Acupuncture Combined With Hydroxychloroquine

Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Primary Sjögren's Syndrome
• Intervention / Treatment: Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Senyue Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acupuncture combined with hydroxychloroquine sulfate tablets; Acupuncture combined with oral hydroxychloroquine sulfate tablets	Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets; Acupuncture combined with oral hydroxychloroquine sulfate tablets
No Intervention: oral hydroxychloroquine sulfate tablets; Oral hydroxychloroquine sulfate tablets (Shanghai Shangyao Sino-Western Pharmaceutical Co., LTD., Fenle, Sinopyma approval number H19990263, 0.1g x 14 tablets) were treated with 0.2g each time, twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary flow rate (Sauf)	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.	8 weeks
Schirmer test	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sjögren's syndrome patient-reported index (ESSPRI)	Used to assess the degree of dryness, pain, and fatigue in pSS patients, it is an evaluation of disease activity based on patients' subjective feelings. On a scale of 0 to 10 from mild to severe, the final ESSPRI score is the average score of dryness, pain and fatigue. Scores <5 were classified as acceptable symptom status and >5 as unsatisfactory symptom status.	8 weeks
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score	used to evaluate disease activity in patients with pSS, ESSDAI is an evaluation of disease activity based on objective facts. The score weight includes 12 dimensions, including systemic symptoms, lymph node disease, glandular disease, joint disease, skin disease, peripheral neuropathy, central neuropathy, lung disease, kidney disease, muscle disease, hematological diseases and serological changes. The total score of ESSDAI is equal to the sum of the score of the severity of each system × the product of the weight of the system. A scale of <5 was classified as low disease activity, 5 to 13 as moderate disease activity, and >14 as high disease activity.	8 weeks

Collaborators and Investigators

• Sponsor: Senyue Zhang
• Investigators: Principal Investigator: Senyue Zhang, Heilongjiang University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 595661170@qq.com

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No