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

systematic review

This systematic review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).

Eleven trials involving 921 participants were included. Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. The findings reveal:

  • High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p=0.004).
  • There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p=0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p=0.11).
  • Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p=0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p=0.008) at the endpoint intervention.
  • There was no evidence indicating the association between pain reduction and different types of cupping (p=0.2).
  • Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p=0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p=0.78) at the endpoint intervention.
  • Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p<0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p=0.29).
  • A potential association between pain reduction and different cupping locations (p=0.05) was found.
  • Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n=8; d=1.8 [95% CI: 1.22 – 2.39], p<0.001) and usual care (n=5; d=1.07 [95% CI: 0.21- 1.93], p=0.01).
  • Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 hours, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p<0.001).
  • Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p=0.03).
  • There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p=0.39).
  • A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).

The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The real therapeutic effects of cupping could be confirmed using a sham device or objective outcome measurements. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.

Confused?

No need, it’s really quite simple: cupping can, according to this review, be shown to have some short-lasting effect, provided the study is flawed and does not control for placebo effects.

Surprised?

No need! There is hardly a form of so-called alternative medicine (SCAM) that does not have a similarly small effect of back pain, if tested in equally dodgy studies. This is particularly true for those treatments that can act as a theatrical placebo, e.g. acupuncture or chiropractic.

So, should a back pain sufferer try cupping?

If he/she insists, why not? But please don’t use wet cupping (which can do quite a bit of harm). Dry cupping (without injuring the skin) is arguably better (less risk, less expense, possibility of home treatment by your partner) than chiropractic, osteopathy, acupuncture, or many other SCAMs.

My conclusions – as mentioned many times previously – are as follows:

  1. Most SCAMs help a little with back pain (and similar conditions) because they can have a powerful placebo effect.
  2. Conventional medicine is also not convincingly effective for back pain.
  3. If you insist on SCAM, it is best to use one that is relatively harmless and inexpensive.

The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:

  • education programs that support knowledge and self-care strategies;
  • exercise programs;
  • some physical therapies, such as spinal manipulative therapy (SMT) and massage;
  • psychological therapies, such as cognitive behavioural therapy; and
  • medicines, such as non-steroidal anti-inflammatory medicines.

The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:

  • lumbar braces, belts and/or supports;
  • some physical therapies, such as traction;
  • and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.

As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:

Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.

The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.

The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.

Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.

The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.

The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.

The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.

___________________________

This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:

WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.

That explains a lot!

It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).

The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.

Why?

Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?

The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.

Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.

 

The purpose of this systematic review was to assess the effectiveness and safety of conservative interventions compared with other interventions, placebo/sham interventions, or no intervention on disability, pain, function, quality of life, and psychological impact in adults with cervical radiculopathy (CR), a painful condition caused by the compression or irritation of the nerves that supply the shoulders, arms and hands.

A multidisciplinary team autors searched MEDLINE, CENTRAL, CINAHL, Embase, and PsycINFO from inception to June 15, 2022 to identify studies that were:

  1. randomized trials,
  2. had at least one conservative treatment arm,
  3. diagnosed participants with CR through confirmatory clinical examination and/or diagnostic tests.

Studies were appraised using the Cochrane Risk of Bias 2 tool and the quality of the evidence was rated using the Grades of Recommendations, Assessment, Development, and Evaluation approach.

Of the 2561 records identified, 59 trials met the inclusion criteria (n = 4108 participants). Due to clinical and statistical heterogeneity, the findings were synthesized narratively.

There is very-low certainty evidence supporting the use of:

  • acupuncture,
  • prednisolone,
  • cervical manipulation,
  • low-level laser therapy

for pain and disability in the immediate to short-term, and

  • thoracic manipulation,
  • low-level laser therapy

for improvements in cervical range of motion in the immediate term.

There is low to very-low certainty evidence for multimodal interventions, providing inconclusive evidence for pain, disability, and range of motion.

There is inconclusive evidence for pain reduction after conservative management compared with surgery, rated as very-low certainty.

The authors concluded that there is a lack of high-quality evidence, limiting our ability to make any meaningful conclusions. As the number of people with CR is expected to increase, there is an urgent need for future research to help address these gaps.

I agree!

Yet, to patients suffering from CR, this is hardly constructive advice. What should they do vis a vis such disappointing evidence?

They might speak to a orthopedic surgeon; but often there is no indication for an operation. What then?

Patients are bound to try some of the conservative options – but which one?

  • Acupuncture?
  • Prednisolone?
  • Cervical manipulation,?
  • Low-level laser therapy?

My advice is this: be patient – the vast majority of cases resolves spontaneously regardless of therapy – and, if you are desperate, try any of them except cervical manipulation which is burdened with the risk of serious complications and often makes things worse.

So-called alternative medicine (SCAM) interventions are often being discussed as possible treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This review aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review.

A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.

A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from neuropsychiatric disorders, olfactory dysfunction, cognitive impairment, fatigue, breathlessness, and mild-to-moderate lung fibrosis. The main interventions reported were self-administered transcutaneous auricular vagus nerve stimulation, neuro-meditation, dietary supplements, olfactory training, aromatherapy, inspiratory muscle training, concurrent training, and an online breathing and well-being program.

The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on SCAM for long COVID are warranted in the future.

The review’s aim is, in my view, nonsense. SCAM is a diverse field which means that the review must capture a wide range of therapies each represented by just one or two primary studies. In turn, this means that general conclusions across all SCAM will be highly questionable, if not misleading.

Furthermore, I find these conclusions odd and irresponsibly misleading. My main reason for this is the poor methodological quality of the primary studies:

  • Four trials were considered to have unknown bias risk for generating the random sequence due to insufficient information about the specific method of randomization used.
  • Only 5 of the trials provided appropriate random allocation concealment.
  • Only 5 trials were blinded to both participants and personnel.
  •  Three trials were rated as unknown risk of bias since insufficient information was provided.
  • Four trials failed to performed outcome assessment blinding.
  • One trial did not report detailed information about drop-out cases and was defined as high risk of bias. 
  • Three study protocols were unavailable and had relevant outcomes that were not reported in the pre-specified way.

Moreover, safety cannot possibly be reliably estimated on the basis of the data. And finally, the statement that SCAM interventions may be effective, as the authors put it, is in my view not a valid conclusion but a silly platitude.

I therefore suggest to re-formulate the conclusion of this review as follows:

At present there is no sound evidence to assume that any SCAM intervention is effective in the management of long COVID.

That proponents of anthroposophic medicine have strange attitudes towards established and effective immunizations is hardly a secret. The authors of this review defined anthroposophic communities as people following some/certain views more or less loosely connected to the philosophies of anthroposophy. Their systematic review firstly collated evidence documenting outbreaks linked to anthroposophic communities.

A total of 18 measles outbreaks occurred between 1997 and 2011 in European countries. Eight out of 18 measles outbreaks started at Waldorf schools throughout Germany, Switzerland, Austria, Netherlands, and the UK. Although data from community reporting was limited, the measles cases at Waldorf schools were predominantly higher than in mainstream private or state schools across the five countries. Offering measles vaccination catch-ups by public health authorities (which is an effective way to manage a measles outbreak) was described in several articles but was largely refused by both parents and Waldorf schools. The most effective outbreak control strategy was the immediate closure of the Waldorf school and strict rules regarding entry to the school upon reopening.

Secondly, the review summarized the literature on vaccination coverage in anthroposophic communities. Six articles described vaccine coverage in anthroposophic communities, and one article described the personal belief exception (PBE) rate at Waldorf school in the USA. The papers focussed predominantly on diphtheria, pertussis, tetanus and poliomyelitis (DPTP), and mumps, measles and rubella (MMR) vaccines. Two studies studying the vaccination coverage at Waldorf pre-schools/schools, demonstrated overall low immunization coverage at those schools. One article focusing on PBE rates demonstrated a proportionally high rate at Waldorf schools in California. Three studies from the Netherlands measure vaccination coverage in general and focussed specifically on whether there were special groups that showed specifically low coverage. In these studies, anthroposophic communities were identified as showing low coverage. However, one study suggested that anthroposophic communities are not as significant in terms of low coverage as low-income groups. One paper described rates of vaccination refusal in Switzerland. It showed that complementary alternative medicine users, including people who draw on anthroposophic medicine, are more likely to refuse vaccination. However, the paper also shows that this group was more likely to vaccinate against tick-borne diseases and encephalitis than the general population.

Thirdly, the review discussed the literature that summarized theories and factors influencing vaccine decision-making in anthroposophic communities. Eight articles examining factors and theories influencing vaccine decision-making in anthroposophic communities were included. Five articles focused on parents of children attending Waldorf schools or who considered themselves part of an anthroposophic community. Three articles focused on the perspectives of anthroposophic healthcare providers, although two of those articles mixed and compared views with other alternative/complementary providers or allopathic health providers. Of the eight articles, two were quantitative and did not provide an in-depth discussion. The qualitative findings from six articles were summarized in-depth and revealed four themes.

The authors concluded that this systematic review showed that there have been several measles outbreaks linked to anthroposophic communities in Europe. Although studies on vaccination coverage in anthroposophic communities are limited, it appears that coverage is lower than in the general population. Monitoring outbreak numbers and vaccination coverage could be important. Popular beliefs about the anthroposophic communities’ vaccination beliefs are challenged in this review. As the evidence shows the communities are not categorically against vaccines. Moreover, there are a myriad of factors that influence vaccine decision-making of parents belonging to an anthroposophic community. The importance of experiencing childhood illnesses and concerns over long-term side effects were mentioned. Moreover, parents want to be able to individually select vaccines for their children. They consider themselves actively engaged in vaccine decision-making and well-informed. Stigma regarding vaccine choices was mentioned repeatedly mostly by people outside of the anthroposophic community but also by people within the community. This review calls for a better understanding of vaccine choices and beliefs for vaccines beyond MMR, in particular HPV vaccines. The review also highlights a potentially important research gap, which constitutes understanding not only a belief system but the role that stigma may play in making decisions about vaccines.

_____________________________

If you ask where this strange anti-vaccination stance of anthroposophic medicine comes from, you don’t need to look far:

“In the future, we will eliminate the soul with medicine.

Under the pretext of a ‘healthy point of view’, there will be a vaccine by which the human body will be treated as soon as possible directly at birth,
(1) so that the human being cannot develop the thought of the existence of soul and Spirit.

To materialistic doctors, will be entrusted with the task of removing the soul of humanity.

As today, people are vaccinated against this disease or disease, so in the future, children will
(2) be vaccinated with a substance that can be produced precisely in such a way that people, thanks to this vaccination, will be immune to being subjected to the “madness” of spiritual life.

He would be extremely smart, but he would not develop a conscience, and that is the
(3) true goal of some materialistic circles.

With such a vaccine, you can easily make the etheric body loose in the physical body.
Once the etheric body is detached, the relationship between the universe and the etheric body would become extremely unstable, and man would become
(4) an automaton, for the physical body of man must be polished on this Earth by spiritual will.

So, the vaccine becomes a kind of arymanique [Ahrimanic] force; man can no longer get rid of a given materialistic feeling.
(5) He becomes materialistic of constitution and can no longer rise to the spiritual “.

Rudolf Steiner 

Certain aspects of yoga can be used as a non-pharmacological conservative therapeutic approach to the management of chronic low back pain (CLBP). This overview summarized and evaluated data from current systematic reviews (SRs) on the use of yoga for CLBP.

The researchers searched SRs on the use of yoga for CLBP in nine electronic databases from inception to September 2023. The methodological quality was evaluated using the Assessment of Multiple Systematic Review Scale-2 (AMSTAR-2). The reporting quality of the included SRs was evaluated using the Preferred Reporting Item for Systematic Review and Meta-Analysis-2020 (PRISMA-2020), and the quality of data was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Two independent researchers performed the screening, data extraction, and quality assessment process of SRs.

A total of 13 SRs were included. The results of the AMSTAR-2 indicated that the methodological quality of the included studies was relatively low. The PRISMA-2020 checklist evaluation results indicated that methodological limitations in reporting, especially regarding data processing and presentation, were the main weaknesses. The GRADE assessment indicated that 30 outcomes were rated moderate, 42 were rated low level, and 20 were rated very low level. Downgrading factors were mainly due to the limitations of the included studies.

The authors concluded that yoga appears to be an effective and safe non-pharmacological therapeutic modality for the Management of CLBP. Currently, it may exhibit better efficacy in improving pain and functional disability associated with CLBP. However, the methodological quality and quality of evidence for SRs/MAs in the included studies were generally low, and these results should be interpreted cautiously.

Sorry, but I beg to differ!

  • The safety of a therapy cannot be ascertained on the basis of such small sample sizes.
  • The effectiveness of yoga has not been demonstrated by these data.
  • All that has been shown with this review is that the quality of the research in this area is too poor for drawing conclusions.

I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):

Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].

Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:

  1. I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
  2. Successful concepts? Really?
  3. So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
  4. I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
  5. No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
  6. I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
  7. The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
  8. Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
  9. Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.

Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.

NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:

Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.

I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:

So, what do we make of this? I think that, on the basis of the evidence:

  • a positive recommendation for all types of chromic pain is not warranted;
  • a positive recommendation for the treatment of TTH is questionable;
  • a positive recommendation for migraine is questionable;
  • a positive recommendation for prostatitis is questionable;
  • a positive recommendation for hiccups is not warranted;
  • a positive recommendation for retinal migraine is not warranted.

But why did NICE issue positive recommendations despite weak or even non-existent evidence?

SEARCH ME!

 

 

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Omega-3 fatty acids (fish oil) supplementation reduces the occurrence of cardiovascular disease (CVD) and CVD-related mortality in patients at high-risk of CVD and in patients with elevated plasma triglyceride level. Yet, some studies have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results.

This review evaluated the effect of omega-3 fatty acids on the risk of AF. The results suggest that omega-3 fatty acids supplementation is associated with increased AF risk, particularly in trials that used high doses. Therefore, several factors should be considered before prescribing omega-3 fatty acids, including their dose, type, and formulation (fish, dietary fish oil supplements, and purified fatty acids), as well as patient-related factors and atrial mechanical milieu. Because the benefits of omega-3 fatty acids are dose-dependent, the associated AF risk should be balanced against the benefit for CVD. Patients who take omega-3 fatty acids, particularly at high doses, should be informed of the risk of AF and followed up for the possible development of this common and potentially hazardous arrhythmia.

Another recent review included 54,799 participants from 17 cohorts. A total of 7,720 incident cases of AF were ascertained after a median 13.3 years of follow-up. In multivariable analysis, EPA levels were not associated with incident AF, HR per interquintile range (ie, the difference between the 90th and 10th percentiles) was 1.00 (95% CI: 0.95-1.05). HRs for higher levels of DPA, DHA, and EPA+DHA, were 0.89 (95% CI: 0.83-0.95), 0.90 (95% CI: 0.85-0.96), and 0.93 (95% CI: 0.87-0.99), respectively.

The authors concluded that in vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF. Our data suggest the safety of habitual dietary intakes of omega-3 fatty acids with respect to AF risk. Coupled with the known benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption can be maintained.

Faced with contradictory results based on non-RCT evidence, we clearly need an RCT. Luckily such a trial has recently been published. It was an ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.

Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). The primary outcome was incident AF confirmed by medical record review.

Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).

The authors concluded that among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.

So, does the regular supplementation with omega-3 fatty acids increase the risk of atrial fibrillation? The evidence is not entirely clear but, on balance, I conclude that the risk is low or even non-existent.

Congratulations to Joseph Prahlow, MD, who is the winner of the Excellence in Homeopathy Award! Here are the conclusions of his winning essay. Special thanks to Hermeet Singh and Boiron for their prize donation.

Despite the many obstacles and challenges which face homeopathy in the 21st century, the homeopathic community should be emboldened and encouraged by the fact that there are also many opportunities for the advancement of homeopathy as an alternative choice in health care.

Proclaim the Truth:  Homeopathy Actually Works

Notwithstanding the challenges involved (especially for a student) in arriving at the correct simillimum for a case, let alone the appropriate follow-up and case management, the truth of the matter is that homeopathy does, in fact, work!  Those of us who have been the beneficiaries of homeopathic care, or who have seen the benefits in others, know with no doubt whatsoever that homeopathy represents a truly amazing form of alternative medicine that is able to successfully treat patients having a wide range of health concerns, including some very ill individuals. And it’s not just based on “experience” or “perception,” although such evidence should not be discounted.  Numerous studies show the effectiveness of homeopathy.6-9 The fact that homeopathy actually works represents one of the biggest and most important opportunities for homeopathy. The corresponding challenge relates to “getting the word out” into the general community as well as the medical community.  Instead of homeopathy being the “last resort,” it should increasingly become the “first choice” amongst patients. Only by “spreading the word” of its success can this become a reality.

What intrigued me here was the evidence that an award-winning homeopath believes might justify the claim that

“Numerous studies show the effectiveness of homeopathy”

6. Mathie RT, Lloyd SM, Legg LA, et al. Randomised placebo-controlled trials of individualized homeopathic treatment: systematic review and meta-analysis. Syst Rev. 2014 Dec 6;3:142. doi: 10.1186/2046-4053-3-142.

As we have discussed previously that meta-analysis is phoney and created a false-positive result by omitting at least two negative studies.

7. Taylor JA, Jacobs J. Homeopathic ear drops as an adjunct in reducing antibiotic usage in children with otitis media. Glob Pediatr Health 2014 Nov 21;1:2333794X14559395. doi: 10.1177/2333794X14559395.

This study had the notorious A+B versus B design and thus was unable to test for specific effects of homeopathy. Moreover, the lead author, Dr Jennifer Jacobs, was a paid consultant to Standard Homeopathic Company.

8. Sorrentino L, Piraneo S, Riggio E, et al. Is there a role for homeopathy in breast cancer surgery? A first randomized clinical trial on treatment with Arnica montana to reduce post-operative seroma and bleeding in patients undergoing total mastectomy. J Intercult Ethnopharmacol 2017 Jan 3;6(1):1-8. doi: 10.5455/jice.20161229055245.

This study showed no significant result in the intention to treat analysis. The positive conclusion seems to be based on data dredging only.

9. Frass M, Lechleitner P, Grundling C, et al. Homeopathic treatment as an add-on therapy may improve quality of life and prolong survival in patients with non-small cell lung cancer: a randomized, placebo-controlled, double-blind, three-arm, multic0-e1955enter study. Oncologist 2020 Dec 25(12):e1930-e1955. doi: 10.1002/onco.13548.

This study is since months under investigation for fraud. The reasons for this have been discussed previously.

Perhaps the award winning author should chance the crucial sentence into something like:

Numerous studies have shown how homeopaths try to mislead the public?

In any case, please do not let this stop you from reading the full paper by the award-winning author. I promise you that it will create much hilarity.

What does homeopathy offer our modern ailing world?

NOTHING!

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