Submitted by: Maria Gracia R. Concepcion 2017-10-04 00:00:00 Last Updated by: Jeverly Ann S. Principe 2017-10-12 15:05:59 Export to PDF

The role of Acupuncture therapy as an adjunct to standard therapy for pruritus in patients with Atopic Dermatitis: A Patient- and Assessor-Blinded, Randomized, Placebo-controlled Trial

PHRR171012-001696

RGAO-2016-0353

Unspecified

The role of Acupuncture therapy as an adjunct to standard therapy for pruritus in patients with Atopic Dermatitis: A Patient- and Assessor-Blinded, Randomized, Placebo-controlled Trial

Pruritus is an unpleasant sensation that is one of major characteristic of Atopic Dermatitis. This sensory experience greatly impairs the quality of life of affected individuals. Non-pharmacologic interventions and physical modalities have been explored but there are limited literature in determining their role as adjunct in therapy. There is some evidence that acupuncture reduces the intensity of itch, decreases eczema severity, and improves quality of life.

This study aims to determine the efficacy of acupuncture in reducing itch intensity, disease severity, improve quality of life, and decrease medication use.

Background: Pruritus is an unpleasant sensory experience and can impair quality of life in affected individuals. As there is no definite way to control it, some patients perceive it as the most unendurable symptom. As this is the characteristic symptom in Atopic Dermatitis, it certainly has a big impact on quality of life. Non-pharmacologic interventions and physical modalities for itch are rarely investigated, despite these methods having neither systemic nor serious side effects, and can be a useful adjunctive therapy. There is some evidence that acupuncture reduces the intensity of itch, decreases eczema severity, and improves quality of life. However there is a lack of clinical trials involving the efficacy of acupuncture in pruritus, especially in the Philippine setting.

Objectives: This study aims to determine the efficacy of acupuncture in reducing itch intensity, disease severity, improve quality of life, and decrease medication use.

Methodology: This will be a prospective, patient- and assessor-blinded, randomized, placebo-controlled trial. Twenty-eight patients clinically diagnosed with Atopic Dermatitis will undergo twice-weekly acupuncture for 12 weeks, with an 8 week follow-up period. Baseline assessment will be done (day 0) and at 1-week intervals using standard data collection forms and validated assessment tools.

Data Management and Analysis: As soon as the data has been checked for completeness and errors, each patient’s data set from every assessment period will be handed to a third-party data collator for encoding. Data will be encoded in Microsoft Excel 2007. Frequencies and percentages, mean scores and standard deviations will be determined for the patient demographics. Comparison of baseline characteristics between the two groups will be done using independent t-test for quantitative variables and Fisher’s exact test for qualitative variables. All outcome measures will be presented either as mean + standard deviation or as frequencies and percentages. Comparisons of continuous variables (SCORAD, VAS, Health-related Quality of life) between the two groups across different time points will be performed using the Repeated Measures Analysis of Variance (ANOVA). All comparisons will be made two-tailed, and p-values <0.05 will be considered to be statistically significant. Intercooled STATA 12 will be used in the analysis. Dichotomous outcomes such as treatment success or failure will be analyzed for Relative Risk (RR), Relative Risk Reduction (RRR), Absolute Risk Reduction (ARR), Number-needed-to treat (NNT), and their respective 95% confidence intervals. An online EBM calculator will be used.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-01-01 15 2018-04-01 2018-04-01

Ongoing

Institution Classification Region LTO #
Philippine General Hospital, Section of Dermatology Government NCR LTO-3000001863742
Institution Amount Region
Philippine Institute of Traditional and Alternative Health Care N/A NCR
Name E-Mail Phone Number Postal Address
Jolene Kristine G. Gatmaitan- Dumlao, MD jolenegatmaitan@gmail.com 554-8400, local 5105-5016, 526-2397 UP-Philippine General Hospital, Section of Dermatology Taft Ave., Manila
Name E-Mail Phone Number Postal Address
Jolene Kristine G. Gatmaitan- Dumlao, MD jolenegatmaitan@gmail.com 554-8400, local 5105-5016, 526-2397 UP-Philippine General Hospital, Section of Dermatology Taft Ave., Manila
Name Expertise Affiliation
Jolene Kristine G. Gatmaitan, MD Dermatology Philippine General Hospital, Section of Dermatology
Rona Maria R. Abad, MD, DPDS Dermatology Philippine General Hospital, Section of Dermatology
Leah Antoinette M. Caro-Chang, MD Dermatology Philippine General Hospital, Section of Dermatology
Erin Jane L. Tababa, MD, DPDS Dermatology Philippine General Hospital, Section of Dermatology
Belen Lardizabal-Dofitas, MD Dermatology Philippine General Hospital, Section of Dermatology
Philip Nino Tan-Gatue, MD, CAc, CMA Acupuncture and Chinese Medicine Philippine General Hospital
Project Location Institutional Ethics Review Board
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital Philippine General Hospital Ethics Review Board

Atopic Dermatitis

Itch intensity determined through Visual Analogue Scale (VAS): expressed as mean difference and % mean difference and 95% CI between VAS scores from baseline to another VAS measurement Key Secondary Outcomes

  • Global assessment (patient-reported)
  • the change in the Scoring Atopic Dermatitis (SCORAD) index:  mean difference and % mean difference, 95% CI
  • the change in Dermatology Life Quality Index (DLQI) for participants aged 16 and above, and either Child Dermatology Life Quality Index (CDLQI) or Indeks ng Kalidad ng Buhay Pangdermatolohiya ng mga Bata (IKPaB) for participants aged 4 and below 16 years old: mean difference and % mean difference
  • the amount of concurrent medication use for atopic dermatitis
  • the presence of any adverse event during the treatment period and follow-up period

Recruiting

  • Philippines

Clinical Trial

Unspecified

2016-06-06

None

INCLUSION CRITERIA

Diagnosis of Atopic dermatitis

  • Must have:
- An itchy condition (or parental report of scratching or rubbing in a child)
  • Plus three or more of the following:
- History of involvement of the skin creases sych as foldsof elbows, behind the knees, fronts of anklesm the neck and around the eyes*
- A personal history of asthma or hayfever (or history of atopic disease in a first-degree relative in children under 4 years of age)
- A history of generally dry skin in the last year
- Visible flexural eczema (or eczema involving the cheeks/forehead and extensor limbs in children under 4 years of age)
- Onset under 2 years of age (not used if child is under 4 years of age)

EXCLUSION CRITERIA
  1. treatment with phototherapy, oral or intravenous immunosuppresive agents or corticosteroids in the preceding 4 weeks before recruitment;
  2. treatment with acupuncture and/or chinese herbal medicine (CHM) in the previous 3 months;
  3. pregnancy; and
  4. severe physical or mental illness, particularly those with leukemia, hemophilia, deranged PT/PTT, and severe anemia
  5. Those without written informed consent will also be excluded from the study

Interventional

True Acupuncture

For this study, the following points will be used: Hegu (LI-4), Quichi (LI-11), Fengshi (GB-31), and Zusanli (St-36). Two points from the upper extremities and two points from the lower extremities were selected for balance. These points are empiric points for itch and are believed to be involved in immunomodulation. Each of these points will be manually stimulated in the bilateral upper and lower extremities.

Randomized

Double Blind

Patients are not aware whether the acupuncture points correspond to true and sham acupuncture. Only Dr. Tan-Gatue, a licensed acupuncturist, will determine these acupuncture points and perform the procedure. Likewise, the outcome assessor is not aware which patient is receiving true and sham acupuncture.

Single Arm

Treatment

Phase II/III

28

9

Unspecified

01 Jan 2017

Utilization Utilization Info
No records found.

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