Mediterranean diet effective nutritional option for improving chance of success in IVF

Adjuvant therapies to help infertile women conceive by IVF – especially those whose treatments have been unsuccessful in the past – are now a common feature both before and during the treatment cycle. Now, a new analysis of the evidence for many nutritional supplements and diets thought to improve outcome in IVF has concluded that adopting a Mediterranean diet during treatment would offer a single ‘straightforward approach’ with good evidence of benefit in contrast to that of a Western diet.

Evidence from studies of nine commonly used nutritional supplements was found to be inconsistent and not always of good quality. The analysis, by Professor Roger Hart, University of Western Australia and City Fertility, Perth, Australia, is published today in the peer-reviewed journal Reproductive Biomedicine Online.

He explained that the extent to which nutritional supplements are used in IVF is largely unknown. ‘Nutritional supplements are usually not prescribed,’ explained Professor Hart, ‘but bought online or over-the-counter. They’re self-medicated and solid data on usage is impossible to determine. Our information is largely anecdotal but it’s quite clear from online IVF discussion forums that they are widely used and of great public interest.’

The nutritional supplements analysed in the study were dehydroepiandrosterone (DHEA), melatonin, co-enzyme Q10 (CoQ1O), carnitine, selenium, Vitamin D, myo-inositol, Omega-3, Chinese herbs and several diets (as well as weight loss). Many were reviewed as adjuvants for poor response to previous IVF treatment, of which DHEA and COQ10 appeared in studies to have more benefit than control therapies. Similarly, there was some evidence of benefit from melatonin, but it remains unclear which patient groups might benefit, nor at which dose.

However, the evidence in favour of a Mediterranean diet is much stronger and includes several well designed randomised clinical trials, showing benefits in both embryo development and pregnancy outcome (even from a six-week intervention programme). Professor Hart explained that the common features of these favourable diets were those with high intakes of fruits and vegetables, whole grains, legumes, nuts, fish, and monounsaturated or polyunsaturated oils, but with a limited intake of highly processed foods. ‘These diets are high in B-vitamins, antioxidants, omega-3 poly-unsaturated fatty acids and fibre and are low in saturated fat, sugar and sodium,’ he said. Omega-3 fatty acids, often taken as combined preparations, are the most studied dietary fatty acids in the IVF literature, largely, said Professor Hart, because of their perceived benefits in general health and reproduction. The evidence suggests that omega-3 fatty acids ‘may be beneficial’ in improving IVF clinical outcomes and embryo quality.

Similarly, antioxidants are usually taken as combinations of supplements but evidence from one major review (of 63 antioxidant studies in reproduction) described them as of low quality and was unable to demonstrate any benefit in terms of live birth rate.

Thus, from this mass of evidence Professor Hart advised that a simple nutritional approach to assist conception via IVF would be the adoption of a Mediterranean diet. The use of COQ-10 and DHEA before starting IVF may be a useful adjunct for women who had a previously poor response to ovarian stimulation, while supplementation with omega-3 free-fatty acids may indeed improve some clinical and embryological outcomes.

Professor Hart also advised that all women attempting to conceive should be taking adequate folate supplementation and should seek the advice of their general practitioner or specialist to ensure they are in their best general health for conception.

Reference:

R.J. Hart, Nutritional supplements and IVF: an evidence based approach, Reproductive BioMedicine Online, DOI: https://doi.org/10.1016/j.rbmo.2023.103770

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Sleep Deprivation can affect our emotional health, finds study

“Slept like a baby” is most heard among people whose has a sound sleep,  however this sleep is lot among todays people where changing lifestyles and daily habit.

Sleep loss does more than just make us tired. It can undermine our emotional functioning, decrease positive moods and put us at higher risk for anxiety symptoms, according to a study published by the American Psychological Association that synthesized more than 50 years of research on sleep deprivation and mood.

“In our largely sleep-deprived society, quantifying the effects of sleep loss on emotion is critical for promoting psychological health,” said study lead author Cara Palmer, PhD, of Montana State University.

“This study represents the most comprehensive synthesis of experimental sleep and emotion research to date, and provides strong evidence that periods of extended wakefulness, shortened sleep duration, and nighttime awakenings adversely influence human emotional functioning.”

The study was published in the journal Psychological Bulletin.

Palmer and her colleagues, including co-lead author Joanne Bower, PhD, of East Anglia University, analyzed data from 154 studies spanning five decades, with 5,715 total participants. In all those studies, researchers disrupted participants’ sleep for one or more nights.

In some experiments, participants were kept awake for an extended period. In others, they were allowed a shorter-than-typical amount of sleep, and in others they were periodically awakened throughout the night.

Each study also measured at least one emotion-related variable after the sleep manipulation, such as participants’ self-reported mood, their response to emotional stimuli, and measures of depression and anxiety symptoms.

Overall, the researchers found that all three types of sleep loss resulted in fewer positive emotions such as joy, happiness and contentment among participants, as well as increased anxiety symptoms such as a rapid heart rate and increased worrying.

“This occurred even after short periods of sleep loss, like staying up an hour or two later than usual or after losing just a few of hours of sleep,” Palmer said. “We also found that sleep loss increased anxiety symptoms and blunted arousal in response to emotional stimuli.”

Findings for symptoms of depression were smaller and less consistent, as were those for negative emotions such as sadness, worry and stress.

One limitation to the study is that the majority of participants were young adults – the average age was 23. Future research should include a more diverse age sample to better understand how sleep deprivation affects people at different ages, according to the researchers.

Other directions for future research could include examining the effects of multiple nights of sleep loss, looking at individual differences to find out why some people may be more vulnerable than others to the effects of sleep loss, and examining the effects of sleep loss across different cultures, as most of the research in the current study was conducted in the United States and Europe, according to the researchers.

“Research has found that more than 30 percent of adults and up to 90 percent of teens don’t get enough sleep,” Palmer said.

“The implications of this research for individual and public health are considerable in a largely sleep-deprived society. Industries and sectors prone to sleep loss, such as first responders, pilots and truck drivers, should develop and adopt policies that prioritize sleep to mitigate against the risks to daytime function and well-being.”

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Colchicine fails to prevent atrial arrhythmia recurrence after ablation for AF, finds trial

Canada: Colchicine administration for ten days following catheter ablation reduced post-ablation chest pain and increased diarrhoea, however, it failed to reduce atrial arrhythmia recurrence or atrial fibrillation (AF)-associated clinical events, a small pilot trial showed.

“Through 14-day Holter monitoring, colchicine failed to prevent the recurrence of atrial arrhythmia after ablation (31% versus 32% with placebo; HR 0.98) nor at three months (14% versus 15%; HR 0.95),” Alexander P. Benz, Population Health Research Institute at McMaster University in Hamilton, Ontario, and colleagues reported in the study published in Circulation: Arrhythmia and Electrophysiology.

During a median follow-up of 1.3 years, the anti-inflammatory drug also did not lower the composite of cardiovascular hospitalizations, emergency department visits, cardioversions, or repeat ablations (29 vs 25 per 100 patient-years; HR 1.18).

Inflammation may promote the recurrence of atrial fibrillation after catheter ablation. Colchicine is a widely prescribed anti-inflammatory agent that has cardiovascular prevention benefits. Therefore, Dr. Benz and colleagues aimed to evaluate a short-term anti-inflammatory treatment with colchicine following AF ablation.

For this purpose, the patients scheduled for ablation were randomized to receive twice daily colchicine 0.6 mg or placebo for 10 days. The study drug’s first dose was administered within 4 hours before ablation.

Atrial arrhythmia recurrence was defined as atrial fibrillation, atrial flutter, or atrial tachycardia >30 s on two 14-day Holters performed immediately and at 3 months following ablation.

Based on the study, the researchers reported the following findings:

· The modified intention-to-treat population included 199 patients (median age, 61 years; 22% female; 70% first procedure) who underwent radiofrequency (79%) or cryoballoon ablation (21%) of AF.

· Antiarrhythmic drugs were prescribed at discharge in 75% of patients.

· Colchicine did not prevent atrial arrhythmia recurrence at 2 weeks (31% versus 32%; hazard ratio [HR]) or 3 months following ablation (14% versus 15%; HR, 0.95).

· Postablation chest pain consistent with pericarditis was reduced with colchicine (4% versus 15%; HR, 0.26) and colchicine increased diarrhoea (26% versus 7%; HR, 4.74).

· During a median follow-up of 1.3 years, colchicine did not reduce a composite of emergency department visits, cardioversion, cardiovascular hospitalization, or repeat ablation (29 versus 25 per 100 patient-years; HR, 1.18).

Limitations include small samples, recurrent arrhythmias were not looked at using implantable loop recorders that would likely result in an undercounting in both treatment groups.

“For patients undergoing catheter ablation for AF there was no signal that a brief course of colchicine reduced atrial arrhythmia recurrence or improved clinical outcomes when taken for 10 days starting right before the procedure,” the researchers concluded.

Reference:

Benz AP, et al “Colchicine to prevent atrial fibrillation recurrence after catheter ablation: a randomized, placebo-controlled trial” Circ Arrhythm Electrophysiol 2023; DOI: 10.1161/CIRCEP.123.012387.

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Cardiosphere-derived stem cells effective for treatment of pulmonary arterial hypertension

USA: Intravenous cardio-sphere-derived cells (CDCs) are safe in both the short and long term in subjects with pulmonary arterial hypertension (PAH), according to findings from Phase I clinical trial published in eBioMedicine, a Lancet journal.

CDCs are heart-derived progenitor cells exhibiting immunomodulatory and anti-inflammatory effects, are anti-oxidative, anti-fibrotic, and anti-apoptotic to potentially impact several aspects of PAH pathobiology

“Infusions of potentially therapeutic cells derived from the heart are safe for people with pulmonary arterial hypertension, a form of high blood pressure that occurs in the blood vessels of the lungs and typically affects middle-aged women,” Cedars-Sinai investigators report. 

“Although several drugs are approved for pulmonary arterial hypertension, mortality remains high,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute at Cedars-Sinai, the Mark S. Siegel Family Foundation Distinguished Professor and senior author of the study. “We tried a fundamentally different approach-cell therapy delivered into the pulmonary artery-and found encouraging results, in patients already on combination conventional therapy.”

Pulmonary arterial hypertension is a rare disease, affecting fewer than 100 people per million. There currently is no cure and the average median life expectancy on treatment for most patients is roughly 6.2 years after diagnosis.

Currently approved medications for the condition aim to open up blood vessels in the lungs, allowing for better blood flow; however, studies on lungs in patients on treatment still show severe occlusive vessel changes. Further, these medications don’t address many of the complex underlying mechanisms that cause the high pulmonary pressures. Even on medication, people with pulmonary arterial hypertension can develop severe dysfunction in the right ventricle of the heart, the part that pumps blood to the lungs and whose function correlates best with survival.

Cedars-Sinai investigators are experimenting with using cardiosphere-derived cells (CDCs) to address some of the biological processes involved in pulmonary arterial hypertension. CDCs were first developed and characterized by Marbán. They have been used in multiple clinical trials for a variety of diseases, most recently, Duchenne muscular dystrophy. These are cells derived from human heart tissue that Marbán and colleagues have discovered reduce inflammation in the body and exert beneficial effects on the immune system.

Called the ALPHA study, this clinical trial was conducted in two phases. In the first, six people with pulmonary arterial hypertension received an infusion of CDCs into their lungs. Three patients received an infusion of 50 million CDCs and the other three received an infusion of 100 million CDCs.

In the second phase, 10 people with pulmonary arterial hypertension were randomized to receive an infusion of 100 million CDCs and 10 people were randomized to receive infusions containing a placebo. Investigators performed right heart catheterization and cardiac MR imaging on each study participant before the infusions and four months after the infusions.

All the participants were on combination pulmonary arterial hypertension-specific medications throughout the course of the study.

The investigators tracked the health of participants for 12 months after the infusions. No adverse effects related to the infusions occurred during this time. Although this study was only designed to assess the safety of the CDC infusions, the investigators observed encouraging changes that might indicate the 16 people who had received the CDC infusions had improved cardiopulmonary health. People who received the infusions, for example, showed improved functioning in the heart’s right ventricle and, at two months post-infusion, were able to walk a greater distance during a six-minute test than people who received placebo.

“The most important takeaway is that this approach is safe and feasible to do in people with pulmonary arterial hypertension,” said Michael I. Lewis, MD, director of Respiratory Care Services at Cedars-Sinai, and first and corresponding author of the study. “These are encouraging exploratory findings that motivate moving on to more advanced studies.”

The investigators plan additional trials to study the effects of repeated infusions of CDCs given to people with pulmonary arterial hypertension.

Reference:

Michael I. Lewis, Shelley Shapiro, Ronald J. Oudiz, Mamoo Nakamura, Dael Geft, Yuri Matusov,The ALPHA phase 1 study: pulmonary ArteriaL hypertension treated with CardiosPHere-Derived allogeneic stem cells, DOI: https://doi.org/10.1016/j.ebiom.2023.104900

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Smartphone-based technology helps in prevention of suicidal behavior

The use of smartphone technologies could be beneficial in preventing suicide among at-risk adults, says a study conducted by investigators from Italy and Spain, published online in the Journal of Psychiatric Research.

Suicide stands among the primary causes of unnatural deaths globally. According to the WHO mortality database, suicides in the United States saw a 53% increase from 2000 to 2020 (WHO, 2022). Essential for preventing suicide is the implementation of secondary prevention strategies. Digital medicine holds the potential to address numerous mental disorders, making it a promising complement to conventional mental health care. Hence, Alejandro Porras-Segovia and the research team conducted this study to investigate the viability and acceptability of a safety plan integrated into a smartphone application.

Scientists carried out a retrospective pilot analysis to assess the practicality and approval of a safety plan incorporated into a smartphone application (MEmind) among adult patients aged 18 years and older who had recently exhibited suicidal behavior.

The key findings of this study were:

Out of the 128 participants, 82% had the safety plan integrated into their smartphones, with approximately half completing end-of-study surveys.

Over an average follow-up duration of 285 days, participants activated their safety plan an average of 9.1 times, with some opting to memorize it.

Ratings on a scale of 1 to 10 indicated a perceived usefulness of 7.4, usability of 8.9, likelihood to recommend it to others at 8.6, and satisfaction with the overall project at 9.6. Internal coping strategies and personal contact functions were identified as the most beneficial features.

Higher usefulness scores correlated with a greater likelihood of recommending the app to family or friends. Feeling sad or lonely was the most commonly reported warning sign, while walking or exercise was the frequently used coping strategy, with visits to public spaces also being popular.

Overall, participants expressed a desire for direct contact with professionals through the app. The smartphone-based safety plan, as demonstrated in this study, appears to be a practical intervention. The data gathered from this pilot study indicated elevated participation rates and strong acceptance among patients. 

Reference:

Porras-Segovia, A., De Granda-Beltrán, A. M., Gallardo, C., Abascal-Peiró, S., Barrigón, M. L., Artés-Rodríguez, A., López-Castroman, J., Courtet, P., & Baca-García, E. (2023). Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. In Journal of Psychiatric Research. Elsevier BV. https://doi.org/10.1016/j.jpsychires.2023.11.039

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Ocular imaging may provide early information on microvascular damage in PAD patients

Peripheral artery disease (PAD) is a prevalent vascular disorder associated with atherosclerosis and reduced blood flow to the extremities. Affecting 8-10 million Americans and over 200 million people globally, it is a complex condition influenced by various risk factors like diabetes, smoking, hypertension, high cholesterol, and coronary artery disease. PAD leads to structural and functional changes in the limbs, resulting in disability, decreased quality of life, increased mortality, etc.

A recent study published in Vascular Medicine concluded that a more specific biomarker for PAD is necessary due to the poor predictive value of clinical assessment. A noninvasive ophthalmic imaging technique can significantly improve the diagnosis rate without putting the patient at risk for complications. Early detection and treatment of PAD can enhance quality of life and improve clinical outcomes.
This study reviewed the current literature on noninvasive ocular imaging for the PAD diagnosis. The search included Medline, Scopus, Embase, Cochrane, and other databases, with five articles selected. Two studies used retinal colour fundus photography, one used optical coherence tomography (OCT), and two used optical coherence tomography angiography (OCTA) to assess ocular changes in PAD.
Key findings from the study are:
· PAD patients showed both structural and functional changes in the retina.
· Structural alterations were found around PAD patients’ optic disc and temporal retinal vascular arcades.
· Retinal hemorrhages, exudates, and microaneurysms, detected through color fundus photography, were associated with an increased future risk of PAD.
· The RNFL (retinal nerve fibre layer) was thinner in the nasal quadrant of PAD patients compared to age-matched healthy individuals in OCT.
· choroidal thickness in the subfoveal region was thinner in PAD patients controls.
· OCTA revealed a significant reduction in the retinal and choroidal circulation in PAD patients compared to healthy controls.
As PAD causes thinning and ischemic changes in retinal vessels, retinal imaging techniques can provide valuable information about early microvascular damage in PAD. Ocular imaging may serve as a potential biomarker for PAD.
Study limitations include a smaller number of studies, bias, only two studies using OCTA, and none of the studies investigating the association between retinal changes and disease severity.
Reference:
Prem Senthil et al. Role of noninvasive ocular imaging as a biomarker in peripheral artery disease: A systematic review. Vascular Medicine. 2023;0(0).

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J&J Gets CDSCO Panel Nod to study anti-cancer drug Talquetamab

New Delhi: The drug major Johnson and Johnson has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical study of the anti-cancer drug Talquetamab.

This came after the firm presented Phase III Clinical Study Protocol No. 64407564MMY3009.

Talquetamab is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma.

Talquetamab is an IgG4-PAA bispecific G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager. It consists of two arms – anti-GPRC5D and anti-CD3 arms – linked by two interchain disulfide bonds, each arm comprising a heavy and light chain. Talquetamab binds to GPRC5D, a cell surface receptor expressed predominantly on multiple myeloma cells, and CD3 on T cells. It works to recruit CD3-expressing T cells to GPRC5D-expressing multiple myeloma cells to induce T-cell–mediated cytotoxicity.

At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the Phase III Clinical Study Protocol of the anti-cancer drug Talquetamab presented by drug major Johnson and Johnson.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

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Use of opioids in Surgery patients declining: JAMA

Post-surgery pain relief has shifted away from opioid-containing medications over the past seven years, but the downward trend has slowed since 2020, a new study shows.

Overall, the rate of surgery-related opioid prescriptions dropped by 36% from 2016 to the end of 2022, and the average amount of opioids in those prescriptions dropped by 46%, the study of pharmacy data finds.

That combination of declines means that the total amount of opioids dispensed to surgical patients in late 2022 was 66% lower compared with early 2016, according to the findings published in JAMA Network Open by a team from the University of Michigan.

But the rate of decline was much faster before the pandemic, the researchers report after comparing surgical opioid patterns before and after 2020. That’s even after they took into account the unusual circumstances of spring 2020, when most elective surgery temporarily stopped to free up hospital capacity for COVID-19 patients and reduce unnecessary exposure to the SARS-CoV-2 virus.

Even with the overall declines, American surgery patients in late 2022 still received the equivalent of 44 5-milligram pills of hydrocodone from pharmacies after their operations on average. That’s far higher than what patients need for most procedures.

“These data suggest surgical teams have substantially reduced opioid prescribing, but also suggest that efforts to right-size opioid prescriptions after surgery must continue,” said Kao-Ping Chua, M.D., Ph.D., the senior author of the new study and an assistant professor of pediatrics at U-M. He worked with first author and former U-M research assistant Jason Zhang, who is now in medical school at Northwestern University.

The researchers also find that some types of surgeons have reduced the amount of opioids dispensed to patients more than others. For instance, reductions were particularly large in cardiothoracic surgery and ophthalmology.

Orthopedic surgeons still account for more than half of all surgical opioids dispensed to American patients, even as the rate and size of prescriptions filled by their patients dropped.

Right-sizing prescribing

The authors note that surgeons should not strive to eliminate opioid prescribing altogether.

“The goal should be to ensure that opioids are only prescribed when necessary, and that the amount of opioids prescribed matches the amount that patients need,” said Zhang. “Achieving these goals could help reduce the risk of opioid misuse, persistent opioid use, and diversion of pills to other people besides the patient.”

The potential for accidental exposure to opioids by others in the household, and interactions between opioids and other substances including alcohol and prescription drugs, are other reasons to focus on non-opioid surgical pain care.

Chua and colleagues have studied procedure-related opioid prescribing multiple times, including a recent study showing that the reduction in the rate of dental opioid prescribing has similarly slowed in recent years.

They have worked with the Michigan Opioid Prescribing Engagement Network (OPEN) to develop prescribing guidelines for adult and pediatric surgical care available at https://michigan-open.org/prescribing-recommendations

Surgical organizations and the Centers for Disease Control and Prevention have advised surgeons to rely less on opioid-based acute pain relief for their patients since the mid-2010s. But no studies have examined surgical opioid prescribing trends using pandemic-era data.

The new study is based on data from a company called IQVIA that tracks prescriptions dispensed at 92% of U.S. pharmacies.

Reference:

Zhang J, Waljee JF, Nguyen TD, et al. Opioid Prescribing by US Surgeons, 2016-2022. JAMA Netw Open. 2023;6(12):e2346426. doi:10.1001/jamanetworkopen.2023.46426.

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PG Medico Suicide Case: Kerala HC grants bail to doctor accused of dowry demands

Thiruvananthapuram: In a significant development, the Kerala High Court on Friday, approved the bail application of a doctor who had faced suspension from the Indian Medical Association (IMA) following accusations of abetting the suicide of his girlfriend.

Medical Dialogues team had earlier reported that the victim, a second-year postgraduate surgery trainee at Government Medical College, Thiruvananthapuram, took her own life after the accused cancelled their wedding plans due to alleged dowry demands.
The allegations suggest that the family of the accused had sought 150 sovereigns of gold, 15 acres of land, and a BMW car from the family of the deceased. Unfortunately, her family was unable to fulfill these demands, leading to the tragic incident. Subsequently, the IMA suspended the accused doctor’s medical license for his alleged involvement in abetting the suicide.

The accused has been charged with offenses under Section 306 IPC (‘Abetment of Suicide’) and Section 4 of the Dowry Prohibition Act (‘Penalty for demanding dowry’). The bail plea was considered by Justice Gopinath P, who, taking into account the accused’s custody since December 7, 2023, concluded that further detention was unnecessary for investigative purposes and allowed for his release on bail, reports LiveLaw

“The allegations against the petitioner are no doubt serious. I had also observed while granting bail to the 2nd accused in the case (Ruvais’ father), that there are clear allegations against the petitioner in the suicide note recovered from the apartment where the deceased was staying. However, as rightly pointed out by the Senior Counsel appearing for the petitioner, a condition under Section 306 IPC can be sustained only if there are clear indications that the petitioner had the mens rea to drive the deceased to suicide, and the actions of the petitioner had left the deceased with no option but to commit suicide,” the Court observed.

The Court had previously granted anticipatory bail to Ruwais’s father, who was also named as the second accused in the case. In the bail application presented by Advocate Nireesh Mathew on behalf of the accused, it was asserted that there was no substantial evidence linking him to the alleged offense. He argued that the relationship between him and the victim had reached a stage where they started talking about a marriage proposal. However, his father had suggested delaying the marriage until the completion of education, a proposal that the victim found unacceptable. The petitioner contended that the victim was pressuring him to marry her against his father’s advice, a decision he chose not to follow. The doctor refused to accept that any conversation regarding any kind of dowry ever took place between the two families. 

The counsel for the accused further argued that the suicide did not result from immediate provocation or instigation, as required by Section 306 IPC. He asserted that he had no intention to harm the victim but had genuinely expressed his desire to marry her. During the hearing, the potential damage to his career and future and the seizure of his belongings, including a laptop and car has also been highlighted. To continue studying alone, he requested bail, even with strict terms attached, such as his inability to leave the College and hostel grounds, reports The Daily. The accused also stated that the doctor should not have taken such a cruel step thoughtlessly. 

The prosecution argued that decisions regarding the accused’s reinstatement in service should be made by the Disciplinary Committee in consultation with the Department of Health, Government of Kerala, and the Kerala University of Health Sciences. The prosecution stressed that the petitioner’s desire to continue his studies was insufficient grounds for bail, as the decision on his course continuation remained pending.

After careful consideration, the Court made it clear that the doctor’s request for bail could not be seen as an entitlement to reinstatement; rather, it should only be resolved in compliance with the relevant legislation, even though the Court granted him a request, it is subjected to certain conditions and regulation. 

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Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation

New Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Zydus Healthcare to conduct a bioequivalence study (BE) of Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation.

This came after Zydus Healthcare presented a proposal along with BE protocol and justification for clinical trial waiver before the committee.

Glycopyrrolate is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia. Glycopyrrolate is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long-acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications. Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5.

Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.

Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD.

At the recent SEC meeting for Pulmonary held on 5th December 2023, the expert panel reviewed the proposal along with the BE protocol and justification for CT waiver of the FDC Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation presented by drug major Zydus Healthcare.

After detailed deliberation, the committee recommended that the firm should conduct a BE study.

In addition, the expert panel stated, “Clinical trial waiver was not considered at this stage.”

Following the above the committee suggested to the firm that the result of the BE study should be presented before the committee for review.

Also Read: Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC

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