Compounds known as glucosides, extracted from the root of a flower called the Chinese peony, alleviated dryness, lessened fatigue, and reduced overall disease burden in Sjögren’s syndrome patients, a randomized trial in China shows.
Trial findings were published in the study, “The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren’s syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial,” in the journal Clinical Rheumatology.
Sjögren’s syndrome is an autoimmune condition where the immune system attacks certain glands, such as those producing saliva and tears. As a result, patients often have dry eyes and mouth. However, nearly a third of patients have symptoms outside these glands.
Current treatments include eye drops and saline solutions that relieve the dryness, but do not target disease mechanisms. Systemic therapies that suppress the immune system are often used for patients with organ manifestations, but studies show their effect is limited in overcoming dry mouth or dry eyes.
Paeonia lactiflora, the common Chinese peony, is frequently used in Chinese medicine. Total glucosides of peony (TGP), which are extracted from the root of this plant, have been approved in China for the treatment of rheumatoid arthritis due to its ability to modulate the immune system.
In animal models, TGP effectively delayed the onset of Sjögren’s syndrome, and studies in humans have shown that the compound also increases saliva and tear flow. But until now, no randomized trials had studied the effects of TGP in primary Sjögren’s syndrome (pSS).
So researchers in China conducted a multicenter trial (ChiCTR-TRC-12002325) comparing the effects of TGP versus a placebo in 320 primary Sjögren’s patients without any symptoms outside the exocrine glands.
“In this study, we focused on pSS patients who did not exhibit significant extra-glandular manifestations to observe the efficacy and safety of TGP for the treatment of pSS,” the researchers wrote.
Patients were recruited between March 2012 and July 2014 across 10 hospitals in China, and received oral treatment twice a day for the first week, and three times daily for the remaining 24-week period.
The study’s primary goal was to see an improvement after 24 weeks in the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), which is a composite measure of pain, fatigue, and dryness.
Secondary objectives included relieving dryness in the eyes, mouth, skin, nose, throat, and vagina, saliva and tear production, fatigue, mental discomfort, and patient-reported disease burden.
The trial met its primary objective, with patients experiencing a higher decrease in ESSPRI scores when treated with TGP than with a placebo. Also, dryness in the eye, throat, and vagina was reduced, and patients produced more saliva then those receiving a placebo. Fatigue and mental discomfort were also lower.
Adverse reactions were experienced by 10.9% of patients receiving TGP, and 2.9% of those treated with placebo. The most common reactions in the TGP group were gastrointestinal discomfort and diarrhea, but only two patients discontinued treatment due to intolerance to TGP. No severe adverse events were reported.
These findings suggest the TGP is safe and effective for treating Sjogren’s syndrome, particularly for managing glandular symptoms of these patients. Studies assessing the long-term effects of TGP and exploring its mechanism of action are now needed.
“This first multi-center, randomized, double-blinded, placebo-controlled clinical study confirms that TGP is effective, safe, and well-tolerated in the treatment of pSS,” the researchers concluded.