ARIA update: I - Systematic review of complementary and alternative medicine for rhinitis and asthma

University of Aberdeen, Aberdeen, Scotland, United Kingdom
Journal of Allergy and Clinical Immunology (Impact Factor: 11.48). 06/2006; 117(5):1054-62. DOI: 10.1016/j.jaci.2005.12.1308
Source: PubMed
ABSTRACT
Complementary-alternative medicines are extensively used in the treatment of allergic rhinitis and asthma, but evidence-based recommendations are lacking. To provide evidence-based recommendations, the literature was searched by using MedLine and the Cochrane Library to March 2005 (Key words: Asthma [OR] Rhinitis, [AND] Complementary [OR] Alternative Medicine, [OR] Herbal, [OR] Acupuncture, [OR] Homeopathy, [OR] Alternative Treatment). Randomized trials, preferably double-blind and published in English, were selected. The articles were evaluated by a panel of experts. Quality of reporting was assessed by using the scale validated by Jadad. The methodology of clinical trials with complementary-alternative medicine was frequently inadequate. Meta-analyses provided no clear evidence for the efficacy of acupuncture in rhinitis and asthma. Some positive results were described with homeopathy in good-quality trials in rhinitis, but a number of negative studies were also found. Therefore it is not possible to provide evidence-based recommendations for homeopathy in the treatment of allergic rhinitis, and further trials are needed. A limited number of studies of herbal remedies showed some efficacy in rhinitis and asthma, but the studies were too few to make recommendations. There are also unresolved safety concerns. Therapeutic efficacy of complementary-alternative treatments for rhinitis and asthma is not supported by currently available evidence.

Full-text

Available from: David Price
Update review
ARIA update: I—Systematic review of
complementary and alternative medicine
for rhinitis and asthma
Giovanni Passalacqua, MD,
a
Philippe J. Bousquet, MD,
b
Kai-Hakon Carlsen, MD,
c
James Kemp, MD,
d
Richard F. Lockey, MD,
e
Bodo Niggemann, MD,
f
Ruby Pawankar, MD,
g
David Price, MD,
h
and Jean Bousquet, MD
b
Genoa, Italy, Montpellier, France, Oslo,
Norway, San Diego, Calif, Tampa, Fla, Berlin, Germany, Tokyo, Japan, and Aberdeen,
United Kingdom
Complementary-alternative medicines are extensively used in
the treatment of allergic rhinitis and asthma, but evidence-based
recommendations are lacking. To provide evidence-based
recommendations, the literature was searched by using MedLine
and the Cochrane Library to March 2005 (Key words: Asthma
[OR] Rhinitis, [AND] Complementary [OR] Alternative
Medicine, [OR] Herbal, [OR] Acupuncture, [OR] Homeopathy,
[OR] Alternative Treatment). Randomized trials, preferably
double-blind and published in English, were selected. The
articles were evaluated by a panel of experts. Quality of
reporting was assessed by using the scale validated by Jadad.
The methodology of clinical trials with complementary-
alternative medicine was frequently inadequate. Meta-analyses
provided no clear evidence for the efficacy of acupuncture in
rhinitis and asthma. Some positive results were described with
homeopathy in good-quality trials in rhinitis, but a number of
negative studies were also found. Therefore it is not possible
to provide evidence-based recommendations for homeopathy
in the treatment of allergic rhinitis, and further trials are
needed. A limited number of studies of herbal remedies
showed some efficacy in rhinitis and asthma, but the studies
were too few to make recommendations. There are also
unresolved safety concerns. Therapeutic efficacy of
complementary-alternative treatments for rhinitis and
asthma is not supported by currently available evidence.
(J Allergy Clin Immunol 2006;117:1054-62.)
Key words: Complementary-alternative medicine, asthma, rhinitis
In Western countries, for cultural and historical reasons,
medical approaches that differ from conventional medi-
cine are grouped under the term alternative medicines.
Some of these techniques have a millenary history and
represent the traditional medicine in many countries.
Therefore the term complementary-alternative medicine
(CAM) is preferred because it does not imply a negative
judgment. There are numerous CAM techniques, and their
number has even increased over the last years with the
introduction of new holistic approaches. A list of the
CAMs is included in Table I.
Allergy and allergic diseases, including asthma and
rhinitis, are frequently treated with CAMs, where home-
opathy, acupuncture, herbal medicines, and yoga are the
most used techniques. Recent studies report that 25% to
50% (up to 70%) of the general population currently use
or have used CAMs on at least one occasion,
1-6
and similar
figures have been reported in children.
7
Complementary-
alternative techniques are also used for diagnostic purposes,
despite limited evidence.
8
Some of the reasons for using
CAMs include the distrust of conventional scientifically
based medicine, the lack of a satisfactory physician-
patient interaction, and the belief that CAMs are safe
(devoid of side effects) products-procedures.
5,8
Recommendations for the use of CAMs should be
based only on rigorous proof of efficacy derived from
high-quality studies because there is considerable cost
(to patients and health care systems) and the potential for
risks (eg, malpractice, incorrect prescription, and drug
From
a
Allergy and Respiratory Diseases, University of Genoa;
b
Service des
Maladies Respiratoires, Hopital A. de Villeneuve, Montpellier;
c
the Norwe-
gian University of Sports and Physical Medicine, Oslo;
d
the Department
of Pediatrics, U niversity of California School of Medicine, San Diego;
e
Allergy and Immunology, University of South Florida and J. A. Haley
Veterans’ Hospital, Tampa;
f
the Department of Pediatric Pneumology and
Immunology, University Hospital Charite`, Berlin;
g
the Department of
Otorhinolaryngology, Nippon Medical School, Tokyo; and
h
the Department
of General Practice and Primary Care, University of Aberdeen, Foresterhill
Health Center.
This article has been prepared by the Internat ional Board of ARIA (Allergic
Rhinitis and its Impact on Asthma) in cooperation with GA
2
LEN (Global
Allergy and Asthma European Network).
Disclosure of potential conflict of interest: K. Carlsen has consultant
arrangements with GlaxoSmithKline and is on the speakers’ bureau for
GlaxoSmithKline, AstraZeneca, and Merck. D. Price has consultant ar-
rangements with Boehringer, GlaxoSmithKline, Pfizer, Ivax, and Viatris;
has received grants from UK National Health Service, Abbot Laboratories,
Altana Pharma, AstraZeneca, Boehringer, Pfizer, GlaxoSmithKline, Ivax,
Merck, Sharpe and Dohme, Novartis, Schering Plough, Trinity Pharmaceu-
ticals, and Viatris; and is on the speakers’ bureau for Altana Pharma, Astra-
Zeneca, Boehringer, Pfizer, GlaxoSmithKline, Ivax, Merck, Sharpe and
Dohme, and Novartis. The rest of the authors have declared that they
have no conflict of interest.
Received for publication September 21, 2005; revised December 12, 2005;
accepted for publication December 12, 2005.
Reprint requests: Giovanni Passalacqua, MD, Allergy and Respiratory
Diseases, Department of Internal Medicine, Padiglione Maragliano, L.go
R. Benzi 10, 16132 Genoa, Italy. E-mail: passalacqua@unige.it.
0091-6749/$32.00
Ó 2006 American Academy of Allergy, Asthma and Immunology
doi:10.1016/j.jaci.2005.12.1308
1054
Rhinitis, sinusitis, and
ocular diseases
Page 1
Abbreviations used
CAM: Complementary-alternative medicine
DBPC: Double-blind, placebo-controlled
QOL: Quality of life
interactions) incurred by their use in a non–evidenced-
based approach. Thus it was believed that a detailed
analysis of the experimental evidence concerning the
clinical use of CAMs in asthma and rhinitis was needed.
METHODS
To provide evidence-based recommendations, the available liter-
ature was searched with MedLine up to September 2005 (key words:
Asthma [OR] Rhinitis, [AND] Complementary [OR] Alternative
Medicine, [OR] Herbal, [OR] Acupuncture, [OR] Homeopathy, [OR]
Alternative Treatment). Randomized trials, preferably double-blind
and published in English, were selected, including all interventions in
which CAMs were used. The Cochrane Library was also searched.
The reference lists of all selected articles were reviewed, and all
members of the group were asked to identify relevant articles possibly
not included in the search.
Quality of reporting was assessed by using the scale developed
and validated by Jadad et al (Table II).
9
This scoring system takes into
account the most relevant characteristics of a clinical trial, which are
randomization and blinding. Two points are given, respectively, to
correct random allocation and to correct blinding, and 1 point is given
if description of dropouts and withdrawals is provided. Thus the
maximum score is 5, and a score of at least 3 indicates an adequate
methodology. The strength of the evidence of the studies was then
evaluated by using the recommendations by Shekelle et al.
10
ACUPUNCTURE
Acupuncture is part of traditional Chinese medicine
and is widely used for the treatment of chronic illnesses,
including asthma. The theory behind the use of acupunc-
ture is to restore the balance of ‘vital flows’ by inserting
needles at exact points of the body surface, where the
‘meridians’ of these flows lie. Stimulation of the specific
points can also be made with pressure or laser application.
Acupuncture can be studied in a rigorous manner by using
sham acupuncture as a control procedure.
11
The efficacy
of acupuncture in asthma has been evaluated in several
randomized controlled trials.
12-24
Few data are available
for rhinitis.
One of the first systematic reviews of acupuncture in
asthma was conducted by Kleijnen et al in 1991.
11
In that
review 13 controlled studies were considered (6 double-
blind and 7 single-blind studies). Four of the double-blind
studies were negative, and 6 of the single-blind studies
were positive. On the basis of the methodologic quality
of the studies, the authors concluded more than 10 years
ago that beneficial effects of acupuncture were more likely
to be found in the low-quality studies (small sample, not
randomized, and inadequate analysis). Looking at the
available literature (Table III),
12-28
many studies have an
inadequate methodology (ie, a Jadad score of less than 3).
On the other hand, some studies in asthma
16-24
were
of good methodologic quality, but the majority of them
showed no difference between active and sham interven-
tion. Medici et al
19
found a decrease in blood eosinophils
in the active group and a transient clinical improvement.
Christensen et al
24
described an overall clinical improve-
ment with acupuncture. A systematic review of the clinical
trials, including non-English articles, concluded that there
was insufficient evidence for the efficacy of acupuncture
in asthma.
29
The 2004 Cochrane review
30,31
included 11
studies with 324 participants. Trial reporting was poor,
and quality was judged inadequate. The conclusion of
this meta-analysis was that acupuncture is not an effective
treatment of asthma.
The majority of the studies with acupuncture in allergic
rhinitis (often in Chinese language) are not randomized,
controlled, or descriptive.
29,32
A randomized controlled
trial failed to demonstrate a protective effect of acupunc-
ture
33
against exposure to allergen in a challenge chamber.
Another nonrandomized study in nonallergic rhinitis
found no difference in nasal airflow and symptoms between
acupuncture and electrostimulation.
25
One randomized
crossover trial
26
in seasonal rhinitis with poor methodo-
logic quality showed that acupuncture significantly re-
duced symptoms without changing the need for rescue
TABLE I. Complementary-alternative medicines
Physical techniques Systematic medicines Other
Acupuncture Anthroposophy Bioresonance
Balneotherapy Indian (Ayurveda) Chromotherapy
Breathing control Japanese (Kampo) Enematherapy
Chiropractic Sciamanic medicine Homeopathy
Massage Traditional Chinese
medicine
Hopi candles
Osteopathy Hypnosis
Spinal manipulation Behavioral Iridology
Yoga Biofeedback Kinesiology
Clinical ecology Prayer
Phytotherapy Dissociated diets Reflexology
Aromatherapy Speleotherapy
Bach’s flowers Urine therapy
Herbal medicine
TABLE II. Scoring system of trials according to Jadad et al
9
Question Score
1 Study described as randomized (including
the words ‘random,’ ‘randomization,’
‘randomly’’)?
Yes 5 1, no 5 0
2 Study described as double-blind? Yes 5 1, no 5 0
3 Withdrawals and dropouts described? Yes 5 1, no 5 0
4 Method of randomization described
and appropriate?
Yes 5 1, no 5 0
Appropriate—tables of random numbers,
computer-generated sequences
Not appropriate—alternate allocation,
birth date
5 Method of double-blinding described
and appropriate?
Yes 5 1, no 5 0
J ALLERGY CLIN IMMUNOL
VOLUME 117, NUMBER 5
Passalacqua et al 1055
Rhinitis, sinusitis, and
ocular diseases
Page 2
medications. Another randomized controlled trial failed to
demonstrate a clinical difference (symptoms and rescue
medications) between real and sham acupuncture.
27
One
controlled clinical trial
28
in children with perennial aller-
gic rhinitis (3-month treatment plus 3-month follow-up)
reported a significant improvement in daily symptoms
(limited to the follow-up period) and an increase of symp-
tom-free days in the active group with no change in the
use of symptomatic medications.
HERBAL MEDICINES (HERBALISM OR
PHYTOTHERAPY)
Information on studies with herbal medicines can be
found in Table IV.
34-51
Drugs derived from plants and herbs are used com-
monly in medicine (eg, theophylline, ephedrine, digitalis,
and morphine). Some medical systems (traditional Chinese
medicine, Japanese, Kampo, and Ayurvedic) largely use
herbs, often in fixed mixtures (eg, ma huang and saiboku-to)
to treat diseases, including asthma and rhinitis.
There are some studies, done between 1968 and 1979,
with Tylophora indica (Indian ipecac) in asthma
34-36
that
report positive results and one that fails to demonstrate
any positive effect.
37
No further studies with T indica have
been published since 1979. One double-blind, placebo-
controlled (DBPC) study performed in asthmatic subjects
showed that the gum resin Boswellia serrata (a component
of Ayurvedic remedies) significantly improved symptoms
and FEV
1
after a 6-week course.
38
One controlled study
reported negative results with Picrorrhiza kurroa in
asthma.
39
Two studies reported that saiboku-to (TJ96) im-
proved symptoms, exerted a glucocorticosteroid-sparing
effect, reduced bronchial responsiveness, and decreased
sputum eosinophils in asthmatic patients,
40,41
but the
TABLE III. Studies of acupuncture
Author Disease Design and control
No. of
patients* Duration
Jadad
score Main results
Medici et al
19
A PG 64 (66) 16 wk 5 No clinical difference among real, sham, and
placebo; transient Y in PEF variability; Y
in blood eosinophils in real vs sham
Sham acupuncture
Malmstrom et al
18
A PG 24 (27) 15 wk 5 No effect on isocapnic hyperventilation with
both treatmentsMock TENS
Ng et al
28
R PG 72 (85) 8 1 12 wk 3 Y Symptom-free days, Y symptom score
only in the follow-up phase; no change
in drug use
Sham acupuncture
Biernacki and
Peake
16
A XO 22 (23) 1 d 4 Improved QOL and Y use of bronchodilators
with both sham and real interventionSham acupuncture
Shapira et al
20
A XO 23 (23) 3 wk 4 No effect on PEF, FEV
1
, use of b
2
-agonists, and
methacholine challengeSham acupuncture
Tandon et al
22
A XO 15 5 wk 4 No difference in PEF, FEV
1
, use of b
2
-agonists,
and asthma score between groupsSham acupuncture
Christensen
et al
24
A PG 18 5 wk 3 Y Symptoms and use of bronchodilators in the
active groupSham acupuncture
Williamson
et al
27
R PG 102 (102) 4 wk 3 No difference in symptoms and use of rescue
medications between groupsSham acupuncture
Tashkin et al
21
A XO 25 4 wk 3 No difference in FEV
1
, use of b
2
-agonists, and
asthma score between groupsSham acupuncture
Gruber et al
17
A XO 44 (44) 1 d 3 No effect on isocapnic hyperventilation
Sham acupuncture
Joos et al
23
A PG 36 (38) 4 wk 3 No difference in pulmonary function and
self-assessment; Y use of bronchodilators
in both groups
Sham acupuncture
Dias et al
15
A No treatment 20 (20) 2 wk 2 Improvement in PEF in active group
Mitchell and
Wells
14
A No treatment 31 6 mo 2 No difference between groups
Morton et al
13
A PG 17 1 d 2 No effect on exercise-induced asthma
Sham acupuncture
Xue et al
26
R XO 26 (30) 4 wk 2 Y Symptom score only in the active group,
no change in medication scoreSham acupuncture
Fung et al
12
A PG 19 (19) 1 d 1 Protection against exercise-induced
bronchoconstrictionSham acupuncture
Davies et al
25
R Sham acupuncture 10 (13) 1 d 0 No difference in nasal flow and visual analog
scale between real and sham acupuncture
and electrostimulation
Electrostimulation
A, Asthma; PG, parallel group; Y, decrease; PEF, peak expiratory flow; TENS, transcutaneous electrical nerve stimulation; R, rhinitis; XO, cross-over.
*Completed (enrolled).
J ALLERGY CLIN IMMUNOL
MAY 2006
1056 Passalacqua et al
Rhinitis, sinusitis, and
ocular diseases
Page 3
quality of these studies was low. Coleus forskolli is an
Indian herb the active ingredient of which, forskoline,
has mild bronchodilator properties. One study has shown
that C forskolli is superior to placebo and equivalent to
fenoterol in protecting against methacholine-induced
bronchoconstriction,
52
but the study was conducted in
healthy subjects. There is also one study with butterbur
(Petasites hybridus) in asthma showing a reduction of
exhaled nitric oxide and bronchial response to adenosine
monophosphate.
42
Wen et al,
43
in a double-blind fashion,
compared a mix of 3 Chinese herbs and oral prednisone
in 91 patients with moderate-severe asthma and found
that both interventions significantly improved clinical
symptoms and functional parameters, with prednisone
being slightly more effective. Similar results were obtained
in a randomized controlled pediatric study
44
that com-
pared the effects of 2 doses of the Chinese formula
Mai-Men-Don-Tang and placebo added to pharmacologic
treatment. Despite such positive results, there are often
methodologic flaws in studies with herbs, and a meta-
analysis concluded that there is still no convincing
evidence of their efficacy in asthma.
53
There have been
some controlled studies performed in rhinitis. One study
on seasonal rhinitis found that a mixture of 18 Chinese
herbs was significantly better than placebo in terms of
symptoms and quality of life (QOL).
45
Another study on
perennial rhinitis found statistically significant effects of
the Chinese herb formulation biminne.
46
One double-
blind, randomized controlled trial found that grapeseed
extract (100 mg twice daily) was no more effective than
placebo for ragweed-induced rhinitis.
47
Two clinical trials
have been conducted with butterbur extract in rhinitis.
The first
51
compared 100 mg of butterbur and 10 mg of ce-
tirizine daily and found that both treatments were equally
effective, as determined on the basis of symptom scores
and QOL. The second study,
48
performed in perennial rhi-
nitis, confirmed that butterbur was equivalent to fexofena-
dine in controlling symptoms. On the other hand, a recent
randomized, placebo-controlled study failed to detect any
significant effect of butterbur on symptoms and nasal
inspiratory peak flow in intermittent rhinitis.
49
Finally,
one single-blind study with combined acupuncture plus a
mixture of Chinese herbs found a significant effect on
symptom scores and QOL in seasonal allergic rhinitis com-
pared with the effect of sham acupuncture plus nonspecific
herbs.
50
TABLE IV. Studies of herbal remedies
Author Disease Treatment Control
No. of
patients*
Jadad
score Main results
Schapowal et al
51
R Butterbur, 50 mg
twice daily
Cetirizine,
10 mg/placebo
125 5 Butterbur 5 cetirizine, both effective
Hu et al
46
R Biminne Placebo 50 (58) 5 Effective on symptoms
Xue et al
45
R Chinese herb mix Placebo 49 (55) 5 Effective on clinical symptoms and QOL
Wen et al
43
A Chinese herb mix Prednisone,
20 mg daily
91 (92) 4 Y Symptoms, [ FEV
1
, Y bronchodilator
significant in both groups
Hsu et al
44
A Chinese MMDT,
2 doses
Placebo 69 (90) 4 Y Symptoms, [ FEV
1
, Y bronchodilator
significant with both dosages vs placebo
Mathew and
Shipvuri
35
A Tylophora indica Placebo 123 4 Y Symptoms, [ FEV
1
Gray et al
49
R Butterbur, 50 mg
twice daily
Placebo 35 (35) 4 No difference between active and placebo
in peak nasal inspiratory flow, symptoms,
and QOL
Bernstein et al
47
R Grapeseed Placebo 41 (44) 3 Not effective
Brinkhaus et al
50
R Chinese herbs
plus acupuncture
Placebo plus sham
acupuncture
52 (56) 3 Significant improvement in symptom score
and rhinitis-related QOL
Doshi et al
39
A Picrorrhiza kurroa Placebo 72 3 Not effective
Urata et al
41
A TJ96 Placebo 33 3 Y Symptoms, Y blood and sputum
eosinophils and methacholine reactivity
Thiruvegadam
et al
36
A Tylophora indica Drug therapy 30 3 Y Symptoms, no statistics for lung function
Shipvuri et al
34
A Tylophora indica Placebo 166 (195) 3 Significant improvement of symptoms
Lee et al
48
R Butterbur, 50 mg
twice daily
Fexofenadine,
180 mg/placebo
16 3 Y Symptom score and adenosine
monophosphate reactivity with both
fexofenadine and butterbur
Egashira and
Hagano
40
A TJ96 plus drugs Drugs only 110 (112) 2 Improvement of symptom score
Gupta et al
37
A Tylophora indica Placebo 135 2 No effect on lung function and symptoms
Gupta et al
38
A Boswellia serrata Lactose 80 (80) 2 Y Symptoms, [ FEV
1
Lee et al
42
A Butterbur, 50 mg
twice daily
Placebo 16 2 Y Blood eosinophils, exhaled NO, and
adenosine reactivity
R, Rhinitis; A, Asthma; Y, decrease; [, increase; NO, nitric oxide.
*Completed (enrolled).
J ALLERGY CLIN IMMUNOL
VOLUME 117, NUMBER 5
Passalacqua et al 1057
Rhinitis, sinusitis, and
ocular diseases
Page 4
Herbal remedies contain several active pharmacologic
ingredients, and therefore it is not surprising that they
might have some measurable clinical effect. However, for
the same reasons, they are not completely devoid of side
effects and pharmacologic interactions. Despite the com-
mon belief that phytotherapy is safe, there are numerous
reports of side effects caused by herbal remedies,
54,55
and
the active principles contained in herbal preparations
might also have important drug interactions. Finally, at
variance with proprietary marketing drugs, herbal reme-
dies carry the risk of adulteration, incorrect collection of
plants, wrong preparation, and inappropriate and nonstan-
dardized dosing.
56,57
HOMEOPATHY
Homeopathy, founded by Hahnemann at the beginning
of the 1800s, relies on the principle that symptoms of a
disease can be cured by the same substances that provoke
them when they are ultradiluted. Homeopathic remedies
are selected according to symptoms and prepared with
a special technique (repeated dilutions with ‘potentia-
tion’’). Homeopathy is a holistic approach to medicine,
with particular attention to the homeopath-patient rela-
tionship. The scientific interest in homeopathy for treating
asthma, allergies, and other chronic illness is considerable,
as attested to by the large number of publications.
58
There
are several controlled trials of good methodologic quality
for homeopathy in rhinitis and asthma (Table V).
59-68
The 3 studies in asthmatic patients
59-61
conducted with
good methodology showed no or marginal effects. Only
one study
59
demonstrated an improvement in an asthma
visual analog scale, although there were no accompanying
changes in objective parameters. The Cochrane review
on homeopathy in stable asthma concluded that ‘there is
not enough evidence to reliably assess the possible role
of homeopathy in asthma.’
69
There are several studies in rhinitis. Wiesenauer and
Gaus
62
compared the effects of a potentiated and a con-
ventional dilution of Galphimia glauca to placebo for
pollen-induced rhinitis, finding no significant difference
between the 2 active treatments and placebo. Reilly et al
63
carried out the first DBPC study in seasonal allergic rhini-
tis, evaluating a visual analog scale and the concomitant
use of antihistamines (chlorpheniramine), and found a
significant difference in favor of homeopathy for both
parameters. Another DBPC trial compared cromolyn
and an intranasal homeopathic remedy (Luffa composi-
tum Heel) in seasonal allergic rhinitis and found that
both were equally effective.
64
Taylor et al
65
performed
a DBPC study in 50 patients with perennial allergic rhi-
nitis and demonstrated a significant improvement in na-
sal flow only in the active group. In this study, however,
there was no difference in the symptomatic improvement
recorded with a visual analog scale. A meta-analysis of 4
trials included in the article concluded in favor of
homeopathy over placebo. A homeopathic dilution of
birch pollen (‘‘isopathy’’) provided only a marginal ef-
fect in seasonal allergic rhinitis and even aggravated
TABLE V. Studies of homeopathy
Author Disease Treatment Control
No. of
patients*
Jadad
score Main results
Aabel et al
66
R Birch 30c Placebo 66 (70) 5 No effect on symptoms
Aabel
67
R Birch 30c Placebo 73 (80) 5 No effect on symptoms
Lewith et al
60
A Dust mite homeopathy Placebo 186 (242) 5 No difference between active and placebo
in FEV
1
, PEF, symptoms, use of
b
2
-agonists, and asthma score
Reilly et al
63
R 30c dilution grass
pollen
Placebo 155 (158) 5 Y Symptom score, visual analog scale, and
use of antihistamines
Taylor et al
65
R 30c dilution of various
allergens
Placebo 50 (51) 5 [ PNIF morning and evening; no difference
between groups in visual analog scale
and symptom score
Weiser et al
64
R Nasal Luffa
compositum Heel
Nasal cromone 135 (147) 5 Homeopathy 5 nasal cromone, both
effective on symptoms
White et al
61
A Individual homeopathy
plus drugs
Placebo plus drugs 74 (93) 5 No difference between active and placebo
in asthma-related QOL, PEF, use of
b
2
-agonists, missing days
Kim et al
68
R Homeopathic grass,
trees, weeds mix
Placebo 40 (40) 5 Significant improvement in active group in
3 QOL questionnaires; no mention of
clinical symptoms
Reilly et al
59
A 30c dilution of
allergens
Placebo 24 (28) 4 No change in PEF, pulmonary function,
and histamine challenge; significant
improvement in the visual analog scale
Wiesenauer and
Gaus
62
R Galphimia
homeopathic
dilution
Conventional
dilution/placebo
104 (164) 4 No significant difference between active
and placebo treatments
R, Rhinitis; A, asthma; PEF, peak expiratory flow; Y, decrease; [, increase; PNIF, peak nasal inspiratory flow.
*Completed (enrolled).
J ALLERGY CLIN IMMUNOL
MAY 2006
1058 Passalacqua et al
Rhinitis, sinusitis, and
ocular diseases
Page 5
symptoms during the pollen season.
66,67
Finally, Kim
et al,
68
in a placebo-controlled multicenter trial in sea-
sonal rhinitis found a significant difference between the
active and placebo groups, but only QOL questionnaires
were used as outcome measures in this study.
Some reviews of the published trials, independent of
the disease and the methodologic quality, conclude that
some effect of homeopathy exists.
30,70-72
Nevertheless, the
measurable effects tend to be greater with smaller samples
and in lower-quality trials.
71,72
A recent review
73
compared
more than 100 clinical trials of either homeopathy or
conventional medicine matched for disease and outcome.
After a detailed analysis of possible biases and confound-
ing factors, this review concluded that evidence for a spe-
cific effect of homeopathy is weak, whereas such evidence
is strong with conventional (‘‘allopathic’’) treatments.
PHYSICAL TECHNIQUES AND OTHER
ALTERNATIVE TREATMENTS
Physical techniques (breathing control, breathing re-
training, yoga, and chiropractic-spinal manipulation) are
purported to relax the patient and improve the breathing
pattern. There are several trials of physical techniques
in asthma. (Table VI).
74-85
Most of them failed to demon-
strate a clinically relevant effect,
74,75,81
or only marginal
benefits were achieved, usually on nonspecific bronchial
hyperresponsiveness.
76,77,79
However, breathing-retraining
physiotherapy was shown to improve the QOL of patients
with stable asthma.
80
On the basis of the experimental evidence, breathing
retraining and yoga techniques can have a positive effect
on self-perceived well-being and on QOL, thus providing
an additional benefit. Nevertheless, because of the heter-
ogeneity of the studies and the variable outcomes used, no
reliable conclusions can be derived on the use of breathing
exercises for asthma in clinical practice.
86,87
There is no
controlled study available for the so-called Alexander
technique (postural exercises).
88
Manipulation techniques
in asthma were found not to be effective in 2 Cochrane
reviews,
89,90
although one randomized study reported a
significant improvement in peak expiratory flow in asth-
matic children.
85
No study is available in allergic rhinitis.
Speleotherapy is a form of therapy used in some regions
of central Europe and the Balkans, sharing some princi-
ples with thermal treatments. A systematic review of the
studies performed with speleotherapy reported that the
available evidence does not allow reliable conclusions as
to whether speleotherapy is effective for the treatment of
chronic asthma.
91
Similarly, biofeedback techniques and
hypnosis to treat asthma were systematically reviewed.
The conclusion was that all studies were of poor quality
and that they failed to demonstrate efficacy.
92,93
There
TABLE VI. Studies of physical techniques
Author Disease Intervention Control
No. of
patients*
Jadad
score Main results
Balon et al
74
A Chiropractic Sham chiropractic 80 (91) 5 Sham 5 real chiropractic for PEF, symptoms,
and b
2
-agonist use
Cooper et al
75
A Buteyko breathing PCLE Placebo
PCLE
60 (89) 5 No effect on FEV
1
, exacerbations, use of
corticosteroids; Y symptoms and
bronchodilators with yoga
Nielsen et al
77
A Chiropractic Sham chiropractic 29 (31) 5 No difference between sham and verum in
symptoms and function; Y response to
methacholine in active
Korek et al
83
R UVA plus
UVB plus
visible light
Visible light 49 (49) 4 Y Total symptom score; Y eosinophils,
IL-5, and eosinophil cationic protein in
nasal lavage
Manocha et al
76
A Sahaja yoga Group therapy
and relaxation
47 (59) 4 No effect on symptoms, use of rescue
medications and asthma-related QOL;
Y response to methacholine
Vedanthan et al
81
A Yoga No yoga 17 4 No effect
Sabina et al
82
A Yoga Stretching 45 (62) 4 Y Morning symptoms in both group;
no difference between groups
Singh et al
79
A Pranayama yoga
(PCLE)
Placebo PCLE 18 (22) 3 No difference between placebo and actual;
Y response to bronchial histamine in active
Thomas et al
80
A Breathing
retraining
Educational program 28 (33) 3 [ In some domains of QOL only in the
physiotherapy group
Neuman and
Finkelstein
84
R Intranasal red
light
Normal light 79 (79) 2 Y Symptoms score and mucosal congestion
(endoscopy)
Guiney et al
85
A Chiropractic Sham chiropractic 150 (150) 2 [ PEFR only in active group; no symptom
evaluation
Birkel and
Edgren
78
A Hatha yoga None 287 0 [ Vital capacity; not randomized
A, Asthma; PEF , peak expiratory flow; PCLE, Pink City Lung Exerciser (simulates yoga breathing); Y, increase; R, rhinitis; [, increase.
*Completed (enrolled).
J ALLERGY CLIN IMMUNOL
VOLUME 117, NUMBER 5
Passalacqua et al 1059
Rhinitis, sinusitis, and
ocular diseases
Page 6
are 2 controlled studies with phototherapy for rhinitis. The
first used a narrow-band light intranasal therapy in
perennial rhinitis. Active treatment produced a significant
improvement of symptoms and endoscopic picture in 70%
of patients, but the methodologic quality was poor.
84
Another randomized controlled trial
83
in seasonal allergic
rhinitis reported that a combination of UV-B, UV-A, and
visible light improved symptoms and decreased eosino-
phils in nasal lavage fluid.
There are no controlled randomized trials performed
in rhinitis or asthma with the other forms of holistic medi-
cine or procedures: aromatherapy, chromotherapy, Bach’s
flowers, anthroposophy, Hopi candles, hydro-colon, urine
therapy, clinical ecology, and iridology. Therefore these
techniques cannot be considered for the treatment of
rhinitis and asthma.
RECOMMENDATIONS AND CONCLUSION
Data on the strength of the recommendations for CAMs
in asthma and rhinitis are shown in Table VII.
10
CAM is widely practiced, and many patients who use
it appear to be satisfied. From a scientific viewpoint, there
is no definitive or convincing proof of efficacy for most
CAMs in rhinitis or asthma. In general, the methods used
to study them are often inadequate (ie, not randomized, not
controlled, and not blinded, with no quantitative measure-
ment).
94
Considering the randomized controlled trials,
there is no clear evidence for the efficacy of acupuncture
in rhinitis and asthma. Some positive results were de-
scribed in rhinitis with homeopathy in good-quality trials,
but an equal number of negative studies counterbalance
the positive ones. Therefore it is not possible to provide
evidence-based recommendations for the use of home-
opathy to treat allergic rhinitis, and further randomized
controlled trials are needed. Some herbal remedies have
proved effective in rhinitis or asthma, but the studies are
too few to make recommendations, and there are safety
and drug interaction concerns. In fact, herbal remedies
are usually not sufficiently standardized and can also
contain harmful substances,
95,96
such as the ephedrine-
containing remedies that have been banned in the United
States.
97
A mandatory prerequisite for evaluating herbal
remedies-mixtures is that method of preparation, doses,
components, and active ingredients are clearly defined ac-
cording to the World Health Organization guidelines.
98,99
Some physical techniques (eg, yoga breathing or breath
retraining) can provide an additional benefit in terms of
perceived well-being, but they cannot be recommended
as effective treatments for asthma.
The therapeutic efficacy of CAM treatments is not
supported by currently available evidence. More data from
randomized DBPC trials are required. In addition, CAMs
might not be devoid of side effects, and some of them
might interact with other medications.
96,100
Special thanks for revising and improving the manuscript are
due to G. W. Canonica, E. O. Meltzer, J. Mullol, R. Naclerio,
TABLE VII. Strength of recommendation for CAMs in asthma and rhinitis
Asthma Rhinitis
Acupuncture B C
Homeopathy C B
Chiropractic C
Yoga–breathing exercises C
Tylophora indica B—
Butterbur C B
Biminne B
Ma-huang B
Picrorrhiza kurroa C—
Saiboku-to (TJ96) B
Grapeseed C
Boswellia gum B
Intranasal red light B
Aromatherapy, antroposophy, Bach’s flowers,
hypnosis, Hopi candles, reflexology
DD
Category of evidence Strength of recommendation
Ia Meta-analysis of randomized controlled trials A Directly based on category I
Ib At least 1 randomized controlled trial
IIa At least 1 controlled trial without randomization B Directly based on category II or
IIb At least 1 type of quasiexperimental study extrapolated from category I
III Nonexperimental descriptive studies C Directly based on category III or
extrapolated from category I-II
IV Expert opinions or committee reports D Directly based on category IV or
extrapolated from category I-III
Data from Sheckelle et al.
10
J ALLERGY CLIN IMMUNOL
MAY 2006
1060 Passalacqua et al
Rhinitis, sinusitis, and
ocular diseases
Page 7
P. van Cauwenberge, J. Warner, B. Yawn, and the ARIA Executive
Committee.
REFERENCES
1. McLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alter-
native medicine in Australia. Lancet 1996;347:569-73.
2. Blanc PD, Trupin L, Earnest G, Katz PP, Yelin EH, Eisner MD. Alternative
therapies among adults with a reported diagnosis of asthma or rhinosinus-
itis: data from a population-based survey. Chest 2001;120:1461-7.
3. Kessler RC, Davis RB, Foster DF, Van Rompay ME, Walters EE, Wil-
key SA, et al. Long term trends in the use of complementary and alter-
native medical therapies in the USA. Ann Intern Med 2001;135:262-8.
4. Fisher P, Ward A. Complementary medicine in Europe. BMJ 1994;309:
107-11.
5. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR,
Delbanco TL. Unconventional medicine in the United States. Preva-
lence, costs, and patterns of use. N Engl J Med 1993;328:246-52.
6. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary
and alternative medicine use among adults: United States, 2002. Adv
Data 2004;343:1-19.
7. Shenfield G, Lim E, Hansel H. Survey of the use of complementary
medicines and therapies in children with asthma. J Paediatr Child
Health 2002;38:252-7.
8. Niggemann B, Gru¨ber C. Unproven diagnostic procedures in IgE-
mediated allergic diseases. Allergy 2004;59:806-8.
9. Jadad AR, Moore RA, Carrol D, Jenkinson C, Reynolds DJ, Gavaghan
DJ, et al. Assessing the quality of reports of randomised clinical trials.
Is blinding necessary? Control Clin Trials 1996;17:1-12.
10. Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines:
developing guidelines. BMJ 1999;318:593-6.
11. Kleijnen J, ter Riet G, Knipshild P. Acupuncture and asthma. A review
of controlled trials. Thorax 1991;46:799-802.
12. Fung KP, Chow OK, So SY. Attenuation of exercise-induced asthma
by acupuncture. Lancet 1986;8521:1419-22.
13. Morton AR, Fazio SM, Miller D. Efficacy of laser-acupuncture in the
prevention of exercise-induced asthma. Ann Allergy 1993;70:295-8.
14. Mitchell P, Wells GE. Acupuncture for chronic asthma a controlled trial
with 6 month follow up. Am J Acupunct 1989;17:5-13.
15. Dias PLR, Subramanian S, Lionel NDW. Effects of acupuncture in
bronchial: preliminary communications. J R Soc Med 1982;75:245-8.
16. Biernacki W, Peake MD. Acupuncture in treatment of stable asthma.
Respir Med 1998;92:1143 -5.
17. Gruber W, Eber E, Malle-Schaed D, Pfleger A, Weinhandl L, Dorfer L,
et al. Laser acupuncture in children and adolescents with exercise
induced asthma. Thorax 2002;57:322-5.
18. Malmstrom M, Ahlner J, Carlsson C, Schmekel B. No effect of Chinese
acupuncture on isocapnic hyperventilation with cold air in asthmatics,
measured with impulse oscillometry. Acupunct Med 2002;20:66-73.
19. Medici TC, Grebski E, Wu J, Hinz G, Wuthrich B. Acupuncture and
bronchial asthma: a long-term randomised study of the effects of real
versus sham acupuncture compared to controls in patients with bron-
chial asthma. J Altern Complementary Med 2002;8:737-50.
20. Shapira MY, Berkman N, BenDavid G, Avital A, Bardach E, Breuer R.
Short term acupuncture is of no benefit in patients with moderate per-
sistent asthma. Chest 2002;121:1396-400.
21. Tashkin DP, Kroening RJ, Bresler DE, Simmons M, Coulson AH, Ker-
schnar H. A controlled trial of real and simulated acupuncture in the man-
agement of chronic asthma. J Allergy Clin Immunol 1985;76:855-64.
22. Tandon MK, Soh PF, Wood AT. Acupuncture for bronchial asthma?
A double blind crossover study. Med J Aust 1991;154:409-12.
23. Joos S, Schott C, Zou H, Daniel V, Martin E. Immunomodulatory effects
of acupuncture in the treatment of allergic asthma: a randomised con-
trolled study. J Altern Complementary Med 2000;6:519-25.
24. Christensen PA, Laursen LC, Taudorf E, Sorensen SC, Weeke B.
Acupuncture and bronchial asthma. Allergy 1984;39:379-85.
25. Davies A, Lewith G, Goddard J, Howarth P. The effect of acupuncture
on nonallergic rhinitis: a controlled pilot study. Altern Ther Health Med
1998;4:70-4.
26. Xue CC, English R, Zhang JJ, Da Costa C, Li CG. Effect of acupunc-
ture in the treatment of seasonal allergic rhinitis: a randomised con-
trolled clinical trial. Am J Chin Med 2002;30:1-11.
27. Williamson L, Yu dkin P, Livingstone R. Hay fever treatment in general
practice: a randomised controlled trial comp aring standardized Western
acupuncture with sham acupuncture. Acupunct Med 1996;14:6-10.
28. Ng DK, Chow PY, Ming SP, Hong SH, Lau S, Tse D, et al. A double-blind,
randomized, placebo-controlled trial of acupuncture for the treatment of
childhood persistent allergic rhinitis. Pediatrics 2004;114:1242-7.
29. World Health Organization. Acupuncture: review and analysis of reports
on controlled clinical trials. Geneva: World Health Organization; 2002.
30. McCarney RW, Brinkhaus B, Lasserson TJ, Linde K. Acupuncture for
chronic asthma. Cochrane Database Syst Rev 2004;1:CD000008.
31. McCarney RW, Lasserson TJ, Linde K, Brinkhaus B. An overview of two
Cochrane systematic reviews of complementary treatments for chronic
asthma: acupuncture and homeopathy. Respir Med 2004;98:687-96.
32. Linde K, Vickers A, Hondras M, Ter Riet G, Thormalen E, Berman B,
et al. Systematic review of complementary therapies—an annotated
bibliography. Part 1. Acupuncture. BMC Complementary Alternat Med
2001;1:3 (www.biomedcentral.com).
33. Wolkenstein E, Horak F. Protective effect of acupuncture on allergen
provoked rhinitis. Wien Med Wochenschr 1998;148:450-3.
34. Shipvuri DN, Singal SC, Prakash D. Treatment of asthma with an
acoholic extract of Tylophora indica: a double blind crossover study.
Ann Allergy 1972;30:40 7-12.
35. Mathew KK, Shipvuri DN. Treatment of asthma with alkaloids of
Tylophora indica: a double blind study. Aspects Allergy Appl Immunol
1974;7:166-78.
36. Thiruvengadam KV, Haranath K, Sudarsan S, Sekar TS, Rajagopal KR,
Zacharian MG, et al. Tylophora indica in bronchial asthma: a controlled
comparison with an antiasthmatic drug. J Ind Med Assoc 1978;71:172-6.
37. Gupta S, George P, Gu pta V, Tandom VR, Sundaram KR. Tylophora
indica in bronchial asthma: a double blind controlled study. Indian
J Med Res 1979;6 9:981-9.
38. Gupta I, Gupta V, Parihar A, Gupta S, Ludtke R, Safayhi H, et al.
Effects of Boswellia serrata gum res in in patients with bronchial
asthma: results of a double blind, placebo contr olled 6-week clinical
study. Eur J Med Res 1998;17:511-4.
39. Doshi VB, Sheythe M, Mahashur AA, Kamashi SR. Picrorrhiza kurroa
in bronchial asthma. J Postgrad Med 1983;29:89-95.
40. Egashira Y, Hagano H. A multicenter clinical trial of TJ-96 on bron-
chial asthma. Ann N Y Acad Sci 1993;685:549-60.
41. Urata Y, Yoshida S, Irie Y, Tanigawa T, Amayashu H, Nakabayashi M,
et al. Treatment of asthma patients with herbal medicine TJ-96: a rand-
omised controlled trial. Respir Med 2002;96:469-74.
42. Lee DK, Haggart K, Robb FM, Lipworth BJ. Butterbur, a herbal remedy,
confers complementary anti-inflammatory activity in asthmatic patients
receiving inhaled corticosteroids. Clin Exp Allergy 2004;34:110-4.
43. Wen MC, Wei CH, Hu ZQ, Shivrastava K, Ko J, Xi ST, et al. Efficacy
and tolerability of anti-asthma herbal medicine intervention in adult
patients with moderate-severe allergic asthma. J Allergy Clin Immunol
2005;116:517-24.
44. Hsu CH, Lu CM, Chang TT. Efficacy and safety of modified Mai-Men-
Dong-Tang for treatment of allergic asthma. Pediatr Allergy Immunol
2005;16:76-81.
45. Xue CC, Thien FC, Zhang JJ, Da Costa C, Li CG. Treatment for
seasonal allergic rhinitis by Chinese herbal medicine: a randomised
placebo controlled trial. Altern Ther Health Med 2003;9:80-7.
46. Hu G, Walls RS, Bass D, Ramon B, Grayson D, Jones M, et al. The
Chinese herbal formulation biminne in management of perennial aller-
gic rhinitis: a randomised, double- blind, placebo-c ontrolled, 12-week
clinical trial. Ann Allergy Asthma Immunol 2002;88:478-87.
47. Bernstein DI, Bernstein CK, Deng C, Murphy KJ, Bernstein IL, Bern-
stein JA, et al. Evaluation of the clinical efficacy and safety of grape-
seed extract in the treatment of fall seasonal allergic rhinitis: a pilot
study. Ann Allergy A sthma Immunol 2002;88:272-8.
48. Lee DK, Gray RD, Robb FM, Fujihara S, Lipworth BJ. A placebo-
controlled evaluation of butterbur and fexofenadine on objective and
subjective outcomes in perennial allergic rhinitis. Clin Exp Allergy 2004;
34:646-9.
49. Gray RD, Haggart K, Lee DK, Cull S, Lipworth BJ. Effects of butterbur
treatment in intermittent allergic rhinitis: a placebo-controlled evalua-
tion. Ann Allergy Asthma Immunol 2004;93:56-60.
50. Brinkhaus B, Hummelsberger J, Kohnen R, Seufert J, Hempen CH,
Leonhardy H, et al. Acupuncture and Chinese herbal medicine in the
J ALLERGY CLIN IMMUNOL
VOLUME 117, NUMBER 5
Passalacqua et al 1061
Rhinitis, sinusitis, and
ocular diseases
Page 8
treatment of patients with seasonal allergic rhinitis: a randomised con-
trolled clinical trial. Allergy 2004;59:953-60.
51. Schapowal A. Randomised controlled trial of butterbur and cetirizine
for treating seasonal allergic rhinitis. BMJ 2002;324:1-4.
52. Kaik KG, Witte PU. Protective effect of forskolin in acetykcoline
provocation in healthy probands. Comparison doses with fenoterol
and placebo. Wien Med Wochenshr 1986;136:637-41.
53. Huntley A, Ernst E. Herbal medicines for asthma. A systematic review.
Thorax 2000;55:925-9.
54. Barrett B, Kiefer D, Rabago D. Assessing the risks and benefits of
herbal medicine: a review of the scientific evidence. Altern Ther Health
Med 1999;5:40-9.
55. Cupp MJ. Herbal remedies: adverse effects and drug interaction. Am
Fam Physician 1999;59:1239-45.
56. Ernst E. Harmless herbs? A review of the recent literature. Am J Med
1998;104:170-8.
57. Ernst E. Adulteration of Chinese herbal medicines with synthetic drugs:
a systematic review. J Intern Med 2002;252:107-13.
58. Linde K, Vickers A, Hondras M, Ter Riet G, Melchart D. Systematic
review of complementary therapies—an annotated bibliography. Part
3. Homeopathy. BMC Complementary Altern Med 2001;1:4 (www.
biomedcentral.com).
59. Reilly DT, Taylor MA, Beattie NGM, Campbell JH, McSharry C,
Aitchison TC, et al. Is evidence homeopathy reproducible. Lancet
1994;344:1601-4.
60. Lewith GT, Watkins AD, Shaw H, Dolan G, Holgate ST. Use of ultramo-
lecular potencies of allergen to treat asthmatic people allergic to
house dust mite: double blind randomised controlled trial. BMJ 2002;
324:1-5.
61. White P, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy
as an adjunct in the treatment of childhood asthma: a randomised pla-
cebo controlled trial. Thorax 2003;58:317-21.
62. Wiesenauer M, Gaus W. Double-blind trial comparing the effectiveness of
the homeopathic preparation Galphimia potentiation D6, Galphimia dilution
10(-6) and placebo on pollinosis. Arzneimittelforschung 1985;35:1745-7.
63. Reilly DT, Taylor MA, McSharry C, Aitkison T. Is homeopathy a pla-
cebo response? Controlled trial of homeopathic potency with pollen in
hayfever as a model. Lancet 1986;2:881-6.
64. Weiser M, Gegenheimer LH, Klein P. A randomised equivalence trial
comparing the efficacy and safety of Luffa comp.-Heel nasal spray
with cromolyn sodium spray in the treatment of seasonal allergic rhini-
tis. Forsch Komplementarmed 1999;6:142-8.
65. Taylor MA, Reilly D, Lyewellyn-Jones RH, McSharry C, Aintchison T.
Randomised controlled trial of homeopathy versus placebo in perennial
allergic rhinitis with overview of four trial series. BMJ 2000;321:471-6.
66. Aaabel S, Laerum E, Dolvik S, Djupesland P. Is homeopathic isopathy
effective? A double blind placebo controlled trial with the isopathic
remedy betula C30 for patients with birch pollen allergy. Br Homeopath
J 2000;89:159-60.
67. Aabel S. No beneficial effect of isopathic prophylactic treatment for
birch pollen allergy during a low-pollen season: a double-blind,
placebo-controlled clinical trial of homeopathic Betulla 30c. Br Homeo-
path J 2000;89:169-73.
68. Kim LS, Riedlinger JE, Baldwin CM, Hilli L, Khalsa SV, Messer SA,
et al. Treatment of seasonal allergic rhinitis using homeopathic prepara-
tion of common allergens in the southwest region of the US: a random-
ized, controlled clinical trial. Ann Pharmacother 2005;39:617-24.
69. McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic
asthma. Cochrane Datab ase Syst Rev 2004;1:CD000353.
70. Linde K, Clausius N, Ramirez N, Melchart D, Eitel F, Hedges SA, et al.
Is the clinical effects of homeopathy placebo effects? A meta-analysis
of placebo controlled trials. Lancet 1997;350:834-43.
71. Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical
efficacy of homeopathy. A meta-an alysis of clinical trials. HMRAG.
Homeopathic Medicines Research Advisory Group. Eur J Clin Pharma-
col 2000;56:27-33.
72. Jonas WB, Kaptchuck TJ, Linde K. A critical overview of homeopathy.
Ann Intern Med 2003;138:393-9.
73. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA,
et al. Are the clinical effects of homeopathy placebo effects? Compar-
ative study of placebo-controlled trials of homeopathy and allopathy.
Lancet 2005;366:726-32.
74. Balon J, Aker PD, Crowther ER, Danielson C, Cox PG, O’Shaugh-
nessy D, et al. A comparison of active and simulate chiropractic
manipulation as adjunct treatment for childhood asthma. N Engl
J Med 1998;339:1013-20.
75. Cooper S, Oborne J, Newton S, Harrison V, Thompson Coon J, Lewis
S, et al. Effect of two breathing exercises (Buteyko and pranayama) in
asthma: a randomised controlled trial. Thorax 2003;58:674-9.
76. Manocha R, Marks GB, Kenchington P, Peters D, Salome CM. Sahaja
yoga in the management of moderate to severe asthma: a randomised
controlled trial. Thorax 2002;57:110-4.
77. Nielsen NH, Bronfort G, Bendix T, Madsen F, Weeke B. Chronic
asthma and chiropractic spinal manipulation: a randomised controlled
trial. Clin Exp Allergy 1995;25:80-8.
78. Birkel DA, Edgren L. Hatha yoga improved vital capacity of college
students. Altern Ther Health Med 2000;6:55-63.
79. Singh V, Wisniewski A, Britton J, Tattersfield A. Effect of yoga breath-
ing exercises (pranayama) on airway reactivity in subjects with asthma.
Lancet 1990;335:1381-3.
80. Thomas M, McKinley RK, Freeman E, Foy C, Prodger P, Price D.
Breathing retraining for dysfunctional breathing in asthma: a rando-
mised controlled trial. Thorax 2003;58:110-5.
81. Vedanthan PK, Kesavalu LN, Murthy KC, Duvall K, Hall MJ, Baker S,
et al. Clinical study of yoga techniques in university students with
asthma: a controlled study. Allergy Asthma Proc 1998;19:3-9.
82. Sabina AB, Williams AL, Wall HK, Bansal S, Chupp G, Katz DL.
Yoga intervention for adults with mild-to-moderate asthma: a pilot
study. Ann Allergy Asthma Immunol 2005;94:543-8.
83. Koreck AI, Csoma Z, Bodai L, Ignacz F, Kenderessy AS, Kadocsa E,
et al. Rhinophototherapy: a new therapeutic tool for the management of
allergic rhinitis. J Allergy Clin Immunol 2005;115:541-7.
84. Neuman I, Finkelstein Y. Narrow-band red light phototherapy in peren-
nial allergic rhinitis and nasal polyposis. Ann Allergy Asthma Immunol
1997;78:399-406.
85. Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic
manipulative treatment on pediatric patients with asthma: a randomized
controlled trial. J Am Osteopath Assoc 2005;105:7-12.
86. Ernst E. Breathing tec hniques—adjunctive treatment modalities for
asthma? A systematic review. Eur Respir J 2000;15:969-72.
87. Holloway E, Ram FS. Breathing exercises for asthma. Cochrane Data-
base Syst Rev 2004;1:CD001277.
88. Dennis J. Alexander technique for chronic asthma. Cochrane Database
Syst Rev 2000;2: CD000995.
89. Hondras MA, Linde K, Jones AP. Manual therapy for asthma. Cochrane
Database Syst Rev 2001;1:CD001002.
90. Hondras MA, Linde K. Jones AP Manual therapy for asthma. Cochrane
Database Syst Rev 2005;2:CD001002.
91. Beamon S, Falkenbach A, Fainburg G, Linde K. Speleotherapy for
asthma. Cochrane Datab ase Syst Rev 2001;2:CD001741.
92. Hackman RM, Sterns JS, Gershwin ME. Hypnosis and asthma: a crit-
ical review. J Asthma 2000;37:1-15.
93. Huntley A, White AR, Ernst E. Relaxation therapies for asthma: a
systematic review. Thorax 2002;57:127-31.
94. Linde K, Jonas WB, Melchart D, Willich S. The methodological quality
of randomised controlled trials of homeopathy, herbal medicines and
acupuncture. Int J Epidemiol 2001;30:526-31.
95. Saper RB, Kales SN, Paquin J, Burns MJ, Eisenberg DM, Davis RB,
et al. Heavy metal content of Ayurvedic herbal medicine products.
JAMA 2004;292:2868-73.
96. Bielory L. Complementary and alternative interventions in asthma,
allergy, and immunology. Ann Allergy Asthma Immunol 2004;
93(suppl 1):S45-54.
97. Final rule declaring dietary supplements containing ephedrine alkaloids
adulterated because they present an unreasonable risk. Final rule.
Federal Register 2004;69:6787-854.
98. WHO Expert committee on specifications for pharmaceutical prepara-
tions. Thirty-fourth report. Geneva: World Health Organization; 1996.
p. 178-84. WHO Technical Report series no. 863.
99. Research Guidelines for evaluation of the safety and efficacy of herbal
medicines. Manila: World Health Organization Regional Office for the
Western Pacific; 1993. p. 35-40.
100. Niggemann B, Gru¨ber C. Side-effects of complementary and alternative
medicine. Allergy 2003;58:707-16.
J ALLERGY CLIN IMMUNOL
MAY 2006
1062 Passalacqua et al
Rhinitis, sinusitis, and
ocular diseases
Page 9
  • Source
    • "Substantial numbers of patients with AR are dissatisfied with conventional medical treatment and repeatedly experience side effects. As a result, many AR sufferers are turning to complementary and alternative treatments [8, 9]. Among them, Chinese medicine, including herbal medicine, acupuncture and Tian Jiu (TJ), are frequently used to manage AR in East Asia [10]. "
    [Show abstract] [Hide abstract] ABSTRACT: Background Allergic rhinitis (AR) is one of the most common allergic diseases. The conventional treatments of allergic rhinitis are oral anti-histamines, the use of intranasal corticosteroids, and immunotherapy. Dissatisfied with the ineffectiveness and side effects of these treatments, substantial numbers of patients are turning to alternative treatments like Chinese herbal medicine, particularly Tian Jiu (TJ). TJ is a form of moxibustion in which herbal patches are applied to specific acupoints on the skin. This study aims to investigate the efficacy and safety of TJ in the treatment of allergic rhinitis. Methods/design This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a 1-week run-in period, eligible subjects will be randomly assigned to the TJ group, placebo-control group or waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The primary outcome will be the change in the weekly average of the Total Nasal Symptom Score recorded from baseline to the end of treatment. The secondary outcomes will be change in symptoms and change in need for medication between baseline and the end of treatment by using the Rhinitis Quality of Life Questionnaire. Rescue medication (RM) needs will be measured using an RM score, comprising the weekly sum of daily assessments and any form of systemic steroids for allergic rhinitis. Discussion This study will be the first study to compare TJ treatment for allergic rhinitis with a placebo-control group, and a waitlist-control group. The investigation of TJ for allergic rhinitis will also suggest recommendations for clinical practice. The results of this study are expected to provide consolidated evidence for the effectiveness and safety of TJ for the treatment of patients with allergic rhinitis. Trial registration NCT02470845 (17 May 2015).
    Full-text · Article · Dec 2016 · Trials
  • Source
    • "Conventional medical treatments for PER include H1-antihistamines, glucocorticosteroids, leukotriene antagonists , decongestants, anticholinergics, and specific immunotherapy [4] . However, several patients experience side effects, become dissatisfied, and seek complementary and alternative treatments [5,6]. In traditional Chinese medicine, physicians have effectively used verum acupuncture to treat allergic rhinitis for many years [7,8]. "
    [Show abstract] [Hide abstract] ABSTRACT: Allergic rhinitis is a symptomatic allergic disease of the nose that affects 10 to 20% of the global population. Chinese otolaryngologists use one acupuncture needle to stimulate the sphenopalatine ganglion because of its potential advantages for treating moderate-severe persistent allergic rhinitis compared with traditional Chinese acupuncture (verum acupuncture); however, little evidence is available to support the wide clinical use thus far. Therefore, we propose a protocol for a parallel, multicenter, assessor-blinded, randomized controlled trial to evaluate sphenopalatine ganglion stimulation with one acupuncture needle compared to verum acupuncture for treatment of moderate-severe persistent allergic rhinitis. In the trial, 96 patients previously diagnosed with moderate-severe persistent allergic rhinitis and meeting all inclusion criteria will be allocated to one of two equal therapeutic groups by using a computer-generated randomization list. The interventional group will receive sphenopalatine ganglion stimulation with one acupuncture needle for 4 weeks (once or twice weekly, total four to eight sessions); attending physicians will decide whether the second session is required in a week by examining signs and symptoms. The control group will receive individualized verum acupuncture for 4 weeks (twice weekly, total eight sessions). Follow-up evaluations will be performed 1 month later. The primary outcome measure is the change in the total nasal symptom score from the baseline to week 4. The secondary outcome measures include onset time and duration of effectiveness in every session, change in number of days with moderate-severe persistent allergic rhinitis from the baseline to week 8, change in total immunoglobulin E level and eosinophil count in venous blood from the baseline to week 4, change in Rhinoconjunctivitis Quality of Life Questionnaire score from the baseline to week 4, and clinical waiting time. The trial should provide evidence for the benefits of sphenopalatine ganglion stimulation with one acupuncture needle for treating moderate-severe persistent allergic rhinitis, including better change in total nasal symptom score, faster onset time, longer duration of effectiveness, and shorter treatment time. Trial registration Current Controlled Trials: ISRCTN21980724 (registered on 27 March 2014).
    Full-text · Article · Dec 2015 · Trials
  • Source
    • "Two important drawbacks of this review are that of the included trials, neither used validated outcome measures nor intention-to-treat analyses. Passalacqua et al. [12] conducted a systematic review on complementary and alternative medicine for 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 on advances in homeopathy and immunology which included AR. "
    [Show abstract] [Hide abstract] 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
    Full-text · Article · Jun 2014 · Systematic Reviews
Show more