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

anxiety

Energy healing is an umbrella term for a range of paranormal healing practices. Their common denominator is the belief in a mystical ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today energy healing systems are amongst the most popular alternative therapies in the US as well as in many other countries.

Energy healing relies on the esoteric belief in some form of ‘energy’ which is distinct from the concept of energy understood in physics and refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be but a veneer of pseudo-science. The ‘energy’ that energy healers refer to is not measurable and lacks biological plausibility.

The purpose of this study was to evaluate the effects of energy healing (EH) therapy prior to and following posterior surgical correction for adolescent idiopathic scoliosis (AIS) compared to controls.

Patients were prospectively randomized to one of two groups: standard operative care for surgery (controls) vs. standard care with the addition of three EH sessions. The outcomes included visual analog scales (VAS) for pain and anxiety (0-10), days until conversion to oral pain medication, and length of hospital stay. For the experimental group, VAS was assessed pre- and post-EH session.

Fifty patients were enrolled-28 controls and 22 EH patients. The controls had a median of 12 levels fused vs. 11 in the EH group (p = 0.04). Pre-operative thoracic and lumbar curve magnitudes were similar (p > 0.05). Overall VAS pain scores increased from pre- to post-operative (p < 0.001), whereas the VAS anxiety scores decreased immediately post-operative (p < 0.001). The control and pre-EH assessments were statistically similar. Significant decreases in VAS pain and anxiety scores from pre to post-EH assessments were noted for the EH group. Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11). The median days to discharge were four in the controls and three in the EH group (p = 0.07).

The authors concluded that EH therapy resulted in a decrease in patient’s pre-operative anxiety. Offering this CAM modality may enhance the wellbeing of the patient and their overall recovery when undergoing posterior surgical correction for AIS.

I am getting tired of explaining that this trial design tells us as good as nothing about the effects of the tested therapy per se. As we have discussed ad nauseam on this blog, A+B is always more than B alone. Such trials appear to be rigorous and fool many people, but they are unable to control for context effects, like placebo or attention. Therefore, I need to re-write the conclusions:

The placebo effect and the extra attention associated with EH therapy resulted in a decrease in patients’ pre-operative anxiety. EH itself is most likely bar any effect. Further studies in this area are not required.

The use of homeopathy in oncological supportive care seems to be progressing. The first French prevalence study, performed in 2005 in Strasbourg, showed that only 17% of the subjects were using it. This descriptive study, using a questionnaire identical to that used in 2005, investigated whether the situation has changed since then.

A total of 633 patients undergoing treatment in three anti-cancer centers in Strasbourg were included. The results of the “homeopathy” sub-group were extracted and studied.

Of the 535 patients included, 164 (30.7%) used homeopathy. The main purpose of its use was to reduce the side effects of cancer treatments (75%). Among the users,

  • 82.6% were “somewhat” or “very” satisfied,
  • 15.5% were “quite” satisfied,
  • 1.9% were “not at all” satisfied.

The homeopathic treatment was prescribed by a doctor in 75.6% of the cases; the general practitioner was kept informed in 87% of the cases and the oncologist in 82%. Fatigue, pain, nausea, anxiety, sadness, and diarrhea were improved in 80% of the cases. Hair-loss, weight disorders, and loss of libido were the least improved symptoms. The use of homeopathy was significantly associated with the female sex.

The authors concluded that with a prevalence of 30.7%, homeopathy is the most used complementary medicine in integrative oncology in Strasbourg. Over 12 years, we have witnessed an increase of 83% in its use in the same city. Almost all respondents declare themselves satisfied and tell their doctors more readily than in 2005.

There is one (possibly only one) absolutely brilliant statement in this abstract:

The use of homeopathy was significantly associated with the female sex.

Why do I find this adorable?

Because to claim that any of the observed outcomes of this study are causally related to homeopathy seems like claiming that homeopathy turns male patients into women.

PS

In case you do not understand my clumsy attempt at humor and satire, rest assured: I do not truly believe that homeopathy turns men into women, and neither do I believe that it improves fatigue, pain, nausea, anxiety, sadness, and diarrhea. Remember: correlation is not causation.

Therapeutic touch (TT) is a form of paranormal or energy healing developed by Dora Kunz (1904-1999), a psychic and alternative practitioner, in collaboration with Dolores Krieger, a professor of nursing. According to Kunz, TT has its origins in ancient Yogic texts. TT is popular and practiced predominantly by US nurses; it is currently being taught in more than 80 colleges and universities in the U.S., and in more than seventy countries. According to one TT-organisation, TT is a holistic, evidence-based therapy that incorporates the intentional and compassionate use of universal energy to promote balance and well-being. It is a consciously directed process of energy exchange during which the practitioner uses the hands as a focus to facilitate the process.

The assumptions that form the basis for TT are not biologically plausible. But that does not necessarily mean it is ineffective.

This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality, and fatigue among students of nursing and midwifery.

A total of 96 students were randomized into three groups: the therapeutic touch (TT) group, the sham therapeutic touch (STT) group, and the control group. The TT group was subjected to therapeutic touch twice a week for 4 weeks with each session lasting 20 min.

When the TT group was compared to the STT and control groups following the intervention, the decrease in the levels of stress, fatigue, and daytime sleepiness, as well as the increase in the sleep quality were found to be significant.

The authors concluded that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.

Several previous trials and reviews of TT are available. However, many of them were conducted ardent proponents of TT, seriously flawed, and thus less than reliable. One rigorous pre-clinical study, co-designed by a 9-year-old girl, found that experienced TT practitioners were unable to detect the investigator’s “energy field.” Their failure to substantiate TT’s most fundamental claim is unrefuted evidence that the claims of TT are groundless and that further professional use is unjustified.

In my recent book, I concluded that there are no reasons to assume that TT causes any meaningful effects beyond placebo. One could, however, argue that, like all forms of paranormal healing, it undermines rational thinking.

Does the new study change my judgment?

I am afraid not!

The objective of this review (entitled ‘Systematic Review on the Use of Homeopathy in Dentistry:
Critical Analysis of Clinical Trials‘) was to map the literature on homeopathy in dentistry and to evaluate the effectiveness of using homeopathy in dental practice through the critical analysis of clinical studies.

The search for scientific articles in any language, year, and place of publication was made in the databases of Public Medline (PUBMED), Web of Science, Cochrane, and Virtual Health Library; the articles selected were later classified according to the type of study. Gray literature was accessed through Google Scholar. Clinical trials were analyzed for methodological quality. Two trained reviewers accomplished the entire process independently.

Of the 281 studies retrieved by means of the search, 44 met the eligibility criteria. The included papers were:

  • literature reviews (56.8%),
  • clinical trials (34.1%),
  • cross-sectional studies (6.8%),
  • laboratory research (6.8%),
  • longitudinal observational studies (4.5%).

The clinical trials were published from 1965 to 2019, using homeopathy in several dental specialties:

  • Endodontics,
  • Periodontics,
  • Orofacial Pain,
  • Surgery,
  • Pediatric Dentistry,
  • Stomatology,
  • dental anxiety.

Qualitative failures, in all criteria investigated, and positive influences of the individual prescriptions on the results of treatments reported were observed.

The authors concluded that there is still a scarcity of studies about homeopathy and dentistry. The clinical trials selected showed positive effects on oral health; however, when they were critically evaluated, it was possible to recognize qualitative failures, mainly relative to double-blinding. It is necessary to encourage research on the subject, using standardized methodological procedures, to obtain better evaluation of the clinical applicability.

According to the authors, their review adhered to the PRISMA guideline of systematic reviews. This is, however, not the case. The authors correctly point out that the primary studies had many flaws: methodological failures were observed in the clinical trials, mainly related to double-blinding (66.7%). Significant failures were also observed in similarity (61.1%), randomization (27.8%), description of losses and exclusions (27.8%), and exclusion criteria (27.8%). They do not seem to realize that flaws of this nature and frequency should prevent positive conclusions.

So, what does this paper actually demonstrate? In my view, it shows that:

  • the peer-review process at the JACM continues to be a joke;
  • poor quality trials run by enthusiasts tend to produce false-positive results;
  • in so-called alternative medicine (SCAM), people get away with publishing even the most obvious falsehoods.

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

 

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