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Tuesday 8 February 2022

can vicks vapor rub help you sleep?

Vicks VapoRub NZ - up to 8 hours peaceful sleep!



Being unable to fall asleep can be frustrating and have consequences for the next day. However, people can learn to fall asleep faster using some simple, natural tips and tricks.


When someone is having difficulty falling asleep, one solution is to take medications that induce sleep. However, such medications are not an ideal long-term solution.


Certain natural methods — such as having a consistent bedtime routine, avoiding screens before bedtime, reading before bed, doing gentle exercise during the day, and practicing certain mindfulness techniques — can help.


Different things work for different people, so take some time to experiment to find what works.


This article looks at 21 natural methods that people can use to help them fall asleep quickly.


21 ways to fall asleep naturally

Having a consistent sleeping pattern may help a person fall asleep more quickly.

Many people who struggle with sleep lie in bed wondering how to fall asleep. When this happens, try using the tips below. Some are long-term lifestyle changes, while others are short-term solutions to try in the moment.


1. Create a consistent sleeping pattern

Going to bed at different times every night is a common habit for many people. However, these irregular sleeping patterns could interfere with sleep because they interrupt the body’s circadian rhythm.


The circadian rhythm is a selection of behavioral, physical, and mental changes that follow a 24-hour cycle. A primary function of the circadian rhythm is to determine whether the body is ready for sleep or not.


This is heavily influenced by a biological clock that releases hormones to induce sleep or wakefulness. Going to bed at the same time every night helps the body clock predict when to induce sleep.


Learn more about the best time to sleep and wake up here.


2. Keep the lights off

Cues such as light also influence the circadian rhythm, which helps the brain and body judge when it is nighttime. Keeping the room as dark as possible when going to bed might help bring on sleep.


3. Avoid napping during the day

Taking naps during the daytime, particularly those that last longer than 2 hours, can also disrupt the circadian rhythm.


One studyTrusted Source found that college students who napped at least three times per week and those who napped for longer than 2 hours each time had lower sleep quality than their peers who did not.


After a poor night’s sleep, it is tempting to take a long nap. However, try to avoid this, as it can adversely affect a healthful sleep cycle.


Learn about the ideal nap length here.


4. Get some exercise during the day

Physical exercise has a positive impact on sleep quality.


One review that looked at 305 people over 40 years old with sleeping difficulties found that moderate or high intensity exercise programs led to improvements in sleep quality. The study also found that participants took their sleep medication less frequently while participating in an exercise program.

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It is currently unclear whether or not exercising at different times of day has an impact on sleep.


When taking on an exercise routine, it can be difficult to know where to start. Learn more here.


5. Avoid using your cell phone

Currently, there is much debate about whether or not the use of cell phones at bedtime affects sleep.


One study in college students found that those who scored high on a scale of problem phone use, such as addictive texting behavior, had a lower sleep quality. However, there was no difference in the length of time they slept.


Much of the current research is in students and young people, so it is unclear whether or not these findings extend to other age groups. Studies also tend to focus on problem phone use. People who do not use their phone in this way may not be as susceptible to sleep disturbances.


More research is necessary in this area to understand the extent to which phone use can impact sleep.


6. Read a book

Reading books can be relaxing and may help prevent anxious thought patterns that could interfere with a person’s sleep. However, it is best to avoid books that might cause strong emotional responses.


7. Avoid caffeine

Caffeine is a stimulant. It stimulates wakefulness and can disrupt sleep patterns. Therefore, it is best to avoid caffeine for at least 4 hours before going to bed.


In some people, consuming caffeine at any time of the day could have a negative impact on sleep quality. For these people, it may be best to avoid caffeine altogether.


8. Try meditation or mindfulness

Meditation and mindfulness can help reduce anxiety, which often disrupts sleep. Using these techniques can help calm an anxious mind, distracting the person from busy thoughts and allowing them to fall asleep more easily.


A studyTrusted Source in older adults with sleeping difficulties found that mindfulness meditation improved sleep quality, compared with people who did not practice mindfulness.


9. Try counting

A longstanding method of inducing sleep is counting down slowly from 100. There are several ideas about why this may work, including boredom and distracting the individual from anxious thoughts.


10. Change your eating habits

What a person eats, particularly in the evening, can have an impact on their sleep. For example, eating a large meal within 1 hour of going to bed may impair a person’s ability to sleep.


Digesting a meal can take at least 2–3 hours. Lying down during this period can cause discomfort or feelings of nausea and slow the digestive process in some people.


It is best to allow the body enough time to digest a meal before lying down. The exact time this takes will vary from person to person.


11. Get the room temperature right

Being too hot or too cold can have a significant impact on a person’s ability to sleep.


The temperature at which people feel the most comfortable varies, so it is important to experiment with different temperatures.


However, the National Sleep Foundation recommend a bedroom temperature of 60–67°F (16–19ºC) to promote sleep.


12. Try aromatherapy

People have long used aromatherapy to induce relaxation and sleep.


Lavender oil is a popular choice for helping with sleep. A study in 31 young adults found that using lavender oil before bed had a positive impact on sleep quality. The participants also reported having more energy after waking up.

USE CHEST/VAPOR RUB FOR OVERNIGHT WEIGHT LOSS! Does not have to be VICKS!



Learn more about aromatherapy here.


13. Find a comfortable position

A comfortable sleeping position is essential for sleep. Frequently changing positions can be distracting, but finding the right spot can make a big difference to the onset of sleep.


Most people find that sleeping on their side is the best position for a good night’s sleep. Learn about the benefits of side sleeping here.


14. Listen to music

Although this may not work for everyone, some people benefit from listening to relaxing music before going to bed.


A person’s response to music will depend on their personal preferences. Sometimes, music may be too stimulating and induce anxiety and sleeplessness.


15. Try breathing exercises

Breathing exercises are a very popular relaxation technique. Practicing deep breathing or doing specific patterns of breathing can help people de-stress and take their mind off anxious thoughts. This can be a powerful tool for getting to sleep.


A common option is 4-7-8 breathing. This involves breathing in for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds. This type of deep, rhythmic breathing is relaxing and can promote sleep.


16. Take a hot bath or shower

Taking a bath or shower can be relaxing and help prepare the body for sleep. It can also help improve temperature regulation before bed.


Hot and cold showers have different benefits. Hot showers can help promote sleep. Learn more here.


17. Avoid reading e-books

E-books have become increasingly popular over the past few years.


They have backlit screens, which make them ideal for reading before bed in a dark room. However, this could negatively affect sleep.


One study gave young adults a printed book and an e-book to read before bed. The researchers found that when using the e-book, the participants took longer to fall asleep.


They were also more alert during the evenings and less alert in the morning compared with when they read the printed book. Such results suggest that e-books could have a negative impact on sleep.


However, the study only involved 12 participants. The researchers also used a study design that meant that the participants read both types of book. It is difficult to determine whether or not exposure to both reading conditions biased the results.


Few reliable studies exist in this area, and more research is necessary to draw any firm conclusions.


18. Take melatonin

Melatonin is known as “the sleep hormone.” The body produces it to induce drowsiness and sleep in line with the body clock. People can also take it as a supplement to increase the chance of getting to sleep.


19. Use a comfortable bed

The National Sleep Foundation recommend that to get a good night’s sleep, people may want to sleep on a mattress and pillows that are comfortable and supportive. Investing in a comfortable mattress could have a positive impact on sleep quality.


20. Avoid noisy environments, if possible

Noise can be distracting, prevent the onset of sleep, and lower the quality of sleep.


A 2016 studyTrusted Source found that participants had significantly worse sleep in a hospital setting than at home. The authors of the study found that this was primarily due to the increased level of noise in the hospital.


21. Avoid excessive alcohol consumption

Drinking large amounts of alcohol before bed can have an adverse impact on sleep. Alcohol is problematic because it can induce feelings of restlessness and nausea, which can delay the onset of sleep.



Summary

Getting to sleep naturally is the best way to ensure that the mind and body get the rest they need.


Trying the methods above can increase the chance of falling asleep without needing to use any sleep aids.

Are you having trouble drifting into a peaceful, nourishing slumber? You’re not sitting up at night alone: More than 60 million Americans suffer from poor sleep quality. 


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Disturbed sleep is more than an inconvenience that leaves you dragging the next day: it can affect your emotional and physical health. It negatively affects your memory, concentration and mood, and it boosts your risk for depression, obesity, type 2 diabetes, heart disease and high blood pressure.


Happily, there are easy, natural fixes that can improve your sleep, says Charlene Gamaldo, M.D. , medical director of Johns Hopkins Center for Sleep at Howard County General Hospital.


“It’s not always necessary to get a prescription for a sleep aid,” she says. “There are natural ways to make adjustments to your sleeping habits.”


Five tips for better sleep

Drink up. No, not alcohol, which can interfere with sleep. Gamaldo recommends warm milk, chamomile tea and tart cherry juice for patients with sleep trouble.


Though there isn’t much scientific proof that any of these nighttime drinks work to improve your slumber, there’s no harm in trying them, Gamaldo says. She recommends them to patients who want treatment without side effects or drug interactions.


“Warm milk has long been believed to be associated with chemicals that simulate the effects of tryptophan on the brain. This is a chemical building block for the substance serotonin, which is involved in the sleep-wake transition,” Gamaldo says.


Chamomile tea can also be helpful. “It’s believed to have flavonoids that may interact with benzodiazepine receptors in the brain that are also involved with the sleep-wake transition,” she says.


Plus, chamomile tea doesn’t have caffeine, unlike green tea or Earl Grey. Finally, tart cherry juice might support melatonin production and support a healthy sleep cycle.


Exercise . Physical activity can improve sleep, though researchers aren’t completely sure why. It’s known that moderate aerobic exercise boosts the amount of nourishing slow wave (deep) sleep you get. 


But you have to time it right: Gamaldo says that aerobic exercise releases endorphins, chemicals that keep people awake. (This is why you feel so energized after a run.)


It can also raise core body temperature; this spike signals the body that it’s time to get up and get going. If you’re having trouble sleeping, try to avoid working out within two hours of bedtime.


Use melatonin supplements . “Melatonin is a hormone that is naturally released in the brain four hours before we feel a sense of sleepiness,” Gamaldo says. It’s triggered by the body’s response to reduced light exposure, which should naturally happen at night. 


These days, though, lights abound after it’s dark outside—whether it’s from your phone, laptop or TV. This exposure to unnatural light prevents melatonin release, which can make it hard to fall asleep. Luckily, melatonin is available in pill form at your local pharmacy as an over-the-counter supplement. 


Just make sure that you consistently buy the same brand. “Because melatonin supplements are unregulated by the FDA, the per-pill dosages and ingredients may differ from manufacturer to manufacturer. Stick with one brand, and don’t buy it online from an unknown source,” Gamaldo cautions.


Keep cool. “The ideal temperature for your thermostat is between 65 and 72 degrees,” Gamaldo says. Women who are going through menopause and experiencing hot flashes should keep the room as cool as possible and wear cotton or breathable fabrics to bed.


Go dark. It’s known that the light from a smartphone interferes with sleep. But what about your bathroom light? If you have the urge to go at night, don’t flick on the lights. “The latest recommendation is to use a flashlight if you need to get up at night,” Gamaldo says, because it offers less visual disruption. And remember: If you do wake up for a bathroom break, it might take up to 30 minutes to drift back off. This is completely normal, she says.

"A vapor rub containing camphor, menthol, and eucalyptus oil provides kids 2 years old and up with some relief from cough and congestion and helps them sleep better," researcher Ian M. Paul, MD, associate professor of pediatrics and public health science at Penn State College of Medicine in Hershey, tells WebMD.

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The study is published in the journal Pediatrics.


The study was funded by an unrestricted grant from Procter and Gamble, which makes Vicks VapoRub, the product used in the study. The researchers were free to publish the study results regardless of how the research turned out.


Parents of young children are left with few options when coughs and colds strike, as the FDA in January 2008 issued a public health advisory saying children younger than 2 should not be given cold medicines because of potentially serious side effects. The American Academy of Pediatric says that over-the-counter cough and cold medicines do not work for kids less than 6 years old and in some cases may pose a health risk.



Vapor Rub vs. Petroleum Jelly

Paul and his colleagues assigned 138 children with upper respiratory infections, ages 2 to 11, to one of three groups:


The vapor rub group used Vicks, which has 4.8% camphor, 2.6% menthol, and 1.2% eucalyptus oil.

The petroleum jelly group used Equate 100% pure white petroleum jelly.

No treatment.

Parents answered questions on two consecutive days about their child's symptoms -- before the treatment and the morning after.



On the treatment night, parents applied the products 30 minutes before their children's bedtimes. To reduce the chances parents would easily tell they were using the vapor rub, due to its distinctive odor, those in both treatment groups first opened a cup filled with vapor rub and applied it between their upper lip and nose before opening their child's treatment, so they smelled the vapor rub regardless of which treatment they then gave their child.


Parents were told to apply the vapor rub or petroleum jelly to their child's upper chest and neck area and to massage the ointment in for one minute. Kids were told not to tell their parents if the treatment had an odor or not.


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Children's Cold Remedies: Results

Parents reported the next day on their child's cough (frequency, duration, severity), congestion, their child's ability to sleep, and their own ability to sleep and not be disturbed by their kids' coughing and other symptoms.


Except for runny noses, the vapor rub gave the greatest improvement, followed by the petroleum jelly. The no-treatment group reported the least amount of improvement.


Kids treated with the vapor rub and their parents had fewer problems sleeping than the other two groups.


"Our data suggest that the vapor rub provides systemic relief," says Paul. He reports having been a paid consultant for Procter and Gamble as well as other companies.


He can't pinpoint a specific improvement, such as the vapor rub kids coughing 25% less, for instance, but says the differences between the treatments were significant from a statistical viewpoint.



While vapor rub has been used for many years, studies on its effectiveness are scarce, Paul says. Menthol may work by improving the nasal sensation of airflow in congested kids and adults, according to some other research. Those in the vapor rub group did have the most side effects, such as skin rash or burning, with 46% of parents reporting them. "My sense is, it couldn't have been all that severe," Paul says of the side effects, "if they slept better."


Children's Cold Remedies: Second Opinion

"Parents are in a quandary right now," says Dennis Woo, MD, an associate professor of pediatrics at the University of California Los Angeles David Geffen School of Medicine and former chair of pediatrics at the Santa Monica-UCLA Medical Center and Orthopaedic Hospital, referring to the move away from OTC cold remedies for young children.


"I would describe it as interesting," Woo says of the vapor rub study results, "something to be aware of."


He does not typically recommend vapor rub, he says, and the study probably won't sway him to start. He cautions parents who may try vapor rub that the study only looked at children ages 2 and up. (Vicks' product information specifies VapoRub is for use in those 2 and up.)


When parents ask what they can do for their children's cold remedies, Woo points out that tea with honey has some research backing it, but not to give honey to children under 1 year, as they are at risk for botulism, a potentially serious food poisoning.

Does putting Vicks on your feet help you sleep?

Does putting Vicks on your feet help you sleep?

One study in the journal Pediatrics examined the effects of Vicks in 138 children between the ages of 2 and 11 years. The researchers found that in comparison with petroleum jelly or no treatment at all, Vicks helped relieve symptoms at night and, thus, improved sleep quality.


Does Vicks vapor rub help itchy feet?

And Vicks VapoRub contains eucalyptus oil and menthol, which can fight fungi. One study showed Vicks reduced athlete’s foot symptoms in more than half of people who applied it.


What age can you put Vicks on feet?

If your baby is under the age of 2, you should never apply Vicks to their chest, nose, feet, or elsewhere. You could try special nonmedicated rub for babies 3 months and older. The blend is dubbed as a “soothing ointment” that contains fragrances of eucalyptus, rosemary, and lavender.



Where do you put Vicks for a cough?

A: For cough suppression, rub a thick layer of Vicks VapoRub on your chest and throat. Cover with a warm, dry cloth, if desired. Keep clothing loose about your throat and chest to help the vapors to reach the nose and mouth.


Why do you put Vicks VapoRub on your feet?

You will benefit from a lot of things when applying this rub on your feet. It will do wonders for them! This method prevents foot and nail fungus, and it can also treat existing ones. This rub also prevents bad odor and kills it. You just have to apply it, wear your soft cotton socks and let it do its work as you sleep at night.


Can you use apple cider vinegar with Vicks VapoRub?


You have apple cider vinegar, Epsom salt baths, all the essential oils, etc. VICKS Vaper Rub, which is really called the trademark name of VICKS VapoRub, is one of the many cheap treatment options out there that some people suggest… But… Does… It… Actually… Work? The answer is YES, at least to some extent…

How to get a better night's sleep without pills



Can you use Vicks Vapor Rub on neuropathy?

If you have any problems with the registration process or your account login, please contact contact us. I recently read an article that Dr. Gott claims to state that vicks vapor rub rubbed all over the feet rids the pain of neuropathy??


Is it safe to put Vicks on Kids feet?

Some people swear that if you put Vicks VapoRub on your feet (or, more likely, your child’s feet) it will help with a cough. While the product has been available and popular for many years, you should know that Vicks is not completely safe for kids.

Efficacy of a Topical Aromatic Rub (Vicks VapoRub®) on Effects on Self-Reported and Actigraphically Assessed Aspects of Sleep in Common Cold PatientsNayantara Santhi1, David Ramsey2, Gill Phillipson3, David Hull3*, Victoria L. Revell4, Derk-Jan Dijk1

1Surrey Sleep Research Centre, School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Surrey, UK.

2The Procter & Gamble Company, Mason Business Center, Mason Montgomery Road, Mason, OH, USA.

3Procter & Gamble, Greater London Innovation Centre, Whitehall Lane, Egham, Surrey, UK.

4Surrey-Clinical Research Centre, Department of Clinical and Experimental Medicine, School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Surrey, UK.

DOI: 10.4236/ojrd.2017.72009   PDF   HTML   XML   1.552 Downloads   3.829 Views   Citations

Abstract


Common cold sufferers frequently report sleep disruption during the symptomatic period of infections. We examined the effects of treatment with a topical aromatic pharmaceutical ointment (Vicks VapoRub®), on associated sleep disturbances. The effects of Vicks VapoRub® versus placebo (petrolatum ointment) on subjective and objective measured sleep parameters were assessed in an exploratory study of 100 common cold patients, in a randomized, single blind, controlled, two-arm, parallel design study. The primary efficacy variable was subjective sleep quality measured with the SQSQ (Subjective Quality of Sleep Questionnaire). Additional measures included, ease of falling asleep and depth of sleep (measured with a post-sleep Visual Analog Scale), total sleep time, sleep onset latency, activity score, percentage of sleep, sleep efficiency (measured with actigraphy and SQSQ) and sleep quality index measured with a modified Karolinska Sleep Diary (KSD). The primary endpoint, “How was the quality of your sleep last night?” showed a statistically significant difference in change from baseline in favour of VapoRub treatment (p = 0.0392) versus placebo. Positive effects of VapoRub versus placebo were also observed for “How refreshed did you feel upon waking up?” (p = 0.0122) (SQSQ), “Did you get enough sleep?” (p = 0.0036) (KSD), “How was it to get up?” (p = 0.0120) (KSD) and “Do you feel well-rested?” (p = 0.0125) (KSD). No statistically significant changes from baseline versus placebo were detected in the Actiwatch endpoints. Vicks VapoRub® when applied before retiring to bed can reduce subjective sleep disturbances during a common cold. The results of this exploratory study support the belief among patients that the use of VapoRub improves subjective sleep quality during common cold which was associated with more refreshing sleep.

Keywords


Upper Respiratory Tract Infection, Common Cold, VapoRub, Sleep Disturbance, Aromatic Oils


Share and Cite:


Santhi, N. , Ramsey, D. , Phillipson, G. , Hull, D. , Revell, V. and Dijk, D. (2017) Efficacy of a Topical Aromatic Rub (Vicks VapoRub®) on Effects on Self-Reported and Actigraphically Assessed Aspects of Sleep in Common Cold Patients. Open Journal of Respiratory Diseases, 7, 83-101. doi: 10.4236/ojrd.2017.72009.

1. Introduction


The common cold, an infection of the upper respiratory tract, is reported to be the most common human infectious disease [1] [2] . Adults can experience two to four episodes a year and children six to eight [2] .


Common cold is generally a mild illness of the upper respiratory tract, primarily affecting the nose, nasopharynx and paranasal sinuses and is readily self-diagnosed by sufferers [3] . Rhinoviruses are the most common causative agents accounting for up to 50% of symptomatic infections [1] . The main symptoms of common cold include nasal congestion, nasal discharge, sneezing, headache, sore throat, and cough [4] . Of these, nasal congestion and cough have been reported as the most bothersome symptoms of a cold on 6 of the first 7 days of a cold [5] .


Additionally, it is well recognised that during symptomatic common cold, sleep can be adversely affected [6] . While this effect may be considered modest (c. 23 minutes decrease in sleep and a 5% reduction in sleep efficiency) from a scientific perspective [7] , it is generally accepted that common cold-induced sleep disruption is clinically meaningful. Smith (2012) [6] showed correlations between symptom scores and sleep parameters. In general sleep measures and total symptom score were correlated, indicating that increasing symptom severity was associated with sleep disturbance. The data suggested that nasal congestion severity was a significant driver of the correlation. Therefore, remedies that can alleviate rhinitis induced disturbances of sleep without the use of sedation, to ensure a well-rested feeling upon awakening, have an important place in therapy.


In the UK and many other countries, Vicks VapoRub® (VVR) is indicated for the reduction in cough frequency [8] and feeling of relief from nasal congestion [9] . As cough and nasal congestion (regardless of aetiology) are recognised barriers to restful and restorative sleep [10] , [11] , [12] , their relief using a topical ointment like VVR can be predicted to improve elements of sleep quality.


VVR is a pharmaceutical preparation containing a combination of levomenthol (2.75% w/w), eucalyptus oil (1.5% w/w), turpentine oil (5% w/w) and camphor (5% w/w) as active ingredients, and thymol, cedarwood oil, and white soft paraffin (petrolatum) as excipients. VVR is an ointment that is either applied topically to the chest, throat, and back or added to hot water and the aromatic vapours inhaled. When applied to the skin, the active ingredients are evaporated by body temperature and inspired into the airways. The therapeutic effects, reduction in cough frequency and relief from nasal congestion, are likely due, at least in part, to interactions of the aromatics with the largely calcium-selective ion channel, transient receptor potential (TRP) receptors. Recent data suggest that the transient receptor potential receptors TRPM8, TRPV1 and TRPA1 are up-regulated in respiratory virus infected cells [13] [14] . TRPM8 mediates the feeling of coolness associated with menthol and eucalyptus oil [15] , [16] and so is likely the main mediator of the sensation of cooling and nasal decongestion associated with menthol and eucalyptus oil [9] . Camphor, eucalyptus oil and menthol have been shown to interact with the TRPV1 and TRPA1 receptors [17] [18] [19] which are implicated in the neurophysiology of cough [13] [14] . These interactions may therefore have a role in controlling cough sensitivity.


This study compared the effects of VVR versus placebo on subjectively and objectively assessed sleep parameters in adult common cold sufferers. Sleep parameters were measured using subjective questionnaires (Subjective Quality of Sleep Questionnaire [SQSQ] [20] , a modified Karolinska Sleep Diary [KSD] [21] , and a study-specific post-sleep questionnaire) and actigraphy, an objective method of monitoring rest-activity patterns [22] . Several subjective questionnaires were employed because this was the first exploration of the effect of VVR on sleep parameters so little knowledge existed of likely effect size or which elements of sleep may be affected. Actigraphy was employed as it is a validated objective albeit surrogate measure of sleep.


2. Methods


2.1. Participants


One hundred and forty-one adult participants were screened for this study and 100 were enrolled and randomized to the 2 treatment groups (Figure 1). The mean (SD) age of those enrolled was 23 years (8.7) with a mean Body Mass Index (BMI) of 23 (2.9). The population was 61% female and most participants (71%) were Caucasian. One participant withdrew consent during the study and their data were not included. Subjects were recruited by advertisement from the staff and students of the University of Surrey and the greater London area. Those participating received £120 compensation.


Randomized participants were suffering from a common cold and experiencing nasal congestion, cough and disturbance to normal sleep. Key inclusion criteria included suffering from a self-diagnosed common cold of no more than 36 hours duration; suffering from at least mild cough and nasal congestion due to the common cold (scores of at least 1 on the 4-point ordinal scale); having an average score of < 50 on the 2 responses to the question “How would you compare the quality of last night’s sleep with your usual sleep without a cold?” from the Leeds Sleep Evaluation Questionnaire (LSEQ) [23] , a 100-mm Visual Analog Scale (VAS), where Response 1 is 0 = “Less restful than usual” and 100 = “More




Figure 1. Subject disposition.


restful than usual” and Response 2 is 0 = “More periods of wakefulness than usual” and 100 = “Fewer periods of wakefulness than usual”.

8 all-natural ways to *stay* asleep all night long



Volunteers were excluded if they had any of the following: A previously diagnosed sleep disorder, a current sleep disturbance or poor sleep quality unrelated to their cold based on the Pittsburgh Sleep Quality Index (PSQI) [24] (i.e., a score of >5); a clinically significant nasal abnormality; a history of clinically relevant anosmia; were employed on night or rotating shift work or needed to travel across more than 2 time zones in the 14 days prior to screening or planned to do so during the study; a history of allergy or hypersensitivity to any of the ingredients of VVR; a history of significant airway disease or pronounced hypersensitivity of the airways/asthma or Chronic Obstructive Pulmonary Disease, a significant history of recurrent sinusitis or currently experiencing allergic rhinitis, or significant history of chronic cough; a body temperature > 100.5°F (38.1˚C); had used, within 5 half-lives, substances or medications known to affect sleep; had used nasal decongestants in the past 24 hours; had a self-reported consumption of >5 caffeinated beverages daily; used nicotine in any form; took naps daily; used inhaled, topical, or oral nedocromil or cromolyn sodium, tricyclic antidepressant medications, or monoamine oxidase inhibitors for 14 days prior to screening; had a history of alcohol or drug abuse within the past 2 years; were currently enrolled in another clinical trial, or had received any other investigational drug within the past 30 days; if female and of child-bearing potential had a positive urine pregnancy test at screening or were lactating; had a history of malignancy within the past 2 years, or had current or past history of serious, severe, or unstable physical or psychiatric illness; or were taking medication that the Investigator believed would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results.


2.2. Study Design


The study (EudraCT# 2013-004524-11) was a randomized, single-(Investigator) blind, controlled, 2-arm (Vicks VapoRub® [VVR] vs. petrolatum), parallel design, single site study conducted at Surrey Clinical Research Centre, University of Surrey, between November 2014 and May 2015.


The study was conducted in accordance with the ICH Guideline for Good Clinical Practice, 1997; the US CFR Title 21 parts 50, 56 and 312; applicable national laws and regulations; the ethical requirements of Directive 2001/20/EC; and the ethical principles with their origin in the Declaration of Helsinki. The study was approved by the NRES Committee London-Brent Ethics Committee and all participants provided written informed consent prior to any study procedures being conducted.


The study included a baseline visit (Day 0) at the study site to confirm study eligibility and to randomly assign subjects to 1 of 2 test products (VVR or petrolatum). Randomized subjects were sent home with the SQSQ, KSD, and post- sleep questionnaire, along with the Actiwatch sleep monitoring equipment and their assigned test product. Subjects were instructed to use the Actiwatch on this first evening of Day 0, but did not apply test product. Upon waking the next morning, subjects completed the SQSQ, KSD, and the post-sleep questionnaire.


The test period began on the evening of Day 1 when subjects applied their randomly assigned test product as directed, immediately before going to bed. Subjects continued using the Actiwatch overnight. Upon waking the next morning, subjects completed the SQSQ, KSD, and post-sleep questionnaire. These procedures were repeated on the evening of Day 2 and the following morning. Subjects then returned to the study site on Day 3 to complete exit procedures and to return their sleep monitoring equipment, completed questionnaires, and test product containers with any remaining study test product. At this point, the subjects exited from the study.


2.3. Test Products


7.5 grams of commercially available VVR and petrolatum base (placebo) were packaged in identical individual 25 gram jars identifiable only by participant number. Participants were provided with 2 identical jars of either VVR or placebo at Day 0 with the instructions to apply all of the product from the first jar on the evening of Day 1 at bedtime, and all of the product from the second jar on the evening Day 2 at bedtime.


2.4. Sleep Measures


The effect size of VVR on sleep was not expected to be large in absolute terms. Further, we were most interested in the subjective perceptions of sleep quality therefore change in the, “How was the quality of your sleep last night?” question of the SQSQ, a validated questionnaire which has been shown to be sensitive to effects of zolpidem, temazepam [25] , gaboxadol and traffic noise [20] and slow wave sleep disruption by acoustic stimuli [26] , was chosen as the primary endpoint. The KSD questionnaire [21] , [27] was modified for this study by removing the first 5 questions due to duplication of sleep measures with the SQSQ.


Actigraphy is considered a valid method to quantify sleep patterns in healthy controls, patients with sleep disorders and their treatment response [28] . This method was included in the study because if positive correlation with the subjective measures were observed, it would provide additional confidence in the effect and its magnitude. The Actiwatch 4® is a gyroscopic actigraphic device worn on the non-dominant wrist to collect objective indirect measurements of sleep and wakefulness (i.e., where movement is a surrogate for wakefulness) utilizing an automated computer and scoring algorithm. Derived sleep measures were total sleep time, sleep onset latency, mean activity score, percentage of sleep (percentage of actual sleep time between sleep onset and sleep end), sleep efficiency (percentage of time spent asleep from “Lights out” to “Lights on”), and number of sleep bouts. For computations of sleep and wakefulness the software algorithm used the activity data recorded by the Actiwatch 4® in a series of linked calculations, such that each data point from each epoch and those surrounding was used to compute a total score based on these activity counts. With a default Medium Sensitivity, for 1-minute epoch data (and pro rata for other epochs used) a total score of 40 was designated as an “Awake” epoch. The activity scale was set to 2000. To determine “Sleep Start”, the algorithm looked for a period of at least 10 minutes of consecutively recorded immobile data, with no more than 1 epoch of movement within that time, following the “Bed Time”. To determine ‘Sleep End’, the algorithm looked for a 10-minute consecutive period of activity around the “Get Up Time” and then worked back to find the last epoch of immobility. To set the analysis window, the actigraphy marker-based bedtime and get-up times were used. In instances, where subjects failed to use the markers, their sleep-diary based bedtime and get up times were used instead.


2.5. Statistical Methods


Randomization and Stratification of Participants: All potential study participants were given a subject number (starting at 1001 in the order in which they were screened for the study). Eligible volunteers were stratified by average LSEQ score on the 2 responses to the question “How would you compare the quality of last night’s sleep with your usual sleep without a cold?” (0 - 20.8 = “Very poor”; > 20.8 - 35.4 = “Rather poor”; > 35.4 - < 50 = “Intermediate”). Participants were then randomly assigned to test products (VVR or placebo) using a block randomization. A unique randomization number (e.g., 101, 102, 103, etc) was assigned to each eligible participant.


Safety Analyses: All safety summarization was done on Intent-to-Treat population (all randomized subjects).


Efficacy Analyses: All efficacy analyses were done on Per-Protocol population. The Per-Protocol population comprised those participants who were generally compliant with test product usage instructions (used ≥ half of the allocated dose) and met key inclusion and exclusion criteria. The Per-Protocol assessment was determined on blinded data prior to receiving treatment codes. In order to obtain a more consistent response, the two treatment days (Day 1 and Day 2) for each endpoint were averaged for analysis purposes and served as the response variable for the analyses.


Comparability of treatments at baseline for demographics, baseline characteristics, SQSQ, post-sleep questionnaire, Actiwatch, and KSD was assessed via 2- sample t-test, Fisher’s exact test, and Cochran-Mantel-Haenszel test, as appropriate per the data type. Analysis of covariance (ANCOVA) was used for analyzing primary and secondary endpoints using the Mixed procedure of SAS version 9.4 (SAS Institute, Cary, NC, USA).The primary endpoint was sleep quality as measured by the SQSQ. Each hypothesis was tested separately using an ANCOVA model that included relevant baseline measures as a covariate and treatment group as independent variable (fixed factor). The following hypotheses were tested separately for each endpoint:

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Null Hypothesis: the change from baseline mean is the same for VVR versus placebo. Alternative Hypothesis: the change from baseline mean is different for VVR versus placebo.


Two of the secondary KSD measures (“Did you take any drugs before retiring?” and “Did you wake up ahead of time without being able to return to sleep?”) required nonparametric assessments as described in the protocol due to assumptions of ANCOVA not being met. All hypotheses were tested at a two-sided significance level of 5%. No corrections for multiplicity were conducted in this exploratory investigation.


2.6. Sample Size


The sample size was determined by logistical considerations and previous experience with sleep studies.


3. Results


Demographics: Table 1 shows the demographic composition of the participants.


Participant screening and baseline characteristics: common cold symptom severity, PSQI, LSEQ (abbreviated, only displayed two Leeds questions that were part of inclusion criteria), SQSQ, KSD and Post-sleep questionnaire, did not differ between groups (Tables 1-3).


Product Dosing Compliance: Product dosing compliance was assessed by weighing the sample jars before and after treatment. On average participants used 23% less product than instructed on both treatment nights. There were no


Parameter Statistic/Category


VapoRub (N = 50)


Petrolatum (N = 50)


P value1


Age


23.1 (9.45)


23.7 (7.99)


0.7154


Sex


0.6820


Female


32 (64%)


29 (58%)


Male


18 (36.0%)


21 (42%)


Race


0.1287


Caucasian


30 (60%)


41 (82%)


Asian Indian


8 (16%)


1 (2%)


Black


3 (6%)


3 (6%)


Other


9 (18%)


5 (10%)


Height (cm)


170.5 (9.24)


170.9 (11.47)


0.8511


Weight (kg)


69.5 (12.66)


67.7 (11.80)


0.4618


BMI


23.8 (3.25)


23.1 (2.46)


0.1915


Nasal Congestion


0.3696


Mild


25 (50%)


23 (46%)


Moderate


25 (50%)


24 (48%)


Severe


0 (0%)


3 (6%)


Cough


0.3235


Mild


38 (76.0%)


33 (66%)


Moderate


11 (22.0%)


16 (32%)


Severe


1 (2%)


1 (2%)


Runny Nose


0.7911


Not Present


3 (6%)


1 (2%)


Mild


16 (32%)


23 (46%)


Moderate


25 (50%)


19 (38%)


Severe


6 (12%)


7 (14%)


Sore Throat


0.6862


Not Present


8 (16%)


6 (12.0%)


Mild


22 (44%)


24 (48.0%)


Moderate


19 (38%)


18 (36.0%)


Severe


1 (2%)


2 (4.0%)


Sneezing


0.5225


Not Present


13 (26%)


12 (24%)


Mild


23 (46%)


22 (44%)


Moderate


14 (28%)


14 (28%)


Severe


0 (0%)


2 (4%)


PSQI total2


2.8 (1.38)


2.9 (1.33)


0.8256


Leeds Quality 1: More/Less Restful3


29.5 (15.68)


27.8 (12.35)


0.5646


Leeds Quality 2: Fewer/More Periods Of Wakefulness4


34.2 (14.00)


32.9 (15.71)


0.6685


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Table 1. Summary of demographics and baseline characteristics (Intent-to-treat).


Values are means (SD) or n(%) of subjects. 1P-values were calculated with 2 sample t-test for continuous variables, Fisher's exact test for non-ordered categorical variables, and Cochran-Mantel-Haenszel test for ordered categorical variables. Continuous data that violated normality were also analyzed nonparametrically with the Wilcoxon Rank Sum Test with similar conclusions of no statistically significant difference (p > 0.05). 2Pittsburgh Sleep Quality Index. Leeds sleep evaluation questionnaire question: “How would you compare the quality of last night’s sleep with your usual sleep without a cold?” 3A 100-mm Visual Analog Scale (VAS), where response is 0 = “Less restful than usual” and 100 = “More restful than usual”. 4A 100-mm Visual Analog Scale (VAS), where response is 0 = “More periods of wakefulness than usual” and 100 = “Fewer periods of wakefulness than usual”.


Parameter/Category


VapoRub (N = 46)


Petrolatum (N = 47)


P value1


Subjective Quality of Sleep Questionnaire


Wake Up Refreshed3


36.5 (15.59)


31.2 (20.00)


0.1575


Sleep Quality2


60.8 (17.49)


65.1 (19.98)


0.2750


Sleep Onset Latency (min)


25.1 (18.08)


26.4 (19.31)


0.7518


Number of Awakenings


2.5 (2.11)


2.9 (2.03)


0.4154


Total Sleep Time (min)


463.1 (57.76)


466.9 (46.96)


0.7337


Wake After Sleep Onset (min)


19.1 (23.61)


18.8 (20.99)


0.9447


Sleep Efficiency


89.5 (7.05)


89.7 (5.92)


0.8527


Post-sleep Questionnaire


How Easy Falling Asleep3


41.7 (17.01)


42.0 (23.85)


0.9472


How Deep Was Sleep2


57.5 (19.15)


57.1 (23.14)


0.9291


Actiwatch


Total Sleep Time (min)


403.7 (65.97)


394.0 (40.77)


0.3939


Sleep Onset Latency (min)


18.7 (28.70)


18.7 (25.47)


0.9992


Mean Activity Score


21.9 (10.26)


21.3 (9.43)


0.7652


Percentage of Sleep


83.4 (5.62)


83.1 (5.84)


0.8070


Sleep Efficiency


79.9 (7.05)


79.2 (7.00)


0.6226


Number of Sleep Bouts


32.9 (8.54)


32.1 (8.79)


0.6637


Wake After Sleep Onset (min)


80.1 (28.14)


81.0 (32.64)


0.8829



Table 2. Summary of subjective quality of sleep questionnaire, post-sleep questionnaire, and actiwatch for baseline (per-protocol).


Values are means (SD). 1P-values were calculated with 2-sample t-test. Continuous data that violated normality were also analyzed nonparametrically with the Wilcoxon Rank Sum Test with similar conclusions of no statistically significant difference (p > 0.05). 2VAS with lower numbers better. 3VAS with higher numbers better.


between-group differences―both groups used between 5.7 and 5.8 grams versus the supplied single-dose amount of 7.5 grams. The Per-Protocol analyses excluded seven participants for the nights they used less than half the allocated dose (3 VVR and 4 placebo participants).


Table 4 shows the data from statistical testing of between group differences in the various subjective scales used.


Subjective Quality of Sleep Questionnaire Endpoints: Statistical testing of the between group differences showed that the primary endpoint of Sleep Quality in the SQSQ showed a statistically significant difference in change from baseline in favour of VVR treatment compared to placebo (Table 4, Figure 2; p = 0.0392). This was also found for the “Wake up refreshed” SQSQ endpoint (Table 4, Figure 2; p = 0.0122). None of the other SQSQ endpoints showed statistically significant between group differences (Table 4, Figure 2). Examination of the monadic changes from baseline were consistent with the between group findings: 89% of participants who used VVR reported an improved quality of sleep vs

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Parameter/Category


VapoRub (N = 46)


Petrolatum (N = 47)


P value1


How well did you sleep


0.2227


1-VERY POORLY


0 (0%)


4 (8.5%)


2-RATHER POORLY


17 (37.0%)


20 (42.6%)


3-INTERMEDIATE


23 (50.0%)


16 (34.0%)


4-RATHER WELL


5 (10.9%)


6 (12.8%)


5-VERY WELL


1 (2.2%)


1 (2.1%)


Difficulties falling asleep


0.5029


1-GREAT DIFFICULTIES


1 (2.2%)


4 (8.5%)


2


13 (28.3%)


12 (25.5%)


3-RATHER


13 (28.3%)


15 (31.9%)


4


14 (30.4%)


10 (21.3%)


5-NOT AT ALL


5 (10.9%)


6 (12.8%)


Have a restless sleep


0.7131


1-VERY


4 (8.7%)


6 (12.8%)


2


14 (30.4%)


12 (25.5%)


3-A LITTLE


15 (32.6%)


19 (40.4%)


4


10 (21.7%)


6 (12.8%)


5-NOT AT ALL


3 (6.5%)


4 (8.5%)


How deep was your sleep


0.9959


1-VERY LIGHT


3 (6.5%)


0 (0%)


2-RATHER LIGHT


4 (8.7%)


15 (31.9%)


3-INTERMEDIATE


28 (60.9%)


18 (38.3%)


4-RATHER DEEP


10 (21.7%)


11 (23.4%)


5-VERY DEEP


1 (2.2%)


3 (6.4%)


How much did you dream


0.3483


1-MUCH


0 (0%)


1 (2.1%)


2


4 (8.7%)


5 (10.6%)


3-A LITTLE


10 (21.7%)


10 (21.3%)


4


4 (8.7%)


8 (17.0%)


5-NOT AT ALL


28 (60.9%)


23 (48.9%)


Did you get enough sleep


0.7085


1-NO FAR TOO LITTLE


0 (0%)


0 (0%)


2-NO TOO LITTLE


8 (17.4%)


11 (23.4%)


3-NOT QUITE


16 (34.8%)


18 (38.3%)


4-YES ALMOST


19 (41.3%)


11 (23.4%)


5-YES DEFINITELY


3 (6.5%)


7 (14.9%)



Table 3. Summary of Karolinska sleep diary for baseline (Per-Protocol).


N = number of subjects within specified treatment. n(%) = number and percentage of subjects within specified parameter, treatment, and category. 1P-values were calculated with Fisher’s exact test and Cochran-Mantel-Haenszel test, as appropriate per the data type.

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Change From Baseline


Endpoint


Count


Adjusted Mean (SE)


Adjusted Mean (SE)


Treatment Difference


VapoRub


Petrolatum


VapoRub


Petrolatum


VapoRub


Petrolatum


Adjusted Mean (SE)


P-value


Subjective Quality of Sleep Questionnaire


Sleep Quality1


46


47


41.4 (2.68)


49.3 (2.65)


−21.6 (2.68)


−13.7 (2.65)


−7.9 (3.78)


0.0392


Wake Up Refreshed2


46


47


53.5 (2.33)


45.0 (2.30)


19.6 (2.33)


11.2 (2.30)


8.4 (3.29)


0.0122


Sleep Onset Latency (min)


46


47


21.8 (2.22)


22.6 (2.20)


−4.0 (2.22)


−3.2 (2.20)


−0.8 (3.13)


0.7929


Number of Awakenings


46


47


1.3 (0.17)


1.7 (0.17)


−1.3 (0.17)


−1.0 (0.17)


−0.3 (0.25)


0.2048


Total Sleep Time (min)


46


47


471.2 (5.91)


472.3 (5.84)


6.2 (5.91)


7.3 (5.84)


−1.1 (8.31)


0.8988


Wake After Sleep Onset (min)


46


47


10.0 (1.49)


12.1 (1.48)


−9.0 (1.49)


−6.9 (1.48)


−2.1 (2.10)


0.3271


Sleep Efficiency


46


47


92.3 (0.77)


91.7 (0.76)


2.7 (0.77)


2.1 (0.76)


0.6 (1.08)


0.5505


Karolinska Sleep Diary


How well did you sleep


46


47


3.5 (0.11)


3.3 (0.11)


0.9 (0.11)


0.7 (0.11)


0.2 (0.16)


0.2272


Difficulties falling asleep


46


47


3.6 (0.12)


3.4 (0.12)


0.5 (0.12)


0.3 (0.12)


0.2 (0.17)


0.2732


Have a restless sleep


46


47


3.6 (0.12)


3.4 (0.12)


0.8 (0.12)


0.6 (0.12)


0.2 (0.17)


0.2843


How deep was your sleep


46


47


3.7 (0.09)


3.5 (0.09)


0.6 (0.09)


0.5 (0.09)


0.1 (0.13)


0.3444


How much did you dream


46


47


3.9 (0.13)


3.8 (0.13)


−0.2 (0.13)


−0.3 (0.13)


0.1 (0.18)


0.6127


Did you get enough sleep


46


47


3.9 (0.11)


3.4 (0.11)


0.6 (0.11)


0.1 (0.11)


0.5 (0.16)


0.0036


How was it to get up


46


47


3.5 (0.11)


3.1 (0.11)


0.8 (0.11)


0.4 (0.11)


0.4 (0.15)


0.0120


Do you feel well rested


46


47


3.4 (0.11)


3.0 (0.11)


0.9 (0.11)


0.5 (0.11)


0.4 (0.16)


0.0125


What caused your final awakening


46


47


4.1 (0.10)


4.1 (0.09)


0.1 (0.10)


0.1 (0.09)


0.0 (0.13)


0.8840


Occurrences that might have affected Sleep


46


47


1.7 (0.19)


2.0 (0.19)


−0.2 (0.19)


0.0 (0.19)


−0.2 (0.26)


0.4165


Sleep Quality Index


46


47


3.9 (0.08)


3.7 (0.08)


0.6 (0.08)


0.5 (0.08)


0.1 (0.11)


0.3124


Post−sleep Questionnaire


How Easy Falling Asleep2


45


46


52.1 (2.59)


50.5 (2.56)


10.3 (2.59)


8.6 (2.56)


1.6 (3.64)


0.6564


How Deep Was Sleep1


46


47


38.1 (2.21)


44.0 (2.18)


−19.2 (2.21)


−13.3 (2.18)


−5.9 (3.11)


0.0606



Table 4. Analysis of covariance of subjective sleep questionnaires and diaries (Per-Protocol).

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1. 0 - 100 VAS scale where lower values are better (negative treatment difference better); 2. 0 - 100 VAS scale where higher values are better (positive treatment difference better).


baseline, and 91% who used VVR reported an improved “wake up refreshed” score vs baseline. In examining the consistency of response of the primary endpoint (sleep quality as measured by SQSQ), subgroup analyses by demographics and baseline characteristics were assessed. The results for all subgroups analysed favoured VVR compared to placebo, indicating consistency of response. Statistical significance of VVR vs. placebo for sleep quality was observed in the subgroup of subjects with moderate-to severe cough at baseline (p = 0.0294), runny nose not present/mild at baseline (p = 0.0492) and PSQI ≥ 3 (p = 0.0486) (Data not shown).


(a)(b)


Figure 2. (a) Plot of mean differences and 95% Confidence Intervals for each of the Subjective Quality of Sleep Questionnaire (SQSQ) questions comparing answers provided “on awakening” with baseline; (b) Primary. Histogram showing the statistical analysis of results from the SQSQ question identified a piori as Primary Objective comparing answers provided “on awakening” with baseline. Visual Analogue Scale?“How was the quality of your sleep last night?” 0 = “Very Good” and 100 = “Very Bad”. Between group difference statistically significant at p < 0.0392. (b) Secondary. Histogram showing the statistical analysis of results from the SQSQ question identified a piori as “First Secondary Objective”, comparing answers provided “on awakening” with baseline. Visual Analogue Scale?“How refreshed did you feel upon waking up?” 0 = “Very Good” and 100 = “Very Bad”. Between group difference statistically significant at p < 0.0122.


Karolinska Sleep Diary Endpoints: Statistical testing of the KSD endpoints showed significant between group differences for “Did you get enough sleep?” (p = 0.0036), “How was it to get up?” (p = 0.0120) and “Do you feel well-rested?” (p = 0.0125) favouring VVR compared to placebo (Table 4, Figure 3). While none of the other KSD or Post-sleep Questionnaire endpoints reached statistical significance, VVR treatment showed a numerical improvement in the KSD results (Table 4 & Figure 3). The two secondary KSD measures (“Did you take any




Figure 3. Plot of mean differences and 95% Confidence Intervals for each of the Karolinska Sleep Diary (KSD) questions comparing answers provided “on awakening” with baseline.


drugs before retiring?” and “Did you wake up ahead of time without being able to return to sleep?”) analyzed by nonparametric measures did not show significant treatment differences (data not shown). A trend in favour of VVR compared to placebo (p = 0.0606), was observed in change from baseline for the “How deep was sleep?” endpoint in the Post-sleep Questionnaire but no difference in ease of falling asleep (Table 4).


Actigraphy Endpoints: There were no statistically significant changes from baseline treatment differences in the Actiwatch endpoints. There was, however, a trend in favour of VVR compared to placebo for change from baseline in Sleep Onset Latency (Table 5, Figure 4; treatment difference 11.5 minutes and p = 0.0538).


Safety


Both treatments were well-tolerated during this study. There were no deaths, serious or other significant Adverse Events (AEs). Eight participants reported 10 AEs; 5 on placebo and 3 on VVR and all resolved without any action being taken to ameliorate the AE.


4. Discussion


The results from this exploratory study show for the first time that application of Vicks VapoRub® before retiring to bed has a positive effect on perceived sleep quality for adults suffering from symptoms of common cold. The primary endpoint subjective finding supports the long-held association described by common cold patients of VVR use and improved sleep. It cannot be determined from these data alone whether this is a result of symptom relief facilitating sleep (as has been suggested for cough relief [29] ) or a direct effect on sleep. However, the active ingredients in VVR are not known to have a sedative effect. This suggests that a patient-perceived sleep quality benefit in patients with a cold would be due to a different mechanism, likely symptom relief. Indeed, the subgroup of patients with moderate-to-severe cough at baseline reported improvement for sleep quality vs placebo (p = 0.0294).


Change From Baseline


Endpoint


Count


Adjusted Mean (SE)


Adjusted Mean (SE)


Treatment Difference


VapoRub


Petrolatum


VapoRub


Petrolatum


VapoRub


Petrolatum


Adjusted Mean (SE)


P-value


Total Sleep Time (min)


46


47


394.9 (7.44)


381.8 (7.36)


−3.9 (7.44)


−17.1 (7.36)


13.2 (10.48)


0.2124


Sleep Onset Latency (min)


46


47


18.8 (4.18)


30.3 (4.14)


0.1 (4.18)


11.6 (4.14)


−11.5 (5.88)


0.0538


Mean Activity Score


46


47


21.4 (1.49)


23.7 (1.48)


−0.2 (1.49)


2.1 (1.48)


−2.3 (2.10)


0.2820


Percentage of Sleep


46


47


83.6 (0.78)


82.7 (0.77)


0.4 (0.78)


−0.6 (0.77)


1.0 (1.10)


0.3837


Sleep Efficiency


46


47


79.6 (1.16)


76.9 (1.15)


0.0 (1.16)


−2.6 (1.15)


2.7 (1.64)


0.1050


Number of Sleep Bouts


46


47


30.1 (0.91)


29.8 (0.90)


−2.3 (0.91)


−2.7 (0.90)


0.3 (1.28)


0.8077


Wake After Sleep Onset (min)


46


47


76.5 (3.82)


80.1 (3.78)


−4.0 (3.82)


−0.5 (3.78)


−3.5 (5.38)


0.5122


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Table 5. Analysis of covariance of Actiwatch (Per-Protocol).


Figure 4. Plot of mean differences and 95% Confidence Intervals for each of the Actiwatch endpoints comparing answers provided on awakening with those at baseline.


It was hypothesised that VVR would affect sleep as a result of its known decongestion and antitussive effects rather than as a sleep aid. Consequently, while for completeness both subjective and objective assessments of sleep were employed, it was predicted that subjective endpoints were most likely to be affected. Change in the SQSQ sleep quality was chosen as the primary objective as it offered a global retrospective assessment of the perceived sleep experience. The KSD was also included as a source of secondary endpoints to permit a more granular description of the subjective elements of sleep affected. As nasal decongestion and cough relief are the licensed indications of VVR in the UK, they were not measured in this study wherein the focus was sleep-related effects.


The difference in perceived sleep quality assessed by the SQSQ was statistically significant (p = 0.0392). To place this change in perspective it is noted that the observed response to VVR compared to placebo for the SQSQ was 7.9 units, which is comparable to the positive effects of gaboxadol on subjective sleep quality in a traffic noise model of sleep disruption [20] and approximately half the size of the effect of zolpidem and temazapam on sleep in middle-aged people [25] . Supporting this is the finding that responses to the “How refreshed did you feel upon waking?” SQSQ endpoint were also significant (p = 0.0122). On average subjects had 58% better sleep quality vs. placebo and 75% better wake up refreshed vs. placebo. The effect sizes for questions [30] would be considered a moderate effect (0.44 and 0.54 respectively). Taken together these findings suggest that VVR had a clinically relevant effect on the perception of sleep quality. We speculate that as subjective sleep assessments are necessarily retrospective, the fact that the VVR aroma would still be noticeable in the morning may have augmented the perception of improved sleep quality.


The SQSQ also includes a series of more specific time and duration related questions. Changes in these parameters did not reach statistical significance, consistent with the objective actigraphy results except for sleep onset latency which objectively favoured VVR with subjects falling asleep approximately 11.5 minutes faster than placebo (p = 0.0538). Arguably, questions around for example, time to get to sleep, number of awakenings, duration of awakenings, etc. require an awareness of sleep and sleep disruption that may be difficult to measure in patients with an illness such as the common cold relative to other conditions; further studies would be useful. It seems reasonable to expect greater effects if subjects had more severe symptoms and/or more severe sleep disturbance at baseline.


There were also positive findings for some of the secondary endpoints assessed by the KSD. Participants provided positive (for VVR) between group responses for, “Did you get enough sleep?” (p = 0.0036), “How was it to get up?” (p = 0.0120) and “Do you feel well-rested?” (p = 0.0125). The effect size for the significant KSD questions (0.62, 0.53, and 0.53 respectively) would be considered moderate effects [30] . These parameters may be considered to be elements of the overall findings of improved sleep quality and the feelings of having had refreshing sleep. They are consistent with improvements in an improved overall sleep experience. The remaining KSD parameters including, “How did you sleep?” and sleep quality index, did not show a statistical significant effect.


The objective effects on sleep were assessed using arm motion during rest as a surrogate measure for wakefulness. The Actiwatch instrument has been validated for the assessment of a variety of sleep parameters [28] [31] . We believe this study is the first use of actigraphy in the investigation of the mild sleep disturbance associated with common cold. The Actiwatch and subjective data were broadly consistent. In this study of sleep disturbance associated with common cold, no significant between-group differences were detected in the objective data-only “Sleep Onset Latency” approached statistical significance (p = 0.0538).


Several limitations of this study merit discussion. An obvious limitation is that it was not double-blind. As the Informed Consent information made clear that participants would be treated either with an aromatic or non-aromatic product, those allocated VVR would have been aware that they had received active product as soon as they sensed the aroma. The difficulty in designing double-blind studies with VVR is a recognized design limitation [32] . It is difficult to blind a study wherein the aroma of the product is so widely recognized and represents the pharmacological effect. Investigators were blinded as no medication was opened at the study site thus preserving the single blind.


Finally, while these data indicate a positive effect of VVR on sleep quality they cannot distinguish between VVR treatment improving sleep quality solely as a result of reducing the symptoms, exerting a direct sleep effect or a combination of both. Further work is recommended wherein the direct sleep quality benefit in persons with sleep disturbance and no infectious disease is examined.


5. Conclusion


Common cold sufferers using Vicks VapoRub® (applied before retiring to bed) experienced significant differences in self-reported sleep quality compared to control. This supports that treatment with this product can be a valuable component in the armamentarium of safe and effective common cold therapies due to the patient perceived improvement in sleep quality, a widespread patient belief measured in this study.


Financial and Competing Interests


This work was sponsored in full by Procter & Gamble. At the time of conducting the study and preparing this manuscript, DH, GP and DR were full-time employees of The Procter & Gamble Company and may have stock and/or stock options in the company. VR, NS and DJD did not receive any financial payments or other inducement apart from their usual university salary, for conducting this study.


DH and DR were responsible for statistical analysis (DR) interpretation of study results (DH, DR) and publication drafting (DH). VR, NS and DJD were responsible for study execution. GP advised on design and was responsible for product supply and management. All attributed authors participated in the development and review of this manuscript.

OK, you don’t have to STOP rubbing Vicks VapoRub into your chest. Just don’t ONLY use it for that purpose when it can do so much more. Little Things recently opened our eyes to just how many uses there are for the mentholated ointment. You know how comforted and soothed you felt when you first tried it out during a heavy cold? You’ll get that feeling all the time. We picked out our favorite, most surprising ways. Just look at all it can do!

This Is How You Get Better Sleep and Improve Your Health | Health Theory



Hide horrible smells.

ToothpasteonFingerLittle Things


This trick gets the stamp of approval from none other than nurses! Spread a little beneath your nose for continuous cover-up, or rub some into your hands for a quick whiff whenever you encounter terrible stenches. You’ll breathe better, too!



Heal headaches.

HeadacheWomanBillionPhotos.com via Dollar Photo Club


Yes, even tough sinus ones. Just rub a little bit of it into your temples and forehead.



Keep mosquitos away.

Garlic MosquitoReader's Digest


Mosquitos – and other insects! – absolutely hate the smell of Vicks VapoRub, so use it to repel them by rubbing some into your neck, inner knees, elbows, behind your ears, or even your clothes. You can also open a jar on a table outside to act as a general repellant.



Remove ticks.

VapoRubForListTatsuo Yamashita via Flickr


If you get bit by this most annoying of burrowing pests, fear not! They hate Vicks VapoRub just as much as mosquitos, so if you rub some into your skin, it can encourage it to crawl out, let go and leave you alone.



Act as a lip balm.

LipCarekb-photodesign via Deposit Photos


Run out of Chapstick? Rub some VapoRub on your chapped lips instead for soothing, smoothing treatment.



Sleep more soundly.

Humidifieryocamon via Deposit Photos


You already know you’ll sleep better with a humidifier, but it can get even better— with Vicks. You don’t even have to buy the specialty kind of humidifier or liquid. Just put a little bit of the regular stuff in the compartment and snooze away.



Heal your heels.

Foot Painvladimirfloyd via Dollar Photo Club


If you have cracked or callused feet, you don’t need to run out for an expensive pedicure or fancy lotions. Just rub some VapoRub in there, put on some socks, and go to sleep!



Treat acne.

GirlWithAcneforListobencem via Deposit Photos


All you need to do is spread VapoRub over every acne-prone area. You’ll start to see results within a week!



Erase stretch marks.

Woman showing her new stretch marksjolopes


It sounds crazy, but people swear by this trick. Rub it into your stretch marks and after two weeks, you’ll notice a difference.



Housetrain your pets.

PuppyPeeingforListwilleecole via Deposit Photos


While we find relief in the smell of VapoRub, pets definitely do not. Place an open jar near the areas you’d most like to prevent your dog from having accidents, or next to the entrance of rooms you don’t want your pets to enter, and they’ll avoid it!

Who would have guessed these crazy uses? Have you ever heard any of them before? There’s more where they came from, too. Check out these lists from Little Things and Feminiya for more ideas, and tell us how you use this multipurpose product in YOUR life.

Yes. I have seen such few cases.

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Vick’s Vaporub is a very tricky product. It does not solve your problem of cold but it just provides temporarily relief. It gains your faith very fast but falsely.


And you become dependent. I feel it could be used when you have problem instead of getting into daily habit. Let her follow following discipline & find if she can sleep without Vick’s.


No AC & if cannot avoid, temp. not less than 26 deg.

Prepare a warm drink using lemon, clove & black pepper and have instead of water after dinner.

No freeze water. Never in a day or night.

Good Luck

 The inundation of technology and busy work schedules has more and more people finding it difficult to “turn it off” when they lie their heads down at night. If you find yourself being a bit of an insomniac, try some of these strange, but effective, ways to catch some sleep.


Give Yourself Some Tingles

ASMR, or autonomous sensory meridian response, has gained a massive online following across Youtube in the past year. The term actually describes a sensation of tingles along the back of the head and down the body, sometimes jokingly referred to as a “brain orgasm,” that is triggered by outside stimuli such as whispering, tapping sounds, or crinkling paper. Whatever it is, it’s incredibly relaxing, and there are thousands of videos on Youtube designed to help you fall asleep.


Rub Your Belly

This might sound like something you’d do to please your dog, but rubbing your own belly has been shown to help your body relax. When you lay down for bed tonight, rub your hand in a slow, circular motion as you rest your eyes. Supposedly, the feeling will soothe you enough to allow you to fall asleep.


Get In Touch With Your Inner Pavlov

If you find yourself tossing and turning all throughout the night, a little behavior modification might be in order. Similar to how Pavlov taught his dogs to salivate on command, you can teach your body to know when it’s time to fall asleep. Pick a habit, such as rubbing the tip of your nose, pulling an earlobe or squeezing your upper arm and do it each night before you fall asleep. Eventually, your body will accept this motion as a signal that it’s time for it to rest.


Replace The Glass of Milk With Cherry Juice

If you’ve been downing a glass of warm milk every night hoping it might make you more sleepy, try trading it in for a glass of cherry juice. Tart cherries are a natural source of melatonin, which helps to regulate your body’s sleep schedule. Studies have shown that a glass of cherry juice taken in the morning and night helped add an average of 90 minutes to sleep to a person’s nightly schedule, especially in older individuals.


Exercise Your Toes

This one might make you feel a little goofy, but it actually works. While lying in bed, slowly squeeze and release your toes for at a minute or two. Curling your toes actually has the effect of helping all of the muscles in your body to relax, and will release any tension in your body built up throughout the day.


Bring Back a Childhood Remedy

You probably remember your mom or dad rubbing some Vicks across your chest when you had a cold as a kid. But did you know Vicks Vaporub actually has quite a few uses, one of which is helping you to fall asleep. That’s because the decongestants in Vicks helps you breathe more steadily, lulling your body into a sense of relaxation. You can rub it onto your chest or, as we do, around the outside of your nostrils to help you relax. You can even add it to special humidifiers that contain an aromatherapy compartment to help circulate it through the air.


Roll Your Eyes Into Your Head

If all else fails you can try to make your body think that it’s already asleep. Lie back and close yours eyes, then slowly roll them backwards in your head. This mimics the actual position and movement of your eyes while you sleep, so it has been found to be effective in many situations involving insomnia.

Vicks VapoRub is a mentholated ointment made by U.S. household and personal care manufacturer Procter & Gamble.

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Originally formulated by North Carolina pharmacist Lunsford Richardson to treat his son’s croup, the salve has been around for more than 125 years.


People are still inventing uses for it — some of which are backed by solid science and others that are (so far) unstudied.


Oliver Contreras/Getty Images

What is Vicks VapoRub?

Procter & Gamble lists the following active ingredients in Vicks VapoRub:


camphor (4.7 percent)

menthol (2.6 percent)

eucalyptus oil (1.2 percent)

It also contains several inactive ingredients that may be responsible for some of its popular uses:


cedarleaf oil

nutmeg oil

petrolatum

thymol

turpentine oil

The salve has a strong menthol scent and a petroleum jelly-like texture.



Uses that have some scientific support

Doctors, researchers, and the product’s manufacturer have recommended Vicks VapoRub for the following purposes.


Relieving congestion

Vicks VapoRub isn’t a decongestant. Rather, strong menthol and camphor vapors create a cooling sensation in your nasal passages that trigger receptors in your brain to feel that you’re breathing more openly.


The results of a 2017 study, in which adult cold patients self-reported how they slept, suggest that using VapoRub can improve subjective sleep quality.


Easing cough

The National Institutes of Health (NIH) lists camphor, eucalyptus oil, and menthol as cough suppressants.


A word of caution, though: Vicks VapoRub isn’t recommended if your cough has lots of phlegm or if it’s chronic, such as with asthma or emphysema.


The manufacturer recommends that you follow these steps to maximize effectiveness for cold symptoms:


Rub a layer of Vicks VapoRub on your chest and neck only. Don’t use it near your mouth or in your nostrils.

Drape a warm, dry cloth over your head while you’re sitting upright or standing.

Loosen any clothing around your chest and throat so vapors can rise to your nose area.

Repeat, if needed, up to three times in 24 hours.

NOT ON YOUR NOSE

Avoid putting Vicks VapoRub on, in, or around your nose. Research from 2014 shows that camphor can be absorbed through your mucous membranes and is toxic, especially to toddlers and babies.

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The Food and Drug Administration (FDA)Trusted Source mandates that no over-the-counter (OTC) product can contain more than 11 percent camphor.

Never use Vicks VapoRub on children younger than 2 years old.

Vicks VapoRub can also damage the cornea, so keep it away from the eyes.

Soothing sore muscles

The NIH describes both camphor and menthol as topical analgesics, or pain relievers you rub on your skin.


Products containing camphor and menthol can create a powerful cooling sensation that may temporarily override your ability to feel the pain of sore muscles and joints.


Similar products like Biofreeze, which contains 4 percent active menthol, have helped reduce pain associated with carpal tunnel syndrome, according to research from 2014Trusted Source.


Treating toenail fungus

All three of the active ingredients in Vicks VapoRub have antifungal properties. After previous studies suggested that OTC mentholated ointments may be effective in treating toenail fungus, a small 2015 study tested the effectiveness of Vicks VapoRub against toenail fungus in people living with HIV.


The results suggested that Vicks VapoRub may be a cost-effective alternative to expensive antifungal medications, especially for those without insurance and who may be socioeconomically disadvantaged.


Not sure about using Vicks VapoRub on toenail fungus? Here are some other remedies to try.


Other uses that people report work for them

While there’s little or no research to support the following uses of Vicks VapoRub, some people have said they tried it with favorable results.


Fading stretch marks

Stretch marks are purplish, red, or white lines that appear on the skin after a period of quick growth. They most often appear around puberty and pregnancy.


ResearchersTrusted Source haven’t found evidence that any topical cream or lotion is effective in reducing stretch marks. Nevertheless, some people report success in fading stretch marks using Vicks VapoRub.


If you want a surefire remedy, you may want to try one of these three treatments:


microdermabrasion

needling (injecting collagen under the skin)

laser therapy

Training pets

Some people believe the strong scent of Vicks VapoRub can keep pets from urinating on or scratching up furniture in your home.


Dabbing a small amount of the product on the area you want to protect may keep your pet at bay, but make sure your pet can’t lick or chew the ointment off the surface.


Never put Vicks VapoRub directly on your pet’s skin.


Camphor is toxic to animals. It can cause a skin reaction, and in large enough amounts, it can cause seizures and even death.


Healing rough skin on your heels

The American Academy of Dermatology Association recommends petroleum jelly as a moisturizer, especially when used on damp skin, because it keeps moisture from evaporating.

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That may explain why some people have found Vicks VapoRub helpful for healing rough skin on the feet and heels.


But more research is needed to support the anecdotal claims about its usefulness as a treatment for dry, calloused skin on the feet.


Repelling mosquitoes

According to a 2013 reviewTrusted Source of older research, the camphor oil found in Vicks VapoRub can repel certain species of mosquitoes. This oil has also been used as an insecticide against certain types of beetles. In addition, research from 2012Trusted Source suggests that products containing menthol may also be effective against mosquitoes.


However, while natural oils may provide some defense, if you really want to keep mosquitoes away, DEET and picaridin are still the most powerful repellents.


Treating acne spots

Beauty bloggers have promoted the use of Vicks VapoRub as an overnight spot treatment to shrink pimples.


Research suggests that several of the ingredients in Vicks VapoRub are effective at healing blemishes, but other ingredients may actually worsen acne.


For example, dermatologists have recommended camphor essential oil as an acne treatment. But another ingredient in Vicks VapoRub — petroleum jelly — may cause breakouts.


The American Academy of Dermatology Association recommends against using products with petroleum jelly on acne-prone skin.


If you want to take advantage of the anti-inflammatory properties of camphor, some beauty bloggers recommend mixing a few drops of camphor essential oil with a carrier oil like jojoba and dabbing it on a blemish.


Relieving headaches

Some small studiesTrusted Source have shown that gels and ointments containing menthol may be effective at relieving headaches when applied to the base of the skull.


However, the amount of menthol in the tested products was much higher (6 percent and 10 percent) than the amount of menthol in Vicks VapoRub (2.6 percent).


So far, there aren’t any studies that support the use of Vicks VapoRub for treating headaches.


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Warnings and cautions

Health officials and the product’s manufacturer say you shouldn’t use Vicks VapoRub:


on children under 2 years old

on open wounds

under tight bandages

Other safety warnings include the following:


Store Vicks VapoRub safely out of reach of children.

Don’t heat Vicks VapoRub before you use it, as it can cause burns.

Never eat or swallow Vicks VapoRub. The ingredients are toxic when ingested.

There have been cases when Vicks VapoRub caused the skin under the nose to lighten.

There have been rare casesTrusted Source when long-term or excessive use of Vicks VapoRub caused a rare form of pneumonia.

If your cough or muscle soreness lasts longer than a week, talk with a doctor.

Frequently asked questions

Is VapoRub good for pneumonia?

Before using Vicks VapoRub for pneumonia, talk with a doctor. According to the directions on the package, you should talk with a doctor before using Vicks VapoRub for any illness with a cough that occurs with too much mucus.


Depending on the severity of your illness, it may also be unsafe to use topical products containing menthol. These products can trick your brain into thinking you’re breathing more easily than you are. This can lead you to avoid seeking medical care for breathing trouble when you need it.

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Is it OK to use Vicks VapoRub with COVID-19?

Products containing menthol are not recommended for people with COVID-19. Menthol can trigger receptors in your brain that make you feel as though you’re breathing more clearly than you are and can lead you to underestimate the severity of your symptoms. This may result in delaying necessary medical treatment.


If you’re experiencing trouble breathing due to a SARS-CoV-2 infection, it’s best to talk with a doctor about treatment options. Do not use off-label medications for treating an infection with the coronavirus.


What does putting Vicks on your feet do?

Some people claim that putting Vicks VapoRub on your feet can help with cold symptoms. However, there isn’t any scientific evidence to support this theory. The manufacturer’s guidelines say to apply the product to your chest.


Menthol and camphor, two of the active ingredients in VapoRub, may help soothe your muscles by acting as a topic anesthetic, according to the NIH. Applying Vicks to your feet may help soothe sore muscles.


Can Vicks hurt your lungs?

Long-term misuse of petroleum-based oils like Vicks VapoRub can cause a rare form of pneumonia called exogenous lipoid pneumonia (ELP)Trusted Source when applied to the nose or nostrils.


Though uncommon, ELP has occurred in patients who have used mineral oil or petroleum-based lubricants and decongestants, like petroleum jelly (Vaseline), Vicks VapoRub, and lip gloss, frequently and over a long period of time.


Symptoms of ELP can include:


cough

difficulty breathing

chest pain

fever

When applying Vicks VapoRub, be sure to follow the manufacturer’s instructions and apply it to your chest or throat. Don’t apply VapoRub to the nose or nostrils or near the mouth.


Does Vicks VapoRub help with breathing?

Vicks VapoRub releases vapors of menthol, eucalyptus, and camphor that can soothe nasal passages. This can trigger receptors in your brain that make you think you are breathing more clearly. But VapoRub isn’t a decongestant.


Studies have shown that using Vicks VapoRub according to the instructions on the package may help improve sleep quality.



The bottom line

Vicks VapoRub has been a medicine cabinet staple for more than 125 years. Although it’s not listed as a decongestant, there’s solid research behind using the product to get relief from a stuffy nose or cough.

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There’s also evidence that the camphor, eucalyptus oil, and menthol in the ointment make it a good choice for relieving muscle and joint pain. And a couple of studies found that it works to stamp out fungal infections in toenails.


Vicks VapoRub is also a popular choice for people trying to fade stretch marks, heal rough skin, treat headaches, and keep outdoor bugs away.


It’s been tried as an acne treatment, but other products may work just as well without risking the irritation some of its ingredients can cause.


Some people have used the strongly scented ointment to keep pets from peeing on or scratching furniture, but be careful using this training method. The ingredients in Vicks VapoRub can be dangerous for animals.


Vicks VapoRub is generally safe for use on older children and adults. Don’t use it on children younger than 2 years old, as it can cause serious health concerns for them.

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