Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2.

ABSTRACT

BACKGROUND: An estimated 60% of pharmacological randomised trials use placebo control interventions to blind (i.e. mask) participants. However, standard placebos do not control for perceptible non-therapeutic effects (i.e. side effects) of the experimental drug, which may unblind participants. Trials rarely use active placebo controls, which contain pharmacological compounds designed to mimic the non-therapeutic experimental drug effects in order to reduce the risk of unblinding. A relevant improvement in the estimated effects of active placebo compared with standard placebo would imply that trials with standard placebo may overestimate experimental drug effects.

OBJECTIVES: We aimed to estimate the difference in drug effects when an experimental drug is compared with an active placebo versus a standard placebo control intervention, and to explore causes for heterogeneity. In the context of a randomised trial, this difference in drug effects can be estimated by directly comparing the effect difference between the active placebo and standard placebo intervention.

SEARCH METHODS: We searched PubMed, CENTRAL, Embase, two other databases, and two trial registries up to October 2020. We also searched reference lists and citations and contacted trial authors.

SELECTION CRITERIA: We included randomised trials that compared an active placebo versus a standard placebo intervention. We considered trials both with and without a matching experimental drug arm.

DATA COLLECTION AND ANALYSIS: We extracted data, assessed risk of bias, scored active placebos for adequacy and risk of unintended therapeutic effect, and categorised active placebos as unpleasant, neutral, or pleasant. We requested individual participant data from the authors of four cross-over trials published after 1990 and one unpublished trial registered after 1990. Our primary inverse-variance, random-effects meta-analysis used standardised mean differences (SMDs) of active versus standard placebo for participant-reported outcomes at earliest post-treatment assessment. A negative SMD favoured the active placebo. We stratified analyses by trial type (clinical or preclinical) and supplemented with sensitivity and subgroup analyses and meta-regression. In secondary analyses, we investigated observer-reported outcomes, harms, attrition, and co-intervention outcomes.

MAIN RESULTS: We included 21 trials (1462 participants). We obtained individual participant data from four trials. Our primary analysis of participant-reported outcomes at earliest post-treatment assessment resulted in a pooled SMD of -0.08 (95% confidence interval (CI) -0.20 to 0.04; I2 = 31%; 14 trials), with no clear difference between clinical and preclinical trials. Individual participant data contributed 43% of the weight of this analysis. Two of seven sensitivity analyses found more pronounced and statistically significant differences; for example, in the five trials with low overall risk of bias, the pooled SMD was -0.24 (95% CI -0.34 to -0.13). The pooled SMD of observer-reported outcomes was similar to the primary analysis. The pooled odds ratio (OR) for harms was 3.08 (95% CI 1.56 to 6.07), and for attrition, 1.22 (95% CI 0.74 to 2.03). Co-intervention data were limited. Meta-regression found no statistically significant association with adequacy of the active placebo or risk of unintended therapeutic effect.

AUTHORS' CONCLUSIONS: We did not find a statistically significant difference between active and standard placebo control interventions in our primary analysis, but the result was imprecise and the CI compatible with a difference ranging from important to irrelevant. Furthermore, the result was not robust, because two sensitivity analyses produced a more pronounced and statistically significant difference. We suggest that trialists and users of information from trials carefully consider the type of placebo control intervention in trials with high risk of unblinding, such as those with pronounced non-therapeutic effects and participant-reported outcomes.

PMID:36877132 | PMC:PMC9989326 | DOI:10.1002/14651858.MR000055.pub2

Eur Rev Med Pharmacol Sci. 2023 Feb;27(4):1667-1680. doi: 10.26355/eurrev_202302_31410.

ABSTRACT

OBJECTIVE: Adverse drug reactions (ADRs) are widespread worldwide, and their intervention is critical to patient safety and healthcare quality. Pharmacists are essential in monitoring and reporting ADRs, directly influencing patient care. This study aimed to examine the prevalence of ADRs among pharmacists and their knowledge regarding ADRs, including the factors affecting ADR reporting.

SUBJECTS AND METHODS: From September 2021 to November 2021, a cross-sectional survey among pharmacists in the Asir area of Saudi Arabia was planned. This study involved contacting 97 pharmacists using a cluster sampling method. The study's goals were met using a 25-item self-administered questionnaire. Data analysis was done using SPSS version 25 (IBM Corp., Armonk, NY, USA).

RESULTS: Ninety-seven pharmacists (male 53.6% and female 46.4%) completed the survey. More than three-fourths of the participants (78.4%) know the ADR reporting system. The survey was completed by 97 pharmacists (male 53.6% and female 46.4%). More than three-quarters of the participants (78.4%) were aware of the ADR reporting system, and the majority (70.8%) were aware that it is done using an online system. Still, only 56.7% knew that the Saudi FDA is the regulatory agency collecting ADR data in Saudi Arabia. Furthermore, 73.2% cited stress in the workplace as a critical deterrent to reporting. Most respondents (76.3%) had an unfavorable attitude about reporting ADRs.

CONCLUSIONS: Pharmacists understand ADR reporting, but most lack the mentality to report the incidents. As a result, comprehensive and ongoing training for pharmacists is required to raise awareness of the need for ADR reporting.

PMID:36876701 | DOI:10.26355/eurrev_202302_31410

Eur Rev Med Pharmacol Sci. 2023 Feb;27(4):1322-1335. doi: 10.26355/eurrev_202302_31366.

ABSTRACT

OBJECTIVE: Myoclonus is one of the main complications of etomidate anesthesia, which would develop into serious consequences during surgery. The present analysis was performed to evaluate systematically the effect of propofol on preventing etomidate-induced myoclonus in adult patients.

MATERIALS AND METHODS: Systematic electronic literature search was performed in the databases PubMed, Cochrane Library, OVID, Wanfang and China National Knowledge Infrastructure (CNKI) from inception to May 20, 2021, without any language restrictions. All randomized controlled trials evaluating the efficacy of propofol on preventing etomidate-induced myoclonus were enrolled. The primary outcome included the incidence and degree of etomidate-induced myoclonus.

RESULTS: 1,420 patients (with 602 received etomidate anesthesia and 818 received propofol plus etomidate anesthesia) from 13 studies were eventually included. Whatever the intravenous propofol dose for anesthesia induction 0.8-2 mg/kg (RR:4.04, 95% CI [2.42,6.74] p<0.0001, I2=56.5%), or the dose of propofol for anesthesia induction 0.5-0.8 mg/kg (RR:3.26, 95% CI [2.03,5.22] p<0.0001, I2=0%), or the dose of propofol for anesthesia induction 0.25-0.5mg/kg (RR:1.68, 95% CI [1.1,2.56] p=0.0160, I2=0%), combination of propofol and etomidate could significantly decrease the occurrence of etomidate-related myoclonus (RR=2.99, 95% CI [2.40, 3.71] p<0.0001, I2=43.4%), compared with etomidate alone. In addition, propofol plus etomidate attenuated the incidence of mild (RR:3.40, 95% CI [1.7,6.82] p=0.0010, I2=54.3%), moderate (RR:5.4, 95% CI [3.01, 9.67] p<0.0001, I2=12.6%), severe (RR:4.15, 95% CI [2.11, 8.13] p<0.0001, I2=0%) of etomidate-induced myoclonus without adverse effects except for the increased incidence of pain on injection (RR:0.47, 95% CI [0.26, 0.83] p=0.0100, I2=41.5%) compared with etomidate alone.

CONCLUSIONS: The meta-analysis currently generates the evidence of combination of propofol with the dosage of 0.25-2 mg/kg and etomidate can alleviate the occurrence and severity of etomidate-induced myoclonus, with decreased incidence of postoperative nausea and vomiting (PONV) and comparative side effects of hemodynamic and respiratory depression of patients in comparison with etomidate alone.

PMID:36876671 | DOI:10.26355/eurrev_202302_31366

Front Endocrinol (Lausanne). 2023 Feb 16;14:1087614. doi: 10.3389/fendo.2023.1087614. eCollection 2023.

ABSTRACT

BACKGROUND AND AIMS: Some studies have reported that the topical forms with aminophylline as the active ingredient appear to be relatively effective on local fat burning while having no/minimal side effects. This systematic review accumulates all of the data on the local fat-burning potency of aminophylline topical formulation.

METHODS: Documents were retrieved from PubMed, Web of Science, and Scopus databases until Aug 2022. Data were extracted from clinical trials reporting the reduction in thigh or waist circumference as a result of using topical forms containing aminophylline. Screening of included studies was performed independently by two authors and the quality assessment of included studies was performed based on the Cochrane Collaboration's approach.

RESULTS: Of the 802 initial studies, 5 studies were included in the systematic review. Several concentrations of aminophylline were used in different studies. Most studies administred the topical formulation on participants' one thigh, and the other thigh was considered to be the control for comparing the fat reduction amount. Except for one study, all other studies reported that all participants lost more fat on the treated area than the control groups. The amount of fat reduction differed in studies regarding their different aminophylline concentrations and administration routines. In the case of side effects, except for some studies reporting skin rashes, other studies reported no significant side effects at all.

CONCLUSIONS: Aminophylline topical formulation offers a safe, effective, and much less invasive alternative to cosmetic surgery for localized fat reduction. It seems that the 0.5% concentration, administered five times a week for five weeks is the most potent concentration. However, more high-quality clinical trials are needed to verify this conclusion.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD42022353578.

PMID:36875487 | PMC:PMC9978326 | DOI:10.3389/fendo.2023.1087614

Front Endocrinol (Lausanne). 2023 Feb 15;14:1044782. doi: 10.3389/fendo.2023.1044782. eCollection 2023.

ABSTRACT

OBJECTIVE: To investigate the efficacy of rituximab in the treatment of idiopathic membranous nephropathy (IMN).

METHODS: A total of 77 patients with IMN diagnosed in both our hospital and other hospitals were included in this study; the patients were divided into two groups: a treatment-naïve group (n = 19) and a refractory/relapsed group (n = 58). The clinical data of the patients, including urine examination, blood test, safety evaluation and efficacy evaluation results, were analysed retrospectively. The changes in clinical biochemical indexes and adverse reactions were compared between the two groups before and after treatment, and the clinical efficacy of rituximab (RTX) in the treatment of primary IMN and refractory recurrent membranous nephropathy was evaluated.

RESULTS: Of the 77 patients included in this study, the average age was 48 years, and there was a male-to-female ratio of 61:16. There were 19 cases in the initial treatment group and 58 cases in the refractory/relapse group. The 24-hour urine protein quantification, cholesterol, B cell count and M-type phospholipase A2 receptor (PLA2R) results in the 77 patients with IMN after treatment were all lower than those before treatment, and the differences were statistically significant (P < 0.05). Serum albumin was higher than before treatment, and the difference was statistically significant (P < 0.05). The total remission rate in the initial and refractory/relapsed treatment groups was 84.21% and 82.76%, respectively. There was no statistical difference in the total remission rate between the two groups (P > 0.05). During treatment, nine patients (11.69%) experienced infusion-related adverse reactions, which were relieved rapidly after symptomatic treatment. The anti-PLA2R antibody titre of the refractory/relapsed group was significantly negatively correlated with serum creatinine (r = -0.187, P = 0.045) and significantly correlated with 24-hour urine protein (r = -0.490, P < 0.001). There was a positive correlation and a significant negative correlation with serum albumin (r = -0.558, P < 0.001).

CONCLUSIONS: Regardless of whether RTX is used as an initial therapy or refractory/relapsed membranous nephropathy, most patients with IMN have complete or partial remission after RTX treatment, with mild adverse reactions.

PMID:36875477 | PMC:PMC9974647 | DOI:10.3389/fendo.2023.1044782

Front Immunol. 2023 Feb 16;14:1115083. doi: 10.3389/fimmu.2023.1115083. eCollection 2023.

ABSTRACT

Bullous pemphigoid (BP) is an autoimmune disease that mainly occurs in the elderly, severely affecting their health and life quality. Traditional therapy for BP is mainly based on the systemic use of corticosteroids, but long-term use of corticosteroids results in a series of side effects. Type 2 inflammation is an immune response largely mediated by group 2 innate lymphoid cells, type 2 T helper cells, eosinophils, and inflammatory cytokines, such as interleukin (IL)-4, IL-5 and IL-13. Among patients with BP, the levels of immunoglobulin E and eosinophils are significantly increased in the peripheral blood and skin lesions, suggesting that the pathogenesis is tightly related to type 2 inflammation. To date, various targeted drugs have been developed to treat type 2 inflammatory diseases. In this review, we summarize the general process of type 2 inflammation, its role in the pathogenesis of BP and potential therapeutic targets and medications related to type 2 inflammation. The content of this review may contribute to the development of more effective drugs with fewer side effects for the treatment of BP.

PMID:36875098 | PMC:PMC9978795 | DOI:10.3389/fimmu.2023.1115083

World J Clin Cases. 2023 Feb 16;11(5):1115-1121. doi: 10.12998/wjcc.v11.i5.1115.

ABSTRACT

BACKGROUND: Combined small cell lung cancer (C-SCLC) is a special subtype of small cell lung cancer that is relatively rare, aggressive, and prone to early metastasis and has a poor prognosis. Currently, there are limited studies on C-SCLC, and there is no uniform standard treatment, especially for extensive C-SCLC, which still faces great challenges. In recent years, the development and progress of immunotherapy have provided more possibilities for the treatment of C-SCLC. We used immunotherapy combined with first-line chemotherapy to treat extensive-stage C-SCLC to explore its antitumor activity and safety.

CASE SUMMARY: We report a case of C-SCLC that presented early with adrenal, rib, and mediastinal lymph node metastases. The patient received carboplatin and etoposide with concurrent initiation of envafolimab. After 6 cycles of chemotherapy, the lung lesion was significantly reduced, and the comprehensive efficacy evaluation showed a partial response. No serious drug-related adverse events occurred during the treatment, and the drug regimen was well tolerated.

CONCLUSION: Envafolimab combined with carboplatin and etoposide in the treatment of extensive-stage C-SCLC has preliminary antitumor activity and good safety and tolerability.

PMID:36874434 | PMC:PMC9979283 | DOI:10.12998/wjcc.v11.i5.1115

Curr Drug Saf. 2023 Mar 3. doi: 10.2174/1574886318666230303085538. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Adverse drug reactions (ADR) are considered any harmful and unintended side effects associated with the use of a drug at the usual therapeutic dose, in which skin is involved in most cases. Therefore, the availability of epidemiological information on reactions, reaction patterns, and their causative drugs can be helpful in timely diagnosis and necessary measures, such as caution in prescribing causative drugs to prevent these types of reactions.

METHODS: In this retrospective descriptive study, the archived files of patients with dermatoses due to ADR referred to Taleghani University Hospital, Urmia, Iran, during 2015-2020 were studied. Patterns and frequency of skin reactions, demographic data, and the frequency of chronic comorbidities were identified.

RESULTS: A total of 50 patients with drug-induced skin rash were found, of which 14 were male (28%) and 36 were female (72%). Skin rashes were most frequently found in patients aged 31-40 years. In 76% of patients, there was at least one chronic underlying disease. The most common reaction pattern was maculopapular rash (44%), and the most common causative drugs were antiepileptic drugs (34%) and antibiotics (22%). Mortality was found in 4 cases, which was due to antibiotics and antiepileptic drugs that caused toxic SJS/TEN and erythroderma. The hospital stays were highest in SJS and lowest in a maculopapular rash.

CONCLUSION: Knowledge about the epidemiology and the frequency of adverse drug reactions may be helpful in increasing the awareness of physicians for correct and rational drug prescriptions, which can reduce unnecessary hospital referrals and treatment costs.

PMID:36872363 | DOI:10.2174/1574886318666230303085538

J Med Case Rep. 2023 Mar 5;17(1):79. doi: 10.1186/s13256-023-03806-3.

ABSTRACT

BACKGROUND: Smartwatches offering electrocardiogram recordings advertise the benefits of supporting an active and healthy lifestyle. More often, medical professionals are faced with privately acquired electrocardiogram data of undetermined quality recorded by smartwatches. This is boasted by results and suggestions for medical benefits, based on industry-sponsored trials and potentially biased case reports. Yet potential risks and adverse effects have been widely overlooked.

CASE PRESENTATION: This case report describes an emergency consultation of a 27-year-old Swiss-German man lacking known previous medical conditions who developed an episode of anxiety and panic due to pain in the left chest prompted by over-interpretation of unremarkable electrocardiogram readings of his smartwatch. Fearing acute coronary syndrome, he presented at the emergency department. His smartwatch electrocardiograms, as well as a 12-lead electrocardiogram, appeared normal. After extensive calming and reassuring, as well as symptomatic therapy with paracetamol and lorazepam, the patient was discharged with no indications for further treatment.

CONCLUSIONS: This case demonstrates the potential risks of anxiety from nonprofessional electrocardiogram recordings by smartwatches. Medico-legal and practical aspects of electrocardiogram recordings by smartwatches need to be further considered. The case shows the potential side effects of pseudo-medical recommendations for the untrained consumer, and may add to the discussion on the ethics of how to evaluate smartwatch electrocardiogram data as a medical professional.

PMID:36871070 | PMC:PMC9985850 | DOI:10.1186/s13256-023-03806-3

J Transl Med. 2023 Mar 3;21(1):169. doi: 10.1186/s12967-023-03935-9.

ABSTRACT

BACKGROUND: Chemotherapy (CT) is central to the treatment of triple negative breast cancer (TNBC), but drug toxicity and resistance place strong restrictions on treatment regimes. Fasting sensitizes cancer cells to a range of chemotherapeutic agents and also ameliorates CT-associated adverse effects. However, the molecular mechanism(s) by which fasting, or short-term starvation (STS), improves the efficacy of CT is poorly characterized.

METHODS: The differential responses of breast cancer or near normal cell lines to combined STS and CT were assessed by cellular viability and integrity assays (Hoechst and PI staining, MTT or H2DCFDA staining, immunofluorescence), metabolic profiling (Seahorse analysis, metabolomics), gene expression (quantitative real-time PCR) and iRNA-mediated silencing. The clinical significance of the in vitro data was evaluated by bioinformatical integration of transcriptomic data from patient data bases: The Cancer Genome Atlas (TCGA), European Genome-phenome Archive (EGA), Gene Expression Omnibus (GEO) and a TNBC cohort. We further examined the translatability of our findings in vivo by establishing a murine syngeneic orthotopic mammary tumor-bearing model.

RESULTS: We provide mechanistic insights into how preconditioning with STS enhances the susceptibility of breast cancer cells to CT. We showed that combined STS and CT enhanced cell death and increased reactive oxygen species (ROS) levels, in association with higher levels of DNA damage and decreased mRNA levels for the NRF2 targets genes NQO1 and TXNRD1 in TNBC cells compared to near normal cells. ROS enhancement was associated with compromised mitochondrial respiration and changes in the metabolic profile, which have a significant clinical prognostic and predictive value. Furthermore, we validate the safety and efficacy of combined periodic hypocaloric diet and CT in a TNBC mouse model.

CONCLUSIONS: Our in vitro, in vivo and clinical findings provide a robust rationale for clinical trials on the therapeutic benefit of short-term caloric restriction as an adjuvant to CT in triple breast cancer treatment.

PMID:36869333 | PMC:PMC9983166 | DOI:10.1186/s12967-023-03935-9

Sci Data. 2023 Mar 3;10(1):119. doi: 10.1038/s41597-023-02032-2.

ABSTRACT

Tumor microenvironment (TME) plays important roles in prognosis and immune evasion. However, the relationship between TME-related genes and clinical prognosis, immune cell infiltration, and immunotherapy response in breast cancer (BRCA) remains unclear. This study described the TME pattern to construct a TME-related prognosis signature, including risk factors PXDNL, LINC02038 and protective factors SLC27A2, KLRB1, IGHV1-12 and IGKV1OR2-108, as an independent prognostic factor for BRCA. We found that the prognosis signature was negatively correlated with the survival time of BRCA patients, infiltration of immune cells and the expression of immune checkpoints, while positively correlated with tumor mutation burden and adverse treatment effects of immunotherapy. Upregulation of PXDNL and LINC02038 and downregulation of SLC27A2, KLRB1, IGHV1-12 and IGKV1OR2-108 in high-risk score group synergistically contribute to immunosuppressive microenvironment which characterized by immunosuppressive neutrophils, impaired cytotoxic T lymphocytes migration and natural killer cell cytotoxicity. In summary, we identified a TME-related prognostic signature in BRCA, which was connected with immune cell infiltration, immune checkpoints, immunotherapy response and could be developed for immunotherapy targets.

PMID:36869083 | PMC:PMC9984471 | DOI:10.1038/s41597-023-02032-2

PLoS One. 2023 Mar 3;18(3):e0282658. doi: 10.1371/journal.pone.0282658. eCollection 2023.

ABSTRACT

Epilepsy is a common, serious condition. Fortunately, seizure risk decreases with increasing seizure-free time on antiseizure medications (ASMs). Eventually, patients may consider whether to stop ASMs, which requires weighing treatment benefit versus burden. We developed a questionnaire to quantify patient preferences relevant to ASM decision-making. Respondents rated how concerning they would finding relevant items (e.g., seizure risks, side effects, cost) on a Visual Analogue Scale (VAS, 0-100) and then repeatedly chose the most and least concerning item from subsets (best-worst scaling, BWS). We pretested with neurologists, then recruited adults with epilepsy who were seizure-free at least one year. Primary outcomes were recruitment rate, and qualitative and Likert-based feedback. Secondary outcomes included VAS ratings and best-minus-worst scores. Thirty-one of 60 (52%) contacted patients completed the study. Most patients felt VAS questions were clear (28; 90%), easy to use (27; 87%), and assessed preferences well (25; 83%). Corresponding results for BWS questions were 27 (87%), 29 (97%), and 23 (77%). Physicians suggested adding a 'warmup' question showing a completed example and simplifying terminology. Patients suggested ways to clarify instructions. Cost, inconvenience of taking medication, and laboratory monitoring were the least concerning items. Cognitive side effects and a 50% seizure risk in the next year were the most concerning items. Twelve (39%) of patients made at least one 'inconsistent choice' for example ranking a higher seizure risk as lower concern compared with a lower seizure risk, though 'inconsistent choices' represented only 3% of all question blocks. Our recruitment rate was favorable, most patients agreed the survey was clear, and we describe areas for improvement. 'Inconsistent' responses may lead us to collapse seizure probability items into a single 'seizure' category. Evidence regarding how patients weigh benefits and harms may inform care and guideline development.

PMID:36867630 | PMC:PMC9983827 | DOI:10.1371/journal.pone.0282658

PLoS One. 2023 Mar 3;18(3):e0281888. doi: 10.1371/journal.pone.0281888. eCollection 2023.

ABSTRACT

Rapamycin treatment significantly increases lifespan and ameliorates several aging-related diseases in mice, making it a potential anti-aging drug. However, there are several obvious side effects of rapamycin, which may limit the broad applications of this drug. Lipid metabolism disorders such as fatty liver and hyperlipidemia are some of those unwanted side effects. Fatty liver is characterized as ectopic lipid accumulation in livers, which is usually accompanied by increased inflammation levels. Rapamycin is also a well-known anti-inflammation chemical. How rapamycin affects the inflammation level in rapamycin-induced fatty liver remains poorly understood. Here, we show that eight-day rapamycin treatment induced fatty liver and increased liver free fatty acid levels in mice, while the expression levels of inflammatory markers are even lower than those in the control mice. Mechanistically, the upstream of the pro-inflammatory pathway was activated in rapamycin-induced fatty livers, however, there is no increased NFκB nuclear translocation probably because the interaction between p65 and IκBα was enhanced by rapamycin treatment. The lipolysis pathway in the liver is also suppressed by rapamycin. Liver cirrhosis is an adverse consequence of fatty liver, while prolonged rapamycin treatment did not increase liver cirrhosis markers. Our results indicate that although fatty livers are induced by rapamycin, the fatty livers are not accompanied by increased inflammation levels, implying that rapamycin-induced fatty livers might not be as harmful as other types of fatty livers, such as high-fat diet and alcohol-induced fatty livers.

PMID:36867603 | PMC:PMC9983852 | DOI:10.1371/journal.pone.0281888

Home Healthc Now. 2023 Mar-Apr 01;41(2):68-77. doi: 10.1097/NHH.0000000000001146.

ABSTRACT

With potentially curative targeted and immunotherapies for non-small cell lung cancer, long term survival of at least 5 to 10 years is increasingly possible. A personalized, holistic, and multidisciplinary home healthcare treatment plan can help cancer patients transition from acute to chronic disease management. Factors to be considered include the patient's goals, treatment-related risks, the degree of metastasis, acute symptom management needs, and the desire and ability to participate in the treatment plan. The case history illustrates how genetic sequencing and immunohistochemistry testing guide treatment decisions. Strategies for pharmacological and nonpharmacological management of acute pain related to pathological spinal fractures are discussed. Care coordination that includes the patient, home care nurses and therapists, the oncologist, and the oncology nurse navigator is essential to transition the patient with advanced metastatic cancer to the highest possible functional status and quality of life. Discharge teaching should include early recognition and intervention for adverse effects of medications and signs or symptoms that may signal disease reoccurrence. The use of a written, patient-driven survivorship plan is important to assure diagnostic and treatment information is summarized, follow-up tests and scans are scheduled, and screening tests for other types of cancer are included.

PMID:36867479 | DOI:10.1097/NHH.0000000000001146

Sultan Qaboos Univ Med J. 2023 Feb;23(1):13-21. doi: 10.18295/squmj.5.2022.035. Epub 2023 Feb 23.

ABSTRACT

OBJECTIVES: This study aimed to examine the longitudinal association between social relationships and physical functioning among community-dwelling older adults with chronic conditions.

METHODS: Self-reported questionnaires were distributed and collected between 2014 and 2017 from participants ≥65 years old. The Index of Social Interaction was used to evaluate social relationships and the instrumental activities of daily living (IADL) subscale of the Tokyo Metropolitan Institute of Gerontology Index of Competence was used to examine functional status.

RESULTS: A total of 422 participants (190 males and 232 females) were included in the final analysis. High social relationships demonstrated significant adverse effects (odds ratio [OR] = 0.77, 95% confidence interval [CI]: 0.64-0.93) on the decline of IADL in the overall sample, particularly for females (OR = 0.71, 95% CI: 0.55-0.93) but not as much for males (P = 0.131).

CONCLUSION: This finding suggests that functional limitation was influenced by social relationships among disabled older adults and the influence of social relationships on functional limitation differed based on gender.

PMID:36865429 | PMC:PMC9974036 | DOI:10.18295/squmj.5.2022.035

Sultan Qaboos Univ Med J. 2023 Feb;23(1):90-98. doi: 10.18295/squmj.1.2022.007. Epub 2023 Feb 23.

ABSTRACT

OBJECTIVES: This study aimed to assess the knowledge, attitudes and practices regarding traditional medicine (TM) in Oman and examine the factors that necessitate its use.

METHODS: This cross-sectional, questionnaire-based study was conducted among the general population from November 2019 and March 2020. All Omani nationals above the age of 18 were eligible to be enrolled. The questionnaire consisted of questions on the knowledge, attitudes and use regarding traditional medicine in Oman.

RESULTS: A total of 598 responses to the questionnaire were received (response rate: 85.4%), of which 552 were deemed complete. Most responses were received from males (62.5%) and the sample had a mean age of 33.6 ± 7.7 years. A majority of the respondents (90%) were aware of the different types of TM in Oman; a high percentage (81.5%) felt that it was effective. Most (67.8%) had tried at least one method of TM use. Individuals who were older had tried TM compared to those who had not (34.5 ± 7.8 years versus 31.8 ± 7.2 years; P <0.001); in addition, more males than females (72.2% versus 27.8%; P <0.001) and those with full-time employment than those without had tried TM (84.2% versus 14.2%; P <0.001). Herbal medications (65.8%) and traditional massage (60.4%) were the most common forms of TM practice. Among females, herbal medications (69.2%) and massage (63.5%) are most often used; among males, cupping (65.2%) followed by herbal medications (64.4%) and massage (59.3%) were used more often. Notably, back pain (74.3%) was the most common condition for which TM was reportedly used, with only a small percentage (8.3%) reporting any concomitant side-effects.

CONCLUSION: There is widespread use of TM among Oman's urban population. An improved understanding of their benefits will facilitate their incorporation into modern health care services.

PMID:36865426 | PMC:PMC9974033 | DOI:10.18295/squmj.1.2022.007

Am J Mens Health. 2023 Mar-Apr;17(2):15579883231159343. doi: 10.1177/15579883231159343.

ABSTRACT

The sarcoid-like reaction is a rare autoinflammatory disease that can affect lymph nodes or organs but does not meet the diagnostic criteria for systemic sarcoidosis. Several drug classes have been associated with the development of a systemic sarcoid-like reaction, which defines drug-induced sarcoidosis-like reactions and can affect a single organ. Anti-CD20 antibodies (rituximab) have rarely been reported as responsible for this reaction and this adverse effect has mainly been described during the treatment of Hodgkin's lymphoma. We report a unique case of a sarcoid-like reaction complicating rituximab following the treatment of a mantle cell lymphoma and interesting only the kidney. The 60-year-old patient presented with severe acute renal failure 6 months after the end of his r-CHOP protocol and the urgent renal biopsy revealed acute interstitial nephritis rich in granulomas without caseous necrosis. After ruling out other causes of granulomatous nephritis, a sarcoid-like reaction was retained since infiltration was limited to the kidney. The temporal relationship between rituximab administration and the sarcoid-like reaction onset in our patient supported the diagnosis of a rituximab-induced sarcoidosis-like reaction. Oral corticosteroid treatment led to rapid and lasting improvement in renal function. Clinicians should be warned of this adverse effect and regular and prolonged monitoring of renal function should be recommended during the follow-up of patients after the end of treatment with rituximab.

PMID:36864684 | DOI:10.1177/15579883231159343

Medicine (Baltimore). 2023 Mar 3;102(9):e33181. doi: 10.1097/MD.0000000000033181.

ABSTRACT

BACKGROUND: Chronic heart failure (CHF) is the ultimate destination of most cardiovascular diseases and one of the leading causes of death for the elderly. Despite significant advances in the therapy of heart failure, the mortality and rehospitalization rates remain high. Guipi Decoction (GPD) has been reported to be significantly effective on patients with CHF, but it still lacks evidence-based medicine support.

METHODS: Two investigators systematically searched a total of 8 databases including PubMed, Embase, The Cochrane Library, Web of Science, Wanfang, China National Knowledge Infrastructure (CNKI), VIP, and CBM from construction to Nov 2022. Randomized controlled trials that compared GPD or in combination with conventional western medicine versus western medicine alone in the treatment of CHF were eligible for selection. The quality of included studies were evaluated and assigned data were extracted according to the method provided by Cochrane. All analyses used Review Manager 5.3 software.

RESULTS: The search identified 17 studies with a sample size of 1806 patients. Meta-analysis showed that GPD intervention was associated with an improvement in total clinical effective rate with a relative risk of 1.19 (95% confidence interval [CI] [1.15, 1.24]), P < .00001]. In terms of cardiac function and ventricular remodeling, GPT could improve left ventricular ejection fraction (mean difference [MD] = 6.41, 95% CI [4.32, 8.50], P < .00001), reduce left ventricular end diastolic diameter (MD = -6.22, 95% CI [-7.17, -5.28], P < .00001) and left ventricular end systolic diameter (MD = -4.92, 95% CI [-5.93, -3.90], P < .00001). In terms of hematological indices, GPD could decrease the levels of N-terminal pro-brain natriuretic peptide (standardized MD = -2.31, 95% CI [-3.05, -1.58], P < .00001) and C-reactive protein (MD = -3.51, 95% CI [-4.10, -2.92], P < .00001). And the analysis of safety revealed no significant differences in adverse effects between the 2 groups with a relative risk of 0.56 (95% CI [0.20, 0.89], P = .55).

CONCLUSION: GPD can improve cardiac function and inhibit ventricular remodeling with few adverse effects. However, more rigorous and high-quality randomized controlled trials are needed to verify the conclusion.

PMID:36862873 | PMC:PMC9981397 | DOI:10.1097/MD.0000000000033181

PLoS One. 2023 Mar 2;18(3):e0281662. doi: 10.1371/journal.pone.0281662. eCollection 2023.

ABSTRACT

BACKGROUND: Inflammatory skin reactions and skin alterations are still a potential side effect in radiation therapy (RT), which also need attention for patients' health care.

METHOD: In a pre-clinical study we consider alterations in irradiated in-vitro skin models of epidermal and dermal layers. Typical dose regimes in radiation therapy are applied for irradiation. For non-invasive imaging and characterization optical coherence tomography (OCT) is used. Histological staining method is additionally applied for comparison and discussion.

RESULTS: Structural features, such as keratinization, modifications in epidermal cell layer thickness and disorder in the layering-as indications for reactions to ionizing radiation and aging-could be observed by means of OCT and confirmed by histology. We were able to recognize known RT induced changes such as hyper-keratosis, acantholysis, and epidermal hyperplasia as well as disruption and/or demarcation of the dermo-epidermal junction.

CONCLUSION: The results may pave the way for OCT to be considered as a possible adjunctive tool to detect and monitor early skin inflammation and side effects of radiotherapy, thus supporting patient healthcare in the future.

PMID:36862637 | PMC:PMC9980765 | DOI:10.1371/journal.pone.0281662

Drug Deliv. 2023 Dec;30(1):2183821. doi: 10.1080/10717544.2023.2183821.

ABSTRACT

Inflammatory bowel disease (IBD) is one of the most common intestinal disorders, with increasing global incidence and prevalence. Numerous therapeutic drugs are available but require intravenous administration and are associated with high toxicity and insufficient patient compliance. Here, an oral liposome that entraps the activatable corticosteroid anti-inflammatory budesonide was developed for efficacious and safe IBD therapy. The prodrug was produced via the ligation of budesonide with linoleic acid linked by a hydrolytic ester bond, which was further constrained into lipid constituents to form colloidal stable nanoliposomes (termed budsomes). Chemical modification with linoleic acid augmented the compatibility and miscibility of the resulting prodrug in lipid bilayers to provide protection from the harsh environment of the gastrointestinal tract, while liposomal nanoformulation enables preferential accumulation to inflamed vasculature. Hence, when delivered orally, budsomes exhibited high stability with low drug release in the stomach in the presence of ultra-acidic pH but released active budesonide after accumulation in inflamed intestinal tissues. Notably, oral administration of budsomes demonstrated favorable anti-colitis effect with only ∼7% mouse body weight loss, whereas at least ∼16% weight loss was observed in other treatment groups. Overall, budsomes exhibited higher therapeutic efficiency than free budesonide treatment and potently induced remission of acute colitis without any adverse side effects. These data suggest a new and reliable approach for improving the efficacy of budesonide. Our in vivo preclinical data demonstrate the safety and increased efficacy of the budsome platform for IBD treatment, further supporting clinical evaluation of this orally efficacious budesonide therapeutic.

PMID:36861451 | DOI:10.1080/10717544.2023.2183821