MD, PhD, FMedSci, FSB, FRCP, FRCPEd

clinical trial

Tui Na is a massage technique that is based on the Taoist principles of TCM. It involves a range of manipulations usually performed by an operator’s finger, hand, elbow, knee, or foot applied to muscle or soft tissue at specific parts of the body. According to one website of TCM-proponents “Tui Na makes use of various hand techniques in combination with acupuncture and other manipulation techniques. To enhance the healing process, the practitioner may recommend the use of Chinese herbs. Many of the techniques used in this massage resemble that of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing and shaking. In Tui Na massage, the muscles and tendons are massaged with the help of hands, and an acupressure technique is applied to directly affect the flow of Qi at different acupressure points of the body, thus facilitating the healing process. It removes the blockages and keeps the energy moving through the meridians as well as the muscles. A typical session of Tui Na massage may vary from thirty minutes to an hour. The session timings may vary depending on the patient’s needs and condition. The best part of the therapy is that it relaxes as well as energizes the person. The main benefit of Tui Na massage is that it focuses on the specific problem, whether it is an acute or a chronic pain associated with the joints, muscles or a skeletal system. This technique is very beneficial in reducing the pain of neck, shoulders, hips, back, arms, highs, legs and ankle disorders. It is a very effective therapy for arthritis, pain, sciatica and muscle spasms. Other benefits of this massage therapy include alleviation of the stress related disorders like insomnia, constipation, headaches and other disorders related to digestive, respiratory and reproductive systems. The greatest advantage of Tui Na is that it focuses on maintaining overall balance with both physical and mental health. Any one who wants to avoid the side effects of drugs or a chemical based treatment can adopt this effective massage technique to alleviate their pain. Tui Na massage therapy is now becoming a more common therapy method due to its focus on specific problems rather than providing a general treatment.”

This clearly begs the question IS IT EFFECTIVE?

This systematic review assessed the evidence of Tui Na for cervical radiculopathy. Seven databases were searched. Randomised controlled trials (RCTs) incorporating Tui Na alone or Tui Na combined with conventional treatment were included. Five studies involving 448 patients were found. The pooled analysis from the 3 trials indicated that Tui Na alone showed a significant lowering immediate effects on pain score with moderate heterogeneity compared to cervical traction. The meta-analysis from 2 trials revealed significant immediate effects of Tui Na plus cervical traction in improving pain score with no heterogeneity compared to cervical traction alone. None of the RCTs mentioned adverse effects. There was very low quality or low quality evidence to support the results.

The authors concluded that “Tui Na alone or Tui Na plus cervical traction may be helpful to cervical radiculopathy patients, but supportive evidence seems generally weak. Future clinical studies with low risk of bias and adequate follow-up design are recommended.”

In my view, this is a misleading conclusion. A correct one would have been: THE CURRENT EVIDENCE IS INSUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE EFFECTIVENESS OF TUI NA.

Why?

Here are some of the most obvious reasons:

Personally, I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.

Drug and alcohol dependencies are notoriously difficult to treat effectively. Patients and their families are often desperate and willing to try anything. This seems like an ideal ground for acupuncturists who are, in my experience, experts in putting up smokescreens hiding the true value of their treatment.

The best way to determine the value of any intervention is probably conducting a systematic review of the evidence from rigorous clinical trials. Today we are in the fortunate position to have not just one of those articles; but do they really tell us the truth?

This brand-new systematic review investigated the effects of acupuncture on alcohol-related symptoms and behaviors in patients with this disorder. The PubMed database was searched until 23 August 2016, and reference lists from review studies were also reviewed. The inclusion criteria were the following: (1) being published in a peer-reviewed English-language journal, (2) use of randomized controlled trials (RCTs), (3) assessing the effects of acupuncture on psychological variables in individuals with a primary alcohol problem, and (4) reporting statistics that could be converted to effect sizes.

Seventeen studies were identified for a full-text inspection, and seven (243 patients) of these met our inclusion criteria. The outcomes assessed at the last post-treatment point and any available follow-up data were extracted from each of the studies. Five studies treated patients by inserting a needle into several acupoints in each ear. Two studies stimulated body points with or without ear stimulation. Four studies treated control patients with a placebo needle or under a completely different type of intervention, such as relaxation or transdermal stimulation, whereas the remaining studies inserted needles into nonspecific points. The patients were treated for 2 weeks to 3 months, and the treatment duration per session was 15–45 min. The results of the meta-analysis demonstrated that an acupuncture intervention had a stronger effect on reducing alcohol-related symptoms and behaviours than did the control intervention. A beneficial but weak effect of acupuncture treatment was also found in the follow-up data.

The authors concluded that although our analysis showed a significant difference between acupuncture and the control intervention in patients with alcohol use disorder, this meta-analysis is limited by the small number of studies included. Thus, a larger cohort study is required to provide a firm conclusion.

I am used to reading poor research papers, but this one is like a new dimension. Here are just the most obvious flaws:

  • by searching just one database, the likelihood of missing studies is huge,
  • by excluding non-English papers, the review automatically becomes non-systematic,
  • the included studies differed vastly in many respects and can therefore not be pooled.

As it happens, a further meta-analysis has just been published. Here is its abstract:

Acupuncture has been widely used as a treatment for alcohol dependence. An updated and rigorously conducted systematic review is needed to establish the extent and quality of the evidence on the effectiveness of acupuncture as an intervention for reducing alcohol dependence. This review aimed to ascertain the effectiveness of acupuncture for reducing alcohol dependence as assessed by changes in either craving or withdrawal symptoms.

Methods

In this systematic review, a search strategy was designed to identify randomised controlled trials (RCTs) published in either the English or Chinese literature, with a priori eligibility criteria. The following English language databases were searched from inception until June 2015: AMED, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and PubMed; and the following Chinese language databases were similarly searched: CNKI, Sino-med, VIP, and WanFang. Methodological quality of identified RCTs was assessed using the Jadad Scale and the Cochrane Risk of Bias tool.

Results

Fifteen RCTs were included in this review, comprising 1378 participants. The majority of the RCTs were rated as having poor methodological rigour. A statistically significant effect was found in the two primary analyses: acupuncture reduced alcohol craving compared with all controls (SMD = −1.24, 95% CI = −1.96 to −0.51); and acupuncture reduced alcohol withdrawal symptoms compared with all controls (SMD = −0.50, 95% CI = −0.83 to −0.17). In secondary analyses: acupuncture reduced craving compared with sham acupuncture (SMD = −1.00, 95% CI = −1.79 to −0.21); acupuncture reduced craving compared with controls in RCTs conducted in Western countries (SMD = −1.15, 95% CI = −2.12 to −0.18); and acupuncture reduced craving compared with controls in RCTs with only male participants (SMD = −1.68, 95% CI = −2.62 to −0.75).

Conclusion

This study showed that acupuncture was potentially effective in reducing alcohol craving and withdrawal symptoms and could be considered as an additional treatment choice and/or referral option within national healthcare systems.

This Meta-analysis is only a little better than the first, I am afraid. What its conclusions do not sufficiently reflect, in my view, is the fact that the quality of the primary studies was mostly very poor – too poor to draw conclusions from (other than ‘acupuncture research is usually lousy’; see figure below). Therefore, I fail to see how the authors could draw the relatively firm and positive conclusions cited above. In my view, they should have stated something like this: DUE TO THE RISK OF BIAS IN MANY TRIALS, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.

The authors of the first meta-analysis open the discussion by proudly declaring that “the present study is the first meta-analysis to examine the effect of acupuncture treatment on patients with alcohol use disorder and to provide data on the magnitude of this effect on alcohol-related clinical symptoms and behaviours.” They discretely overlook this meta-analysis from 2009 (and several others which even their rudimentary search would have identified):

Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook.

Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal.

The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues.

One does not need to be an expert in interpreting meta-analyses, I think, to see that this paper is more rigorous than the new ones (which incidentally were published in the very dubious journals). And this is why I trust the conclusions of this last-named meta-analysis more than those of the new one: the efficacy of acupuncture remains unproven. And this means that we should not employ or promote it for routine care.

How Jackfruit Kills Cancer… This title hardly left any doubt that jackfruit (Artocarpus heterophyllus Lam) is effective in curing cancer. The website continued in this vein:

“Jackfruit contains phytonutrients like lignans, saponins, and isoflavones, which have anticancer, antihypertensive, anti-ulcer, antioxidant, and anti-aging properties (2).

Lignans are tissue-selective phytoestrogens that have anti-estrogenic effects in reproductive tissues that can be beneficial in preventing the hormone-associated cancers of the breast, uterus, ovary, and prostate. It may also help maintain bone density (3).

Isoflavones are also beneficial phytoestrogens that have been proven to reduce the risk of breast, endometrial, and prostate cancers (4,5).

Saponins, on the other hand, kill cancer cells by directly binding to cells as well as boosting white blood cell activity and preventing cell differentiation and proliferation (6,7).

Hình ảnh có liên quan

Lastly, the cancer-preventing abilities of the fruit are due in part to dietary TF-binding lectins (8). The pulp has the ability to reduce the mutagenicity of carcinogens and combat the proliferation of cancer cells (9).

In addition, the fruit contains carotenoids, flavonoids, and polyphenols that lower blood pressure, fight stomach ulcers, boost metabolism, support nerve function, and play a role in hormone synthesis. They also contain polysaccharides that boost immunity by interacting with white blood cells, including T cells, monocytes, macrophages, and polymorphonuclear lymphocytes (10).

Each part of the fruit and tree can be used: the flowers help stop bleeding in open wounds, prevent ringworm infestations, and heal cracks in dry feet while the root is used to treat skin diseases, asthma, and diarrhea. Additionally, the wood has a sedative and abortifacient effect…”

END OF QUOTE

To many desperate cancer patients, this would sound convincing, not least because the references provided by the author look sophisticated and seem to back up most of the claims made.

But where are the references to clinical trials showing that jackfruit does cure this or that type of cancer? Where is the evidence that it does “lower blood pressure, fight stomach ulcers, boost metabolism, support nerve function, and play a role in hormone synthesis”? Where are the data to prove that it does “boost immunity”?

I did conduct a ‘rough and ready’ Medline search and found precisely nothing; not a single clinical trial that would confirm the multiple claims made above.

You are not surprised?

Neither am I!

But what about the desperate cancer patients?

How many fell for the scam? How many gave up their conventional cancer treatments and used jackfruit instead? How many consumers know that it is not unusual for plants to contain lignans, saponins, isoflavones and many other ingredients that have amazing effects in vitro? How many know that this rarely translates into meaningful health effects in human patients?

We will never know.

One thing we do know, however, is that articles like this one can cost lives, and that alternative cancer cures are and always will be a myth.

It was a BBC journalist who alerted me to this website (and later did an interview to be broadcast today, I think). Castle Treatments seem to have been going already for 12 years; they specialise in treating drug and alcohol dependency. And they are very proud of what they have achieved:

“We are the U.K.’s leading experts in advanced treatments to help clients to stop drinking, stop cocaine use and stop drug use. Over the last 12 years we have helped over 9,000 private clients stop using: alcohol, cocaine, crack, nicotine, heroin, opiates, cannabis, spice, legal highs and other medications…

All other treatment methods to help people stop drinking or stop using drugs have a high margin for error and so achieve very low success rates as they use ‘slow and out-dated methods’ such as talking therapies (hypnosis, counselling, rehab, 12 steps, CBT etc) or daily medications (pharma meds, sprays, opiates, subutex etc) which don’t work for most people or most of the time.

This is because none of these methods can remove the ’cause’ of the problem which is the ‘frequency of the substance’ itself. The phase signal of the substance maintains the craving or desire for that substance, once neutralised the craving/desire has either gone or is greatly diminished therefore making it much easier to stop drinking or using drugs as per the client feedback.
When compared to any other method there is no doubt our treatments produce the best results. Over the last 12 years we have helped over 9,000 clients the stop drinking, stop cocaine use or stop using drugs with excellent results as each client receives exactly the same treatment program tailored to their substance(s) which means our success rates are consistently high, making our advanced treatment the logical and natural choice when you want help.

Our technicians took basic principles in physics and applied them to new areas to help with addiction and dependency issues. Our treatment method uses specific phase signals (frequency) to help:

  • neutralise any substance and reduce physical dependency
  • improve and restore physical & mental health

When the substance is neutralised, the physical urge or craving has ‘gone or is greatly diminished’ therefore making it much easier to stop drinking or using drugs. The body can also absorb beneficial input frequencies so physically and mentally our clients feel much better and so find it much easier to ‘stop and regain control’…

The body (muscle, tissue, bones, cells etc) radiate imbalances including disease, physical, emotional and psychological conditions which have their own unique frequencies that respond to various ‘beneficial input frequencies’ (Hz) or ‘electroceuticals’ which can help to improve physical and mental health hence why our clients feel so much better during/after treatment…”

END OF QUOTE

Sounds interesting?

Not really!

To me this sounds like nonsense on stilts.

Bioresonance is, as far as I can see, complete baloney. It originates from Germany and uses an instrument that is not dissimilar to the e-meter of scientology (its inventor had links to this cult). This instrument is supposed to pick up unhealthy frequencies from the body, inverses them and thus treats the root cause of the problem.

There are two seemingly rigorous positive studies of bioresonance. One suggested that it is effective for treating GI symptoms. This trial was, however, tiny. The other study suggested that it works for smoking cessation. Both of these articles appeared in a CAM journal and have not been independently replicated. A further trial published in a conventional journal reported negative results. In 2004, I published an article in which I used the example of bioresonance therapy to demonstrate how pseudo-scientific language can be used to cloud important issues. I concluded that it is an attempt to present nonsense as science. Because this misleads patients and can thus endanger their health, we should find ways of minimizing this problem (I remember being amazed that a CAM journal published this critique). More worthwhile stuff on bioresonance and related topics can be found here, here and here.

There is no good evidence that bioresonance is effective for drug or alcohol dependency (and even thousands of testimonials do not amount to evidence: THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!!!). Claiming otherwise is, in my view, highly irresponsible. If I then consider the fees Castle Treatments charge (Alcohol Support: Detox 1: £2,655.00, Detox 2: £3,245.00, Detox 3: £3,835.00) I feel disgusted and angry.

I hope that publishing this post somehow leads to the closure of Castle Treatments and similar clinics.

The title of the press-release was impressive: ‘Columbia and Harvard Researchers Find Yoga and Controlled Breathing Reduce Depressive Symptoms’. It certainly awoke my interest and I looked up the original article. Sadly, it also awoke the interest of many journalists, and the study was reported widely – and, as we shall see, mostly wrongly.

According to its authors, the aims of this study were “to assess the effects of an intervention of Iyengar yoga and coherent breathing at five breaths per minute on depressive symptoms and to determine optimal intervention yoga dosing for future studies in individuals with major depressive disorder (MDD)”.

Thirty two subjects were randomized to either the high-dose group (HDG) or low-dose group (LDG) for a 12-week intervention of three or two intervention classes per week, respectively. Eligible subjects were 18–64 years old with MDD, had baseline Beck Depression Inventory-II (BDI-II) scores ≥14, and were either on no antidepressant medications or on a stable dose of antidepressants for ≥3 months. The intervention included 90-min classes plus homework. Outcome measures were BDI-II scores and intervention compliance.

Fifteen HDG and 15 LDG subjects completed the intervention. BDI-II scores at screening and compliance did not differ between groups. BDI-II scores declined significantly from screening (24.6 ± 1.7) to week 12 (6.0 ± 3.8) for the HDG (–18.6 ± 6.6; p < 0.001), and from screening (27.7 ± 2.1) to week 12 (10.1 ± 7.9) in the LDG. There were no significant differences between groups, based on response (i.e., >50% decrease in BDI-II scores; p = 0.65) for the HDG (13/15 subjects) and LDG (11/15 subjects) or remission (i.e., number of subjects with BDI-II scores <14; p = 1.00) for the HDG (14/15 subjects) and LDG (13/15 subjects) after the 12-week intervention, although a greater number of subjects in the HDG had 12-week BDI-II scores ≤10 (p = 0.04).

The authors concluded that this dosing study provides evidence that participation in an intervention composed of Iyengar yoga and coherent breathing is associated with a significant reduction in depressive symptoms for individuals with MDD, both on and off antidepressant medications. The HDG and LDG showed no significant differences in compliance or in rates of response or remission. Although the HDG had significantly more subjects with BDI-II scores ≤10 at week 12, twice weekly classes (plus home practice) may rates of response or remission. Although the HDG, thrice weekly classes (plus home practice) had significantly more subjects with BDI-II scores ≤10 at week 12, the LDG, twice weekly classes (plus home practice) may constitute a less burdensome but still effective way to gain the mood benefits from the intervention. This study supports the use of an Iyengar yoga and coherent breathing intervention as a treatment to alleviate depressive symptoms in MDD.

The authors also warn that this study must be interpreted with caution and point out several limitations:

  • the small sample size,
  • the lack of an active non-yoga control (both groups received Iyengar yoga plus coherent breathing),
  • the supportive group environment and multiple subject interactions with research staff each week could have contributed to the reduction in depressive symptoms,
  • the results cannot be generalized to MDD with more acute suicidality or more severe symptoms.

In the press-release, we are told that “The practical findings for this integrative health intervention are that it worked for participants who were both on and off antidepressant medications, and for those time-pressed, the two times per week dose also performed well,” says The Journal of Alternative and Complementary Medicine Editor-in-Chief John Weeks

At the end of the paper, we learn that the authors, Dr. Brown and Dr. Gerbarg, teach and have published Breath∼Body∼Mind©, a technique that uses coherent breathing. Dr. Streeter is certified to teach Breath∼Body∼Mind©. No competing financial interests exist for the remaining authors.

Taking all of these issues into account, my take on this study is different and a little more critical:

  • The observed effects might have nothing at all to do with the specific intervention tested.
  • The trial was poorly designed.
  • The aims of the study are not within reach of its methodology.
  • The trial lacked a proper control group.
  • It was published in a journal that has no credibility.
  • The limitations outlined by the authors are merely the tip of an entire iceberg of fatal flaws.
  • The press-release is irresponsibly exaggerated.
  • The authors have little incentive to truly test their therapy and seem to use research as a means of promoting their business.

A recently published study was aimed at evaluating the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). This 24-week, randomized, double-blind, placebo-controlled trial included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score≥5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI).

The EAPP global score (VAS: range 0 to 50) decreased by 12.82 in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28;), non-cyclic pelvic pain (2.71), and cyclic bowel pain (3.40). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). The placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen.

The authors concluded that potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.

The study is unusual in several ways. For instance, contrary to most trials of homeopathy, its protocol had been published in ‘Homeopathy’ in August 2016. Here is the abstract:

BACKGROUND:

Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic pain. Thus being, many patients seek help in complementary and alternative medicine, including homeopathy. The effectiveness of homeopathic treatment for endometriosis is controversial due to the lack of evidences in the literature. The aim of the present randomized controlled trial is to assess the efficacy of potentized estrogen compared to placebo in the treatment of chronic pelvic pain associated with endometriosis.

METHODS/DESIGN:

The present is a randomized, double-blind, placebo-controlled trial of a homeopathic medicine individualized according to program ‘New Homeopathic Medicines: use of modern drugs according to the principle of similitude’ (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to the adverse events caused by estrogen were recruited at the Endometriosis Unit of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HCFMUSP). The participants were selected based on the analysis of their medical records and the application of self-report structured questionnaires. A total of 50 women meeting the eligibility criteria will be randomly allocated to receive potentized estrogen or placebo. The primary clinical outcome measure will be severity of chronic pelvic pain. Statistical analysis will be performed on the intention-to-treat and per-protocol approaches comparing the effect of the homeopathic medicine versus placebo after 24 weeks of intervention.

DISCUSSION:

The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016.

END OF QUOTE

As far as I can see, this study has no major flaws (I do not have access, however, to the full article). It seems to suggest that highly diluted homeopathic remedies are efficacious. I am aware of the fact that this will be difficult to accept for many readers of this blog.

So, what should we make of this new trial?

Should we recommend homeopathic estrogen to women suffering from endometriosis? I don’t think so. On the contrary, I recommend a healthy dose of scepticism. Clinical trials can produce false results sometimes by chance or through fraud. In any case, we hardly ever rely on the findings of a single study. The sensible course of action always is to wait for an independent replication (and, of course, study the full text of the paper).

 

One phenomenon that can be noted more frequently than any other in alternative medicine research is that studies arrive at wrong or misleading conclusions. This is more than a little disappointing, not least because it is the conclusion of a trial that is often picked up by health writers and others who in turn mislead the public. On this blog, we must have seen hundreds of examples of this irritating phenomenon. Here is yet another one. This study, a randomized, parallel, open-label exploratory trial, evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. It included patients who suffered from idiopathic tinnitus for more than two weeks were recruited. They were divided into three groups:

  1. systemic manual acupuncture group (MA),
  2. periauricular electroacupuncture group (PE),
  3. distal electroacupuncture group (DE).

Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of 8 sessions over 4 weeks. Outcome measures were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud, and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. In total, 39 subjects were eligible for analysis. No differences in THI and VAS loudness scores were observed between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. The authors concluded that there was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS. Neither of the three treatments tested in this study have been previously proven to work. Therefore, it is quite simply nonsensical to compare them. Comparative studies are indicated only with therapies that have a solid evidence-base. They are called ‘superiority trials’ and require a different statistical approach as well as much larger sample sizes. In other words, this study was an unethical waste of resources from the outset. With this in mind, there is only one conclusion that fits the data: there was no statistically significant difference between the three types of acupuncture. The data are therefore in keeping with the notion that all three are placebos. Alternatively one might conclude more clearly for those who are otherwise resistant to learning a lesson: POORLY DESIGNED CLINICAL TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS.

Dana Ullman is an indefatigable promotor of bogus claims and an unwitting contributor of hilarity. Therefore he has become a regular feature of this blog (see for instance here, here and here). His latest laughable assertion is that lead and other poisonings can be successfully treated with homeopathy.

Just to make sure: lead poisoning is no joke. The greatest risk is to brain development in babies, where irreversible damage can occur. Higher levels can damage the kidneys and nervous system in both children and adults. Very high lead levels may cause seizures, unconsciousness and death.

In view of this, Ullman’s claim is surprising, to say the least. In order to persuade the unsuspecting public of his notion, Ullman first cites a review of basic research on homeopathy and toxins published in Human and Experimental Toxicology. “Of forty high-quality studies, 27 showed positive results from homeopathic treatment”, Ullman states.

Now, now, now Dana!

Has your mom not taught you that telling porkies is forbidden?

Or did you perhaps miss this line in the article’s abstract? “The quality of evidence in these studies was low with only 43% achieving one half of the maximum possible quality score and only 31% reported in a fashion that permitted re-evaluation of the data. Very few studies were independently replicated using comparable models.”

Hardly ‘high quality studies’, wouldn’t you agree?

But this review was of pre-clinical studies; what about the much more important clinical evidence?

Here Ullman cites one trial where a potentized homeopathic remedy, Arsenicum Album 30C, was administered to  55 people who were entered into a double-blind, placebo-controlled trial. According to Ullman, the homeopathically treated group “experienced higher excretion of arsenic in their urine for the first eleven days, compared to those given a placebo.”

Na, na, na, Dana, this is getting serious!!!

Another porky – and not even a little one.

The authors of this study clearly stated that, at the end of the 11-day RCT, there was no significant difference between the homeopathy and the placebo group: “The differences in the concentration between the two groups (drug versus placebo) were generally a little higher during the first week, but subsequently the differences were not so palpable, particularly at the 11th day.” And for those who are a bit slow on the uptake, they even included a graph that makes it abundantly clear.

The only other clinical study cited by Ullman in support of his surprising claim is a double-blind randomized trial which was conducted with 131 workers who suffered lead poisoning at the Ajax battery plant in Bauru, São Paulo State, Brazil. Subjects were prescribed homeopathic doses of lead (Plumbum metallicum 15C) or placebo which they took orally for 35 days. The results of this RCT show that homeopathy is not better than placebo.

So, we seem to have all of two RCTs on the subject (I did a quick Medline-search and also found no further RCTs), and both are negative.

Anyone who is not given to compulsive porky-telling would, I guess, conclude from this evidence that people suffering from lead poisoning should urgently see conventional experts and avoid homeopaths at all costs – not so Dana Ullman who boldly concludes his article with these words:

“As an adjunct to conventional medical treatment, professional homeopathic care is recommended for people who have been exposed (or think they have been exposed) to toxic substances… Even if you do not have a professional homeopath in your town, many homeopathic practitioners “see” their patients via Skype or do consultations over the telephone. Unlike acupuncturists, who put needles in you, or chiropractors, who adjust your spine, homeopaths are not “hands-on”: they simply need to conduct a detailed interview… If your symptoms are serious or potentially serious, it is important to see a professional homeopath and/or physician. While a homeopath will commonly prescribe a safe homeopathic dose of the toxic substance to which one was exposed, the homeopath may instead decide that a different substance more closely matches the patient’s unique symptoms…”

It takes a lot these days to make me speechless but there, Dana, you almost succeeded!

A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.

Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.

A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).

The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.

Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”

The authors were, of course, well advised to be so atypically cautious:

  • Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
  • Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
  • The effect size of the benefit is tiny and of doubtful clinical relevance.

My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.

So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.


You may recall, we have dealt with the JCAM many times before; for instance here, here, here and here. Now they have come out with another remarkable paper. This study – no, the authors called it a ‘pilot study’ – was to compare the efficacy of Emotional Freedom Techniques (EFT) with that of Cognitive-Behavioral Therapy (CBT) in reducing adolescent anxiety. Sixty-three American high-ability students in grades 6–12, ages 10–18 years, who scored in the moderate to high ranges for anxiety on the Revised Children’s Manifest Anxiety Scale-2 (RCMAS-2) were randomly assigned to one of three groups:

  • CBT (n = 21),
  • EFT (n = 21),
  • or waitlist control (n = 21).

EFT is an alternative therapy that incorporates acupoint stimulation. Students assigned to the CBT or EFT treatment groups received three individual sessions of the identified protocols from trained graduate counseling, psychology, or social work students enrolled at a large northeastern research university. The RCMAS-2 was used to assess preintervention and postintervention anxiety levels in participants.

EFT participants showed significant reduction in anxiety levels compared with the waitlist control group with a moderate to large effect size. CBT participants did not differ significantly from the EFT or control.

The authors concluded that EFT is an efficacious intervention to significantly reduce anxiety for high-ability adolescents.

They also state in their abstract that EFT is an evidence-based treatment for anxiety…

Are you happy with these conclusions?

Are you convinced that this trial lends itself to establish efficacy of anything?

Are you impressed with the trial design, the sample size, etc?

Are you sure that EFT is plausible, credible or evidence-based in any way?

No?

Me neither!

If you look up EFT, you will find that there is a surprising amount of papers on it. Most of them have one thing in common: they were published in highly dubious journals. The field does not inspire trust or competence. The authors of the study state that EFT is an easily implemented strategy that uses such techniques as awareness building, exposure, reframing of interpretation, and systematic desensitization, while teaching the participant to self-stimulate protocol-identified acupoints (i.e., acupuncture points) by tapping. The effectiveness of acupuncture for treating anxiety has been well documented. Rather than using acupuncture needles, EFT relies on the manual stimulation of the acupoints. A recent meta-analysis indicated that interventions using acupoint stimulation had a moderate effect size (Hedge’s g = −0.66 95% CI [−0.99, −0.33]) in reducing symptoms. In EFT, the client stimulates the protocol-identified acupoints by tapping on them. Preliminary studies have suggested that tapping and other alternative ways of stimulating acupuncture points to be as effective as acupuncture needling. The EFT protocol and identified acupoints that were used in this study are the ones recommended for research purposes by the Association for Comprehensive Energy Psychology…

Wikipedia tells us that “Emotional Freedom Techniques (EFT) is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy (TFT). It is best known through Gary Craig’s EFT Handbook, published in the late 1990s, and related books and workshops by a variety of teachers. EFT and similar techniques are often discussed under the umbrella term “energy psychology”. Advocates claim that the technique may be used to treat a wide variety of physical and psychological disorders, and as a simple form of self-administered therapy.[1] The Skeptical Inquirer describes the foundations of EFT as “a hodgepodge of concepts derived from a variety of sources, [primarily] the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body.” The existence of this life force is “not empirically supported”.[2] EFT has no benefit as a therapy beyond the placebo effect or any known-effective psychological techniques that may be provided in addition to the purported “energy” technique.[3] It is generally characterized as pseudoscience and it has not garnered significant support in clinical psychology.”

A recent systematic review of EFT concluded that “there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioral therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.”

Notwithstanding these and many other verdicts on EFT, we now are asked to agree with the new study that EFT IS EFFICACIOUS.

Is this a joke?

They want us to believe this on the basis of  a PILOT STUDY? Such studies are not even supposed to test efficacy! (Yet the authors of the trial state that this study was designed to meet the American Psychological Association (APA) Division 12 quality control criteria and the Consolidated Standards for Reporting Trials (CONSORT) criteria. I have to admit, they could have fooled me!)

No, it is not a joke, it is yet another nonsense from the ‘The Journal of Complementary and Alternative Medicine’ which, in my view, should henceforth be called THE JOURNAL OF ALTERNATIVE FACTS (JAF).

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