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

depression

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This study evaluated and compared the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients’ negative emotional states. This quas-experimental research design was carried out at the National Institute of Diabetes and Endocrinology’s Hospital in Cairo, Egypt. It included 200 Type 2 diabetes patients randomized into two equal groups, one for Qigong and one for Reiki techniques. A self-administered questionnaire with a standardized tool (Depression Anxiety Stress Scales [DASS[) was used in data collection. The intervention programs were administered in the form of instructional guidelines through eight sessions for each group.

The results showed that the two study groups had similar socio-demographic characteristics. After implementation of the intervention, most patients in the two groups were having no anxiety, no depression, and no stress. Statistically significant improvements were seen in all three parameters in both groups (p<0.001). The multivariate analysis identified the study intervention as the main statistically significant independent negative predictor of the patients’ scores of anxiety, depression, and stress. Reiki technique was also a statistically significant independent negative predictor of these scores.

The authors conclused that both Reiki and Qi-gong therapy techniques were effective in improving diabetic patients’ negative emotional states of anxiety, depression, and stress, with slight superiority of the Reiki technique. The inclusion of these techniques in the management plans of Type-2 diabetic patients is recommended.

This is an excellent example of how NOT to design a clinical trial!

  • If your aim is to test the efficacy of Reiki, conduct a trial of Reiki versus sham-Reiki.
  • If your aim is to test the efficacy of Qi-gong, conduct a trial of Qi-gong versus sham-Qi-gong.
  • If you compare two therapies in one trial, one has to be of proven and undoubted efficacy.
  • Comparing two treatments of unproven efficacy cannot normally lead to a meaningful result.
  • It is like trying to solve a mathematical equasion with two unknowns.
  • A study that cannot produce a meaningful result is a waste of resorces.
  • It arguably also is a neglect of research ethics.
  • Even if we disregarded all these flaws and problems, recommending therapies for routine use on the basis of one single study is irresponsible nonsense.

All this is truly elementary and should be known by any researcher (not to mention research supervisor). Yet, in the realm of so-called alternative medicine (SCAM), it needs to be stressed over and over again. The ‘National Institute of Diabetes and Endocrinology’s Hospital in Cairo’ (and all other institutions that produce such shameful pseudoscience) urgently need to get their act together:

you are doing nobody a favour!

The aim of this systematic review and network meta-analysis was to identify the optimal dose and modality of exercise for treating major depressive disorder, compared with psychotherapy, antidepressants, and control conditions.

The screening, data extraction, coding, and risk of bias assessment were performed independently and in duplicate. Bayesian arm based, multilevel network meta-analyses were performed for the primary analyses. Quality of the evidence for each arm was graded using the confidence in network meta-analysis (CINeMA) online tool. All randomised trials with exercise arms for participants meeting clinical cut-offs for major depression were included.

A total of 218 unique studies with a total of 495 arms and 14 170 participants were included. Compared with active controls (eg, usual care, placebo tablet), moderate reductions in depression were found for

  • walking or jogging,
  • strength training,
  • mixed aerobic exercises,
  • and tai chi or qigong.

The effects of exercise were proportional to the intensity prescribed. Strength training and yoga appeared to be the most acceptable modalities. Results appeared robust to publication bias, but only one study met the Cochrane criteria for low risk of bias. As a result, confidence in accordance with CINeMA was low for walking or jogging and very low for other treatments.

The authors concluded that exercise is an effective treatment for depression, with walking or jogging, yoga, and strength training more effective than other exercises, particularly when intense. Yoga and strength training were well tolerated compared with other treatments. Exercise appeared equally effective for people with and without comorbidities and with different baseline levels of depression. To mitigate expectancy effects, future studies could aim to blind participants and staff. These forms of exercise could be considered alongside psychotherapy and antidepressants as core treatments for depression.

As far as I can see, there are two main problems with these findings:

  1. Because too many of the studies are less than rigorous, the results are not quite as certain as the conclusions would seem to imply.
  2. Patients suffering from a major depressive disorder are often unable (too fatigued, demotivated, etc.) to do and/or keep up vigorous excerise over any length of time.

What I find furthermore puzzling is that, on the one hand, the results show that – as one might expect – the effects are proportional to the intensity of the excercise but, on the other hand tai chi and qugong which are both distinctly low-intensity turn out to be effective.

Nonetheless, this excellent paper is undoubtedly good news and offers hope for patients who are in desperate need of effective, safe and economical treatments.

This study was aimed at evaluating the effectiveness of osteopathic visceral manipulation (OVM) combined with physical therapy in pain, depression, and functional impairment in patients with chronic mechanical low back pain (LBP).
A total of 118 patients with chronic mechanical LBP were assessed, and 86 who met the inclusion criteria were included in the randomized clinical trial (RCT). The patients were randomized to either:

  • Group 1 (n=43), who underwent physical therapy (5 days/week, for a total of 15 sessions) combined with OVM (2 days/week with three-day intervals),
  • or Group 2 (n=43), which underwent physical therapy (5 days/week, for a total of 15 sessions) combined with sham OVM (2 days/week with three-day intervals).

Both groups were assessed before and after treatment and at the fourth week post-treatment.

Seven patients were lost to follow-up, and the study was completed with 79 patients. Pain, depression, and functional impairment scores were all improved in both groups (p=0.001 for all). This improvement was sustained at week four after the end of treatment. However, improvement in the pain, depression, and functional impairment scores was significantly higher in Group 1 than in Group 2 (p=0.001 for all).

The authors concluded that the results suggest that OVM combined with physical therapy is useful to improve pain, depression, and functional impairment in patients with chronic mechanical low back pain. We believe that OVM techniques should be combined with other physical therapy modalities in this patient population.

OVM was invented by the French osteopath, Jean-Piere Barral. In the 1980s, he stated that through his clinical work with thousands of patients, he discovered that many health issues were caused by our inner organs being entrapped and immobile. According to its proponents, OVM is based on the specific placement of soft manual forces that encourage the normal mobility, tone and function of our inner organs and their surrounding tissues. In this way, the structural integrity of the entire body is allegedly restored.

I am not aware of good evidence to show that OVM is effective – and this, sadly, includes the study above.

In my view, the most plausible explanation for its findings have little to do with OVM itself: sham OVM was applied “by performing light pressure and touches with the palm of the hand on the selected points for OVM without the intention of treating the patient”. This means that most likely patients were able to tell OVM from sham OVM and thus de-blinded. In other words, their expectation of receiving an effective therapy (and not the OVM per se) determined the outcome.

 

The BBC has a popular program entitled JUST ONE THING presented by Dr, Michael Mosely. In each of these short broadcasts, Mosely presents JUST ONE THING that will make your life more healthy. Whenever I listen to them, I get slightly irritated. Mosely is clearly a very skilled presenter and makes complicated things easy to understand; but for my taste his approach is totally devoid of critical thinking. This is obviously the point of the series and probably one reason for its success. So, maybe it needs to be tolerated – perhaps, but surely not if it seriously misleads the public on important health issues.

The most recent broadcast was entitled EMBRACE THE RAIN and, in my view, it did cross this crucial line. Mosely explained that after it has rained, the air is full of negative ions and these ions are effective against depression. The center piece was his interview with Prof Michael Terman who explained some of his research on the subject, in particular a clinical trial which showed that intensely ionized air was effective against depression. Terman explained that this was more than a placebo effect, that it worked even for serious chronic depressed patients, and that the effect was better than standard treatments.

At no stage was there an even mildly critical question from Mosely. Consequently many depressed patients might now abandon their standard treatments and opt for air ionizers in their homes or walks in the rain which was deemed to be just as effective. In view of the fact that chronic depression, through its suicide risk, can be a life-threatening condition, I find this rather concerning.

My concerns were not exactly alleviated when I did a quick search for the evidence. The most recent review on the subject states that there has been considerable interest in the potential effects of negative air ions (NAIs) on human health and well-being, but the conclusions have been inconsistent and the mechanisms remain unclear. So, why does Terman promote NAIs as though they are the best thing since sliced bread? It took me less than a minute to find a possible answer: he holds a patent for a NEGATIVE ION GENERATOR!

It is laudable of the BBC and Michael Mosely to present aspects of healthcare in a simple, understandable way. Yet, it would be even more laudable, if they did their homework a bit better and, crucially, tried to also educate the public in critical thinking. After all ’embracing the rain’ will not change lives but critical thinking most certainly does!

Acupuncture is questionable.

Acupressure is highly questionable.

Auricular acupressure is extremely questionable.

This study investigated the effect of auricular acupressure on the severity of postpartum blues. A randomized sham-controlled trial was conducted from February to November 2021, with 74 participants who were randomly allocated into two groups of either routine care + auricular acupressure (n = 37), or routine care + sham control (n = 37). Vacaria seeds with special non-latex adhesives were used to perform auricular acupressure on seven ear acupoints. There were two intervention sessions with an interval of five days. In the sham group, special non-latex adhesives without vacaria seeds were attached in the same acupoints as the intervention group. The severity of postpartum blues, fatigue, maternal-infant attachment, and postpartum depression was assessed.

Auricular acupressure was associated with a significant effect in the reduction of postpartum blues on the 10th and 15th days after childbirth (SMD = −2.77 and −2.15 respectively), postpartum depression on the 21st day after childbirth (SMD = −0.74), and maternal fatigue on 10th, 15th and 21st days after childbirth (SMD = −2.07, −1.30 and −1.32, respectively). Also, the maternal-infant attachment was increased significantly on the 21st day after childbirth (SMD = 1.95).

The authors concluded that auricular acupressure was effective in reducing postpartum blues and depression, reducing maternal fatigue, and increasing maternal-infant attachment in the short-term after childbirth.

Let me put my doubts about these conclusions in the form of a few questions:

  1. If you had sticky tape on your ear, would you sometimes touch it?
  2. If you touched it, would you feel whether a vacaria seed was contained in it or not?
  3. Would you, therefore, say that such a trial could be properly blinded (not to forget the therapists who were, of course, in the know)?
  4. If the trial was thus de-blinded, would you claim that patient expectation did not influence the outcomes?

If you answered all of these questions with NO, you are – like I – of the opinion that the results of this trial could have easily been brought about, not by the alleged effects of acupressure, but by placebo and other non-specific effects.

It has been reported that King Charles refused to pay Prince Andrew’s £ 32,000-a-year bill for his personal healing guru. The Duke of York has allegedly submitted the claim to the Privy Purse as a royal expense having sought the help of a yoga teacher.

However, the claim has reportedly been denied by the King, who is said to have told Andrew the bill will need to be covered using his own money. It comes after sources claimed Andrew has been using the Indian yogi for a number of years for chanting, massages, and holistic therapy in the privacy of his mansion. The healer has reportedly enjoyed month-long stays at a time at the £30 million Royal Lodge in Windsor.

Previously, the Queen seems to have passed the claims. But now Charles is in control. A source said: “While the Queen was always happy to indulge her son over the years, Charles is far less inclined to fund such indulgences, particularly in an era of a cost-of-living crisis. “Families are struggling and would rightly baulk at the idea of tens of thousands paid to an Indian guru to provide holistic treatment to a non-working royal living in his grace and favour mansion. This time the King saw the bill for the healer submitted by Andrew to the Privy Purse and thought his brother was having a laugh.”

________________________

Poor Andrew!

How is he going to cope without his guru?

Will he be able to recover from the mysterious condition that prevents him to sweat?

Will his ego take another blow?

How will he be able to afford even the most basic holistic wellness?

How can Charles – who knows only too well about its benefits – be so cruel to his own brother?

Should I start a collection so that Andrew can pay for his most basic needs?

____________________________

Yes, these are the nagging questions and deep concerns that keep me awake at night!

 

 

PS

I have just been asked if, by any chance, the yoga teacher is a 16-year-old female. I have to admit that I cannot answer this question.

 

During the last few days, several journalists have asked me about ayahuasca. Apparently, Harry Windsor said in an interview that it changed his life! However, the family of a young woman who took her own life after using ayahuasca has joined campaigners condemning his comments. Others – including myself – claim that Harry is sending a worrying message talking about his ‘positive’ experience with ayahuasca, saying it ‘brought me a sense of relaxation, release, comfort, a lightness that I managed to hold on to for a period of time’.

So, what is ayahuasca?

This paper explains it quite well:

Ayahuasca is a hallucinogen brew traditionally used for ritual and therapeutic purposes in Northwestern Amazon. It is rich in the tryptamine hallucinogens dimethyltryptamine (DMT), which acts as a serotonin 5-HT2A agonist. This mechanism of action is similar to other compounds such as lysergic acid diethylamide (LSD) and psilocybin. The controlled use of LSD and psilocybin in experimental settings is associated with a low incidence of psychotic episodes, and population studies corroborate these findings. Both the controlled use of DMT in experimental settings and the use of ayahuasca in experimental and ritual settings are not usually associated with psychotic episodes, but little is known regarding ayahuasca or DMT use outside these controlled contexts. Thus, we performed a systematic review of the published case reports describing psychotic episodes associated with ayahuasca and DMT intake. We found three case series and two case reports describing psychotic episodes associated with ayahuasca intake, and three case reports describing psychotic episodes associated with DMT. Several reports describe subjects with a personal and possibly a family history of psychosis (including schizophrenia, schizophreniform disorders, psychotic mania, psychotic depression), nonpsychotic mania, or concomitant use of other drugs. However, some cases also described psychotic episodes in subjects without these previous characteristics. Overall, the incidence of such episodes appears to be rare in both the ritual and the recreational/noncontrolled settings. Performance of a psychiatric screening before administration of these drugs, and other hallucinogens, in controlled settings seems to significantly reduce the possibility of adverse reactions with psychotic symptomatology. Individuals with a personal or family history of any psychotic illness or nonpsychotic mania should avoid hallucinogen intake.

In other words, ayahuasca can lead to serious side effects. They include vomiting, diarrhea, paranoia, and panic. Ayahuasca can also interact with many medications, including antidepressants, psychiatric medications, drugs used to control Parkinson’s disease, cough medicines, weight loss medications, and more. Those with a history of psychiatric disorders, such as schizophrenia, should avoid ayahuasca because this could worsen their psychiatric symptoms. Additionally, taking ayahuasca can increase your heart rate and blood pressure, which may result in dangerous consequences for those who have a heart condition.

Thus ayahuasca is an interesting albeit dangerous herb (in most countries it is illegal to possess or consume it). Currently, it is clearly under-researched, which means we know very little about its potential benefits and even less about the harm it can do.

Considering this, one would think that any half-intelligent person with loads of influence would not promote or encourage its use – but, sadly, it seems that one would be mistaken.

Norbert Hofer is the former leader of the Austrian right-wing FPÖ party who almost became Austria’s President. Currently, he is the 3rd member of the National Council. Hofer is a man full of surprises; he stated, for instance, that the Quran was more dangerous than COVID-19 during a speech held at a 2020 campaign event. As a result, he was sued for hate-speech.

Hofer’s latest coup is not political but commercial: Hofer is launching his own dietary supplement on the market. It is called “Formula Fortuna” and contains:

  • L-tryptophan; a Cochrane review concluded that “a large number of studies appear to address the research questions, but few are of sufficient quality to be reliable. Available evidence does suggest these substances are better than placebo at alleviating depression. Further studies are needed to evaluate the efficacy and safety of 5‐HTP and tryptophan before their widespread use can be recommended. The possible association between these substances and the potentially fatal Eosinophilia‐Myalgia Syndrome has not been elucidated. Because alternative antidepressants exist which have been proven to be effective and safe the clinical usefulness of 5‐HTP and tryptophan is limited at present.”
  • Hydroxypropylmethylcellulose, a common delivery system.
  • Rhodiola rosea extracts; human studies evaluating R. rosea did not have sufficient quality to determine whether it has properties affecting fatigue or any other condition.The U.S. Food and Drug Administration (FDA) has issued warning letters to manufacturers of R. rosea dietary supplement products unapproved as new drugs, adulterated, misbranded and in federal violation for not having proof of safety or efficacy for the advertised conditions of alleviating Raynaud syndromealtitude sicknessdepression or cancer.
  • Ginseng root extract. Although ginseng has been used in traditional medicine for centuries, modern research is inconclusive about its biological effects. Preliminary clinical research indicates possible effects on memory, fatigue, menopause symptoms, and insulin response in people with mild diabetes. Out of 44 studies examined between 2005–2015, 29 showed positive, limited evidence, and 15 showed no effects. As of 2021, there is insufficient evidence to indicate that ginseng has any health effects. A 2021 review indicated that ginseng had “only trivial effects on erectile function or satisfaction with intercourse compared to placebo”. The constituents include steroid saponins known as ginsenosides, but the effects of these ginseng compounds have not been studied with high-quality clinical research as of 2021, and therefore remain unknown. As of 2019, the United States FDA and Federal Trade Commission have issued numerous warning letters to manufacturers of ginseng dietary supplements for making false claims of health or anti-disease benefits, stating that the “products are not generally recognized as safe and effective for the referenced uses” and are illegal as unauthorized “new drugs” under federal law. Concerns exist when ginseng is used chronically, potentially causing side effects such as headachesinsomnia, and digestive problems. Ginseng may have adverse effects when used with the blood thinner warfarin. Ginseng also has adverse drug reactions with phenelzine, and a potential interaction has been reported with imatinib, resulting in hepatotoxicity, and with lamotrigine. Other side effects may include anxiety, insomnia, fluctuations in blood pressure, breast pain, vaginal bleedingnausea, or diarrhea.
  • Zinc gluconate which has been used in lozenges for treating the common cold. However, controlled trials with lozenges which include zinc acetate have found it has the greatest effect on the duration of coldsInstances of anosmia (loss of smell) have been reported with intranasal use of some products containing zinc gluconate. In September 2003, Zicam faced lawsuits from users who claimed that the product, a nasal gel containing zinc gluconate and several inactive ingredients, negatively affected their sense of smell and sometimes taste. Some plaintiffs alleged experiencing a strong and very painful burning sensation when they used the product. Matrixx Initiatives, Inc., the maker of Zicam, responded that only a small number of people had experienced problems and that anosmia can be caused by the common cold itself. In January 2006, 340 lawsuits were settled for $12 million.
  • Pyridoxine hydrochloride (vitamin B6) is usually well tolerated, though overdose toxicity is possible. Occasionally side effects include headache, numbness, and sleepiness. Pyridoxine overdose can cause a peripheral sensory neuropathy characterized by poor coordination, numbness, and decreased sensation to touch, temperature, and vibration.

‘Formula Fortuna’ allegedly is for lifting your mood. If I, however, tell you that you need to pay one Euro per day for the supplement, your mood might even change in the opposite direction.

What next?

I think I might design a dietary supplement against stupidity. It will not carry any of the risks of Hofer’s new invention but, I am afraid, it might be just as ineffective as Hofer’s ‘Formual Fortuna’.

In case you have categorized Harry Windsor as an ungrateful brat, you are entirely wrong! He did thank a lot of people – Ophra and Gwyneth Paltrow, for instance. No, I did not read Harry’s bestseller ‘SPARE’. But I did, of course, read the odd report about it simply because it is almost impossible to escape the current press hoo-ha about it.

Most of what I learned is of no interest to me. Some of it, I have to admit, made me concerned about Hary’s wellbeing – after all, we know that chronic drug-taking can severely affect one’s mental health! However, one recent article in Newsweek managed to reassure me on that score:

Among the “professionals, medical experts, and coaches” thanked by the prince for “keeping me physically and mentally strong over the years,” is John Amaral, a Los Angeles-based chiropractor, energy practitioner, author and educator. Amaral is known for his self-developed “energy flow formula,” which combines body and energy work to include mindfulness, meditation and breathing.

This sounded sufficiently relevant for me to look up Amaral. This is what we learn from one website:

Dr. John Amaral is a holistic chiropractor that practices Network Spinal (NSA). This technique helps people release stored tension in their muscles and joints through gentle force adjustments, also known as entrainments. Instead of the traditional cracking or popping of bones that you’re used to seeing at chiropractic offices, John Amaral leverages different energetic intelligences to help people heal physically and emotionally.

Another source tells us the following:

John Amaral is a chiropractor, energy healer and educator who works behind the scenes helping celebrities, entrepreneurs, pro athletes and influencers elevate their energy so they feel and perform their best. John has worked with thousands of people from over 50 countries. He is the Founder of Body Centered Leadership… How much do his sessions cost? According to the Wall Street Journal, a healing session with Amaral will run you $2,500.

And a third website informs us that:

Amaral works with what he calls the “subtle energy body”, which is the energy field around the body that can extend around 3 to 8 feet from the physical body. His work is primarily focused on shifting the tension state of the body and help in freeing up bound-up energy that’s held in different parts of the body. He accesses the energy around the body to achieve this.

In case you have not yet got the drift, take a look at this video; impressive isn’t it?

Yes, Amaral is not cheap but he must be worth it! And because he is such a genial healer, I am confident that we can all relax now knowing that Harry’s health is in such good hands. Personally, I am thrilled by Harry’s hint that there might be a second book in the offing – one with the really dirty linen. I think I might actually buy that one, now that I know how badly he needs the money for keeping healthy.

Electroacupuncture (EA) is often advocated for depression and sleep disorders but its efficacy remains uncertain. The aim of this study was, therefore, to “assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression.”

A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive

  1. EA treatment and standard care,
  2. sham acupuncture (SA) treatment and standard care,
  3. standard care only as control.

Patients in the EA or SA groups received a 30-minute treatment 3 times per week (usually every other day except Sunday) for 8 consecutive weeks. All treatments were performed by licensed acupuncturists with at least 5 years of clinical experience. A total of 6 acupuncturists (2 at each center; including X.Y. and S.Z.) performed EA and SA, and they received standardized training on the intervention method before the trial. The regular acupuncture method was applied at the Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), and SanYinjiao (SP6) acupuncture points, with 0.25 × 25-mm and 0.30 × 40-mm real needles (Wuxi Jiajian Medical Device Co, Ltd), or 0.30 × 30-mm sham needles (Streitberger sham device [Asia-med GmbH]).

For patients in the EA group, rotating or lifting-thrusting manipulation was applied for deqi sensation after needle insertion. The 2 electrodes of the electrostimulator (CMNS6-1 [Wuxi Jiajian Medical Device Co, Ltd]) were connected to the needles at GV20 and GV29, delivering a continuous wave based on the patient’s tolerance. Patients in the SA group felt a pricking sensation when the blunt needle tip touched the skin, but without needle insertion. All indicators of the nearby electrostimulator were set to 0, with the light switched on. Standard care (also known as treatment as usual or routine care) was used in the control group. Patients receiving standard care were recommended by the researchers to get regular exercise, eat a healthy diet, and manage their stress level during the trial. They were asked to keep the regular administration of antidepressants, sedatives, or hypnotics as well. Psychiatrists in the Shanghai Mental Health Center (including X.L.) guided all patients’ standard care treatment and provided professional advice when a patient’s condition changed.

The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score.

Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported.

The result of the blinding assessment showed that 56 patients (62.2%) in the SA group guessed wrongly about their group assignment (Bang blinding index, −0.4 [95% CI, −0.6 to −0.3]), whereas 15 (16.7%) in the EA group also guessed wrongly (Bang blinding index, 0.5 [95% CI, 0.4-0.7]). This indicated a relatively higher degree of blinding in the SA group.

The authors concluded that, in this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32.

This trial seems rigorous, it has a sizable sample size, uses a credible placebo procedure, and is reported in sufficient detail. Why then am I skeptical?

  • Perhaps because we have often discussed how untrustworthy acupuncture studies from China are?
  • Perhaps because I fail to see a plausible mechanism of action?
  • Perhaps because the acupuncturists could not be blinded and thus might have influenced the outcome?
  • Perhaps because the effects of sham acupuncture seem unreasonably small?
  • Perhaps because I cannot be sure whether the acupuncture or the electrical current is supposed to have caused the effects?
  • Perhaps because the authors of the study are from institutions such as the Shanghai Municipal Hospital of Traditional Chinese Medicine, the Department of Acupuncture and Moxibustion, Huadong Hospital, Fudan University, Shanghai,
  • Perhaps because the results seem too good to be true?

If you have other and better reasons, I’d be most interested to hear them.

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