Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjögren's Syndrome: A Randomized Controlled Trial

Primary Sjögren's syndrome is an autoimmune disease that affects millions of people worldwide, especially women. This condition primarily attacks the glands that produce saliva and tears, causing three main symptoms that significantly impact patients' quality of life: intense dryness of the mouth and eyes, joint pain, and persistent fatigue. Currently, available treatments for this syndrome are limited and frequently fail to provide satisfactory symptom relief. Faced with this unmet medical need, researchers have been investigating alternative therapies, including acupuncture, an ancient Chinese technique that has shown potential in the treatment of various inflammatory and autoimmune conditions.

This randomized clinical trial was conducted at Guang'anmen Hospital in Beijing, China, between March 2016 and September 2018. The researchers evaluated 120 patients diagnosed with primary Sjögren's syndrome, divided equally into two groups of 60 people each. One group received true acupuncture, while the other received sham acupuncture, in which special needles did not effectively penetrate the skin, serving as a placebo. Treatment lasted eight weeks, with sessions three times a week in the first four weeks and twice a week in the following four weeks, totaling twenty sessions.

Patients were followed for an additional sixteen weeks after the end of treatment. The primary objective was to determine whether acupuncture could reduce by at least 30% two of the three main symptoms of the syndrome, using numerical scales from zero to ten points to measure dryness, pain, and fatigue.

The results did not demonstrate significant differences between true and sham acupuncture in relieving the main symptoms. Approximately 28% of patients who received real acupuncture showed at least 30% improvement in two of the three symptoms assessed, compared with 32% in the group receiving sham acupuncture. Both groups showed improvements in symptoms over time, but without statistically significant differences between them. Interestingly, some important biological changes were observed: levels of immunoglobulin G, a marker of immune system activity, showed significant differences between the groups after sixteen weeks of follow-up.

In addition, salivary gland ultrasound examinations revealed greater improvement in the homogeneity of glandular tissue in the group that received true acupuncture, suggesting possible anti-inflammatory effects of the technique. Both groups also showed an increase in unstimulated salivary flow and a reduction in disease activity scores.

For patients with Sjögren's syndrome, these results indicate that, although acupuncture did not prove superior to placebo in relieving the main symptoms, it appears to be safe and may have some beneficial biological effects. The findings of improvement in salivary gland structure and changes in immunological markers suggest that acupuncture may influence the inflammatory processes underlying the disease, even if this does not translate into clinically significant symptomatic relief. For health care professionals, the study highlights the importance of rigorous controlled studies to evaluate complementary therapies. The results also suggest that the placebo effect may be particularly relevant in conditions such as Sjögren's syndrome, where both groups experienced improvements, possibly due to the special attention received during the study.

The study presents some important limitations that must be considered. The use of standardized acupuncture points for all patients may not reflect the actual clinical practice of traditional Chinese medicine, which normally personalizes treatment for each individual. The sham acupuncture may have had some therapeutic effect of its own, since it stimulated the same points as true acupuncture, only without deep skin penetration. In addition, the sample size may have been insufficient to detect smaller but clinically relevant differences between the groups.

The fact that approximately one-third of patients in both groups showed clinically significant improvement suggests that factors such as intensive medical attention, positive expectations, and lifestyle changes during the study may have contributed to the results. Although this specific study did not demonstrate superiority of acupuncture over placebo, it contributes to the scientific knowledge on treatments for Sjögren's syndrome and highlights the need for further research to better understand how different therapies may benefit patients with this challenging condition.