Design

Randomized controlled pilot study

N= 11

Objective

To evaluate the effects of topical application of sesame oil on chemotherapy-induced oral mucositis

Study Groups

Sesame Oil (n= 7)

Control (n= 4)

Inclusion Criteria

Admission to general hospital, receiving chemotherapy for hematopoietic cancer

Exclusion Criteria

Patients who didn't consent to study participation

Methods

Duration

Treatment: 14 days 

Outcome Measures

Baseline Characteristics

Sesame Oil (n= 7)

Control (n= 4)

Age, years 

Female

Diagnosis

AML

ALL

NHL

NHL (recurrence)

3

1

2

1

2

1

0

1

Regimens and phases of chemotherapy differed among the subjects. However, agents with higher risks of oral mucositis were administered to five subjects in the sesame oil group and two subjects in the control group.

No statistical difference was found in both lowest leukocyte count and highest c-reactive protein value. No symptoms were caused by sesame oil application.

Abbreviations: AML, Acute Myeloid Leukemia; ALL, Acute Lymphoblastic Leukemia; NHL, Non-Hogkins Lymphoma

Results

Endpoint

Sesame Oil (n= 7)

Control (n= 4)

Average of CTCAE v3.0 grade/day

None of the sesame oil cohort reported mucositis during the duration of their treatment. One patient saw Grade 1 mucositis upon termination of sesame oil application, began applying again on day 17 and saw resolution by day 20. He continued to apply until day 37 and stopped application, but had a recurrence of mucositis the next day. His regimen included methotrexate.

In the control cohort, oral mucositis was observed in two patients, both on regimens with high incidence of oral mucositis.  

After 14 days, inflammatory change grades improved in the sesame oil cohort in three subjects, was unchanged in three subjects, and worsened in one subject. In the control group, inflammatory change grades worsened in all subjects. However, no statistical significance was found between Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grades of the sesame oil and control groups.

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events

Adverse Events

Four sesame oil patients briefly stopped application due to fever, severe fatigue, or discharge.

Study Author Conclusions

InpharmD Researcher Critique

While sesame oil may be efficacious in preventing chemotherapy-induced oral mucositis, the sample size of this study was particularly small, limiting these findings to speculative implications that require a larger randomized study to establish benefit.

"Ozone" – The New NEMESIS of Canker Sore

Design

Single-center, single-blinded, placebo-controlled trial 

N= 30

Objective

To compare the effectiveness of ozonated oil and sesame oil in the treatment of recurrent aphthous ulcer

Study Groups

Ozonated oil (n= 10)

Sesame oil (n= 10)

Placebo (n= 10)

Inclusion Criteria

Age > 16 years, 1 to 5 ulcers of duration < 48 hours of appearance, located on reachable sites of oral mucosa that limited activities such as talking, eating, or carrying out oral hygiene

Exclusion Criteria

Less than 2 recurrent episodes of aphthous ulcers, ulcers lasted > 7 days in previous episode, any systemic disease and under systemic or topical corticosteroid therapy, immunomodulating agents, pregnant or nursing women

Methods

Patients were randomized to receive ozonated oil, sesame oil, or placebo (distilled water). Agents were applied topically over the ulcers using two drops (approximately 0.2 mL) on a cotton-tipped applicator four times per day for five days. After clinical examination of the ulcer, pretreatment photographs were taken and were compared with post-treatment photographs taken at the patient's consecutive visits. Changes of the index ulcer's size were graded on a scale of 0-4 (0= no change from day 1 or aphthous ulcer worsened; grade 4= aphthous ulcer cleared).

Duration

October 2013 to June 2014

Treatment: 5 days

Outcome Measures

Pain reduction, ulcer healing

Baseline Characteristics

Ozonated oil (n= 10)

Sesame oil (n=10)

Placebo (n= 10)

Age, years

Female

Results

Endpoint

Ozonated oil (n= 10)

Sesame oil (n=10)

Placebo (n= 10)

Pain, VAS

Pretreatment

Day 2

Day 4

Day 6

8.10 ± 0.70

6.50 ± 0.90

4.10 ± 1.00

1.50 ± 0.70

8.20 ± 0.79

5.70 ± 0.82

3.50 ± 0.97

1.80 ± 0.79

7.90 ± 0.74

7.60± 0.52

7.40 ± 1.07

4.60 ± 0.70

Ulcer healing assessment difference from baseline

Day 2

Day 4

Day 6

2.00 ± 0.82

3.20 ± 0.79

3.70 ± 0.48

0.90 ± 0.74

2.40 ± 0.52

3.10 ± 0.74

0.20 ± 0.42

0.30 ± 0.48

0.40 ± 0.52

There was reported to be a significant reduction in both the ozonated oil and sesame oil groups compared with placebo for both pain reduction and ulcer healing (p < 0.05).

Adverse Events

Common Adverse Events: Three patients from the ozonated oil group experienced a transient bitter sensation shortly following application.

Serious Adverse Events: none

Percentage that Discontinued due to Adverse Events: none

Study Author Conclusions

Ozonated oil and sesame oil, both showed similar effectiveness in relieving the ulcer pain. Ozone with its wide variety of inherent properties has proven to be choice of treatment in completely relieving the ulcer pain and ulcer size when compared with that of its counter medication (i.e. sesame oil). Therefore the results obtained in the present study forecast ozone to be used as a novel treatment approach in recurrent aphthous ulcers.

InpharmD Researcher Critique

This was a small study that likely lacked power and the ability to detect a difference. The product used in this study was sesame oil and not a sesame paste or butter (i.e., tahini).

Effects of Topical Sesame Oil Extracted from Tahini (Ardeh) on Pain Severity in Trauma Patients: A Randomized Double-Blinded Placebo-Controlled Clinical Trial

Design

Double-blinded, randomized clinical trial

N= 90

Objective

To investigate the effects of sesame oil extracted from tahini (Ardeh) on pain severity in patients with upper or lower limbs trauma

Study Groups

Sesame oil (n= 49)

Placebo (n= 41)

Inclusion Criteria

Aged 15 to 40 years; lack of: bone fractures, internal or external bleeding, dislocation, amputation, presence of a foreign body, nerve damage, fever, infection, cast or splint at the trauma site, regional pain based on Visual Analog Scale (VAS), history of addiction, cigarette and alcohol abuse, sensitivity or allergy to the sesame plant group, comorbid diseases that may affect the pain severity; not receiving drugs or herbal extracts which may interact with the study therapeutic protocol; blunt trauma in extremities occurring 1 to 6 hours after admission

Exclusion Criteria

Allergy to sesame oil or peptic or duodenal ulcers, receiving treatment outside of the study, inappropriate follow-up by patients, and patient’s willingness to withdraw in any phase of the study

Methods

Patients were randomly assigned to either the intervention group, which received topical sesame oil extracted from tahini (Ardeh), and the placebo group, which received cooking oil with the same container and color. Routine care was implemented based on care protocol for trauma patients. Ten drops (~3.8 mL) of each oil extract were applied for every 50 cm² on the trauma site via dropper, then the trauma site was massaged lightly.

Patients were educated to use a cold compress on the site on the first day, then warm compresses on the following days. Usage of other medications or herbal extracts for pain management was prohibited.

Duration

May 2016 to November 2016

Follow-up: 48 hours

Outcome Measures

Pain severity, pain sensitivity and heaviness of painful site

Baseline Characteristics

Sesame Oil (n= 49)

Placebo (n= 41)

Age, n (%)

15 to 25

25 to 35

35 to 40

9 (18.4%)

25 (51%)

15 (30.6%)

16 (39%)

15 (36.6%)

10 (24.4%)

Male

 32 (65.3%)

31 (75.6%)

Site of Injury, n (%)

Upper Extremity

Lower Extremity

Both

23 (47%)

16 (32.6%)

10 (20.4%)

14 (34.2%)

21 (51.2%)

6 (14.6%)

Results

Endpoint

Sesame Oil (n= 49)

Placebo (n= 41)

p-value

Pain Severity, mean difference

<0.001

Pain Sensitivity, mean difference

-1.45 ± 0.64

0.39 ± 0.61

<0.001

Pain Heaviness, mean difference

Adverse Events

N/A

Study Author Conclusions

In conclusion, our findings suggest that the topical use of sesame oil extracted from Tahini has a pain reliever effect on the skin after bruising and it helps prevent skin discoloration. Further larger studies are required to confirm the results of the current study.

InpharmD Researcher Critique

As this study was conducted in Iran and used a small cohort of patients to assess primary outcomes, the findings are limited in their generalizability. The investigators' conclusion on skin discoloration or bruising effects were also never elaborated upon or reported within their study. 

Use of Virgin Sesame Oil in Addition to Soda Saline Mouthwash for the Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Prospective Study

Design

Single‑arm, open‑label, prospective study

N= 58 patients

Objective

To evaluate the efficacy of using virgin sesame oil in conjunction with conventional soda saline mouthwash (SSM) in preventing acute oral mucositis in patients with head and neck cancer undergoing definitive chemoradiotherapy (CRT)

Study Groups

Study cohort (N= 58)

Inclusion Criteria

Aged 18 to 70 years; Karnofsky Performance Score ≥70; squamous cell carcinoma of the head and neck (oropharynx, hypopharynx, and larynx) planned for definitive CRT

Exclusion Criteria

Postoperative patients, history of either radiotherapy (RT) to head‑and‑neck region or chronic steroid use

Methods

Patients were instructed to swish and gargle two tablespoons of commercially available virgin sesame oil of the same brand six times daily, 3 minutes at a time, as well as SSM 15 mL ten times daily, starting from the first day of RT until 6 weeks following RT, weekends, and holidays included. All patients were instructed to practice basic oral hygiene, e.g. twice-daily brushing with a soft bristle toothbrush and the same toothpaste.

Each patient had their mouth examined by a dentist pretreatment. When necessary, dental extractions were performed. Mucositis was graded using the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria.

Duration

Study duration: 1 year

Follow-up: 3 weeks, 6 weeks, 3 months after radiation treatment

Outcome Measures

Development of oral mucositis

Baseline Characteristics

Study cohort (N= 58)

Age, years

Female, n (%)

Karnofsky Performance Status

Primary site, n (%)

Hypopharynx

Larynx

Oropharynx

14 (24.1%)

15 (25.9%)

29 (50%)

Cancer stage, n (%)

III

IVA

IVB

15 (25.9%)

33 (56.9%)

10 (17.2%)

Histopathological examination, n (%)

Moderately differentiated SCC

Poorly differentiated SCC

Well‑differentiated SCC

52 (89.7%)

3 (5.2%)

3 (5.2%)

Abbreviations: SCC, Squamous cell carcinoma

Results

Endpoint

Time of development, weeks

Median (IQR) 

Grade I mucositis

Grade II mucositis

Grade III mucositis

Abbreviations: IQR, interquartile range

Mucositis of any grade was observed in 51 patients (87.9%) by the end of the study; seven patients who developed Grade I mucositis previously were found to have no mucositis with continuous application of the mouthwash. All patients developed Grade I mucositis at some point during the treatment, with 29 patients progressing to Grade II (50%) and 7 patients progressing to Grade III (12.1%).

Adverse Events

N/A

Study Author Conclusions

This study concluded that radiation‑induced mucositis could be delayed, and the severity can be reduced by rinsing the mouth with sesame oil and SSM. Although this study’s results, given its small sample size, may not warrant incorporation into the current standard of care, it provides promising results that can be a basis for further trials. Therefore, large sample size replication studies or randomized controlled studies comparing sesame oil with different mouthwashes are necessary for its incorporation into the routine regimen.

InpharmD Researcher Critique

This study did not have a control arm as a comparator for the combined use of sesame oil and SSM. Additionally, the small sample size, the open label design, and the study location in Northeast India limits the strength and generalizability of these investigative findings.