Banerjee et al.

Systematic Reviews 2014, 3:59

http://www.systematicreviewsjournal.com/content/3/1/59

PROTOCOL Open Access

Homeopathy for allergic rhinitis: protocol for a

systematic review
Kushal Banerjee1*, Ceire Costelloe2, Robert T Mathie3 and Jeremy Howick4

Abstract
Background: Allergic rhinitis is a global health problem that is often treated with homeopathy. The objective of
this review will be to evaluate the effectiveness of homeopathic treatment of allergic rhinitis.
Methods/Design: The authors will conduct a systematic review. We will search Medline, CENTRAL, CINAHL,
EMBASE, AMED, CAM-Quest, Google Scholar and reference lists of identified studies up to December 2013.
The review will include randomized controlled trials that evaluate homeopathic treatment of allergic rhinitis. Studies
with participants of all ages, with acute or chronic comorbidities will be included. Patients with immunodeficiency
will not be included. The diagnosis will be based on the published guidelines of diagnosis and classification.
Studies of all homeopathy modalities (clinical, complex and classical homeopathy, and isopathy) will be included.
We will include trials with both active controls (conventional therapy, standard care) and placebo controls.
The primary outcomes are: an improvement of global symptoms recorded in validated daily or weekly diaries and
any scores from validated visual analogue scales; the total Quality of Life Score (such as the Juniper RQLQ);
individual symptoms scores which include any appropriate measures of nasal obstruction, runny nose, sneezing,
itching, and eye symptoms; and number of days requiring medication. Secondary outcomes selected will include
serum immunoglobin E (IgE) levels, individual ocular symptoms, adverse events, and the use of rescue medication.
Treatment effects will be measured by calculating the mean difference and the standardized mean difference with
95% confidence interval (CI) for continuous data. Risk ratio or, if feasible, odds ratio will be calculated with 95% CI
for dichotomous data. After assessing clinical and statistical heterogeneity, meta-analysis will be performed, if
appropriate. The individual participant will be the unit of analysis. Descriptive information on missing data will be
included about participants missing due to drop out, whether there was intention to treat or per protocol analysis
and missing statistics. A number of subgroups, homeopathic potency, age groups, and types of allergic rhinitis
(seasonal or perennial) will be analyzed. Sensitivity analysis will be performed to explore the impact of risk of bias
on overall treatment effect.
Systematic review registration: PROSPERO CRD42013006741
Keywords: Homeopathy, Homeopathic, Allergic, Allergy, Rhinitis, Hay fever, Pollinosis, Rhinorrhea, Hypersensitivity

Background (IgE)-mediated immunologic response of the nasal mu-

Description of the condition cosa to airborne allergens such as pollens, dust, or ani-
Rhinitis is described as inflammation of the nasal mucosa mal dander. Inhalation of allergens in individuals with
and includes common symptoms like nasal discharge, a sensitized immune system produces degranulation of
itching, sneezing, nasal blockage, or congestion. There are mast cells with the release of chemical mediators.
three types of rhinitis commonly seen in clinical practice: These mediators are responsible for the symptoms of
allergic, non-allergic, and infective. Mixed forms also AR. AR is clinically defined by the presence of rhinorrhea,
occur [1]. Allergic rhinitis (AR) is an immunoglobin E nasal obstruction, nasal itching, and sneezing which are
reversible spontaneously or with treatment [2]. Rhinitis af-
* Correspondence: [email protected] fects quality of life, performance and attendance at school
1
Dr. Kalyan Banerjee’s Clinic, I-1691 Chittaranjan Park, New Delhi 110019, [3], and work. It has significant impact on healthcare costs
India
Full list of author information is available at the end of the article [4]. Allergies are responsible for an estimated annual

© 2014 Banerjee et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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expenditure of one billion pounds in the National from the effects of longer consultations and other ‘context
Health Services in the United Kingdom [5]. Conven- effects’ [14,15]. Clinical homeopathy, on the other hand, is
tional treatment includes oral or topical antihistamines, delivered in much the same way that conventional drugs
intranasal or systemic corticosteroids, and allergen im- are prescribed. Complex homeopathy is similar to clinical
munotherapy. A cohort of 16-year-olds in the United homeopathy but more than one remedy is prescribed in a
Kingdom showed 23% to be suffering from hay fever in single formulation. Neither clinical nor complex homeop-
1986 [6]. athy requires lengthy and comprehensive homeopathic
AR is also a global health problem, affecting 500 mil- case-taking [16,17]. In both of these forms the interven-
lion patients worldwide (10 to 20% of the population) tion is linked to a disease state and not individualized for
[7]. It may commonly be caused by house dust mites, every patient. Clinical homeopathy, isopathy, and complex
pollen from grass, trees and weeds, and animal dander. homeopathy could also be more cost-effective and there-
AR can be broadly classified into seasonal and perennial. fore more feasible in environments with limited resources
AR has been found to significantly impair psychological such as India.
wellbeing and perceived to impair cognitive functioning A systematic review that includes clinical, complex
[8]. The prevalence of AR is also high in developing homeopathy and isopathy is therefore required to assess
nations: rhino-conjunctivitis was 15.3% amongst 11 to the benefits of homeopathy for treating AR.
15 year old school-going children in northern Africa [9].
In addition, there is growing evidence to support a link Methods/Design
between allergic rhinitis and asthma [10]. Description of the intervention
Several trials have evaluated the effectiveness of hom- The review will include trials of clinical, complex, isopathic,
eopathy for AR. Results from these trials are mixed and and classical homeopathy. Homeopathic remedies are de-
their quality is poor. One systematic review involving a fined as medicines listed in homeopathic materia medica
single homeopathic remedy (Galphimia glauca) for treat- (texts containing symptoms of homeopathic remedies) and
ing AR has been published in English [11]. Three out of prepared according to the homeopathic pharmacopoeia of
four studies included in that review reported significant the country in which the trial is being conducted.
results in favor of the intervention, however, it only in-
cluded one homeopathic medicine. Two important draw-
Objective
backs of this review are that of the included trials, neither
Our primary objective is to determine the efficacy and
used validated outcome measures nor intention-to-treat
effectiveness of homeopathic treatment of AR. Our sec-
analyses. Passalacqua et al. [12] conducted a systematic
ondary aim is to compare the effectiveness of different
review on complementary and alternative medicine for
forms of homeopathy on AR.
rhinitis and asthma, concluding that the evidence for a
specific effect of homeopathy is weak. Bellavite et al.
[13] conducted a descriptive review of clinical research Criteria for including studies for this review
on advances in homeopathy and immunology which Types of studies
included AR. No meta-analysis was performed in this Randomized, double-blinded (both patients and doctors
review. Apart from Ernst [11], no systematic review blinded), controlled trials comparing homeopathy (clas-
evaluating only homeopathic treatment for allergic sical, clinical, isopathic, or complex) with conventional
rhinitis has been published in English. treatment, other homeopathy, or placebo, for the treat-
ment of seasonal or perennial AR in patients of any
Why is it important to do this review? age.
No systematic review of all homeopathy modalities for
treating AR has been conducted. A problem with evaluat- Types of participants
ing classical homeopathy is that it involves an extensive All age groups (newborn to adult) suffering from any
consultation and an individualized treatment regimen. form of AR will be included. These may include partici-
Treatment regimens are decided based on disease state pants with acute or chronic comorbidities but without
and information gathered in the comprehensive homeo- immunodeficiency. Participants may also include those
pathic case-taking by a qualified homeopathic physician. on conventional treatment for other health issues. Symp-
Hence two patients with the same (conventional) diagno- toms of allergic rhinitis include rhinorrhea, nasal obstruc-
sis may receive very different homeopathic treatments. tion, nasal itching, and sneezing which are reversible
Classical homeopathy therefore involves more extensive spontaneously or with treatment [2]. A diagnosis of AR
consultations which themselves might have effects, at least will include the following symptoms based on the Guideline
for subjective outcomes. Hence apparent positive effects Summary of Management of Allergic and Non Allergic
of classical homeopathy might be difficult to disentangle Rhinitis [7]:
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Nose: nasal discharge (runny nose),sneezing, nasal The alleged difference between homeopathy type
blockage or congestion, and itchy nose and palate. Eye: (classical, clinical, and complex) is important and might
bilateral itchy eyes, red eyes (concomitant allergic con- be inadequately reported. To deal with this we will use
junctivitis), and swollen eyes. two strategies. First, we will examine individual studies
There is no specific duration of symptoms required for to verify the classification of homeopathy type (classical,
diagnosis; however, a very short or non-repetitive history clinical, complex, or isopathy) using standard defini-
of symptoms generally excludes a diagnosis of AR. The tions [16]. These are:
presence of any one of the nasal symptoms will be es-
sential for a diagnosis of AR except when nasal blockage ‘Classical [individualized] homeopathy: When a single
is the only symptom. Nasal blockage on its own rarely homeopathic remedy was selected based on the total
indicates allergy [2]. The duration of symptoms will not symptom picture of a patient.
be present as a criterion since this has not been defined
for a diagnosis of AR. Clinical homeopathy: When one or several single
remedies were administered for standard clinical
Exclusion criteria for systematic review situations or conventional diagnoses.
The exclusion criteria for this review are as follows: con-
ference proceedings and other abstracted articles in which Complex homeopathy: When multiple remedies were
risk-of-bias assessments cannot usefully be applied; studies mixed into a standard formula to ‘cover’ a person’s
in which a non-randomized method of sequence gener- symptoms and diagnoses.
ation and/or a single-blinded approach is explicitly used
by the authors; studies using formulations not described Isopathy: When serial agitated dilutions were made
by the authors as ‘homeopathic’; studies with a crossover from the causative agent in an infectious or
trial design; and studies in which homeopathy is combined toxicological condition’ (from Linde et al. [16]).
with another intervention.
The exclusion criteria for quantitative data extraction Therefore when classical homeopathy is used, any
(for meta-analysis are: studies from which no data are pro- homeopathic medicine may be selected based on com-
vided or data are otherwise not extractable. The latter cat- prehensive case taking. In clinical homeopathy, for ex-
egory includes studies with continuous outcomes from ample, Allium cepa (a common homeopathic remedy
which standard deviations are not derivable and those that from onions) may be prescribed based on indications
report non-parametric data only. that match the clinical picture of allergic rhinitis. In
complex homeopathy a preparation containing Luffa oper-
culata, Galphimia glauca, Histamine and Sulphur [19]
Investigations may be used to treat AR.
Investigations are not always required to confirm diagno- A preparation from an allergen such as Betula (birch)
sis. However, a confirmation of allergic rhinitis sometimes [20] is an example of an isopathic intervention for AR.
involves a skin prick test and/or specific and serum total In practice, medicines used by clinical homeopaths may
IgE tests [18]. The use of investigations for confirming also be prescribed by classical homeopaths should they
diagnosis will not be an inclusion criterion. Trials allowing be indicated after comprehensive case-taking. By classi-
the administration of conventional treatment as a rescue fying included studies according to type of homeopathy,
medication will be included. this review will inform practitioners for the first time
about homeopathic medicines according to homeopathy
Types of interventions type for AR.
We will include trials involving experimental homeopathic The current authors’ classification, made according to
treatments delivered orally, through olfaction, or applied these published definitions, will override reported clas-
on the body. Therefore, globules, nasal sprays, ointments, sifications where appropriate. Second, we will conduct a
and other applications prepared with homeopathic medi- subgroup analysis to detect any differences between
cines will be included in this review. In these trials the homeopathy types for any outcome measure. If a particu-
homeopathic preparations may contain a single medicine lar type fails to demonstrate a statistically significant bene-
or more than one medicine as in complex homeopathy, fit over another then the debate over homeopathy types
the homeopathic interventions may be administered as becomes moot. On the other hand, if we do find a statisti-
one single preparation or more than one preparation, and cally significant difference in effects then we will have
the comparators in the included trials will be placebos or shown the importance of specifying homeopathy type.
conventional treatment which may include antihistamines, There will be no limit on the maximum dilution of the
immunotherapy, and decongestants and so forth. homeopathic medicine. Trials with homeopathic ‘mother
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tinctures’ will be included in this review as part of sub- Table 1 Search strategy: homeopathy for allergic rhinitis
group analyses (see below). Step Search procedure
1 Homeopathy/
Primary outcomes 2 (Homoeopathy or homoeopathic or homeopathic).mp. [mp =
The primary outcomes of this review are as follows: the title, abstract, original title, name of substance word, subject
improvement of global symptoms recorded in validated heading word, keyword heading word, protocol supplementary
concept, rare disease supplementary concept, unique identifier]
daily or weekly diaries and any scores from validated visual
analogue scales; the total Quality of Life Score (such as the 3 1 or 2
Juniper RQLQ); individual symptoms scores which include 4 Rhinitis, Allergic, Perennial/or Rhinitis, Vasomotor/or Rhinitis/or
any appropriate measures of nasal obstruction, runny Rhinitis, Atrophic/or Rhinitis, Allergic, Seasonal/
nose, sneezing, itching, and eye symptoms; and the num- 5 (nasal congestion or rhinorrhea or rhinorrhea or sneezing or itchy
nose).mp. [mp = title, abstract, original title, name of substance
ber of days requiring medication. In case of child partici- word, subject heading word, keyword heading word, protocol
pants, AR symptoms rated by parents will be considered supplementary concept, rare disease supplementary concept,
acceptable. unique identifier]
6 Exp Rhinitis/
Secondary outcomes 7 (rhiniti* or rhinoconjunctivitis or SAR or PAR).mp. [mp = title,
The secondary outcomes of this review are as follows: abstract, original title, name of substance word, subject heading
IgE levels, individual ocular symptoms, any adverse event, word, keyword heading word, protocol supplementary concept,
rare disease supplementary concept, unique identifier]
hospitalization due to an adverse event, and use of con-
8 (hay fever or hay next fever or pollinosis or pollenosis).mp. [mp =
ventional medication (frequency and quantity). title, abstract, original title, name of substance word, subject
heading word, keyword heading word, protocol supplementary
Search concept, rare disease supplementary concept, unique identifier]
Electronic search 9 4 or 5 or 6 or 7 or 8
The search to locate randomized trials will be based 10 3 and 9
on the Cochrane Highly Sensitive Search Strategy [21].
Manual search of the results will supplement the elec-
tronic search. is due to a difference in interpretation. If no clear
Medline (1946 to December 2013 inclusive) on Ovid, categorization can be made of a selected study it will be
CENTRAL, The Cochrane Ear Nose and Throat Disorder categorized as one that is awaiting assessment. Study au-
Group Trials Register, CINAHL, EMBASE (1974 to thors will be contacted for further information wherever
December 2013) on Ovid, Allied and Complementary necessary. RTM may be asked to categorize the study. The
Medicine Database (AMED) (1985 to December 2013) selected studies will then be further evaluated for meth-
on Ovid, CAM-Quest and Google Scholar. odological quality (risk of bias).
The search will not have any language filters. The refer-
ence lists of identified studies will be searched for add- Data extraction and management
itional trials and trial authors will be contacted if data are A data extraction form will be designed and the relevant
missing from reports of studies. Filters for randomized details will be transferred to the standard data extraction
controlled trials, human trials, and so forth will not be sheet after the form is reviewed by all authors. This will
applied. cover study type and methods including number and de-
The search strategy that will be used to search Medline scription of participants; details of type, mode of admin-
and adapted for the other sources is detailed in Table 1. istration, dosage, and duration of intervention; and type,
Bibliographies of identified studies and reviews will be timing, and measurement method of outcomes. The au-
hand searched. thors, publication year, and journal of publication will
also be recorded. Two review authors (KB and RTM)
Selection of studies will independently extract data from every included trial
Studies will be eligible for inclusion if they have a random- to minimize error and reduce potential bias.
ized, blinded and controlled design, validated measures of
outcome, and evaluate homeopathic treatment for AR. Assessment of risk of bias in included studies
Two review authors (KB and JH) will independently Two review authors (KB and JH) will independently as-
review titles and abstracts to select potentially eligible sess the risk of bias of each study using the Cochrane
studies. This will be followed by a full text analysis of Risk of Bias Tool from the Cochrane Handbook for Sys-
the selected studies to assess compliance with the eligibil- tematic Reviews of Intervention [22]. These consist of
ity criteria. Disagreements will be resolved by discussion sequence generation, allocation concealment, blinding
first. A third author (CC) will arbitrate if the disagreement of participants and personnel, blinding of outcome
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assessment, incomplete outcome data, selective out- The Cochrane Collaboration, 2012. RevMan 5.2 will be
come reporting, and other sources of bias. used for data synthesis and meta-analysis. The primary
Each of these factors will be described as reported in analyses are homeopathy (all forms) compared with pla-
the trial. Attributes of ‘low’, ‘high’, or ‘unclear’ risk will be cebo, and homeopathy (all forms) compared with con-
made for each of them. We will resolve any disagree- ventional treatment. The additional analyses are: (1)
ments about inclusion of a study by discussion and clinical homeopathy compared with placebo; (2) clinical
consensus first. A third reviewer (CC or RTM) will ar- homeopathy compared with conventional treatment; (3)
bitrate if disagreement is due to difference in interpret- complex homeopathy compared with placebo; (4) com-
ation. Trial authors will be contacted if clarification is plex homeopathy compared with conventional treat-
required. ment; (5) classical homeopathy compared with placebos;
and (6) classical homeopathy compared with conventional
Measurement of treatment effect treatment. We shall compare the pooled effect sizes of: #1
Baseline comparability of treatment groups for known and #3 and #5; #2 and #4 and #6.
prognostic variables will be assessed. For continuous
data, individual and pooled statistics as mean difference Subgroup analyses
and standardized mean difference with 95% CI will be If sufficient data are available, subgroup analyses will be
calculated. In case of dichotomous outcomes, risk ratios conducted to investigate the effect of homeopathic po-
(or, if feasible, odds ratios) will be calculated with 95% tency (mother tincture; potency <12C; potency >12C);
CI. If appropriate, meta-analysis will be performed after different age groups (children versus adults) and differ-
assessment of clinical or statistical heterogeneity. The in- ent types of AR (perennial versus seasonal). It is recog-
dividual participant will be the unit of analysis. Descrip- nized that there will be relatively low power to detect
tive information on missing data will be included about effects at the subgroup level; hence these analyses will
participants missing due to dropout, whether there was be undertaken with the aim of hypothesis generation
intention-to-treat or per-protocol analysis, and about only.
missing statistics.
Sensitivity analyses
Assessment of heterogeneity and reporting biases A sensitivity analysis will be performed to explore the
Heterogeneity will be assessed by comparing trial popu- impact of risk-of-bias on overall treatment effect. Studies
lations, settings, and methods. Statistical heterogeneity will be pooled according to low, uncertain or high risk
will be assessed using the I2 statistic. A value of greater of bias. The contribution of studies to heterogeneity will
than 50% will be considered as important heterogeneity. be assessed.
Both fixed-effect and random-effect models will be ap-
plied to the data. If the fixed effect and random effect Discussion
meta-analyses give identical results then it is unlikely This will be the first systematic review of all types of
that there is important statistical heterogeneity, and the homeopathy for allergic rhinitis. We have attempted to
fixed-effect result will be presented. If the results vary, design a robust protocol which should result in an ob-
possible causes of heterogeneity will be examined. This jective and adequate summary of the available evidence
will inform which result should be reported - stable robust in this area of research. The review is not limited to
techniques with an underlying assumption of a fixed effect studies published in the English language: such limita-
(which may be incorrect) or less stable, sometimes unpre- tion might have excluded several studies that met all
dictable techniques based on an underlying assumption of other inclusion criteria. The selected databases index a
random effect (which may be more likely). A sensitivity large number of CAM journals and the search strategy
analyses will be performed by conducting the meta- is expected to identify most of the relevant studies that
analysis including and excluding studies which were exist.
deemed to affect heterogeneity. Changes, if any, will be
Abbreviations
reported in a table. Funnel plots will be constructed, if
AMED: Allied and Complementary Medicine Database; AR: Allergic Rhinitis;
possible. This is a scatter plot of the intervention effect CAM: Complementary and Alternative Medicine; IgE: Immunoglobulin E.
estimates from individual studies against some measure
(usually the standard error of the mean) of each study’s Competing interests
The authors declare that there are no competing interests.
sample size or precision.
Authors’ contributions
Data synthesis KB conceived of the review, designed, and wrote the protocol. KB will carry
out the searches, extract data, conduct risk-of-bias assessment, carry out the
Review Manager (RevMan) [Computer program], Ver- meta-analysis, draw the conclusions, and write the manuscript for the review.
sion 5.2. Copenhagen: The Nordic Cochrane Centre, JH edited the protocol, will carry out the searches, extract data, conduct
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risk-of-bias assessment, will draw conclusions, and edit the manuscript for complementary and alternative medicine for rhinitis and asthma.
the review. CC and RTM edited the protocol, will resolve issues relating to J Allergy Clin Immunol 2006, 117:1054–1062.
inclusion of studies, risk-of-bias assessment, and conclusions. CC and RTM 13. Bellavite P, Marzotto M, Chirumbolo S, Conforti A: Advances in
will assist KB with meta-analysis and edit the manuscript. All authors have homeopathy and immunology: a review of clinical research. Front Biosci
approved the protocol. All authors read and approved the final manuscript. (Schol Ed) 2011, 3:1363–1389.
14. Nuhn T, Lüdtke R, Geraedts M: Placebo effect sizes in homeopathic
Authors’ information compared to conventional drugs – a systematic review of randomized
KB is a homeopath practicing in New Delhi, India and has completed the controlled trials. Homeopathy 2010, 99:76–82.
coursework for a Master of Science in Evidence Based Healthcare from the 15. Spence D: Good medicine: homeopathy. BMJ 2012, 345:e6184.
University of Oxford. JH is a senior research associate at the University of 16. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB:
Oxford.CC is lecturer in medical statistics at the Clinical Trials Unit at the Are the clinical effects of homoeopathy placebo effects? A meta-analysis
Queen Mary University of London.RTM is the Research Development Adviser of placebo-controlled trials. Lancet 1997, 350:834–843.
of the British Homeopathic Association, UK. 17. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JAC, Pewsner
D, Egger M: Are the clinical effects of homoeopathy placebo effects?
Comparative study of placebo-controlled trials of homoeopathy and
Acknowledgements
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The authors would like to acknowledge the contribution of Professor George
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