A blend of four traditional Chinese herbal remedies may help improve sleep and lower levels of certain antibodies in patients with Sjögren’s disease, a Taiwanese study suggests.
However, no difference was observed in disease severity scores between patients treated with the Chinese medicine mixture versus those on placebo.
The study, “Traditional Chinese medicine in patients with primary Sjögren syndrome: a randomized, double-blind, placebo-controlled clinical trial,»Was published in the journal Frontiers in medicine.
Primary Sjögren syndrome is an autoimmune disease characterized by a misguided immune response against the glands that produce tears and saliva. Currently, no effective therapy targeting the underlying cause is available, with patients relying instead on therapies that relieve symptoms.
In Taiwan, Sjögren’s syndrome affects around 0.8% of the population (mostly women) and more than 90% of patients with primary Sjögren syndrome are said to be treated with traditional Chinese medicines. However, the effectiveness of these treatments remains unknown.
To answer this question, a team led by researchers at Chung Shan Medical University Hospital in Taiwan conducted a clinical trial to assess the efficacy and safety of a blend of four commonly prescribed traditional Chinese herbal medicines – called Gan-Lu-Yin (GLY), Jia-Wei-Xiao-Yao-San (JWXYS), Suan-Zao-Ren-Tang (SZRT) and Ye-Jiao-Teng (YJT) – selected from the national insurance system Taiwan disease.
A total of 42 patients with Sjogren’s syndrome (aged 20 to 80 years) were randomized to either a placebo group (14 patients) or to the traditional Chinese medicine group (28 patients). The placebo looked and tasted the same as Chinese medicine, but only a tenth of the dose.
People in the Chinese medicine group were given six grams of GLY granules after breakfast and six grams of JWXYS combined with one gram each of SZRT and YJT after dinner, every day for 12 weeks. Patients were assessed every four weeks.
No other traditional Chinese medicine was allowed during the study. An exception was made for patients treated with Western medicine for more than two weeks prior to the trial, with patients being required to maintain treatment.
The primary objective of the study was a modification of the Patient-Reported EULAR Sjögren Index (ESSPRI), which measures fatigue, pain and dryness. ESSPRI scores range from zero to 10, with higher scores indicating more serious symptoms.
Secondary goals included changes in disease activity (assessed as changes in the Sjögren syndrome disease activity index EULAR, or ESSDAI), sleep (assessed by the sleep quality index of Pittsburgh, or PSQI), fatigue (assessed with the Multidimensional Fatigue Inventory), as well as overall health, assessed by a Physician’s Comprehensive Assessment (PGA).
A total of 21 patients in the Chinese drug group and nine patients in the placebo group completed the trial.
At the start of the trial, the general health of the patients in the Chinese drug group was worse than that of the patients in the placebo group. In addition, they had poorer quality of sleep, as shown by the higher PSQI scores – mean average of 11.25 versus 10.57 in the placebo group.
At the end of 12 weeks, the two groups showed no difference in the majority of the laboratory parameters evaluated. However, the levels of IgG – a type of antibody often increased in patients with Sjögren’s disease due to an overactive immune system – have significantly decreased in the group of traditional Chinese medicines.
ESSPRI scores were reduced – indicating a decrease in symptoms – in both groups, but the decrease was more pronounced in the placebo group (decrease of 0.91) compared to the treatment group (decrease of 0.62) . The researchers noted, however, that “the ESSPRI scores of patients in the treatment group were higher than those of patients in the control group” at the start of the trial.
Despite a significant reduction in ESSDAI disease activity scores after 12 weeks in patients treated with traditional Chinese medicines, the placebo group also experienced a reduction in ESSDAI scores and no significant difference was observed between the two groups. .
In turn, PGA scores, another measure of disease activity, were significantly reduced in the Chinese drug group compared to the placebo group.
Patients treated with the mixture of traditional Chinese medicines experienced an improvement in their sleep duration compared to the placebo group, as shown by an additional 30 minutes of sleep per day. Their blood pressure also improved.
The only serious adverse event reported was due to a stretched and swollen kidney, but no connection to Chinese herbal remedies was found.
Overall, the results suggest that although the mixture of traditional Chinese medicines had no effect on the severity of illness in patients with Sjögren’s syndrome, this combo “could prolong the duration of sleep of patients”, wrote the researchers.
“We also discovered that this formula could decrease serum [blood] IgG level and blood pressure at the end of the study, ”they concluded.