Clinical trial NCT02691377: Acupuncture for Primary Sjögren Syndrome
Official title: Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sjogren's Syndrome
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of Primary Sjögren Syndrome.

Detailed description: This randomized, double-blinded, sham acupuncture controlled trial is aimed to assess the effectiveness and safety of acupuncture in the treatment of Primary Sjögren Syndrome.The eligible participants will be randomly allocated to receive acupuncture or sham acupuncture for 8 weeks.

Assuming a two-sided alpha of 0.05, power of 85%, and a 20% drop-out, a sample sized of 30 would be needed for each group. The statistical analysis will be based on the intention-to-treat principle. Continuous variables will be compared by Student t test or Mann-Whitney U test; categorical variables will be analyzed by chi-square test, Fisher's exact test or Kruskal-Wallis H test as appropriate. For comparison between two time points, paired t-test or Wilcoxon signed rank test will be used as appropriate. A statistically significant difference was set at P\<0.05.

Eligibility criteria: Inclusion Criteria:

* To fulfill the American-European Consensus Group Criteria for primary Sjögren syndrome.
* With the symptoms of primary Sjögren syndrome less than 5 years.

Exclusion Criteria:

* With an acupuncture contraindication (allergy to metals, skin lesions on relative acupoints, etc.)
* Taking or taken medicine for primary Sjögren syndrome within last 4 weeks before the enrollment.

Primary outcomes:
measure: The proportion of participants who has a 30% or greater reduction in 2 of 3 items,including the numeric analog scale (NAS) of dryness, fatigue, and pain.
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in NAS of each item including dryness, fatigue, and pain.
timeFrame: 24 weeks
measure: Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
timeFrame: 24 weeks
measure: Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36)
timeFrame: 24 weeks
measure: Change in Hospital Anxiety and Depression (HAD) scale score
timeFrame: 24 weeks
measure: Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels
timeFrame: 24 weeks
measure: Change in image of Salivary glands measured by ultrasound
timeFrame: 24 weeks
measure: Change in Schirmer test score and unstimulated salivary flow
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital
name: Xinyao Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou X, Xu H, Chen J, Wu H, Zhang Y, Tian F, Tang X, Zhang H, Ge L, Li K, Jiang W, Liu Z, Jiang Q. Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjogren's Syndrome: A Randomized Controlled Trial. Front Med (Lausanne). 2022 May 6;9:878218. doi: 10.3389/fmed.2022.878218. eCollection 2022.
citation: Jiang Q, Zhang H, Pang R, Chen J, Liu Z, Zhou X. Acupuncture for Primary Sjogren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2017 Jan 19;17(1):61. doi: 10.1186/s12906-017-1559-9.