Probiotics formulations may be used as complementary treatment for depressive disorders, claims study

A recent study highlighted the potential of probiotics as a supplementary treatment for depression, while also uncovering the impact of metabolic factors on their effectiveness. The key findings of this study were published in the recent edition of Nutrients Journal.

This research included a total of 116 participants who were diagnosed with depression. These individuals were randomly assigned to receive either a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 or a placebo over a span of 60 days. The study utilized a parallel-group, prospective, randomized, double-blind, controlled design to ensure the reliability of the findings.

Throughout the intervention period, the psychometric data of the participants were assessed at five different time points. Also, various metabolic parameters such as blood pressure, body weight, waist circumference and serum levels of C-reactive protein, cholesterol, triglycerides and fasting glucose were measured at the outset of the study.

While the overall depression scores did not show a significant advantage for the probiotics group over the placebo group, this study revealed a marked trend. The participants supplemented with probiotics expressed a higher rate of minimum clinically important differences when compared to the participants on placebo which indicated potential benefits. This effect was particularly pronounced in the subgroup of participants who also received antidepressant treatment.

The study also brought to light a crucial factor that influenced the efficacy of probiotics in treating depression which was metabolic abnormalities. The research found that individuals with more advanced metabolic issues, such as overweight, excess central adipose tissue and liver steatosis underwent lower improvements in psychometric scores. Also, the individuals with higher baseline stress levels showed better improvements by suggesting a complex interplay of factors at play.

The study illuminated that while probiotics show promise as complementary treatments for depressive disorders, they may not suffice as standalone interventions. The findings highlight the need for a precise approach to depression treatment in cases where metabolic abnormalities are present.

This study marks a crucial step forward in improving the existing understanding of the potential role of probiotics in mental health. Further research with in depth focus into the intricate connections between gut health, metabolism and depression are imperative as new avenues for more effective treatment strategies may emerge to offer better management of this debilitating condition.

Source:

Gawlik-Kotelnicka, O., Margulska, A., Płeska, K., Skowrońska, A., & Strzelecki, D. (2024). Metabolic Status Influences Probiotic Efficacy for Depression—PRO-DEMET Randomized Clinical Trial Results. In Nutrients (Vol. 16, Issue 9, p. 1389). MDPI AG. https://doi.org/10.3390/nu16091389

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Individuals of all ages with positive skin or blood test must receive preventive treatment for TB: LANCET

Preventive treatment for tuberculosis (TB) can stop latent TB infections from developing into deadly TB disease. Despite TB infection being fully treatable, there is no global consensus as to which subgroups of individuals exposed to TB should be prioritized for preventive treatment, nor whether the benefits of this treatment vary based on factors such as age or confirmed infection.

A new study led by a Boston University School of Public Health (BUSPH) researcher provides clarity to this issue, finding that exposed individuals with confirmed TB infection-i.e. a positive skin or blood test-should receive priority treatment in settings with a low prevalence of the disease, regardless of their age.

However, in high-burden settings, all exposed individuals should be considered for preventative treatment, even without a confirmed infection, according to the findings published in The Lancet Respiratory Medicine.

This strategy can help end the tuberculosis epidemic and support global public health efforts to reduce TB mortality by 95 percent by 2035 (from 2015 estimates). In 2022, there were more than 10 million cases of active TB worldwide, resulting in 1.5 million deaths.

“Tuberculosis affects tens of millions of people every year and has long-term lasting effects, even after people recover,” says study lead and corresponding author Dr. Leonardo Martinez, assistant professor of epidemiology at BUSPH. “Finding ways to optimize prevention is really important to tackle the epidemic.”

For the study, Dr. Martinez and colleagues conducted a comprehensive review and analysis to identify new cases of TB among people who were in close contact with individuals diagnosed with the disease, and compared the effectiveness of preventive treatment in these exposed individuals based on age, infection status, and burden of TB in their settings.

Among 439,644 participants, the team found that preventive TB treatment was 49 percent effective among the 2,496 individuals who developed TB, but particularly among individuals with a positive skin or blood test (for which the effectiveness was 80 percent).

Notably, the researchers found that preventive TB treatment was not effective in most individuals who did not show evidence of infection, except for children under 5.

For those who did have a positive skin or blood test, the effectiveness of the treatment was comparable among individuals of all age groups-adults, children ages 5-17, and children under 5-and the treatment was more effective among individuals in high-burden settings than low-burden settings.

The team also estimated the number of individuals needed to receive treatment (NNT) in order to prevent one person from developing TB disease. Regardless of infection status, the NNT was lower in high-burden settings (29 to 43 people) versus low-burden settings (213 to 455 people). Despite the fact that individuals with negative blood or skin tests do not seem to benefit from preventive treatments, the researchers say the overall low NNT may justify prioritizing this treatment to all exposed contacts in areas where testing for TB infection is inaccessible.

“While it is critical to find and treat people who are spreading TB in the community, the threat of global TB will never end until people with latent TB receive treatment,” says study coauthor Dr. C. Robert Horsburgh, professor of global health. “The results of this study show just how effective such treatment can be.” 

Reference:

Leonardo Martinez, James A Seddon, Prof C Robert Horsburgh, Prof Christoph Lange, Prof Anna M Mandalakas, Effectiveness of preventive treatment among different age groups and Mycobacterium tuberculosis infection status: a systematic review and individual-participant data meta-analysis of contact tracing studies, The Lancet Respiratory Medicine, DOI:https://doi.org/10.1016/S2213-2600(24)00083-3.

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Multifrequency tympanometry useful aid for diagnosing Meniere disease, claims study

Multifrequency tympanometry useful aid for diagnosis of Meniere disease, claims study published in the Journal of Clinical Medicine.

Ménière’s disease (MD) is a disease of the inner ear, presenting with episodes of vertigo, hearing loss, and tinnitus.This study aims to examine the role of multifrequency tympanometry (MFT) in the diagnosis of Ménière’s disease. A systematic review of MEDLINE (via PubMed), Scopus, Google Scholar, and the Cochrane Library was performed, aligned with the PRISMA guidelines. Only studies that directly compare ears affected by Ménière’s disease with unaffected or control ears were included. Random-effects model meta-analyses were performed. Results: Seven prospective case-control studies reported a total of 899 ears, 282 of which were affected by Ménière’s disease (affected ears—AE), 197 unaffected ears in patients with Ménière’s disease (UE), and 420 control ears (CE) in healthy controls. No statistically significant differences between the groups were observed regarding resonant frequency (RF). The pure tone audiometry average of the lower frequencies (PTA basic) was significantly greater in affected ears when compared with unaffected ears. The conductance tympanogram at 2 kHz revealed a statistically significantly greater G width of 2 kHz in the affected ears when compared to both unaffected and control ears, while control ears had a statistically significant lesser G width of 2 kHz compared to both the other two groups. multifrequency tympanometry, and specifically G width at 2 kHz, could be an important tool in the diagnosis of Ménière’s disease.

Reference:

Tsilivigkos C, Vitkos EN, Ferekidis E, Warnecke A. Can Multifrequency Tympanometry Be Used in the Diagnosis of Meniere’s Disease? A Systematic Review and Meta-Analysis. Journal of Clinical Medicine. 2024; 13(5):1476. https://doi.org/10.3390/jcm13051476

Keywords:

Multifrequency, tympanometry, useful, aid, diagnosis, Meniere disease, study, Journal of Clinical Medicine, multifrequency tympanometry; impedance tympanometry; tympanometry; Meniere’s disease; endolymphatic hydrops; systematic review; meta-analysis

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Endotracheal tube cuff lignocaine prevents postextubation cough in children undergoing elective surgery: Study

Recently published research paper investigates the efficacy of using intracuff lignocaine in preventing postextubation cough in pediatric patients undergoing elective surgeries. The study, conducted in India, involved 120 pediatric patients randomized into two groups: one with intracuff air and the other with intracuff 2% lignocaine. The incidence of postextubation cough was significantly lower in the group with intracuff lignocaine compared to the group with intracuff air. The study also found a significant increase in heart rate in patients with intracuff air compared to those with intracuff lignocaine. Furthermore, the study demonstrated that the diffusion of lignocaine through the cuff was sufficient to provide an adequate localized effect on the tracheal mucosa.

Surgery Duration and Cough Occurrence

The research also explored the relationship between the duration of surgery and the occurrence of cough in patients with reduced end-operative cuff pressure. It was found that as the duration of surgery increases, more time is available for the diffusion of lignocaine through the cuff at lower cuff pressure to produce the desired effect on the tracheal mucosa. The study highlighted a few limitations, including the lack of assessment of plasma concentration of lignocaine and the duration of action of intracuff lignocaine on the tracheal mucosa. The findings suggest that intracuff lignocaine significantly reduces postextubation cough in pediatric patients and mitigates adverse haemodynamic responses compared to intracuff air.

Future Considerations

Overall, the research contributes valuable insights into the potential of intracuff lignocaine in preventing postextubation cough and adverse events in pediatric patients undergoing elective surgeries. The study provides important considerations for future research, such as the assessment of plasma levels of lignocaine, the duration of action of intracuff lignocaine, and the exploration of alkalinised lignocaine as a superior option for cuff inflation in pediatric patients.

Key Points

– The research explored the relationship between the duration of surgery and the occurrence of cough in patients with reduced end-operative cuff pressure. It was observed that as the surgery duration increased, more time was available for the diffusion of lignocaine through the cuff at lower cuff pressure to produce the desired effect on the tracheal mucosa. The study did note some limitations, including the lack of assessment of plasma concentration of lignocaine and the duration of action of intracuff lignocaine on the tracheal mucosa.

– Overall, the study highlighted the potential of intracuff lignocaine in reducing postextubation cough and adverse events in pediatric patients undergoing elective surgeries. It also provided important considerations for future research, such as the assessment of plasma levels of lignocaine, the duration of action of intracuff lignocaine, and the exploration of alkalinized lignocaine as a superior option for cuff inflation in pediatric patients.

Reference –

Kavyashree, M. B.; Kundra, Pankaj; Vinayagam, Stalin. Efficacy of endotracheal tube cuff lignocaine in the prevention of postextubation cough in children undergoing elective surgeries – A randomised controlled trial. Indian Journal of Anaesthesia 68(5):p 486-491, May 2024. | DOI: 10.4103/ija.ija_1013_23

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Higher dietary intake of several nutrients may slow progression of Geographic Atrophy: Study

Researchers have found that specific nutrients in the diet may have a significant impact on the progression of geographic atrophy (GA) in age-related macular degeneration (AMD), according to new data presented at the 2024 Association for Research in Vision and Ophthalmology (ARVO). GA is a form of advanced AMD characterized by the degeneration of cells in the macula, leading to central vision loss. Elvira Agron, MS, DECA, and colleagues from the National Eye Institute investigated the association between dietary nutrient intake and GA progression towards the central macula.

Out of the 347 participants included in the study, a total of 413 eyes with non-central geographic atrophy (GA) were analyzed. Among these eyes, GA was already present in 88 cases, while it occurred incidentally in 326 cases. The researchers identified specific nutrients that were strongly associated with a reduction in GA progression. These nutrients included lutein/zeaxanthin, β-carotene, zinc, and omega-3 fatty acids. Participants with the highest intake of these nutrients showed significantly slower GA progression compared to those with lower intake levels.

  • Comparisons between the highest and lowest intake cohorts demonstrated significantly slower GA progression per year for zinc (34.8 vs. 45.5 µm/y), β-carotene (29.8 vs. 46.6 µm/y), lutein/zeaxanthin (32.9 vs. 47.5 µm/y), and EPA (35.5 vs. 43.7 µm/y).

  • higher intake levels of lutein/zeaxanthin, β-carotene, zinc, and omega-3 fatty acids were associated with slower GA progression towards the FCP. These nutrients are known for their antioxidant and anti-inflammatory properties, which may help protect retinal cells from degeneration.

  • Adherence to the Mediterranean diet, which is rich in fruits, vegetables, whole grains, and healthy fats, did not show a strong association with decreased GA progression. This suggests that specific nutrients within the diet may have a more significant impact on AMD progression than overall dietary patterns.

The findings highlight the potential role of dietary nutrients in slowing GA progression in AMD. Patients with non-central GA may benefit from dietary advice targeting specific nutrients, such as lutein/zeaxanthin, β-carotene, zinc, and omega-3 fatty acids, to potentially alter the natural course of the disease. Further research is needed to explore the efficacy of nutrient-rich diets as part of AMD management strategies.

Reference:

Agron E, Keenan TDL, Vitale S, Chew EY. Associations between Dietary Nutrient Intake and Geographic Atrophy Progression towards the Central Macula. Poster presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Meeting, May 5–9, 2024.

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Source of sugar more important than amount for development of obesity in children, reveals study

New research being presented at the European Congress on Obesity (ECO) in Venice, Italy (12-15 May) suggests that the source of sugar is more important than the amount of sugar when it comes to the development of obesity in children.

The study found that the total amount of sugar consumed when very young was not associated with weight at age 10 or 11.

However, children who got a higher proportion of their sugar from unsweetened liquid dairy products (milk and buttermilk) were less likely to go on to live with overweight or obesity.

Similarly, getting more sugar from fruit was associated with less weight gain. However, getting a lot of sugar from sweet snacks such as cakes, confectionery and sweetened milk and yoghurt drinks, such as chocolate milk, was linked to being of higher weight.

“The high consumption of sugary foods is considered a risk factor for childhood overweight and obesity and so children are advised to consume less sugar-rich foods, such as confectionery, cakes and sugar-sweetened drinks, and eat more fruit and unsweetened dairy products, such as milk and yoghurt,” says lead researcher Junyang Zou, of the Department of Epidemiology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.

“But while fruit and unsweetened dairy products are considered healthy, they contain high amounts of intrinsic sugars-sugar that occurs naturally in the food, rather than being added. We wanted to know if the source of sugar, added versus intrinsic, as well as the amount, affects the likelihood of developing overweight or obesity.

“While this has been studied before, the results are inconsistent and there is a lack of high quality research on the topic.”

To address this, Ms Zou and colleagues used data from the GEKCO Drenthe study1, an ongoing longitudinal study of a cohort of children born in Drenthe, in the northern Netherlands, between April 2006 and April 2007, to explore the association between total sugar intake in early childhood and the intake of sugar from different sources on weight, weight gain and the development of overweight and obesity.

The answers to a food intake questionnaire filled in by the parents of 891 children (448 males) when the children were 3 years were used to calculate daily total sugar intake and the daily sugar intake from 13 food groups [vegetables; fruits (whole fruit only); cereals; starchy vegetables; nuts; legumes; meat, eggs, vegetarian meat substitutes, and oil, butter, and margarines; milk and milk products; coffee and tea, and coffee and tea-based drinks; sugar-sweetened beverages (including fruit juice, lemonade and sweetened milk and yoghurt drinks); savoury products including homemade and ready meals and soup; sugary snacks such as cakes, confectionery and chocolate; toppings/sauces/sugars].

Height and weight, as measured by trained nurses, were used to calculate BMI Z-scores, the change in this score between 3 and 10/11 years and weight status at 10/11 years (normal weight/overweight/obese, as defined by International Obesity Task Force 2012 criteria).

BMI Z-scores are a widely used measure of weight in childhood and adolescence. They show how a young person’s BMI compares to the average BMI for their age and sex, with higher values representing a higher weight.

All 891 children were included in the BMI-Z score at 10/11y and change in BMI-Z score analyses. 817 of the children (414 males) were included in the weight status analysis (74/891 were living with overweight or obesity at age 3 and were excluded from this analysis).

Average total daily sugar intake was 112g. This made up around a third (32%) of the total daily energy intake of 1,388 calories.

The main sources of sugar were fruit (average daily intake = 13g), dairy products (18.6g), sugar-sweetened beverages (41.7g) and sugary snacks (13.1g).

At 10/11 years of age, 102 children with normal weight at the age of 3 had developed overweight or obesity.

Total sugar intake at 3 years was not related to BMI Z-score, weight gain or weight status 10/11 years.

However, a higher intake of sugar from sugary snacks was related to a higher BMI Z-score at 10/11.

In contrast, a higher daily sugar intake from fruit (whole fruit only) was related to a lower BMI Z-score at 10/11 years and less weight gain. (No significant association was found between fruit juice and weight.)

And a higher sugar intake from unsweetened liquid dairy products (milk and buttermilk) was related to a lower odds of developing overweight/obesity at age 10/11. Children with the highest intake of these products aged 3 had a 67% lower risk of going on to have overweight/obesity, compared to those with the lowest intake.

The study didn’t look at why these foods affected weight differently. However, possible explanations include slower release of sugar from pieces of fruit than from sugary snacks and differences in how the sugars in the different foods (sucrose in cakes and confectionery, fructose in fruit and lactose in dairy) act on the body.

The researchers conclude that when it comes to developing obesity in childhood, the source of sugar seems to be more important than the amount.

Ms Zou adds: “Children should be encouraged to have fruit and milk instead of sweetened milk and yoghurt drinks, sweets, cakes and other foods rich in added sugar.”

Reference:

Source of sugar may be more important than amount when it comes to the development of obesity in children, European Association for the Study of Obesity, Meeting: European Congress on Obesity (ECO2024).

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Children born after fresh and frozen embryo transfers at increased leukemia risk than children conceived naturally: JAMA

France: In recent years, the use of medically assisted reproduction (MAR) techniques, such as in vitro fertilization (IVF) and intrauterine insemination (IUI), has become increasingly common among couples facing fertility challenges. However, there have been concerns about the potential long-term health effects on children conceived through these methods, particularly regarding the risk of cancer.

A new cohort study published in JAMA Network Open provides reassuring findings on this front, suggesting that offspring of MAR procedures are not at a significantly higher risk of developing cancer compared to those conceived naturally.

In the cohort study of 8 526 306 children, there was no difference in the overall risk of cancer among children born after fresh embryo transfer (ET), frozen embryo transfer (FET), or artificial insemination (AI) and children conceived naturally. However, an increased leukemia risk was observed among children born after fresh ET (especially those with the longest follow-up) and among children born after FET (particularly acute lymphoblastic leukemia).

“These findings suggest that leukemia risk among children conceived by frozen embryo transfer or fresh embryo transfer should be further monitored,” the researchers wrote.

Cancer is the foremost cause of death among children worldwide. Treatments used for MAR are suspected risk factors because of their potential for epigenetic disturbance and associated congenital malformations. Paula Rios, French National Health Insurance, Saint-Denis, France, and colleagues aimed to assess the risk of cancer, overall and by cancer type, among children born after MAR compared with children conceived naturally.

For this purpose, the researchers searched the French National Mother-Child Register (EPI-MERES) for all live births in France between 2010 and 2021 (followed up until June 30, 2022). The EPI-MERES was built from comprehensive French National Health Data System data.

Using Cox proportional hazards regression models adjusted for maternal and child characteristics at birth, the risk of cancer was compared, overall and by cancer type, among children born after fresh ET, FET, or artificial insemination and children conceived naturally.

The study included 8 526 306 children with a mean age of 6.4 years; 51.2% were boys, 96.4% were singletons, 12.1% were small for gestational age at birth, and 3.1% had a congenital malformation.

The study revealed the following findings:

  • There were 3.1% of children born after MAR, including 1.6% after fresh ET, 0.8% after FET, and 0.7% after AI.
  • A total of 9256 case-patients with cancer were identified over a median follow-up of 6.7 years; 165, 57, and 70 were born after fresh ET, FET, and AI, respectively.
  • The overall risk of cancer did not differ between children conceived naturally and those born after fresh ET (hazard ratio [HR], 1.12), FET (HR, 1.02), or AI (HR, 1.09).
  • The risk of acute lymphoblastic leukemia was higher among children born after FET (20 case-patients; HR 1.61; risk difference [RD], 23.2 per million person-years) compared with children conceived naturally.
  • Among children born between 2010 and 2015, leukemia risk was higher among children born after fresh ET (45 case-patients; HR, 1.42; adjusted RD, 19.7 per million person-years).

The study findings suggest that children born after FET or fresh ET had an increased leukemia risk compared with children conceived naturally. There is a need to monitor this risk, although resulting in a limited number of cases, given the continuous increase in the use of ART.

Reference:

Rios P, Herlemont P, Fauque P, et al. Medically Assisted Reproduction and Risk of Cancer Among Offspring. JAMA Netw Open. 2024;7(5):e249429. doi:10.1001/jamanetworkopen.2024.9429

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Hand grip strength predicts shoulder function after rotator cuff repair, reports study

A recent study published in the Journal of Orthopaedic Surgery and Research highlights the role of a potential new indicator for postoperative success in rotator cuff tear repairs. The study analyzes the correlation between preoperative grip strength and postoperative shoulder function following arthroscopic rotator cuff repair (ARCR) where precise predictions can make all the difference in patient outcomes.

Rotator cuff tears (RCTs) are a widespread musculoskeletal issue that often necessitates surgical intervention for repair. ARCR is a common procedure for tendon repair which is frequently used in addressing this condition. The ability to accurately predict postoperative outcomes remains an ongoing challenge for orthopedic surgeons.

The study prospectively enrolled a total of 52 patients with full-thickness repairable RCTs to bridge this gap in knowledge. The baseline parameters like patient characteristics and intraoperative findings were meticulously analyzed along with postoperative shoulder functional outcomes. The Quick Disabilities of the Arm, Shoulder and Hand (QDASH) questionnaire and Constant–Murley scores (CMSs) served as the measures to evaluate shoulder function.

The study discovered a strong association between preoperative grip strength and postoperative shoulder function. The patients who expressed higher grip strength prior to surgery tended to experience more favorable outcomes following ARCR. This finding suggests that a simple preoperative grip strength test could serve as a valuable predictor for postoperative shoulder functional recovery.

The study identified other factors that influenced postoperative outcomes. The number of total suture anchors utilized during surgery inversely correlated with postoperative CMSs by indicating a potential impact of surgical technique on patient recovery. The higher body mass index (BMI) was associated with poorer postoperative QDASH scores during follow-up by highlighting the multifaceted nature of factors that influence surgical outcomes.

These findings suggest that implementing preoperative grip strength assessments as part of the standard evaluation process could provide valuable insights into expected postoperative recovery trajectories. Surgeons can tailor interventions and support strategies accordingly by identifying patients who may face challenges in their rehabilitation journey which could ultimately enhance the overall patient care and satisfaction.

The studies like this serve as important steps toward improving surgical outcomes and patient quality of life. Further research and clinical validation will help in making preoperative grip strength testing as a fundamental tool to offer personalized care and optimized results for individuals who undergo ARCR.

Source:

Liu, Y.-C., Huang, S.-W., Adams, C. R., Lin, C.-Y., Chen, Y.-P., Kuo, Y.-J., & Chuang, T.-Y. (2024). Preoperative handgrip strength can predict early postoperative shoulder function in patients undergoing arthroscopic rotator cuff repair. In Journal of Orthopaedic Surgery and Research (Vol. 19, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s13018-024-04750-8

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Pulsed radiofrequency on suprascapular and axillary-circumflex nerve effective for Shoulder pain relief: Study

Recently published randomized clinical trial compared the efficacy of combined pulsed radiofrequency (PRF) on suprascapular nerve (SN) and axillary-circumflex nerve (ACN) versus PRF on SN alone for the treatment of painful shoulder. This comprehensive study provides valuable insights into the efficacy of PRF techniques for treating painful shoulders and highlights the safety and effectiveness of these procedures. Sixty patients were included in the trial, with the primary outcome being pain intensity measured by the Numerical Rating Scale (NRS), and secondary outcomes including the Shoulder Pain and Disability Index (SPADI), the Constant–Murley range of motion scale, and Disability of the Arm, Shoulder and Hand (DASH) scale. A decline in pain intensity was observed at the end of the study, with the combined PRF on SN and ACN not showing significant differences in NRS pain scores compared to single SN PRF. Similar results were observed in the secondary outcomes, with no significant differences in SPADI, Constant–Murley, and DASH scores between the study groups.

Study Conclusions and Limitations

The study concluded that combined PRF applied to SN and ACN was not superior to PRF applied to SN alone in reducing pain intensity and improving shoulder functionality. The technique was found to be safe and effective in treating painful shoulder, demonstrating reasonable pain relief without causing significant complications. The combined technique produced sustained pain relief, similar to the single puncture technique over SN, with no statistically significant benefits from the combined technique. Some limitations of the study were acknowledged, such as the absence of a group without intervention as a comparator and the broad inclusion criteria covering a wide range of pathologies in painful shoulder syndrome, making the extrapolation of results difficult.

Overall Study Conclusion

In conclusion, the study found that PRF over SN or over SN and ACN provides sustained pain relief in patients with painful shoulders, with the combined technique not offering statistically significant benefits over the single puncture technique over SN.

Key Points

– The study found that there were no significant differences in NRS pain scores or secondary outcomes between the two study groups. Combined PRF on SN and ACN was not superior to PRF on SN alone in reducing pain intensity and improving shoulder functionality. The technique was considered safe and effective, providing sustained pain relief without significant complications. However, the combined technique did not show statistically significant benefits over the single puncture technique over SN.

– The study concluded that PRF over SN or SN and ACN provides sustained pain relief in patients with painful shoulders. However, the combined technique did not offer statistically significant benefits over the single puncture technique over SN. The study acknowledged limitations such as the absence of a group without intervention as a comparator and the broad inclusion criteria, making the generalization of the results challenging.

Reference –

Miñana, José Miguel Esparza1,2,3; Mazzinari, Guido3,4; Llopis-Calatayud, Jose Emilio5,6; Cerdá-Olmedo, Germán7. Efficacy of pulsed radiofrequency on the suprascapular and axillary-circumflex nerve for shoulder pain: A randomised controlled trial. Indian Journal of Anaesthesia 68(5):p 473-479, May 2024. | DOI: 10.4103/ija.ija_1107_23

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Alkem Laboratories Gets CDSCO Panel Nod To Manufacture Market Relugolix Tablets 120mg

New Delhi: Alekm Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Relugolix Tablets 120 mg.

However, this approval is subject to a condition that the firm conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.

This came after Alekm Laboratories presented the bioequivalence (BE) study report along with other documents:

1. Justification/clarification regarding significant inter-subject variability in presented BE study data.
2. Published Pharmacokinetic-Pharmacodynamic (PK/PD) data
3. Data on the ratio of serum to CSF concentration
4. Minimum effective concentration in CSF required for pharmacological action of the proposed drug.

Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions. It was first approved in Japan in 2019, under the brand name Relumina, for the symptomatic treatment of uterine fibroids, and more recently by the United States’ FDA in 2020, under the brand name Orgovyx, for the treatment of advanced prostate cancer. This branded product was later approved by the European Commission on April 29, 2022. Relugolix has also been studied in the symptomatic treatment of endometriosis.

Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer. Relugolix is indicated for the treatment of adult patients with advanced prostate cancer. In a combination product with estradiol and norethindrone, relugolix is indicated for the once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Relugolix 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 Oncology held on 7th May 2024, the expert panel reviewed the BE study report along with other documents presented by the drug major Alkem Laboratories.

The committee noted that the drug was already approved in the country on 16.10.2023.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Relugolix tablets 120mg with the condition that the firm should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.

Also Read: Submit Data on Paracetamol-Tapentadol Combination: CDSCO Panel tells MSN Laboratories

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