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

Karadeniz Technical University

Status: Completed

Conditions: Quality of Life; Mucositis

Treatments: Other: Green Tea Group; Other: Hawthorn Vinegar Group; Other: Black Mulberry Syrup Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06481254

RCS06022024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Having a known psychological disorder,
• Having HbA1c <7%,
• Not having oral mucositis,
• Having hearing loss.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Hawthorn Vinegar Group

Experimental group

Description:

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).

Treatment:

Other: Hawthorn Vinegar Group

Black Mulberry Syrup Group

Experimental group

Description:

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).

Treatment:

Other: Black Mulberry Syrup Group

Green Tea Group

Experimental group

Description:

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).

Treatment:

Other: Green Tea Group

Control Group

No Intervention group

Description:

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).