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

symptom-relief

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Tai chi is a meditative exercise therapy based on Traditional Chinese Medicine. On this blog, we have repeatedly discussed this so-called alternative medicine (SCAM). It involves meditative movements rooted in both Traditional Chinese Medicine and the martial arts. Tai chi was originally aimed at enhancing mental and physical health; today it has become a popular alternative therapy.

This systematic review assessed the efficiency of tai chi (TC) in different populations’ cognitive function improvement.  Randomized controlled trials (RCTs) published from the beginning of coverage through October 17, 2020 in English and Chinese were retrieved from many indexing databases. Selected studies were graded according to the Cochrane Handbook for Systematic Reviews of Intervention 5.1.0. The outcome measures of cognitive function due to traditional TC intervention were obtained. Meta-analysis was conducted by using RevMan 5.4 software. We follow the PRISMA 2020 guidelines.

Thirty-three RCTs, with a total of 1808 participants, were included. The results showed that TC can progress global cognition when assessed in middle-aged as well as elderly patients suffering from cognitive and executive function impairment. The findings are as follows:

  • Montreal Cognitive Assessment Scale: mean difference (MD) = 3.23, 95% CI = 1.88-4.58, p < 0.00001,
  • Mini-Mental State Exam: MD = 3.69, 95% CI = 0.31-7.08, p = 0.03,
  • Trail Making Test-Part B: MD = -13.69, 95% CI = -21.64 to -5.74, p = 0.0007.

The memory function of older adults assessed by the Wechsler Memory Scale was as follows: MD = 23.32, 95% CI = 17.93-28.71, p < 0.00001. The executive function of college students evaluated by E-prime software through the Flanker test was as follows: MD = -16.32, 95% CI = -22.71 to -9.94, p < 0.00001.

The authors concluded that TC might have a positive effect on the improvement of cognitive function in middle-aged and elderly people with cognitive impairment as well as older adults and college students.

These days, I easily get irritated with such conclusions. That TC might improve cognitive function is obvious. If not, there would be no reason to do a review! But does it?

This paper does not provide an answer. All it shows is that TC trials are of lousy quality and that the observed effects might well be due not to TC itself by to non-specific effects.

Cupping is a so-called alternative medicine (SCAM) that has been around for millennia in many cultures. We have discussed it repeatedly on this blog (see, for instance, here, here, and here). This new study tested the effects of dry cupping on pain intensity, physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms, and medication use in individuals with chronic non-specific low back pain.

Ninety participants with chronic non-specific low back pain were randomized. The experimental group (n = 45) received dry cupping therapy, with cups bilaterally positioned parallel to the L1 to L5 vertebrae. The control group (n = 45) received sham cupping therapy. The interventions were applied once a week for 8 weeks.

Participants were assessed before and after the first treatment session, and after 4 and 8 weeks of intervention. The primary outcome was pain intensity, measured with the numerical pain scale at rest, during fast walking, and during trunk flexion. Secondary outcomes were physical function, functional mobility, trunk range of motion, perceived overall effect, quality of life, psychological symptoms, and medication use.

On a 0-to-10 scale, the between-group difference in pain severity at rest was negligible: MD 0.0 (95% CI -0.9 to 1.0) immediately after the first treatment, 0.4 (95% CI -0.5 to 1.5) at 4 weeks and 0.6 (95% CI -0.4 to 1.6) at 8 weeks. Similar negligible effects were observed on pain severity during fast walking or trunk flexion. Negligible effects were also found on physical function, functional mobility, and perceived overall effect, where mean estimates and their confidence intervals all excluded worthwhile effects. No worthwhile benefits could be confirmed for any of the remaining secondary outcomes.

The authors concluded that dry cupping therapy was not superior to sham cupping for improving pain, physical function, mobility, quality of life, psychological symptoms or medication use in people with non-specific chronic low back pain.

These results will not surprise many of us; they certainly don’t baffle me. What I found interesting in this paper was the concept of sham cupping therapy. How did they do it? Here is their explanation:

For the experimental group, a manual suction pump and four acrylic cups size one (internal diameter = 4.5 cm) were used for the interventions. The cups were applied to the lower back, parallel to L1 to L5 vertebrae, with a 3-cm distance between them, bilaterally. The dry cupping application consisted of a negative pressure of 300 millibars (two suctions in the manual suction pump) sustained for 10 minutes once a week for 8 weeks.

In the control group, the exact same procedures were used except that the cups were prepared with small holes < 2 mm in diameter to release the negative pressure in approximately 3 seconds. Double-sided adhesive tape was applied to the border of the cups in order to keep them in contact with the participants’ skin.

So, sham-controlled trials of cupping are doable. Future trialists might now consider the inclusion of testing the success of patient-blinding when conducting trials of cupping therapy.

Always on the lookout for so-called alternative medicine (SCAM) that we have not yet covered on this blog, I came across a really weird one. ‘Access Consciousness’ (AC) is claimed to be a form of self-improvement therapy based on the idea that you are not wrong, that you know, and that consciousness can shift anything. It gives you access to the possibilities that exist when you no longer stick yourself and no longer believe that you are stuck. [1] Gary Douglas ([pictured below] “bestselling author, international speaker and business innovator”) pioneered this set of transformational tools in the 1990s. His work is claimed to have now spread to more than 170 countries and is claimed to have transformed the lives of tens of thousands of people.

Access Consciousness allegedly empowers people to help themselves. The techniques of AC focus on your knowledge about yourself and the world around you. Part of what makes AC so different, according to its promoters, is that it is continuously being created. [2] AC promises to assist people with their health, weight, money, sex, relationships, anxiety, etc. It promises members, known as ‘Accessories,’ to become more conscious. To fully get it, Accessories should take part in classes. There they have 32 points on their heads lightly touched which is supposed to help them let go of all the thoughts, ideas, and emotions stored in any lifetime. Accessories are claimed to be able to “uncreate” memories of the past, or preconceived ideas picked up throughout a lifetime. As far as I can see, there is no evidence to suggest that AC is effective.

Some ex-members have alleged that AC is a “scam cooked up by a conman to rinse the vulnerable of their savings, a Scientology knock-off, and even a cult”. One ex-Accessory, for instance, claimed the group “programs its members to think like robots. It is very clever how it is done. Because it’s not like any other cult but it is mind control.” [3] In each 90-minute session, which costs up to US$ 300, 5,000 to 10,000 years of “limitations” are released, it is claimed.

My conclusion: there is no evidence that AC is plausible or effective and it is a SCAM and possibly also a cult.

[1] About Access Consciousness | Dr. Dain Heer (drdainheer.com)

[2] About Access Consciousness | Access Consciousness

[3] ‘Scientology knock-off’: Whistleblower exposes ‘cult’ that thinks ‘children are sexy’ (EXCLUSIVE) — RT UK News

Bloodletting therapy (BLT) has been widely used for centuries until it was discovered that it is not merely useless for almost all diseases but also potentially harmful. Yet in so-called alternative medicine (SCAM) BLT is still sometimes employed, for instance, to relieve acute gouty arthritis (AGA). This systematic review aimed to evaluate the feasibility and safety of BLT in treating AGA.

Seven databases were searched from the date of establishment to July 31, 2020, irrespective of the publication source and language. BLT included fire needle, syringe, three-edged needle, and bloodletting followed by cupping. The included articles were evaluated for bias risk by using the Cochrane risk of bias assessment tool.

Twelve studies involving 894 participants were included in the final analysis. A meta-analysis suggested that BLT was highly effective in relieving pain (MD = -1.13, 95% CI [-1.60, -0.66], P < 0.00001), with marked alterations in the total effective (RR = 1.09, 95% [1.05, 1.14], P < 0.0001) and curative rates (RR = 1.37, 95%CI [1.17, 1.59], P < 0.0001). In addition, BLT could dramatically reduce serum C-reactive protein (CRP) level (MD = -3.64, 95%CI [-6.72, -0.55], P = 0.02). Both BLT and Western medicine (WM) produced comparable decreases in uric acid (MD = -18.72, 95%CI [-38.24, 0.81], P = 0.06) and erythrocyte sedimentation rate (ESR) levels (MD = -3.01, 95%CI [-6.89, 0.86], P = 0.13). Lastly, we demonstrated that BLT was safer than WM in treating AGA (RR = 0.36, 95%CI [0.13, 0.97], P = 0.04).

The authors concluded that BLT is effective in alleviating pain and decreasing CRP level in AGA patients with a lower risk of evoking adverse reactions.

This conclusion is optimistic, to say the least. There are several reasons for this statement:

  • All the primary studies came from China (and we have often discussed that such trials need to be taken with a pinch of salt).
  • All the studies had major methodological flaws.
  • There was considerable heterogeneity between the studies.
  • The treatments employed were very different from study to study.
  • Half of all studies failed to mention adverse effects and thus violate medical ethics.

I came across this article via a German secondary report about it entitled “Scientists discover what else protects from severe symptoms” (Forscher finden heraus, was noch vor schweren Symptomen schützt). The article rightly stressed that vaccination is paramount and then explains that, once you have caught COVID, nutrition can prevent serious symptoms.

Even though I rarely discuss standard nutritional issues on my blog (nutrition belongs to mainstream not so-called alternative medicine [SCAM], in my view), this subject did attract my attention. Here are the essentials of the original scientific paper:

Australian scientists studied the association between habitual frequency of food intake of certain food groups during the COVID-19 pandemic and manifestations of COVID-19 symptoms in adult outpatients with suspected SARS-CoV-2 infection. They included 236 patients who attended an outpatient clinic for suspected COVID-19 evaluation. Severity of symptoms, habitual food intake frequency, demographics and Bristol chart scores were obtained before diagnostic confirmation with real-time reverse transcriptase PCR using nasopharyngeal swab.

The results of the COVID-19 diagnostic tests were positive for 103 patients (44%) and negative for 133 patients (56%). In the SARS-CoV-2-positive group, symptom severity scores had significant negative correlations with the habitual intake frequency of specific food groups. Multivariate binary logistic regression analysis adjusted for age, sex, and occupation confirmed that SARS-CoV-2-positive patients showed a significant negative association between having higher symptom severity and the habitual intake frequency of legumes and grains, bread, and cereals.

The authors concluded that an increase in habitual frequency of intake of ‘legumes’, and ‘grains, bread and cereals’ food groups decreased overall symptom severity in patients with COVID-19. This study provides a framework for designing a protective diet during the COVID-19 pandemic and also establishes a hypothesis of using a diet-based intervention in the management of SARS-CoV-2 infection, which may be explored in future studies.

So, the authors seem to think that they found a causal relationship: A CHANGE IN DIET DECREASES SYMPTOMS. In different sections of the article, they seem to confirm this notion, and they state that they tested the hypothesis of the effect of diet on SARS-CoV-2 infection symptom severity.

Yey, the investigation was merely a correlative study that cannot establish cause and effect. There are many other variables that might be linked to dietary habits which could be the true cause of the observed phenomenon (or contributors to it).

What’s the harm? If the article makes people adopt a healthier diet, all is pukka!

Perhaps, in this case, that might be true (even though one could argue that this paper might support anti-vax notions arguing that vaccination is not important if it is possible to prevent severe symptoms through dietary changes). But the confusion of correlation with causality is both frequent and potentially harmful. And it is unquestionably poor science!

I feel that we need to be concerned about the fact that even reputable journals let such things pass – not least because the above example shows what the popular press subsequently can make of such misleading messages.

 

Aromatherapy, the use of essential oils for medicinal purposes, exists in several guises. One of them is inhalation aromatherapy which is a complementary therapy used in different clinical settings. But is there any sound evidence about its effectiveness?

The aim of this review was to assess the effectiveness of inhalational aromatherapy in the care of hospitalized pediatric patients.

A systematic review of clinical trials and quasi-experimental studies was conducted, based on PRISMA recommendations, searching Medline, Web of ScienceScopus, SciELO, LILACS, CINAHLScience Direct, EBSCO, and updated databases. The Down and Black 2020, RoB 2020 CLARITY, and ROBINS-I 2020 scales were used through the Distiller SR software to verify the studies’ internal validity and risk of bias.

From 446 articles identified, 9 fulfilled the inclusion criteria. Seven were randomized controlled trials (RCTs), one pilot RCT, and one non-randomized quasi-experimental trial.

Different outcomes were analyzed, with pain being the most frequently measured variable. None of the 6 studies that evaluated pain showed significant effects with inhalation aromatherapy. Additionally, non-significant effects were found regarding nausea, vomiting, and behavioral/emotional variables.

The authors concluded that the findings are still inconclusive, and more evidence is required from future studies with high methodological quality, blinding, and adequate sample sizes.

Inconclusive?

Really?

Call me a skeptic, but I think the findings show quite clearly that there is no sound evidence to suggest that inhalation aromatherapy might be effective for kids.

Lian gong (LG), also called Lian Gong Shi Ba Fa, is a form of so-called alternative medicine (SCAM) from China.  More specifically, it is a set of stretching, breathing exercises, and self-massaging techniques aimed at preventing and relieving stress as well as acute pains around the neck, shoulders, back, hips, legs, joints, and connective tissues.  Even though it is relatively new, it is based on old Chinese stretching, breathing, and warm-up exercises dating back more than 1,000 years, including the Eight Silk Brocade (八段錦).  Lian gong has spread rapidly from China to other countries, especially to Japan and Brazil.

Lian Gong was developed by Dr. Zhuang Yuan Ming (1919- ), a traditional Chinese medical doctor, who started conducting a series of clinical trials around 1974 in a Shanghai hospital on patients suffering from a variety of stress-related conditions. Lian Gong is now being promoted as “massage in motion”.

One of the few controlled clinical studies of Liam gong aimed to evaluate the effects of LG on the impact of dizziness on the quality of life and fear of falling in primary health care patients. It was designed as a randomized clinical trial with 36 patients with dizziness not caused by central changes. The participants were randomly assigned to 3 groups:

  • the Liam gong (LG) group ( n = 11),
  • the vestibular rehabilitation (VR) group ( n = 11),
  • the control group ( n = 14).

The treatments were carried out over a period of 12 weeks.

Lian gong reduced the influence of dizziness on the quality of life in physical (1.8 points, 95% confidence interval [CI]: 0.2-3.4), functional (4.0 points, 95% CI: 2.1-5.9), and emotional domains of quality of life (4.4 points, 95% CI: 1.7-7.2), with no differences, compared with VR.

The authors concluded that Lian gong was shown to be an effective balance rehabilitation strategy to reduce the impact of dizziness on quality of life, with similar results to those of VR.

Unfortunately, this study has many flaws – not least its minute sample size. Therefore, the conclusions seem more than a little over-optimistic. I would not be all that surprised to learn that these exercises can have beneficial effects for a range of conditions. What seems doubtful in my view, however, is whether it is superior to more conventional exercise therapies.

This review investigated whether mind-body therapies are effective for relieving cancer-related pain in adults, since at least one-third of adults with cancer are affected by moderate or severe pain.

The authors searched for all randomized or quasi-randomized controlled trials that included adults (≥18 years) with cancer-related pain who were treated with:

  • mindfulness,
  • hypnosis,
  • yoga,
  • guided imagery,
  • progressive muscle relaxation.

The primary outcome was pain intensity.

A total of 40 primary studies involving 3569 participants were found. The meta-analysis included 24 studies (2404 participants) and showed a significant effect of -0.39 (95% CI -0.62 to -0.16) with considerable heterogeneity (I2 = 86.3%, p < 0.001). After excluding four “outlier” studies in sensitivity analyses, the effect size remained significant but became weaker. There was a high risk of bias in all studies, for example, performance bias due to lack of participant blinding. Patients in multiple settings were included but many studies were of low quality.

The authors concluded that mind-body therapies may be effective in improving cancer pain, but the quality of the evidence is low. There is a need for further high-quality clinical trials.

These conclusions are broadly correct. I can confirm this because I recently summarized the evidence in a book and arrived at very similar conclusions. If I had to criticize the review, it would be for not including all mind-body therapies for which there is evidence from clinical trials. In my book, I was able to include the following additional treatments:

  • Autogenic training
  • Music therapy
  • Qigong
  • Tai chi

The effects of these treatments are about the same regardless of which one we use. This might lead us to suspect that they work not via specific but via non-specific effects, e.g. placebo.

Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving an inert sugar pill with no activity of its own. Intuitively, we think that such treatments must be ineffective. Yet, there have been several studies that seemed to show otherwise.

The objective of this paper was to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and 13 studies were included in the systematic review. Eleven trials were eligible for meta-analysis.

These trials assessed the effects of OLPs on

  • back pain,
  • cancer-related fatigue,
  • attention deficit hyperactivity disorder,
  • allergic rhinitis,
  • major depression,
  • irritable bowel syndrome,
  • menopausal hot flushes.

The risk of bias was moderate among all studies.

Click to enlarge.

A significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions. Yet, the researchers spotted several caveats and discuss them in some detail.

First, we detected hints of a publication bias in the study sample, but the respective test was not significant. The quantitative basis of the meta-analysis is based on a small number of studies, reflecting the early state of research in this field. Moreover, the set of studies showed some heterogeneity. Finally, four studies were rated to have a high risk of bias, and nine to have some concerns.

In order to assess the impact of these high-risk studies we performed an exploratory best-evidence synthesis. We excluded the four studies with a high risk of bias. In this analysis, the heterogeneity could be reduced to a non-critical value and almost all variance in the set of studies could be explained by a sampling error (I2 = 4%). With the exclusion of these four studies the mean effect size was reduced to a more conservative SMD = 0.49.

Regardless of this reduction of the overall effect, the same conclusions about the treatment-effect of OLPs can be drawn, although the lack of robustness means that interpretations require some caution. The decrease of heterogeneity shows that methodological impairments might be responsible for the considerable unexplained variance in our results. We abstained from carrying out a further sensitivity analysis for explaining heterogeneity because of the small number of studies.

This is certainly an interesting subject. And the above findings are certainly counter-intuitive.

My impression is that the effect of OLPs is small and of doubtful value in clinical practice. My prediction is that, as more and better research emerges, it will diminish further, if not vanish totally. I think that there are several reasons for this:

  • The number of trials is still quite small.
  • The studies obviously lack patient blinding.
  • Positive messages can be included alongside open-label placebos.
  • The “time lag bias” is high.

This type of bias means that, due to initial enthusiasm in a new subject, negative results are published with some delay. I have observed this bias repeatedly in the past. A new treatment initially tends to generate nothing but positive results, and only after a while, when the researchers’ euphoria has subsided, more realistic findings emerge.

Psychosocial distress, depression, or anxiety are frequent problems of women after a breast cancer diagnosis and treatment. Many try so-called alternative medicine (SCAM) in an attempt to deal with them. But is this effective?

The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction.

This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or a placebo (coconut oil) throughout their period of hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards-Campbell Sleep Questionnaire, and the visual analogue scale.

Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression, sleep, or pain scores. No adverse events were noted, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores, while depression scores were significantly higher postoperatively as compared with preoperatively.

The authors concluded that, in the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

One could argue that the sample size of the trial was too low to pick up small differences in the outcome measures. Yet, even then, the findings do not suggest that the treatment did make a large enough difference to justify the effort and expense of the treatment.

One could also argue that – who cares? – if a patient wants aromatherapy (or another SCAM that is harmless), why not? The answer to this is the fact that researchers have the ethical duty to identify the most effective treatment, and clinicians have the ethical duty to employ not just any odd therapy but the one that works demonstrably best. Seen from this perspective, the place of SCAM in cancer care seems far less certain than many enthusiasts try to make us believe.

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