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Results from a phase II clinical trial indicate that psilocybin, a hallucinogenic chemical found in certain mushrooms of the genus Psiloybe, may benefit individuals with cancer and major depression. Trial participants treated with psilocybin not only experienced a lessening of depressive symptoms but also spoke highly of the therapy when interviewed at the end of the trial. The findings are published by Wiley in two articles appearing online in CANCER, a peer-reviewed journal of the American Cancer Society.

By binding to a specific subtype of serotonin receptor in the brain, psilocybin can cause alterations to mood, cognition, and perception. Psilocybin is currently classified as a Schedule I drug-defined as having no accepted medical use and a high potential for abuse-and is not approved by the US Food and Drug Administration for clinical use. However, multiple randomized controlled trials have demonstrated the safety and potential efficacy of psilocybin-assisted therapy-which combines psilocybin with psychological support from trained therapists-to treat major depressive disorder. Additionally, ongoing research is looking into the use of psilocybin-assisted therapy for various other mental health conditions, such as anxiety, addiction, and post-traumatic stress disorder.

In this latest phase II open-label trial involving adults with cancer and major depression, 30 participants at Sunstone Therapies in Rockville, Maryland received a single 25 mg dose of synthesized psilocybin plus a 1:1 session with a therapist and group therapy support.

“This study was differentiated by its group approach. Cohorts of 3-4 patients were simultaneously treated with 25 mg of psilocybin in adjacent rooms open at the same time, in a 1:1 therapist:patient ratio. The cohorts had preparation for the therapy as well as integration sessions following the psilocybin session as a group,” explained lead author Manish Agrawal, MD, of Sunstone Therapies.

Participants enrolled had moderate to severe depression scores at baseline. After eight weeks of treatment, Dr. Agrawal and his colleagues observed that patients’ depression severity scores dropped by an average of 19.1 points, a magnitude that would indicate the majority no longer experienced depression. Furthermore, 80% of participants experienced a sustained response to treatment, and 50% showed full remission of depressive symptoms after one week, which was sustained for eight weeks. Treatment-related side effects such as nausea and headache were generally mild.

“As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumor,” said Dr. Agrawal. “This was a small, open-label study and more research needs to be done, but the potential is significant and could have implications for helping millions of patients with cancer who are also struggling with the severe psychological impact of the disease.”

Dr. Agrawal is also the senior author of a second study led by Yvan Beaussant, MD, MSc, of Dana-Farber Cancer Institute that gathered input from patients in the trial during exit interviews. Participants described generally positive experiences. In terms of safety, they noted that being a part of the group calmed their fears and increased their sense of preparedness to engage in therapy. Regarding therapeutic efficacy, they felt that being connected to the group deepened and enriched their experience, ultimately contributing to their experience of self-transcendence and compassion for one another. Also, the use of both individual and group sessions was found to support the therapy in different ways. For example, the implementation of individual and group sessions allowed the therapy to remain an intimate introspective process while adding a sense of “togetherness” to it.

“As a hematologist and palliative care physician and researcher, it was profoundly moving and encouraging to witness the magnitude of participants’ improvement and the depth of their healing journey following their participation in the trial. Participants overwhelmingly expressed positive sentiments about their experience of psilocybin-assisted therapy while emphasizing the importance of the supportive, structured setting in which it took place,” said Dr. Beaussant. “Many described an ongoing transformative impact on their lives and well-being more than two months after having received psilocybin, feeling better equipped to cope with cancer and, for some, end of life.”

Before this intervention is implemented into clinical practice, additional studies should include larger numbers of patients, along with a control arm to compare its effects with other treatments or placebo.

Reference:

Manish Agrawal, William Richards, Yvan Beaussant, Sarah Shnayder, Rezvan Ameli, Kimberly Roddy, Norma Stevens, Brian Richards, Nick Schor, Betsy Jenkins, Mark Bates, Psilocybin-assisted group therapy in patients with cancer diagnosed with a major depressive disorder, Cancer, https://doi.org/10.1002/cncr.35010.

UK: A recent study published in Neurology, the medical journal of the American Academy of Neurology, has revealed that the regularity of a person’s sleep is an important factor when considering a person’s risk of dementia. 

The researchers showed that people who have very irregular sleep patterns may have a higher risk of dementia than those who have more regular sleep patterns. The study does not prove that sleep irregularity causes dementia. It only shows an association.

Sleep regularity is how consistent you are at going to sleep and waking up at the same time each day.

“Sleep health recommendations often focus on getting the recommended amount of sleep, which is seven to nine hours a night, but there is less emphasis on maintaining regular sleep schedules,” said study author Matthew Paul Pase, PhD of Monash University in Melbourne, Australia. “Our findings suggest the regularity of a person’s sleep is an important factor when considering a person’s risk of dementia.”

The study involved 88,094 people with an average age of 62 in the United Kingdom. They were followed for an average of seven years.

Participants wore a wrist device for seven days that measured their sleep cycle. Researchers then calculated the regularity of participants’ sleep. They determined the probability of being in the same sleep state, asleep or awake, at any two time points 24 hours apart, averaged over seven days. A person who sleeps and wakes at the exact same times each day would have a sleep regularity index of 100, while a person who sleeps and wakes at different times every day would have a score of zero.

Researchers then looked at medical data to identify which participants developed dementia and found 480 people developed the disease.

Researchers found links between sleep regularity scores and risk of dementia. Compared to those with an average sleep regularity index, the risk of dementia was highest for people who had the most irregular sleep.

People in the lowest fifth percentile had the most irregular sleep with an average score of 41. Those in the highest 95th percentile had the most regular sleep with an average score of 71. People between these two groups had an average sleep regularity score of 60.

After adjusting for age, sex and genetic risk of Alzheimer’s disease, researchers found that those with the most irregular sleep were 53% more likely to develop dementia than people in the middle group. For people with the most regular sleep, researchers found they did not have a lower risk of developing dementia than people in the middle group.

“Effective sleep health education combined with behavioral therapies can improve irregular sleep patterns,” Pase said. “Based on our findings, people with irregular sleep may only need to improve their sleep regularity to average levels, compared to very high levels, to prevent dementia. Future research is needed to confirm our findings.”

Pase said that although they adjusted for several factors that can affect the risk of dementia, they cannot rule out that another unknown factor may play a role in the association between sleep regularity and dementia.

Japan: Initiatin of diltiazem therapy led to pregnancy and the successful birth of a child in a woman diagnosed with severe vasospastic angina (VSA), a recent case study published in JACC: Case Reports has shown.

Chennai: The District Consumer Disputes Redressal Commission, Chennai (North), recently exonerated an Orthopaedic surgeon and a hospital from charges of medical negligence while opining that doctors cannot be held negligent for the consequences of treatment arising due to pre-existing conditions. 

Referring to relevant legal precedents, the Commission reiterated that medical practitioners would be liable only where their conduct fell below the standards of a reasonably competent practitioner in his field.

It further pointed out that in the realm of diagnosis and treatment, there is scope for difference of opinion and one professional doctor cannot be held negligent merely because his conclusion differs from that of other professional doctors. Doctors cannot be held negligent so long the doctor persons his/her duties with reasonable skill and competence.

With such opinions, the Commission exonerated a Chennai-based hospital and its Orthopaedic doctor (head of the Orthopaedics department) from charges of medical negligence while treating a patient diagnosed with comminuted intera articular supra condylar fracture of left distil femur.

After perusing the medical records, the consumer court opined that the doctor followed and adopted recognized medical procedure in respect of the surgery. Further, the Commission found that the increase in pain and the second surgery were because the complainant did not have normal shape or strength in his left leg due to pre-existing polio. Referring to this, the Commission opined that the doctor and the hospital cannot be blamed in this context and therefore they were not liable to pay the alleged medical expenses as demanded by the complainant.

The matter goes back to 2009 when the complainant sustained an injury on his left knee and was admitted to St. Isabel Hospital for treatment. He was diagnosed with comminuted intera articular supra condylar fracture of left distil femur with pain and swelling on his left knee. He was admitted as an in-patient and the head of the department of Orthopaedics in the hospital, the treating doctor, advised him to undergo surgery.

Accordingly, the doctor conducted surgery and the complainant was discharged on 12.06.2009. However, even after discharge, the pain continued and therefore the patient first consulted the treating doctor and later prof. Dr.P.V.A Mohandas at MIOT Hospitals Manappakkam, Chennai for a second opinion.

The complainant was shocked when the second doctor, after studying the X-ray, opined that the report showed a poor reduction of the fracture and therefore, he advised the complainant to have corrective surgery for realignment and knee-spanning fixation. Another doctor advised removal of entire implants assembling refixation after proper alignment of the supra condylar fracture and bone grafting. The Plan II, as advised by the doctor was that in case of deep infection, implant removal wound debridement and external fixation. Plan III was after the control of infection to plan for a definitive internal fixation and bone grafting.

Consequently, the patient was admitted to Balaji Hospitals Chennai to undergo corrective surgery on 22.06.2009 and the concerned doctor conducted the same. Under the corrective surgery after administering to the complainant spinal anaesthesia, the implant was removed and the madiel femur condyle was displaced and refixed. Then a vascular edge of shift of femur nibbled and fractured aligned and fixed with a contoured locking plate with screw. Post operative period was uneventful and the complainant was discharged from the hospital on 08.07.2009.

However, the complainant alleged that he had to pay substantial amount of money for the 1st surgery and also for the corrective surgery later which was necessitated because of gross negligence of the treating doctor at the first hospital. He demanded Rs 4,87,362.50 from the doctor and the hospital as compensation. 

On the other hand, the hospital submitted that it is a Charitable institution governed by nun sisters on a non-profitable basis. It also mentioned that the complainant was a known case of post-polio residual paralysis that had affected both his lower limbs even before the accident. Further, the hospital submitted that it did not decide to operate the very same day of admission but it was done later as a last resort attempt to extend the flexed knee.

It claimed that the nature and probable consequence of the surgery was explained to the complainant who was convinced that it was only an attempt to provide relief to the complainant from not only what he had sustained as a result of the alleged injury but also from what he had been suffering from prior to the fall.

As per the hospital, the patient was advised non-weight bearing knee brace and a review after 6 weeks and the requirement for a further review was also mentioned in the discharge summary which the complainant did not follow.

The treating doctor informed the consumer court that the complainant suffers from post polio residual paralysis of both legs with approximately 90 degree fixed flexion of the knees due to which he will not be able to straighten his legs at all.

He further submitted that as a reputed Orthopaedic surgeon, he was of the opinion that surgery should be done to correct the flexion deformity in the knee on the left leg to the maximum extent possible and due to pre existing polio the affected bone in his left leg does not have normal shape or strength. He also informed that the consequences of surgery were informed to the complainant prior to surgery and post operative pain is a common one and it takes time to for the fracture to heel.

Further, the doctor contended that he cannot be blamed for different opinions among professionals and further contended that the second treating doctor in no manner decry the earlier surgery it find fault with the same and the opinion of Dr Mohandass was based on X-ray showing poor reduction of fracture. The treating doctor opined that Dr. Mohandass’s opinion was misplaced since the complainant at no point in time had normal anatomy.

He further claimed that his attempt was to achieve flexibility in the complainant’s lower limb in the left leg so as to make the patient to stand up and the surgery done by him has been of the highest order and comparable with the services offered anywhere in the world.

After perusing the entire records and considering the arguments by both parties, the consumer court noted that the treating doctor conducted the surgery aiming at union of the fracture and to achieve strengthening of the lower limb in the left leg so that the patient  may try to stand since he was previously crawling with his knees.

Referring to the operation notes and discharge summary, the commission opined that the treating doctor

“…followed and adopted the recognized medical procedure in respect of the surgery undergone by the complainant and no fault and defectiveness in the surgery is established by the complainant or by the two other doctors who subsequently gave opinion by examining the complainant and therefore the question of negligence will not arise since the complainant fail to prove that the surgery has not be done in accordance with the normal and acceptable practice in the medical field…”

Noting the pre-existing polio of the complainant, the consumer court observed that the doctor cannot be held negligent for the consequences of the pre-existing condition of the patient and noted,

“…it is further found that the increase in pain and the 2nd surgery by Dr.L.Subramaniyan were due to the fact that the complainant does not have normal shape or strength in his left leg due to pre existing polio and for which the opposite parties cannot be blame by the complainant and hence the opposite parties or not liable to pay the alleged medical expenses of Rs.487362.50/- as claimed in the complaint.”

The Commission referred to Supreme Court order in the case of Kusum Sharma and Others versus Batra hospital and medical research centre and others and the landmark judgment in the case of Kusum Sharma and others Versus Batra hospital and medical research centre and others.

Referring to these orders, the Commission reiterated that a medical practioner would be liable only where is contact fell below that of the standards of a reasonably competent practioner in his field. It further opined that in the realm of diagnosis and treatment there is scope for difference of opinion and one professional doctor is not negligent merely because his conclusion differs from that of other professional doctors. It further reiterated that one professional doctor is not negligent merely because his conclusion differs from that of other professional doctors and negligence cannot be attributed to a doctor so long as he perform his duties with reasonable skill and competence.

Therefore, exonerating the doctor and the hospital, the Commission mentioned in the order,

“In the present complaint also the 2nd opposite party has done surgery with reasonable skill and competence and hence he cannot be held liable for medical negligence. The 2nd opposite party relied upon a decision reported in (2009) 9 Supreme Court Cases 709 and contended that without examining the expert as a witness in court no reliance can be placed on an opinion alone and hence contended without examining the two doctors who gave opinion it is not possible to come to a conclusion that the 2nd opposite party as committed medical negligence in performing surgery. The above said case is applicable to the present complaint and hence it is found after careful scrutiny of documents that the complainant failed to prove the alleged medical negligence on the part of opposite parties and hence there is no deficiency in service on the part of opposite parties.”

“Based on findings given to point.no.1 since there is no deficiency in service or medical negligence on the part of opposite parties hence the complainant is not entitled for sum of Rs.487362.50/- with interest as claimed in the complaint. Point no.2 is answered accordingly. In the result the complaint is dismissed. No cost,” it added.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/chennai-dcdrc-228131.pdf

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