screened, 9 met all selection criteria and reported data on major depressive disorder (MDD) (n = 4), generalized anxiety disorder (n = 1), attention-deficit/hyperactivity disorder (n = 2), and premenstrual syndrome/dysphoric disorder (n = 2). Eight of 9 randomized controlled trials showed high risk of bias. Homeopathy showed greater efficacy in MDD compared with fluoxetine, and in premenstrual syndrome/dysphoric disorder compared with placebo, whereas no difference emerged between homeopathy and placebo in MDD and attention deficit/hyperactivity disorder.

The authors concluded that the available data on homeopathy in psychiatric disorders are insufficient to support their use in clinical practice.

In their discussion section, they also add an interesting note of caution: Ethical considerations should therefore prevent clinicians from recommending HRs, which have a cost either for patients or for health care systems, until when a sufficient amount of solid evidence becomes available. In addition, systematic reviews of randomized trials, if unavailable, are advisable for all medical conditions for which homeopathy is currently prescribed.

This is a rigorous, transparent and clear review which generates no surprises. Few critical thinkers would have expected a positive result. It also teaches us, I think, a valuable lesson about the difference between a rigorous and a flimsy review, between independent and biased research. In 2011, evidently pro-homeopathy authors published a paper of the latter kind. Here is its abstract:

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.

The two conclusions speak for themselves, I think. They should remind us that, although systematic reviews are in principle the most reliable source of evidence, it is still necessary to check the quality of the work and the independence of the worker.

Bach-Flower Remedies (BFRs) are often confused with homeopathics. Like them, they contain no active molecule; unlike them, they are not potentised nor used according to the ‘like cures like’ assumption. Both have in common that they are as popular as implausible.

Few studies have tested BFRs; my own systematic review of controlled clinical trials was published in 2010:

Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.

Now a new study has emerged. This trial from the Department of Pedodontics and Preventive Dentistry, DY Patil University – School of Dentistry, Navi Mumbai, Maharashtra, India, compared the effects of Bach Flower Therapy (BFT) and music therapy (MT) on the dental anxiety in paediatric patients. A total of 120 children (aged 4-6 years) were selected and randomly allocated to one of three groups:

  • BFT group: Children from this group were administered orally four drops of “rescue remedy” diluted in 40 mL of water 15 min before the treatment. Children were asked to wear headphones without playing any music during the dental treatment
  • MT group: Children from this group were provided with a headphone, and Indian classical instrumental music (Raag Sohni played by Pandit Shiv Kumar Sharma on santoor) was played during the scheduled dental treatment. Children were also given 40 mL plain water to drink 15 min before the treatment
  • Control group: Children from this group were given 40 mL plain water 15 min before the treatment. During the treatment, children were asked to wear the headphone without playing any music.

All children received oral prophylaxis and fluoride treatment (no further details provided). Dental anxiety was evaluated using

  • North Carolina Behavior Rating Scale (NCBRS), the primary outcome measure,
  • Facial Image Scale (FIS),
  • and physiological parameters.

Significantly better behaviour was seen in children from the BFT group as compared to the control group (P = 0.014). FIS scores measured postoperatively did not show significant differences among the groups.

Table 2: Comparison of North Carolina Behavior Rating Scale scores of child's behavior measured during the dental procedure between the three groups

Table 3: Comparison of postoperative patient-reported dental anxiety as measured by Facial Image Scale among the three groups

Children from the BFT and MT groups showed a significant decrease in the pulse rates intraoperatively from the preoperative period. Intraoperative systolic blood pressure in children from the MT group was significantly lower than both the BFT and the control groups. Diastolic blood pressure significantly increased in the control group intra-operatively, whereas other groups showed a decrease.

The authors concluded that the results of this study demonstrate significant effects of both single dose of BFT and exposure to MT, on reduction of dental anxiety in children aged between 4 and 6 years.

I find these findings most puzzling (like all BFRs, Rescue Remedies do not contain a single active molecule that could explain them) and strongly recommend that we wait until we have an independent replication before accepting these results as trustworthy.

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