Use of elderberry as herbal supplement may exacerbate dermatomyositis and cutaneous lupus erythematosus: Study

Researchers found that among those patients affected by autoimmune skin diseases such as dermatomyositis (DM) and cutaneous lupus erythematosus (CLE), the use of herbal supplements is widespread. A recent study, performed in the rheumatologic-dermatology clinic at the University of Pennsylvania, highlights the need to enhance patient and provider education regarding the risks of herbal supplements in autoimmune disorders. The study was published in ACR Open Rheumatology by Daniella and colleagues.

In recent studies, there is a growing trend to undergo herbal remedies; patients have gradually accepted alternate or additive therapies for chronic diseases. However, some supplements can stimulate the immune system, which may worsen the condition by causing immunological derangement. The present study focused on the use of herbal supplements in autoimmune skin disease and aspires to define some patterns and risk involved in them.

A retrospective analysis was conducted on the cohort of 673 adult patients with validated cases of dermatomyositis or cutaneous lupus erythematosus treated at the University of Pennsylvania’s rheumatologic-dermatology clinic between January 2007 and February 2024. Data collected include demographic data, as well as those regarding disease characteristics, and detailed data regarding herbal supplement use. Predictors of supplement treatment were evaluated through chi-square tests, and results are reported in odds ratios to outline significant patterns and risks.

Key Findings

32% of patients reported using herbal supplements. Patterns of use were associated with marked variability based on age and ethnicity:

  • 44% of patients aged 18–29 years used herbal supplements, compared to 29% of patients aged 50–64 years (P = 0.02) and 23% of patients aged 65 years and older (P = 0.003).

  • Herbal supplement use was significantly more common among Hispanic/Latino patients at 58% compared with White patients at 31%, P = 0.009.

  • Sex and race did not differ in supplement use (33% of women patients vs 29% of men patients, P = 0.49) or race (31% of Whites, 31% of African Americans, P = 1.0; 38% of Asians, P = 0.55). No differences occurred between patients with DM (30%) and those with CLE (36%, P = 0.12).

However, the study did reveal some important information regarding the risk of herbal supplements.

  • Among DM patients, 31% reported onset or worsening of disease after initiation of herbal therapy, compared with 10% of CLE patients.

  • Among these herbal supplements, elderberry appears to be the most commonly linked with exacerbation in both DM and CLE patients, with symptoms worsening in 62% of DM and 50% of CLE.

In conclusion, the prevalence of supplement use was high in autoimmune skin disease patients. Of these supplements, elderberry posed the greatest risk to patients’ conditions, particularly for dermatomyositis sufferers. Healthcare providers need to be vigilant in terms of screening and advising patients against using risky supplements so that patients are protected from immune dysregulation and worsening of conditions.

Reference:

Faden, D. F., Stone, C. J., Xie, L., Lopes Almeida Gomes, L., & Werth, V. P. (2024). Prevalence and risk of immunostimulatory herbal supplement treatment among autoimmune dermatology patients. ACR Open Rheumatology. https://doi.org/10.1002/acr2.11735

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ASSIST II study evaluated Feasibility, Safety, and Efficacy of the OdonAssist Device for Assisted Vaginal Births

Recent study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial for assisted vaginal births. The study involved 104 participants who received the OdonAssist intervention, as well as a nested cohort of participants who consented but did not receive the intervention.

Primary and Secondary Outcomes

The primary outcome was the proportion of births successfully assisted with the OdonAssist device. Secondary outcomes included clinical, patient-reported, operator-reported, device, and health care utilization measures, as well as maternal and neonatal outcomes. The study found that the success rate of the OdonAssist device was 66% (69/104), meeting the threshold for a future randomized controlled trial. There were no serious device-related maternal or neonatal adverse reactions, and potential advantages were observed for neonatal outcomes, with only 4% of the successful OdonAssist group experiencing any device-related adverse effects in the form of neonatal soft tissue bruising, compared to 20% in the unsuccessful OdonAssist group and 23% in the nested cohort.

Factors Affecting OdonAssist Success

Factors associated with higher OdonAssist success rates included shorter total second stage duration, lower station at birth, and more operator experience. Participants reported high birth perception scores, and all practitioners found the device easy to use.

Feasibility, Recruitment, and Future Trial Implications

The study demonstrated that recruitment to an interventional study of a new device for assisted vaginal birth is feasible, with 64% of eligible participants willing to participate. The results provide important data to inform the design of a future randomized controlled trial to compare the OdonAssist with current standard practice for assisted vaginal births.

Key Points

1. The study aimed to determine the feasibility, safety, and efficacy of the OdonAssist device for assisted vaginal births, involving 104 participants who received the intervention and a nested cohort who did not.

2. The primary outcome was the success rate of the OdonAssist device, which was 66%, meeting the threshold for a future randomized controlled trial. There were no serious device-related adverse reactions, and potential advantages were observed for neonatal outcomes.

3. Factors associated with higher OdonAssist success rates included shorter total second stage duration, lower station at birth, and more operator experience. Participants reported high birth perception scores, and practitioners found the device easy to use.

4. The study demonstrated that recruitment to an interventional study of a new device for assisted vaginal birth is feasible, with 64% of eligible participants willing to participate.

5. The results provide important data to inform the design of a future randomized controlled trial to compare the OdonAssist with current standard practice for assisted vaginal births.

6. Overall, the study suggests that the feasibility, safety, and efficacy of the OdonAssist device are sufficient to justify conducting a future randomized controlled trial for assisted vaginal births.

Reference –

Hotton EJ, Bale N, Rose C, White P, Wade J, Mottet N, Loose AJ, Elhodaiby M, Lenguerrand E, Draycott TJ, Crofts JF; ASSIST II Study Group. The OdonAssist inflatable device for assisted vaginal birth-the ASSIST II study (United Kingdom). Am J Obstet Gynecol. 2024 Mar;230(3S):S932-S946.e3. doi: 10.1016/j.ajog.2023.05.018. Epub 2023 Jul 30. PMID: 38462264.

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Extra Virgin Olive Oil Preserves Cognitive Function in Down Syndrome, suggests study

Researchers working with the Alzheimer’s Center at Temple (ACT) recently investigated the effect of extra virgin olive oil (EVOO) on brain health and memory to determine if consumption of extra virgin olive oil, the main component of the Mediterranean diet, can delay cognitive decline in people with Down Syndrome (DS). DS is the most common genetically induced form of physical and intellectual disability, and while modern medical advances have helped to prolong life expectancy from around 40 years to an average of 60, the development of Alzheimer’s disease (AD) in DS patients has become more common than ever before. Individuals with Down syndrome develop age dependent cognitive decline and synaptic dysfunction.

Studies have shown that by the age of 40, about 50% of people with DS manifest significant learning and memory problems which are associated with the presence of Alzheimer’s-like impairment.

The paper, “Extra virgin olive oil beneficial effects on memory, synaptic function, and neuroinflammation in a mouse model of Down syndrome,” describes the results of the study in the Journal of Alzheimer’s Disease. 

Using a mouse model of DS, researchers administered EVOO for 5 months in their diet, after which they were tested for learning and memory impairment. Synaptic function was then measured, and brain tissues were assessed for inflammatory biomarkers. Researchers found that mice receiving EVOO had a significant improvement in learning and spatial memory. Additionally, treated mice had an improvement in synaptic function, and EVOO decreased levels of several inflammatory biomarkers.

“Administration of EVOO to a mouse model of Down syndrome has beneficial effects on memory impairments, synaptic function deficits and neuroinflammation,” says senior author Domenico Praticò, MD, the Scott Richards North Star Foundation Chair for Alzheimer’s Research, Professor of Neural Sciences and Founding Director of the Alzheimer’s Center at Temple (ACT), at the Lewis Katz School of Medicine at Temple University (LKSOM). “Our findings provide additional support for the potential therapeutic effects of EVOO also in individuals with Down syndrome.” 

Reference:

Li J-G, Leone A, Servili M, Praticò D. Extra virgin olive oil beneficial effects on memory, synaptic function, and neuroinflammation in a mouse model of Down syndrome. Journal of Alzheimer’s Disease. 2024;0(0). doi:10.1177/13872877241283675.

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Xanthelasma Palpebrarum Not Linked to Increased Cardiovascular or Dyslipidemia Risk: Study

Research has established that xanthelasma palpebrarum (XP), which is associated with yellowish cholesterol deposits on the eyelids, does not significantly contribute to the incidence of dyslipidemia and cardiovascular disease (CVD). A recent study was published in the journal Ophthalmology conducted by Lustig-Barzelay and colleagues..

This study was designed to establish a hypothesis to identify an association between xanthelasma palpebrarum and dyslipidemia, cardiovascular disease, and other systemic conditions within a large population.

Case-control study was carried out at a single tertiary care center in the medical records of 2001 to 2020. Available records were reviewed on the grounds of ophthalmic evaluations, results from blood tests, and diagnoses for systemic conditions. The study group consisted of patients diagnosed with XP in at least one eye, while a control group without XP was established and matched by age and sex at a ratio of 10:1 for the purposes of robust statistical comparisons between the two groups. The main outcome measures were associations of XP with dyslipidemia and cardiovascular disease with an emphasis on comparing lipid profiles and use of medications between the groups.

  • The database consisted of 35,452 individuals with an average age of 52.2 ± 12.2 years. Of the total number, 24,287 patients (69%) were males.

  • Of these, 203 patients had a diagnosis of XP, while there were 2,030 matched controls included in the study population.

  • The prevalence of dyslipidemia was not significantly different between groups, 42% in XP compared with 46% in controls (P = 0.29).

  • The use of lipid-lowering agents, that is, statins and fibrates, was nearly the same for both study groups ( P = 0.88).

  • Lipid profiles, including total cholesterol, HDL, LDL, and triglyceride levels, were similar in XP patients compared with controls. As an example, median total cholesterol was 192 (XP) vs. 187 (controls) (P = 0.093); LDL was 125 (XP) vs. 120 (controls) (P = 0.17).

  • The rates of CVDs were similar between the groups, though 8.9% of XP patients had a history of CVD as compared to 10% controls (P = 0.56).

  • Other systemic conditions were also similar between the groups and include hypertension, with 23% of XP and 24% controls. Diabetes mellitus was found in 10% XP as opposed to 14% controls, and cerebrovascular accidents with 1% XP versus 1.3% controls (P>0.05).

XP in itself is not an indicator of an increased incidence of dyslipidemia and cardiovascular disease, as was observed in this large population study. However, based on the present results, the presence of XP should by itself not be used as a marker for heightened cardiovascular or lipid-related risk. This study points out the necessity for further research with respect to systemic relevance and supports a more conservative interpretation of its clinical significance in cardiovascular and lipid health.

Reference:

Lustig-Barzelay, Y., Kapelushnik, N., Goldshtein, I., Leshno, A., Segev, S., Ben-Simon, G. J., & Landau-Prat, D. (2024). Association between xanthelasma palpebrarum with cardiovascular risk and dyslipidemia. Ophthalmology. https://doi.org/10.1016/j.ophtha.2024.07.033

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Menstrual cycle luteal phase lengths are not ‘fixed’ at 13-14 days, claims study

The current expectation is that every ovulatory menstrual cycle will have a luteal phase (the time from egg released until the next flow) that lasts approximately 14 days. It is simple, ovulation covers half of the expected, classical 28-day menstrual cycle. That fits with another current concept, “All regular month-apart menstrual cycles are ovulatory.”

“We discovered a wide variety of luteal phase lengths, even in healthy premenopausal women who needed two cycles in a row that were both of normal cycle length and ovulatory in order to join the original study,” said this study’s first author, Sarah Henry, BSc (hons), MD, now in her University of British Columbia family practice residency who did this research as a medical student. “Although the luteal phase was not predictable in length, it was usually less variable than the follicular phase.”

The findings, just published in Human Reproduction, show that the luteal phase is quite variable. It was documented using the validated Quantitative Basal Temperature© (QBT©) method. By QBT©, a normal luteal phase length is ≥10 days; short luteal cycles are <10 days.

“This year-long study is a rare one examining within-woman follicular phase and luteal length variabilities,” said Sonia Shirin MD, MHSc, CeMCOR research associate and co-author who worked with Dr. Henry on statistical analyses. “We studied 53 healthy women’s cycles over about a year; all had at least 8, and an average of 13 menstrual cycles.”

“An amazing thing is that, despite rigorous screening, only 6 of 53 women (11%) had normally ovulatory cycles the whole year,” said Azita Goshtasebi, MD, MPH, PhD, CCFP, co-author and family physician as well as woman’s public reproductive health expert. “Fifty-five percent of women across the study year had more than one short luteal phase in an ovulatory cycle.”

Does it matter if the luteal phase is short?

Yes. A meta-analysis CeMCOR published in 2014 (Li D, Epidemiol Rev) showed there was bone loss in those with more short luteal phase ovulatory and anovulatory cycles compared with those having more normally ovulatory cycles over a year, even if all cycles remained month-apart. It is also likely that short luteal phase cycles, as well as those without ovulation, are related to trouble becoming pregnant.

“I wish I had known that my perfectly regular, month-apart menstrual periods might have hidden silent ovulatory disturbances that could make fertility difficult for me,” said Sophia Park, MD, FRCPC, MBA, associate clinical professor in Pathology and Laboratory Medicine at the University of British Columbia with the lived experience of infertility.

“It is important to know about our own ovulation and luteal phase lengths. Why? Because increasing evidence says that estrogen, a powerful growth stimulator, needs to be counterbalanced. Progesterone decreases proliferation while encouraging cells to become more well-developed and specialized,” reported senior author, Jerilynn C. Prior, BA, MD, FRCPC, professor of endocrinology at the University of British Columbia.

The researchers say this new information about the variability of the luteal phase lengths is important for two reasons:

1. We cannot assume month-apart menstrual cycles mean ovulation or normal-length luteal phases

2. Women need to know about ovulation both for health and fertility. 

Reference:

Sarah Henry, Sonia Shirin, Azita Goshtasebi, Jerilynn C Prior, Prospective 1-year assessment of within-woman variability of follicular and luteal phase lengths in healthy women prescreened to have normal menstrual cycle and luteal phase lengths, Human Reproduction, 2024;, deae215, https://doi.org/10.1093/humrep/deae215.

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Study Recommends Double-J Stent for Enhanced Outcomes in Staghorn Stone Treatment via Percutaneous Nephrolithotomy

Iran: A recent study published in BMC Urology has raised important questions about the necessity of using a double-J stent (DJ stent) after complete supine percutaneous nephrolithotomy (csPCNL) in adult patients with staghorn renal stones. Staghorn stones are large, branched calculi that can significantly impair kidney function and lead to severe complications if not treated effectively. 

The researchers suggest that while omitting a double-J stent after csPCNL can yield acceptable outcomes, the higher residual stone rates associated with staghorn stones lead to increased incidences of renal colic, longer hospital stays, and extended recovery periods. Therefore, they recommend the insertion of a DJ stent.

The research highlights that while csPCNL has become a popular minimally invasive technique for managing these complex stones, postoperative management remains a critical discussion topic. Traditionally, placing a DJ stent following the procedure has been standard practice. The stent maintains urinary drainage, reduces the risk of complications, and adds to patient discomfort and recovery time.

Against the above background, Samira Kazemi, Guilan University of Medical Sciences, Rasht, Iran, and colleagues compared the outcomes of ureteral catheters versus double-J stents in tubeless complete supine PCNL for staghorn stone treatment.

For this purpose, the researchers conducted an analytical cross-sectional study from May 2008 to August 2022, assessing 123 patients who underwent tubeless csPCNL. The patients were categorized into two groups: those who received a double-J (DJ) stent (Group I; n = 23) and those who had a totally tubeless approach using only a perioperative ureteral stent (Group II; n = 100). The study compared demographic characteristics, stone-related factors, and perioperative and postoperative parameters between the two groups.

The following were the key findings of the study:

  • Baseline characteristics were similar across both groups. However, the operative time for Group I was significantly longer than for Group II (68.26 versus 55.25 minutes).
  • In contrast, the duration of hospitalization was shorter for Group I (1.81 versus 2.37 days).
  • The stone-free rate was higher in Group I (90.5% versus 79.8%), although this difference was not statistically significant.
  • There were no major complications between the groups.
  • Patients in Group II experienced a significantly shorter time to return to normal activities (6.48 versus 7.91 days).
  • Multivariable linear regression analysis indicated that preoperative creatinine levels and stone size significantly affect operative time. However, the number of stones and underlying health conditions influenced the length of hospital stay.

“While the necessity of a DJ stent in PCNL for staghorn stones remains debated, its use is advised for these patients due to benefits such as shorter hospital stays, quicker recovery times, and improved success rates,” the researchers concluded.

Reference:

Falahatkar, S., Esmaeili, S., Kazemi, S. et al. Is double-J stent mandatory in complete supine percutaneous nephrolithotomy for adult patients with staghorn renal stones? BMC Urol 24, 216 (2024). https://doi.org/10.1186/s12894-024-01610-9

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Cycling may improve physical function and reduce hospital stays among critically ill patients, finds study

A new systematic review led by researchers in Hamilton, Canada has shown that specialized in-bed cycling therapy, when used in the intensive care unit with critically ill patients, leads to better physical function and a one-day shorter length of stay in the ICU.

The review showed on average, patients who cycled spent one day less in the ICU compared to those who didn’t, and 1.5 days less in the hospital overall, freeing up an important bed sooner. , the average costs per patient can be up to $7,300 per ICU day and $1,500 per hospital day.

Traditionally, ICU rehabilitation studies have been inconclusive or lacked clear results. With this systematic review, a clearer picture is emerging around the safety and benefits of cycling as a rehabilitation intervention in the ICU.

The research – published in NEJM Evidence and simultaneously announced at the European Society of Intensive Care Medicine Congress in Spain – was led by researchers with McMaster University’s School of Rehabilitation Science and St. Joseph’s Healthcare Hamilton. The review analyzed data from 33 rehabilitation clinical trials in 13 countries and included nearly 3,300 patients.

“This research is a major win for patients and their families,” said Heather O’Grady, lead author and recent PhD graduate from Rehabilitation Science at McMaster. “This analysis shows that cycling as part of rehabilitation in the ICU can decrease ICU and overall hospital length of stay, is safe and perhaps most importantly for patients, leads to better physical function post-ICU discharge.”

The review builds off previous research conducted by senior author Michelle Kho, a professor with McMaster’s School of Rehabilitation Science, that first highlighted the potential benefits of cycling by patients in the ICU.

In addition to the main findings, the review showed that adverse events during cycling are uncommon, occurring in less than one per cent of patients. Importantly, patients who received cycling in the ICU did not have higher mortality than those in the comparison groups.

The researchers say the findings provide a distinct research pathway for future study because the model of rehabilitation uses clear-cut equipment, is reproducible and easily standardized.

Reference:

 Heather K. O’Grady, Hibaa Hasan, Bram Rochwerg, Deborah J. Cook, Alyson Takaoka, Rucha Utgikar, Julie C. Reid, and Michelle E. Leg Cycle Ergometry in Critically Ill Patients-An Updated Systematic Review and Meta-Analysis, NEJM Evidence, doi/full/10.1056/EVIDoa2400194.

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Twice-Yearly Depemokimab Effectively Lowers Exacerbation Rates in Severe Eosinophilic Asthma: Study Reveals

USA: A recent study published in the New England Journal of Medicine highlights the effectiveness of Depemokimab, an innovative monoclonal antibody, in managing severe asthma among patients with an eosinophilic phenotype.

The findings reveal that administering Depemokimab twice yearly significantly lowers the annualized rate of asthma exacerbations, offering hope for better disease management.

Eosinophilic asthma, characterized by elevated eosinophil levels in the airways, often leads to more severe symptoms and frequent exacerbations compared to other asthma phenotypes. Traditional treatments may not always provide adequate relief, prompting the need for targeted therapies like Depemokimab, which specifically aims to reduce inflammation associated with eosinophils. Depemokimab is a long-acting biologic therapy with improved binding affinity for interleukin-5, potentially allowing for effective dosing every six months.

In this context, David J. Jackson, the King’s College London, London, and colleagues assessed the efficacy and safety of depemokimab in patients with severe asthma characterized by an eosinophilic phenotype. This phenotype was defined by a high eosinophil count (≥300 cells per microliter in the past 12 months or ≥150 cells per microliter at screening) and a history of exacerbations despite receiving medium- or high-dose inhaled glucocorticoids. The evaluation was conducted through phase 3A, randomized, placebo-controlled trials known as SWIFT-1 and SWIFT-2.

Patients were randomly assigned in a 2:1 ratio to receive either 100 mg of depemokimab administered subcutaneously or placebo at weeks 0 and 26, along with standard care. The primary endpoint was the annualized rate of exacerbations at 52 weeks. Secondary endpoints, analyzed hierarchically to account for multiple comparisons, included changes from baseline in the St. George’s Respiratory Questionnaire (SGRQ) scores, forced expiratory volume in one second (FEV1), and reports of asthma symptoms at 52 weeks.

The researchers reported the following findings:

  • Across the two trials, 792 patients were randomized, with 762 included in the full analysis—502 received depemokimab and 260 received placebo.
  • In the SWIFT-1 trial, the annualized rate of exacerbations was 0.46 for the depemokimab group compared to 1.11 for the placebo group, resulting in a rate ratio of 0.42.
  • In SWIFT-2, the annualized rates were 0.56 for depemokimab and 1.08 for placebo, yielding a rate ratio of 0.52.
  • No significant differences in the change from baseline in SGRQ scores were found in either trial, precluding statistical inferences for subsequent secondary endpoints.
  • In both trials, adverse event occurrence was comparable between the two groups.

The findings showed that depemokimab decreased the annualized rate of exacerbations in patients with severe asthma characterized by an eosinophilic phenotype.

“The study’s outcomes signal a promising advancement in asthma care, especially for those suffering from the eosinophilic form of the disease. With ongoing research and potential regulatory approvals on the horizon, Depemokimab could soon become a vital tool in the fight against severe asthma,” the researchers concluded.

Reference:

Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luíz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Sep 9. doi: 10.1056/NEJMoa2406673. Epub ahead of print. PMID: 39248309.

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Aerobic Physical Activity Linked to Reduced Depression in Cancer Patients: JAMA

Canada: A recent systematic review and meta-analysis have shed light on the positive effects of aerobic physical activity (APA) on depression among patients with cancer.

The research, published in JAMA Network Open, revealed that APA was linked to modest reductions in depression both in the short term and long term among adults with cancer. The researchers advise recommending aerobic physical activity to adults with cancer as a means to help reduce depression.

Depression is a common and debilitating condition that affects many individuals diagnosed with cancer. The emotional toll of a cancer diagnosis, along with the physical side effects of treatment, often exacerbates feelings of hopelessness and anxiety. Traditional therapeutic approaches for managing depression may not be sufficient on their own, prompting researchers to explore complementary strategies, such as physical activity.

While aerobic physical activity is recognized as an effective strategy for managing depression in the general population, its effectiveness in alleviating depressive symptoms among cancer patients needs further investigation. To fill this knowledge gap, Matthew Kulchycki, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada, and colleagues aimed to assess whether APA reduces the severity of depression in cancer patients by synthesizing data from published randomized clinical trials (RCTs).

For this purpose, the researchers systematically searched six databases for relevant citations published from January 1, 1980, to July 5, 2023. This systematic review and meta-analysis included RCTs that compared APA interventions with usual care, waitlist control, or attention control for managing depression in cancer patients, regardless of age or cancer type.

Two reviewers independently conducted the screening and data extraction, assessing the risk of bias using the Cochrane Risk of Bias Tool, version 2, while adhering to the PRISMA guidelines. Standardized mean differences (SMDs) were calculated using a random-effects model. Data collection and analyses took place from June 2022 to March 2024.

The primary outcome measured was the severity of self-reported depression within one-month post-intervention (short-term). Secondary outcomes included depression severity between one and six months post-intervention (medium-term) and between six and twelve months post-intervention (long-term).

The meta-analysis included 25 randomized controlled trials (RCTs) involving 1,931 adults with cancer aged 18 to 80 years. Based on the study, the researchers reported the following findings:

  • Among these studies, ten RCTs exhibited a low risk of bias.
  • Aerobic physical activity was associated with a reduction in self-reported depression among the participants (SMD, −0.3).
  • The reduction in depression scores was statistically significant for long-term outcomes in three trials (n = 299 participants; SMD, −0.32).
  • There was no significant impact on medium-term depression across two trials (n = 143 participants; SMD, −0.27.

The findings of the review highlight the importance of prioritizing trials focused on understudied populations, such as children with cancer and individuals with metastatic disease. This approach is essential for gaining a more comprehensive understanding of the potential benefits of aerobic physical activity in alleviating depression within these groups.

“Future research should also explore the effectiveness of APA in conjunction with other strategies for managing depression among diverse cancer patient populations,” the researchers concluded.

Reference:

Kulchycki M, Halder HR, Askin N, et al. Aerobic Physical Activity and Depression Among Patients With Cancer: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024;7(10):e2437964. doi:10.1001/jamanetworkopen.2024.37964

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Serratiopeptidase with diclofenac sodium effective for pain after day care obstetric and gynaecological surgeries: Study

Postoperative pain is a major complication after surgery
which can affect functional recovery and also diminish patients’ overall
quality of life. Inflammation plays critical role in the postoperative pain
pathophysiology. Due to surgical procedures tissue damages and inflammatory
cells proliferate at the surgical site, generating inflammatory mediators that
induce tissue inflammation. Analgesic or anaesthetic measures are used to
inhibit the potential transition from acute to chronic postoperative pain.
These measures reduce the frequency and intensity of acute pain during and immediately
after surgery. Current treatment strategies in the postoperative pain
management includes the usage of systemic non-opioid and opioid pain relievers,
along with analgesics, peripheral nerve blockers, and, as per the need, the
utilization of additional pharmaceutical agents to alleviate pain.

The attention of surgeons has been focused on the elements
of patient care that can be improved in the light of the modern emphasis on
managed care and shorter hospital stays. Reducing or even eliminating post-operative
pain, without introducing excessive sedation, promotes rapid mobilization and
return to autonomy. Targeted multimodal pain management can reduce
postoperative ileus and other adverse reactions to analgesics.

One proteolytic enzyme that has been used to lessen
inflammation is serratiopeptidase. Because of its antiinflammatory and
anti-edema qualities, enteric coated oral formulations of this enzyme are
frequently used in a variety of specialties, including surgery, orthopaedics,
otolaryngology, gynecology, and dentistry. When used in conjunction with
surgery, nonsteroidal anti-inflammatory drugs, or NSAIDs, have demonstrated
their efficacy as analgesics, as evidenced by either a decrease in pain scores
or an opioid sparing effect. Diclofenac is one of the NSAIDs commonly
prescribed for pain relief. Although the efficacy and safety of
Serratiopeptidase and Diclofenac Sodium has been proven in few randomized
clinical trials, data regarding the effectiveness of this combination for
relief of symptoms in clinical practice settings in obstetric and
gynaecological surgeries, are scarce. Therefore, based on a retrospective
pooled analysis of data in clinical practice settings, Bapat et al. aimed to
assess the fixed dose combination (FDC) of Serratiopeptidase (10 mg) with
Diclofenac Sodium (50 mg) in day care obstetric and gynaecological surgeries in
daily practice.

This was a single centre, retrospective, observational data
collection in reallife scenario. Data of adult women who had undergone day care
OBG surgery and received a FDC of Serratiopeptidase (10 mg) with Diclofenac
Sodium (50 mg) gastro-resistant tablets TID for period of 24 hours was
retrieved and analysed. VAS (Visual Analogue Scale) data on post-operative pain
at rest and pain on movement as well as post-operative swelling were analyzed
in conjunction with monitoring for adverse events.

Among 61 patient’s data included in the study, 40 (65.57%)
had undergone Minimally Invasive Vaginal Hysterectomy (MIVH), 4 (6.56%) had
MIVH with Bilateral Salpingo-oophorectomy, and 17 (27.87%) had other OBG
surgeries. The average VAS scores for pain at rest (VAS), pain on movement
(VAS) and swelling were significantly reduced compared to baseline at all-time
points (p>0.001). Clinical global impression of efficacy and safety for 95%
physician’s and 93.3% patients was good to very good. FDC was found to be well
tolerated without any serious adverse reaction.

Postoperative pain is the major concern in surgeries of
obstetrics and gynaecology department and it is associated with the highest
severity. So it is highly essential to improve the postoperative pain management
in minor surgeries. For certain patients, postoperative pain control still
requires improvement despite advancements in pharmacology and surgical techniques.
Inadequate management of pain following surgery is linked to longer hospital
stays, ER visits, and readmissions. Insufficient postoperative pain control
also leads to the development of chronic pain. Multi-modal pain management
strategy along with reduction in swelling is needed in post obstetric and
gynaecological surgeries.

Serratiopeptidase is a proteolytic enzyme excreted by
non-pathogenic Enterobacteria serratia isolated from intestine of silkworms
Bombyx mori L Serratiopeptidase exhibits notable analgesic, anti-inflammatory,
and antiedema characteristics. This enzyme was discovered to be used for pain,
inflammation brought on by trauma, and surgery. It reduces inflammation in
three ways: by breaking down blood coagulation-related insoluble protein
byproducts, by thinned inflammation- and injury-related fluids, and by speeding
up tissue repair. It lessens pain by preventing the amines that cause pain. It
also aids in healing by dissolving the dead tissue that surrounds the wounded
area. Moreover, serratiopeptidase functions by altering adhesion molecules on
the cell surface. Serratiopeptidase is not addictive and does not result in
hazardous internal bleeding like NSAID painkillers do. Its application lies in
its ability to suppress and eradicate hemorrhage following surgery.

It was found that this enzyme is used for pain relief. It
breaks down protein deposits like fibrin in the human body. This is a safe,
natural substitute for NSAIDs and steroids that doesn’t have any negative side
effects.

A FDC of an effective proteolytic enzyme, Serratiopeptidase
and a potent NSAID Diclofenac, complement the action of each other by
inhibiting the release of bradykinin and blocking production of prostaglandins.
It is approved for use as a pharmaceutical ingredient in India to treat acute
pain in conjunction with other medications. This combination not only controls
inflammation but also helps in the clearance of exudates and improving
microcirculation.

The use of enzymes in medical therapy has been limited. Serratiopeptidase
has revealed interesting applications in the field of pain management.
Serratiopeptidase has a remarkable record of safety from decades of use by
millions of users all around the world. Authors did not record any serious
adverse events in our study either. Serratiopeptidase dosage recommendations
range from 10 mg to 30 mg daily. It is commonly known that serratiopeptidase
reduces pain by preventing the release of molecules that cause pain from
inflammatory tissues. Enzymes have a higher affinity and specificity for their
targets, which allows them to convert multiple target molecules into desired
products. As a result, enzymespecific drugs have been developed to treat a wide
range of disorders.

Results of this study provides direct clinical evidence of
the efficacy and safety of FDC of Serratiopeptidase and Diclofenac sodium in
day care obstetric and gynaecological surgeries in reducing post-operative pain
and swelling in the early post-operative period.

Source: Bapat et al. / Indian Journal of Obstetrics and
Gynecology Research 2024;11(3):442–446

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