CBD Study- A Wellness Rx LLC Report

CBD Study- A Wellness Rx LLC Report

WELLNESS Rx REPORT: CBD OIL

Abstract:

Objective: Hemp Oil is the newest natural remedy to hit the mainstream market. Hemp Oil is produced by extraction from hemp plants and contains over eighty compounds or cannabidiols. CBD oil is the most common extracted cannabidiol and it does not contain the cannabidiol THC or the psychoactive ingredient that produces an altered state of consciousness.

CBD oil can be taken as an edible, inhaled as a vapor, or taken as a sublingual tincture (under the tongue). Products can be pure CBD oil (isolate) or a mixture of CBD oil with other extracted cannabidiols (full-spectrum oil).

The source of the extract hemp plants is important to know especially if pesticides have been used. The final product make-up will determine bioavailability or the amount of active ingredient that enters the blood stream. The higher the bioavailability, the less product is needed to achieve results.

CBD oil works primarily by calming down the brain and spinal cord. Hence, it helps to stabilize neuro-inflammation in the brain and reduce overall neuro inflammation throughout the body. Reduced inflammation improves the immune system, increases body and mind detoxification and reduces pain.

The goals for CBD oil treatment range from reduced sickness, improved relaxation and sleep quality, improved clarity of thought, enhanced energy, reduced body pain, reduced addictive urges and treatment of chronic conditions such as epilepsy, ADHD, manic depression, Alzheimers disease and certain cancers.

While CBD oil is generally well-tolerated, and serious adverse effects are rare, it should be avoided or used with caution by high-risk groups such as pregnant women, nursing mothers, infants or patients at risk of psychosis. CBD oil is also a potent inhibitor of certain enzymes that metabolize about a quarter of all drugs. (Footnote 3).

Although over 250 different companies are now marketing CBD oil, little hard evidence has been produced to validate its effect in humans and animals. This controlled study was an attempt to address this issue.

Methods: In this study the participants were patients of Wellness Rx, a wellness center that blends traditional pharmacy with natural medicine. Participants ranged from age 6 to 88 and each presented symptoms that suggested benefits that could be realized from CBD oil use.

A total of twenty-one (21) qualified participants (footnote 1) were carefully evaluated over a period of 60 days to regulate dosage, to enhance compliance and to evaluate success. Assessment tools used were interviews and a Wellness Rx Personal Journal Questionnaire (Exhibit A).

The product used throughout the trial was pure CBD oil from Pacific Cultivation. The CBD oil was extracted from the Hemp plant by pressurized carbon dioxide (CO2), converted to a pure isolate crystal powder and mixed into a clear & tasteless tincture. The product was certified as a pure CBD isolate (995.70 mg./g) by  ProVerde Laboratories. The final tincture provided a dosage of 33.33 mg. of CBD oil per 1.0 ml.

Results/Observations:

*All patients liked presentation of product with Wellness Rx label, all found taste of product acceptable & all found under tongue administration of product with measured glass dropper easy to use.

*Finding the right patient dosage (their “sweet zone”) is critical to success. CBD oil works quickly (within 5-10 minutes) with under the tongue administration. With reverse tolerance (the more you use, the less you need), dosage was able to be adjusted to allow each patient to experience benefits (if a patient doesn’t experience benefits in a short period of time, they lose interest in product). Once benefits were realized, daily dosage was adjusted to meet individual needs with most participants taking 0.5 ml. to 1.0 ml. of CBD oil twice a day.

*Number one benefit described by patients was a calming of the body/reduced stress/improved coping skills (90% of participants) and better sleep (80% of participants). Second was improved brain health (85% of participants reported improved clarity of thought and better concentration). Third was reduced body pain (65% of participants). Fourth was using CBD oil prior to an event that historically had produced or triggered anxiety/stress or panic. Other reported benefits were specific to participant health needs such help with migraine headaches or appetite stimulation.

*Patients observed few side effects from CBD oil usage and CBD oil appears to be safe for children (under supervision), seniors (two big growth markets) & pets.

*Potential body and mind resulting detoxification from CBD oil usage should not be underestimated and patients must be aware of potential issues. 12% of participants experienced emotional detoxification (footnote 2).

*Number one indicator of success is a patients “perceived” or “real” ability to have improved coping skills. This leads to overall good outcomes (stress reduction, better sleep, more energy, better decision-making, improved brain health and improved confidence).

*CBD oil can increase the potency of a select number of prescription medications (footnote 3). One patient that was discharged from a hospital after heart surgery, was advised to discontinue use of CBD oil while taking a new calcium-blocker drug so that his blood pressure wouldn’t fall too low.

*CBD oil does hold promise in helping patients remove or reduce daily use of both prescription (i.e. benzodiazepines, sleep medications & opioids) and OTC medications (i.e. ibuprofen).

*Three study participants were asked to experiment with both the pure CBD oil and a full-spectrum Hemp Oil. All three participants expressed greater satisfaction with the pure CBD oil.

*Daily use of CBD oil appears to be needed by most patients to sustain positive benefits. The exception seems to be for patients only using CBD oil for specific situations that often produce problems (personal “triggers”) or for sleep/bad dreams as they needed.

*As CBD oil use becomes more mainstream and objective research increases, the benefits of reduced body inflammation & body detoxification could start to demonstrate expanded therapeutic benefits for patients. This could include the broad field of wellness and prevention (improved immune systems; less sleep deprivation; lower cortisol levels), chronic diseases (i.e. Crohn’s disease, allow more insulin to enter cells to reduce glucose levels for diabetics , improved management of high blood pressure or less episodes of migraine headaches), mental and behavioral health challenges (i.e. ADHP; obsessive-compulsive disorder; PTSD; autism; depression; addictions) & public health challenges (i.e. technology induced anxiety (cell phones, etc.); dementia; Lyme disease; certain cancers).

CBD Oil Study of its Effectiveness

Participants

Amount of CBD

Method of Research

Duration of Study

21 individuals ranging

from 6yo to 88yo both

Male and Female

33.33mg of CBD Oil per 1ml (most took .5ml-1ml twice a day).

Interviews and a Personal Journal Questionnaire

60 Days

Conclusion:

The use of high-quality CBD oil by motivated patients can clearly produce positive benefits in a short period of time with few side effects. Some patients, however, will not receive any positive benefits from CBD oil usage.

The high percentage of study participants that reported sustainable reduction in stress level (better coping skills; more at ease; better attitude & more energy), improved sleep, improved brain health (clarity of thought/concentration/short term memory), reduced body pain & inflammation & reduced sickness was truly extraordinary (footnote 4: Special Case Studies).  12% of participants also experienced some level of emotional detoxification.

The reported success of participants did not appear to be related to age, sex, education, culture or background.

The need to find the right CBD dosage for patients or the need to optimize one’s therapeutic use is critical to success and requires experimentation and patient compliance. The ultimate goal is to administer consistent, measurable doses of CBD oil with few side effects.

The report also suggested that daily use of a high quality CBD oil product may be needed for patients to experience sustainable benefits. If this assumption is correct, the tested CBD oil preparation exhibited an excellent safety profile for long term usage.

Different from drug therapy where high doses may produce better benefits with greater side effects, CBD oil appears to be well tolerated at higher doses without greater side effects. However, higher doses doesn’t always mean better results and will only add to the product cost. Higher doses can also increase the potency of certain prescription medications that could produce serious side effects.

This study was very promising and clearly supports the increased research of CBD oil as a low-cost therapeutic option for improving patient outcomes while reducing total health care costs

BIO OF STUDY GROUP INVESTIGATOR

Ed Ullmann, R.PH., MPA is the owner and Pharmacy Manager of Wellness Rx, LLC, an independent pharmacy in Tannersville, NY that blends pharmacy with natural medicine. Mr. Ullmann is a member of the President's Advisory Council at Albany College of Pharmacy & Health Services and he serves as an Adjunct Experiential Faculty member for the school. Mr. Ullmann has developed over 30 start-up companies, and for 16 years served as an HMO founder & CEO. He has also been a Pharmacy District Manager, a mental health director, county legislator & was owner /operator of the world-renowned Warm Mineral Springs in Florida. Mr. Ullmann was named “1994 Health Care Entrepreneur of the Year in Southern New England” by Inc. Magazine & received the CHIP Visionary Award from Sarasota County, Florida in 2007. Mr. Ullmann holds a BS degree in Pharmacy from Albany College of Pharmacy & Health Services, an MPA degree from the Maxwell School of Citizenship and Public Affairs, Syracuse University, and was a National HMO Fellow at Georgetown Medical School, Washington, D

Ed Ullmann with Intern Connie Wang from Albany College of Pharmacy

Footnotes:

1). Participants that stopped the use of the CBD Oil within days (i.e. afraid of drug testing; didn’t feel comfortable; potential drug interaction) or experienced a side effect (one participant became nauseous after 7 days of use) were not considered part of the study and were deemed non-participants.

2). Emotional detoxification refers to the elimination of negative thought patterns and subconscious behavioral patterns from the body. These emotional and mental energy blocks are stored in organ cells and cranial sacral fluid which protects the spinal cord. The effects from an emotional experience can persist in the body long after the actual event has occurred.

The release of emotional and mental energy blocks can be difficult to control especially if one is unprepared, alone or within an environment that is not conducive to the release. On the positive, most patients report positive relief and euphoria 24 hours after the release and report that the specific released emotional block does not reappear.

3). According to the FDA, CBD Oil may increase serum concentrations (make the medication more potent) of macrolide antibiotic (azithromycin; erythromycin; clarithromycin), heart medications (calcium blockers and beta blockers), cyclosporine, sildenafil (Viagra), antihistamines, anti-retrovirals, some statins (atorvastatin and simvastatin), mental health medications (benzodiazepines; SSRIs & tricyclic antidepressants, haloperidol & antipsychotics) and opioids (including codeine, hydrocodone & oxycodone).

4). Interesting Case Studies:

*17- year old male patient was having a tough time in school. Acting out, insular, GI issues, poor concentration & sleeping at school. High risk family background. After two days of usage, mother observed success. After four days, patient experienced strong emotional detoxification for over two hours. Family held each other and cried together. Day five, mother said she had her son back. Patient reported that released emotions never came back. Patient is doing much better at school and is feeling much better about himself.

*After observing above, father of participant asked if he could join study group. Patient struggles with deep anxiety issues and, until recently, rarely left his house. After a few days of CBD oil usage, patient expressed relaxation, better sleep & better coping skills. Wife observed that husband was expressing his feelings like never before. During the exit interview, patient explained that he was experiencing release of emotions daily and that released emotions were not re-appearing.

*71-year old female patient had sleeping and muscular issues. High sensitivity to drugs or natural products (CBD oil dosage was reduced).  After a week of usage, patient experienced reduced anxiety, better sleep and a profound reduction in muscular inflammation (was able to hold a pen and write letters again). Positive benefits continued throughout study period.

*26- year old female with two small children recently relocated to Tannersville. Came into pharmacy very stressful and said that her old doctor would no longer prescribe Xanax for her.  After one week of usage, patient came back to pharmacy a totally new person (happy, facial relaxation, calmness) and never made mention of need for Xanax prescription.

*Six-year old male diagnosed with ADHD and on Ritalin remained withdrawn, agitated & continued to have major trouble at school. Local primary care mid-level professional removed Ritalin after patient started to show positive effects from daily CBD oil use (0.5 ml. three times daily). Within one week of Ritalin removal, patient gained 2 & 1/2 pounds and started to become more engaged in life and experienced better concentration at school.

Unfortunately, after 3 weeks of CBD oil use, patient had a set-back and experienced old behavior. Suspended from school and placed back on an extended-release Ritalin medication. Patient continued to use CBD oil daily for calming effect and now appears in a stable condition at home and school.

*Thirty-eight year old female suffering from chronic migraine headaches used 0.5 ml. of CBD oil twice a day. Immediately patient experienced calmness and reported at the end of a 30 day period, that while she did experience occasional mild “tension headaches”, she did not experience one migraine headache.

*Sixteen year old male diagnosed with obsessive-compulsive disorder (OCD) and depression began using 0.5 ml. of CBD twice a day. As we many high-risk teenagers, mother had been carefully monitoring son’s behavior for many years with poor results. Patient was having trouble at both work and school. Mother was informed about potential problems with existing prescription medications and was asked to work closely with son’s medical team. Mother reported that son did experience a significant calming effect from CBD oil and that son noticed a difference when he stopped daily use of the CBD oil. On the exit interview, mother reported that the daily use of the CBD oil continued to be beneficial for her son and that she didn’t want to see him go back to high-risk behavior.

*The most remarkable story of the study was the impact of CBD oil on a 52-year old man who claimed to have been in a chronic state of stress most of his adult life. Never relaxed, short-tempered, angry and combative. After one day of CBD use (1.0 ml. twice a day), patient came back to store and said that he no longer recognized “who he was”. His wife said that she had her husband back again. After one month of CBD oil usage, patient reported that feelings of relaxation, better coping skills, improved sleep and better concentration continued. Patient said that he had learned how to live comfortably in this new state of consciousness.