Besides being investigated the protective effect on RA by inhibiting inflammation via IL-17/NF-κB pathway,[4] JGL also showed effect of against neurotoxicity via oxidative stress, preventing abnormality of neurotransmitters and modulating pharmacokinetics such as reducing expression of cytochrome P450 enzymes.[9] As an OTC approved, the function of JGL indicated by instruction are to treat conditions like limited movement, joint swelling and pain by expelling wind, eliminating dampness (wind and dampness were pathogenic factors in traditional Chinese medicine theory[10, 11]), reducing swelling, and relieving pain. However, its clinical effect has not been strictly verified. In China, Phase III clinical studies may not be needed to verify the efficacy of a classic folk prescription such as JGL. These recipes are usually the result of a long period of clinical practice and experience, and are believed to be effective in treating specific symptoms or diseases in some cases. However, conducting Phase III clinical studies is standard practice to verify the safety and effectiveness of a drug or treatment.[12] Therefore, even if some folk classic recipes are widely used in practice, more rigorous scientific studies may be needed to confirm their efficacy and safety.
In this RWS, It is hypothesized by adding on JGL to regular western medical treatment might benefit RA patients with better results in controlling of disease activity or improving QoL. But the results were not satisfactory. Although, at baseline, the patients in the reference and the study groups showed different age and IgM-RF levels, but the inflammation markers of ESR and CRP without significant differences. Within one year of treatment, the patients in the study group that adding on JGL to the treatment showed higher levels of ESR and CRP in 3-6m. It indicates that adding on JGL might not befitting controlling of disease activity.
To say the least, if adding on JGL to the therapy could reduce the application of GCs or immunosuppressors, which also be contribution to the patients’ management. On the contrary, the RA patients received JGL needs more kinds of anti-rheumatic drugs and application ratio of NSAIDs was significantly increased. As the data recorded every patients’ treated drugs in one year, the results indicate a patient in the study group might treated with more anti-rheumatic drugs at the same time, another possibility was they need to constantly switch between different drugs due to the uncontrolled pain. That is the drug survival rate in the study group might lower than the reference group. And the drug survival rate is a key metric for evaluating long-term treatment effects. A high drug survival rate usually means that the drug is considered beneficial in long-term management, effectively controlling the activity of the disease and maintaining a steady remission of the condition.[13]
Adding on JGL did not decreased complications such as GI symptoms and attack of pneumonia, herpes zoster, URTIs, UTIs and LTBIs. For QoL, JGL treated group showed better performance on bodily pain, mental health, vitality and social functioning. But due to lack of baseline data, the results were as uncertain, the overall score of SF-36 showed no significant difference.
RWS, also known as real-world evidence studies, are observational studies conducted in real-world settings to evaluate the effectiveness, safety, and outcomes of medical interventions in a diverse patient population. RWS offer valuable insights to help inform clinical decision-making, healthcare policy making, and regulatory decisions. It is important to note that real world studies are observational in nature and are subject to various potential sources of bias, such as patient selection bias, treatment selection bias, etc.[14] To validate our results, the research flow was conducted in HCQ, a commonly used csDMARD, which is widely prescribed to patients with autoimmune diseases including RA.[15] The results indicated that RA patients received HCQ showed lower CRP levels within 3m of treatment than patients without. Furthermore, the application ratio of NSAIDs were decreased. The research on HCQ suggests the current RWS approach is a feasible way to evaluate the clinical efficacy of drugs.