Blind Trial Research Articles

Efficacy of tryushnadya churna in metabolic syndrome with obesity – A randomized double blind controlled clinical trial

Metabolic syndrome (MetS) with obesity has significant mortality and morbidity. Integrative Ayurveda management is explored for it's possible effect. To evaluate the effect of Tryushnadi churna in the management of Metabolic syndrome with obesity. Study is a Randomized, Controlled, double blind, parallel group comparative clinical trial. 48 participants meeting the National Cholesterol Education Programme Adult Treatment panel 3 diagnostic criteria were recruited in the study. They were divided in two 2 groups. Placebo group were administered with Placebo 1gm twice a day, Ayurveda diet and yoga. Tryushnadi Group were intervened with Tryushnadi churna 1gm twice a day, Ayurveda diet and yoga. Interventions were for 90 days. Assessments criteria included Weight, BMI,Waist circumference (WC), Waist hip ratio, Skin fold thickness (SFT), Body fat, blood pressure, WHO-QOL BREF scale, Clinical Global Impression Scale (CGI)- Severity, Global improvement and Efficacy index, Fasting blood sugar (FBS) were assessed on every 30th day. Other blood parameters like Glycated haemoglobin (HbA1c), Triglycerides, High density lipoproteins (HDL), Low density lipoproteins (LDL), Total cholesterol (TC) were evaluated at pre and post study. Between groups comparison showed, Tryushnadi group had significant improvements in BMI, Weight, WHOQOL-Bref and had large effect size. Both the groups showed improvement in WC, body fat, SFT, CGI severity, CGI efficacy index and improvement in quality of life in within group assessment. Study showed that Tryushnadi churna was effective in management of MetS with Obesity. Integrated management of Ayurveda medicine, Ayurveda diet and yoga had beneficial effect.

Effectiveness of epidural dexamethasone vs triamcinolone to relieve neuropathic pain of cervical disc herniation patients; 3-months follow-up

Background & objective: Cervical disc herniation (CDH) is the most common cause of radicular pain; with one-third of the patients suffering for more than six months. Epidural steroid injections (ESI) are widely performed by the pain specialists and the neurosurgeons in this disorder, acute or chronic. We compared triamcinolone and dexamethasone regarding their efficacy to improve neuropathic pain at three months follow-up. Methodology: This randomized blinded control trial was conducted at Dr. Kariadi Hospital in Semarang, Indonesia, on 42 chronic CDH patients. Patients were divided into two equal groups of 21 each, to receive, interlaminar cervical epidural injections of triamcinolone or dexamethasone under fluoroscopic guidance. The study was conducted from January 2022 to July 2023. Follow-up on the PainDETECT score was carried out before and 3 months after the ESI. Data collected was analyzed by using the Mann-Whitney test (P < 0.05). Results: Forty-two CDH subjects were involved in the study grouped as Dexamethasone group (21) and Triamcinolone group (21). Both groups observed significant pain improvement (P < 0.001, and P = 0.020). In the Dexamethasone group 16 out of 21 (76.2%) subjects showed improvement at 3 months of follow-up in the neuropathic pain, while in Triamcinolone group 10 out of 21 (47.6%) showed improvement at 3 months of follow-up. The differences in the two groups were significant (P < 0.001 vs P = 0.007). Conclusion: The results of this study prove that epidural injection of dexamethasone is more effective than triamcinolone for improving neuropathic pain syndrome associated with chronic cervical disc herniation. Keywords: Chronic CDH, Neck pain, Epidural steroid injection, Dexamethasone, Triamcinolone, Pain DETECT Citation: Budisulistyo T, Yudhasyah RA, Kustiowati E, Husni A, Muhartomo H, Suryadi. Effectiveness of epidural dexamethasone vs triamcinolone to relieve neuropathic pain of cervical disc herniation patients; 3-months follow-up. Anaesth. pain intensive care 2024;28(4):732−736; DOI: 10.35975/apic.v28i4.2515 Received: December 28, 2023; Reviewed: February 12, 2024; Accepted: February 17, 2024

High-sensitivity cardiac troponin I-guided combination angiotensin receptor blockade and beta blocker therapy to prevent anthracycline cardiotoxicity: the Cardiac CARE RCT

Background Anthracycline-induced cardiotoxicity has a variable incidence, and the development of left ventricular dysfunction is preceded by rises in plasma cardiac troponin concentrations. Beta-adrenergic receptor blocker and renin-angiotensin-system inhibitor therapies have been associated with modest cardioprotective effects in unselected patients receiving anthracycline chemotherapy. Methods In a multicentre prospective randomised open-label blinded end-point trial, patients with breast cancer and non-Hodgkin lymphoma receiving anthracycline chemotherapy underwent plasma high-sensitivity cardiac troponin concentration monitoring and cardiac magnetic resonance imaging before and 6 months after anthracycline treatment. Randomised controlled trial – patients at high risk of cardiotoxicity (plasma cardiac troponin I concentrations in the upper tertile during chemotherapy) were randomised to standard care plus cardioprotection (combination carvedilol and candesartan therapy) or standard care alone. The primary end point was 6-month change in left ventricular ejection fraction. Prognostic cohort study – in low-risk non-randomised patients with plasma cardiac troponin I concentrations in the lower two tertiles, we hypothesised the absence of a 6-month change in left ventricular ejection fraction (± 2%). Results Between October 2017 and June 2021, 175 patients (mean age 53 years; 87% female; 71% breast cancer) were recruited. Patients randomised to cardioprotection (n = 29) or standard care (n = 28) had mean left ventricular ejection fractions of 65.7 ± 6.6% and 64.9 ± 5.9%, respectively, at 6 months. Twenty patients (68.9%) were adherent to cardioprotection therapy at 6 months. Adverse events were more commonly reported in the cardioprotection group, with 71.4% of patients having at least one adverse event compared with 12.7% non-randomised and 10.3% standard care patients. After adjusting for age, pre-treatment left ventricular ejection fraction and planned anthracycline dose, the estimated mean percentage-point difference in 6-month left ventricular ejection fraction between the cardioprotection and standard care groups was –0.4% (95% confidence interval –3.59 to 2.85%; p = 0.82). In low-risk non-randomised patients, baseline and 6-month left ventricular ejection fractions were 69.3 ± 5.7% and 66.4 ± 6.3%, respectively (estimated mean difference 2.9%, 95% confidence interval 1.45 to 4.28%; p = 0.92, not equivalent). The main secondary objective of demonstrating zero percentage-point change with equivalence of ± 2% was not met. Conclusions Combination candesartan and carvedilol therapy had no demonstrable cardioprotective effect in patients receiving anthracycline-based chemotherapy with high-risk on-treatment plasma cardiac troponin I concentrations. Low-risk non-randomised patients had similar modest declines in left ventricular ejection fraction, suggesting that the clinical utility of routine cardiac troponin monitoring remains undefined. The modest short-term declines in left ventricular ejection fraction suggest that early cardioprotection therapy has a limited role in patients receiving anthracycline-based chemotherapy. Limitations Treatment effect might have been influenced by several patients stopping cardioprotection treatment within 2 months of randomisation. Across all groups, reduction in left ventricular ejection fraction was lower than expected and patients with high-risk cardiac troponin I concentrations did not exhibit a greater fall in left ventricular ejection fraction than low-risk patients. These factors, together with the trial being powered to detect a 5-percentage-point change in left ventricular ejection fraction, mean that a small treatment effect was not excluded. Future work Future work should aim to understand the transition from small changes in cardiac function, 6 months after completion of anthracycline chemotherapy, to the late development of heart failure in this population. Trial registration This trial is registered as ISRCTN24439460 and EudraCT 2017-000896-99. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 15/48/20) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 12. See the NIHR Funding and Awards website for further award information.

Update on APPEAL, an International Randomized Controlled Trial Evaluating Ciprofloxacin Versus Placebo in Patients Undergoing Shockwave Lithotripsy for Urolithiasis

The blinded APPEAL trial is assessing the effectiveness of antimicrobial prophylaxis in preventing infections after shockwave lithotripsy for urinary stones. This large, pragmatic, international trial will provide trustworthy evidence to inform guidelines and influence global practices.

Time to sense biofield (Prana) experiences between hands: A preliminary single blinded randomized placebo controlled trial

Aims There is minimal research on the duration of biofield experiences. This preliminary study used the experiential learning practice of Master Choa Kok Sui's hands sensitisation to determine the duration to experience biofield sensations in between hands and to find the relationship between learning style preferences and biofield sensations. Methods This randomized placebo controlled, single blinded trial included 88 male and female pre-service teachers, aged 22.8±1.2 years. Participants completed a ruler drop test for reaction time, and Six Letter Cancellation test for measuring attention, learning style questionnaire for preferred method of learning, before randomization. The experimental (hands facing each other as introduced by Master Choa Kok Sui) and sham (hands facing opposite) groups practiced hands sensitisation. A semi-structured questionnaire was provided to gather information about biofield sensations and the time it took to experience these sensations between the hands. Results All (N=44) the participants in the experimental group and 13 participants in the sham group reported experiencing biofield sensations. A significant difference was noticed in experiencing magnetic (X2 = 38.247, p ≤ .001), physical sensations of energy (X2 = 12.02, p ≤ .001) and pain (X2 = 62.259, p ≤ .001) among the experimental and sham group . In the experimental group, the average time taken to first experience magnetic sensation, other biofield sensations and temperature variation was 34.84±12.97seconds, 40.28±20.96 seconds and 42.50±19.79 seconds, respectively. Minimum time taken to first experience biofield sensation was 5 seconds and lasted up to study duration of 120 seconds. There was no correlation found between reaction time, sustained attention, and the time needed to experience biofield sensations. Conclusions This study highlights importance of Master Choa Kok Sui hand sensitization in controlled setting revealing differences in experiences of various biofield sensations, showing valuable time-related insights and variability of sensation based on preferred learning.

Opioid-Free Anesthesia and Analgesic Quality During the Postoperative Period of Oncological Breast Surgery

<i>Background: </i>Pain is one of the most common symptoms in cancer patients. We can understand it as a multifactorial phenomenon. Breast cancer surgical treatment generates real damage to the structures and activates nociception which can generate persistent pain. Current anesthetic management is based on the use of opioids, which generate a large number of complications that can severely affect this group of patients, increasing morbidity and mortality. Opioid-free techniques have been shown to reduce complications and generate optimal anesthetic-analgesic management as well as decrease postoperative misuse. The purpose of this research is to compare both approaches and evaluate their impact on this population group. <i>Methods: </i>Simple, prospective, randomized, controlled blind clinical trial in 30 patients undergoing oncological mammary quadrantectomy a. The patients were divided into two groups study, the first (group A) received balanced general anesthesia with opioids as an analgesic strategy, the other group (group B) received general anesthesia balanced opioid-free supplemented with a PECs II regional block and/or Serratus (BRILMA) according to the patient's sonoanatomy, and ketamine-lidocaine as adjuvant drugs. Analgesia was assessed using the numerical pain scale at 2, 4, and 6 o'clock. The severity and impact of pain on the daily performance of patients were measured using the Brief Pain Inventory (BPI) short form in combination with clinical examination, the presence of postoperative complications, the length of stay in hours and the need for rescue with opioids. <i>Results: </i>35% of the patients in group A required analgesic rescue with Tramadol to improve pain postoperative, while in group B only 10% needed it. 33% of the patients in group A completed their postoperative period with nausea and vomiting, while in the opioid-free group the percentage was only 1%. Referring to the length of hospital stay from surgery to discharge, group A was hospitalized for a period of 25 hours (SD=21.2), while group B was there for 15.2 hours (SD=8.7). <i>Conclusions:</i>. Use of opioid-free anesthesia along with adjuvant strategies (drugs and nerve blocks) represent a safe and effective anesthetic strategy related with a lower incidence of complications from the use of opioids in the postoperative period, a lower consumption of analgesic rescues, a decrease in the length of hospitalization and a greater degree of comfort for the patient. This protocol represents an alternative when it comes to providing good intra and postoperative conditions for such a susceptible group of patients.

The effect of intravenous magnesium sulphate infusion on total intravenous anesthesia with propofol in adult dogs: A randomized, blinded trial

ObjectiveTo evaluate cardiopulmonary, arterial blood gas and propofol-sparing effects of magnesium sulfate (MgSO4) constant rate infusion (CRI) in mechanically ventilated dogs maintained under total intravenous anesthesia with propofol. Study designBlinded, randomized, clinical trial. AnimalsA total of 24 healthy adult dogs. MethodsDogs were premedicated with intramuscular acepromazine (0.05 mg kg–1) and morphine (0.5 mg kg–1), followed by an intravenous (IV) bolus of saline or MgSO4 (50 mg kg–1 over 15 minutes) and propofol (given to effect to induce anesthesia). Anesthesia was maintained with an IV propofol infusion (beginning at 0.3 mg kg–1 minute–1, adjusted as necessary). Concurrently, one of three IV infusions were administered: GS (0.9% NaCl), GM30 (MgSO4, 30 mg kg–1 hour–1) or GM80 (MgSO4, 80 mg kg–1 hour–1). Propofol induction and maintenance doses were recorded. The following variables were recorded at baseline (T0), after bolus treatment (T1), after beginning mechanical ventilation (T5) and every 15 minutes until the end of the procedure (T15–T120): mean arterial pressure, heart rate, peripheral oxygen saturation, end-tidal partial pressure of CO2, temperature, blood gas variables, indirect calorimetry and extubation time. Values of p < 0.05 were considered significant. ResultsPropofol induction bolus dose was lower in GM30 (31.2%, p = 0.04) and GM80 (38.9%, p = 0.003) than in GS. The maintenance propofol infusion rate in GM80 was 16.9% lower (p = 0.03), resulting in fewer propofol CRI rescues during the perioperative period. GM30 and GM80 exhibited faster extubation times than GS (46.2%, p = 0.002 and 48.9%, p = 0.001, respectively). Conclusions and clinical relevanceInfusion of a 50 mg kg–1 bolus, followed by CRI of MgSO4 (30 and 80 mg kg–1 hour–1), reduces the propofol induction and maintenance (CRI) requirement, maintaining cardiorespiratory stability and reducing the time required to extubation.

Randomized, Blinded, Controlled Clinical Trial of Polylactide-Collagen Scaffold in Treatment of Shoulder Osteochondritis Dissecans in Dogs.

The aim of our study was to investigate a degradable polylactide-collagen scaffold (COPLA) in the treatment of shoulder osteochondritis dissecans (OCD) in dogs. The study was a controlled, randomized, blinded clinical trial with a parallel group design with a 1.5-year follow-up. Twenty dogs with uni- or bilateral shoulder OCD (29 shoulders) were randomized to receive a COPLA or arthroscopic debridement only (Control). The outcome of treatment was assessed with gait and stance analysis, passive range of motion measurement, pain and lameness evaluation, Helsinki Chronic Pain Index, and computed tomography (CT). Eighteen dogs (25 shoulders) completed the study. The clinical outcome variables improved significantly from baseline in COPLA and Control groups after treatment but no significant differences emerged between groups. Significantly fewer COPLA than Control shoulders had osteoarthritis (OA) in CT at 6 months (p = 0.019) but the difference was not significant at 1.5 years. At 1.5 years, all dogs were sound and pain-free in joint palpation, but OA was diagnosed in 13/18 dogs (18/25 shoulders) with CT. The results suggest that COPLA scaffold slowed down the development of OA at 6 months but it did not improve the clinical recovery or prevent OA in dogs with shoulder OCD in long-term follow-up at 1.5 years compared with arthroscopic debridement only. Regardless of the treatment method, clinical recovery was good, but OA developed in the majority of dogs.

Effect of Using Mouthwash Containing Cibotium barometz J. Smith on Cariogenic Bacteria and Acid-producing Ability of Saliva: A Randomised Blinded Clinical Trial.

To examine the anti-caries effect of mouthwashes containing Cibotium barometz J. Smith (CB), a natural substance, and compare it with chlorhexidine and saline solution. A randomised, blinded clinical trial was conducted on 76 study participants. The differences between the 3 gargle groups (saline gargle: SAL; chlorhexidine gargle: CHX; CB gargle group: CB) and the differences over time (baseline, after 1 week, after 2 weeks) were compared. To this end, ANOVA was performed on caries-related clinical indicators (e.g. O'Leary plaque index, caries activity, and satisfaction). The O'Leary index, caries activity, and saliva tests, gradually improved in group CB at one and two weeks. In the case of bacterial tests, unlike SAL and CHX, only in group CB did the decrease occur one and two weeks later. The caries-related indicators decreased significantly over time in group CB compared to SAL and CHX groups, and there was also a statistically significant difference in interaction between groups and time (p<0.05). The mouthwash containing CB extract showed statistically significant improvement in biofilm adhesion as well as the saliva and bacterial tests compared to SAL and CHX. However, since there were differences in the initial oral conditions of the three groups, additional long-term research is needed through crossover clinical trials to supplement these.

Perioperative Dexamethasone Split Between Two Doses Further Reduced Early Postoperative Nausea and Vomiting Than Single-Dose Dexamethasone: A Randomized Blinded Placebo-Controlled Trial

BackgroundWe investigated whether two doses of dexamethasone are more effective than a single dose in reducing early postoperative nausea and vomiting (PONV) during total knee arthroplasty (TKA). MethodsA total of 150 patients between June 2021 and June 2022 were randomized into 3 groups: two doses of normal saline (group A), a single dose of 10 mg dexamethasone before surgery and normal saline after surgery (group B), and two doses of 5 mg dexamethasone during the perioperative period (group C). Primary outcomes were incidences and severity of PONV within 24 hours after surgery, the number and consumption of patients requiring morphine and metoclopramine, and visual analog scale scores for nausea and vomiting at 2, 4, 6, and 24 hours after surgery. Blood glucose levels on days 1, 2, and 3 after operation and incidences of surgical site infection (SSI) as well as gastrointestinal bleeding (GIB) within 45 days after operation were compared. ResultsWithin 24 hours after operation, the number and consumption of patients requiring morphine and metoclopramide in groups B and C were significantly lower than those in group A. Incidences and severity of PONV in groups B and C were significantly lower than those in group A. And these differences between groups B and C were significant. At 2, 4, 6, and 24 hours after operation, there were significant differences in visual analog scale scores of PONV between groups A and B, A and C, as well as B and C. On postoperative days 1, 2, and 3, there were no significant differences in blood glucose levels among the groups, and there were no incidences of SSI or GIB in any group within 45 days after operation. ConclusionDexamethasone significantly reduces PONV within 24 hours after TKA, does not result in significant changes in postoperative blood glucose levels, and does not increase the risk of SSI or GIB, particularly on group C. Registration numberChiCTR2400088512. Registration centerChinese Clinical Trial Registry (ChiCTR). Websitewww.chictr.org.cn.

Effects of brief remote high ventilation breathwork with retention on mental health and wellbeing: a randomised placebo-controlled trial

High ventilation breathwork with retention (HVBR) has been growing in popularity over the past decade and might be beneficial for mental and physical health. However, little research has explored the potential therapeutic effects of brief, remotely delivered HVBR and the tolerability profile of this technique. Accordingly, we investigated the effects of a fully-automated HVBR protocol, along with its tolerability, when delivered remotely in a brief format. This study (NCT06064474) was the largest blinded randomised-controlled trial on HVBR to date in which 200 young, healthy adults balanced for gender were randomly allocated in blocks of 2 by remote software to 3 weeks of 20 min daily HVBR (fast breathing with long breath holds) or a placebo HVBR comparator (15 breaths/min with short breath holds). The trial was concealed as a ‘fast breathwork’ study wherein both intervention and comparator were masked, and only ~ 40% guessed their group assignment with no difference in accuracy between groups. Both groups reported analogous credibility and expectancy of benefit, subjective adherence, positive sentiment, along with short- and long-term tolerability. At post-intervention (primary timepoint) for stress level (primary outcome), we found no significant group × time interaction, F(1,180) = 1.98, p = 0.16, ηp2 = 0.01, d = 0.21), nor main effect of group, (F = 0.35, p = 0.55, ηp2 < 0.01) but we did find a significant main effect of time, (F = 13.0, p < 0.01, ηp2 = 0.07). There was a significant improvement in stress pre-post-intervention in both groups, however there was no significant difference in such improvement between groups. In addition to stress at follow-up, we found no significant group x time interactions for secondary trait outcomes of anxiety, depression, mental wellbeing, and sleep-related impairment. This was also the case for state positive and negative affect after the first session of breathwork and at post-intervention. Brief remote HVBR therefore may not be more efficacious at improving mental health than a well-designed active comparator in otherwise healthy, young adults.

Effectiveness of Pranic Healing as complementary therapy on lower urinary tract symptoms and sleep: Single-blind randomized trial

BackgroundBenign Prostatic Hyperplasia (BPH) commonly affects older men, leading to lower urinary tract symptoms (LUTS) that affect sleep and quality of life. This study evaluates the effect of Pranic Healing (PH) as a complementary therapy for bothersome LUTS by normalising biofield energy centres called Chakras. MethodologyA single blind trial involving 76 men with LUTS was conducted, randomised into Medication-only (MED) and Medication-plus-Pranic Healing (MEDPH) groups. The MEDPH received PH sessions twice weekly for 5 weeks. ResultsThe study compared MED (n = 30) and MEDPH (n = 36) participants, finding significant improvements in IPSS scores (p ≤ .001) in both groups. The MEDPH group showed a greater reduction in incomplete bladder emptying and intermittency. The post void residual volume increased significantly in the MED group (Wilcoxon Z = −2.335, p = .02), while the MEDPH group reduced non-significantly. Sleep quality index improved significantly (McNemar=.013) in the MEDPH group, while the MED group showed no significant change. Subjective sleep quality, duration, and latency improved significantly in the MEDPH group. Healers reported improved energy balance in chakras of MEDPH group. Perceived energy by healers in lower chakra relates to urinary parameters. ConclusionPH could alleviate LUTS, enhancing quality of life due to urination, and improved sleep, among moderate BPH patients. Trial registrationThis study has been registered under the Clinical Trial Registry of India. (CTRI No: CTRI/2023/01/049004)

Post-operative pain after root canal preparation with different apical finishing sizes a triple blinded split mouth clinical trial

BackgroundThis is a triple-blinded, prospective split-mouth clinical trial. It is important to shed light on the effect of different apical preparation sizes regarding postoperative pain within the same patient with the same pulpal histological status. The aim is to compare and evaluate the severity of postoperative pain following apical enlargement with two different sizes after the IBF using the visual analogue scale.MethodsFifty “teeth” in 25 patients were assigned into two equal groups (25 per group) using E3 Azure rotary files; Group A was prepared two sizes greater than the Initial binding file (IBF) (the largest K file to bind at the actual working length) mesial canals, which were enlarged to 35#/0.04 and 40#/0.04 for the distal canals. Group B was prepared in three sizes larger than the IBF: 40#/0.04 for mesial canals and 45#/0.04 for the distal canals. On a modified VAS form, patients were questioned to indicate the degree of their pain and assisted in narrating their pain intensity during the following periods: 12, 24, and 72 h, and after a week. VAS data were non-parametric and analyzed using the signed-rank test for intergroup comparisons, Freidman’s test, and the Nemenyi post hoc test for intragroup comparisons. The significance level was set at p < 0.05.Resultsshowed that regardless of measurement time, enlargement of apical preparation was significantly associated with higher pain scores (p < 0.001). Within both groups, there was a significant reduction of measured pain score with time, with values measured after 12 and 24 h being significantly higher than values measured at other intervals (p < 0.001) and with values measured after three days being significantly higher than 1-week value (p < 0.001).ConclusionThe size of apical preparation had a significant effect on postoperative pain.Trial registration number & dateNCT05847738, 08/05/2023.

The effect of vitamin D on the development of Hashimoto's disease and the reduction of the inflammatory process in its course - review

Introduction Hashimoto's disease is an autoimmune chronic lymphocytic thyroiditis. It is a common condition, more frequent in women. Its diagnosis is based on the presence of specific antithyroid antibodies in the patient's blood which lead to the destruction of the thyroid gland. This can result in the development of hypothyroidism, requiring levothyroxine replacement therapy. Aim of the review A summary of the information gathered so far on the involvement of vitamin D in the development and course of Hashimoto's disease. Results The articles analyzed have mixed results. Most of them show a positive correlation between vitamin D and Hashimoto's disease, paying particular attention to the contribution of vitamin D in moderating the inflammatory process in HT. Other studies show significant differences in vitamin D levels between groups with different HT severity. Others show a negative correlation between vitamin D levels and the development of Hashimoto's disease. Conclusions Large well-controlled randomized double blind trials are needed in order to determine the exact role of vitamin D in Hashimoto’s disease.

Effects of open-label transdermal nicotine antidepressant augmentation on affective symptoms and executive function in late-life depression

BackgroundLate-life depression (LLD) is characterized by a poor response to antidepressant medications and diminished cognitive performance, particularly in executive functioning. There is currently no accepted pharmacotherapy for LLD that effectively treats both mood and cognitive symptoms. This study investigated whether transdermal nicotine augmentation of standard antidepressant medications benefitted mood and cognitive symptoms in LLD. MethodsNonsmoking participants aged 60 years or older with unremitted LLD on stable SSRI or SNRI medications (N = 29) received transdermal nicotine patches up to a 21 mg daily dose over 12 weeks. Clinical measures assessed depression severity, secondary affective symptoms, and cognitive performance. Nicotine metabolite concentrations were obtained from blood samples. ResultsDepression severity significantly decreased over the trial, with a 76 % response rate and 59 % remission rate. Change in depression severity was positively associated with nicotine exposure. Participants also exhibited improvement in self-reported affective symptoms (apathy, insomnia, rumination, and generalized anxiety symptoms), negativity bias, and disability. Executive function test performance significantly improved, specifically in measures of cognitive control, as did subjective cognitive performance. Adverse events were generally mild, with 75 % of the sample tolerating the maximum dose. ConclusionThe current study extends our previous pilot open-label trial in LLD, supporting feasibility and tolerability of transdermal nicotine patches as antidepressant augmentation. Although preliminary, this open-label study supports the potential benefit of transdermal nicotine patches for both mood and cognitive symptoms of LLD. Further research, including definitive randomized, blinded trials, is warranted to confirm these findings and explore long-term risk and benefit. Trial registrationThe study was registered with clinicaltrials.gov (NCT04433767).

Efficacy of adjuvant photobiomodulation therapy in recurrent herpes labialis, a randomized clinical trial study

ObjectiveThis study aimed to determine the effect of Photobiomodulation therapy (PBMT) in the treatment of recurrent herpes labialis (RHL), one of the most common herpes simplex virus type 1 infections. Material and MethodsIn this randomized double blind controlled trial, Twenty-two symptomatic patients with RHL were enrolled. The patients were randomly allocated into one group (5 % acyclovir cream with 940±10 nm wavelength and 4 J/cm2 energy density and 100 mW output power) and another group (5 % Acyclovir 5 times/5 days and sham laser). Lesion size, and pain intensity were considered as the outcome at baseline, 1st 2nd and 3rd days postoperatively. ResultsPain intensity in PBM + Acyclovir group was significantly lower than Acyclovir without PBM group in both two and three days after intervention (p < 0.001). The lesion size in case group was significantly lower on 7 and 10 days (p < 0.05). Patients in the treatment group were significantly more satisfied with their treatment process (p = 0.008). ConclusionPBMT can be used as an adjuvant tool to acyclovir cream, due to higher potential in reducing postoperative pain, lesion size and also patients satisfaction.

Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial

BackgroundNeck pain is a prevalent global musculoskeletal issue, significantly contributing to the loss of years of healthy life due to disability. Chronic nonspecific neck pain (CNNP) involves diverse symptoms impacting mobility and quality of life. While therapeutic exercises demonstrate efficacy, the role of photobiomodulation therapy (PBMT) remains uncertain. This study aims to assess the additional effects of PBMT within a multimodal therapeutic intervention for CNNP.MethodsA randomized, two-arm, controlled, blind clinical trial follows CONSORT and SPIRIT guidelines. Participants diagnosed with CNNP will receive a stand-alone multimodal therapeutic intervention or the same program with additional PBMT. The primary outcomes will be assessed by the functional disability identified through applying the NDI (Neck Disability Index). Secondary outcomes will be pain intensity during rest and active neck movement, catastrophizing and kinesiophobia, functionality, and disability assessed at baseline, after 8 weeks, and at a 4-week follow-up. Both groups receive pain education before personalized interventions, including resistance exercises, neuromuscular activities, mobility, and body balance. The PBMT group undergoes low-level light therapy. Intention-to-treat analysis, using linear mixed models, employs data presented as mean, standard deviation, and differences with a 95% confidence interval. Non-normally distributed variables transform. Statistical significance is set at 5%.DiscussionThis study addresses a critical gap in understanding the combined effects of PBMT and therapeutic exercises for CNNP. The findings aim to guide clinicians, researchers, and CNNP sufferers through rigorous methodology and diverse outcome assessments, offering valuable insights into evidence-based practices for CNNP management. Data confidentiality is maintained throughout, ensuring participant privacy during statistical analysis.Trial registrationEffects of adding photobiomodulation to a specific therapeutic exercise program for the treatment of individuals with chronic nonspecific neck pain, registration number: NCT05400473, on 2022-05-27.

The effects of mouth rinsing and gargling with mouthwash containing povidone-iodine and hydrogen peroxide on the cycle threshold value of Severe Acute Respiratory Syndrome Coronavirus 2: A randomized controlled trial of asymptomatic and mildly symptomatic patients.

Coronavirus disease 2019 can spread rapidly. Surgery in the oral cavity poses a high risk of transmission of severe acute respiratory syndrome coronavirus 2. The American Dental Association and the Centers for Disease Control and Prevention recommend the use of mouthwash containing 1.5% hydrogen peroxide (H 2O 2) or 0.2% povidone iodine (PI) to reduce the viral load in the upper respiratory tract and decrease the risk of transmission. The aim of the present study was to analyze the effect of mouth rinsing and gargling with mouthwash containing 1% PI, 0.5% PI, 3% H 2O 2, or 1.5% H 2O 2 and water on the cycle threshold (CT) value obtained by real-time reverse transcription polymerase chain reaction (RT-PCR). This study is a randomized single blind controlled clinical trial which has been registered in the International Standard Randomized Controlled Trial Number (ISRCTN) registry on the 3 rd February 2022 (Registration number: ISRCTN18356379). In total, 69 subjects recruited from Persahabatan General Hospital who met the inclusion criteria were randomly assigned to one of four treatment groups or the control group. The subjects were instructed to gargle with 15 mL of mouthwash for 30 s in the oral cavity followed by 30 s in the back of the throat, three times per day for 5 days. CT values were collected on postprocedural days 1, 3, and 5. The results of the Friedman test significantly differed among the groups (n=15). The CT values increased from baseline (day 0) to postprocedural days 1, 3, and 5. Mouth rinsing and gargling with mouthwash containing 1% PI, 0.5% PI, 3% H 2O 2, or 1.5% H 2O 2 and water increased the CT value.

Evaluation of lavender and rose aromatherapies on the success of inferior alveolar nerve block in symptomatic irreversible pulpitis: A randomized clinical trial

Trial designThis is a prospective, block-randomized, blinded, multiple arm and parallel-group superiority clinical trial. MethodsSeventy-eight patients satisfying the recruitment standards, were randomly allocated into three groups as follows: Group I (n = 26) – Inferior alveolar nerve block (IANB) devoid of aromatherapy (AT); Group II (n = 26) - IANB with lavender AT and Group III - IANB with rose AT (n = 26) with the help of the ultrasonic aroma diffuser (with respective oils)for 20 min/2 h in operatories 1,2 and 3 respectively. For AT, 3–4 drops of lavender and rose-conditioned oils were added from a 100 ml solution containing 100 mg of these medicinal plants. The pre-operative (PRO) and access opening (AO) pain as well as the anxiety of patients were recorded using the Visual Analog Scale (VAS) and Modified Dental Anxiety Scale (MDAS) respectively. Data thus obtained was entered into the Excel sheet and subjected to statistical tests (analysis of variance and paired t-test). The p-value less than 0.05 was considered statistically significant. ResultsGroup I showed non-significant disparity between PRO and AO for both VAS as well as MDAS (p = 0.62, p = 0.71). However, group II (p = 0.04, p = 0.02) and group III (p = 0.03, p = 0.01) revealed significant differences between PO - AO VAS and MDAS. MDAS and VAS intergroup comparison revealed a significant difference among groups I and II (p = 0.03, p = 0.04), and groups I and III (p = 0.02, p = 0.03). However non-significant disparity was observed among groups II and III (p = 0.85, 0.34). Moreover, there was a statistically significant reduction in anxiety levels in females compared to males after rose AT (p = 0.02). Nevertheless, groups I and II did not show any gender predilection for anxiety as well as pain. ConclusionAlleviation of dental anxiety as well as reduction in pain during AO of teeth with SIP can be achieved using Lavender and rose AT. In female patients, rose AT can be preferred over lavender AT.

Comparison of subarachnoid administration of low-dose bupivacaine and lidocaine in healthy goats.

This study aimed to compare the effects of low-dose subarachnoid injections of 2% lidocaine (LIDO) and 0.5% bupivacaine (BUPI) in goats. 6 healthy, privately owned female goats. In this randomized blind crossover clinical trial, each goat received 0.05 mL/kg-1 of LIDO, BUPI, or sterile saline solution into the lumbosacral subarachnoid space, with a seven-day washout. Cardiorespiratory variables, rectal temperature, and somatosensory (pinprick) and motor (ataxia) functions were recorded at baseline (time 0) and 2, 5, 10, 15, and 30 minutes after injection, then every 20 minutes until the goat was standing and able to walk. Time to regain somatosensory and motor functions was compared between treatments using Kaplan-Meier survival curves and the Cox proportional hazards model. Linear mixed-effects models were used to compare cardiorespiratory variables between treatments and over time. A P value ≤ .05 was considered significant. Somatosensory recovery was longer with BUPI, though not statistically significant. The median time to stand was 50 (50, 67) minutes after LIDO injection and 104 (101, 156) minutes after BUPI injection (P = .031). The median time to walk was 72 (54, 85) minutes after LIDO versus 225 (220, 245) minutes after BUPI injection (P = .031). Cardiovascular and respiratory variables showed no significant differences between treatments. Despite prolonged ataxia with BUPI, pinprick sensation recovery did not differ. At reduced doses, both LIDO and BUPI are deemed acceptable for short procedures of the flank, pelvic limb, or tail in healthy goats.