Could poor sleep in middle age speed up brain aging?

People in early middle age who have poor sleep quality, including having difficulty falling or staying asleep, have more signs of poor brain health in late middle age, according to a study published in the October 23, 2024, online issue of Neurology®, the medical journal of the American Academy of Neurology. The study does not prove that poor sleep accelerates brain aging. It only shows an association between poor sleep quality and signs of brain aging.

“Sleep problems have been linked in previous research to poor thinking and memory skills later in life, putting people at higher risk for dementia,” said study author Clémence Cavaillès, PhD, of the University of California San Francisco. “Our study which used brain scans to determine participants’ brain age, suggests that poor sleep is linked to nearly three years of additional brain aging as early as middle age.”

The study included 589 people with an average age of 40 at the start of the study. Participants completed sleep questionnaires both at the beginning of the study and again five years later. Participants had brain scans 15 years after the study began.

Researchers reviewed participants’ responses to questions such as, “Do you usually have trouble falling asleep?” “Do you usually wake up several times at night?” and “Do you usually wake up far too early?” They recorded the number of six poor sleep characteristics for each participant: short sleep duration, bad sleep quality, difficulty falling asleep, difficulty staying asleep, early morning awakening and daytime sleepiness.

Participants were divided into three groups. Those in the low group had no more than one poor sleep characteristic. People in the middle group had two to three, and those in the high group had more than three. At the start of the study, about 70% were in the low group, 22% were in the middle and 8% were in the high group.

Researchers examined participants’ brain scans where the level of brain shrinkage corresponds to a specific age. Researchers used machine learning to determine the brain age for each participant.

After adjusting for factors such as age, sex, high blood pressure and diabetes, researchers found people in the middle group had an average brain age that was 1.6 years older than those in the low group, while those in the high group had an average brain age 2.6 years older.

Of the sleep characteristics, bad sleep quality, difficulty falling asleep, difficulty staying asleep and early morning awakening were linked to greater brain age, especially when people consistently had these poor sleep characteristics over five years.

“Our findings highlight the importance of addressing sleep problems earlier in life to preserve brain health, including maintaining a consistent sleep schedule, exercising, avoiding caffeine and alcohol before going to bed and using relaxation techniques,” said author Kristine Yaffe, MD, of the University of California San Francisco and a member of the American Academy of Neurology. “Future research should focus on finding new ways to improve sleep quality and investigating the long-term impact of sleep on brain health in younger people.”

A limitation of the study was that participants reported their own sleep problems and it is possible they may not have reported them accurately.

Reference:

Clémence Cavaillès, Christina Dintica, Mohamad Habes, Association of Self-Reported Sleep Characteristics With Neuroimaging Markers of Brain Aging Years Later in Middle-Aged Adults, Neurology, https://doi.org/10.1212/WNL.0000000000209988.

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Oral Tranexamic Acid Promising in Treatment and Prevention of Post Inflammatory Hyperpigmentation: Study

Researchers have found traditional use of oral tranexamic acid (TXA) as an agent to control excessive bleeding and it is now becoming a safe and effective option to treat post inflammatory hyperpigmentation (PIH). A recent study was published in the journal Dermatologic Surgery by Minasyan and colleagues..

Postinflammatory hyperpigmentation is a common cutaneous disorder due to exaggerated inflammation or injury that results in abnormal pigment deposition in the skin. Although it has long been known as a treatment for melasma, oral TXA is increasingly being considered as an effective treatment of PIH. Indeed, PIH has emerged as one of the most common complications following various skin treatments, including laser-based therapies. Thus, the demand for effective prevention and treatment of PIH is high.

The review was aimed to identify the mechanism of oral TXA in the treatment of PIH and further investigation of its role in preventing PIH associated with laser-based or light-based therapy. The rationale behind this was the collection of data from available studies between 2000 and 2023 that could shed insight into the effectiveness and safety profile of TXA in the context of PIH.

To gather comprehensive data, researchers conducted a systematic review of literature published in the databases such as Cochrane Library, PubMed, Embase, and Google Scholar. The review was conducted using articles that may discuss oral tranexamic acid for the treatment or prevention of PIH and included all studies from 2000 up to now.

The results gathered include data from clinical trials and observational studies that provide an overview of the potential therapeutic outcome of the TXA.

  • All the reviewed studies show improvement of patients treated with oral TXA in post inflammatory hyperpigmentation; these improvements include a decrease in the areas and the skin tone overall.

  • There were decreased incidences of developing new PIH lesions with TXA used in conjunction with laser or light therapies. Prophylactic use of TXA was associated with lower rates of PIH development subsequent to these therapies.

  • TXA was in general, well tolerated with fewer adverse reactions. No major side effects were ever reported and the results of the studies reviewed did not show any indication of dangerous side effects, hence presenting proof of the safety of the drug in terms of using it to treat PIH.

Oral tranexamic acid has proven to be safe and effective as a treatment for PIH with marked improvements without significant side effects. Its effectiveness in the prevention of PIH is also seen when combined with laser and light-based treatments for different skin disorders, in which case it would be an exciting tool for dermatology practice. With the significant additional research that will be conducted to confirm its effectiveness, TXA will play a major role in the prevention and treatment of disorders such as hyperpigmentation, particularly in skin of color.

Reference:

Minasyan, M., Hogan, S., & Lal, K. (2024). Oral tranexamic acid for prevention and treatment of postinflammatory hyperpigmentation. Dermatologic Surgery, 10.1097/DSS.0000000000004400. https://doi.org/10.1097/dss.0000000000004400

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OPTIMAS Trial Challenges Guidelines: Early Anticoagulation Safe After Ischemic Stroke in Atrial Fibrillation

UK: In a recent study known as OPTIMAS, researchers have found that initiating direct oral anticoagulants (DOACs) within four days of an ischaemic stroke associated with atrial fibrillation is as safe as delaying treatment. The findings were published online in The Lancet.

This multicentre, phase 4, randomised controlled trial involving blinded endpoints revealed that starting DOAC therapy within four days following an ischemic stroke related to atrial fibrillation (AF) showed comparable safety to delayed initiation, with no significant difference in the composite outcomes of ischemic stroke, intracranial hemorrhage, unclassifiable stroke, or systemic embolism at 90 days.

Traditionally, guidelines have recommended postponing the initiation of anticoagulation therapy following an ischaemic stroke. This cautious approach aims to mitigate the risks of potential complications, such as further strokes or intracranial hemorrhages.

“Our findings challenge the widely accepted practice and guidelines that recommend delaying DOAC initiation following an ischemic stroke in patients with atrial fibrillation,” the researchers wrote.

Prof David J Werring, University College London Queen Square Institute of Neurology, London, UK, and colleagues examined the efficacy and safety of starting DOACs early versus delaying their initiation in patients experiencing acute ischemic stroke related to AF.

For this purpose, the researchers conducted a multicentre, open-label, blinded-endpoint, parallel-group, phase 4 randomized controlled trial at 100 UK hospitals. Adults with atrial fibrillation and a clinical diagnosis of acute ischemic stroke, whose physicians were uncertain about the timing of DOAC initiation, were included. Participants were randomly assigned (1:1) to receive anticoagulation either early (≤4 days post-stroke) or delayed (7–14 days).

While participants and clinicians were aware of treatment assignments, outcomes were adjudicated by a masked independent committee reviewing clinical records and imaging reports. The primary outcome measured was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, unclassifiable stroke, or systemic embolism within 90 days in a modified intention-to-treat population. The study employed a gatekeeper approach for sequential testing of a non-inferiority margin of 2 percentage points, followed by superiority testing.

The following were the key findings of the study:

  • Between July 5, 2019, and January 31, 2024, 3,648 patients were randomly assigned to either early or delayed initiation of DOACs.
  • After excluding 27 participants who did not meet eligibility criteria or withdrew consent, 3,621 patients were included in the modified intention-to-treat analysis (1,814 in the early group and 1,807 in the delayed group; 1,981 men and 1,640 women).
  • The primary outcome occurred in 3.3% of participants in both the early and delayed groups (adjusted risk difference [RD] 0.000).
  • The upper limit of the 95% CI for the adjusted RD was below the non-inferiority margin of 2 percentage points, but superiority was not demonstrated.
  • Regarding symptomatic intracranial hemorrhage, 0.6% in the early group experienced this outcome, compared to 0.7% in the delayed group (adjusted RD 0.001).

The OPTIMAS trial has demonstrated that early initiation of direct oral anticoagulants after ischemic stroke associated with AF is non-inferior to delayed initiation regarding the composite outcomes of ischemic stroke, intracranial hemorrhage, unclassifiable stroke, or systemic embolism within 90 days. There was no increase in the risk of intracranial hemorrhage, nor was there a reduction in the risk of recurrent ischemic stroke.

“These findings challenge current guidelines that recommend delaying DOAC initiation due to concerns about early intracranial hemorrhage, especially in patients with moderate to severe strokes,” the researchers concluded.

Reference: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02197-4/fulltext

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Multiplexed serum biomarkers may help discriminate nonviable and ectopic pregnancy: Study

For decades, the standard of care for early pregnancy
assessment has been transvaginal ultrasound (TVUS) and serum human chorionic
gonadotropin (hCG) levels. An accurate diagnosis of live intrauterine pregnancy
(IUP), early pregnancy loss (EPL), or ectopic pregnancy (EP) can be made in
most individuals at initial presentation. However, a definitive diagnosis often
cannot be made early in gestation when a normal IUP is not expected to be
visualized using ultrasound or when normal ultrasound milestones are not
present. Even when gestational age is advanced enough to use ultrasound as a
diagnostic test, approximately 20%–40% of individuals will not have a
definitive diagnosis and are at risk of having a nonviable pregnancy (EP or
EPL). The standard of care for follow-up is serial hCG levels, but this
approach also has limitations and can misclassify.

The successful identification and application of biomarkers
produced during early pregnancy could change the diagnostic standard, providing
an earlier diagnosis or useful information when ultrasound is not diagnostic.
Biomarkers could be useful before TVUS visualization of a pregnancy or when
TVUS is not definitive.

The development of a companion diagnostic on the basis of
biomarkers is an iterative process. Authors first evaluated biomarkers
suggested in the literature to have biological plausibility to predict early
pregnancy outcomes in a series of case-control experiments. After establishing
and validating candidates with acceptable assay performance and discriminatory
capacity individually, they sought to further improve predictive capacity by
assessing them in combination. In this study, they assessed the most promising
24 markers and used multiple machine learning (ML)-based methodologies to
evaluate combinations of these top candidates to develop a multiplexed
prediction model for the identification of a nonviable pregnancy and an EP.

A nested case-control design evaluated the predictive
ability and discrimination of biomarkers in patients at risk of early pregnancy
failure in the first trimester to classify viability and location. A total of
218 individuals with pain and/or bleeding in early pregnancy: 75 had an ongoing
intrauterine gestation; 68 had ectopic pregnancies (EPs); and 75 had
miscarriages. Serum levels of 24 biomarkers were assessed in the same patients.
Multiple machine learning-based methodologies to evaluate combinations of these
top candidates to develop a multiplexed prediction model for the identification
of a nonviable pregnancy (ongoing intrauterine pregnancy vs. miscarriage or EP)
and an EP (EP vs. ongoing intrauterine pregnancy or miscarriage). The predicted
classification using each model was compared with the actual diagnosis, and
sensitivity, specificity, positive predictive value, negative predictive value,
conclusive classification, and accuracy were calculated.

Models using classification regression tree analysis using 3
(pregnancy-specific beta-1-glycoprotein 3 [PSG3], chorionic gonadotropin-alpha
subunit, and pregnancy-associated plasma protein-A) biomarkers were able to
predict a maximum sensitivity of 93.3% and a maximum specificity of 98.6%. The
model with the highest accuracy was 97.4% (with 70.2% receiving
classification). Models using an overlapping group of 3 (soluble fms-like
tyrosine kinase-1, PSG3, and tissue factor pathway inhibitor 2) biomarkers
achieved a maximum sensitivity of 98.5% and a maximum specificity of 95.3%. The
model with the highest accuracy was 94.4% (with 65.6% receiving
classification). When the models were used simultaneously, the conclusive
classification increased to 72.7% with an accuracy of 95.9%. The predictive
ability of the biomarkers in the random forest produced similar test
characteristics when using 11 predictive biomarkers.

Authors demonstrated that a small pool of biomarkers, used
in combination, can be used to classify individuals with potential EPL as not
viable and extra uterine. The overall test characteristics are modestly
dependent on the number of biomarkers used. The biomarkers CG-alpha, PAPPA, and
PSG3 can be used to predict viability and sFlT, TPFI2, and PSG3 can be used to
predict pregnancy location.

Source: Fertil Steril® Vol. 122, No. 3, September 2024

https://doi.org/10.1016/j.fertnstert.2024.04.028

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SGLT2 inhibitor canagliflozin has Heart and kidney benefits among patients across all age categories: Study

Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce the risk of cardiovascular and kidney outcomes in patients with type 2 diabetes, but it is unclear whether their effects differ based on patients’ age. A recent analysis of clinical trial data reveals that the SGLT2 inhibitor canagliflozin benefited patients across all age categories. The findings will be presented at ASN Kidney Week 2024 October 23-27.

The analysis pooled individual participant data from the CANVAS Program and CREDENCE trial and assessed efficacy and safety according to baseline age. Among the 14,543 participants, 7,927 (54.5%) were <65 years, 5,281 (36.3%) were 65 to <75 years, and 1,335 (9.2%) were ≥75 years.

Across age groups, canagliflozin reduced risks of major adverse cardiovascular events, hospitalization for heart failure or cardiovascular death, and chronic kidney disease progression.

Although the overall incidence of adverse events increased with age, the effects of canagliflozin on safety outcomes including acute kidney injury, volume depletion, urinary tract infections and hypoglycemia, were not modified by age.

“The prevalence of diabetes among older adults aged ≥65 years in the United States is estimated at 29.2%, a prevalence rate more than double that for the overall adult population aged ≥18 years, and older individuals with diabetes have higher absolute risks of cardiovascular events and kidney complications. Despite this, real-world uptake of SGLT2 inhibitors in older age groups is among the lowest of all patient groups,” said corresponding authorAmanda Siriwardana, MBBS (Hon), GCert Public Health, FRACP, of The George Institute for Global Health in Australia. “The data presented in this analysis suggests clear extension of the cardiorenal benefits of SGLT2 therapy to older individuals and should engender confidence amongst clinicians and patients regarding the safety of canagliflozin in older adults.”

Study: “Cardiovascular, kidney and safety outcomes with canagliflozin in older adults: A pooled secondary analysis of the CANVAS Program and CREDENCE trial”

Reference:

Heart and kidney outcomes after canagliflozin treatment in older adults, American Society of Nephrology, Meeting: ASN Kidney Week 2024.

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Perinatal and postnatal outcomes after transfer of low level mosaic embryos comparable to euploid embryos: Study

To date, data after the transfer of blastocysts diagnosed as
mosaic remain limited, especially regarding neonatal and early childhood
outcomes. This study by Ruth Morales aimed to compare perinatal and postnatal
outcomes of children born from mosaic embryo transfer (ET) with those born from
euploid ET.

In this retrospective cohort study, cycles of
vitrified-warmed ET after preimplantation genetic testing for aneuploidy (PGTA)
leading to the live birth of a newborn were assessed between October 2017 and
August 2022. Newborns included were categorized into two groups based on their
classification as either euploid (n ¼ 115) or mosaic embryos (n ¼ 57) after PGT-A.
The mosaicism threshold was 25%–50% of aneuploidy. The clinical outcomes
analyzed and compared in both groups were prenatal screening and testing as
well as pregnancy complications, maternal age at birth, gestational age, type
of delivery and delivery complications, newborn measures, neonatal admission,
congenital anomalies, hospital admission, chronic diseases and chronic use of
medication, and other health problems not involving hospital admission.
Postnatal karyotyping was performed in six children from the mosaic group, by
parental choice.

The analysis included a total of 172 singleton live births
resulting from a single ET after PGT-A analysis (euploid group, n ¼ 115; mosaic
group, n ¼ 57). Variables related to prenatal and perinatal periods, such as
pregnancy and delivery complications, type of delivery, and gestational age,
were comparable in both groups. Only maternal age was higher in the mosaic
group. Regarding newborn measures, there were no significant differences
between the groups in birth weight, length, head circumference, and the Apgar
score.

The main reasons for neonatal admission were prematurity and
pulmonary maladaptation in both groups. With regard to congenital anomalies,
all anomalies were minor, except for a single case of a major anomaly
(hypospadias) in the euploid group. The most common minor defects in the
euploid group included hip dysplasia (in 3 [2.6%] children) and mild facial
dysmorphia (in 2 [1.7%] children). Other anomalies such as hydrocele,
strabismus, pyelectasis, and fossa sacra were reported in only 1 (0.9%) child
each.

In the mosaic group, there were 2 (3.5%) cases of skin
anomalies (cafe-au-lait spots or hemangioma), 1 (1.8%) of ectopic kidney, and 1
(1.8%) of syndactyly. In the euploid group, surgical intervention was performed
in two children, and medical hospitalization was required in four children. No
hospital admission was reported in the mosaic group. Comparable rates of
chronic diseases were reported in the two groups, and no other health problems
were recorded. The average age of the children at the time of the study was
3.48±
0.81 years in the euploid group and 2.92 ±1.32 years in the mosaic
group. Prenatal screening and testing were performed in 50.9% of pregnancies in
the mosaic group with a normal result. In addition, postnatal karyotyping in
six children was also normal. Finally, the analysis revealed that clinical
outcomes did not differ on the basis of the classification of the transferred
embryo (mosaic or euploid) until the child’s average age of approximately 3
years.

This study suggests that the transfer of low-level mosaic
embryos results in apparently healthy children up to the age of 3 years,
similar to the transfer of euploid embryos. It is the first study to analyze
prenatal, perinatal, and postnatal outcomes beyond birth weight, gestational
age, and congenital anomalies in children from mosaic embryos compared with
those from euploid embryos, and it is also the first to report details of
physical health during early infancy. Although these data are limited by the
relatively small cohort size, which does not allow for the analysis of the
impact of mosaicism type, and the shorter follow-up period for the mosaic
group, it provides reassuring evidence that there are no health problems
inchildren from this type of mosaic embryo. Further long-term follow-up studies
are necessary to assess the safety of mosaic ET.

Source: Ruth Morales, Ph.D.a Belen Lledo, Ph.D. a Jose A. Ortiz, Ph.D.; VOL. 122 NO. 3 /
SEPTEMBER 2024; Fertility Sterility

https://doi.org/10.1016/j.fertnstert.2024.04.040

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Cervical fibroid: A diagnostic dilemma and operative challenge reports year long study

Uterine fibroids are the most common benign smooth muscle
tumour in women of the reproductive age group. Despite having a fairly high
frequency of 70%, uterine fibroid only impacts 20–40% of females
symptomatically. Ninety-five percent of leiomyomas are found in the uterine
corpus; just one to two percent are seen in the cervicalregion. These tumours
are estrogen-dependent. The cervical fibroid can arise either from the
supravaginal or infravaginal portion of the cervix. It may originate from the
anterior, posterior, central, or lateral regions. Cervical fibroid is classified
as type 8 in the FIGO classification of uterine fibroid. Cervical fibroid may
be present with varied symptoms like irregular vaginal bleeding, heavy
menstrual bleeding, dysmenorrhea, chronic pelvic pain, and pressure effects
caused disturbance in bladder and bowel habits. Cervical leiomyoma can change
the shape of the cervix and cause its lengthening and effacement. It can also
cause the uterus to push upwards or the bladder to be drawn up when its size
increases, which causes urinary tract infections.

Cervical fibroid may have an impact on a woman’s obstetric
outcomes because it can result in abortion, infertility, early discomfort, more
surgical intervention, and a protracted postpartum recovery. Sometimes it is
difficult to reach the diagnosis of cervical fibroid as it mimics various other
gynaecological conditions or because of some atypical presentation like
polypoidal vaginal mass, incarcerated procidentia, chronic uterine inversion,
uterocervical descent, ovarian mass, acute urinary retention, or cervical
carcinoma. This study aimed to find out how common cervical fibroids are among
different ages, where they start, the most common symptom that led women to the
hospital, as well as any site-specific symptoms. It also was to find out if
there is a link between size and symptoms, surgical problems, and the development
of cancer. How to differentiate it from the other gynaecological entities
mentioned above? What are modalities that help in diagnosis and rule out
malignancies?

A two-year retrospective analysis of women diagnosed with
cervical leiomyoma was conducted at Obstetrics and Gynaecology department,
PGIMS Rohtak (a tertiary care institute in Northern India). A total of 24 cases
diagnosed with cervical fibroid (CF) were studied.

75% of the females had vaginal bleeding, 44.6% had heavy
menstrual bleeding, 33.3% had irregular bleeding, and one had postmenopausal
bleeding. 41.6% had urinary symptoms; 1.5% complained of vaginal discharge;
difficulty in stools (16.6%); and leiomyosarcoma (8.3%). It was discovered that
the development of malignancy and bladder and intestinal problems was linked to
an increase in CF mass, while severe anaemia and vaginal bleeding were not.

Cervical fibroid is mostly benign, can be present at
extremes of age, and its atypical presenting symptoms pose difficulty in
diagnosis. Vaginal bleeding and retention of urine are the most common
symptoms. Central and supravaginal fibroids are difficult to operate. Authors
cannot find a clear demarcation of presenting symptoms between the anterior and
posterior fibroids. Preoperative clinical evaluation, radiological imaging, and
proper intraoperative delineation of pelvic anatomy can help in their
successful management and anticipating intraoperative complications.

Intracapsular enucleation is the best approach to preventing
ureteric injury. Its management is still a challenge for gynaecologists, as
they are difficult to operate due to their proximity to the pelvic structure.
In large cervical firoids, always suspect malignancy before moving to surgery,
and hidden cervical malignancy can coexist.

Source: Dahiya et al. / Indian Journal of Obstetrics and
Gynecology Research 2024;11(3):409–414

https://doi.org/10.18231/j.ijogr.2024.074

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Study suggests gallstones to be associated with increased depression risk

A recent study has identified a significant link between gallstones and depressive symptoms in adults by highlighting a previously unclear relationship. The study aimed to investigate the association between gallstone disease and mental health, particularly focusing on depression and the findings were recently published in the Psychology Research and Behavior Management journal. By using data from the National Health and Nutrition Examination Survey (NHANES) conducted between 2017 and March 2020, the study offered strong evidence that gallstones may play a role in increasing depression risk.

This cross-sectional analysis initially assessed thousands of participants in the NHANES database. After screening, they identified 835 matched pairs of adults (some with gallstones and others without) through a statistical technique called propensity score matching (PSM). This matching process ensured that both groups were comparable in factors like age, lifestyle, and other health conditions, isolating the effect of gallstones on depressive symptoms. The study then applied a multivariate logistic regression model to adjust for additional variables which yielded more nuanced understanding of the association between gallstones and depression.

The findings suggest that adults with gallstones had an 82% higher likelihood of experiencing depressive symptoms compared to the individuals without gallstones. The data showed that participants with gallstones had an odds ratio (OR) of 1.821 (with a confidence interval of 1.181 to 2.808) and a statistically significant p-value of 0.007 which indicated a strong association. These findings were robust even after accounting for multiple health and demographic factors.

To determine if gallstones might actually cause depression, the study utilized Mendelian randomization (MR) which used genetic data to help establish causal links between gallstones and depression. With the data from genome-wide association studies, this research performed both univariate and multivariate MR analyses. These analyses suggested that gallstones could indeed causally contribute to depressive symptoms, as shown by a forward univariate MR analysis with an odds ratio of 1.04 and a p-value of 0.002, along with a multivariate MR analysis with an odds ratio of 1.03 and a p-value of 0.009. Also, there was no evidence supporting reverse causation which meant that depression did not appear to lead to gallstones.

The findings underlined the importance of mental health screenings for patients diagnosed with gallstones. Early detection and treatment of depressive symptoms could significantly improve quality of life for these individuals by reducing the mental health burden on both patients and the healthcare system.

Source:

Ma, R., Li, W., Peng, Q., Ren, A., Zhao, L., Li, J., & Luo, S. (2024). Association Between Gallstones and Depressive Symptoms: Results from NHANES and Mendelian Randomization Study. In Psychology Research and Behavior Management: Vol. Volume 17 (pp. 3659–3676). Informa UK Limited. https://doi.org/10.2147/prbm.s477449

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Rural Posting allotted 1.5 yrs after completing MBBS! HC issues notice as Doctor challenges Rs 25 lakh bond penalty

Bhopal/Jabalpur: The Madhya Pradesh High Court has asked the State Government, Director of Medical Education, and Commissioner of Health Services to respond to a doctor’s plea challenging the imposition of Rs 25 Lakh penalty on him for failing to undergo compulsory rural service for five years after completing his MBBS course.

Issuing notice to the State Government authorities, the HC bench comprising Justice Sanjeev Sachdeva and Vinay Saraf has listed the matter for further hearing in the week commencing 13.01.2025.

“Notice is accepted by learned counsel appearing for the respondents, who prays for time to file counter. Let the same be filed within four weeks. Rejoinder two weeks thereafter. List in the week commencing 13.01.2025,” ordered the bench.

In his plea, the Bhopal-based doctor submitted that he executed a bond pledging to serve in the rural area for five years after graduating. However, he was not given a posting for one and a half years after he completed his MBBS course.  Ultimately, he was given a posting in September 2024 and when he did not join the service, the authorities imposed a penalty of Rs 25 lakh on him.

Also Read: HC Grants Interim Relief to Doctor from Rs 30 Lakh Seat Leaving Bond penalty, MGM Indore told to Return Original Documents

As per the latest media report by the Times of India, the counsel for the petitioner argued that the amount of penalty of Rs 25 lakh was exorbitant and also pointed out that the doctor was given the rural posting only after one and a half years later he completed his UG medical education course. It was argued by the counsel that since the doctor was given the posting later after passing the MBBS course, he was left behind in his career compared to his peers in college by the same amount of time.

TOI has reported that the issue was also raised in the Parliament, where the Indian Medical Association (IMA) asked the Madhya Pradesh Government to review the penalty. The counsel for the doctor, Aditya Sanghi, said that not only was the State Government at fault for not giving him a posting for one and a half years, but a penalty of Rs 25 lakh was imposed on him which is too much for an MBBS graduate. He argued that Madhya Pradesh is a poor State and imposing such a heavy penalty on a student goes against the entire scheme of things of the Indian Constitution.

Medical Dialogues had earlier reported that back in 2022, the Jabalpur Bench of Madhya Pradesh High Court had directed Indore-based Mahatma Gandhi Medical College to return the original documents of a doctor after noting that if the bond service postings are not given within three months from the passing the final exam, conditions mentioned in the bond will be treated as infructuous.

To view the HC order, click on the link below:

https://medicaldialogues.in/pdf_upload/mp-hc-order-258621.pdf

Also Read: Bond Service Postings must be given within 3 months of Passing final Exam: HC relief to Doctor, directs Medical College to return documents

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49 drugs samples including PAN 40, Calvam 625, Zerodol-SP Tablet fail to meet CDSCO quality test

New Delhi: In its latest drug alert, the Central Drug Standard Control Organization (CDSCO) has flagged forty-nine medicine batches for failing to qualify for a random drug sample test for September 2024.

The list declared not of standard quality includes Pantoprazole Gastro -resistant Tablets IP.. (PAN 40), Amoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) manufactured by Alkem Health Science, Ciprofloxacin Tablets IP 500 mg (CIPRODAC 500) manufactured by Cadila Pharma, Paracetamol Paediatric Oral Suspension IP manufactured by Vivimed Labs, Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets(ZEROD OL-SP TABLETS) manufactured by Ipca Labs.

Also Read: CDSCO declares 4 formulations as spurious including PAN D, SHELCAL 500

As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.

A. CDSCO/Central Laboratories

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reported

by CDSCO

Laboratory

1.

Metronidazole Tablets I.P. 400 mg

HMAA04

07/2023

06/2025

M/s. Hindustan Antibiotics Ltd., At: 11

W.E.A. Faridabad – 121001 (Haryana)

R.O. Pimpri, Pune – 411 018, India

Dissolution

CDL, Kolkata

2.

Domperidon Suspension (Vomitel)

U587F2401

06/2024

05/2026

M/s. Rainbow Life Sciences Pvt. Ltd., C/o. Unijules Life Sciences Ltd., B-35, 36, MIDC Kalmeshwar,

Nagpur 441 501.

Assay

CDL, Kolkata

3.

Oxytocin Injection I.P. 5 IU/1 ml

OTC-382A

04/2023

03/2025

M/s. Pushkar Pharma, Kheri, Kala Amb – 173030 (H.P.).

Description, Particulate matter & Assay of Oxytocin

CDL, Kolkata

4.

Metformin Hydrochloride 500 mg SR & Glimepiride 2 mg Tablets IP (SPAMET GM 2

Tablets)

TF147A

02/2024

01/2026

M/s. Swiss Biotech Parenterals , Kewat No. 1138, VPO –

Kachhwa, Karnal- 132001, Haryana

Dissolution of Glimepiride

CDL, Kolkata

5.

Diclofenac Sodium Tablets IP 50 mg

HDFA02

11/2023

10/2025

M/s. Hindustan Antibiotics Ltd., At: 11

W.E.A. Faridabad – 121001 (Haryana)

R.O. Pimpri, Pune – 411 018, India

Dissolution

CDL, Kolkata

6.

Calcium Gluconate Injection I.P. 10 ml

MA24E55

05/2024

04/2026

M/s. Martin & Brown Biosciences Pvt. Ltd.,

K. No. 918/419,

Malkumajra, Nalagarth Road, Baddi, Dist.

Solan (H.P.) 173205

Description & Particulate matter

CDL, Kolkata

7.

Oxytocin Injection I.P. 1 ml

22X23002

07/2023

06/2027

M/s. Radiant Parenterals Ltd., 242/4, 5 & 6, G.I.D.C.

Estate at & Post Waghodia, Dist. Vadodara, Gujarat 391

760.

Assay

CDL, Kolkata

8.

Ceftriiaxone Injection I.P. 1g

324476

04/2024

03/2026

M/s. Zee Laboratories Ltd., Behind 47,

Industrial Area, Paonta Sahib-173025

Particulate Matter & Clarity of Solution

CDL, Kolkata

9.

Gentamycin Sulphate

Injection I.P. 40 mg/ml

324-564

05/2024

04/2026

M/s. Zee Laboratories Ltd., Behind 47,

Industrial Area, Paonta Sahib-173025

Description & Particulate matter

CDL, Kolkata

10.

Glycopyrrolate

0.5 mg / 5ml + Neostigmine methysulfate Injection 2.5 mg

/ 5ml) (Stimin)

GNI2406AC

07/2024

06/2026

M/s. Celon Laboratories Pvt. Ltd., Plot No. 2, ALEAP

Industrial Estate, Gajularamaram, Medchal District – 500 090, Telangana State,

India.

Description & Clarity of Solution

CDL, Kolkata

11.

Ketoconazole Cream BP (Nozal Cream)

4129

01/07/2024

30/06/20

26

M/s. Olcare Laboratories 505/A, GIDC Estate, Wadhwan City – 363035, Dist. Surendranagar, Gujarat

Assay

CDL, Kolkata

12.

Heparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial)

L1192317G

08/2023

07/2025

M/s. Protech Telelinks, Mauza Ogli, Suketi Road, Kala Amb, Dist- Sirmour (H.P.) 173030

Description & Particulate matter

CDL, Kolkata

13.

Heparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial)

L1192317C

08/2023

07/2025

M/s. Protech Telelinks, Mauza Ogli, Suketi Road, Kala Amb, Dist- Sirmour (H.P.) 173030

Description, Particulate matter and Assay of Heparin (Anti- factor IIa

activity)

CDL, Kolkata

14.

Gentamicin Injection I.P. (Gentagain )

IGMJ330

10/2023

09/2025

M/s. Regain Laboratories 134/5,

HTM Road, Raipur Lane, Hisar-125001

Description & Particulate matter

CDL, Kolkata

15.

Glipizide Tablets I.P. 5 mg

Z24-187

02/2024

01/2026

M/s. Zee Laboratories Ltd., Behind 47,

Industrial Area, Paonta Sahib-173205

Dissolution

CDL, Kolkata

16.

Omeprazole & Domperidone Capsules IP

(Omerin-D Capsules)

RC-331223

12/2023

11/2025

M/s. Renowed Life Sciences, Plot No-12, Sector-6B, SIDCUL,,

Haridwar, Uttarakhand (India) 249403

Dissolution of Omeprazole

CDL, Kolkata

17.

Dried Aluminium Hydroxide, Magnesium Hydroxide & Activated Dimethicone

Suspension (Chill Acid MPS)

DNS- 2210001

10/2022

09/2024

M/s. Devout Nord (I) Ltd., Plot No. 28B, Sector-8B, IIE, Sidcul, Haridwar-249 403 (U.K).

Description, Microbial Limit Test, Identification and Assay of Activated Dimethicone

CDL, Kolkata

18.

Nimesulide & Paracetamol Tablets (Nimuvent-P Tablets)

GD332005

04/2022

03/2025

M/s. Innova Captab Limited, 1281/1, Hilltop Industrial Estate, Near EPIP, Phase-I,

Jharmajri, Baddi, Dist. Solan (H.P.)

Description

CDL, Kolkata

19.

Cipronir 500 (Ciprofloxacin Tablets IP 500 mg)

CCF212003

12/2022

11/2025

M/s. Celebrity Biopharma Ltd., Vill. Panga, Via – Jharmajri, Hill Top Estate, Barotiwala, Distt.

Solan, H.P. 174103

Dissolution

CDL, Kolkata

20.

Ofloxacin & Ornidazole Tablets I.P. (SMB OZ TABLETS)

B22-114

08/2022

07/2025

M/s. Saint Michael Biotech, No. 130, Village Kurdi, Manglore, Jharbrera Road, Roorkee- 247656 (Haridwar)

(U.K.)

Dissolution of Ofloxacin & Ornidazole

RDTL, Guwahati

21.

Calcium 500 mg and Vitamin D3 250 IU Tablets IP

LMT240025

01/2024

12/2025

M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL,

Haridwar249403 (U.K)

Assay of Calcium and Vitamin D3 and

Dissolution of Calcium

RDTL, Guwahati

22.

Loperamide Hydrochloride Tablets I.P. 2 mg (LOMJAN)

L-2401

01/2024

12/2025

M/s.Arya Pharmaceuticals, 111- c, Industrial Estate, Indore-15.

Dissolution and Assay/ Content of Loperamide Hydrochloride and Description

RDTL, Guwahati

23.

Glimepiride Tablets IP 1 mg

LMT240339

03/2024

02/2026

M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A,

Sector6A, IIE, SIDCUL,

Haridwar249403 (U.K)

Dissolution

RDTL, Guwahati

24.

Fexofenadine Hydrochloride Tablets I.P.

658-021

11/2023

10/2025

M/s. Signature Phytochemical Industries, 122, MI, Selaqui Industrial

Area, Dehradun – 248 011.

Dissolution

RDTL, Guwahati

25.

Glimepiride Tablets I.P. 2 mg

LMT240157

02/2024

01/2026

M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A,

Sector6A, IIE, SIDCUL,

Haridwar249403 (U.K)

Dissolution

RDTL, Guwahati

26.

Pantoprazole Gastro-resistant Tablets IP.. (PAN 40)

22442076

07/2022

12/2024

M/s. Alkem Health Science, A Unit Of Alkem Laboratories Limited, Unit-2, Samardung, Karek Block, P.O.:

Namthang, South Sikkim – 737 137.

Assay and Dissolution in acid stage

RDTL, Guwahati

27.

Cefpodoxime Tablets IP 200 mg (Monocef-O 200)

BPH232520

08/2023

07/2025

M/s. Aristo Pharmaceuticals Pvt. Ltd., Village: Makhnumajra. P.O.- Bhud, Baddi, Dist: Solan (H.P.)- 173205

Identification and Assay/ Content of Cefpodoxime

RDTL, Guwahati

28.

Cefpodoxime Tablets IP 200 mg (Monocef-O 200)

BPD231045

04/2023

03/2025

M/s. Aristo Pharmaceuticals Pvt. Ltd., Village: Makhnumajra. P.O.-

Bhud, Baddi, Dist: Solan (H.P.)- 173205

Identification and Assay/ Content of Cefpodoxime

RDTL, Guwahati

29.

Amoxicillin And Potassium Clavulanate Tablets I.P.

(CLAVAM 625)

23443940

11/2023

04/2025

M/s.Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit-2,

Samardung, Karek

Block, P.O. Namthang, South Sikkim – 737 137

Identification, Dissolution and Assay of Amoxicillin and

Clavulanic Acid

RDTL, Guwahati

30.

Fexofenadine Hydrochloride Tablets IP

T-2403971

03/2024

02/2026

M/s. Oscar Remedies Pvt. Ltd., Oscar House, Badi Majra, Yamuna Nagar – 135

001 (HR)

Uniformity of Weight and Dissolution

RDTL, Guwahati

31.

Ciprofloxacin Tablets IP 500 mg (CIPRODAC 500)

JKBD24009

01/2024

12/2026

M/s.Cadila Pharmaceuticals Limited,, Industrial Growth Center, Samba

-184 121, State of J & K

Dissolution of Ciprofloxacin

RDTL, Guwahati

32.

Ramipril Tablets

I.P. 2.5 mg

RT-231084

10/2023

09/2025

M/s.Relief Biotech Pvt. Ltd., Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee – 247656,

Haridwar (U.K.).

Assay of Ramipril

RDTL, Guwahati

33.

COMPOUND SODIUM LACTATE INJECTION I.P. (RL)

03BF2475

04/2024

03/2027

M/s.Paschim Banga Pharmaceuticals, NH- 31, TIN MILE HAT, SONAPUR HAT, P. S. CHOPRA, DISTRICT- UTTAR DINAJPORE, PIN-733214 (W.B.)

Bacterial Endotoxins Test

RDTL, Guwahati

34.

Promethazine Hydrochloride Injection I.P. (PHENERGAN)

AHH0367

12/2022

11/2025

M/s.Nitin Lifesciences Ltd., Rampur Road, Paonta Sahib, Dist.

Sirmour – 173025 (H.P.), India

Assay of Promethazine Hydrochloride

RDTL, Guwahati

35.

Paracetamol Paediatric Oral

Suspension IP

V0244001

02/2024

01/2026

M/s.Vivimed Labs Limited., Plot No. 25,

Kundeshwari Village, Kashipur 244713, Uttarakhand

Related Substances

CDTL-Mumbai

36.

Aluminum Hydroxide, Simethicone & Magnesium Hydroxide Suspension (Spisam Gel)

L22455

12/2022

11/2024

M/s.Aan Pharma Pvt. Ltd., 816/1, Rakanpur, Tal. Kalol, Dist.

Gandhinagar, 380060, Gujarat, (India)

Assay / Content of Magnesium Hydroxide, Simethicone and Aluminium Hydroxide gel

CDTL-Mumbai

37.

Gentamicin Sulphate Injection IP (P- Genta Injection)

PA022415

02/2024

01/2026

M/s.Primus Pharmaceuticals, Sadhoura Road, Mouza ogli Khari Vill Asgarpur Majra, Kala Amb. Distt. Sirmour-

(H. P.) 173030

pH

CDTL-Mumbai

38.

Fluconazole Tablets IP 150 mg (Flucse – 150)

CHT23621

02/2024

01/2026

M/s.Cureza Healthcare Pvt. Ltd., A.B. Road, Girwai- 474001

Uniformity of weight

CDTL-Mumbai

39.

BISACODYL TABLETS I.P.

(Bisalax Tablets)

T-14996

12/2022

05/2025

M/s. Karnani Pharmaceutical Pvt. Ltd., Fact. 38, Pharma City, Selaqui

Dehradun- 248011 (Uttarakhand)

Dissolution (Buffer stage), Related substances and

Assay of Bisacodyl

CDTL-Mumbai

40.

Cetirizine Dihydrochloride Syrup (Citrize-

P)

275

06/2024

05/2026

M/s. Arrow Pharma, Palia road, Hatod- 453111

pH

CDTL, Hyderabad

41.

Ifosfamide for Injection IP with Mesna Injection (Celofos 1000 Injection)

OL0492(for Ifosfamide), GN2064(for Mesna)

08/2023 (for Ifosfamide) 08/2023 (for Mesna)

07/2025

(for Ifosfamid e) 07/2026(f

or Mesna)

M/s. Kwality Pharmaceuticals Limited,1-A,Industrial Area,Raja Ka Bagh, Tehsil Nurpur, Kangra- 176201(India)

Water and Assay of Ifosfamide

RDTL,Chandigarh

42.

Aceclofenac 100 mg, Serratiopeptidas e 15 mg & Paracetamol 325 mg Tablets(ZEROD

OL-SP TABLETS)

FND033076 AS

08/2023

01/2026

M/s. Ipca Laboratories Ltd. .,393/394, Melli Jorethang Road, Gom Block, Bharikhola, South District, Sikkim- 737 121

Identification and Assay of Aceclofenac Serratiopeptidas e and Paracetamol

RDTL,Chandigarh

43.

Ofloxacin and Ornidazole Intra Uterine Solution (Vet.) (UTROCLEAR-

OZ SOLUTION)

V-2727

01/2024

12/2025

M/s. Ramson Remedies,186-187, Industrial Focal Point, Amritsar.

Assay of Ofloxacin and Ornidazole

RDTL,Chandigarh

44.

Bupropion Hydrochloride Extended Release Tablets USP (Nopion

150 Tablets)

GTD0768

11/2023

10/2025

M/s. Digital Vision, 176, Mauza Ogli, Nahan road, Kala- Amb, Distt. Sirmour (H.P.)-17030

Description and Assay of Bupropion Hydrochloride

RDTL,Chandigarh

45.

Dextromethorph an Hydrobromide, Chlorpheniramin e Maleate and Phenylephrine Hydrochloride Syrup (COUGH-

DM Cough Syrup)

SHL3037

11/2023

10/2025

M/s.Sunfine Healthcare,Plot No. 63, Ind. Area Lodhimajra, Tehsil Baddi, Distt. Solan (H.P.) 173205

Assay of Phenylphrine Hydrochloride

RDTL,Chandigarh

46.

Cefoperazone and Sulbactam for Injection (KEFZONE-S INJECTION)

AB234007C

06/2024

05/2026

M/s.ANG Lifesciences India Ltd.,Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt.: Solan, HP- 174101

Particulate Matter

RDTL,Chandigarh

47.

Piperacillin and Tazobactam Injection IP (CASIDTAZ P

Injection)

AB154006B

06/2024

05/2026

M/s.ANG Lifesciences India Ltd.,Village: Kishanpura, Nalagarh Road, Tehsil: Baddi,

Distt.: Solan, HP- 174101

Particulate Matter

RDTL,Chandigarh

48.

Methylcobalami n Injection 2500 mcg (NUROFENS-

2500 Injection)

SRID24010 1

04/2024

09/2025

M/s.Systole Remedies Pvt. Ltd.,Vill. Ogli, Kala Amb, Teh. Nahan,

Distt. Sirmour (H.P.) – 173 030

Particulate matter and Assay of

Methylcobalami n

RDTL,Chandigarh

49.

Torsemide Tablets IP 10 mg (Torverge- 10 Tablets)

GT7137A

03/2023

02/2025

M/s. J.M.LABORATORIES.,

Village-

Bhanat, PO – Ghatti, Subathu Road, Solan (HP) 173211Himachal Pradesh – 173 205

Assay of Torsemide

RDTL,Chandigarh

The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality mean that the drug complies with the standards set out in the Second Schedule of the said Act.

For more details, check out the full story on the link below:

https://medicaldialogues.in/pdf_upload/nsq-alert-for-the-month-of-sept-2024-258519.pdf

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