Author: Yili Hu
Abstract: The objective is to evaluate the effectiveness and safety level of the traditional Chinese medicine Uric Acid Ease Capsules in the intervention of hyperuricemia through randomization and placebo control.
Method: 110 patients with hyperuricemia were selected and randomly divided into control group and intervention group, each with 55 cases, for a 4-week course of treatment, a total of 1-2 courses of oral intervention and observation. Both groups were given basic interventions such as diet and exercise. The intervention group was given oral Uric Acid Ease capsules and the control group was given a placebo. The effect of this product was evaluated by comparing the symptoms of the two groups before and after the intervention and serum uric acid. The liver function of the two groups was observed before and after the intervention (ALT, AST), renal function (UR, CR) and adverse reactions, and evaluate the results.
Results: The total effective rates of the first course and the second course of the Uric Acid Ease capsule intervention group were 78.2% and 86.7%, respectively. The intervention group fared Significantly better than the control group (P＜0.01, P＜0.001); the Uric Acid Ease capsule intervention group saw reductions in the users’ serum uric acid levels. The first course and the second course of treatment were compared with those before the intervention (P＜0.001, P＜0.001). Compared with the control group (P＜0.001, P＜0.001); the comparison of liver function (ALS, AST) and renal function (UR, CR) between the two groups before and after intervention was not statistically significant; there were no adverse reactions and serious effects in the two groups during the observation period Adverse events occurred.
Conclusion: Uric Acid Ease Capsule has a significant effect on the intervention of hyperuricemia. It is a safe and effective uric acid-lowering product, which is worthy of promotion.
Keywords: hyperuricemia; intervention effect; safety
Hyperuricemia (HUA) is a metabolic disease in which the metabolism of purines in the body is irregular, and the excretion of uric acid is reduced. Hyperuricemia is closely related to hypertension, diabetes, coronary heart disease, and cerebrovascular disease. It has become the second most serious metabolic disease after diabetes, and it is extremely harmful to the human body [1]. The 2007-2008 National Health and Nutrition Survey (NHANES) in the United States found that the prevalence of hyperuricemia was 21.4%, which was 3.2% higher than the 18.2% found in the 1988-1994 survey (NHANES-Ⅲ) [2]. Western medicine has many side effects in the control and treatment of hyperuricemia, especially liver and kidney function damage is large, and the incidence of allergic rash is high, so the use of Western medicine is restricted [3]. Traditional Chinese medicine has a unique effect in the intervention of hyperuricemia. Through the analysis of the law of traditional Chinese medicine intervention in hyperuricemia in the past 20 years, we have culminated in a high-efficiency combination of traditional Chinese medicines for the intervention of hyperuricemia. The core Chinese medicine ingredients are Rhozoma Polygoni (Rhozoma Polygoni). Cuspidati, Radix Clematidis, Herba Polygoni Avicularis, Lysmachia, Cortex Fraxini. Named Uric Acid Ease, by observing the effect and safety of its intervention in hyperuricemia, it has significantly reduced blood uric acid. There were no liver and kidney function damage and no adverse reactions. The report is as follows:
1 Materials and methods
1.1 Information
In this study, a total of 110 cases of users who were diagnosed with hyperuricemia in the hospital from May 2020 to April 2021 were collected, and they were randomly divided into an intervention group and a control group with 55 cases each. There were 51 males and 4 females in the intervention group; they were 27-64 years old, with an average of (49.27 ± 1.12) years; the duration of the disease was 3 months to 5.5 years, with an average of (2.82 ± 0.22) years. In the control group, there were 55 males and 5 females; ages were 25-65 years old, with an average of (51.12 ± 1.18) years; duration of illness was 5 months to 5 years, with an average of (2.98 ± 0.26) years. There was no statistically significant difference in age and course of disease between the two groups.
1.2 Selection criteria
Blood uric acid (UA) concentration:>420umol/L, female UA concentration:>360umol/L; age between 20-65 years old.
Exclusion criteria: patients with severe complications, pregnant or preparing to become pregnant or breast-feeding, unwilling to cooperate, and mentally ill patients.
1.3 Method
In this study, the two groups of hyperuricemia patients received basic intervention: both groups of patients were restricted to high-purine foods, abstained from alcohol, increased exercise, and drank not less than 2000ml of water per day. Intervention group: Uric Acid Ease Capsules (Rhozoma Polygoni Cuspidati, Radix Clematidis, Herba Polygoni Avicularis, Lysmachia, Cortex Fraxini))are provided by Wefine Health Technology Corporation in the United States. Ingestion method: 3 times a day, 1 capsule once a day, orally, 4 weeks as a course of treatment. Total of 1-2 courses. Control group: simulated placebo, 3 times a day, taking 1 capsule orally each time, 4 weeks as a course of treatment, with 1-2 courses of treatment in a row. During the observation period, Chinese medicines that affect the judgment of curative effect and Western medicines that affect uric acid levels are prohibited. Detection and observation indicators: blood uric acid, liver function (ALT, AST), renal function (UR, CR), before treatment, and after one course of treatment, and once after two courses of treatment.
1.4 Efficacy criteria
Make reference to relevant standards [4]. Healed: blood uric acid returned to normal; markedly effective: blood uric acid decreased by more than 25% compared to levels prior to treatment; effective: blood uric acid decreased by more than 15% compared to levels prior to treatment; invalid: blood uric acid decreased by less than 15% compared to levels prior to treatment
1.5 Statistical analysis Using SPSS22.0 software: for statistical analysis, data was tested by X2; measurement data was represented by（X(—)±S）and processed by t test; P<0.05 indicated that the difference was statistically significant.
2 Results
2.1 Comparison of intervention effects The total effective rate of the intervention group of the first course of treatment was 78.2%, and the total effective rate of the control group was 52.7%; the total effective rate of the intervention group of the second course of treatment was 86.7%, and the total effective rate of the control group was 56.9%; the intervention of the first course of treatment Compared with the control group, P<0.01, compared with the control group in the second course of treatment, P<0.001, see Table 1
Table 1 Comparison of the effects of the two groups on the intervention of blood uric acid
*P＜0.01, compared with the control group; **P＜0.001, compared with the control group
2.2 Comparison of blood uric acid levels between the two groups before the intervention: There was no statistically significant difference in blood uric acid values between the two groups before the intervention (P=0.638); the first course and the second course after the intervention were significantly lower than before the intervention, P<0.001, the first course of the intervention group Compared with the second course of treatment and the control group, P<0.001, the difference is significant. See table 2
Table 2 Comparison of blood uric acid before and after intervention between the two groups (X(—)±S, μmol/L)
*P＜0.001, compared with the control group; △P＜0.001, compared with before the intervention
2.3 Comparison of liver and kidney function indexes between the two groups before and after the intervention There was no significant change in liver and kidney function between the two groups before and after the intervention, P>0.05. See Table 3
Table 3 Comparison of liver and kidney function indexes between the two groups before and after intervention（X(—)±S）
2.4 Analysis of adverse reactions There were 2 cases in the intervention group: 1 case of oral ulcer, 1 case of hemorrhoids; 1 case of the control group, left knee pain. According to the criteria for judging the causal relationship between adverse reactions and drugs, they were all judged to have nothing to do with drug use.
3 Discussion
Hyperuricemia has become one of the most common diseases in the world. Hyperuricemia increases the risk of hypertension by 41%[5], the risk of stroke is increased by 47% [5]., the risk of coronary heart disease is increased by 9%, etc [6]. The risk of death from coronary heart disease increased by 16% [7], and the risk of death in patients with renal function deterioration and kidney disease increased [8]. Blood uric acid increased by 100umol/L, the risk of type 2 diabetes increased by 17% [9], the risk of hypertension increased by 13% [10], and the risk of heart failure increased by 19% [11]. At the same time, evidence shows that hyperuricemia has a relation with gout and obesity [12], metabolic syndrome [13], fatty liver [14], chronic kidney disease [15], hypertension [12], and cardiovascular and cerebrovascular diseases [16]. It is closely related to the occurrence and development of diseases such as diabetes [17], and is an independent predictor of premature death.
For the medical treatment of asymptomatic hyperuricemia, there are mainly drugs that can inhibit uric acid, promote uric acid excretion, and prevent urate deposition. However, these drugs have obvious adverse reactions, such as allergic rash, abdominal pain, diarrhea, white blood cell and thrombocytopenia. Liver and kidney damage, bone marrow suppression, hair loss, mental depression, etc. For this reason, it is necessary and urgent to research and find new treatment methods with no toxic side effects.
Traditional Chinese medicine has no official records of "hyperuricemia", but the symptoms of "gout" caused by hyperuricemia have been well known as early as the Han Dynasty. Present day doctors have further knowledge and explanation of its etiology and pathogenesis. Traditionally, it was believed that it results from insufficient congenital endowment, eating disorders, or exogenous feelings of six obscene evils. The pathogenesis lies in the deficiency of the original and excess, and the location of the disease involves the spleen and kidney. Especially in the past two decades, doctors from all over the world have carried out research on the clinical efficacy and safety of TCM medications. According to over 102 clinical research literature on the disease, with documented cases of >30 involving an efficacy rate of more than 70%, this new prescription was developed to evaluate the intervention effect and safety of hyperuricemia.
Rhozoma Polygoni Cuspidati has mild bitterness and coldness, and can promote blood circulation, dispel blood stasis, relieve menstruation and promote dampness. Modern pharmacology has also confirmed that Rhozoma Polygoni Cuspidati has obvious anti-hyperuric acid effect [18-21]. Rhozoma Polygoni Cuspidati contains polydatin which can inhibit uric acid reabsorption. The mRNA expression of the transporter URAT1 increases the mRNA expression of the uric acid secretion transporter OAT1 and OAT3, thereby enhancing the excretion of uric acid by the kidneys. This also shows that polydatin has a good effect on hyperuricemia from the genetic level [22]. Radix Clematidis is pungent, salty and warm, and belongs to the bladder meridian. It can dispel rheumatism and clear the meridians. The Compendium of Materia Medica describes Radix Clematidis as an essential medicine for gout, which is suitable for both upper and lower levels. Pharmacological studies have shown that Radix Clematidis can significantly reduce blood uric acid, and because Radix Clematidis has a strong anti-inflammatory effect, it can effectively protect the kidneys and treat kidney damage caused by hyperuricemia [23]. Herba Polygoni Avicularis diuresis, dehumidification, and eliminates toxins from the body. Modern pharmacological studies have also proved its pharmacological effects such as diuresis, anti-oxidation and liver protection [24]. Cortex Fraxini has the effects of clearing heat, drying dampness, and detoxification. Animal experiments show that the total coumarin in Cortex Fraxini can significantly reduce the blood uric acid level of mice with chronic hyperuricemia, and it has preventive and protective effects on uric acid nephropathy. The mechanism of action and effective inhibition activity of xanthine oxidase are related [25]. Lysimachia has the functions of clearing heat, removing dampness, and removing stones. Animal experiments have found that the serum uric acid level of mice with hyperuricemia in the Lysimachia group has been significantly reduced [26]. Therefore, this prescription has a good regulation of purine metabolism, promotes the excretion of uric acid, and significantly reduces blood uric acid; at the same time, it has the comprehensive effects of regulating immune function, anti-inflammatory, analgesic, and protecting damaged tissues and target organs, and is worthy of development and promotion.
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