Background
Methods & Design
Study design
Randomization and blinding
-
penetrating acupuncture: 60 subjects
-
sham acupuncture: 60 subjects
Patients
Inclusion criteria
-
Age 18+
-
To meet the American-European Consensus Group Criteria for primary Sjögren syndrome [11]
-
Symptoms have been appearing for less than 5 years; signed a written informed consent form
-
Without taking pSS medicines, or have not been taking pSS medicines for at least 4 weeks before the recruitment, or have been taking the same kinds and doses of pSS medicines (non-steroidalanti-inflammatory drugs, NSAIDs; oral taken cortical hormone; pilocarpine; artificial eye liquid; herbal decoctions) for more than 4 weeks before the recruitment, or have been taking the same kinds and doses of other pSS medicines (tripterygium wilfordii; methotrexate; cyclophosphamide; cyclosporin; azathioprine; hydroxychloroquine sulfate) for more than 6 months before the recruitment.
Exclusion criteria
-
Secondary Sjogren syndrome
-
Have been having serious systemic disorders recently (lymphoma; central nervous system, renal, or pulmonary involvement; myositis; or vasculitis) or severe renal or liver failure
-
Have had acupuncture treatments in last 20 days
-
With acupuncture contraindications (allergy to metals, skin lesions on relative acupoints, etc.)
-
Subjects who participate in any other clinical trials in last 30 days before recruitment
-
Currently or planning to be pregnant, or at risk of being pregnant without contraception
-
Subjects with a physical or psychological problem, which may confound the trial results, interfere with other subject’s participation, or may make it risky to follow the investigators’ requirements
-
Subjects known for or persistent in drug or alcohol abuses
Recruitment strategies
Intervention
Description of sham acupuncture
Process of the intervention
Primary outcome
Secondary outcome
-
EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) [16] is a very simple index completed by patients to measure symptoms in pSS. With good construction validity, it is used as an outcome measure in clinical trials. There is a 0–10 numerical scale for each of the four domains, dryness, discomfort (including pain), global fatigue and mental fatigue, which are gathered to form the ESSPRI. For sicca features, six components were identified, which are ocular, oral, skin, nasal, tracheal and vaginal.
-
EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) [17, 18] is a clinical index completed by physicians to measure disease activity in patients with pSS. There are 12 organ-specific ‘domains’ contributing to disease activity. For each domain, features of disease activity are classified into three or four levels according to their severity.
-
Schirmer test score and unstimulated salivary flow [19]: these two tests are the objective reflection to the lacrimal gland and salivary glands, the results of which can be greatly impacted by the operator. Thus, there will be a technician performing these two tests during the whole trial to maintain the homogeneity of the operation.
-
Serum Immunoglobulin G, A, M levels [20]: Immunoglobulin G (IgG) is commonly believed in clinic a reflection of pSS symptom activities and a study shows weak associations between increasing fatigue and serum IgG, and the pro-inflammatory cytokine interleukin-17 (IL-17), were observed.
-
Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36) [21, 22] is a self-administered questionnaire with 36 items, which assesses the concepts of physical function, role limitations due to physical problems, social function, body pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. Note that both physical and mental component summaries can be combined. Scores range from 0 to 100, with higher scores indicating better health status [23].
-
Salivary glands ultrasounds [24]: image of salivary glands structures. This can be quantified by a form based on different features.
-
Hospital Anxiety and Depression (HAD) scale score [25]: A self-assessment scale which has been developed and found as a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.