MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge

The Efficacy of the MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge A Randomized, Double-blind, Adaptive-design Study

This randomized, double-blind, adaptive design study aims to prove that the Methylsulfonylmethane study product improves nasal breathing and "stuffy nose" symptoms after exposure to environmental allergens. Endpoints include percent change in Peak Nasal Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in response to allergen exposure.

Study Overview

• Status: Completed
• Conditions: Nasal Breathing
• Intervention / Treatment: Dietary supplement: MSM

Detailed Description

Allergic rhinitis, or nasal allergy, is a common condition throughout the world which affects both adult and children alike. It is a group of symptoms characterized by red, itchy eyes, a blocked, itching, runny nose, rhinorrhea, and sneezing. Other reported symptoms include throat clearing, headaches, facial pain, ear pain, itchy throat and palate, snoring, and sleep disturbances. Nasal allergy commonly occurs when an individual's immune system reacts to allergens such as grass, weed, or tree pollens, house dust, mites, mold, and animal dander [1, 2].

Allergic rhinitis is considered to have a substantial effect on the quality of life of a person. Due to the significant effects it demonstrated when left untreated, the disease has gone from being labelled simply as a nuisance to being a serious illness that has to be accounted and medicated. More importantly, such illness was proven to cause asthma and sinusitis [3].

One of the popular nutritional supplements used in treating allergies such as allergic rhinitis, allergic sinusitis, inhalant allergens, and environmental allergens is Methylsulfonylmethane [4].

Methylsulfonylmethane (MSM), also known as dimethyl sulfone and methyl sulfone, is an organic compound containing sulfur that occurs naturally in a variety of fruits, vegetables, grains, and animals, including humans [5]. It is also used in treating arthritis pain, musculoskeletal pain, parasitic infections, rosacea, stretch marks, and alopecia among others [4].

The use of MSM was found to be effective in reducing symptoms of seasonal allergic rhinitis (SAR). It improves the frequency of upper respiratory signs and symptoms such as runny nose, nasal obstruction, and paroxysmal sneezing after a week of oral intake. Furthermore, few side effects were observed, but were not deemed to be of great significance. Thus, MSM was evaluated as a safe medication for SAR [6].

Likewise, MSM administration in rats displayed no adverse events or mortality. No pathological lesions or changes in organ weights were observed [4, 7]. It is proved that MSM is well tolerated in rats and can be a dietary supplement for allergies [4]. In addition, pregnant rats orally administered with MSM showed no adverse effects as well [8]. MSM can be rapidly absorbed, well distributed, and completely disposed from the body 120 hours after initial administration [9].

This randomized, double-blind, adaptive design study aims to prove that the Methylsulfonylmethane study product improves nasal breathing and "stuffy nose" symptoms after exposure to environmental allergens. Endpoints include percent change in Peak Nasal Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in response to allergen exposure.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers ≥ 18 and ≤ 65 years of age
• Subjects with history of nasal congestion in response to pollen, dust mites, cat dander, and/or dog dander
• Subjects who score "moderate" or "severe" on the VAS Nasal Symptom Score in response to an allergenic challenge at screening (V1)
• Judged by the Investigator to be in general good health on the basis of medical history

Exclusion Criteria:

• Pregnant and/or lactating women
• Subjects with idiopathic rhinitis, atrophic rhinitis, or rhinitis medicamentosa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1g; METHYLSULFONYLMETHANE	Dietary supplement: MSM
Active Comparator: 3g; METHYLSULFONYLMETHANE	Dietary supplement: MSM
Active Comparator: 6g; METHYLSULFONYLMETHANE	Dietary supplement: MSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Nasal Inspiratory Flow (PNIF)	14 days
VAS Nasal Symptom Score	14 days
Number of sneezes in response to allergen exposure	14 days
Number of used tissues in response to allergen exposure	14 days
Weight of used tissues in response to allergen exposure	14 days

Collaborators and Investigators

• Sponsor: Medicus Research, LLC

Publications and helpful links

General Publications

• Hewlings S, Kalman DS. Evaluating the Impacts of Methylsulfonylmethane on Allergic Rhinitis After a Standard Allergen Challenge: Randomized Double-Blind Exploratory Study. JMIR Res Protoc. 2018 Nov 29;7(11):e11139. doi: 10.2196/11139.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: BERG1200