MD, PhD, FMedSci, FSB, FRCP, FRCPEd

depression

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.

Aromatherapy is popular and pleasant – but does it have real health effects? The last time I tried to find an answer to this question was in 2012. At that time, our systematic review concluded that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.” But 5 years can be a long time in research, and more up-to-date information would perhaps be helpful.

This systematic review of 2017 aimed to provide an analysis of the clinical evidence on the efficacy of aromatherapy specifically for depressive symptoms on any type of patients. The authors searched 5 databases for relevant studies Outcome measures included scales measuring depressive symptoms levels. Twelve randomized controlled trials (RCTs) were included. Aromatherapy was administered by inhalation (5 studies) or massage (7 studies). Seven RCTs showed improvement in depressive symptoms. The quality of half of the studies was low, and the administration protocols varied considerably among the studies. Different assessment tools were employed in the studies. In 6 of the RCTs, aromatherapy was compared to no intervention.

Despite these caveats, the authors concluded that aromatherapy showed potential to be used as an effective therapeutic option for the relief of depressive symptoms in a wide variety of subjects. Particularly, aromatherapy massage showed to have more beneficial effects than inhalation aromatherapy.

Apart from the poor English, this paper is irritating because of the almost total lack of critical input. Given that half of the trials were of poor quality (only one was given the full points on the quality scale) and many totally failed to control for placebo-effects, I think that calling aromatherapy an effective therapeutic option for the relief of depressive symptoms is simply not warranted. In fact, it is highly misleading and, given the fact that depression is a life-threatening condition, it seems unethical and dangerous.

Considering these facts, my conclusion remains that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition, including depression.”

I have blogged about the herbal antidepressant before; for instance about the fact that it can cause potentially dangerous herb-drug interactions. When taken alone, however, it seems to be both safe and efficacious in reducing the symptoms of depression. This notion has just been confirmed yet again.

A new systematic review evaluated St. John’s wort (SJW) for the treatment of Major Depressive Disorder (MDD). The objectives of this review were to (1) evaluate the efficacy and safety of SJW in adults with MDD compared to placebo and active comparator and (2) evaluate whether the effects vary by severity of MDD.

The authors searched 9 electronic databases and existing reviews to November 2014. Two independent reviewers screened the citations, abstracted the data, and assessed the risk of bias. They included randomized controlled trials (RCTs) examining the effect of at least a 4-week administration of SJW on depression outcomes against placebo or active comparator in adults with MDD. Risk of bias was assessed using the Cochrane Risk of Bias tool and USPSTF criteria. Quality of evidence (QoE) was assessed using the GRADE approach.

Thirty-five studies examining 6993 patients met inclusion criteria; 8 studies evaluated a SJW extract that combined 0.3 % hypericin and 1-4 % hyperforin. SJW was associated with more treatment responders than placebo (relative risk [RR] 1.53; 95 % confidence interval [CI] 1.19, 1.97; I(2) 79 %; 18 RCTs; N = 2922, moderate QoE; standardized mean differences [SMD] 0.49; CI 0.23, 0.74; 16 RCTs; I(2) 89 %, N = 2888, moderate QoE). Compared to antidepressants, SJW participants were less likely to experience adverse events (OR 0.67; CI 0.56, 0.81; 11 RCTs; moderate QoE) with no difference in treatment effectiveness (RR 1.01; CI 0.90, 1.14; 17 RCTs, I(2) 52 %, moderate QoE; SMD -0.03; CI -0.21, 0.15; 14 RCTs; I(2) 74 %; N = 2248, moderate QoE) in mild and moderate depression.

The authors concluded that SJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence. Adverse events reported in RCTs were comparable to placebo and fewer compared with antidepressants. However, assessments were limited due to poor reporting of adverse events and studies were not designed to assess rare events. Consequently, the findings should be interpreted with caution.

This is an excellent review from a reputable and independent team. The findings are therefore trustworthy.

Does that mean that we can now recommend SJW for patients suffering from depression?

Perhaps – but we need to keep an eye on the interaction issue. As a sole treatment, SJW is much safer than conventional antidepressants. But if a patient takes other medicines, we ought to be very careful.

Other currently unresolved issues are the questions of which extract and which dose. At present, there is not enough evidence to provide conclusive answers to either of these, and therefore the enthusiasm of many doctors for prescribing SJW is understandably limited.

Irrespective of these problems, I have to say that SJW is without question one of the biggest ‘success stories’ from the realm of alternative medicine. Pity that there are not more of them!

A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:

1. Addiction recovery

Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.

2. Helps the body heal itself

The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.

3. Builds a stronger immune system

The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.

4. Eliminate that killer hangover

While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.

5. Mood stabilizer

If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.

6. Chronic stomach problems

Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.

7. Coping with death

Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.

END OF QUOTE

The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:

  1. There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation.  There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
  2. Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
  3. Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
  4. Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
  5. The same applies to acupuncture to ‘stabilize’ your mood.
  6. Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
  7. I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.

So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!

Why?

Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!

IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE

  1. Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
  2. ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
  3. Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
  4. Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
  5. For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
  6. The claim of acupuncturists that acupuncture is entirely safe is false.
  7. Acupuncture studies from China cannot be trusted.

The ACUPUNCTURE NOW FOUNDATION (ANF) have recently published a document that is worth drawing your attention to. But first I should perhaps explain who the ANF are. They state that “The Acupuncture Now Foundation (ANF) was founded in 2014 by a diverse group of people from around the world who were concerned about common misunderstandings regarding acupuncture and wanted to help acupuncture reach its full potential. Our goal is to become recognized as a leader in the collection and dissemination of unbiased and authoritative information about all aspects of the practice of acupuncture.”

This, I have to admit, sounds like music to my ears! So, I studied the document in some detail – and the music quickly turned into musac.

The document which they call a ‘white paper’ promises ‘a review of the research’. Reading even just the very first sentence, my initial enthusiasm turned into bewilderment: “It is now widely accepted across health care disciplines throughout the world that acupuncture can be effective in treating such painful conditions as migraine headaches, and low back, neck and knee pain, as well as a range of painful musculoskeletal conditions.” Any review of research that starts with such a deeply uncritical and overtly promotional statement, must be peculiar (quite apart from the fact that the ANF do not seem to appreciate that back and neck pain are musculoskeletal by nature).

As I read on, my amazement grew into bewilderment. Allow me to present a few further statements from this review (together with a link to the article provided by the ANF in support and a very brief comment by myself) which I found more than a little over-optimistic, far-fetched or plainly wrong:

Male fertility, especially sperm production and motility, has also been shown to improve with acupuncture. In a recent animal study, electro-acupuncture was found to enhance germ cell proliferation. This action is believed to facilitate the recovery of sperm production (spermatogenesis) and may restore normal semen parameters in subfertile patients.

The article supplied as evidence for this statement refers to an animal experiment using a model where sperm are exposed to heat. This has almost no bearing on the clinical situation in humans and does not lend itself to any clinical conclusions regarding the treatment of sub-fertile men.

In a recent meta-analysis, researchers concluded that the efficacy of acupuncture as a stand-alone therapy was comparable to antidepressants in improving clinical response and alleviating symptom severity of major depressive disorder (MDD). Also, acupuncture was superior to antidepressants and waitlist controls in improving both response and symptom severity of post-traumatic stress disorder (PTSD). The incidence of adverse events with acupuncture was significantly lower than antidepressants.

The review provided as evidence is wide open to bias; it was criticised thus: “the authors’ findings did not reflect the evidence presented and limitations in study numbers, sample sizes and study pooling, particularly in some subgroup analyses, suggested that the conclusions are not reliable”. Moreover, we need to know that by no means all reviews of the subject confirm this positive conclusion, for instance, thisthis, or this one; all of the latter reviews are more up-to-date than the one provided by ANF. Crucially, a Cochrane review concluded that “the evidence is inconclusive to allow us to make any recommendations for depression-specific acupuncture”.

“A randomized controlled trial of acupuncture and counseling for patients presenting with depression, after having consulted their general practitioner in primary care, showed that both interventions were associated with significantly reduced depression at three months when compared to usual care alone.”

We have discussed the trial in question on this blog. It follows the infamous ‘A+B versus B’ design which cannot possibly produce a negative result.

Now, please re-read the first paragraph of this post; but be careful not to fall off your chair laughing.

There would be more (much more) to criticise in the ANF report but, I think, these examples are ENOUGH!

Let me finish by quoting from the ANF’s view on the future as cited in their new ‘white paper’: “Looking ahead, it is clear that acupuncture is poised to make significant inroads into conventional medicine. It has the potential to become a part of every hospital’s standard of care and, in fact, this is already starting to take place not only in the U.S., but internationally. The treatment is a cost-effective and safe method of relieving pain in emergency rooms, during in-patient stays and after surgery. It can lessen post-operative nausea, constipation and urinary difficulties, and have a positive impact on conditions like hypertension, anxiety and insomnia…

Driven by popular demand and a growing body of scientific evidence, acupuncture is beginning to be taken seriously by mainstream conventional medicine, which is incorporating it into holistic health programs for the good of patients and the future of health care. In order for this transition to take place most effectively, misunderstandings about acupuncture need to be addressed. We hope this white paper has helped to clarify some of those misunderstandings and encourage anyone with questions to contact the Acupuncture Now Foundation.”

My question is short and simple: IGNORANCE OR FRAUD?

 

Reiki is one of the most popular types of ‘energy healing’. Reiki healers believe to be able to channel ‘healing energy’ into patients’ body thus enabling them to get healthy. If Reiki were not such a popular treatment, one could brush such claims aside and think “let the lunatic fringe believe what they want”. But as Reiki so effectively undermines consumers’ sense of reality and rationality, I feel I should continue informing the public about this subject – despite the fact that I have already reported about it several times before, for instance here, here, here, here, here and here.

A new RCT, published in a respected journal looks interesting enough for a further blog-post on the subject. The main aim of the study was to investigate the effectiveness of two psychotherapeutic approaches, cognitive behavioural therapy (CBT) and a complementary medicine method Reiki, in reducing depression scores in adolescents. The researchers from Canada, Malaysia and Australia recruited 188 adolescent depressed adolescents. They were randomly assigned to CBT, Reiki or wait-list. Depression scores were assessed before and after 12 weeks of treatments/wait list. CBT showed a significantly greater decrease in Child Depression Inventory (CDI) scores across treatment than both Reiki (p<.001) and the wait-list control (p<.001). Reiki also showed greater decreases in CDI scores across treatment relative to the wait-list control condition (p=.031).  Male participants showed a smaller treatment effects for Reiki than did female participants. The authors concluded that both CBT and Reiki were effective in reducing the symptoms of depression over the treatment period, with effect for CBT greater than Reiki.

I find it most disappointing that these days even respected journals publish such RCTs without the necessary critical input. This study may appear to be rigorous but, in fact, it is hardly worth the paper it was printed on.

The results show that Reiki produced worse results than CBT. That I can well believe!

However, the findings also suggest that Reiki was nevertheless “effective in reducing the symptoms of depression”, as the authors put it in their conclusions. This statement is misleading!

It is based on the comparison of Reiki with doing nothing. As Reiki involves lots of attention, it can be assumed to generate a sizable placebo effect. As a proportion of the patients in the wait list group are probably disappointed for not getting such attention, they can be assumed to experience the adverse effects of their disappointment. The two phenomena combined can easily explain the result without any “effectiveness” of Reiki per se.

If such considerations are not fully discussed and made amply clear even in the conclusions of the abstract, it seems reasonable to accuse the journal of being less than responsible and the authors of being outright misleading.

As with so many papers in this area, one has to ask: WHERE DOES SLOPPY RESEARCH END AND WHERE DOES SCIENTIFIC MISCONDUCT BEGIN?

The website of the Brighton and Hove News informs us that the Brighton charity Rockinghorse is paying for a Reiki healer to treat young patients at the Royal Alexandra Children’s Hospital in Kemp Town. They claim that studies suggest that Reiki can relieve symptoms of chronic and acute illness, manage stress levels and aid relaxation and sleep. Rockinghorse has provided funding for an initial three years to therapists from Active LightWorks who have already been treating patients at the Alex as volunteers since 2012. The funding will allow the therapists to double the amount of time that they are able to offer treatments from five hours a week to ten.

One of the HDU patients to receive Reiki therapy is eight-month-old Blake Mlotshwa. He suffered a serious infection when he was 18 days old which led to him having two thirds of his bowel removed. Blake is unable to absorb the food and nutrients that he needed to grow and his condition remains critical. The reiki therapists are working with his doctors and nurses to help keep him as comfortable as possible.

Ali Walters, a Reiki therapist, said: “It is wonderful to be able to give both the children and parents an opportunity to relax and unwind. So often parents tell me they are delighted that during treatment their child drops off to sleep or they see their child become more calm and comfortable. I am delighted that Rockinghorse is now funding our work so we can provide more therapists and treatments to support the critical care that is provided in HDU.”

Kamal Patel, paediatric consultant at the Alex, said: “The reiki treatment has improved sleep, fear, anxiety, distress and pain for children on our Paediatric Critical Care Unit over and above what we can achieve through modern medicine. To have such a fantastic team of people offering reiki really helps our patients get better quicker.”

Yes, we have discussed Reiki several times already on this blog. For instance, I quoted the Cochrane review aimed at evaluating the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over.

Literature searches were conducted in the Cochrane Register of Controlled Trials (CENTRAL – all years), the Cochrane Depression, Anxiety and Neurosis Review Group’s Specialised Register (CCDANCTR – all years), EMBASE, (1974 to November 2014), MEDLINE (1950 to November 2014), PsycINFO (1967 to November 2014) and AMED (1985 to November 2014). Additional searches were carried out on the World Health Organization Trials Portal (ICTRP) together with ClinicalTrials.gov to identify any ongoing or unpublished studies. All searches were up to date as of 4 November 2014.

Randomised trials were considered in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner. The two authors independently decided on inclusion/exclusion of studies and extracted data. A prior analysis plan had been specified.

The researchers found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students. These studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively.

The findings did not show any evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduced the certainty of the evidence.

The authors of this Cochrane review concluded that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.

On a different blog post, I concluded that “we do not need a trained Reiki master, nor the illusion of some mysterious ‘healing energy’. Simple companionship without woo or make-believe has exactly the same effect without undermining rationality. Or, to put it much more bluntly: REIKI IS NONSENSE ON STILTS.”

Perhaps someone should tell the guys at Rockinghorse that they are funding nonsense?

Perhaps the charity should have been responsible enough to do a quick search on the evidence BEFORE they committed their funds?

Perhaps the consultant pediatrician should be sent to a refresher course in evidence-based medicine?

So many ‘perhapses’ – and only one certainty: THIS CHARITY IS WASTING ITS FUNDS ON OFFENSIVE NONSENSE.

A reader of this blog recently sent me the following message: “Looks like this group followed you recent post about how to perform a CAM RCT!” A link directed me to a new trial of ear-acupressure. Today is ‘national acupuncture and oriental medicine day’ in the US, a good occasion perhaps to have a critical look at it.

The aim of this study was to assess the effectiveness of ear acupressure and massage vs. control in the improvement of pain, anxiety and depression in persons diagnosed with dementia.

For this purpose, the researchers recruited a total of 120 elderly dementia patients institutionalized in residential homes. The participants were randomly allocated, to three groups:

  • Control group – they continued with their routine activities;
  • Ear acupressure intervention group – they received ear acupressure treatment (pressure was applied to acupressure points on the ear);
  • Massage therapy intervention group – they received relaxing massage therapy.

Pain, anxiety and depression were assessed with the Doloplus2, Cornell and Campbell scales. The study was carried out during 5 months; three months of experimental treatment and two months with no treatment. The assessments were done at baseline, each month during the treatment and at one and two months of follow-up.

A total of 111 participants completed the study. The ear acupressure intervention group showed better improvements than the two other groups in relation to pain and depression during the treatment period and at one month of follow-up. The best improvement in pain was achieved in the last (3rd) month of ear acupressure treatment. The best results regarding anxiety were also observed in the last month of treatment.

The authors concluded that ear acupressure and massage therapy showed better results than the control group in relation to pain, anxiety and depression. However, ear acupressure achieved more improvements.

The question is: IS THIS A RIGOROUS TRIAL?

My answer would be NO.

Now I better explain why, don’t I?

If we look at them critically, the results of this trial might merely prove that spending some time with a patient, being nice to her, administering a treatment that involves time and touch, etc. yields positive changes in subjective experiences of pain, anxiety and depression. Thus the results of this study might have nothing to do with the therapies per se.

And why would acupressure be more successful than massage therapy? Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc. Features like that have the potential to maximise the placebo-response. Therefore it is conceivable that they have contributed to the superiority of acupressure over massage.

What I am saying is that the results of this trial can be interpreted in not just one but several ways. The main reason for that is the fact that the control group were not given an acceptable placebo, one that was indistinguishable from the real treatment. Patients were fully aware of what type of intervention they were getting. Therefore their expectations, possibly heightened by the therapists, determined the outcomes. Consequently there were factors at work which were totally beyond the control of the researchers and a clear causal link between the therapy and the outcome cannot be established.

An RCT that is aimed to test the effectiveness of a therapy but fails to establish such a causal link beyond reasonable doubt cannot be characterised as a rigorous study, I am afraid.

Sorry! Did I spoil your ‘national acupuncture and oriental medicine day’?

On this blog, I have repeatedly stressed that there is reasonably good evidence to show that some herbal medicines are effective. The one that is probably supported with better evidence than any other is St. John’s wort (SJW). The first systematic review of SJW was published in 1995 and concluded that SJW is an effective symptomatic treatment for various forms of depressions. Meanwhile, many more trials have become available, and the current Cochrane review concludes that the available evidence suggests that the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants. 

This must be good news for many patients; particularly the fact that SJW is much safer than synthetic antidepressants seems attractive. But don’t be fooled – SJW may still cause harm. If taken on its own, it is almost as safe as placebo, but when it is combined with other drugs, it can powerfully interact and significantly lower the plasma level of a wide range of prescription medicines.

Some proponents of alternative medicine have suggested that this caution is alar@BocktheRobber mist, and they insist that, actually, the danger is minimal. Are they correct? We need data, I think, not opinion.

A new article provides new insights.

The objective of this study was to assess how often SJW is prescribed with medications that may interact dangerously with it. The researchers conducted a retrospective analysis of nationally representative data from the National Ambulatory Medical Care Survey. The study setting was U.S. non-federal outpatient physician offices. Patients who were prescribed SJW between 1993 and 2010 were the subjects. The outcome measures were medications co-prescribed with SJW.

Twenty-eight percent of SJW visits involved a drug that has potentially dangerous interaction with SJW. These included selective serotonin reuptake inhibitors, benzodiazepines, warfarin, statins, verapamil, digoxin, and oral contraceptives.

The authors concluded that SJW is frequently used in potentially dangerous combinations. Physicians should be aware of these common interactions and warn patients appropriately.

There is little to add – perhaps just this: the awareness of physicians is undoubtedly desirable, but it is not enough; as SJW and other herbal medicines are usually self-prescribed, consumers’ awareness of the risks associated with herbal medicines is at least as important, I think.

According to its authors, this RCT was aimed at investigating the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression. In particular the second research question is intriguing, I think – so let’s have a closer look at this trial.

The study was designed as a randomized, partially double-blind, placebo-controlled, four-armed, 2×2 factorial trial with a 6-week study duration. A total of 44 patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was thus underpowered for the pre-planned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo, and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups.

The conclusions were remarkable: although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting.

Alright, the authors encountered problems in recruiting enough patients and they therefore decided to stop the trial early. This sort of thing happens. Most researchers would then not publish any data at all. This team, however, did publish a report, and the decision to do so might be perfectly fine: other investigators might learn from the problems which led to early termination of the study.

But why do they conclude that the results were INCONCLUSIVE? I think the results were not inconclusive but non-existent; these were no results to report other than those related to the recruitment problems. And even if one insists on presenting outcome data as an exploratory analysis, one cannot honestly say they were INCONCLUSIVE, all one might state in this case is that the results failed to show an effect of the remedy or the consultation. This is far less favourable for homeopathy than stating the results were INCONCLUSIVE.

And why on earth do the authors conclude “we cannot recommend undertaking a further trial addressing this question in a similar setting”? This does not make the slightest sense to me. If the trialists encountered recruitment problems, others might find ways of overcoming them. The research question asking whether the effects of an extensive homeopathic case taking differ from those of a shorter conventional one seems important. If answered accurately, it could disentangle much of the confusion that surrounds clinical trials of homeopathy.

I have repeatedly commented on the odd conclusions drawn by proponents of alternative medicine on the basis of data that did not quite fulfil their expectations, and I often ask myself at what point this ‘prettification’ of the results via false positive conclusions crosses the line to scientific misconduct. My theory is that these conclusions appear odd to those capable of critical analysis because the authors bend over backwards in order to conclude more positively than the data would seem to permit. If we see it this way, such conclusions might even prove useful as a fairly sensitive ‘bullshit-detector’.

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