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Polyprezinc improves taste disorders: a randomized, double-blind, placebo-controlled, multi-center study

Polyprezinc improves taste disorders: a randomized, double-blind, placebo-controlled, multi-center study

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-01
  • Views:0

(Summary description)

Polyprezinc improves taste disorders: a randomized, double-blind, placebo-controlled, multi-center study

(Summary description)

  • Categories:Stomach healthy
  • Author:
  • Origin:
  • Time of issue:2020-12-01
  • Views:0
Information

  Preface

  Many people in the world suffer from taste disorders. In 1994, there were 1.1 million patients with taste disorders in the United States. In 2003, Japan reported 240,000 newly diagnosed patients with taste disorders. Nevertheless, the medical profession has not paid due attention to this disease. Dysgeusia can lead to anorexia and even life-threatening.

  It is well known that taste buds contain a variety of zinc-containing enzymes. Zinc is the most important and essential element for maintaining human health and plays a vital role in regulating enzyme activity. Therefore, a sufficient supply of bioactive zinc is very important for the homeostasis of taste buds and taste sensitivity. It has been reported that zinc plays an important role in the pathology of dysgeusia, and zinc supplementation can improve the loss of taste.

  Polyprezinc is a chelate composed of zinc ions and L-carnosine, which is widely used clinically to treat gastric ulcers. The purpose of this article is to conduct a randomized, double-blind, placebo-controlled, multi-center clinical study in accordance with clinical trial specifications (GCP) standards to evaluate the effect of zinc-containing compound polyprezinc on the treatment of taste disorders.

  1 Research objects and methods

  1.1 Research subjects The research was conducted in 22 centers and was approved by the ethics committee of each participating institution. All subjects signed an informed consent form. A total of 129 subjects with dysgeusia were included. Inclusion criteria: age 20-80 years old, course of disease less than 6 months, no underlying disease, no drugs that affect the condition. In the end, 109 participants met the requirements. During the baseline observation period, the subjects’ taste sensitivity score was ≥3.5 points, and the difference between the first and second sensitivity scores was 0.75. 109 eligible subjects were randomly divided into 4 groups, namely the placebo group And 3 different doses of polyprezinc treatment groups. 1.2 Evaluation of taste sensitivity The paper filter disc (PFD) method was used to evaluate the taste perception of the subjects for 4 different taste qualities. Using the PFD test kit, the taste sensitivity was detected in 4 discrete areas on both sides of the cord drum and the glossopharyngeal nerve, starting with the No. 2 disc for each taste quality. In the case of the glossopharyngeal nerve, the intervertebral disc is placed close to the palatal lobe arch because the pharyngeal reflex at this location is the least common. During the baseline observation period, each subject was subjected to 2 PFD tests. The subjects’ taste disorders were rated. When the total mean value is less than 3.5, the patient is diagnosed as normal; when the total mean value is ≥3.5 to <4.5, the diagnosis is mild; when the total mean value is ≥4.5 to <5.5, the diagnosis is moderate; when the value is ≥5.5 At that time, the diagnosis was severe. 1.3 Subjective symptoms Information on subjective symptoms of subjects is provided through a questionnaire survey. Symptoms are divided into 1-5 points, 1 as "no taste", and 5 as "normal taste". 1.4 Study design In 109 subjects, 28 subjects were in the placebo group, 27 subjects were in the treatment group, 26 subjects were in the treatment group, and 28 subjects were received in the treatment group. They received 75 mg, 150 mg, and 300 mg polyprezinc, which contained About 17mg, 34mg and 68mg zinc, a total of 12 weeks of treatment. Before and after treatment, PFD method was used for taste sensitivity test and serum zinc level determination. Adverse reactions are evaluated throughout the study period. 1.5 The main efficacy indicators are evaluated by quantitative analysis of taste according to the PFD method, and the values ​​before and after treatment are compared. The degree of efficacy is evaluated according to the following criteria: cured, total average value <3.5; improvement, improvement of the tympanic cord area or glossopharyngeal nerve area ≥1.0; unchanged, neither cured nor improved or worsened; worsened, the tympanic cord area and glossopharynx The nerve area aggravated ≥1.0. The total average is calculated by dividing the sum of the scores of the discs containing each taste quality at 4 different positions by 16. The number of "effective" cases is the sum of "cured" and "improved" cases. 1.6 Evaluation of other curative effects

  1.6.1 Average PFD test score

  Obtain the average PFD test score after treatment, and compare the data of the zinc treatment group and the placebo group. 1.6.2 Subjective symptoms The change of subjective symptoms is the difference between the values ​​obtained before and after treatment.

  1.6.3 Serum zinc level.

  Use atomic absorption spectrometry to measure serum zinc levels. The change in serum zinc level was determined by subtracting the value on day 0 from the value at 4, 8 and 12 weeks after treatment. 1.7 Safety statistics analysis the incidence of adverse drug reactions. 1.8 Statistical analysis The Shirley-Williams test was used for statistical analysis of the main efficacy indicators, and the α level was set to 0.025. Other comparisons used unpaired Student’s t test, Dunnett’s test, linear regression analysis or Fisher’s exact test, and the α level was set to 0.05.

  2 Results and analysis

  2.1 Subject characteristics

  Among the 109 subjects included in this study, one subject was excluded because it did not meet the participation criteria, and the other subject voluntarily withdrew from the study. Finally, a total of 107 subjects were evaluated in this study. The characteristics of the subjects are shown in Table 1. There were 56 female subjects and 51 male subjects, ranging in age from 21 to 77 years old. Among them, the blood zinc concentration of 51 cases was lower than 569mg/dl and 56 cases were higher than 70mg/dl. Table 1 Patient characteristics

  2.2 Main efficacy indicators

  Use the PFD test to detect taste sensitivity, divide the number of patients cured or improved by the taste sensitivity score by the total number of patients in each dose group participating in the treatment, and calculate the effective rate (%). As shown in Table 2, the effective rates of placebo group, 17mg, 34mg and 68mg zinc groups were 63.0%, 51.9%, 80.0% and 89.3%, respectively. The results showed that patients treated with 68 mg zinc had a significant improvement compared with the placebo group (p=0.018, Shirley-Williams test). Table 2 Evaluation of effective efficiency by paper filter disc method

  2.3 Evaluation of other therapeutic effects

  2.3.1 Average PFD test score

  "After treatment, the average PFD scores (mean±SD) were 4.095±1.148 (placebo), 4.350±1.030 (17mg), 3.448±0.928 (34mg) and 3.454±1.138 (68mg), respectively. Compared with the placebo group, the scores of the 34 mg and 68 mg zinc treatment groups were significantly different (p<0.05, unpaired Student’s t test).

  2.3.2 Subjective symptoms

  Compare subjective symptom scores before and after treatment. The average score increases were 0.6 (placebo), 0.9 (17mg), 1.2 (34mg), and 1.0 (68mg). The results showed that compared with the placebo group, the average scores of subjective symptoms in the 34 mg and 68 mg zinc treatment groups improved.

  2.3.3 Serum zinc level

  The average serum zinc level measured at each evaluation time point is shown in Figure 1. The average serum zinc level of the zinc treatment group increased in a dose-dependent manner throughout the treatment period. Figure 1 Changes in serum zinc concentration

  The difference in serum zinc concentration before and after treatment is as follows (mean ± SD): placebo group 1.8 ± 12.7, placebo group 5.7 ± 13.5 (17 mg), 11.4 ± 16.6 (34 mg), 20.6 ± 21.3 (68 mg). The results clearly showed that serum zinc levels increased in a dose-dependent manner (p<0.001; linear regression analysis), and the increase in the 68 mg zinc treatment group was statistically significant (p<0.001; Dunnett’s test).

  2.4 Security

  The incidence of adverse drug reactions in the placebo group and zinc treatment group was not statistically significant, p=0.703, p=0.283, p=0.295; Fisher's exact test. Adverse reactions include: a slight increase in blood triglycerides (1 patient in the 17 mg group, and 2 patients in the 34 mg and 68 mg groups), blood alkaline phosphatase increase (the placebo group, the 17 mg group and the 68 mg group each have 1 patient), decreased blood iron (1 patient in each of the 17 mg and 34 mg groups), constipation (1 patient in the 34 mg group and 2 patients in the 68 mg group), stomach upset (1 in the placebo, 17 mg and 34 mg groups) Cases), abdominal distension (1 case each in the 34 mg group and 68 mg group), the reaction was not serious. In general, these results indicate that zinc doses up to 68 mg are safe and well tolerated by patients with idiopathic dysgeusia.

  Discuss

  Taste is one of the most important sensory elements necessary for the quality of human life. Dysgeusia is caused by insufficient supply of nutrient zinc; low zinc metabolism caused by systemic diseases such as the kidney, liver and other organs, side effects of certain drugs, postoperative damage to taste-related sensory organs, and radiotherapy can also cause low zinc metabolism.

  The results show that polyprezinc with a daily dose of more than 150 mg (zinc, 34 mg/day) can effectively improve the taste sensitivity of patients with idiopathic dysgeusia, while a dose of 300 mg (zinc, 68 mg/day) can improve significantly For taste sensitivity, zinc administration dose up to 68mg is safe, and it is well tolerated by patients with idiopathic dysgeusia without serious adverse reactions. Moreover, the average serum zinc level increased in a dose-dependent manner throughout the treatment period.

  Ruilaisheng (Polyprezinc particles) is a chelate composed of zinc ions and L-carnosine. Polyprezinc can correct the abnormal taste of rats caused by zinc-deficient diet and reverse the decrease in the turnover rate of taste bud cells. For patients with insufficient zinc supply and affected taste bud function, Polyprezinc has potential therapeutic value.

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