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

study design

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Ever since the government in Bavaria has been misguided enough to agree to a research programme testing whether homeopathy has a role in curtailing the over-use of anti-biotics, the subject of homeopathics as a replacement of antibiotics has been revived.

In this paper, homeopaths describe four female cases with recurrent urinary tract infections. The patients were treated successfully with the homeopathic strategy after several conventional approaches revealed no improvement. The follow-up period was a minimum of 3 years and the frequency of episodes with urinary tract infection as well as of antibiotic treatment was documented. Additionally, the patients were asked to assess the treatment outcome retrospectively in a validated questionnaire.

The treatment resulted in a reduction of urinary tract infections and the need for antibiotics from monthly to less than 3 times a year. Three of the four women had no cystitis and related intake of antibiotics for more than 1.5 years. A relapse of symptoms could be treated efficiently with a repetition of the homeopathic remedy. All subjective outcome assessments resulted positive.

The authors concluded that this case series suggests a possible benefit of individualized homeopathic treatment for female patients with recurrent urinary tract infections. Larger observational studies and controlled investigations are warranted. 

Such articles make me quite angry! They have the potential to mislead many patients and, in extreme cases, might even cost lives.

The ‘possible benefit’ of any treatment cannot be demonstrated with such flimsy case series. It has to be shown in properly controlled clinical trials. The findings of case series are confounded by dozens of variables and tell us next to nothing about cause and effect.

Case series make sense when they explore possible new therapeutic avenues. Homeopathy does certainly not fall into this category. The notion that homeopathics might be an alternative to antibiotics has been tested many times before in different settings, in animals, in humans, it vivo and in vitro. This has never generated convincingly positive findings. To re-address it by reporting uncontrolled cases is not just a nonsense; in my view, it is an unethical attempt to mislead us.

About 85% of German children are treated with herbal remedies. Yet, little is known about the effects of such interventions. A new study might tell us more.

This analysis accessed 2063 datasets from the paediatric population in the PhytoVIS data base, screening for information on indication, gender, treatment, co-medication and tolerability. The results suggest that the majority of patients was treated with herbal medicine for the following conditions:

  • common cold,
  • fever,
  • digestive complaints,
  • skin diseases,
  • sleep disturbances
  • anxiety.

The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events.

The authors concluded that the results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.

If you are a fan of herbal medicine, you will be jubilant. If, on the other hand, you are a critical thinker or a responsible healthcare professional, you might wonder what this database is, why it was set up and how exactly these findings were produced. Here are some details:

The data were collected by means of a retrospective, anonymous, one-off survey consisting of 20 questions on the user’s experience with herbal remedies. The questions included complaints/ disease, information on drug use, concomitant factors/diseases as well as basic patient data. Trained interviewers performed the interviews in pharmacies and doctor’s offices. Data were collected in the Western Part of Germany between April 2014 and December 2016. The only inclusion criterion was the intake of herbal drugs in the last 8 weeks before the individual interview. The primary endpoint was the effect and tolerability of the products according to the user.

And who participated in this survey? If I understand it correctly, the survey is based on a convenience sample of parents using herbal remedies. This means that those parents who had a positive experience tended to volunteer, while those with a negative experience were absent or tended to refuse. (Thus the survey is not far from the scenario I often use where people in a hamburger restaurant are questioned whether they like hamburgers.)

So, there are two very obvious factors other than the effectiveness of herbal remedies determining the results:

  1. selection bias,
  2. lack of objective outcome measure.

This means that conclusions about the clinical effects of herbal remedies in paediatric patients are quite simply not possible on the basis of this survey. So, why do the authors nevertheless draw such conclusions (without a critical discussion of the limitations of their survey)?

Could it have something to do with the sponsor of the research?

The PhytoVIS study was funded by the Kooperation Phytopharmaka GbR Bonn, Germany.

Or could it have something to do with the affiliations of the paper’s authors:

1 Institute of Pharmacy, University of Leipzig, Brüderstr. 34, 04103, Leipzig, Germny. nieberkaren@gmx.de.

2 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 573, Bonn, Germany. nieberkaren@gmx.de.

3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

4 ClinNovis GmbH, Genter Str. 7, 50672, Cologne, Germany.

5 Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.

6 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn, Germany.

7 Institute of Pharmaceutical Biology, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany.

8 Chair of Naturopathy, University Medicine Rostock, Ernst-Heydemann Str. 6, 18057, Rostock, Germany.

WHAT DO YOU THINK?

I have been sceptical about Craniosacral Therapy (CST) several times (see for instance here, here and here). Now, a new paper might change all this:

The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.

Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.

Compared to treatment as usual, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
  • disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).

Compared to manual/non-manual sham, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
  • disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;

Compared to active manual treatments, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
  • disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .

At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.

The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.

Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:

  1. The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
  2. Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
  3. The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
  4. This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
  5. One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
  6. The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
  7. Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.

Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.

So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

Yesterday, we discussed a paper concluding (amongst other things) that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain. Today, we are looking at one that overtly contradicts this verdict.

This systematic review (published in JAMA Oncology) evaluated the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale.

A total of 17 RCTs (with 1111 patients) were included, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity. A favourable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity and in 2 RCTs for reducing opioid dose. The evidence grade was moderate because of the substantial heterogeneity among studies.

The authors concluded that this systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.

So, which of the two conclusions should we trust?

Personally, I find the JAMA paper unimpressive to the point of being suspect. Here are some of my reasons:

  • About half of the primary studies are Chinese; and we have seen repeatedly that they are unreliable and report only positive results.
  • Many of the trials are published in Chinese and can thus not be checked by non-Chinese readers (nor, presumably, by the experts who acted as peer-reviewers for JAMA Oncology).
  • I have my doubts about the rigor of the peer-review of some of the journals that published the primary studies included in the review.
  • One paper included in the review is even a mere doctoral thesis which usually is not peer-reviewed in the usual sense.
  • The authors state that they included only clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care. However, this is evidently not true; many of the studies had the infamous A+B versus B design comparing acupuncture plus a conventional therapy against the conventional therapy. As we have discussed ad nauseam on this blog, such trials cannot produce a negative finding even if ‘A’ is a placebo.
  • Contrary to what the authors claim, the quality of most of the included studies was extremely poor, as far as I can see.
  • One included paper which I cannot access is entitled ‘Clinical observation on 30 cases of moderate and severe cancer pain of bone metastasis treated by auricular acupressure‘. Are the review authors seriously claiming that this is an RCT?

The more I study the details of the JAMA Oncology paper, the more I feel it might be worth a complaint to the editor with a view of initiating a thorough investigation and a possible retraction.

 

The aim of this review is to synthesise systematic reviews (SRs) of randomised clinical trials (RCTs) evaluating the efficacy of acupuncture to alleviate chronic pain. A total of 177 reviews of acupuncture from 1989 to 2019 met the eligibility criteria. The majority of SRs found that RCTs of acupuncture had methodological shortcomings, including inadequate statistical power with a high risk of bias. Heterogeneity between RCTs was such that meta-analysis was often inappropriate.

Having (co-) authored 13 of these SRs myself, I am impressed with the amount of work that went into this synthesis. The authors should be congratulated for doing it – and for doing it well! The paper itself differentiates the findings according to various types of pain. Here I reproduce the authors’ conclusion regarding different pain entities:

  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for chronic pain associated with various medical conditions. There is no specific NICE guidance about the use of acupuncture for chronic pain conditions irrespective of aetiology or pathophysiology, although some guidance exists for specific pain conditions (see respective sections below). Guidance by NICE on chronic pain assessment and management is currently being developed (GIDNG10069) with publication expected in August 2020.
  • Evidence from the SRs suggests that acupuncture prevents episodic or chronic tension‐type headaches and episodic migraine, although long‐term studies and studies comparing acupuncture with other treatment options are still required. The current NICE guidance (clinical guideline CG150) is that a course of up to 10 sessions of acupuncture over 5–8 weeks is recommended for tension‐type headache and migraine.
  • The most recent evidence from a Cochrane review of 16 RCTs suggests that acupuncture is not superior to sham acupuncture for OA of the hip, although in contrast, evidence from nonCochrane reviews suggests that there is moderate‐quality evidence that acupuncture may be effective in the symptomatic relief of pain from OA of the knee. Why there should be a difference in evidence between the knee and the hip is not known. Interestingly, guidance from NICE (CG177) states: “Do not offer acupuncture for the management of osteoarthritis”.
  • Evidence suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for low back pain. In 2009, NICE published guidance for the management of nonspecific low back pain that recommended a course of acupuncture as part of first line treatment. This guidance produced much debate. Subsequently, NICE have updated guidance for the management of low back pain and sciatica in people over 16 (NG59) and currently recommend in Section 1.2.8 “Do not offer acupuncture for managing low back pain with or without sciatica”, even though the evidence had not significantly changed.
  • Evidence from SRs suggests that dry needling acupuncture might be effective in alleviating pain associated with myofascial trigger points, at least in the short‐term, although there are insufficient high‐quality RCTs to judge the efficacy with any degree of certainty. There is no guidance from NICE on the management of myofascial pain syndrome.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain and more high‐quality, appropriately designed and adequately powered studies are needed. The most recent guidance from NICE (CSG4) recognises that patients who are receiving palliative care often seek complementary therapies, but it does not specifically recommend acupuncture. It recognises that “Many studies have a considerable number of methodological limitations, making it difficult to draw definitive conclusions”.
  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for fibromyalgia pain. There is no NICE guidance on the treatment of fibromyalgia.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for primary dysmenorrhea or chronic pelvic pain. There is NICE guidance on endometriosis (NG73) [200] but this does not recommend any form of Chinese medicine for this type of pelvic pain, although acupuncture is not specifically mentioned.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for pain in inflammatory arthritis. There is a NICE guideline (NG100) [201] for the treatment of rheumatoid arthritis but this does not recommend acupuncture.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for neuropathic pain or neuralgia. There is NICE guidance (CG173) on the management of neuropathic pain, but acupuncture is not included in the list of recommended/not recommended treatments.
  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for a variety of other painful conditions, including lateral elbow pain, shoulder pain and labour pain. There is no guidance available from NICE on the treatment of any of these conditions.

So, what should we make of all this?

Maybe I just point out two things:

  1. This is a most valuable addition to the literature about acupuncture. It can serve as a reference for all who are interested in an honest account of the (lack of) value of acupuncture in the management of chronic pain.
  2. If a therapy has been tested in hundreds of (sadly often flawed) trials and the conclusions fail to come out clearly in favour of it, it is most likely not a very effective treatment.

Until we have data to the contrary, acupuncture should not be considered to be an effective therapy for chronic pain management.

Many patients with chronic pain (CP) are prescribed opioids, a situation which has led to the much-discussed opioid crisis. Integrative medicine (IM), which combines pharmacological and so-called alternative medicine (SCAM), has been proposed as a solution. Yet, the role of SCAM therapies in reducing opioid use remains unclear.

This systematic review explored the effectiveness of the IM approach or any of the SCAM therapies to reduce or cease opioid use in CP patients. Electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, seven were retrospective studies, four studies were prospective observational, three were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM/SCAM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioral therapy, and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.

The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including SCAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/SCAM therapies for CP.

I am unimpressed by this review.

And here is why:

  1. Because of their design, most of the included studies do not allow any conclusions about cause and effect.
  2. The 8 RCTs that would allow such conclusions are mostly of poor quality.
  3. Some of the 8 RCTs are not even what the review authors claim to be. Here is just one example:

Background: Current levels and dangers of opioid use in the U.S. warrant the investigation of harm-reducing treatment alternatives.

Purpose: A preliminary, historical, cohort study was used to examine the association between enrollment in the New Mexico Medical Cannabis Program (MCP) and opioid prescription use.

Methods: Thirty-seven habitual opioid using, chronic pain patients (mean age = 54 years; 54% male; 86% chronic back pain) enrolled in the MCP between 4/1/2010 and 10/3/2015 were compared to 29 non-enrolled patients (mean age = 60 years; 69% male; 100% chronic back pain). We used Prescription Monitoring Program opioid records over a 21 month period (first three months prior to enrollment for the MCP patients) to measure cessation (defined as the absence of opioid prescriptions activity during the last three months of observation) and reduction (calculated in average daily intravenous [IV] morphine dosages). MCP patient-reported benefits and side effects of using cannabis one year after enrollment were also collected.

Results: By the end of the 21 month observation period, MCP enrollment was associated with 17.27 higher age- and gender-adjusted odds of ceasing opioid prescriptions (CI 1.89 to 157.36, p = 0.012), 5.12 higher odds of reducing daily prescription opioid dosages (CI 1.56 to 16.88, p = 0.007), and a 47 percentage point reduction in daily opioid dosages relative to a mean change of positive 10.4 percentage points in the comparison group (CI -90.68 to -3.59, p = 0.034). The monthly trend in opioid prescriptions over time was negative among MCP patients (-0.64mg IV morphine, CI -1.10 to -0.18, p = 0.008), but not statistically different from zero in the comparison group (0.18mg IV morphine, CI -0.02 to 0.39, p = 0.081). Survey responses indicated improvements in pain reduction, quality of life, social life, activity levels, and concentration, and few side effects from using cannabis one year after enrollment in the MCP (ps<0.001).

Conclusions: The clinically and statistically significant evidence of an association between MCP enrollment and opioid prescription cessation and reductions and improved quality of life warrants further investigations on cannabis as a potential alternative to prescription opioids for treating chronic pain.

This study is evidently NOT an RCT!

Most of the 8 RCTs investigate whether SCAM is useful for weaning opioid-dependent patients off their drug. To equate this with the question whether IM/SCAM can reduce or cease opioid use in CP patients is, I think, wrong. The way to reduce opioid use in CP patients is to prescribe less opioids. And for prescribing less opioids, we need no SCAM but we need to remember what we learned in medical school: opioids are not for routine treatment of CP!

So, why do the authors of this review try to mislead us?

Could it have something to do with some of their affiliations and the bias that goes with it?

  • Canadian College of Naturopathic Medicine, North York, Ontario, Canada.
  • Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, Australia.
  • Pacific College of Oriental Medicine, San Diego, California, USA.

What do you think?

Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.

The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.

Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).

The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.

In essence this two-centre study shows that:

  • real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
  • real acupuncture is not significantly better than sham acupuncture;
  • the findings differ remarkably between the US and the Chinese centre.

I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.

In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.

Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”

Who do you think is closer to the truth?

An intercessory prayer (IP) is an intervention characterized by one or more individuals praying for the well-being or a positive outcome of another person. There have been several trials of IP, but the evidence is far from clear-cut. Perhaps this new study will bring clarity?

The goal of this double-blind RCT was to assess the effects of intercessory prayer on psychological, spiritual and biological scores of breast 31 cancer patients who were undergoing radiotherapy (RT). The experimental group was prayed for, while the controla group received no such treatment. The intercessory prayer was performed by a group of six Christians, who prayed daily during 1 h while participant where under RT. The prayers asked for calm, peace, harmony and recovery of health and spiritual well-being of all participants. Data collection was performed in three time points (T0, T1 and T2).

Significant changes were noted in the intra-group analysis, concerning the decrease in spiritual distress score; negative religious/spiritual coping prevailed, while the total religious/spiritual coping increased between the posttest T2 to T0.

The authors concluded that begging a higher being for health recovery is a common practice among people, regardless of their spirituality and religiosity. In this study, this practice was performed through intercessory prayer, which promoted positive health effects, since spiritual distress and negative spiritual coping have reduced. Also, spiritual coping has increased, which means that participants facing difficult situations developed strategies to better cope and solve the problems. Given the results related to the use of intercession prayer, as a complementary therapeutic intervention, holistic nursing care should integrate this intervention, which is included in the Nursing Interventions Classification. Additionally, further evidence and research is needed about the effect of this nursing spiritual intervention in other cultures, in different clinical settings and with larger samples.

The write-up of this study is very poor and most confusing – so much so that I find it hard to make sense of the data provided. If I understand it correctly, the positive findings relate to changes within the experimental group. As RCTs are about compating one group to another, these changes are irrelevant. Therefore (and for several other methodological flaws as well), the conclusion that IP generates positive effects is not warranted by these new findings.

Like all other forms of paranormal healing, IP is implausible and lacks support of clinical effectiveness.

I have recently gone to the trouble of evaluating 150 different modalities from the realm of so-called alternative medicine (SCAM) in a book. This is what it tells you about Reiki:

Reiki is a form of paranormal or energy healing popularised by Japanese Mikao Usui (1865-1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy.

    1. Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines our health.
    2. Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
    3. There is no scientific basis for such notions, and reiki is therefore not plausible.
    4. Reiki is used for a number of conditions, including the relief of stress, tension and pain.
    5. There have been several clinical trials testing the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
    6. A systematic review summarising this evidence concluded that the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven.[1] And a Cochrane review found 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.[2]
    7. Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.

PLAUSIBILITY

Negative

EFFICACY

Negative

SAFETY

Positive

COST

Positive

RISK/BENEFIT BALANCE

Negative

[1] https://www.ncbi.nlm.nih.gov/pubmed/?term=lee+pittler+ernst%2C+reikiv

[2] https://www.ncbi.nlm.nih.gov/pubmed/25835541

So, Reiki is both implausible and unproven. Now a new, large trial has emerged that might change this verdict. The main purpose of this study (published in JCAM) was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample.

The study design was a single arm effectiveness trial with measures at pre-and postintervention. The study took place at private Reiki practices across the United States. Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session.

Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. The 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session.

A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001).

The authors concluded that the results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.

Really?

This ‘large scale’ effectiveness trial’ could make you laugh and cry at the same time.

  • Laugh, because it is almost comically daft.
  • Cry, because the conclusion is bound to mislead a lot of gullible people.

Without a control group, the study cannot even attempt to determine anything like the effectiveness of Reiki. What the results truly show is that consumers who consult (and pay) a Reiki master expect to have a positive effect. The expectation translates into a sizable placebo response. The investigators seem to be clueless scientists, or they wilfully mislead the public (the senior author is from the ‘The Center for Reiki Research‘ which, according to its mission statement, is dedicated to gaining acceptance for the practice of Reiki by the medical community).

The only conclusion that can honestly be drawn from the data is that consumers who pay for a serivce often like this service (otherwise they would not use it!). It’s a bit like the thing with the hamburger joint that I often cite: if you ask people eating in a McDonalds whether they enjoy hamburgers, most will answer in the affirmative.

But there might be a valuable lesson in this paper after all: never trust the JACM further than you can throw it.

Burning mouth syndrome (BMS) is a rare but potentially debilitating condition. So far, individualised homeopathy (iHOM) has not been evaluated or reported in any peer-reviewed journal as a treatment option. Here is a recently published case-report of iHOM for BMS.

At the Centre of Complementary Medicine in Bern, Switzerland, a 38-year-old patient with BMS and various co-morbidities was treated with iHOM between July 2014 and August 2018. The treatment involved prescription of individually selected homeopathic single remedies. During follow-up visits, outcome was assessed with two validated questionnaires concerning patient-reported outcomes. To assess whether the documented changes were likely to be associated with the homeopathic intervention, an assessment using the modified Naranjo criteria was performed.

Over an observation period of 4 years, an increasingly beneficial result from iHOM was noted for oral dysaesthesia and pains as well as for the concomitant symptoms.

The authors concluded that considering the multi-factorial aetiology of BMS, a therapeutic approach such as iHOM that integrates the totality of symptoms and complaints of a patient might be of value in cases where an association of psychological factors and the neuralgic complaints is likely.

BMS can have many causes. Some of the possible underlying conditions that can cause BMS include:

  • allergies
  • hormonal imbalances
  • acid reflux
  • infections in the mouth
  • various medications
  • nutritional deficiencies in iron or zinc
  • anxiety
  • diabetes

Threatemnt of BMS consists of identifying and eliminating the underlying cause. If no cause of BMS can be found, we speak of primary BMS. This condition can be difficult to treat; the following approaches to reduce the severity of the symptoms are being recommended:

  • avoiding acidic or spicy foods
  • reducing stress
  • avoiding any other known food triggers
  • exercising regularly
  • changing toothpaste
  • avoiding mouthwashes containing alcohol
  • sucking on ice chips
  • avoiding alcohol if it triggers symptoms
  • drinking cool liquids throughout the day
  • smoking cessation
  • eating a balanced diet
  • checking medications for potential triggers

The authors of the above case-report state that no efficient treatment of BMS is known. This does not seem to be entirely true. They also seem to think that iHOM benefitted their patient (the post hoc ergo propter hoc fallacy!). This too is more than doubtful. The natural history of BMS is such that, even if no effective therapy can be found, the condition often disappears after weeks or months.

The authors of the above case-report treated their patient for about 4 years. The devil’s advocate might assume that not only did iHOM contribute nothing to the patient’s improvement, but that it had a detrimental effect on BMS. The data provided are in full agreement with the notion that, without iHOM, the patient would have been symptom-free much quicker.

 

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