Nasal allergies (a.k.a. Allergic Rhinitis, or hay fever) represent a frequent allergic disorder that reduces the sufferer’s quality of life, and has harsh economic implications in terms of healthcare costs and social productivity.

A 2003 retrospective study from Germany estimated that average annual cost of season allergic rhinitis was approximately €1,089 per child/adolescent and €1,543 per adult, considering direct medical and nonmedical costs. (Note: €1 = US $1.0503, on January 1, 2003, the day this study was published.) During the year under study, physicians were consulted about 11 and 15 times, respectively, for children/adolescents and adults, and medical services were accessed 10-20 times, in relation to allergic rhinitis.

Pollen Grains

Image Credit: Edna, Gil, and Amit Cukierman, Fox Chase Cancer Center, Philadelphia, via Life Online Exhibit of NIGMS Pollen grains: male germ cells in plants and a cause of seasonal allergies

In the US, 2005 estimates by the US Agency for Healthcare Research and Quality revealed that total expenditure to treat allergic rhinitis was over $11 billion. In 2010, 11 million doctor’s office visits were attributable to a diagnosis of allergic rhinitis. According to a 2011 review, on an average, every year 4 out of 10 children and 1-3 in 10 adults are afflicted with allergic rhinitis, representing 30-60 million individuals. In 2012, 9% (about 7 million) children and 7.5% (about 18 million) adults reported at least one instance of hay fever in the past year.

Clearly, a serious disorder afflicting many and with a substantial healthcare burden; and so, when this morning, I was alerted via Twitter to a week-old headline in the NPR, “Acupuncture May Help With Nasal Allergies, Doctors Say“, I took notice, because that is a significant claim.

NPR talked about treatments of allergic rhinitis to Dr. Sandra Yi-Sheng Lin, an associate professor of otolaryngology at the Johns Hopkins School of Medicine; Dr. Lin is an accomplished physician and researcher in allergy and rhinology, a fellow and erstwhile-president of the American Academy of Otolaryngic Allergy, and also one of the authors of the just-published 2015 allergic rhinitis clinical practice guidelines.

First, a bit about Allergic Rhinitis (AR); it is an inflammatory, immunological reaction mediated by a type of antibody called Immunoglobulin E (IgE) at the nasal mucosa (interior lining of the nose). The symptoms of this disorder, which usually occur following exposure to some allergen (e.g. animal dander, pollen, dust mites, mold spores), range from stuffy nose (congestion and/or obstruction), runny nose (rhinorrhea), nasal itching, post-nasal drip, and sneezing. The definitive diagnosis is made by the detection of a cutaneous response or elevation of serum IgE specific to a particular allergen.

AR may be triggered seasonally, episodically (e.g. allergen exposure in a non-home environment), or perennially/chronically – especially in people who are sensitized to multiple different allergens. The symptoms may vary in severity, as well as in frequency (intermittent or persistent); these factors often influence treatment decisions.

Treatment is usually initiated empirically, which often includes allergen avoidance via environmental control, along with pharmacological therapy. Diagnostic confirmation is usually post hoc, but may guide therapy in difficult, uncertain, or more severe cases. Medicines mostly seek to alleviate the symptoms (antihistamines, and/or moderate-dose steroids), failing which allergen-specific immunotherapy is recommended for typically 3-5 years. There is a significant body of evidence accumulated in favor of these treatment options – gathered from well-designed, good quality randomized controlled trials (RCTs) with subjects closely approximating the target population, as well as systematic reviews – which shows the therapy to be effective and beneficial.

Medical management may fail in rare cases, and in such situations, nasal surgery may be recommended. However, as the guidelines point out, the evidence base for this option is comparatively weak, depending upon only observational studies (even though significant benefit from surgery was indeed observed).

That brings me to another recommendation made in the guidelines: acupuncture, the topic that was highlighted in the NPR report. Dr. Lin was quoted as saying: “I’m telling you there is some evidence base for it.” Even though Dr. Lin didn’t provide any specifics as to said evidence, it is reasonable to assume that she meant the evidence which the guideline committee (comprised of ENT physicians, including Dr. Lin as an assistant chair, as well as primary care doctors and patients) sifted through while they deliberated on the recommendations for acupuncture.

There are some interesting points mentioned therein, which need to be considered – including the fact that the guideline committee considered the evidence quality to be of Grade B, which means it was garnered from RCTs with various limitations and observational studies where the effect was considered to be consistent.

  • A meta-analysis of alt-med use in rhinitis and asthma, published in 2006, found most studies to be of methodologically poor quality, and no clear evidence emerged for the efficacy of acupuncture in these conditions.
  • A 2009 systemic review of 12 RCTs (of variable qualities) found that acupuncture had no effect on the symptoms of seasonal AR, but appeared to have some positive effect on symptoms in perennial/chronic AR, and in neither type, was acupuncture superior to conventional medical therapy. More importantly, comparison of various placebo methods raised the possibility that the effect, if any, may be non-specific.
  • Most studies showing benefits of acupuncture in AR originate mainly in South Asian countries (where acupuncture is considered a valid therapeutic modality and actively promoted by the government), as well as in Germany and other European nations (where many alt-med modalities have significant traction; a German study of more than a decade ago, using telephone interviews, determined that a third of patients used some form of alternative medicine for various allergies (including AR), and about a fifth of these alt-med aficionados preferred acupuncture). A non-exhaustive list of these studies (mentioned in the guidelines) includes:
A 2004 RCT study of pediatric patients from Hong Kong which demonstrated that active acupuncture decreased the symptom score for AR better than did sham acupuncture. [NOTE: The needles were placed between the eyebrows, the top of the cheek skinfold where it meets the nose, and by the side of the knee; for the active acupuncture, the needles were inserted to the depth where the patient felt a burning sensation (interpreted as the achievement of ‘qi’ or life-force energy) for 20 minutes, whereas the sham treatment had only lightly penetrated needles causing no discomfort.]
  • Small study with 35-37 final participants in each group.
  • Participants also received an oral antihistamine as relief medication; during acupuncture treatment, the children in both groups, actual & sham, needed about one tablet every 5 days.
  • Objectively observable parameters, such as eosinophil counts and IgE levels, varied greatly within a group but remained similar between the groups.
  • As authors have pointed out, culturally-mediated selection bias is an important confounder. The outpatient setting of the therapeutic study likely introduced other uncontrollable variables.
A 2007 RCT study in Australia found decrease in symptom scores in perennial AR patients, greater in the acupuncture group than in sham.
  • Small study with approximately 40 subjects randomized to each group.
  • Participants also allowed conventional medication for symptomatic relief.
A large 2008 RCT study from Germany included both patients who were randomized to either acupuncture or delayed (by 3 months) acupuncture groups, and non-randomized patients who received acupuncture. The efficacies were semi-subjectively estimated using quality of life questionnaire scores, and at 3 months there were a small but significant lowering of scores in the acupuncture vs. the control group.
  • Some confounding factors were considered, especially how better education of the subject seemed to lower the scores. However, various other possible confounding factors were not accounted for.
  • There was no blinding in the study, and no accounting for selection bias; the patient pool was already biased towards acupuncture.
  • Possible effects of the additional conventional treatments that patients were allowed to use as needed.
  • Unaccounted for effects of variations in number of needles and acupuncture points
  • Arbitrary cut-off of scores used to determine clinical significance
  • No explanation for the observation of significant difference of scores in respect of sleep, symptoms, practical problems, activities, emotional states, and mental health between randomized and non-randomized groups at baseline; it appears as if the decision to be randomized per se provided health benefits (!), or more likely, more troubled patients in poorer health declined to be randomized, indicating a possible source of bias.
A 2013 RCT study from the same group in Germany focused on the seasonal AR.
  • The Editors included a word of caution: “The improvements were statistically significant but may not be clinically significant.”
Another smaller 2013 RCT study jointly by two South Korean and two Chinese centers looked at persistent AR, using a protocol in which real and sham acupuncture groups, as well as a no acupuncture group, were included and not given any conventional medication.
  • Small differences between active and sham acupuncture.
  • Sham acupuncture showed a significant reduction of symptoms by itself.

Interesting to note here is that, while treatment most certainly helps, AR symptoms may also be reversible spontaneously – which means that these symptoms, especially for seasonal allergies, may go away on their own. This is a clinical observation with various thoraco-pulmonary allergic, inflammatory conditions including asthma. Alt-med modalities have this neat trick of claiming clinical benefits in a disorder in which symptoms may resolve spontaneously – this is not the first time. I have earlier written about the claims of homeopathy in another largely self-correcting condition, hemorrhoids.

To me, additionally interesting is the fact that the panel members were not unanimous in their appreciation of acupuncture as a valid therapeutic modality, and they left it as an ‘Option’, as opposed to ‘recommendation’. The current rate of acupuncture use in the US to treat AR is not known; but as this guideline is adopted for treatment of AR, it is likely that the use of modalities like acupuncture, however unproven, will increase.

Acupuncture chart with a series of points indicated

Credit: Wellcome Trust images, under CC-BY-4.0 license, via Wikimedia Commons Acupuncture Chart with series of points indicated

Several decades of research (spending a king’s ransom of money), including clinical trials, have failed to unequivocally establish the benefit of acupuncture as a therapeutic modality for any condition. I focused in this post on AR; others have written on the claimed benefits in other conditions, such as pain. The perceived benefits (from clinical trials which appeared to show benefits) have uniformly been too small to be significant clinically. In 2013, Steven Novella and David Colquhoun argued conclusively in an editorial in favor of cessation of acupuncture as a therapeutic consideration, simply because it doesn’t work as claimed. And that is of little surprise, for acupuncture is an Eastern-mysticism-saturated modality which is based on prescientific misunderstandings of vertebrate anatomy, with low prior probability of efficacy. It exemplifies what Harriet Hall coined the term Tooth Fairy Science for.

Let’s take the examples of Tooth Fairy Science corresponding to the studies mentioned in the guidelines, which purport to provide a mechanistic explanation – currently unknown – for the claimed efficacy of acupuncture. A 1999 Swedish study treated a small number of patients of xerostomia (dry mouth) with acupuncture, and found a significant increase in a neuropeptide in the saliva following the treatment; interestingly, there were no sham or no-acupuncture control, making any unbiased interpretation difficult. Needles stuck on skin may well locally increase blood flow and stimulate nerve endings (similar to the principle behind the transcutaneous electrical nerve stimulation procedure), but where is the evidence that it is specific to the claimed neuropeptides or to the so-called acupuncture points of traditional Chinese medicine?

A few random studies from early to late 1990s (referred to in the guidelines) claim that acupuncture can modulate immunity via effects of several cytokines, but the evidence for such effects is rather poor (and I am not even going to touch acupuncture studies in mice), and the clinical correlates of such effect, if any, are unknown and unlikely. Many of the clinical studies claim persistent effect of acupuncture lasting for months to a year after cessation of therapy. I shudder to think what would happen to the internal homeostasis of the physiological system if claimed cytokines remain elevated or depressed for that long a time!

Yet – Oh, the humanity of it all! – “quackademic medicine” (hat tip to Dr. RW) marches on boldly under the silhouette of lofty-sounding terms, such as ‘holistic’, ‘integrative’, and the most compelling, ‘patient-centered’ (as if conventional medicine doesn’t care for patients). The pseudoscience of acupuncture continues to attract followers, amongst which are now counted, inexplicably, some major academic centers and hospitals in this country – including, sadly, my own institution.