FDA approves Laser system for long term treatment of inflammatory acne

The US Food and drugs administration has approved Accure Laser System that is indicated for long term treatment of patients known to have mild to severe inflammatory acne vulgaris.

The Accure Laser System unlocks the unique selectivity of the 1726 nm laser wavelength, adding proprietary and first-in-class technology to precisely control thermal gradient depth to have maximum impact on the sebaceous gland. This treat-to-temperature mechanism of action has been validated through multiple IRB-approved clinical trials in the United States, achieving an average inflammatory lesion count reduction of 70% at 6 months after a series of four treatments spaced about one month apart. This was observed for all skin types and severities of acne.

Accure Acne recently completed a limited commercial release earlier this year in the United States, delivering significant clinical outcomes, as well as consistent provider and patient satisfaction scores of over 4.4 out of 5. Since then, Accure has expanded the availability of the Accure Laser System in multiple regions, with first adopters in the Middle East, Europe, The Caribbean, and Asia Pacific, where patients of all severities and skin types can benefit from a safe, effective, and now durable clinical outcome.

“This accomplishment is a testament to the relentless pursuit of this goal by Accure, Quanta System, and the team of clinicians and researchers who have spent many years together to bring the Accure Laser to the world”, added Emil Tanghetti, MD, Founder of The Center for Dermatology and Laser Surgery in Sacramento, CA, and the first Accure Laser investigator in the world. “Our journey in understanding the unique nature of this wavelength and the clinical requirements needed to deliver significant clinical outcomes was certainly challenging. The technical innovations of using temperature as an endpoint, combined with forced air cooling and real-time monitoring algorithms has produced a solution that stands alone from more traditional power-based methods. This unique laser has a platform that can be modified and adjusted to possibly treat a number of other skin conditions. I am excited about the future of this device and technology.”

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Vitamin B12 Identified as potential therapeutic agent in prevention and treatment of acute pancreatitis: Study

Acute pancreatitis (AP), which affects people of all ages, is one of the leading causes of hospital admission due to gastrointestinal diseases. Approximately 20% of patients develop moderate or severe acute pancreatitis, which carries extremely high mortality and disability rates. Even for those who recover, lifelong complications often follow, significantly affecting their quality of life. To date, many questions regarding the optimal treatment of acute pancreatitis remain unanswered. Most importantly, pharmacological agents that can inhibit early organ injury in the pancreas are needed.

A team led by Dr. Chuanwen Fan (Department of Gastrointestinal Surgery, West China Fourth Hospital, Sichuan University, and Department of Biomedical and Clinical Sciences, Linköping University), under the supervision of Prof. Dr. Xianming Mo (the senior author, West China Center of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, Laboratory of Stem Cell Biology, State Key Laboratory, West China Hospital, Sichuan University), combined human genetic epidemiology and animal models to discover and confirm the role of vitamin B12 in the prevention and mitigation of acute pancreatitis.

Fan explained that the team first conducted meta-analyses of genome-wide association studies (GWAS) using the largest genetic datasets available for pancreatitis. They then employed a Mendelian randomization approach to investigate the relationships between various one-carbon metabolism nutrients and the risk of pancreatitis. The analysis revealed that higher serum vitamin B12 levels were strongly associated with a reduced risk of developing different types of pancreatitis.

Next, the team determined whether vitamin B12 displayed protective and potential therapeutic effects using experimental models of pancreatitis in CD320 knockout mice, which lack a key gene responsible for vitamin B12 absorption. Two distinct models of pancreatitis were used in the study: one to observe early pancreatic injury responses, and the other to track the pathological progression of acute pancreatitis.

The results revealed that VB12 directly protects acinar cells from necrosis during the early stages of acute pancreatitis and subsequently reduces T lymphocyte infiltration. Notably, artificially increasing serum B12 levels before and after the induction of pancreatitis not only reduced the severity of the condition but also promoted tissue repair after pancreatic injury. Interestingly, despite vitamin B12’s known role in the one-carbon metabolism pathway, its protective effects in pancreatitis were not mediated through the reduction of homocysteine or the glutathione (GSH) pathways, as was previously hypothesized. Instead, vitamin B12 was found to enhance ATP production in pancreatic tissue, thereby reducing acinar cell necrosis and preventing disease progression. ATP supplementation in CD320-deficient mice also alleviated pancreatic damage, further supporting the hypothesis that vitamin B12’s protective effects result from improved cellular energy supply rather than oxidative stress regulation.

“These exciting new findings add to the growing evidence that vitamin B12 can reduce the severity of acute pancreatitis by increasing ATP levels in pancreatic tissue, offering novel insights into potential therapeutic strategies for this disease. This study lays a robust foundation for future clinical applications of vitamin B12 in managing acute pancreatitis,” Prof. Mo concludes.

Reference:

Yulin Chen, Xue Li, Ran Lu, Yinchun Lv, Yongzi Wu, Junman Ye, Jin Zhao, Li Li, Qiaorong Huang, Wentong Meng, Feiwu Long, Wei Huang, Qing Xia, Jianbo Yu, Chuanwen Fan, Xianming Mo, Vitamin B12 protects necrosis of acinar cells in pancreatic tissues with acute pancreatitis, MedComm, https://doi.org/10.1002/mco2.686.

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Are Hormonal Treatments and Vaginal Moisturizers useful for Genitourinary Syndrome of Menopause?

Recent systematic review published in the Annals of Internal Medicine offers insights into the effectiveness and safety of treatments for genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), and oral ospemifene, as well as vaginal moisturizers, are commonly used to alleviate symptoms of GSM, including vaginal dryness and painful intercourse. The review, led by Elisheva Danan, MD, MPH, and her colleagues, encompassed 46 randomized controlled trials, with most treatments lasting for 12 weeks or less. However, the safety of long-term use of these therapies remains unclear, particularly regarding the potential risk of uterine cancer with extended use of vaginal estrogen or ospemifene. The findings from the review indicate that hormonal treatments are associated with reduced pain during intercourse and decreased vaginal dryness, while moisturizers are linked to reduced dryness. Vaginal estrogen showed mixed effectiveness in reducing pain during intercourse compared to DHEA or ospemifene, although it outperformed placebo. The review also highlighted the scarcity of evidence on the benefits of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for the treatment of GSM. Notably, the conclusions drawn from the review have low certainty due to the short duration of most studies and varying definitions of GSM symptoms. Furthermore, the review did not address the association between GSM and recurrent urinary tract infections (UTIs). According to Rachel Rubin, MD, a urologist and sexual medicine specialist, hormones are essential for addressing the root cause of GSM and reducing the risk of recurrent UTIs. Rubin emphasized the link between UTIs and GSM, indicating that the lack of hormones to the tissue due to GSM can lead to recurrent UTIs, underscoring the importance of longer-term safety data for these treatments. In an accompanying editorial, Stephanie Faubion, MD, MBA, raised concerns about the lack of diversity among the patients represented in GSM treatment trials and the exclusion of women with cardiovascular challenges or cancer. This raises questions about the safety of these treatments for women with specific health conditions, such as cardiovascular risk factors or a history of cancer. Overall, the review provides important insights into the effectiveness of various treatments for GSM but underscores the need for further research, particularly regarding long-term safety and the association between GSM and UTIs.

Key Points

1. The systematic review in the Annals of Internal Medicine evaluates the effectiveness and safety of treatments for genitourinary syndrome of menopause (GSM), including vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), oral ospemifene, and vaginal moisturizers.

2. The review encompasses 46 randomized controlled trials, with most treatments lasting for 12 weeks or less. It highlights the reduced pain during intercourse and decreased vaginal dryness associated with hormonal treatments and moisturizers, but also notes the uncertainty regarding the long-term safety of these therapies, particularly the potential risk of uterine cancer with extended use of vaginal estrogen or ospemifene.

3. Vaginal estrogen, DHEA, and ospemifene show varying effectiveness in reducing pain during intercourse, with vaginal estrogen outperforming placebo, while the evidence on the benefits of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for the treatment of GSM is limited.

4. The review did not address the association between GSM and recurrent urinary tract infections (UTIs), which is highlighted as crucial, emphasizing the link between UTIs and GSM due to the lack of hormones to the tissue, and the importance of longer-term safety data for these treatments.

5. An accompanying editorial raises concerns about the lack of diversity among the patients in GSM treatment trials and the exclusion of women with cardiovascular challenges or cancer, which questions the safety of these treatments for women with specific health conditions.

6. The review provides vital insights into the efficacy of various GSM treatments but underscores the need for further research, particularly regarding long-term safety and the association between GSM and UTIs.

Reference –

Elisheva R. Danan, Catherine Sowerby, Kristen E. Ullman, et al. Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause: A Systematic Review. Ann Intern Med.2024;177:1400-1414. [Epub 10 September 2024]. doi:10.7326/ANNALS-24-00610

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High Topical Corticosteroid Phobia Reduces Treatment Adherence in Chronic Hand Eczema Patients: Study

According to researchers, nearly half of the adults with chronic hand eczema (CHE) have long-term health concerns over the use of topical corticosteroid (TCS), and over one-third of affected patients demonstrate at least some degree of fear about application. A recent study was published in the Journal of the American Academy of Dermatology. The study was conducted by Christensen and colleagues.

The investigation aimed to assess patient-reported outcomes related to the use of TCS and was conducted among a subgroup of participants from the Danish Skin Cohort (DSC). Fear and beliefs of patients toward TCS were measured using the TOPICOP scale, and adherence rates among patients were assessed using the Medication Adherence Report Scale (MARS-5). The results of the study are quite relevant because the majority of patients with CHE are requiring proper information about TCS.

The study involved 1340 eligible patients from the DSC and focused on 927 (69.2%) who participated in the study. Of this population, 71.7% were women with a mean age of 55.4 years. The mean age at onset of TCS in chronic hand eczema was set at 35.9 years. Information on current and previous TCS use has been obtained. Secondly, information on patients’ adherence to prescription-taken treatment as well as about their attitude towards TCS has been collected.

Key Findings

  • A total of 345 (37.2%) participants said that they were actively using TCS, while 251 (27.1%) participants reported any use of them in the past three to twelve months. Key findings in the study were as follows:

  • 48.9% of patients either completely agreed (12.1%) or almost agreed (36.8%) that TCS could harm their future health.

  • 73.4% patients with mild disease and 81.8% patients with severe disease felt that TCS could harm their skin.

  • 36.3% of patients were afraid of TCS not knowing the side effects, while 64.1% complained about the overuse of TCS.

  • 40.0% of those who are using TCS responded that they did not know of any side effects but fear to use TCS.

  • Nearly half of all patients (47.4%) said that they do not stop the treatment without a delay, and 30.5% report repeating early discontinuation.

  • Treatment Adherence and TCS Phobia

  • The overall median TOPICOP score was 51.9% and represented a moderate degree of fear related to corticosteroids among the patients. Other findings included:

  • 38.8% of the patients reported taking less medication than prescribed, often or very often. Greater TOPICOP scores were associated with lesser medication adherence as indicated by MARS-5 results (β = –0.02; 95% CI, –0.031 to –0.006; P <.005).

  • Increased fear of TCS was also related to low adherence, and patients had increased scores in the fear domain of the TOPICOP scale (β = –0.02; 95% CI, –0.029 to –0.009; P <.005).

The topical corticosteroid phobia is highly prevalent among patients with CHE and is closely associated with poor adherence to medication. The researchers call for increased education among patients and healthcare professionals aimed at dispelling fears associated with use of TCS. This also depends on improving non-steroidal treatments for CHE in an effort to improve patient outcomes and adherence to treatment.

Reference:

Christensen MO, Sieborg J, Nymand LK, et al. Prevalence and clinical impact of topical corticosteroid phobia among patients with chronic hand eczema – findings from the Danish Skin Cohort. J Am Acad Dermatol. Published online August 22, 2024. doi:10.1016/j.jaad.2024.07.1503

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Long term consumption of dark chocolate beneficial in preventing retinal vascular disease, reveals research

Research published in Scientific Reports reveals that long-term consumption of dark chocolate is beneficial in preventing retinal vascular disease.

There is a lack of knowledge about the effect of flavanols-rich dark chocolate intake on the anatomy and functionality of retinal vessels. The aim of this study prospective, randomized, blind, crossover clinical trial (ClinicalTrials.gov Identifier: NCT05227248, 07/02/2022) was to evaluate the effect of dark-chocolate intake on the functionality and anatomy of the retinal vessels in healthy subjects using dynamic vessel analyzer (DVA) and optical coherence tomography angiography (OCT-A). Twenty eyes of 20 healthy subjects (mean age, 24.4 ± 1.6 years; 12 females) were enrolled. Participants were randomized to consume 20 g of dark chocolate or 7.5 g of milk chocolate. Visual function, DVA and OCT-A parameters were evaluated before chocolate consumption and two hours later. One week later, the same participants were tested before and after consuming the opposite chocolate. Using OCT-A, no differences were disclosed in terms of perfusion density changes after dark-chocolate and milk-chocolate intake analyzing all chorioretinal plexuses (p > 0.09 in all analyses). Using DVA, a significant increase in the arterial dilation percentage after flicker stimulation was disclosed comparing baseline (2.750 ± 2.054%) with values after the dark chocolate intake (4.145 ± 3.055%, p = 0.016). This difference was not disclosed after the milk chocolate intake (p = 0.465). We disclosed that a reasonable amount of flavanols-rich chocolate in healthy subjects has benefic functional short-term effects in retinal vessels measured with DVA. This suggests a potential role of dark chocolate intake on retinal vessels. Further studies with long-term follow-up are warranted to show if the chronic assumption of dark chocolate could play a favorable role in the prevention of retinal diseases.

Reference:

Sacconi, R., Pezzella, M., Ribarich, N. et al. Benefits of dark chocolate intake on retinal vessels functionality: a randomized, blind, crossover clinical trial. Sci Rep 14, 20203 (2024). https://doi.org/10.1038/s41598-024-70289-7

Keywords:

Long term, consumption, dark chocolate, beneficial, preventing, retinal, vascular, disease, reveals, research, Scientific Reports, Sacconi, R., Pezzella, M., Ribarich, N.

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Preoperative Carbohydrate Drinks Improve Safety and Recovery in Elective Cesarean: Study Reveals

India: Recent research highlights the potential benefits of preoperative carbohydrate loading in preventing perioperative ketoacidosis during elective cesarean deliveries. The study suggests that administering an oral carbohydrate drink two hours before surgery can enhance clinical outcomes, providing a safer approach for patients.

“An oral carbohydrate (CHO) drink is safe to administer two hours before uncomplicated elective cesarean deliveries and may positively impact various perioperative clinical outcome markers,” the researchers wrote in the Journal of Anaesthesiology Clinical Pharmacology.

Long periods of fasting during the third trimester of pregnancy can be harmful, as they may cause hypoglycemia, elevated free fatty acid (FFA) levels, and increased ketones in the blood and urine. In these cases, preoperative carbohydrate-rich drinks may help. The Enhanced Recovery After Surgery (ERAS) guidelines suggest offering oral CHO fluid supplementation to nondiabetic pregnant women two hours before a cesarean delivery.

Against the above background, Ankita Sharma, Dayanand Medical College, Ludhiana, Punjab, All India Institute of Medical Sciences Bathinda, Punjab, India, and colleagues aimed to evaluate the effectiveness of preoperative oral CHO loading in preventing perioperative ketoacidosis during elective cesarean deliveries.

For this purpose, the researchers enrolled 120 parturients classified as American Society of Anesthesiologists (ASA) II/III who were undergoing elective cesarean sections with subarachnoid block (SAB). After providing written informed consent, the participants were divided into two groups of 60. Group A received 400 ml of filtered water two hours before surgery, while Group B received 400 ml of a nonparticulate CHO drink.

The primary outcome measured was the incidence of ketonuria, assessed using the dipstick method. Secondary outcomes included hunger and thirst scores, anxiety levels, dominant hand grip strength, and the quality of recovery scores.

The following were the key findings of the study:

  • Urine ketone levels were positive (+1) in 8.3% of participants in Group A, compared to only 1.7% in the carbohydrate (CHO) group.
  • The CHO group also reported significantly lower hunger and thirst scores and modified Beck’s anxiety scores.
  • Dominant hand grip strength remained stable in both groups.
  • The quality of recovery score was significantly higher in the CHO group.
  • No serious adverse effects were observed in either group.

The researchers wrote, “From our results, we conclude that allowing clear fluids or a nonparticulate carbohydrate drink up to two hours before surgery is safe for the parturient. This practice may help improve preoperative discomfort related to hunger, thirst, and anxiety.”

They further noted, “the quality of recovery regarding postoperative experiences such as pain, nausea, vomiting, and overall comfort improved with CHO loading. Thus, administering oral CHO drinks before surgery is safe for elective cesarean deliveries and may positively influence perioperative clinical outcomes.”

Reference:

Sharma A, Singh U, Kaur G, Grewal A, Maingi S, Tidyal S. Role of preoperative carbohydrate loading for prevention of perioperative ketoacidosis in elective cesarean delivery. JAnaesthesiol Clin Pharmacol 2024;40:439-44.

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Outcomes of Immediate implant placement in damaged extraction sockets comparable to conventional implant placement finds study

A study published in Quintessence International found outcomes of immediate implant placement in damaged extraction sockets comparable to conventional implant placement.

This study aimed to observe whether immediate implant placement (IIP) into damaged extraction sockets is a successful modality for treating hopeless teeth that require extraction. An electronic search was carried out through four databases (PubMed/MEDLINE, Web of Science, Scopus, and ScienceDirect) to identify randomized controlled trials (2013-2023) to understand whether IIP in damaged sockets is a successful treatment. The focus question was, ‘In a patient with a hopeless tooth that needs extraction with the indication for dental implant treatment, is IIP in damaged extraction sockets, compared to undamaged sockets or healed sites, an effective method for the replacement of hopeless teeth and achieving a favourable clinical result?’ The risk of bias was appraised and a meta-analysis using random effect was applied. Five studies with 135 patients and 138 implants were included. The implant survival rate was 100% for all studies and periods evaluated; the pink esthetic score (PES) scores had no statistically significant result for all articles that evaluated this parameter; two studies reported the soft tissue changes: one found no significant differences and the other showed that the test group experienced reduced soft tissue loss at the 1-year evaluation (measured with digital intraoral scanners); other two studies assessed the marginal bone loss, presenting no differences between groups. The meta-analysis showed homogeneity between the studies. There was an equilibrium among the groups in the various studies included, and age tended to be lower in the test group. The buccal bone tissue and the pink esthetic score showed favouritism for the test group but without statistical significance. This study suggests that IIP in the presence of buccal bone defects can achieve comparable clinical and radiological outcomes to traditional methods in the short term of the limited studies available. The buccal aspect is not possible to be evaluated through radiographs. Bone regeneration was essential to reach optimal results. It is important to emphasize that IIP requires adherence to rigorous criteria to ensure functionally acceptable results.

Reference:

Campi M, Leitão-Almeida B, Pereira M, Shibli JA, Levin L, Fernandes JCH, Fernandes GVO, Borges T. Immediate implant placement in damaged extraction sockets: a systematic review and meta-analysis of randomized controlled trials. Quintessence Int. 2024 Oct 1;0(0):0. doi: 10.3290/j.qi.b5768294. Epub ahead of print. PMID: 39351790.

Keywords:

Outcomes, Immediate, implant, placement, damaged, extraction, sockets, comparable, conventional, implant, placement, finds, study, Campi M, Leitão-Almeida B, Pereira M, Shibli JA, Levin L, Fernandes JCH, Fernandes GVO, Borges T, Buccal bone defect; Compromised extraction sockets; Dental implants; Fresh sockets; Immediate implant placement.

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Compound from mushroom new colorectal cancer therapy, reveals surgery

Novel chemical compounds from a fungus could provide new perspectives for treating colorectal cancer, one of the most common and deadliest cancers worldwide. In the journal Angewandte Chemie, researchers have reported on the isolation and characterization of a previously unknown class of metabolites (terpene-nonadride heterodimers). One of these compounds effectively kills colorectal cancer cells by attacking the enzyme DCTPP1, which thus may serve as a potential biomarker for colorectal cancer and a therapeutic target.

Rather than using conventional cytostatic drugs, which have many side effects, modern cancer treatment frequently involves targeted tumor therapies directed at specific target molecules in the tumor cells. However, the prognosis for colorectal cancer patients remains grim-there is a need for new targets and novel drugs.

Targeted tumor therapies are mostly based on small molecules from plants, fungi, bacteria, and marine organisms. About half of current cancer medications were developed from natural substances. A team led by Ninghua Tan, Yi Ma, and Zhe Wang at the China Pharmaceutical University (Nanjing, China) chose to use Bipolaris victoriae S27, a fungus that lives on plants, as the starting point in their search for new drugs.

The team first analyzed metabolic products by cultivating the fungus under many different conditions (OSMAC method, one strain, many compounds). They discovered twelve unusual chemical structures belonging to a previously unknown class of compounds: terpene-nonadride heterodimers, molecules made from one terpene and one nonadride unit. Widely found in nature, terpenes are a large group of compounds with very varied carbon frameworks based on isoprene units. Nonadrides are nine-membered carbon rings with maleic anhydride groups. The monomers making up this class of dimers termed “bipoterprides” were also identified and were found to contain additional structural novelties (bicyclic 5/6-nonadrides with carbon rearrangements).

Nine of the bipoterprides were effective against colorectal cancer cells. The most effective was bipoterpride No. 2, which killed tumor cells as effectively as the classic cytostatic drug Cisplatin. In mouse models, it caused tumors to shrink with no toxic side effects.

The team used a variety of methods to analyze the drug’s mechanism: bipoterpride 2 inhibits dCTP-pyrophosphatase 1 (DCTPP1), an enzyme that regulates the cellular nucleotide pool. The heterodimer binds significantly more tightly than each of its individual monomers. The activity of DCTPP1 is elevated in certain types of tumors, promoting the invasion, migration, and proliferation of the cancer cells while also inhibiting programmed cell death. It can also help cancer cells to resist treatment. Bipoterpride 2 inhibits this enzymatic activity and disrupts the-pathologically altered-amino acid metabolism in the tumor cells.

The team was thus able to identify DCTPP1 as a new target for the treatment of colorectal cancer and bipoterprides as new potential drug candidates.

Reference:

Dr. Li Feng, Xinjia Wang, Xinrui Guo, Liyuan Shi, Shihuang Su, Xinjing Li, Dr. Jia Wang, Prof. Ninghua Tan, Prof. Yi Ma, Prof. Zhe Wang, Identification of Novel Target DCTPP1 for Colorectal Cancer Therapy with the Natural Small-Molecule Inhibitors Regulating Metabolic Reprogramming, Angewandte Chemie International Edition, https://doi.org/10.1002/anie.202402543.

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Mini-PCNL Safe and Effective for Treating Kidney Stones in Children: Study Reveals

Iraq: A recent study published in Urolithiasis Journal has highlighted the safety and efficacy of miniaturized percutaneous nephrolithotomy (mini-PCNL) as a treatment for kidney stones in pediatric patients. This innovative surgical technique offers a minimally invasive option for addressing renal stones, which can cause significant discomfort and complications if left untreated.

The study found that mini-PCNL is safe and achieves a high stone-free rate, making it an appealing choice for patients and healthcare providers.

“In patients with stones larger than 15 mm, the stone-free rate was 87.01%, comparable to the 88.57% observed in adults. Although adults experienced a slightly greater drop in hemoglobin levels, there were no significant differences in complications, including blood transfusions, postoperative fever, or the need for additional interventions,” the researchers wrote.

Mini-PCNL is a refined version of traditional percutaneous nephrolithotomy (PCNL), designed specifically for children. It employs smaller instruments and accesses the kidney through a tiny incision, reducing tissue damage and recovery time. Waleed N. Jaffal, College of Medicine, University of Anbar, Ramadi, Al Anbar, Iraq, and colleagues aimed to evaluate the safety and efficacy of mini-PCNL for treating renal stones in children.

For this purpose, the researchers enrolled 77 patients under the age of 15 with renal stones larger than 15 mm in a prospective case-controlled study conducted at Al-Ramadi Teaching Hospital, Ar Razi Private Hospital, and Ghazi Al-Hariri Hospital for Surgical Specialties in Anbar and Baghdad, Iraq, from January 2020 to January 2024. This group, referred to as group A, was compared to a control group (group B) comprising 70 adult patients aged 18 to 60. Both groups underwent mini-PCNL procedures.

The study compared various factors, including gender, stone size, and location, operation time, stone-free rate, hemoglobin drop, need for blood transfusion, incidence of postoperative fever, any associated visceral injuries, and the requirement for further interventions such as extracorporeal shock wave lithotripsy or flexible ureteroscopy (ESWL or FURS).

The following were the key findings of the study:

  • The ages of patients in group A ranged from 8 months to 15 years, with a mean of 4.30 ± 3.16 years, while group B included adults aged 18 to 60 years, with a mean age of 36.3 ± 12.0 years.
  • There were no significant differences in gender distribution, stone size, or location.
  • The stone-free rate was 87.01% for group A and 88.57% for group B, showing no statistical difference.
  • The average hemoglobin drop was 1.096 ± 0.412 in group A and 1.195 ± 0.110 in group B.
  • Blood transfusions were required in one case from each group, with no significant difference.
  • There were three cases in group A and two in group B needing ESWL, with no statistical difference between the groups.
  • FURS was required in four cases in group A and three in group B.
  • The operative time ranged from 30 to 125 minutes for group A and from 34 to 129 minutes for group B.
  • Postoperative fever occurred in 23 cases in group A and 21 cases in group B (p-value 0.986).
  • Minor liver injuries were reported in one case from each group.

“The findings indicate that mini-PCNL is a safe and effective method for treating renal stones in children, with a low rate of significant complications and a high stone-free rate,” the researchers concluded.

Reference:

Jaffal, W.N., Al-Timimi, H.F.H., Hassan, O.A. et al. The safety and efficacy of miniaturized percutaneous nephrolithotomy in children. Urolithiasis 52, 142 (2024). https://doi.org/10.1007/s00240-024-01643-7

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Medication and cognitive behavioral therapy can reduce fatigue among MS patients, finds study

In a study of commonly used treatments for people with multiple sclerosis, both medical and behavioral interventions, and a combination of the two, resulted in meaningful improvements in fatigue, a University of Michigan-led study finds.

The randomized clinical trial compared the effectiveness of modafinil, a wake-promoting medication used to treat sleepiness in people with sleep disorders, and cognitive behavioral therapy, or CBT, on reducing fatigue for over 300 adults with multiple sclerosis whose symptoms interfered with their daily activities.

Overall, investigators found that treatment with either modafinil or CBT alone, which was delivered over the phone, was associated with significant reductions of fatigue over 12 weeks.

A combination of both treatments also worked as well as each individual treatment but did not result in better fatigue scores than the independent interventions.

The findings are published in The Lancet Neurology.

“Fatigue is one of the most common and debilitating symptoms of multiple sclerosis, yet there is still uncertainty about how available treatments should be used or how medication-based treatments compare to behavioral treatments in the real world” said first author Tiffany J. Braley, M.D., M.S., director of the Multiple Sclerosis/Neuroimmunology Division and co-founder of the Multidisciplinary MS Fatigue and Sleep Clinic at University of Michigan Health.

“This research offers new evidence to show that both CBT and modafinil are comparably effective for MS fatigue, which could shape treatment approaches to one of the most challenging symptoms experienced by people with multiple sclerosis.”

Of nearly 3 million people with multiple sclerosis worldwide, up to 90% experience fatigue. Nearly half describe it as their most disabling and impactful symptom.

The research used a real world approach that more closely resembled clinical practice than traditional clinical trials and included stakeholders with MS who helped design the study.

More than 60% of participants in each group of the study reported clinically meaningful improvement in fatigue, which was measured with a survey called the Modified Fatigue Impact Scale.

“These treatments, both individually and as a combination, should be considered as potential options for people with multiple sclerosis with chronic, problematic fatigue,” said senior author Anna L. Kratz, Ph.D., professor of physical medicine and rehabilitation at U-M Medical School.

Braley and Kratz co-led the study, which was funded by the Patient-Centered Outcomes Research Institute.

Collaborators at a secondary study site, the University of Washington, contributed to this pragmatic trial.

“This study focused intently on patient-centered outcomes, and our findings highlight the importance of shared decision making about treatment selection, with consideration of patient characteristics and broader treatment goals,” Braley said.

Trial participants who received only CBT maintained lower fatigue scores at an additional follow-up appointment 12 weeks after the study treatments ended.

CBT has shown robust and durable effects on fatigue in previous research.

“While many people with multiple sclerosis have limited access to behavioral health care like CBT, offering the treatment through telehealth can help reach more patients,” Kratz said.

“Our study shows that CBT is a feasible treatment that teaches fatigue management skills that can be employed indefinitely, with enduring benefits that last well beyond the treatment period.”

Although the three treatment assignments worked similarly well overall, participants’ sleep habits, or “sleep hygiene”, affected how well the treatment worked for fatigue.

Those with poor sleep hygiene tended to have better fatigue outcomes with CBT, and participants with very good sleep hygiene showed better fatigue outcomes with modafinil.

“Using wake promoting medications such as modafinil could worsen sleep quality in patients whose sleep problems are behavioral in nature,” Braley said.

“As sleep disturbances also contribute to fatigue in people with MS, it is important to avoid selecting fatigue treatments that could make sleep worse. Behavioral treatments such as CBT that include sleep education may be preferable for people with MS who have poor sleep habits.”

Reference:

Braley, Tiffany J et al., Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial, The Lancet Neurology, DOI:10.1016/S1474-4422(24)00354-5 

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