Acupuncture for Nasal Congestion in Allergic Rhinitis: An Open-Label, Randomized, Monocenter Trial (ANCAR Trial)

Worldwide more than approximately 500 million people suffer from AR[1, 2] (30%
of the Dutch population (Mylan Update, 2018[2]) and its prevalence is
expanding[1]. Nasal congestion (i.e. reversible mucosal congestion [3]/nasal
mucosal obstruction[4]) is one of the most general and bothersome symptoms in
rhinitis[5, 6] and is associated with other medical conditions such as
rhinosinusitis and otitis media[7, 8]. This study is relevant as in addition to
the high global occurrence of AR, this disorder has substantial effects on the
quality of life (QOL) (e.g. during sleep and work)[9]. AR is related to high
direct medical costs (mainly prescriptions of medications and outpatient
visits) and indirect economic costs (including productivity decrease)[8, 10,
11]. Current medications are undesirable due to their side-effects (such as
sedation in the case of intranasal antihistamines (INAH)[11].
Acupuncture for AR in general can be considered as safe and can be seen as a
potential remedial blueprint for nasal congestion[12]. Evidence supported that
acupuncture is clinically used for signs and symptoms of nose disorders, such
as nasal congestion, with effectiveness, but whether acupuncture has immediate,
post-treatment and long-term effects on specifically nasal congestion in AR is
not verified by strictly designed clinical study.
The ANCAR trial aims to evaluate the effects of an acupuncture treatment
protocol for nasal congestion in AR compare to azelastine nasal spray. A
standard treatment protocol with a fixed set of acupuncture points has been
stablished - to be as scientific as possible from Western medical viewpoint -
and this selection of acupuncture points can be seen as a solid and profound
approach from which every AR patient may benefit. This standard set opens the
nose and affects the underlying energetic imbalance and immunity at the same
time to maintain its nose opening effect (i.e. to prevent recurrence of the
complaint).
The acupuncture protocol concerns 8 treatments during 6 weeks (i.e. 2
treatments per week during the first 2 weeks and 1 treatment per week in the
consecutive 4 weeks). The positive effects of this treatment protocol (such as
improvement QOL), may result in more confidence in the direct, post-treatment
and long-term effects of acupuncture and lead to more acceptance of acupuncture
as a solid treatment option for nasal congestion in AR instead of using an INAH
spray.

References: See page 37 ANCAR Research Protocol.

To evaluate the effects of an acupuncture treatment protocol for nasal
congestion in AR.

The trial is designed as an open-label, randomised, monocenter trial. All
eligible patients will be randomized (1:1) between two arms (open-label), i.e.,
arm A (Acupuncture) and arm B (Control).
Short-Term-Intervention RCT: 6 weeks treatment protocol with measurements
before and at 15 minutes after the 1st acupuncture treatment/1st azelastine
usage (to compare the immediate effects), at 15 minutes after the 2nd - 8th
acupuncture treatment and final usage of azelastine (= parallel to 8th
acupuncture treatment = post-treatment), then following the treatment period
after 2 weeks and 2 months (to compare the long-term effects). The accrual
expected to be 60 days.

To compare the effects of acupuncture with azelastine nasal spray (Carelastin®)
on nasal congestion in AR based on VAS (Visual Analog Scale) score.

Burden: Visits to Mermaid Medicine® (time investment), completing VAS and
Adapted NOSE questionnaires, undergoing PNIF-measurements.

Participation in the study has a negligible risk. Acupuncture for AR in general
can be considered as safe[20, 21]. No fatal or serious events are reported[20,
21], solely mild side-effects such as pain, papules, pruritus, subcutaneous
hematomas, dizziness, numbness and headache[20].
Side-effects Carelastin® azelastine nasal spray: bitter taste, drowsiness[11,
27], headache and burning sensation in the nose[27].
Benefits: Acupuncture and Carelastin® azelastine nasal spray can reduce AR
symptoms.

References: See pages 37-38 ANCAR Research Protocol.