hay fever

Seasonal allergic rhinitis (hay fever) is a common condition which can considerably reduce the quality of life of sufferers. Homeopathy is often advocated – but does it work?

A new study was meant to be an “assessment of the clinical effectiveness of homeopathic remedies in the alleviation of hay fever symptoms in a typical clinical setting.”

The investigator performed a ‘clinical observational study’ of eight patients from his private practice using Measure Yourself Medical Outcome Profile (MYMOP) self-evaluation questionnaires at baseline and again after two weeks and 4 weeks of individualized homeopathic treatment which was given as an add-on to conventional treatments.

The average MYMOP scores for the eyes, nose, activity and wellbeing had improved significantly after two and 4 weeks of homeopathic treatment. The overall average MYMOP profile score at baseline was 3.83 (standard deviation, SD, 0.78). After 14 and 28 days of treatment the average score had fallen to 1.14 (SD, 0.36; P<0.001) and 1.06 (SD, 0.25; P<0.001) respectively.

The author concluded as follows: Individualized homeopathic treatment was associated with significant alleviation of hay fever symptoms, enabling the reduction in use of conventional treatment. The results presented in this study can be considered as a step towards a pilot pragmatic study that would use more robust outcome measures and include a larger number of patients prescribed a single or a multiple homeopathic prescription on an individualized basis.

It is hard to name the things that are most offensively wrong here; the choice is too large. Let me just list three points:

  • The study design is not matched to the research question.
  • The implication that homeopathy had anything to do with the observed outcome is unwarranted.
  • The conclusion that the results might lend themselves to develop a pilot study is meaningless.

The question whether homeopathy is an effective therapy for hay fever has been tested before, even in RCTs. It seems therefore mysterious why one needs to revert to tiny observational studies in order to plan a pilot, and even less for an assessment of effectiveness.

There are few conditions which are more time-dependent than hay fever. Any attempt of testing the effectiveness of medical interventions without a control group seems therefore not just questionable but wasteful. Clinical studies absorb resources; even if the author was happy to waste his time, he should not assume that he can freely waste the time, effort and availability of his patients.

Two final points, if I may:

  • An observational study of homeopathy for hay-fever without a control group might be utterly useless but it is still an investigation that requires certain things. As far as I can see, this study did not even have ethics approval nor is there a mention of informed consent. Strictly speaking, this makes it an unethical study.
  • If we allow research of this nature to take place and be published, we give clinical research a bad name and undermine the confidence of the public in science.

I am puzzled how such a paper could pass peer review and how an Elsevier journal could even consider publishing it.

The ‘ALTERNATIVE MEDICINE SOCIETY’ claims to be a ‘a global network of medical practitioners and contributors who scour the best research and findings from around the world to provide the best advice on alternative, holistic, natural and integrative medicines and treatments for free.’

Sounds great!

They even give advice on ‘7 common diseases you can treat through natural medicine.’ This headline fascinated me, and I decided to have a closer look at what is being recommended there. The following is copied from the website which looks to me as though it was written by a naturopath. My comments appear dispersed in the original text and are in bold.

Despite an exponential research advancement in recent years, we’re finding more and more problems with conventional medicine – from reports of fraud, to terrible medicinal side effects, to bacterial tolerance to antibiotics. Thus, it’s no surprise that more and more people are looking towards more natural medicine for disease management. Many people are seeking solutions which are not only inexpensive, but are also less harmful. Did you know that a lot of the medical conditions suffered by patients today can be adequately treated with natural medicine? Here are seven diseases you can treat through natural medicine:

  1. High blood pressure/hypertension

High blood pressure, or hypertension, is a condition most of us are really familiar with. It’s a risk factor, not a ‘disease’. Defined as the elevation of blood pressure in systemic arteries, hypertension left untreated could lead to serious, possibly fatal complications such as strokes and heart attacks. Conventional treatments for hypertension usually include a cocktail of several drugs (no, good conventional doctors start with life-style advice, if that is not successful, one adds a diruretic, and only if that does not work, one adds a further drug) consisting of vasodilators, alpha/beta blockers, and enzyme inhibitors. However, hypertension can be managed, and altogether avoided with the use of natural medicine. Alternative treatments involve lifestyle changes (e.g. intentionally working out, alcohol intake moderation), dietary measures (e.g. lowering salt intake, choosing healthier food options), and natural medicine (e.g. garlic). As pointed out already, this is the conventional approach! Unfortunately, it often does not work because it is either not sufficiently effective or the patient is non-compliant. Altogether alternative treatments play only a very minor (many experts would say no) role in the management of hypertension.

  1. Arthritis

Arthritis literally translated from Greek, means joint (arthro-) inflammation (-itis). There are two main categories of arthritis: inflammatory and degenerative, and they need to be managed differently. This condition is common in old patients, due to prior dietary choices (diet is not important enough to be mentioned on 1st place), and the natural wearing out of joint structures. Doctors typically prescribe anti-inflammatory drugs (e.g. steroids) to reduce irritation, and pain relievers (e.g. analgesics) for managing the pain. On the other hand, natural medicine could do an equally effective job in treating arthritis, through the use of several herbs such as willow, turmeric, ginger, and capsicum. It is not true that these herbs have been shown to be of equal effectiveness. Research has also shown that lifestyle measures such as weight loss (that would be the advice of conventional doctors), and other natural treatments such as acupuncture (not very effective for degenerative arthritis and ineffective for inflammatory arthritis) and physical therapy (that is conventional medicine), also lessen pain and inflammation in patients. Altogether alternative treatments play only a very minor role in the management of arthritis.

  1. Bronchitis

Bronchitis may be defined as the irritation, or swelling of the bronchial tubes connecting our nasal cavity to our lungs commonly cause by infections or certain allergens (that would be asthma, not bronchitis). Patients with bronchitis typically deal with breathing difficulties, coughing spells, nasal congestion, and fever. There are usual prescriptions for bronchitis, but there are also very effective natural medicine available. Natural medicine include garlic, ginger, turmeric, eucalyptus, Echinacea, and honey. None of these have been shown by good evidence to be ‘very effective’! These herbs may be prepared at home as tonics, tea, or taken as is, acting as anti-microbial agents for fighting off the infections. Altogether alternative treatments play only a very minor role in the management of bronchitis.

  1. Boils

Boils are skin infections which occur as pus-filled pimples in various parts of the body. Despite being highly contagious and painful, boils can easily be treated with natural medicine. Some of the herbs proven to be effective in treating boils include Echinacea, turmeric, garlic, and tea tree oil, due to the presence of natural chemicals which have antibiotic capacities. There is no good evidence to support this claim. Repeated exposure to topical application of these natural medicine is guaranteed to cure your boils in no time. Altogether alternative treatments play only a very minor role in the management of boils.

  1. Eczema

Eczema is also a skin condition resulting from allergic reactions which are typically observed as persistent rashes. The rashes are usually incredibly itchy, showing up in the most awkward places such as the inside of the knees and thighs. Thankfully, eczema can be managed by lifestyle measures (such as avoiding certain foods which elicit allergies – these measures would be entirely conventional and require conventional allergy testing to be effective), and natural medicine. These includes herbal components such as sunflower seed oil, coconut oil, evening primrose oil and chamomile. There is no good evidence to show that these therapies are effective. These natural medicine contain different active ingredients which are not only able to moisturize the affected skin, but are also able to reduce inflammation and soothe itchiness. Altogether alternative treatments play only a very minor role in the management of eczema.

  1. Constipation

Constipation is a normal (??? why should it be normal???) medical condition in which patients are unable to empty bowels at ease. It may be caused by a wide variety of reasons such as bowel stricture, hyperparathyroidism, or simply a case of terrible (???) food choices. However, it can very easily be treated with natural medicine. Some common remedies are molasses, sesame seeds, fiber, ginger or mint tea, lemon water, prunes, castor oil (an old-fashioned and largely obsolete conventional treatment) and coffee (for none of the other treatments is there good evidence). The action of these natural medicine involves laxative effects which stimulate contractions along the colon which incidentally moves your bowels along. Conventional doctors would recommend life-style changes and would warn patients NOT to use laxatives long-term. Altogether alternative treatments play only a very minor role in the management of constipation.

  1. Hay Fever

Allergic rhinitis, as hay fever is also known, are allergic reactions to certain particles like dust or pollen which incite coughing sprees, sneezing spells, and congested sinuses. There are very good natural medicine options for treating hay fever, which contain ingredients which act the same way as your conventional anti-histamine drugs. If they act the same way, what would be their advantage? Some of the natural medicine used to treat hay fever include chamomile, ginger, green, and peppermint teas, as well as butterbur, calendula, and grapefruit. Butterbur is the only one in this list that is supported by some evidence. Altogether alternative treatments play only a very minor role in the management of hay fever.

In essence, none of the 7 ‘diseases’ can be treated effectively with any of the alternative treatments recommended here. ‘The best advice on alternative, holistic, natural and integrative medicines and treatments’, it seems to me, is therefore: AVOID CHARLATANS WHO TELL YOU THAT ALTERNATIVE TREATMENTS ARE MORE EFFECTIVE THAN CONVENTIONAL MEDICINE. 

Clinical trials of acupuncture can be quite challenging. In particular, it is often difficult to make sure that any observed outcome is truly due to the treatment and not caused by some other factor(s). How tricky this can be, shows a recently published study.

A new RCT has all (well, almost all) the features of a rigorous study. It tested the effects of acupuncture in patients suffering from hay fever. The German investigators recruited 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. In total, 422 patients with IgE sensitization to birch and grass pollen were randomized into three groups: 1) acupuncture plus rescue medication (RM) (n= 212), 2) sham acupuncture plus RM (n= 102), or 3) RM alone (n= 108). Twelve acupuncture sessions were provided in groups 1 and 2 over 8 weeks. The outcome measures included changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMs) from baseline to weeks 7, 8 and 16 in the first year as well as week 8 in the second year after randomization.

Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score and RMS. There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over  sham were noted.

Based on these results, the authors concluded that “acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

The popular media were full of claims that this study proves the efficacy of acupuncture. However, I am not at all convinced that this conclusion is not hopelessly over-optimistic.

It might not have been the acupuncture itself that led to the observed improvements; they could well have been caused by several factors unrelated to the treatment itself. To understand my concern, we need to look closer at the actual interventions employed by the investigators.

The real acupuncture was done on acupuncture points thought to be indicated for hay fever. The needling was performed as one would normally do it, and the acupuncturists were asked to treat the patients in  group 1 in such a way that they were likely to experience the famous ‘de-qi’ feeling.

The sham acupuncture, by contrast, was performed on non-acupuncture points; acupuncturists were asked to use shallow needling only and they were instructed to try not to produce ‘de-qi’.

This means that the following factors in combination or alone could have caused [and in my view probably did cause] the observed differences in outcomes between the acupuncture and the sham group:

1) verbal or non-verbal communication between the acupuncturists and the patient [previous trials have shown this factor to be of crucial importance]

2) the visibly less deep needling in the sham-group

3) the lack of ‘de-qi’ experience in the sham-group.

Sham-treatments in clinical trials serve the purpose of a placebo. They are thus meant to be indistinguishable from the verum. If that is not the case [as in the present study], the trial cannot be accepted as being patient-blind. If a trial is not patient-blind, the expectations of patients will most certainly influence the results.

Therefore I believe that the marginal differences noted in this study were not due to the effects of acupuncture per se, but were an artifact caused through de-blinding of the patients. De facto, neither the patients nor the acupuncturists were blinded in this study.

If that is true, the effects were not just not clinically relevant, as noted by the authors, they also had nothing to do with acupuncture. In other words, acupuncture is not of proven efficacy for this condition – a verdict which is also supported by our systematic review of the subject which concluded that “the evidence for the effectiveness of acupuncture for the symptomatic treatment or prevention of allergic rhinitis is mixed. The results for seasonal allergic rhinitis failed to show specific effects of acupuncture…”

Once again, we have before us a study which looks impressive at first glance. At closer scrutiny, we find, however, that it had important design flaws which led to false positive results and conclusions. In my view, it would have been the responsibility of the authors to discuss these limitations in full detail and to draw conclusions that take them into account. Moreover, it would have been the duty of the peer-reviewers and journal editors to pick up on these points. Instead the editors even commissioned an accompanying editorial which displays an exemplary lack of critical thinking.

Having failed to do any of this, they are in my opinion all guilty of misleading the world media who reported extensively and often uncritically on this new study thus misleading us all. Sadly, the losers in this bonanza of incompetence are the many hay fever sufferers who will now be trying (and paying for) useless treatments.

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