Clinical challenges in Transitioning

There is a dearth of clinical knowledge and expertise in the slowly yet surely evolving field of Transgender Medicine as only lately most practicing physicians have honestly  acknowledged that they know little or next to nothing about Transitioning for these patients. But many enthusiastic and honest professionals are starting to study the clinical challenges posed by these patients and trying some specific, practical steps.

Considering that Transgender people are usually receiving treatment with exogenous hormones that alter their metabolism, the established treatment protocols might not be entirely appropriate and they must be adjusted. Moreover since the hormonal schedules are often changed in composition and dosage, the treatment of chronic ailments must be adjusted accordingly.

The use of Testosterone in the female to male transitioning schedule could worsen a previously existing endometrial neoplasia. The use of estrogens in the male to female transitioning schedule can stimulate the appearance of blood clots. The use of hormones can affect chronic neurological diseases like Epilepsy. Some studies have suggested that there is negative interaction of Estrogen with antiepileptic drugs but its extent has not been established. The control of seizures becomes more difficult as new hormones are added.Transgender people have a higher rate of HIV infections and use retro-viral medication, which can interact with the hormones in still unforeseen ways.

Sadly one of the commonest reactions of clinicians who encounter treatment difficulties in their Transgender patients is that they must immediately stop the use of hormones until further notice. The subconscious in their minds still resists the idea that Transgender people are different and they need their hormonal treatments to become fully identified with their gender of choice. The only way to surpass this obstacle is to maintain good communications between the clinicians and the experts managing the hormonal treatments. Trans patients occasionally complain that some drugs are promoting a faster metabolic degradation of the hormones in their livers, for which they cannot benefit from their full metabolic effects in their Transitioning protocols. Instead of just dismissing those complaints, physicians should find solutions.

What do you think? Please tell us.

Don’t leave me alone.

Arnica

The name of “Arnica” comes from a Latin deformation of the Greek term “pragmique”, which is related to “pragmos” and it refers to its capacity to induce cough. It is a very ancient remedy that became very popular in the Middle Ages in Europe and then reached the Americas with the arrival of the colonists.

Arnica belongs to the genus of Asteraceae, the sunflower family of plants. It is an aromatic plant measuring 20-60 of height with simple stems and with bright yellow flowers in a star or sunflower distribution that bloom from June through august in the Northern Hemisphere. There are two original plants from Eurasia but “Arnica Montana’ is the most widely distributed. It prefers the temperate zones of sub-alpine regions and avoids strong winds; it avoids the soils with too much clay and is a fixture of the spring meadows.

Its flowers contain between o.3% and 1.5/6% of Sespquiterpene lactones that are useful in the treatment of cardiovascular diseases and neoplasia. Helenalin, one of the main sesquiterpenes found in Arnica Montana has strong anti-inflammatory properties, for which it has been used to treat the osteo-articular pain and limitation of movements for hundreds of years; it is very effective in stimulating the tissue regeneration in local inflammatory processes like arthritis or trauma. It is not an edible plant as it can be very toxic in large quantities. It is used as the main ingredient of creams and tinctures that are applied topically to skin; it is found in many homeopathic preparations. A scientific study found that applied topically it can have the same curative effect as Ibuprofen, a strong anti-inflammatory medication.

A few weeks ago I was suffering badly from my injured left knee—I had fallen from a horse almost twenty years ago and the resulting trauma has produced arthrosis of the joint—and I was limping badly. Blanca, a gentle nurse form Peru that works in my office saw my distress and offered help. She asked me to lay my bare knee on top of my desk and proceeded to apply a tincture of Arnica that her husband had recently brought from Lima. I cannot fully explain the almost instantaneous relief that I felt with it; its balsamic properties extended to my irascible mood at the time. The curative effect lasted for at least 5-6 hours, which enabled me to function adequately. Thank you dear Blanca.

Alleluia!

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Cannabis in Parkinson’s Disease – Part II

Physicians’ reports, patient surveys and clinical studies have indicated that Cannabis may help alleviate the motor and non-motor symptoms in chronic Parkinson’s Disease as we have discussed in a previous post.However the lack of properly designed clinical trials for Cannabis, and its derivatives like CBD, has limited its acceptance by the medical community.

Two big studies presented in the “21st International Congress of Parkinson’s Disease and Movement Disorders” evaluated the effects of oral cannabidiol (CBD) and inhaled Cannabis in patients that had Parkinson’s Disease.

Dr. Maureen A. Leehey et al. from the University of Colorado in Aurora carried on a phase II, open-label, dose –escalation study to determine the safety and efficacy of Epidiolex (a commercial form of CBD) in humans. The study included 13 volunteers—without a history of drug or alcohol dependence or took cannabinoids in the previous 30 days—who were treated with 5, 7.5, 10, 15 and 20 mg/kg/day doses of CBD for 31 days; they ere evaluated at triage, baseline and 31-days treatment. The adverse effects were usually mild to moderate: fatigue, diarrhea, somnolence, rising liver enzymes and dizziness. Only seven patients finally completed the treatment.

The “Unified Parkinson’s Disease rating scale” (whose acronym is UPDRS) is a comprehensive rating scale for patients with PD that includes:

  1. alterations of intellectual function
  2. alrerations of cognitive function
  3. depression
  4. motivation-initiative
  5. language
  6. salivary function
  7. swallowing
  8. writing
  9. cut the food and handling cutlery
  10. personal grooming
  11. personal hygiene
  12. behavior in bed
  13. falls
  14. gait
  15. tremor
  16. sensory symptoms

For each item the rating scale goes from 0 (no abnormalities) to 4 (presence of abnormalities) The mean total UPDRS score decreased from 45.9 at baseline to 36.4 at the last visit; the UPDRS motor score decreased from 27.3 to 20.3. Mean rigidity subscore significantly decreased from 9.14 to 6.29. Some patients stated that their pain and irritability have also decreased.

Dr. Laurie K. Mischley et al, from the Bastyr University Research Institute, studied the effects of inhaled cannabis (Epidiolex) on the tremors of PD patients by using motion sensors and interviewing the patients themselves. The participating patients wore a device to monitor their movements for two weeks and they logged their impressions in a daily journal. The sensors registered the frequency and amplitude of the parkinsonian tremor during the wakeful state; the patients pressed a button each time they took the drug.

In this study the duration and the magnitude of the tremor was compared one hour before and hour after the inhalation of Epidiolex; after the study ended the patients responded a few questions about their impressions of the effects. Four patients that took more than 10 doses and had a tremor more than 2% of the time in the hour before the use of Epidiolex, showed decreased tremor in the hour after they took the drug. The monitored data showed that the effect might have lasted up to three hours after the use of Epidiolex. In the follow-up, 9 out of the 10 participants said their symptoms had ameliorated. The side effects included: sleepiness, short-term memory loss and dry throat. An unexpected but useful collateral effect was the improvement of sleep.

What do you think? Please tell us.

Don’t leave me alone.

Cannabis in PTSD – Part II

“In spite of his family’s pampering, Bobby felt strange in civilian life. Preceded by the slap on his face of a freezing wind —stinking of diesel fuel, spent gunpowder and suffocating sand—a recurring image haunted his sleep.

The troubling, taciturn hitchhiker—smelling of mirth and holding a sharp scythe—hops into their patrolling Humvee at the camp’s gate. Clad with a paltry poncho, he silently squats in a corner. Waiting.

-“WATCH OUT FOR IDES,” Bobby yelled. “One hit—you’re toast.”

-“Easy,” William Senior said coming to his bedside. “I’ll bring a snack—“ He came back shortly holding a tray with two glasses of milk and cookies.

-“We booked a predator-hunting trip out West. Want to saddle up, Cochise?”

In my novel, Bobby, the main character’s high school sweetheart, suffers from PTSD after spending several tours of combat in Iraq and Afghanistan. Many active duty American servicemen and veterans have this disease, which has been properly recognized as such and is being studied at present.

The web page of the “Veterans for Medical Cannabis Access” says, “despite the anecdotal evidence to the contrary, most of the experimental studies that have been conducted so far indicate that by and large the administration of exogenous cannabinoids such as vaporizing therapeutic cannabis may not be the most reliable nor effective means of utilizing the eCB system to treat anxiety and aversive memories such as those formed in PTSD.” They advocate the investigation of other mechanisms to limit the eCB breakdown, which coupled with the extinction/habituation therapy might alleviate PTSD.

Considering the humongous amount of human and material resources that the U.S. military has been deploying worldwide, it is certainly not too much asking that they assign a fraction to PTSD’s scientific and clinical research.

One of the most pressing issues for the veterans with grave symptoms of PTSD is the unrelenting persecution of some authorities in a few states when one of them is caught consuming or, worse, planting some marijuana in their backyard for their consumption. In the “First Southeast Cannabis Conference and Expo of South Florida” held at the Fort Lauderdale Convention Center on June 10, 11 2017, Attorney Michael Minardi gave a good presentation about the legal challenges and remedies in these prosecutions. He said that the dismissal of these cases must be based on proving “the medical necessity’ of this act. However he gave several examples of harrowing ordeals veterans had to go through.

The soldiers that carry the defense of the realm deserve an equitable redress.

What do you think? Please tell us.

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Cannabis in PTSD – Part I

We can still remember that great scene in Oliver Stone’s “Platoon” movie where the stressed-out grunts dance in their tent while passing around a bamboo pipe. The association of marijuana with the U.S. military dates back to the Vietnam War where it was a good, ready solace for the terrified and tired soldiers in the field.

The diagnostic term “Post-Traumatic Stress Disorder” (PTSD) refers to a series of psychiatric symptoms secondary to an unusually stressful/traumatic emotional event, a common occurrence in the military. The fifth edition of the “Diagnostic and Statistical Manual” (DSM) has these criteria categories:

  • Criteria A: the person was exposed to death, threatened death of threatened serious injury or sexual violence by direct or indirect ways.
  • Criteria B: the traumatic event is consistently experienced.
  • Criteria C: avoidance of trauma-related stimulation after the trauma.
  • Criteria D: frequent thoughts or feelings that began or worsened after the trauma.
  • Criteria E: trauma related arousal and activity that began or worsened after the trauma.
  • Criteria F: symptoms last greater than one month.
  • Criteria G: creates distress or functional impairment.
  • Criteria H: symptoms are not due to medications, drug abuse or medical illness.

The PTSD complex can include the syndromes of Depersonalization (observers consider that the individual is dreaming) and Derealization (the individual feels things that do not have an external stimuli) Exposure to high explosive blasts account for a considerable number of PTSD cases, for which physicians must always suspect and rule out structural brain changes before using the PTSD label as a primary psychiatric – not physical disorder.

In PTSD there is an endocannabinoid deficiency, as the body does not produce enough to fill all the brain receptor sites; by replenishing them, the CB-1 signals deactivate the traumatic memories, avoiding the impaired fear extinction, aversive memory consolidation and chronic anxiety of PTSD. Cannabis can produce acute anxiety reactions and panic attacks, especially in individuals not used to THC. Is it an adjuvant cause or a needed relief?

A paper by the “National Center for PTSD” said that the effects of cannabis use vary according to the concentration and potency of the cannabinoids. “The concentration of THC in the marijuana plant can range in strength from less than 1% to 30% based upon strain  and cultivation methods…Cannabis extract products, such as waxes and oils, have been produced and sold in which the concentration of THC can be as high as 90%.” Even though the prolonged use of Cannabis may reduce the worst symptoms of PTSD, it can produce a steady physiological tolerance and eventually drug addiction.

We will continue this discussion in an upcoming second part of this article.

What do you think? Please tell us.

Don’t leave me alone.

Cannabis in Epilepsy

There is an increasing interest in the use of marijuana products to treat grave neurological disorders like Parkinson’s disease and Multiple Sclerosis. However the American Academy of Neurology (AAN) has said in a position statement that anecdotal evidence is not enough to support this use because:

  1. Its efficacy is not supported by properly conducted clinical trials
  2. Its clinical safety is still being questioned for long-term use
  3. Its interaction with prescription medications is still unknown

The AAN has requested the reclassification of marijuana-based products from their current Schedule 1 status according the DEA guidelines in order to allow its use under International Review Board (IRB) clinical protocols. This administrative step is especially needed to protect the investigators who study patients with grave diseases and/or children with vulnerable brains. Most of the standardized preparations used in clinical trials are not available in the USA and the results cannot be extrapolated to non-standardized weed. Moreover most marijuana products sold in the USA are not controlled by any federal agency, for which they may not contain the labelled ingredients.

Epidiolex is a purified, 99% oil-based Cannabidiol (CBD) product that delivers known and consistent amounts of drug in each dosage; the FDA has given selected Epilepsy centers the permission for its “compassionate use” in some the 30% of patients who do respond to the traditional therapies. An open-label study—without a placebo control—of this drug that included 214 patients aged 2 to 26 years old with epilepsy refractory to currently available treatments showed that seizures decreased an average of 54% in the 12 weeks. Patients taking Onfi had a better response than those who did not. Two studies of the use of Epidiolex in the Lennox-Gastaut syndrome and the Dravet syndrome have recently been completed with encouraging results.

The most common side effects observed in the 214 people were: sleepiness (21%), diarrhea (17%), fatigue (17%) and decreased appetite (16%). The safety data from the trials with epileptic children had similar side effects.

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Cannabis in Multiple Sclerosis

As Marijuana is being considered as an adjuvant in the treatment of several neurological diseases to relieve the spasticity, tremors and insomnia, there is still disagreement as to whether it is indeed helpful in Multiple Sclerosis. In contrast to the advanced age of most patients with Parkinson’s disease, MS usually starts in earlier stages of life with crippling personal consequences. Some scientific studies have attempted to solve the clinical controversies.

In one study participants with a stable stage of their MS were divided into two groups of 144 people that received a Cannabis extract and another one of 135 people who received a placebo before and after three months of treatment, their perception of changes in their muscle tone was recorded. The muscular hypertonicity improved two fold in the group taking cannabis; the most frequent adverse events were urinary tract infections and dizziness.

In a 2011 European clinical study Naxibimols—an oral spray derived from Cannabis—were used to improve the spasticity of MS patients with good results that heralded its approval for use in many countries, except the USA.

In 2005 630 patients with stable stage of MS from 33 specialized centres in the United Kingdom were randomly assigned to receive THC or a placebo for fifteen weeks. Patients receiving marijuana reported improvements in pain and spasticity, which could not be confirmed by standardized testing.

Oral dosage of Dronabidol—a synthetic Cannabis derivative—was used to treat a particularly aggressive type of MS: the progressive-relapsing form; the drug did not have a significant clinical effect on progression of the MS.

In 2014 the American Academy of Neurology released a report on Cannabis use in neurological disorders, which stated that the use of oral cannabis extract and synthetic THC might be effective in the treatment of spasticity. The use of the oral spray Sativex might be helpful in the treatment of spasticity, pain and urinary frequency, with dizziness as a collateral effect.

As many more states approve the use of marijuana for medical purposes in the USA, other properly designed clinical studies will be implemented.

What do you think? Please tell us.

Don’t leave me alone.