Clinical comprehensive evaluation of Xiangju Capsules in treatment of rhinosinusitis / 中国中药杂志

The articles involving Xiangju Capsules were retrieved, and qualitative research and quantitative research methods were combined to evaluate the evidence of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) of this drug. Multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Xiangju Capsules in the treatment of rhinosinusitis and clarify the precise clinical positioning. The dimensions are graded A, B, C, or D. Multi-source safety evidence showed that the main adverse reactions were gastrointestinal reactions, rash, itching, dizziness, and headache. Based on the available studies, the risk is controllable and the safety is grade A. Meta-analysis showed that Xiangju Capsules + conventional western medicine could recover the Lund-Kennedy score, Lund-Mackay score, and CT score, relieve headache, nasal congestion, olfactory disturbance, and facial pain, with the effectiveness is grade B. The incremental cost-effectiveness ratio of Xiangju Capsules + conventional western medicine compared with conventional western medicine alone in the treatment of chronic rhinosinusitis was 263.71 yuan, about 0.82% of the per capita disposable income. The results of sensitivity analysis showed that the research results were relatively robust. Based on the assumption that the per capita disposable income in 2020 will be the threshold of patients' willingness to pay, it is more economical to use Xiangju Capsules + conventional western medicine. The drug belongs to grade A of the national medical insurance, with an average daily cost of 3.06 yuan, and the economy is grade B. This formula is modified from classic formulas and characteristic empirical formulas, be capable of improving immunity and preventing repeated attacks. It can be used for acute and chronic rhinitis-rhinosinusitis. It had a wide range of applicability, especially for the patients with head and face tenderness. Service innovation was reflected in the measures to guarantee supply, capacity, scalability, and coverage of grass-roots sales channels. The industrial innovation was improved through the management of medicinal resources, pharmaceutical industry, production technology, quality control, scientific research and development, and this formula won three national invention patents. Comprehensively, the innovation of Xiangju Capsules is grade B. According to the survey of 188 medical practitioners and 196 patients in 20 provinces, municipalities, and autonomous regions of China, the drug was characterized by easy preparation and administration, individualized medication, simple technology and management, convenient use, storage, and transport, and controllable adverse reactions, with the suitability is grade B. Xiangju Capsules showed the cost of 45.9 and 275.4 yuan for treatment of acute and chronic rhinitis-rhinosinusitis, respectively, being well affordable. It was sold in 35 000 medical institutions in China. The dosage form was suitable for transportation, storage, and grass-root application. With rich, sustainable, and available medicinal resources, the accessibility of Xiangju Capsules is grade A. This drug can be used for both acute and chronic rhinitis-rhinosinusitis, clearing heat and expelling pus, and strengthening the exterior to prevent relapse. After this drug was available on the market, over 4 000 cases were studied, with rich experience in human use accumulated, and characteristics of traditional Chinese medicine is grade B. Overall, the clinical value of Xiangju Capsules is class B. It is suggested that Xiangju Capsules should be used in accordance with the relevant policies of basic clinical drug administration to play its role.

Systematic review and Meta-analysis of efficacy and safety of Xiangju Capsules in treatment of sinusitis / 中国中药杂志

The present study evaluated the efficacy and safety of Xiangju Capsules in the treatment of sinusitis. CNKI, Wanfang, VIP, CBM, Cochrane Library, PubMed, EMbase, Web of Science and ClinicalTrials.gov were systematically searched for randomized controlled trials(RCTs) of Xiangju Capsules in the treatment of sinusitis, and Meta-analysis was performed on the included articles using RevMan 5.3. Twenty-nine articles were included, involving 4 331 cases, including 2 196 cases in the experimental group and 2 135 cases in the control group. Meta-analysis results showed that the conventional therapy combined with Xiangju Capsules showed better significant efficiency(RR=1.30, 95%CI[1.15, 1.47], P<0.000 01), total response rate(RR=1.19, 95%CI[1.16, 1.23], P<0.000 01), and Lund-Mackay scores(MD=-1.23, 95%CI[-1.39,-1.07], P<0.000 01) than conventional therapy alone. The conventional therapy combined with Eucalyptol-limonene-pinene Enteric Soft Capsules and Xiangju Capsules showed better total response rate(RR=1.14, 95%CI[1.07, 1.21], P<0.000 1) and VAS scores than conventional therapy combined with Eucalyptol-limonene-pinene Enteric Soft Capsules(MD_(headache)=-1.29, 95%CI[-1.48,-1.10], P<0.000 01; MD_(congestion)=-1.08, 95%CI[-1.21,-0.95], P<0.000 01; MD_(olfactory dysfunction)=-1.05, 95%CI[-1.23,-0.87], P<0.000 01; MD_(facial disorder)=-1.38, 95%CI[-1.49,-1.27], P<0.000 01). The conventional therapy combined with clarithromycin and Xiangju Capsules displayed a better total response rate(RR=1.15, 95%CI[1.08, 1.21], P<0.000 01) than conventional therapy combined with clarithromycin, while no significant difference was observed in the significant efficiency(RR=1.27, 95%CI[0.98, 1.65], P=0.07). The significant efficiency(RR=2.16, 95%CI[1.47, 3.18], P<0.000 1) and total effective rate(RR=1.48, 95%CI[1.28, 1.72], P<0.000 01) of clarithromycin combined with Xiangju Capsules in patients with sinusitis and CT scores(MD=-1.87, 95%CI[-2.01,-1.74], P<0.000 01) was significantly better than clarithromycin alone. Trial sequential analysis(TSA) showed that the cumulative sample size of the main outcome indicators had met expectations. The main adverse reactions included drowsiness, diarrhea, and abdominal pain, which had no direct relationship with Xiangju Capsules. Based on the available data and methods, the combination of Xiangju Capsules with multiple treatments showed significant efficiency and total response rate in the treatment of sinusitis, and improved CT scores, VAS scores, and Lund-Mackay scores, without serious adverse reactions. The efficacy and safety of Xiangju Capsules in the treatment of sinusitis still need to be verified by a large-sample, well-designed, and internationally standardized clinical trial scheme.