A  CLINICA L  STUDY

CONDUCTED BY
Charan Chadha

The Effects of High Phenolic Extra Virgin Olive Oil on Chronic Pain, Inflammation, and Osteoarthritis





About Olives and Olive Oil

Olive (Olea Europaea) is a tree with edible fruit, leaves, and seeds. Olive oil comes from the olive fruit and contains monounsaturated fatty acids.

Fatty acids in olive oil seem to decrease cholesterol levels and have anti-inflammatory effects.

Olive oil is commonly used in foods. As medicine, people most commonly use olive oil for heart disease, diabetes, and high blood pressure. It is also used for high cholesterol, cancer, memory and thinking skills, migraine, obesity, and many other conditions, but there is no good scientific evidence to support many of these other uses.

Don’t confuse olive oil with olive. These are not the same.

Purpose


This study was done to understand if we can use a “food” source of high phenols to help with
reducing pain and inflammation while also improving function and lifestyle without all the side effects that prescription and non-prescribed medications have.





Some Statistics for Context


Chronic Pain and Inflammation are a pervasive part of our health care system and those suffering from form these conditions often seek medical attention from various resources including but not limited to medical doctor, chiropractor, physical therapists, massage therapists, and other health care professionals.
They are often treated with a course of prescription medications, over the counter medications, injections, surgeries and so on.

During 2021, an estimated 20.9%  of U.S. adults (51.6 million persons) experienced chronic pain,
and 6.9% (17.1 million persons) experienced high-impact chronic pain (i.e., chronic pain that results in substantial restriction to daily activities.)

Osteoarthritis


Based on data from the National Health Interview Survey (NHIS), during 2016 – 2018, an estimated
58.5 million US adults (23.7%) had ever been told by a doctor (doctor-diagnosed) that they had some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia.
•By 2040, an estimated 78.4 million (25.9%) US adults aged 18 years or older are projected to have doctor-diagnosed arthritis (BRFSS).4
•Arthritis limits the activities of 25.7 million US adults. Around 44% of adults with doctor-diagnosed arthritis had arthritis-attributable activity limitations during 2016 – 2018 (NHIS).1
•In 2013, the national costs of arthritis were $304 billion overall.8
•Arthritis-attributable medical costs were $140 billion.8
•Arthritis-attributable lost wages were $164 billion.




Prevalence by Age


•Arthritis affects adults of all ages and prevalence of arthritis increases with age. From 2016 to 2018 in the United States (NHIS):
•7.1% of adults 18 to 44 years old reported arthritis.1
•Among adults aged 45 to 64 years, nearly one-third (30.5%) reported doctor-diagnosed arthritis.1
•(50.4%) reported doctor-diagnosed arthritis.1

Falls and Fall Injuries


•Falls and fall injuries are an important concern for adults with arthritis.
•In 2012, compared to adults aged 45 years and older who do not have arthritis, adults
45 years and over with arthritis were (BRFSS):
•4 times more likely to have two or more falls.7
•5 times more likely to have a fall injury.7


Data from the National Health and Nutrition Examination Survey


In 2015–2018, 10.7% of U.S. adults aged 20 and overused one or more prescription pain medications (opioid or non-opioid) in the past 30 days.
In 2015–2018, 5.7% of U.S. adults used one or more prescription opioids.

Prescription opioid use was higher among women than men, and use increased with age.

In 2015–2018, 5.0% of adults used non-opioid prescription pain medications without prescription opioids in the past 30 days; use was lowest among non-Hispanic Asian adults.
From 2009–2010 through 2017–2018, no significant change in the use of prescription opioids was seen, but use of non-opioid prescription pain medications (without prescription opioids) increased.





Prescription Pain Medications

are used to treat pain due to injury, surgery, and health conditions, such as arthritis and cancer. While opioids may be prescribed together with non-opioid pain medications, non-pharmacologic and non-opioid- containing pharmacologic therapies are preferred for management of chronic pain, where appropriate.9
This report shows the percentage of U.S. adults who, in the past 30 days, used one or more prescription pain medications, used prescription opioid medications, or used non-opioid prescription pain medications (without prescription opioids) in 2015–2018.


In a study of more than 340 patients suffering from low back or neck pain, a team of Australian researchers found there was no difference in pain severity after six weeks between those who received opioids versus a placebo sugar pill.
The Centers for Disease Control and Prevention (CDC) recommends that practitioners not prescribe opioids as a first-line treatment for chronic back pain. The CDC recommends that healthcare providers initially treat patients with chronic back or neck pain using non-drug therapies or medications other than opioids, and opioids should be used only if expected benefits for both pain and function are anticipated to outweigh risks to the patient.

The study also states that reviews of the medical literature found “scant evidence” that opioids are effective for treating chronic back pain. Additionally, the study showed that for all types of non-cancer pain — which includes, but is not limited to, neck
and back pain — the effectiveness of opioids is about 30% for short term pain relief and did not improve physical functioning.
Side Effects of Medications


Can Vary based on each individual. Based on reports (although not all inclusive), the following have been symptoms have been identified:
•Itching
•Constipation
•Hives
•Ulcer
•Rash
•Vomiting
•Mouth or facial swelling
•Sedation
•Shortness of breath
•Increased risk for falls and fractures
•Disruptive sleep
•Several others
•Nausea

A 2015 study reports while opioids are the most prescribed painkillers in the U.S. (with more than half of regular opioid users experiencing back pain), they are not proven to help people return to work faster, nor do they improve functioning when used for treatment of an acute episode.2




Study Subjects and Medicinal Protocol

When Taken by Mouth
When taken by mouth, olive oil is commonly consumed in foods. Up to one liter of extra virgin olive oil weekly has been used safely as part of a Mediterranean-style diet for up to 5.8 years. Olive oil is usually well-tolerated. It might cause nausea in a small number of people.

As a reminder to all, the purpose of this study was to understand the benefits of phenols (Specifically
Oleocanthal along with others found in olives) on pain and inflammation as they relate to loss of function.

The study was performed over a 30-day period and included an initial thirty qualified subjects. None of the thirty subjects had reported taking high phenolic olive oil in the past for any reason. The protocol included the following;

1.Initial pain report (on an analog scale of 0-10) All subjects had to have a minimum pain of 4/10 and a maximum of 9/10.
2.All subjects had to have a medical diagnosis of chronic pain, or osteoarthritis, along with the original parameters as set out prior to study initiation.
3.All subjects had a reported loss of function in daily activities including but not limited to (walking, stair climbing/descending, golfing, tennis, sleeping and so on).
4.Subjects were required to discontinue all pain medications prior to onset of study for a
minimum of 3 days prior to study. This was done to have the body system cleared of medications that could influence the results of the high phenolic olive oil as it relates to this study.
5.All subjects followed the protocol of 2 Tablespoons (TBSP) each morning without eating for 30 minutes. This protocol was created by scientists for The World Olive Center for Health.
6.Weekly reports were provided to study researcher outlining changes (if any) in pain and or function. This would also include any other findings that were “side effects” (defined on page 6).




Results


Thirty subjects were selected for the study. There were twenty-six female subjects and 4 male subjects that qualified for the study. Ages ranged between 22-76 years old.

Two (2) subjects were disqualified during the study for varying reasons as they relate to the protocol requirements and one subject suffered an injury that required prescription medication for managing swelling.

Final subject reports included twenty-seven subjects. For the purposes of the study the final reports included pain levels and functional improvements based on the original deficits.
The percentages below are based on final sample size of twenty-seven.

Twenty-five subjects (93%)
Reported significant differences in pain levels and/or improved function. All subjects reporting pain reduction cited no need for taking any additional pain medications. In fact, they even reported that their digestive system regulated.
Three subjects (11%)
Reported a reduction of menstrual cramping that they have suffered from throughout adulthood.
Eleven subjects (41%)
Reported an increased sleep improvement citing the following examples (Sleeping longer, sleeping deeper, less frequency of getting up due to pain levels reducing).
Sixteen subjects (59%)
Reported improved stools and less constipation. Less bloating, decreased reflux symptoms.
Two subjects (7%)
Reported that they had difficulty with tolerating swallowing the 2 TBSP of olive oil but were able to complete the protocol.
One subject (3%)
Reported nausea while taking high phenolic olive oil.
Two subjects (7%)
Reported no change in pain levels but reported an increase in function.

As most Americans with chronic pain and inflammation and/or osteoarthritis can attest, their pain levels and loss of function cause them to seek out medical attention which can and often includes prescription/non-prescription medications, injections, surgeries as well as other alternative treatments.

This study was performed to understand if there are benefits of using high phenolic olive oil as a substitute synthetic or pharmaceutical medications for the managing chronic pain/inflammation or osteoarthritis.

As the results noted above, there is strong statistical data showing that the benefits of high phenolic
olive oil can reduce the pain levels and improve the function and lifestyles of humans suffering from these conditions.




Future Studies
As there were several positive side effects as it relates to sleep improvement and menstrual cramping
there were other additional benefits reported that researcher will explore as future studies.

Limitations of the Study
As most studies may include a control and/or placebo- this study did NOT employ placebo or double blind. Researcher was looking for specific subjects that may benefit from (HPEVOO).

This study instituted no pain medications prior or during the study so that the only variable was the subject of the study (High Phenolic Olive Oil). If subjects were taking medications previously, they discontinued for a minimum of 3 days
prior to study.

The study was NOT performed as a randomized double-blind study. For the purposes of clinical trial, it would be beneficial to perform a randomized double-blind study to fully recognize the benefits
of or differences between medical interventions.

The study was performed on thirty subjects. Though a good initial sample size, the next phase of the study would be performed in a greater sample size.


1. Theis KA, Murphy LB, Guglielmo D, et al. Prevalence of Arthritis and arthritis-attributable activity limitation — United States, 2016–2018. MMWR Morb Mortal Wkly Rep 2021;70:1401–1407. doi: http://dx.doi.org/10.15585/mmwr.mm7040a2 2. Duca LM, Helmick CG, Barbour KE, et al. State-specific prevalence of inactivity, self-rated health status, and severe joint pain among adults with arthritis — United States, 2019. Prev Chronic Dis 2022;19:210346. doi: http://dx.doi.org/10.5888/pcd19.210346 3. Barbour KE, Moss S, Croft JB, et al. Geographic variations in arthritis prevalence, health-related characteristics, and management — United States, 2015. MMWR Surveill Summ 2018;67(No. SS-4):1–28. doi: http://dx.doi.org/10.15585/mmwr.ss6704a1. 4. Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated projected prevalence of self-reported doctor-diagnosed arthritis and arthritis-attributable activity limitation among US adults, 2015–2040. Arthritis & Rheumatol. 2016;68(7):1582–1587. doi: 10.1002/art.39692. PubMed PMID: 27015600. 5. Barbour KE, Boring M, Helmick CG, Murphy LB, Qin J. Prevalence of severe joint pain among adults withdoctor-diagnosed arthritis — United States, 2002–2014. MMWR Morb Mortal Wkly Rep 2016;65:1052–1056. doi: http://dx.doi.org/10.15585/mmwr.mm6539a2. 6. Theis KA, Roblin D, Helmick CG, Luo R. Prevalence and causes of work disability among working-age US adults: 2011–2013. Disabil Health J. 2018;11(1):108–115. doi: 10.1016/j.dhjo.2017.04.010. PMID: 28476583. 7. Barbour KE, Stevens JA, Helmick CG, et al. Falls and fall injuries among adults with arthritis—United States, 2012. Morb Mortal Wkly Rep.2014;63(17):379-383. 8. Murphy LB, Cisternas MG, Pasta DJ, Helmick CG, Yelin EH. Medical expenditures and earnings losses among US adults with arthritis in 2013. Arthritis Care Res (Hoboken). 2018;70(6):869-876. doi: 10.1002/acr.23425. 9. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep 65(1):1–49. 2016.