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

Uncategorized

A number of German health insurances are offering integrated care contracts for homeopathy (ICCHs) that cover the reimbursement of homeopathy. But the effectiveness and cost-effectiveness of these contracts are highly questionable. Now a team of German researchers evaluated the effectiveness and cost-effectiveness of treatment after an additional enrolment in an ICCH in a comparative, prospective, observational study (sponsored by the health insurance company Techniker Krankenkasse).

The participants in the ICCH (HOM group) were compared with matched (on diagnosis, sex and age) insured individuals (CON group) who received usual care alone. Those insured with either

  • migraine or headache,
  • allergic rhinitis,
  • asthma,
  • atopic dermatitis,
  • depression

were included. Primary effectiveness outcomes were the baseline adjusted scores of diagnosis-specific questionnaires (e.g. RQLQ, AQLQ, DLQI, BDI-II) after 6 months. Primary cost-effectiveness endpoints were the baseline adjusted total costs from an insurer perspective in relation to the achieved quality-adjusted life years (QALYs). Costs were derived from health claims data and QALYs were calculated based on SF-12 data.

Data from 2524 participants (1543 HOM group) were analysed. The primary effectiveness outcomes after 6 months were statistically significant in favour of the HOM group for:

  • migraine or headache (Δ = difference between groups, days with headache: – 0.9, p = 0.042),
  • asthma (Δ-AQLQ(S): + 0.4, p = 0.014),
  • atopic dermatitis (Δ-DLQI: – 5.6, p ≤ 0.001),
  • depression (Δ-BDI-II: – 5.6, p ≤ 0.001).

Only the BDI-II differences reached the minimal clinically important difference.

For all diagnoses, the adjusted mean total costs over 12 months were higher in the HOM group from an insurer perspective, with

  • migraine or headache,
  • atopic dermatitis,
  • depression

suggesting cost-effectiveness in terms of additional costs per QALY gained.

The authors concluded that after an additional enrolment in the ICCH, the treatment of participants with depression showed minimally clinically relevant improvements. From an insurer perspective, treatment with an ICCH enrolment resulted in higher costs over all diagnoses but seemed to be cost-effective for migraine or headache, atopic dermatitis and depression according to international used threshold values. Based on the study design and further limitations, our findings should be considered cautiously and no conclusions regarding the effectiveness of specific treatment components can be made. Further research is needed to overcome limitations of this study and to confirm our findings.

Normally, I find newly published studies by conducting Medline searches. This one, I found because the insurance company in question, the Techniker Krankenkasse, is already using it for their advertising. No wonder – this is not a scientific study but a clever marketing coup!

THE RESULTS OF THIS ‘STUDY’ WERE CLEAR, EVEN BEFORE THE FIRST PATIENT WAS RECRUITED. 

Imagine you are a patient with one of the 5 conditions listed above, and you evidently like homeopathy – so much so that you approach your insurance and ask to get cover for homeopathy at extra cost to yourself. These were the patients of experimental group. They were compared to patients who could not care less about homeopathy and thus did not get this extra cover.

Who do you think claims to feel better in a self-administered questionnaire?

Is there anyone surprised at the findings of this study?

Well, actually I am a little surprised. Not that the results were positive, but that the results were not more positive. With such a monsterous bias built in the ‘study’, I would have expected much larger differences.

And I am surprised about something else too: how come BMC Health Services Research publishes such promotional marketing masquerading as scientific research?

This clever marketing coup can in no way determine the effectiveness of homeopathy. For that, we need RCTs of which there are already plenty; and we all know what they show: the effects of homeopathy are indistinguishable from those of placebo.

This means there is no proven effectiveness. And what did the director of NICE England once tell me?

WHERE THERE IS NO EFFECTIVENESS, THERE CAN ALSO BE NO COST-EFFECTIVENESS!

Across the world, researchers are frantically trying to find a treatment for COVID-19. Thus many trials have been initiated – and some are better than others.

The aim of this study was to develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.

A putative ARDS-suppressing drug Keguan-1 was evaluated in a randomized, controlled two-arm trial. The two groups were:

  1. A control therapy receiving alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively.
  2. The experimental group receiving the control therapy plus Keguan-1 19.4 g twice daily. The new formula was derived from 3 different formulae, Yinqiao Powder (银翘散), Sangju Drink (桑菊饮), and Sanren Decoction (三仁汤), named “Keguan-1” (meaning anti-coronavirus 1 in Chinese) with 7 components: Lonicera japonica Thunb. (Jinyinhua, lot. 19040301) 30 g, Forsythia suspensa (Thunb.) Vahl, (Lianqiao, lot. 19040221) 30 g, Morus alba L. (Sangye, lot. 19045321) 15 g, Chrysanthemum morifolium Ramat. (Juhua, lot. 19040811) 10 g,
    Coix lacryma-jobi L. var. mayuen (Roman.) Stapf, Yiyiren, lot. 19025161) 30 g, Fritillaria thunbergii Miq. (Zhebeimu, lot. 19041161) 15 g, and Prunus armeniaca L. var. ansu Maxim. (Kuxingren, lot. 19045591) 9 g. The powder versions of the drugs for the 7 components of Keguan-1 were obtained from Beijing Tcmages Pharmaceutical Co. Ltd. (Beijing, China) and mixed in the defined ratio.

After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.

An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm).

The results show that, compared with the control arm, the experimental group exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).

The authors (who almost out-number the patients in the study) concluded that Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients.

The mixture used in this trial is adventurous, to put it mildly (although the authors state that they report the development of a TCM-medicine “We have reported here the development of Keguan-1, a new CM drug that was specifically designed for suppressing ARDS development in patients of COVID-19 and/or of other RDI” they actually do nothing of the sort). The trial design is flimsy, to put it politely. And the conclusion is unjustified, to put it scientifically.

One might even say that – pandemic or not – it is irresponsible to conclude from a sample size of 2 x 24 on the safety and efficacy of any therapy – TCM or not.

 

Excessive eccentric exercise of inadequately conditioned skeletal muscle results in focal sites of injury within the muscle fibres. These injuries cause pain which usually is greatest about 72 hours after the exercise. This type of pain is called delayed-onset muscle soreness (DOMS) and provides an accessible model for studying the effects of various treatments that are said to have anaesthetic activities; it can easily be reproducibly generated without lasting harm or ethical concerns.

In so-called alternative medicine (SCAM) DOMS is employed regularly to test treatments which are promoted for pain management. Thus several acupuncture trials using this method have become available. Yet, the evidence for the effects of acupuncture on DOMS is inconsistent which begs the question whether across all trials an effects emerges.

The aim of this systematic review therefore was to explore the effects of acupuncture on DOMS. Studies investigating the effect of acupuncture on DOMS in humans that were published before March 2020 were obtained from 8 electronic databases. The affected muscles, groups, acupuncture points, treatment sessions, assessments, assessment times, and outcomes of the included articles were reviewed. The data were extracted and analysed via a meta-analysis.

A total of 15 articles were included, and relief of DOMS-related pain was the primary outcome. The meta-analysis showed that there were no significant differences between acupuncture and sham/control groups, except for acupuncture for DOMS on day 1 (total SMD = -0.62; 95% CI = -1.12∼0.11, P < 0.05) by comparing with control groups.

The authors concluded that acupuncture for DOMS exhibited very-small-to-small and small-to-moderate effects on pain relief for the sham and no acupuncture conditions, respectively. Evidence indicating the effects of acupuncture on DOMS was little because the outcome data during the follow-up were insufficient to perform an effective meta-analysis.

A mere glance at the Forrest plot reveals that acupuncture is unlikely to have any effect on DOMS at all. The very small average effect that does emerge originates mainly from one outlier, the 2008 study by Itoh et al. This trial was published by three acupuncturists from the Department of Clinical Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Kyoto, Japan. It has numerous weaknesses, for instance there are just 10 volunteers in each group, and can therefore be safely discarded.

In essence, this means that there is no good evidence that acupuncture is effective at reducing pain caused by DOMS.

As mentioned already yesterday, NICE published a draft report on pain treatments. The draft is now open to public consultation until 14 September 2020, and some of my readers might want to comment. It suggests that people with chronic primary pain (CPP) should not get pain-medication of any type, but be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture.

No recommendation is made for manual therapy, but a lengthy document evaluates with the subject in some detail. Here are what I consider to be the key passages from its clinical evidence section:

Mixed modality manual therapy versus usual care/acupuncture/dry needling
Pain reduction
Low quality evidence from 2 studies with a total of 52 participants showed no clinically important difference between mixed modality manual therapy and usual care at time points up to 3 months. Low quality evidence from 1 study with a total of 33 participants showed a clinically important benefit of mixed modality manual therapy over usual care at time points after 3 months. Low quality evidence from 1 study with a total of 26 participants showed no clinically important difference between mixed modality manual therapy and acupuncture/dry needling at time points up to 3 months.

Soft tissue technique versus usual care/acupuncture/dry needling
Pain reduction
Low quality evidence from 3 studies with a total of 286 participants showed a clinically important benefit of soft tissue technique over usual care at time points up to 3 months. Very low quality evidence from 2 studies with a total of 115 participants showed a clinically important benefit of acupuncture/dry needling over soft tissue technique at time points up to 3 months.

Manipulation/mobilisation versus usual care/acupuncture/dry needling

Pain reduction
Low quality evidence from 1 study with a total of 30 participants showed a clinically important benefit of manipulation/mobilisation over usual care at time points up to 3 months. Very low quality evidence from 1 study with a total of 24 participants showed no clinically important difference between manipulation/mobilisation and acupuncture/dry needling at time points up to 3 months.

Manual therapy interventions compared with each other
Pain reduction
Moderate quality evidence from 1 study with a total of 63 participants showed a clinically important benefit of mixed modality manual therapy over soft tissue technique at time points up to 3 months. Low quality evidence from 1 study with a total of 63 participants showed a clinically important benefit of mixed modality manual therapy over soft tissue technique at time points after 3 months. Low quality evidence from 1 study with a total of 30 participants showed a clinically important benefit of mixed modality manual therapy over manipulation/mobilisation at time points up to 3 months. Very low quality evidence from 3 studies with a total of 125 participants showed a clinically important benefit of manipulation/mobilisation over soft tissue technique at time points up to 3 months. Low quality evidence from 1 study with a total of 68 participants showed no clinically important difference between manipulation/mobilisation and soft tissue technique at time points after 3 months.

In my view, this is a sound assessment of effectiveness. Nonetheless, I should to mention a few critical points.

Manual therapy is a very heterogeneous group of interventions. Massage and spinal manipulation, for instance, are very different in almost every respect. It would therefore be more constructive to name the techniques more precisely. Evaluating them together makes little sense to me and is hardly different from an assessment of all pharmacological treatments.

Much more important is the fact that the document lacks an assessment of harms. All I did find was a comment saying ‘THERE WAS NO EVIDENCE OF HARM’. This statement is certainly misleading. Perhaps the clinical trials did not report adverse effects, but this is (as I have often pointed out) because these studies usually defy research ethics by failing to mention them. As we have discussed ad nauseam on this blog (for instance here, here and here), spinal manipulation has regularly been associated with severe harms many times.

As NICE do not suggest to recommend manual therapy for CPP, this is perhaps not so crucial in this particular instance. However, I do believe that, for completeness of the evidence as well as for the credibility of the research, an in-depth assessment of the risks is paramount when it comes to the assessment of any therapy.

ANDREW WAKEFIELD has been mentioned on this blog before (see here and here, for instance). He is, of course, the UK doctor who published false data about vaccination and autism in the Lancet, was struck off the medical register, and then moved to the US where he has become the darling of anti-vaxxers of all types, including Donald Trump, chiropractors and homeopaths. More recently, he seems to have become the star and guru of the growing cult opposing a vaccination against COVID-19, even before one has become available.

Already in March, Wakefield attended an anti-vaxx meeting and told those watching: “One of the main tenets of the marketing of mandatory vaccination has been fear. And never have we seen fear exploited in the way that we do now with the coronavirus infection.”

Citing what he called ‘unambiguous’ evidence that the coronavirus is no more deadly than seasonal flu, and claiming that the pathogen’s death toll had been greatly exaggerated, Wakefield more recently claimed that the crisis had led to ‘a destruction of the economy, a destruction of people and families, and unprecedented violations of health freedom… and it’s all based upon a fallacy’.

The disgraced ex-doctor noted that the COVID-19 pandemic is one big hoax: a cynical plot by pharmaceutical giants — aided by governments, scientists and the media — to force the world to be unnecessarily and dangerously vaccinated. Describing vaccines as ‘intrinsically unsafe’, ex-doctor Wakefield called on free-thinking people to refuse to be vaccinated against Covid-19 if and when a jab becomes available.

‘We have to stand and fight,’ the 63-year-old intoned. ‘As Nelson Mandela said at his trial, there are ideals worth dying for . . . I don’t want to get too dramatic, but better to die as a free man than live as a slave . . . We have to fight to preserve [our] freedom because it will be surely stripped from us in a very short space of time if we don’t.’

Convincing his disciples that he was the victim of a conspiracy by the pharmaceutical industry, medical establishment and media, Wakefield now neatly argues that the same shadowy cabal are lying to the public about coronavirus. Having terrified one generation of parents — leading, some believe, to a spike in measles among children and a number of deaths in countries where a minority have promoted his claims — Wakefield is spreading fear and misinformation again.

And the anti-vaxxers are proving alarmingly successful. It has been estimated that around 60 million people subscribe to anti-vaxx propaganda. It is conceivable therefore that these science-deniers could seriously undermine efforts to tackle the current pandemic effectively.

A reader of this blog reminded me of the fact that I have so far not written anything about VAT (thanks Kathryn) – no, not ‘value added tax’ but Vibroacoustic Sound Therapy. This so-called alternative therapy (SCAM) uses sound and vibrations and is promoted mainly for:

  • reducing stress,
  • relieving pain,
  • improving sleep,
  • ‘restoring balance’ (bank balance of the therapist?),
  • and enhancing the quality of life.

The VAT frequencies range between 30Hz and 120Hz and are applied directly to the body through a treatment table topped with a water-filled mattress. If you go on the Internet, you will find that there are lots of devices you can buy, if you want to do the therapy at home.

Like so many other SCAMs, VAT is claimed to work with resonant frequency whereby our cells copy vibrations they are exposed to.  VAT is said to introduce the healthy vibration of cells into the body.  This results in a healthy resonant response in our cells, VAT-proponents claim. Over 100 customized frequencies can be employed to address specific health problems.

Yes, you are right: this is about as genuine as a £4 note.

Those practitioners offering VAT sessions claim that the best results occur with cumulative sessions for between 10 – 12 weeks and recommend a minimum treatment schedule of 8 weeks for the majority of cases, either once or twice per week.  In view of the fact that these would-be healthcare professionals want to make a living, this seems almost modest, in my view. But, as they are keen to point out, more chronic conditions require 2-3 times per week.

Any evidence?

I found plenty of statements arguing that VAT is solidly evidence-based. However, when I searched for it, I failed to locate anything other than uncontrolled studies, pilot studies and promotional articles of VAT. I admit that I did not spend much time looking (it somehow did not seem worth the effort); it is therefore possible that I missed the definitive RCT of VAT. If someone knows of a piece of conclusive evidence, I’d be most thankful to learn about it.

Under the heading ‘Who should not receive vibroacoustic therapy?’ one VAT practitioner listed several contra-indications for VAT:
•    Individuals with Pacemakers
•    People with very low blood pressure
•    People with a DVT, bleeding disorder, or recent surgery
•    Individuals who have had a recent psychotic episode

To this list, I would urgently add this: individuals who are capable of critical thinking!!!

I was surprised to see a paper entitled ‘Yogurt Intake Reduces All-Cause and Cardiovascular Disease Mortality‘ in the current issue of the Chinese Journal of Integrative Medicine. My surprise turned into disbelief when I read the abstract. Here it is in its unabbreviated beauty:

Objective

To assess the relationship between yogurt intake and mortality risk from prospective cohort studies.

Methods

The PubMed, EMBASE, and Web of Science databases were searched for all records related to yogurt intake and mortality risk [all-cause or cardiovascular disease (CVD) or cancer mortality] before October 1, 2018. The Newcastle-Ottawa Quality Scale was used to estimate the quality of all eligible articles. The results of the highest and lowest categories of yogurt intake in each study were collected and the effect size was pooled using a random effects model. The dose-response analysis was calculated using the generalized least squares trend estimation model.

Results

Eight eligible cohort studies were included in this meta-analysis. There were 235,676 participants in the 8 studies, and the number of deaths was 14,831. Compared with the lowest category, the highest category of yogurt intake was not significantly related with all-cause mortality [hazard ratio (HR)=0.93; 95% confidence interval (CI): 0.85, 1.01], CVD mortality (HR=0.92; 95% CI: 0.81, 1.03) and cancer mortality (HR=0.97; 95% CI: 0.83, 1.12). These studies were homogenous, since the homogeneity test showed that I2 was 28.7%, 15.1% and 11.8%, respectively. However, yogurt intake ⩾200 g/d was significantly associated with a lower all-cause mortality (HR=0.88; 95% CI: 0.80, 0.96) and CVD mortality (HR=0.87; 95% CI: 0.77, 0.99) in the subgroup analysis. The dose-response analysis showed that yogurt intake of 200 g/d was inversely associated with all-cause mortality (P=0.041, HR=0.95, 95% CI: 0.92, 1.00) and CVD mortality (P=0.009, HR=0.92, 95% CI: 0.86, 0.98), and all of which were linear relationship (P>0.05).

Conclusions

This review provided the evidence regarding yogurt intake can reduce all-cause and CVD mortality. Although some positive findings were identified, more high-quality cohort studies and randomized controlled trials are warranted on a possible protective effect of yoghurt on health.

 

As the above three graphs indicate (and as researchers learn in their first lesson of statistics),

CORRELATION IS NOT CAUSATION.

We all know that, of course – except those of us who work in the so-called alternative medicine (SCAM), it seems – and except the editors of Chinese Journal of Integrative Medicine or the people who do the peer-reviewing for this publication. How else would we explain that a conclusion such as yogurt intake can reduce all-cause and CVD mortality can get published (not to mention the title of the paper)?

But what is the explanation of the intriguing association discovered by the authors of this paper? As far as I can see, there are several possibilities:

  1. The investigators could be correct, and the link could indeed be causal (in this case, they need to prove it).
  2. The finding could be coincidental, due to random noise (there are hundreds of epidemiological studies, and they tend to report mainly positive associations [big fishing expeditions really]; thus, it is conceivable that 8 of them found an association where in truth none exists).
  3. It could be that people who eat a yoghurt tend to not eat a ‘full English’ for breakfast, thus avoiding the harm of unhealthy nutrition)
  4. Similarly, it might be that yoghurt consumers care more about their health in general (including exercise, body weight, smoking, etc.) than those who shun yoghurt.

And how do we decide which explanation applies? The answer is simple: by doing proper research and drawing appropriate conclusions from it.

Perhaps something like this?

Background: Although a link between regular yogurt consumption and mortality appears plausible, data are sparse and have yielded inconsistent results.

Objectives: We examined the association between regular yogurt consumption and risk of all-cause and cause-specific mortality among US women and men.

Methods: A total of 82,348 women in the Nurses’ Health Study and 40,278 men in the Health Professionals Follow-Up Study without a history of cardiovascular disease (CVD) and cancer in 1980 (women) or 1986 (men) were followed up until 2012. Yogurt consumption was assessed by updated validated FFQs.

Results: During 3,354,957 person-years of follow-up, 20,831 women and 12,397 men died. Compared with no yogurt consumption, the multivariable-adjusted HRs (95% CIs) of mortality were 0.89 (0.86, 0.93), 0.85 (0.81, 0.89), 0.88 (0.84, 0.91), and 0.91 (0.85, 0.98) for ≤1-3 servings/mo, 1 serving/wk, 2-4 servings/wk, and >4 servings/wk in women (P-trend = 0.34), respectively. For men, the corresponding HRs (95% CIs) were 0.99 (0.94, 1.03), 0.98 (0.91, 1.05), 1.04 (0.98, 1.10), and 1.05 (0.95, 1.16), respectively. We further noted inverse associations for cancer mortality (multivariable-adjusted HR comparing extreme categories: 0.87; 95% CI: 0.78, 0.98; P-trend = 0.04) and CVD mortality (HR: 0.92; 95% CI: 0.79, 1.08; P-trend = 0.41) in women, although the latter was attenuated in the multivariable-adjusted model. Replacement of 1 serving/d of yogurt with 1 serving/d of nuts (women and men) or whole grains (women) was associated with a lower risk of all-cause mortality, whereas replacement of yogurt with red meat, processed meat (women and men), and milk or other dairy foods (women) was associated with a greater mortality.

Conclusions: In our study, regular yogurt consumption was related to lower mortality risk among women. Given that no clear dose-response relation was apparent, this result must be interpreted with caution.

_________________________

I rest my case.

I started my full-time research into so-called alternative medicine (SCAM) at Exeter in 1993. It became soon clear to me that the most urgent subject to investigate was the safety of SCAM. Safety is more important than efficacy for treatments that are already out there. My decision to prioritise safety quickly led to the bewilderment of the SCAM community. They pointed out that SCAM was safe and that the true risks in healthcare were with conventional medicine. Belief was strong, but data were scarce.

My counter arguments therefore were:

  1. Safety is too important a subject to leave it to belief, and we need evidence.
  2. SCAM is hugely popular and it was my ethical duty to provide data on safety.

The SCAM community were unconvinced by my logic. But that did not stop me.

In the course of dozens of investigations, we then found that adverse effects of SCAM do exist and some can be quite dramatic. Again, I was told that this might be so, but the real dangers surely lie elsewhere, namely in conventional medicine.

Meanwhile, I began to find that, while the direct risks of SCAM were real, the indirect risks were much more important. During virtually every talk I gave and in most papers I published, I started including this message:

EVEN A HARMLESS SCAM WILL BECOME LIFE-THREATENING, IF IT IS USED AS AN ALTERNATIVE TO CONVENTIONAL CARE FOR A SERIOUS CONDITION.

Even though the statement seems quite clear, it does not really capture the complexity of the issues involved. Let’s take (yet again) the example of homeopathy (because it is one of the most clear-cut cases).

The remedy is normally harmless; after all it contains nothing. Therefore, there are no or very few adverse effects. If a patient is naïve enough to use homeopathy in an attempt to cure a life-threatening condition, it is hardly the fault of homeopathy – at least this is what some defenders of the homeopathic realm claim. So why blame homeopathy?

Indeed, this could be unfair, because then we would have to say that water is dangerous because you can easily kill yourself with it.

But the water companies do not recommend abusing water for suicidal purposes!

And homeopaths do unquestionably recommend homeopathy for serious conditions!

So, it is not the remedy and not homeopathy itself that makes it dangerous. What makes it risky is the combination of two things:

  1. the inertness of the remedy
  2. the unsubstantiated claims that are being made for it.

The two together create a potentially deadly mixture. Without false claims, nobody could classify homeopathy as life-threatening. Due to the plethora of false claims, nobody can reasonably deny that it is.

What follows is simple, I think: one would only need to stop the claims. Subsequently, homeopathy – and many other forms of SCAM – could be classified as harmless (yes, I know, this is purely theoretical because in practice this will never happen). They would still be ineffective, of course, but safety was and is the priority.

In a recent 3-part series of posts, I have demonstrated how very unconvincing the evidence for acupuncture really is. But new studies emerge all the time and many of them suggest that acupuncture does work. Take this one, for instance.

This new study compared the effects and safety of acupuncture for the treatment of irritable bowel syndrome (IBS) with those of polyethylene glycol (PEG) 4000 and pinaverium bromide.

This multicentre randomized clinical trial was conducted in 7 hospitals in China. The researchers enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018. Participants were first stratified into constipation-predominant or diarrhoea-predominant IBS groups. Patients from each group were randomly assigned in a 2:1 ratio to receive acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide (150 mg/d, for IBS-D) over a 6-week period, followed by a 12-week follow-up. The primary outcome was the change in total IBS-Symptom Severity Score from baseline to week 6.

531 patients were randomized and 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set. From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and by 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group. The between-group difference was 28.78 (95% CI, 16.84 to 40.72; P<.001). No participant experienced severe adverse effects.

The authors concluded that acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.

I am not impressed by this study.

Here are a few reasons why:

  • There was no attempt to control for placebo effects or to blind patients. The placebo response rate varies in randomized controlled trials of IBS from 20 to 70% and can persist for up to 1 year based and does not wane after 1 or 2 months.
  • The design of the study is odd. I suspect that, as an equivalence trial with 175 patients in the control group which was split up into two sub-groups, it may have been under-powered.
  • The control treatments might not be as effective as the authors try to make us believe. This could be particularly true, if the allocation to the two sub-groups within the control group was suboptimal.
  • According to previous studies, acupuncture does not seem to have specific effects in IBS. The current Cochrane review concluded that 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.

I think that this study shows just one very unsurprising phenomenon: spending a total of 9 extra hours with empathetic therapists (who must have been highly motivated to encourage patients to experience less symptoms) has a positive effect on IBS patients – no matter what treatment the therapist might apply. I find it regrettable that supposedly decent journals publish such papers without even the slightest attempt of a critical discussion of its findings.

Homeopathy International‘, is a London-based membership organisation which connects practitioners of homeopathic medicine, homeopathy colleges and the homeopathy profession. They currently issue the following ‘COVID-19 advice‘:

Homeopathic medicines have a long history of use in respiratory tract infections, infections with flu-like symptoms and in epidemics.

Homeopathy is a system of medicine that is individualised for each person rather than for a named disease, however there are a group of remedies that are frequently used in flu-like and respiratory tract infections.

Choose the homeopathic medicine that best fits your particular symptoms.

Commonly used homeopathic remedies for influenza – like symptoms.

Aconite: When it starts suddenly, a fever with chilliness, throbbing pulses, Feeling restless and anxious. After being out in cold dry weather and bitter winds.

Gelsemium: The opposite of Aconite. Comes on slowly. A feeling of heaviness and tiredness in the body and limbs, head feels to heavy to hold up. Chills in the back. A bursting headache. No thirst.

Bryonia: Comes on slowly. Thirsty for cold drinks. Headache, irritability, wants to be in own home, left alone. Everything is worse for movement and better for pressure.

Eupatorium perf:  Severe aches in limbs and back, a feeling “like broken bones”.  Dare not move for pain. A bursting headache. Sore eyeballs. Feels better for talking to someone.

Baptisia: Rapid onset, then falls into a kind of stuporous state with a red face and looks drugged. Falls asleep while talking. May be strange feelings as if limbs are distorted or out of place. May be vomiting and diarrhoea and mucous in the chest.

I am lost for words when I read such irresponsible nonsense. And my amazement is not reduced by studying the rest of their website:

… We provide the public with the facts about homeopathy so they can understand its potential as a viable alternative, and explain the ongoing threat at work to prevent patient access to this safe, effective, sustainable system of medicine.

Our six member Steering Committee is made up of homeopathic practitioners both medical and professional and patients who between them have worked with homeopathic medicine for more than 170 years. They have witnessed its potential as well as the campaign waged against it, and as a group are committed to protect access to this precious alternative at a time when it is needed more than ever…

It is not widely known but as a patient it is your right to choose the kind of medicine you want to use to resolve your issues and maintain your health. Your GP is legally obliged to provide you with information about options so that you can make an informed choice. That is your legal right and your GP’s legal obligation…

Our Steering Group is composed of:

Michael O’Brien Acting Lay Chair
Paul Burnett Communication Lead
Carol Boyce Education Lead
Dr Noel Thomas Practitioner Representative
Karyse Day Lay Representative
Barry Tanner Regulatory Adviser
Ursula Kraus-Harper Specialist Adviser EASE

I feel that these people should be ashamed of themselves.

Do they not have a code of ethics?

Yes they do!

Here it is:

As a member of Homeopathy International, you are personally accountable for your practice. In caring for patients and clients you must:

♦   Respect the patient or client as an individual and honour their integrity as well as respecting their customs, creed, race, ability, sexuality, economic status, lifestyle, political beliefs and religion.

♦   Obtain consent before you give any treatment or care and work according to holistic principles.

♦   Protect confidential information.

♦   Recognise the value of other therapies and health care professionals, both within complementary and conventional medicine and work with other practitioners and refer when it is in the patient’s/client’s best interests. A practitioner must not treat a patient/client in any case which exceeds his/her capacity, training, and competence.

♦   Maintain your professional knowledge and competence on a continuous basis so that you may offer the very best standard of treatment.

♦   Be trustworthy and not exploit the patient or client. Members must maintain the highest morals and behave with courtesy, respect, dignity, discretion and tact.

♦   Act to identify and minimise risk to patient and clients.

These people clearly violate their own code of ethics in more than one way:

  • they do not behave morally,
  • they do not offer the best standard of treatment,
  • they lack the competence to advise the public about the current pandemic.

YES, YOU GUESSED IT: I FEEL SICK!

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