Herbal Anti-Itch Gel Symptom Regression Rate Study via Questionnaire Follow-Up

Pruritus at the slight to moderate level is a very common skin disease symptom in the world; it is often caused by dry skin, minor insect bites, seasonal dermatitis or mild contact irritation. Although not life-threatening, it has been persistent discomfort and has affected people's quality of life in daily life, so there is a large need for convenient symptom relief. Historically, steroidal anti-itch ointments have been the main drug for this disease; however, after long-term use, there may be side effects such as skin atrophy, telangiectasia and systemic absorption. Therefore, there has been a shift in recent years towards non-steroidal, plant-based topical skincare products by consumers. Herbal anti-itch gels are natural anti-inflammatory and soothing; thus, many people have started to use them to treat mild skin injuries.

Although there has been an increase in the number of herbal products on the market, how effective they are in practice is still unknown. The current data on effectiveness come from controlled in-clinic trials conducted under strict conditions in a limited number of people for a short time; therefore, the general situation cannot be judged. Laboratory data do not usually capture the subtle changes in symptoms over a long period of time for the average consumer in different daily situations. There is a lack of data from large numbers of actual users to assess how commercially available herbal anti-itch gels work outside the hospital environment, and thus, it is difficult to determine their actual therapeutic effects.

To address the problems in the methodology, a solid real-world evidence model needs to be built. A long-term follow-up survey is cost-effective and feasible for bridging the gap between the results obtained in the laboratory and the actual living environment of users. It is possible to record the self-reported changes in the symptoms of many users over a long period of time and thus reflect the different circumstances of application in daily life. To observe the symptoms of healing over time, it is necessary to have a standardised and practical method for evaluating the practical application of herbal anti-itch gels in daily skin care.

The following are the main research questions in this paper: First, based on the survey of people with real pruritus who used the target herbal anti-itch gel, what were the rates of symptom regression in days 7, 14, and 28? Based on the above quantitative time points, we can learn about the pharmacodynamic changes of the product in daily life. Second, some controllable use and individual reasons have been found that affect the actual anti-itch effect of the product. Through analysis of application frequency, dosage and individual skin conditions, the key operating parameters that can enhance the therapeutic effect of the drug have been determined. Thirdly, we are going to build up a reasonable questionnaire-based evaluation framework so that it can be continued to be used to track the effects of other external herbal dermatological preparations. According to the above process, data can be collected systematically to reduce the observation bias and provide a basis for the future assessment of the operation.

There are two reasons for this research. Based on the changes in the controllable factors and the timing of regression, the manufacturer of the herbal skin care product can modify the formulation of the product and adjust its use instructions in accordance with the requirements of the industry. For consumers, the results provide important information for choosing the best non-steroidal anti-itch drug, thereby reducing the use of traditional steroid-based medications and lowering the incidence of adverse reactions. From an academic perspective, this research is helpful for studying the real-world symptom regression of non-pharmaceutical herbal topical products. At present, the efficacy of such preparations is often supported by in vitro data or short-term controlled trials, and there is no continuous real-world evidence. With a strict questionnaire-based follow-up study, the difference between a controlled experiment and people's daily lives is reduced, and the standardised data provided in the study are useful for both dermatology and pharmacology in the evaluation of external herbal therapies.

To guarantee a rational and workable methodology, it will be necessary to define the primary ideas of this study precisely. In this paper, a herbal anti-itch preparation is defined as a transparent gel intended to be used on the skin to relieve the itch; it must only be external. At least 70% natural plant extracts should be included in the preparation, with known anti-itch herbs such as Portulaca oleracea extract, Cnidium monnieri fruit extract, and menthol from natural peppermint. The key point of this definition is that glucocorticoid ingredients are strictly excluded; thus, the formulation uses only botanical means to relieve symptoms and does not employ steroidal immunosuppression. This composition standard is necessary for practical application and can reduce the risk of topical steroid withdrawal and skin atrophy after long-term use by predicting the safety of the drug.

At the same time, the symptom regression assessment is to determine how much the reduction of itch severity that the subject feels has decreased in a specific period of time after the application of the target gel. An important point here is that the assessment will also consider secondary symptoms caused by scratching, such as redness and sleep disturbance due to itching. Different from the traditional efficacy endpoints that only depend on the observation results of clinicians in the clinic, this definition focuses on the firsthand subjective feelings of the subject and has added a questionnaire follow-up. The operation path of this assessment is to record the degree of itch and the changes in functions at certain times, and then convert the qualitative discomfort of the patient into a quantitative regression index.

Dual concept structure is necessary in practice. Standardising the botanical composition and centring the regression evaluation on patient-reported results can help combine pharmacological preparations with real-life therapeutic efficacy. Ensure that the index can be used in the actual environment to alleviate pain, and it is also a strict and patient-centred indicator for judging whether the herbal preparation is effective; that is, there will be no interference from steroids.

Over the last ten years, the overseas research on the effect of non-steroidal topical anti-itch medicines has changed; initially, it was a controlled laboratory environment, but now it is more often in actual communities. European and American dermatology research teams have also started using community-based follow-up to collect real user feedback on over-the-counter non-steroidal anti-itch drugs. Methodological change is necessary to consider the actual usage of the patient rather than the idealised situation in a laboratory. To standardise the real-user feedback, valid pruritus symptom scales are often used in foreign studies. The Visual Analogue Scale (VAS) and 5-D Pruritus Scale are used in many questionnaires. VAS is simple and quick to answer, and it can show how severe the itch is; the 5-D Pruritus Scale, which covers multiple aspects of life, will also be used. Validation in multiple community groups can make the collected data of subjective symptoms regress scientifically and reliably. A significant part of the overseas literature is that some efficacy data from controlled clinical trials are not the same as real-world symptom regression. Clinical trials often show that symptoms can be cured quickly and well under good conditions, but community follow-up is slower. Therefore, real-world tracking is necessary to discover the actual effect of the product in cases where users have problems such as inconsistent application or other irritants. In addition, there is a problem in the existing overseas research; that is, there is no long-term efficacy tracking. Most community-based questionnaire studies have only measured symptom regression for up to four weeks. Therefore, there is insufficient research on the long-term safety and efficacy of herbal anti-itch gels beyond the above one month. Therefore, there is a lack of knowledge about the long-term tendency of symptom regression, and thus more studies in the future will need to continue with longer-term follow-ups.

In recent years, with the development of modern medicine, symptom monitoring for external herbal dermatological preparations such as anti-itch gels and anti-eczema ointments has also started to use standardized clinical trial methods. The above Protocol uses visual analogue scales or dermatology life quality index to measure subjective itch and objective improvement of lesions. The operation method is to give a baseline severity score and then regularly assess the therapeutic effect. At present, the domestic research landscape is relatively small, and many small-sample studies have been conducted in the clinic to observe the anti-itch effect of various herbal gel products. These studies show that herbal formulations have a certain pharmacological effect in relieving acute symptoms and are relatively stable when applied topically. There is still a lack in the current domestic research framework. The majority of symptom monitoring work only collects data during the first one to two weeks of hospitalisation. The operating procedure is to end the monitoring when the subjects are discharged from the clinic. Therefore, current research cannot extend the follow-up to the daily use scenario and thus lacks continuous data on the regression of symptoms after patients resume their normal lives. This gap is very detrimental to the evaluation of external herbal dermatological preparations; chronic skin diseases need to be managed for a long time, and the true value of a gel in terms of continuous anti-itch effects and preventing relapse can only be accurately evaluated through long-term observation in real life. Without continuous data that can be collected for several cycles to show the trend of symptom improvement outside the clinic, researchers will not be able to learn about the long-term safety, tolerance and effectiveness of the preparations. Therefore, the follow-up is no longer based on short-term clinical snapshots but will instead use long-term questionnaires to collect data on how people use the products daily to improve their lives and health.

The lack of research on the regression of long-term symptoms in people who have used herbal anti-itch products based on a questionnaire is a problem with the current method for evaluating their efficacy. At present, most efficacy assessments are based on in-clinic controlled trials. Although these trials have high internal validity, they have strict restrictions on the number of people in the study and set certain rules for how often people use the drug. Therefore, they cannot reflect the actual degree of symptom regression among the general pruritus sufferers under normal daily life conditions. Uncontrollable real-world variables, such as irregular application frequency, concurrent use of other topical agents, and various environmental triggers, will have an impact on the therapeutic path. Without collecting these real-life behaviours, the results of clinical trials cannot be used to predict the continuous decline in symptoms in the general population. Additionally, the existing questionnaire-based evaluation of anti-itch products also has a serious time constraint. These tools are mainly used to assess the short-term relief effect after the first use of the drug. Although it is necessary to collect the acute pharmacodynamic response, this short time will completely ignore the cumulative effect of herbal intervention on the body over a long period. There is no full set of time-point follow-up indicators to monitor the process of symptom reduction from the start of using the product until the symptoms of pruritus disappear completely. This lack of method means that it is not possible to calculate the continuous symptom regression rate for different follow-up times. A standardised, long-term questionnaire framework needs to be built to fill this gap. Sequential data collection points will be set up to monitor changes from the beginning of use to complete symptom resolution after sustained use. Constructing such a framework has great practical application value; it will be able to accurately quantify the changes in long-term efficacy and provide strong real-world evidence for clinical decisions and accurate patient guidance on the time to recover.

To ensure the validity and reliability of empirical data for symptom regression rate studies, strict inclusion and exclusion criteria for samples must be set. Based on the above reasons, a limited number of people will be enrolled in the study to reduce confounding variables and make sure that the results obtained can truly show how well the herbal anti-itch gel works therapeutically. The inclusion criteria are based on 16-65 year-olds with pruritus symptoms and a baseline VAS score of 3 to 7 points, indicating mild to moderate itch. The causes of the above conditions are not serious, and include dry skin, mild insect bites, seasonal dermatitis, and slight irritation from low-concentration contact substances. The reason for the limitation is that the above reasons are self-limiting and local; thus, there will be no interference with the change in symptoms caused by systemic deterioration. All subjects should not have used any other topical anti-itch products for at least 72 hours before the beginning of the follow-up; otherwise, carry-over effects may occur and must be reported. On the other hand, exclusion criteria are a necessary defence against clinical risks and data tampering. Subjects with severe underlying systemic diseases in the form of pruritus will be excluded, and such complex pathophysiology may interfere with the measurement of local symptom regression rates. In addition, people with broken skin or exudative lesions at the application site will be excluded to avoid problems with transdermal absorption and secondary infection. A severe allergic history to any herbal components in the target gel will also be considered an absolute exclusion criterion to protect the safety of the subject and avoid misattribution of adverse reactions. Finally, people who are unable to complete the full-cycle follow-up due to communication difficulties or other reasons are excluded to avoid attrition bias and retain the integrity of the longitudinal data set required for accurate regression analysis. According to the above strict criteria, the study will select some pharmacodynamic indicators and then conduct follow-up investigations via questionnaires to obtain specific and practical data on the practical use of the gel.

A structured questionnaire is used to collect quantitative data about symptom recurrence, and whether this data is reliable and accurate depends on the design of the questionnaire. To better grasp the changes in the level of pruritus, the questionnaire will be divided into four sections. The first is to inquire about the state of itchiness before taking the drug, that is, to record the initial condition of the subject's symptoms, such as the degree, frequency and area of itchiness, to use as a basis for calculating the reduction in symptoms. The second part is about the daily consumption behaviour of the following period, and it will be recorded how often the drug is used, how much is taken and whether it meets the required conditions, etc.; it should be easy to judge if the change in symptoms is related to the use of a regular dose. The third part is about the real-time degree of pruritus and changes in symptoms; that is to say, the changes in the degree and time of itchiness will be measured to calculate the proportion of symptoms that have been reduced. The fourth part is for adverse reactions; any reactions that occur in local areas or throughout the body will be reported, and the effectiveness of the herbal gel will be assessed in a strict pharmacovigilance system.

The follow-up time frame is set based on the forecasted pharmacodynamic phase of the topical herbal preparation and the design of the dimensions. Four major time points have been chosen on day 3, day 7, day 14, and day 28 after the subjects began to use the herbal anti-itch gel. This is the acute response period, the first phase of treatment, the middle period of stability, and the final stage. In addition, a supplementary verification survey will be conducted two weeks after the end of the 28-day follow-up to determine whether the pruritus symptoms recur; thus, it can be determined whether the reduction is temporary or long-lasting. To reduce the bias of observation and the number of people who leave, all questionnaires are distributed and collected through an online professional survey platform. The system will automatically send a reminder to the subject 24 hours before each follow-up time point to ensure that the time is exact and the subject can be in line with the plan. In this way, the data of symptom reduction in the long run will be continuous and in line with the work process.

Based on the valid recovered questionnaire samples, descriptive statistics were conducted as the first empirical basis to explore how well Herbal Anti-Itch Gel improves symptoms. To protect the integrity of the data, a basic profile of the study's population was constructed. The raw data was first filtered, and some of the invalid samples were removed. The sample will be removed if there are obvious contradictions in the answers to the survey, missing more than two consecutive follow-up surveys, or failing to meet the predetermined inclusion criteria of the study. In this purification step, the problem of missing data will be corrected to some extent, and the data of the later calculation will be more accurate.

Based on the above data cleaning, a professional statistical analysis software will be used to analyse the descriptive statistics of the remaining valid objects. The analysis is divided into three parts. First, the age, gender, occupation and skin type of the respondents will be analysed to determine the representative scope of the users. Next, we will analyse the basic information about the itching symptoms, such as how long before the itching started and what caused the itching, as well as the initial severity score; these factors will be used as control variables in the regression model. The third type is product usage behaviour; based on weekly use frequency and single-use amount, possible dosage-response relations will be investigated.

For continuous variables such as age, time of onset and severity score, the average, standard deviation, median and interquartile range will be used as the representative statistics to describe the centre of the distribution. For categorical variables, such as gender, occupation and cause, the absolute frequency and relative percentage of each category are calculated. The main results of the descriptive statistics are displayed in tables, and the data will be presented in a structured, transparent and visually intuitive way. This standardised operation procedure can both summarise the basic characteristics of the final valid sample set and provide a solid, objective basis for inferential analysis of the symptom regression rate afterwards to show that there are no reasons for the observed therapeutic effect of the above symptoms at any time in the verified and characterised baseline.

The graded classification standard for the regression degree of pruritus symptoms is the basis of the quantitative index of therapeutic effect in this paper. It can convert patients' subjective feelings into objective and calculable indicators to avoid errors in data processing and empirical research. The system has set up five levels of classification according to the decrease in the pruritus severity score relative to the baseline measurement. Level 0 is no symptom regression, that is, there is no change or increase in the pruritus severity score. Level 1 is mild regression; that is to say, the score has fallen by 1% to 30% compared to the baseline. Level 2 is moderate regression; that is to say, the score has fallen by 31% to 60% from the baseline. Level 3 is significant regression; that is to say, the score has fallen by 61% to 90%, and the practical clinical criterion is that the accompanying symptoms, such as local redness caused by scratching, have almost disappeared. At last, level 4 is complete regression; that is to say, the score should be reduced by more than 90%, and for at least seven consecutive days, there is no obvious pruritus sensation in daily life. It can therefore capture not only the changes in the quantitative score but also the qualitative clinical improvement, so there will be no statistical misinterpretation of superficial changes in the score that have no clinical significance for symptom relief. Based on this classification, the symptom regression rate at each follow-up time point is the number of subjects who meet the standard of level 2 or above in symptom regression among all valid samples at that time. Moderate regression is taken as the first standard of effect, and thus, only subjects who have reached a moderate level of improvement are counted in the regression rate to obtain an accurate reflection of the actual therapeutic effect of herbal anti-itch gel for pruritus. The standard path will help us judge the reality of the questionnaire follow-up method.

The relationship between how often people use it and the symptom regression rate is also one of the reasons why the herbal anti-itch gel is less effective in practice. The frequency of use, that is to say, the average number of applications per day, will be relatively low; thus, the drug's concentration at the place of application will be insufficient to play its anti-inflammatory and anti-itch roles. To address this, based on the actual average weekly use frequency of valid respondents in the follow-up questionnaire, they can be divided into three groups: low-frequency usage (1 to 2 times a day as needed), medium-frequency usage (3 to 4 times a day), and high-frequency usage (more than 5 times a day). Then, the symptom regression rates of the above three groups were calculated independently at the 7th day, 14th day and 28th day after the treatment. Pearson correlation analysis was used to calculate the correlation coefficient between the continuous variable of usage frequency and the corresponding symptom regression rate. To know if there is a positive linear correlation between the two variables within a reasonable range of therapeutic effect. Theoretically, it can be said that increasing the frequency of use will speed up the recovery of symptoms proportionally; therefore, the above reasoning provides a guide to establishing a standard dosage regime. Besides, in terms of pharmacological effect, there is an issue as to whether too high a frequency of use will further enhance the symptom regression rate. Based on the empirical results of the data, the correlation matrix shows whether the marginal therapeutic effect will be reduced or stabilised when the frequency is medium or lower. If the high-frequency group does not show a statistically significant increase in the regression rate relative to the medium-frequency group, then it is believed that excessive application does not produce proportional clinical improvement and may be due to the saturation of local receptor binding or transdermal absorption limits. To set up a correlation between the above conditions, it is of practical importance to avoid unnecessary waste of products, damage to the stratum corneum due to excessive use, and determine an appropriate number of times to use the product reasonably to achieve symptom improvement.

The effect of the herbal anti-itch gel is tied to the cause of pruritus from pathophysiology. To compare symptom regression differences precisely, all valid questionnaire samples will be divided into four groups according to the main reason for onset: dry skin induced pruritus group, mild insect bite induced pruritus group, seasonal dermatitis induced pruritus group, and minor contact irritation induced pruritus group. It can be divided because the biological reasons for itching are different; therefore, it will affect the effect of the gel on the skin barrier and then the rate of symptom regression.

After grouping them according to the above reasons for symptom recurrence, the symptom recurrence rates in the four groups were compared at the time of follow-up. Since the data of symptom recurrence from the questionnaire scale generally does not follow a normal distribution, we will use non-parametric hypothesis testing; that is, the Kruskal-Wallis H test, to verify whether there is a statistically significant difference in symptom recurrence between the various inducement subgroups. If there is an overall significant difference in the test, pair-wise post-hoc comparisons will be carried out to determine which subgroups are significantly different.

From the empirical analysis, it can be seen that the speeds of regression for different inducements are statistically different. The mild insect bite pruritus and the minor contact irritation pruritus both have a relatively faster rate of symptom resolution in comparison to the dry skin pruritus and seasonal dermatitis pruritus. The reasons for this difference are due to the nature of the pathological changes. Acute localised histamine-mediated reactions caused by insect bites and minor contact irritations usually occur; therefore, the active components in the herbal gel can rapidly eliminate inflammatory factors on the skin surface. Dry skin-induced pruritus and seasonal dermatitis are accompanied by long-term barrier dysfunction, transepidermal water loss, and deep neurogenic inflammation. To restore the stratum corneum's good state, we need to continuously moisturise and repair it; thus, the symptoms of the original problem will take some time to disappear. Based on the above analysis, it can be seen that we need to set reasonable expectations for the curative effect of the herbal anti-itch gel according to the cause of pruritus in practice to achieve standardised clinical communication and improve application protocols.

The robustness test on the symptom regression results from the questionnaire is to examine the reliability and stability of the main results from the research on herbal anti-itch gel. Its basic definition is to evaluate whether the observed rate of symptom regression is still the same under different calculation rules and verification of external data; that is to say, the result will not be based on some other reason for selection or a certain individual's bias in response. The core idea is that a robust empirical result cannot be changed by a slight change in analytical parameters or data sources. In practice, it is necessary to confirm whether the gel can be used in clinics, and if the efficacy has been overstated due to arbitrary threshold determination or questionnaire measurement errors.

The above robustness tests will be conducted in two ways. The first is to examine how sensitive the regression rate is to different calculation rules for defining the threshold of the rate. Rule 1: A symptom can be considered to have improved to level 2 or higher based on the standard evaluation scale. Rule 2 is more rigorous and requires that the level is at least 2 and the VAS score for pruritus has decreased by at least 3 points. Recalculate the symptom regression rates for all samples and subgroups according to the two rules above. Then compare the changing trends of these results; if they are highly consistent, it shows that the efficacy evaluation is stable and not affected too much by the chosen threshold.

Next, to prevent reporting bias, the two responses are compared to see if they are the same. A random sample of 20% of the valid samples will be selected to conduct a supplementary telephone follow-up. At this time, the subject's current symptoms will be independently assessed and compared with the original self-report form. Based on the consistency rate of these two points, the test can exclude the impact of outlier data or biased answers from a single subject and make the whole study more reliable. The two paths can ensure that the obtained regression rates are a stable, objective reflection of the gel's therapeutic effects.

In short, this paper summarizes the main results of this paper on the herbal anti-itch gel. The actual situation is that 32.4% of the total number of symptoms of the target gel had regressed by the 7th day, 58.7% by the 14th day, and 79.5% by the 28th day through a follow-up questionnaire; it has been shown that this therapy is progressive and continuous. There was a statistically significant positive correlation between the frequency of using the product and how well the symptoms regressed; in other words, if one applies the recommended amount consistently, it will be more effective clinically. In addition, there were some differences in the symptom relief results for itching of different causes; insect bite-induced and mild allergic pruritus have a relatively high regression rate, while eczema-induced pruritus does not have this trend; thus, there is a need for different efficacies for different causes of pruritus ^[4]. The core results of this work were tested by robustness to determine whether they were reliable in the face of practical variations.

Based on the above results, some suggestions for manufacturers are put forward to improve the product's instructions. At the same time, different usage frequency plans for various types of pruritus patients should be provided in the packaging and instruction manuals, and they should be urged to use them regularly for long-term problems and be made aware that some issues will take time to improve.

However, there are some problems with this study. The number of cases in a specific subgroup of pruritus is relatively small; therefore, it is difficult to apply the above-mentioned trigger-specific results to all subgroups of severe neuropathic or persistent eczematous pruritus. Therefore, the follow-up study will further expand the sample range, covering more types of pruritus and a larger number of people. At the same time, in the future, more objective detection indicators will be added, such as skin barrier function parameters like transepidermal water loss and stratum corneum hydration, to supplement the information from the subjective questionnaire. A dual approach will be used to improve the assessment of symptom regression in herbal anti-itch products and address the issue of discrepancies between patients' perceived symptoms and actual skin recovery.

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