Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Senyue Zhang
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Salivary flow rate (Sauf)
Overview
Brief Summary
To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.
Detailed Description
Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of primary Sjögren's syndrome
- •Must be able to receive acupuncture treatment and swallow tablets
Exclusion Criteria
- •Patients with malignant tumors or severe organ function impairment
- •Patients who are lactating or pregnant.
- •Persons who are participating in clinical trials of other drugs.
Outcomes
Primary Outcomes
Salivary flow rate (Sauf)
Time Frame: 8 weeks
Used to evaluate the salivary flow rate of pSS patients before and after treatment. Before the start of the experiment, the patient gargled with water to keep the mouth clean and free of irritation. Saliva collected at the bottom of the mouth and spit it into the measuring cup every 1min. After collecting it for 10min, the value was recorded. The less the saliva flow rate within 10 minutes, the worse the symptoms, and less than 1ml is abnormal.
Schirmer test
Time Frame: 8 weeks
Used to evaluate the degree of tear secretion in pSS patients before and after treatment. The 5mm×35mm filter paper was folded at a right Angle at 5mm from one end, and the end was placed in the conjunctival sac at 1/3 of the outer eyelid of the patient. The eyes were closed and the clamp was held for 5min, and the wet length of the filter paper was measured, and the filter paper was positive if it was less than 5mm/5min. The less tears are secreted within five minutes, the more severe the symptoms.
Secondary Outcomes
- Sjögren's syndrome patient-reported index (ESSPRI)(8 weeks)
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score(8 weeks)
Investigators
Senyue Zhang
Principal Investigator
Heilongjiang University of Chinese Medicine