Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Oral Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-06

Study Completion Date

2024-02-20

Brief Summary

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In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.

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Detailed Description

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Diabetes Mellitus (DM) is a chronic metabolic disease that causes serious damage to the heart, blood vessels, eyes, kidneys and nerves. Both the number of cases and the prevalence of diabetes have been increased rapidly over the past 30 years. According to the report of the International Diabetes Federation (IDF) Report, approximately 537 million people worldwide (700 million in 4045) have diabetes and 6.5 million people were reported to have died due to diabetes in 2021. In Turkey, it is estimated that approximately 9 million people (about 13.5 million in 2045) are diagnosed with diabetes and approximately 80 thousand people will die from diabetes.

Prolonged hyperglycemia in DM can lead to microvascular (nephropathy, retinopathy and neuropathy) and macrovascular (peripheral vascular disease, hypertension, cerebrovascular disease, ischaemic heart disease) complications. However, due to poorly controlled DM, complications can be seen in the oral mucosa of patients with many immunological and metabolic changes. Oral complications seen in patients with DM include hyposalivation, xerostomia, bacterial, viral and fungal infections, poor wound healing, increased severity and incidence of caries, gingivitis and periodontal disease, periapical abscess, and burning mouth syndrome (BMS). These complications can lead to the development of oral mucositis in patients.

Many pharmacological and non-pharmacological agents are used in the prevention/treatment of oral mucositis. According to the classification of the National Center for Complementary and Integrative Health (NCCAM), complementary therapies methods are divided into three groups as nutritional, psychological and physiological and other complementary approaches. However, it is reported in the literature that complementary therapies such as cryotherapy (oral cooling), honey, propolis, vitamin E, selenium, aloe vera, black mulberry, apple cider vinegar, rose water and green tea are effective in the treatment of oral mucositis. Again in the literature, there are studies in which the effect of black mulberry syrup in patients with Chronic Obstructive Pulmonary Disease (COPD), apple cider vinegar and rose water mixture in cancer patients and green tea in the treatment of oral mucositis has been proven.

Oral mucositis is one of the oral diseases that can cause oral dysfunction, dysphagia and reduced oral health-related quality of life in patients. Oral and dental health affects a person's quality of life by affecting their physiological, psychological and social functioning. However, improving oral health is part of nursing care. In order to maintain a good quality of life, it is necessary to improve awareness of oral complications that occur in patients with DM. In the literature reviewed, only one experimental study was found in cancer patients in which oral mucositis-related quality of life was evaluated. There is no international or Turkish study on the treatment of oral mucositis in patients with DM. There are also no studies comparing hawthorn vinegar, black mulberry syrup and green tea in different sample groups. In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.

Conditions

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Mucositis Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The sample size of the study was calculated as 128 individuals in total (32 for each group) for 4 groups (hawthorn vinegar, black mulberry syrup, green tea, control group) with an effect size of 0.25 with α=0.05 and the power of the targeted test was 0.80 (80%) in the G\*Power 3.1.9.7 program, which could not be used as a reference since there was no previous four-group study on the subject. Each group was increased to account for drop-outs and deaths and a total of 140 individuals, 35 for each group, were included in the study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

The principal investigator completed the consent and assent forms after explaining the purpose of the study to all participants. In the research planned as a single-blind randomized controlled clinical study, the other researcher who applied the data collection tools to reduce bias was not told who the experimental groups (hawthorn vinegar group, black mulberry syrup group, green tea group) and the patients with DM in the control group were.

Study Groups

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Hawthorn Vinegar Group

Before starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).

Group Type EXPERIMENTAL

Hawthorn Vinegar Group

Intervention Type OTHER

To routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Black Mulberry Syrup Group

Before starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the black mulberry syrup group gargled with 1 tablespoon (10 cc) of pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).

Group Type EXPERIMENTAL

Black Mulberry Syrup Group

Intervention Type OTHER

To routine oral mucositis treatment, patients with DM in the black mulberry syrup group pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Green Tea Group

Before starting the study (pre-test/0. week), "Patient Information Form", "OAG" and "OHQoL-UK" were administered to all group participants to evaluate the level of oral mucositis in patients. In addition to routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days. "OAG" and "OHQoL-UK" were administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).

Group Type EXPERIMENTAL

Green Tea Group

Intervention Type OTHER

To routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Control Group

Patients in the control group received no any treatment other than routine oral mucositis treatment and data collection tools. "Patient Information Form", "OAG" and "OHQoL-UK" were administered to the patients before the study (pre-test/0th week) and "OAG" and "OHQoL-UK" were administered again on the 7th day (mid-measurement) and 14th day/end of the study (post-test).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hawthorn Vinegar Group

To routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Intervention Type OTHER

Black Mulberry Syrup Group

To routine oral mucositis treatment, patients with DM in the black mulberry syrup group pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Intervention Type OTHER

Green Tea Group

To routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Overs 18 years of age,
* Voluntary participation in the study,
* Be lucid and able to communicate,
* Be diagnosed with DM for at least 3 months ago,
* Willing to use either hawthorn vinegar, black mulberry syrup or green tea as a complementary treatment for oral mucositis,
* HbA1c ≥ 7% (Wang and Hng, 2021),
* Oral mucositis score of 14\< in oral assessment.