A study conducted at the Department of Dermatology and Allergy in Germany in conjunction with Harvard researchers shows acupuncture as an effective complementary treatment for itch in atopic dermatitis.
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by intense itching, skin dryness, erythema, exudate, crust, and lichenification [1]. Globally, AD is a common health problem, and its incidence rate has increased 2-3 times in recent years in industrialized countries. Approximately, 20% of children and 3% of adults are suffering from atopic dermatitis (AD) [2, 3].
Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects.
Initial treatments for AD are emollients, topical corticosteroids, and topical calcineurin inhibitors [4, 5]. Depending on severity, antihistamines, systemic corticosteroid, immunosuppressant, antibiotics, allergen-specific immunotherapy, or phototherapy may be used [6–8]. Complementary and alternative medicine treatments are used in patients with atopic dermatitis (AD), especially when there is no response to conventional therapies or side effects occurring [9–11].
Atopic dermatitis (AD) has been effectively treated with acupuncture, which has been shown to lack side effects when used with conventional therapies [12–16]. In animal models, acupuncture treatment resulted in decreased skin overgrowth and pruritus and improved biomarkers [5, 17]. To our knowledge, randomized controlled studies of the effectiveness of acupuncture-only treatment for AD are lacking [18], with the exception of our pilot study [19].
Itch is a major symptom of a skin condition called atopic dermatitis (AD). Previous neuroimaging studies have shown that acupuncture modulates some of the same brain structures known to process itch sensation in both healthy adults and patients with AD.
In this double-blinded study, verum acupuncture was compared with oral histamine (cetirizine), placebo acupuncture, placebo cetirizine, and no-intervention control for the treatment of itch in atopic dermatitis patients. The study was a double-blinded, randomized, placebo-controlled crossover trial in which itch was induced on subjects’ forearms, using allergen solution, grass, birch pollen, or dander, and temperature was modulated for a total of 27 warm-cool cycles within 20 minutes.
The acupuncture points used were:
LI-11(QuChi, on the elbow at the midpoint of the line joining the lateral end of the transverse cubital crease and the lateral epicondyle of the humerus),
HT-3 (ShaoHai, between the ulnar end of the cubital crease and medial epicondyle of the humerus),
ST-34 (LiangQiu, 2 cm above the superior lateral border of the patella) and
SP-10 (Xuehai, 2 cm above the superior medial border of the patella).
Both acupuncture and cetirizine significantly reduced type I hypersensitivity itch in patients with atopic dermatitis (AD) compared with the other treatment groups.
While preventive acupuncture (that which is applied prior to induced itch) was similar in effect to cetirizine, abortive acupuncture (that which is applied during the induced itch) was significantly more effective than preventive acupuncture or cetirizine.
These findings suggest that the introduction of acupuncture needles induce counter-irritation or distraction of the itch sensation. The study additionally used the D2 test of attention score, and found that cetirizine produced significant reduction of cognitive function in comparison with the placebo cetirizine.
These results suggest that acupuncture may be a useful complementary therapy to downregulate itch, urticaria, or eczema in atopic patients with fewer cognitive side-effects.
Study at the Kyung Hee University Korean Medicine Hospital
Another randomized study conducted at the Kyung Hee University Korean Medicine Hospital designed the proposed trial: verum acupuncture (VA) and sham acupuncture (SA) concluded that acupuncture treatment may relieve atopic dermatitis (AD) symptoms, and following the pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol.
A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796; date of registration: April 13, 2018).
In this pilot study [19], a verum acupuncture (VA) treatment group showed significant alleviation of AD symptoms relative to the sham acupuncture (SA) group, including pruritus.
Also, we found a positive relationship between the severity of atopic dermatitis (AD) symptoms and gastrointestinal (GI) symptoms such as epigastric tenderness and dyspepsia. Several studies show that GI and AD symptoms are related to unbalance of autonomic nerve system with sympathetic hyperactivity and parasympathetic dysfunction [20, 21]. Acupuncture treatment is known to affect autonomic nerve system [22]. Also, the relationship between AD and the central nervous system (CNS) has been well studied. Stress aggravates and sustains the itch-scratch cycle of AD by affecting the CNS [23]. Acupuncture treatment of AD patients may reduce brain activity of the insula, putamen, premotor and prefrontal cortical areas, which is induced by itching [24]. These findings can support the hypothesis of a “gut-brain-skin axis” suggesting a relationship between the GI tract, brain, and skin [25].
Taken together, this recent evidence suggests the need for a randomized controlled trial assessing the efficacy of acupuncture in reducing the symptoms of atopic dermatitis (AD). The trial aims to assess the effect of twice-weekly acupuncture treatment on the symptoms of mild-to-moderate AD in adults, including changes in quality of life (QoL), GI symptoms, and EEG.
Design
The main study objective is to determine whether or not twice-weekly acupuncture treatment improves symptoms and quality of life (QoL) in adults with mild-to-moderate AD. Other objectives are (1) to investigate the relationship between severity of AD symptoms and GI symptoms and (2) to determine the effect of acupuncture on the CNS of AD patients using EEG.
Inclusion Criteria
(A) 19 to 65-year-old men and women able to read and write the Korean language
(B) AD diagnosed according to the Hanifin and Rajka criteria [26]
(C) Scores from 30 to 80 points on a 100 mm Visual Analog Scale (VAS) for pruritus (0, no symptom at all; 10, worst symptom ever) [27]
(D) Scores from 10 to 40 points on the objective Scoring Atopic Dermatitis (SCORAD) scale [28]
(E) Abstinence from prescribed medications for AD for the preceding month
(F) Agreement with a study protocol and willingness to sign written informed consent
(G) No participation in other clinical studies for the preceding month
Exclusion Criteria
(A) Severely fluctuating AD symptoms
(B) Treatments (e.g., oral steroids) that may affect the symptoms of AD or that the study KMD deems inappropriate
(C) Secondary infection of AD lesions
(D) Severe mental problems
(E) Pregnancy, breastfeeding, or plans to have a baby during the study period
(F) Medical history that the study KMD considers to be inadequate
Recruitment of Participants
Based on our pilot study [19], we aim to recruit 36 mild-to-moderate AD patients using posters on noticeboards at the Kyung Hee Medical Center, nearby schools and local community centers.
Details of Needling
The acupuncture selection points were partially individualized based on the traditional meridian theory, clinical experience, and consensus by the experts in acupuncture and atopic dermatitis (AD), that is, 6 fixed points plus optional points according to individual symptoms.
The number of needle insertions per subject per session (mean and range where relevant) from 6 to 19 body acupoints per participant per session.
Fixed bilaterally choosen points:
PC6,
LI11,
ST36.
Optional points:
ST43,
GB11,
LI2,
TE3,
TE6,
SI2,
SI3,
BL66,
LR3,
SP3
Contralaterally (it can be applied bilaterally according to the signs or symptoms of the patient):
GB41,
TE3,
SI3
Intradermal Acupuncture:
LI11 bilaterally and
auricular shenmen contralaterally
The frequency and duration of treatment sessions was twice a week for 4 weeks, 15 minutes for each session and 8 sessions was the number of treatment sessions. A sterilized stainless steel needle were used and a hypoallergic adhesive tape. The depth of insertion, based on a specified unit of measurement or on a particular tissue level was from 5 to 30 mm, perpendicular to skin surface and for intradermal acupuncture a 1.5 mm, perpendicular to skin surface, until the response sought “de qi” sensation or muscle twitch response), wirh manual stimulation, needle rotation with thumb and index fingers for the first 10-15 seconds and electrical needle stimulation. Participants will be educated to press PTNS at LI11 for more than 3 minutes when they feel severe itching. Details of lifestyle advice will be given to all participants. Any other interventions will be prohibited during study period.
Verum Acupuncture (VA) Group
Participants in the VA group will receive eight acupuncture treatments twice a week for a total of four weeks. All VA group patients will receive acupuncture needling at six fixed acupoints. Up to 10 additional acupoints will be used, depending on each participant’s daily general conditions. The six fixed acupoints are:
LI11,
ST36, and
PC6 bilaterally.
Additional acupoints for gastric stuffiness or dyspepsia include:
ST43,
GB41,
LI2,
TE3,
SI3,
TE6,
SI2,
BL66,
LR3,
SP3,
ST43, and
GB41.
For tenderness around ST25, diarrhea, or constipation:
LI2 and
GB41.
For fullness in the chest and hypochondrium;
TE3 and
SI3.
For lower abdominal pain and tenderness on CV17:
TE3 and
TE6.
for lower abdominal pain and dry skin:
SI3 and
GB41.
For lower abdominal pain and heat in the upper body and cold in the lower body:
SI2 and
BL66.
For pain in the hypogastric region with darkness of the sublingual collateral vessels:
LR3 and
SP3.
Disposable sterile stainless needles (0.25 x 40 mm; Dongbang Acupuncture Inc., Bundang, Seongnam, Korea) will be used. Acupuncture needles will be inserted to depths of 5 to 30 mm, depending on the acupoint, and will remain in place for 15 minutes.
After removal of acupuncture needles, three acupoints will be treated with IA using 1.5 mm press tack needles (Haeng Lim Seo Won Medical Co., Korea). These are bilateral LI11 and auricular-Shenmen contralaterally to the side with more severe symptoms. Participants will be instructed by the study KMD to press LI11 for more than three minutes when they experience severe itching.
Sham Acupuncture (SA) Group
Participants in the SA group will receive sham acupuncture treatment eight times twice a week for four weeks. Unlike the VA group, SA group patients will receive sham acupuncture treatment at only six fixed control points. These bilateral acupoints are as follows: 1 to 2 cm proximal and 1 cm medial to LI7, 1 cm proximal and 1 cm medial to LI11, and 1 cm proximal and 1 cm lateral to ST36. To maintain participant blinding, a nonpenetrating sham device (Park sham acupuncture needles, AcuPrime Co., Ltd., Exeter, UK) will be used and left in place for 15 minutes.
After removal of sham acupuncture needles, the IA procedure used in the VA group will be replaced with application of needle-free, stainless steel rings that do not penetrate the skin. These will be attached to three control points: 1 cm proximal and 1 cm medial to LI11 bilaterally and finger point in the ear contra-laterally to the side with more severe symptoms. Unlike the VA group, SA group patients will not be instructed to press the control point.
Acupuncture was shown to be more effective in relieving the symptoms of atopic dermatitis (AD) than sham acupuncture, and the severity of atopic dermatitis (AD) was associated with the presence of gastrointestinal (GI) symptoms.
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