Advancing Urolithiasis Treatment with Plant-Based Therapies: Study Sheds Light on Current Insights and Future Directions

Egypt: Natural substances provide a potential alternative or adjunctive therapy for urolithiasis, offering the prospect of reducing pain and enhancing patients’ quality of life, a recent review has found.

The study, published in International Urology and Nephrology, however, has shown the need for additional research to elucidate their mechanisms of action and refine their therapeutic application. The promising potential of plant-based therapies in urolithiasis underscores ongoing research aimed at advancing global patient treatment outcomes.

Urolithiasis, commonly known as kidney stones, affects millions worldwide and presents with symptoms ranging from intense pain to complications such as obstruction of urinary flow. Current treatments primarily involve surgical intervention or pharmacological management, but their side effects and recurrence rates prompt the exploration of alternative therapies, particularly those derived from plants.

Considering the worldwide need for affordable treatment options, Essmat A. H. Allam & Mahmoud S. Sabra from Assiut University in Assiut, Egypt, explored the utilization of plant extracts and phytochemicals in preventing and treating urolithiasis.

For this purpose, the researchers systematically reviewed the literature on online databases following PRISM standards, focusing on herbal items evaluated in in vivo models, in vitro studies, and clinical trials related to nephrolithiasis/urolithiasis. They searched English language publications from 2021 to 2023.

The review included studies assessing the therapeutic potential of plant extracts and phytochemicals in urolithiasis. Data extracted included study design, plant type, stone type, solvent type, part of plant used, study references, and main findings. A total of sixty-four studies were included.

The researchers reported the following findings:

  • Most studies used ethylene glycol to induce hyperoxaluria and nephrolithiasis in rat models.
  • Various extraction methods were used to extract bioactive compounds from different plant parts.
  • Several plants and phytochemicals, including Dolichos biflorus, Alhagi maurorum, Aerva lanata, Cucumis melo, and quercetin, demonstrated potential effectiveness in reducing stone formation, size, and number.

The systematic review underscores the growing interest and potential of plant-based therapies in urolithiasis treatment, aligning with a broader trend towards natural and holistic healthcare approaches. As research continues to evolve, the researchers hope these findings will pave the way for novel therapeutic options that improve outcomes and quality of life for patients.

“The systematic review offers a comprehensive evaluation of plant-based therapies for urolithiasis, highlighting their efficacy and paving the way for future advancements in kidney stone management,” the researchers concluded.

Reference:

Allam, E.A.H., Sabra, M.S. Plant-based therapies for urolithiasis: a systematic review of clinical and preclinical studies. Int Urol Nephrol (2024). https://doi.org/10.1007/s11255-024-04148-9

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Delayed Cholecystectomy for Acute Cholangitis Linked to Worse Outcomes: Study

Researchers have found that compared to surgery done at index admission, delayed cholecystectomy for acute cholangitis did have much worse postoperative outcomes. A latest study published by Ayesha P. and colleagues in The American Journal of Surgery. This study compares the outcome when cholecystectomy is performed during the initial admission versus a delayed admission for acute cholangitis, using data from the Nationwide Readmissions Database covering 2011-2020.

This was a retrospective study of 65,753 adult patients admitted for acute cholangitis who had undergone cholecystectomy. Patients were stratified as index, if the surgery was performed during the index admission, or delayed, if the surgery occurred after the index admission. The impact of timing of cholecystectomy on several outcomes was assessed by Royston-Parmar time-adjusted analyses using multivariable regression.

Key Findings

  • Out of 65,753 patients, 82% had cholecystectomy during the index admission, while 18% had the procedure delayed.

  • Delayed surgery was linked to a 67% increased odds of mortality (Adjusted Odds Ratio [AOR] 1.67, 95% Confidence Interval [CI] 1.10-2.54).

  • Delayed cholecystectomy was associated with a 25% higher likelihood of complications (AOR 1.25, 95% CI 1.13-1.40), and a 69% increased chance of conversion to an open surgical procedure (AOR 1.69, 95% CI 1.48-1.93).

  • The risk of bile duct injury repair was 66% higher in the delayed group (AOR 1.66, 95% CI 1.15-2.41), and 30-day readmission rates were more than three times higher (AOR 3.52, 95% CI 3.21-3.86).

  • Patients with delayed cholecystectomy incurred an average additional cost of $14,200 compared to those who had surgery during their index admission.

The findings of this study are that delayed cholecystectomy for acute cholangitis is associated with poorer outcomes, including increased mortality and more complications, besides an increased conversion to open surgery, along with higher costs. Under these circumstances, considering the data presented, cholecystectomy during the index admission could be a safer and more cost-effective strategy. Further studies should be done to confirm these results and optimize treatment protocols for acute cholangitis.

Reference:

Ng, A. P., Seo, Y.-J., Ali, K., Coaston, T., Mallick, S., de Virgilio, C., & Benharash, P. (2024). National analysis of outcomes in timing of cholecystectomy for acute cholangitis. American Journal of Surgery, 115851, 115851. https://doi.org/10.1016/j.amjsurg.2024.115851

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Does fertility affect a woman’s body odor?

The researchers combined two methods to test whether and how body odour changes during the female cycle and whether men perceive it differently depending on the day of the cycle. They took samples of underarm odour from 29 women on ten days spread over a menstrual cycle, with more samples taken during the fertile period. Ninety-one men were then asked to rate the odour samples. In 16 of the women, the research team also looked at whether the chemical composition of the odour samples differed between the women’s fertile and infertile days.

The results of both tests pointed in the same direction: there was no evidence from the odour ratings that men found a woman’s odour more attractive – and therefore that they preferred her – on her fertile days than on her infertile days. Chemical analysis of the odour samples also showed no correlation between the composition of the underarm odour and the women’s current fertility status.

New results from combined and more stringent methods

There is some controversy in the research literature about the theory that a woman’s body odour smells better to men around ovulation than on infertile days. The findings from Leipzig and Göttingen now add to our understanding of body odour and hormonal influences. Madita Zetzsche, biologist and first author of the study, explains that the results of her research differ from some previous studies because of the combined and more robust methodology.

“The female cycle is an incredibly complex process. This makes research into the effects associated with the cycle very challenging, especially when it comes to finding the right methodology,” explains Zetzsche. For example, in most previous studies, women’s fertile days were determined based only on the length of their cycle, whereas the new analysis also confirmed the day of ovulation using hormones, which is much more accurate. “We now have more robust methods at our disposal. This means that it is possible that newer and more methodologically rigorous studies will come to different conclusions than those of ten years ago.”

Zetzsche adds that there are still no agreed methodological standards for investigating cycle-related perceptual effects, such as changes in body odour perception between fertile and non-fertile days. Professor Lars Penke, a psychologist at the University of Göttingen, led the perceptual analysis in the research project. He said: “We hope that the results of our study will help to keep the dialogue in this field of research open and that further collaboration will pave the way for a robust methodological standard. This would also help us to re-examine the findings of older studies.”

More in-depth research into the chemical and evolutionary aspects of body odour

The research team sees its new study as an important contribution to the question of how and whether changes in body odour can be detected chemically, a question that has remained unanswered for decades. Professor Anja Widdig, a biologist from Leipzig University who led the chemical analysis, says: “We hope that this study will inspire further research that looks more closely at the chemical component of body odour.” Evolutionary issues are another focus of the research. “In some non-human primates, my team and I have managed to demonstrate a link between body odour and fertility. How this phenomenon has developed in the course of human evolution is therefore of great interest to us.”

Reference:

Zetzsche Madita, Weiß Brigitte M., Kücklich Marlen, Stern Julia, Birkemeyer Claudia, Widdig Anja and Penke Lars 2024Combined perceptual and chemical analyses show no compelling evidence for ovulatory cycle shifts in women’s axillary odourProc. R. Soc. B.29120232712 http://doi.org/10.1098/rspb.2023.2712

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Prenatal Cannabis Use Linked to Adverse Maternal Health Outcomes: JAMA Study

A recent study discovered the use of cannabis during pregnancy to be associated with several adverse health outcomes of the mother. While a number of debates have been ongoing relating to the effects of in utero cannabis exposure on fetal health, less focus has been placed on prenatal cannabis use exposure effects on maternal health. This research work by Kelly and colleagues was published in JAMA Internal Medicine.

While prenatal cannabis use has been widely investigated for its effects on fetal and neonatal outcomes, much less is known about its implications for maternal health. This was a population-based retrospective cohort study to determine whether there is an association between prenatal cannabis use and various maternal health outcomes during pregnancy. The study examined data from pregnancies in Northern California occurring from January 2011 to December 2019.

This was a cohort study of pregnancies at a minimum gestational age of 20 weeks, screened for prenatal cannabis use using an electronic health record. Prenatal cannabis use was ascertained by self-report or positive toxicology tests at the initiation of prenatal care, approximately 8-10 weeks of gestation. Measurements included gestational hypertension, preeclampsia, eclampsia, gestational diabetes, and a set of complications related to placental health. The risk ratios were estimated by the investigators using a modified Poisson regression model, accounting for a number of potential confounders.

Key Findings

  • Prenatal cannabis use was associated with a 17% increased risk of gestational hypertension (aRR, 1.17; 95% CI, 1.13-1.21).

  • The risk of preeclampsia was 8% higher among those who used cannabis during pregnancy (aRR, 1.08; 95% CI, 1.01-1.15).

  • Cannabis use was linked to both insufficient and excessive weight gain during pregnancy.

  • A 5% increased risk of weight gain less than guidelines, (aRR 1.05, 95% CI 1.01 to 1.08), and 9% increased risk of weight gain greater than guidelines, (aRR 1.09, 95% CI 1.08 to 1.10).

  • Users were at 19% increased risk of placental abruption, with an adjusted (RR of 1.19 and a 95% CI of 1.05–1.36).

  • It reported similar associations, whether prenatal cannabis use was defined by self-report or by toxicology testing, with variations dependent on the frequency of use.

This study found significant associations between prenatal cannabis use and gestational hypertension, preeclampsia, anomalous weight gain, and placental abruption. Accordingly, these data suggest that prenatal exposure to cannabis is not only dangerous for fetal and neonatal health but may also be potentially dangerous for the life course of a mother.

Prenatal cannabis use is linked to several adverse maternal health outcomes, emphasizing the need for further research to understand the influence of cannabis characteristics—such as dose, mode, and timing—on these associations. Pregnant individuals and healthcare providers should be aware of these potential risks when considering cannabis use during pregnancy.

Reference:

Young-Wolff, K. C., Adams, S. R., Alexeeff, S. E., Zhu, Y., Chojolan, E., Slama, N. E., Does, M. B., Silver, L. D., Ansley, D., Castellanos, C. L., & Avalos, L. A. (2024). Prenatal cannabis use and maternal pregnancy outcomes. JAMA Internal Medicine. https://doi.org/10.1001/jamainternmed.2024.3270

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Effective and Safe: Polycarbophil Vaginal Gel Extends Relief for Vaginal Atrophy in Menopausal Women, study reveals

Italy: A comprehensive study, known as the TRIPLE study, has delved into the effects of polycarbophil vaginal gel on vaginal atrophy among peri- and post-menopausal women, shedding new light on effective treatments for this common condition.

In peri- and post-menopausal women, polycarbophil vaginal gel (PCV) administration rapidly improves vaginal atrophy (VA) symptoms, and its efficacy is further increased by prolongation up to 6 months. The findings were published online in the European Journal of Obstetrics & Gynecology and Reproductive Biology on June 27, 2024.

Vaginal atrophy is a significant concern for many women during and after menopause that results from declining estrogen levels that lead to thinning, dryness, and inflammation of the vaginal walls. These symptoms can cause discomfort, pain during intercourse, and even urinary symptoms, significantly impacting quality of life.

Angelo Cagnacci from the Genetic and Sciences of the Mother and the Infant in Genoa, Italy, and colleagues aimed to evaluate the efficacy of polycarbophil vaginal gel in treating symptoms of vaginal atrophy of peri- and post-menopausal women.

For this purpose, the researchers progressively enrolled and treated sexually active women in peri- (n = 29) and post-menopause (n = 54) suffering from VA for 30 days with PCV. Those wishing to continue (n = 73) were given an additional 180 days of treatment. PCV was administered as one application twice a week.

The study assessed the vaginal health index (VHI, ranging from 5 to 25) and visual analog scores (VAS, ranging from 0 to 100 mm) for symptoms such as vaginal dryness, pain, and irritation during intercourse. Additionally, it evaluated the global symptom score (GSS, ranging from 1 to 15) and treatment safety at the beginning and after 30 days. Participants who continued treatment underwent a follow-up evaluation after an additional 180 days.

The following were the key findings of the study:

· Women in peri and post-menopause were of 48.7 ± 3.3 years and 57.5 ± 5.7 years old., respectively.

· At baseline, all outcomes were significantly worse in the postmenopausal group, except the VHI.

· After 30 days, VHI increased by 4.1 ± 0.5 (mean ± SE), and 5.1 ± 0.4 in peri- and post-menopausal women respectively.

· VAS of vaginal dryness decreased by −24.4 ± 3.6, and −52.7 ± 2.6, VAS of irritation decreased by −18.6 ± 4.4 and −47.8 ± 3.2, VAS of pain decreased by −26.2 ± 4.3 and −55.6 ± 3.1, and the GSS decreased of −3.9 ± 0.3, and −4.9 ± 0.2, in peri and post-menopausal women, respectively.

· All the modifications were significantly greater in postmenopausal women, and after 30 days, all outcomes were similar in the two groups of women.

· In comparison to baseline, after 210 days of treatment, VHI increased by 7.7 ± 0.3, VAS of vaginal dryness decreased by –53.6 ± 1.9 VAS of irritation by −42.6 ± 1.4 VAS of the pain of −46.7 ± 2.3 and the GSS of −6.5 ± 0.2 ± 0.2.

· All outcomes improved over the values observed after 30 days of treatment. No side effect was reported.

In conclusion, the 30-day administration of PCV in treating symptoms of VA was effective in postmenopausal women, as previously published in perimenopausal women-.

Treatment prolongation up to 210 days was safe and further led to vaginal atrophy improvement and its symptoms in both peri- and postmenopausal women.

Reference:

https://doi.org/10.1016/j.ejogrb.2024.06.033

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Semaglutide promising for smoking cessation among patients of tobacco use disorder, suggests study

New use of semaglutide was associated with a lower risk for medical care related to tobacco use disorder (TUD) in smokers with type 2 diabetes compared with 7 other anti-diabetes medications. Those who used semaglutide were less likely to have a medical encounter that included a diagnosis of tobacco use disorder, prescribing of smoking cessation medication, or smoking cessation counseling during the study timeframe. These findings suggest the need for clinical trials to evaluate semaglutide’s potential for use in smoking cessation. The study is published in Annals of Internal Medicine.

Previous reports of reduced desire to smoke in patients treated with semaglutide, a glucagon-like peptide receptor agonist (GLP-1RA) medication for type 2 diabetes mellitus and obesity, have raised interest about its potential benefit for tobacco use disorders. Researchers from the National Institute on Drug Abuse, National Institutes of Health and Case Western Reserve University School of Medicine used a target trial emulation framework to evaluate the comparative effectiveness of the new use of semaglutide versus the new use of 7 other anti-diabetes medications, including other GLP-1RAs, on TUD-related health care measures in 3 study populations: patients with comorbid type 2 diabetes and TUD, patients with comorbid type 2 diabetes and TUD who had a diagnosis of obesity, and those who did not have a diagnosis of obesity.

The researchers found that semaglutide was associated with a lower risk for smoking-related health care utilization-including use that would indicate smoking cessation efforts. Similar effects were observed in subpopulations without and with a diagnosis of obesity and results were seen primarily within 30 days of prescription. While the findings were consistent with the hypothesis that semaglutide might be beneficial for smoking cessation, the authors say study limitations preclude firm conclusions and should not be interpreted to justify clinicians’ use of semaglutide off-label for smoking cessation.

Reference:

William Wang, Nora D. Volkow, Nathan A. Berger, Pamela B. Davis, David C. Kaelber, Association of Semaglutide With Tobacco Use Disorder in Patients With Type 2 Diabetes: Target Trial Emulation Using Real-World Data, Annals of Internal Medicine, https://doi.org/10.7326/M23-2718.

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NEET MDS 2024 Admissions: MP DME Releases Vacancy position For Candidates

Madhya Pradesh- The Madhya Pradesh Directorate of Medical Education (MPDME) has released the category and class-wise vacancies in government and private dental colleges in the state. The category and class-wise vacancies are released for MDS courses for the 2nd round of MP state-level joint counselling of National Eligibility and Entrance Test-Master of Dental Surgery (NEET-MDS) 2024.

As per the notice, a total of 7 seats are vacant in government dental colleges and a total of 200 seats are vacant in private dental colleges. 

Below are the detailed category and class-wise vacancies in Government Dental Colleges for MDS Courses for the second round of MP State Level combined Counselling of NEET-MDS 2024.

Also Read: MDS Admissions in Madhya Pradesh: DME releases Fee Structure at Private Dental Colleges this year

SEAT VACANT

S.NO

INSTITUTE

VACANT SEATS

1

GOVERNMENT AUTONOMOUS COLLEGE OF DENTISTRY.

7

2

BHABHA COLLEGE OF DENTAL SCIENCES BHOPAL.

25

3

COLLEGE OF DENTAL SCIENCES AND HOSPITAL RAU.

5

4

HITKARINI DENTAL COLLEGE AND HOSPITAL.

10

5

INDEX INSTITUTE OF DENTAL SCIENCES.

9

6

MAHARANA PRATAP COLLEGE OF DENTISTRY AND RESEARCH CENTER.

15

7

MANSAROVAR DENTAL COLLEGE.

8

8

MODERN DENTAL COLLEGE AND RESEARCH CENTRE.

21

9

PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE.

21

10

PEOPLES DENTAL ACADEMY.

18

11

RISHIRAJ COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE.

24

12

RKDF DENTAL COLLEGE AND RESEARCH CENTRE.

23

13

SRI AURBINDO COLLEGE OF DENTISTRY.

21

Medical Dialogues had earlier reported that there are a total of 13 colleges that are participating in the MP state joint NEET MDS counselling 2024. Among these 13 colleges, only 1 college namely the Government Autonomous College of Dentistry is a Government college and the rest 12 colleges are private participating in the NEET MDS counselling 2024. Meanwhile, fees for a total of 12 private medical colleges have also been released. All the NEET MDS-qualified candidates who are interested in getting admission this year in the private dental colleges of Madhya Pradesh state are advised to go through the complete fee details.

To view the category and class-wise vacancies, click the link below

https://medicaldialogues.in/pdf_upload/neet-mds-2024-mpdmereleases-category-class-wise-vacancies-for-candidates-245525.pdf

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MoS Health apprises Parliament about steps taken to curb illegal organ trade

New Delhi: In a significant move to combat illegal organ transplant activities in the country, Union Minister of State for Health Smt. Anupriya Patel recently informed the Lok Sabha on the measures implemented by the Government.

As per the MoS Health, the Transplantation of Human Organs and Tissues Act, 1994 provides for an appropriate authority to be appointed by every State for investigating any complaint or breach of any of the provisions of this act, or any of the rules thereunder.

A series of questions raised by Shri Hibi Eden about the number of cases have been registered in illegal organ trade during the last five years, State/UT-wise, the conviction rate of such cases, the steps taken/proposed to be taken by the Government to curb such illegal activities, whether there are any recent regulations brought in place to prevent organ trafficking and ensure ethical organ transplantation practices.

In response to these questions, the MoS Health said, “The Transplantation of Human Organs and Tissues Act, 1994 provides for an appropriate authority to be appointed by every State for investigating any complaint or breach of any of the provisions of this act, or any of the rules thereunder. ‘Health’ and ‘Law & Order’ are State subjects. Thus, it is primarily the responsibility of the State Government/ UT Administration to take action for prevention and control of organ trafficking and monitor the same. The State Appropriate Authority shall, for the purposes of this act, have all the powers of a civil court to try a suit under the Code of Civil Procedure, 1908(5 of 1908). Whenever any complaint regarding organ trafficking is received in this Ministry, the same is referred to the concerned State/UT for appropriate action. The data in this regard is not maintained in this Ministry.”

Further, the Minister said that the National Organ and Tissue Transplant Organization (NOTTO) along with Regional Organ and Tissue Transplant Organizations (ROTTOs), State Organ and Tissue Transplant Organizations (SOTTOs) and other institutions organize awareness programs across the country to disseminate information about provisions of The Transplantation of Human Organs and Tissues Act and rules, so that people are cognizant towards the Government recognized process of organ donation permitted by the law, along with the illegality and repercussions associated with indulgence in organ trafficking, to make it easy for them to comply with the provisions of law.

Medical Dialogues team in June this year reported that the Union Government had sent out an alert to all States/Union Territories on websites and social media groups engaged in such activities after it noticed certain websites and social media posts that were promoting and offering organ trading in violation of the provisions of the Transplantation of Human Organ & Tissue Act (THOTA) 1994.

The Union Government shared the web link and other such social media posts that were being shared regularly and said that such activities were punishable offences under Section 18 of the Act with fines ranging from Rs 20 lakh to Rs 1 crore and imprisonment ranging from 5 years to 10 years.

Earlier this year, the Union Health Ministry had asked all states and UTs to investigate any violations and take appropriate action, including suspension of registration, against hospitals performing illegal organ transplants. The DGHS had urged all States and Union Territories to ensure regular collection and sharing of data on all transplant cases, including those of foreigners, with the National Organ and Tissue Transplant Organization (NOTTO) every month.

The Ministry had issued the direction around two weeks after an organ trafficking racket, involving Bangladeshi nationals, being run in Haryana and Rajasthan was busted.

The following steps taken by the Govenment to curb illegal organ transplant activities, as informed by MoS Health are as follows:

• A letter was sent by the Ministry of Health and Family Welfare to the Ministry of External Affairs (MEA) after which, a note verbale was circulated by MEA to all the Embassies/ Foreign Missions in India apprising them about the legal provisions of the organ transplant Act in India to prevent illegal organ transplants involving foreigners. Rules for transplants involving foreigners were shared with the Ministry of External Affairs for dissemination to Indian Missions abroad and the same have also been displayed on ports and Airports.

• States/UTs have been requested to ensure that every hospital performing organ transplantation or retrieval needs to be linked to the website of the National Organ & Tissue Transplant Organization (NOTTO) and data related to both deceased and living donors and recipients of transplants is required to be uploaded in the National Registry maintained by NOTTO. Further, each donor and recipient of human organ will have a unique NOTTO ID in cases of both deceased as well as living donor transplant and the same is to be generated by the concerned hospitals.

•All States/UTs have been advised to constitute an Advisory Committee as per provisions of the Transplantation of Human Organs and Tissues Act (THOTA), 1994 to aid and advise the Appropriate Authority in discharging its functions of controlling illegal organ transplant activities.

Also read- Centre Sends Alerts To States, UTs On Websites, Social Media Involved In Illegal Trading Of Human Organs

In another set of questions raised by Dr Bhola Singh regarding the government fixing any timeline for organ transplantation from living donors, the Minister said that the health department has prescribed timelines for the functioning of the Authorization Committee constituted under the Transplantation of Human Organs and Tissues Act (THOTA), 1994 for the guidance of State / Union Territory to expedite the decision-making process regarding living donor organ transplantation. 

Further, Dr Singh asked about the steps taken/proposed to be taken by the Government to ensure compliance with this timeline under the Transplantation of Human Organs and Tissues Act, 1994, whether a dedicated task force or committee is proposed to be established to monitor adherence to these timelines, the measures being taken to address delays in organ transplantation, specifically in cases where patients have died waiting for permissions; and whether any amendments are proposed to The Transplantation of Human Organs and Tissues Act, 1994 to improve the process and if so, the details thereof along with the other steps taken/proposed to be taken in this regard.

In response to these questions, the Minister said, “It is for the State Government / UT Administration to implement and monitor while ensuring compliance with the aforesaid timelines. THOTA provides for an Appropriate Authority in every State to be appointed by the State Government which is authorized to undertake such measures as may be prescribed. State Government is also authorized to constitute by notification the Authorization Committee at the State / district / hospital level. THOTA also provides for an Advisory Committee to be constituted by the State by notification to aid and advise the Appropriate Authority in discharging its functions.”

To review the THOTA, 1994, a ‘National symposium on Legal and Ethical Aspects of Organ Donation and Transplantation’ involving State/UT representatives, organ donation and transplantation experts, legal experts, NGOs and other relevant stakeholders was organised in January,2024 by National Organ & Tissue Transplant Organisation (NOTTO), the minister further stated.

Last year, the Medical Dialogues team reported that India had achieved more than 15,000 transplants in a year (2022) for the first time. Along with this, there was an annual increase of 27% in transplant numbers. This was informed by Union Health Secretary Shri Rajesh Bhushan at the National Organ & Tissue Transplant Organisation (NOTTO) Scientific Dialogue 2023.

The dialogue was organized to bring all the stakeholders under one roof to brainstorm ideas about interventions and best practices in the organ and tissue transplant field that can be taken up to save lives.

Also read- Over 15000 Organ Transplants Recorded In 2022, Union Health Secretary Says At NOTTO Scientific Dialogue 2023•

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Akums Drugs and Pharmaceuticals Gets CDSCO Panel Nod To study Norethindrone, Estradiol, Relugolix FDC

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Akums Drugs and Pharmaceuticals to conduct the Phase III clinical trial of Norethindrone Acetate USP 0.5 mg plus Estradiol (as Hemihydrate) USP eq. to Anhydrous Estradiol 1 mg plus Relugolix 40 mg film-coated tablet.

However, this approval came with conditions, which stated that a record of the training document should be maintained for each subject. In addition, the expert panel stated that a pictorial blood loss assessment chart (PBAC) should be available in a vernacular language with reference images to each subject.

The committee further stated that subjects need to be educated for the filing of the Blood Loss Assessment Chart.

This approval came after Akums Drugs and Pharmaceuticals presented the proposal along with a revised Phase III clinical trial protocol.

Norethindrone acetate is a synthetic form of the hormone progesterone. This medication is a hormone replacement to balance progesterone in the body. Norethindrone acetate treats endometriosis, uterine bleeding caused by abnormal hormone levels and secondary amenorrhea.

Estradiol is an estrogenic steroid used to treat vasomotor symptoms of vulvar and vaginal atrophy in menopause, hypoestrogenism, prevention of postmenopausal osteoporosis, treatment of breast cancer, and advanced androgen-dependent carcinoma of the prostate.

Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the revised Phase III clinical trial protocol of the fixed dose combination (FDC) Norethindrone Acetate plus Estradiol plus Relugolix film-coated tablet.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase III clinical trial with the conditions mentioned below:

1. Subject to be educated for filing of Pictorial Blood Loss Assessment Chart.

2. A record of the training document should be maintained for each subject.

3. Pictorial Blood Loss Assessment Chart (PBAC) should be available in a vernacular language with reference images to each subject.

Accordingly, the expert panel suggested that the firm should submit a Phase III clinical trial report to CDSCO for further review by the committee.

Also Read: Novartis Healthcare Gets CDSCO Panel Nod to Study Asciminib Filmcoated Tablets

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Rs 10000 fine, upto 3 months jail for insulting doctors on social media: Karnataka Govt Bill

Persons causing “intentional insult” to doctors either directly or indirectly through social media will now face penalty in Karnataka as the State Legislative Assembly has now passed the Karnataka Medical Registration and Certain Other Law (Amendment) Bill 2024.
As per the new amendments introduced by the Government, anyone found guilty of insulting a doctor directly, on social media or using unauthorised audio and video will be punished with a jail term extending up to three months or with a fine extending up to Rupees 10 thousand.
For more information, click on the link below:

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