Triple-blind Controlled Trial Research Articles

Efficacy of azasetron on postoperative chronic pain after pulmonary surgery: a randomized triple-blind controlled trial

BackgroundInhibition of 5-HT3 (5-Hydroxyl Tryptamine) receptors is known to enhance morphine analgesia in animal models. We tested the efficacy of azasetron, a 5-HT3 receptor antagonist, on postoperative chronic pain after pulmonary surgery in a randomized triple-blind controlled study.MethodsA total of 250 patients who were scheduled to receive pulmonary surgery were randomized to patient-controlled analgesia (PCA) using 200 µg sufentanil with normal saline or 200 µg sufentanil with 20 mg azasetron. The numerical rating scale of pain (NRS) was recorded at baseline, postoperative day (POD) 1, 2, 3, 90, and 180. Negative binomial regression was used to identify associated factors for postoperative NRS six months after surgery.ResultsThe results showed that azasetron did not affect the primary outcomes: the incidence of postoperative chronic pain on POD90 and 180. However, azasetron decreased postoperative NRS at rest and activity on POD1, 2, and 3. Furthermore, azasetron decreased postoperative nausea and vomiting on POD1 and 2. Univariate and multivariate negative binomial regression analysis identified preoperative pain, smoking, drinking and open surgery are risk factors of chronic pain six months after surgery.ConclusionsAzasetron did not affect the incidence of chronic pain after pulmonary surgery. The presence of preoperative pain, smoking, drinking, and open surgery were found to be associated with chronic pain six months after surgery.Clinical trial registrationThe trial was registered prior to patient enrollment at the Chinese Clinical Trial Registry (ChiCTR2200060139), 20/05/2022; the site url is https://www.chictr.org.cn/.

Comparative Study of Ropivacaine and Ropivacaine With Dexmedetomidine in Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia in Patients Undergoing Cesarean Sections.

Background Adequate post-operative analgesia in the obstetric patient is necessary to facilitate breastfeeding and the care of the newborn. Considering the limitations of intravenous analgesic options such as non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, other alternatives have been tried for offering better analgesia with fewer potential side effects. Transversus abdominis plane (TAP) block is one such option that has been tried with various local anesthetic drugs, either alone or in combination with other adjuvants. The addition of dexmedetomidine to bupivacaine in TAP block has been shown to prolong the duration of post-operative analgesia when compared to local anesthetic alone. This study was conducted to determine the efficacy of dexmedetomidine, as an adjuvant to ropivacaine, when administered in TAP block in patients undergoing cesarean section. Methodology The study was a prospective, randomized, parallel assignment, triple-blinded controlled trial. Hundred patients posted for elective lower segment cesarean section, fulfilling the inclusion criteria, were randomly divided into two equal groups, group R and group RD, comprising 50 patients each. Patients in group R were administered bilateral TAP block by landmark technique using ropivacaine alone, whereas patients in group RD were administered TAP block with dexmedetomidine 1 micrograms/kg, in addition to a similar dose of ropivacaine. Mean arterial pressure (MAP), heart rate (HR), visual analog scale (VAS)-R (pain score on VAS scale at rest), VAS-C (pain score on VAS scale on coughing), nausea and vomiting, and Ramsay sedation score were recorded on admission to post-operative care unit (PACU), and at first, fourth, eighth, 12th, 18th,and 24th hours post-operatively. Rescue analgesia was provided with intravenous morphine. Short Assessment of Patient Satisfaction Score (SAPS) was noted on a five-point scale after 24 hours based on patient satisfaction regarding the quality of post-operative analgesia. Results While there was no significant difference between groups R and RD with respect to VAS-C and VAS-R immediately after shifting and at the first, fourth, and eighth hours, a significant difference was observed at the 12th and 18th hours post-operatively. After 24 hours, no significant difference was observed between groups R and RD with respect to VAS-C and VAS-R. While 50% of patients needed rescue analgesia in group R, only 28% of patients needed rescue analgesia in group RD. There was significantly better patient satisfaction measured by the Short Assessment of Patient Satisfaction Score (SAPS) with respect to the quality of analgesia in patients in group RD as compared to those in group R. Conclusions The addition of dexmedetomidine to ropivacaine increased the duration of post-operative analgesia up to 18 hours post-operatively in cases of elective lower segment cesarean section. Also, the quality of post-operative analgesia is better in such patients, as shown by a significant difference in patient satisfaction scores between the two groups.

Subpectineal obturator nerve block reduces opioid consumption after hip arthroscopy: a triple-blind, randomized, placebo-controlled trial

BackgroundHip arthroscopy causes severe pain during the first few hours in the postoperative care unit. This is probably due to the intraoperative stretching of the hip joint capsule. Pain relief...

Study Protocol for Assessing the Effectiveness of Agomelatine on the Severity and Frequency of Episodic Migraine Attacks Without Aura: A Randomized Triple-Blind, Placebo-Controlled Trial

Background: Migraine is a chronic condition characterized by moderate to severe headache attacks, adversely affecting individual and social quality of life. Given the chronic nature of this disease, it is crucial to find medications that offer fewer side effects and enhanced effectiveness. Agomelatine, a synthetic analogue of the hormone melatonin, shares similar pharmacodynamics, such as stimulating melatonin receptors and inhibiting the 5HT2c receptor. Due to its favorable side-effect profile and high tolerability, agomelatine presents a viable alternative to traditional preventive treatments for migraines. Objectives: The primary objective of this trial is to evaluate the effectiveness of agomelatine in reducing the severity and frequency of episodic migraine attacks without aura. Methods: This study utilizes a parallel, triple-blind controlled trial design. Patients, aged between 18 and 60 years, who have been definitively diagnosed with episodic migraine without aura and have not received prior severity treatment, are eligible for this randomized controlled trial (RCT). A convenience sample of patients will be recruited from individuals visiting the clinic for migraine issues. If these individuals agree to participate and meet the inclusion criteria, they will be randomly assigned to either the intervention or control group using a random number table or software. The intervention group will receive 25 mg of agomelatine daily, while the control group will be given vitamin B1 as a placebo. Both the frequency and severity of migraine attacks will be monitored, along with the mean monthly migraine days (MMD) and migraine disability assessment (MIDAS) scores, before and after the intervention.

Effect of topical application of ibuprofen/arginine on the in-office bleaching-induced tooth sensitivity: A randomized, triple-blind controlled trial

ObjectiveThe application of anti-inflammatories as topical desensitizers before dental bleaching is an approach to reduce bleaching-induced tooth sensitivity (TS). This randomized controlled trial compared the risk and intensity of TS and the color change resulting from in-office dental bleaching after using an experimental desensitizing gel containing ibuprofen and arginine. MethodsSixty-two participants with upper canine shades A2 or darker were randomly assigned to either the ibuprofen-arginine desensitizing group or the placebo group. The desensitizing gel was applied for 15 min before in-office bleaching with 35 % hydrogen peroxide gel for 50 min (2 sessions). To assess the absolute risk and intensity of TS, visual (0–10) and numeric rating (0–5) scales were used, and group comparisons were made using the McNemar test, Wilcoxon test, and paired Student t-test (α = 0.05). Color change was evaluated using Vita Classical, Vita Bleachedguide (ΔSGU), and Vita EasyShade (ΔEab, ΔE00, and ΔWID) before and one month after the bleaching procedure. Group comparisons for color change were done using a paired t-test (α = 0.05). ResultsThe odds ratio for TS was 0.14 [95 % CI 0.02 to 0.6], meaning lower odds of TS for the desensitizing gel. A lower intensity of TS was also observed for the experimental group (p < 0.005) up to 48 h after bleaching. All color evaluation tools demonstrated effective and similar whitening for both groups (p > 0.05). ConclusionsUsing the experimental desensitizing gel containing ibuprofen and arginine effectively reduced the risk and intensity of TS without compromising the bleaching efficacy. Clinical relevanceThe topical application of ibuprofen/arginine on the in-office bleaching reduced risk and intensity of bleaching-induced tooth sensitivity.

Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial

BackgroundThere are complicated mechanisms that link the disruption of the gut microbiome to the symptoms and complications of polycystic ovary syndrome (PCOS). In this study, an attempt was made to assess the effects of synbiotics on the health-related quality of life (HRQoL) in women with PCOS .MethodsFifty-six women with PCOS were enrolled in a triple-blind controlled trial for 12 weeks. They were randomly assigned to receive a daily 2-gram synbiotic sachets (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnosus, Lactobacillus helveticus, and fructooligosaccharide) (n = 28) or placebo (n = 28). To evaluate the impact on the HRQoL, participants were required to fill 26-Item Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ-26), 12-Item Short-Form Health Survey (SF-12) and Perceived Stress Scale (PSS-10) pre and post the intervention.ResultsFinally, statistical analyses were performed on 52 participants who finished the trial. Synbiotic supplementation improved the scores of emotional (P = 0.044), body hair (P = 0.016), weight (P = 0.033) and infertility domains (P = 0.027) of PCOSQ-26 compared to placebo group. The physical score within SF-12 also had a significant enhancement (P = 0.035). No significant improvement was seen in the PSS-10 score at the end of the trial.ConclusionThis study illustrated the advantageous effects of synbiotics on the health-related quality of life in women with PCOS. Further studies are required to confirm our findings.Trial registrationhttp://www.irct.ir: IRCT20211108053007N1; date of registration: 14/02/2023.

The effects of propolis supplementation on high-sensitivity C-reactive protein, testosterone hormone, and metabolic profile in women with polycystic ovary syndrome: A randomized, triple-blinded, placebo-controlled clinical trial.

One of the most prevalent ovulation disorders is polycystic ovarian syndrome (PCOS). According to the anti-inflammatory and beneficial effects of propolis, this triple-blind controlled trial was designed to evaluate the effect of propolis on metabolic factors, high-sensitivity C-reactive protein, and testosterone in women with PCOS. Recruited patients from the gynecologist clinic were randomized based on a stratified permuted four-block randomization procedure to supplement with propolis tablets, two tablets/day (500 mg propolis/day) (n = 30) or identical placebo tablets (n = 30) for 12 weeks in 2021 until 2022. Data were collected using a demographic questionnaire, blood samples, and a checklist to record the measured parameters. A total of 57 patients completed the trial. ANCOVA test showed that hip circumference (HC)) p = 0.03), fasting insulin (p = 0.007), homeostatic model assessment for insulin resistance (p = 0.004), testosterone (p = 0.004), and low-density lipoprotein (LDL)/high-density lipoprotein (HDL) (p = 0.02) were significantly decreased in the propolis versus the placebo group after adjustment for confounders. Although fasting blood glucose (p = 0.04) decreased significantly in the propolis group compared to the placebo, after adjusting for confounders, significance was lost (p = 0.09). Supplementation with propolis elicited positive effects on fasting insulin and insulin resistance, in addition to reducing the testosterone level, LDL/HDL, and HC, in PCOS women.

The effect of cannabidiol on seizure features and quality of life in drug-resistant frontal lobe epilepsy patients: a triple-blind controlled trial.

Treatment-resistant epileptic seizures are associated with reduced quality of life (QoL). As polypharmacy with routine antiseizure medications has many side effects, novel add-on treatments are necessary. Recent research showed the efficacy of add-on therapy by cannabidiol (CBD) on refractory epilepsy. We attempted to extend data on the efficacy and safety profile of CBD in patients with frontal lobe treatment-resistant epilepsy. A total of 27 patients were recruited into two CBD (n = 12) and placebo (n = 15) groups. The CBD group received a highly purified liposomal preparation of the drug in addition to routine antiseizure medications. The placebo group only received antiseizure medications. This experiment followed a triple-blinding protocol. Outcome measures were seizure frequency, the Chalfont seizure severity scale (CSSS), and the quality of life questionnaire score (QOLIE-31) assessed at baseline, 4 weeks, and 8 weeks. At 4 weeks, results indicated that a higher fraction of patients in the CBD group (66.67%) showed improvement in seizure, compared to the placebo group (20.00%). Before-after comparison revealed that CBD, unlike routine ADEs, was effective in reducing the occurrence of seizures at the study's final timepoint [mean difference 45.58, 95% CI (8.987 to 82.18), p = 0.009]. Seizure severity was not affected by study groups or time intervals (repeated-measures ANOVA p > 0.05). Post-hoc tests found that the QoLI-31 score was improved at 8 weeks compared to baseline [mean diff. -5.031, 95% CI (-9.729 to -0.3328), p = 0.032]. The difference in cases who experienced enhanced QoL was meaningful between the CBD and placebo groups at 8 weeks [RR: 2.160, 95% CI (1.148 to 4.741), p = 0.018] but not at 4 weeks (p = 0.653). A positive finding for QoL improvement was associated with a positive finding for seizure frequency reduction [r = 0.638, 95% CI (0.296 to 0.835), p = 0.001]. Interestingly, limiting the correlation analysis to cases receiving CBD indicated that QoL improvement was not linked with seizure parameters such as severity and frequency (p > 0.05). The present study suggests the benefit of a purified and highly efficient preparation of CBD for seizure frequency reduction and improvement of QoL in refractory frontal lobe epilepsy. Further study with longer follow-ups and larger sample size is advised. https://www.irct.ir/trial/56790, identifier: IRCT20210608051515N1.

Oral vitamin D supplemental therapy to attain a desired serum 25-hydroxyvitamin D concentration in essential healthcare teams

BackgroundThe study objectives were to ascertain the efficacy of vitamin D supplementation in rapidly increasing serum vitamin D and of implementation of a hybrid (virtual and in-person) trial.MethodsIn a randomized triple-blind controlled trial, healthcare workers were allocated to receive an oral bolus of 100,000 IU with 10,000 IU/week of vitamin D3 or placebo. The co-primary outcomes were the change from baseline in serum 25-hydroxyvitamin D [(Δ) 25(OH)D] and proportion with vitamin D sufficiency (25(OH)D ≥ 75 nmol/L), at endpoint. Adherence to supplements and procedures as well as adverse event rates were documented.ResultsThirty-four (19 intervention, 15 control) subjects were randomized, with 28 (41%) virtual visits. After 44.78 ± 11.00 days from baseline, a significant adjusted group difference of 44.2 (34.7, 53.8) nmol/L was observed in the Δ 25(OH)D (95% CI) in favor of supplementation; 77.8% of intervention, and 13.3% of control, patients were vitamin D sufficient (OR:6.11, 95% CI:1.6, 22.9). The adherence to intervention was 94.7% in the intervention and 100% in the control groups. Irrespective of visit type, high adherence was observed in sampling procedures and completion of fortnightly online questionnaire. No adverse events attributable to vitamin D were reported.ConclusionThe vitamin D supplementation rapidly and safely raised 25(OH)D levels to sufficient levels for a biological effect. Similarly high adherence to study procedures was observed with virtual and in-person participation.Trial registrationThis trial was registered at https://clinicaltrials.gov on July 23, 2020 (#NCT04483635).

Evaluation and comparison of vitamin A supplementation with standard therapies in the treatment of patients with COVID-19.

Incomplete data are often presented for determining the role of vitamin A supplement therapy for improving treatment outcomes in patients with COVID-19. We compared treatment effects between a group that received vitamin A added to the standard COVID-19 treatment and another group that received the standard drug treatment alone. Participants in this triple-blind controlled trial comprised 182 COVID-19 outpatients in Saveh City, Markazi Province, Islamic Republic of Iran, in 2020. Patients were randomly divided into experimental (n = 91) and control (n = 91) groups. Patients in the control group received the national standard treatment for COVID-19 (hydroxychloroquine), and those in the intervention group received 25 000 IU/d oral vitamin A for 10 days in addition to the standard treatment recommended by the national protocol. We evaluated the clinical symptoms, paraclinical criteria, and hospitalization status before and after 10 days of interventions. The treatment groups did not differ significantly in clinical and paraclinical symptoms before the intervention. However, clinical symptoms such as fever, body ache, weakness and fatigue, paraclinical symptoms, white blood cell count, and C-reactive protein showed significantly greater decreases in the experimental group 10 days post-intervention compared with the standard treatment alone (P < 0.05). Vitamin A supplementation demonstrated efficacy in improving some clinical and paraclinical symptoms in patients with COVID-19. Future studies should evaluate vitamin A supplementation with a larger sample size and compare different dosages, especially in hospitalized patients.

The effect of intra-vaginal oxytocin on sexual function in breastfeeding mothers: a randomized triple-blind placebo-controlled trial

BackgroundConsidering the importance of sexual function, high prevalence of sexual dysfunction (especially dyspareunia caused by atrophic vaginitis) in breastfeeding women, and lack of effective interventions, the present research aimed to determine the effect of oxytocin (OXT) vaginal gel on sexual function (primary outcome), sexual satisfaction, and depression (secondary outcomes) in the breastfeeding women.MethodsThis randomized triple-blind controlled trial was conducted on 64 breastfeeding women who referred to health centers in the city of Tabriz, Iran, in 2020-21. Participants were equally assigned to intervention/control groups using block randomization. 200 IU of OXT vaginal gel was given to the participants in the intervention group daily for eight week and the same protocol was carried out for the control group with placebo. Standard questionnaires of Female Sexual Function Index (FSFI), Edinburgh Postpartum Depression Scale (EPDS) and Sexual satisfaction scale for women (SSSW) were completed at baseline and 8 weeks after intervention. ANCOVA test was used to compare post-intervention mean score of the groups, adjusted for the baseline values.ResultsAfter intervention, there was no statistically significant difference between groups in terms of mean total score of FSFI (Adjusted Mean Difference (AMD): 1.14; 95% Confidence Interval (95% CI): -1.28 to 9.16; P= 0.349) and sexual satisfaction (AMD: 5.01; 95% CI: -0.53 to 10.56; P= 0.075). However, there was statistically significant difference between the groups in terms of mean scores of sexual contentment (AMD: 1.56; 95% CI: 0.29 to 2.83; P = 0.017) and depression (AMD: -1.90; 95% CI: -1.27 to -2.54; P < 0.001). One participant in the OXT group and one participant in the placebo group reported mild uterine contraction and one person in the placebo group reported vaginal burning sensations.ConclusionsNo evidence was found for the effects of OXT gel in the improvement of FSFI, even though, OXT significantly improved sexual satisfaction in the domain of contentment, and improved the symptoms of depression in comparison to the placebo group. However, a definite conclusion requires more research in this regard.Trial registrationthe Iranian Registry of Clinical Trials (IRCT), code: IRCT20120718010324N55, Date of registration: 27/05/2020, URL: https://en.irct.ir/user/trial/44986/view.

Whole-body electrical stimulation as a strategy to improve functional capacity and preserver lean mass after bariatric surgery: a randomized triple-blind controlled trial.

Bariatric surgery (BS) is a successful, long-lasting treatment option for obese. The early postoperative (PO) period is followed by dietary restriction and physical inactivity, leading to declines in muscle mass and functional capacity. Whole-body electromyostimulation (WB-EMS) may be a feasible and potential early rehabilitation strategy post BS. The aim was to evaluate the effects of WB-EMS with exercise training (Fe) on functional capacity, body composition, blood biomarkers, muscle strength, and endurance post BS. This is a randomized, triple-blind, sham-controlled trial. Thirty-five volunteers underwent a Roux-en-Y gastric bypass and were randomized into a WB-EMS (WB-EMSG) or control group (ShamG). Preoperative evaluations consisted of maximal and submaximal exercise testing, body composition, blood biomarkers, quadriceps strength, and endurance. After discharge, functional capacity and body composition were obtained. Exercise training protocols in both groups consisted of 14 dynamic exercises, 5 days per week, completing 30 sessions. The WB-EMSG also underwent an electrical stimulation protocol (Endurance: 85 Hz, 350 ms, 6 s of strain, 4 f of rest; Strength: 30 Hz, 350 ms, 4 s of strain, 10 seconds of rest, with bipolar electrical pulse). After intervention, subjects were reevaluated. The protocol started on average 6.7 ± 3.7 days after discharge. Both groups presented with a decline in functional capacity after BS (p < 0.05) and a reduction in all body composition measurements (p < 0.05). The exercise training program led to significant improvements in functional capacity (ShamG - PO: 453.8 ± 66.1 m, Post: 519.2 ± 62.8 m; WB-EMSG- PO: 435.9 ± 74.5, Post: 562.5 ± 66.4 m, p < 0.05), however, only the WB-EMSG demonstrated significant changes of distance walked (interaction time vs group effect, p < 0.05). In addition, adiponectin significantly increased only in the WB-EMSG (p < 0.05). The WB-EMSG was also able to preserve muscle strength, endurance, and fatigue index, while the ShamG demonstrated significant decline (p < 0.05). WB-EMS + Fe can be an attractive and feasible method following BS to enhance functional capacity and prevent deterioration of muscle function in the early PO. ReBEC, RBR-99qw5h, on 20 February 2015.

Efficacy of 2% lignocaine medicated pad for pain alleviation during rabies immunoglobulin administration: A randomized controlled trial

Rabies immunoglobulin (RIG) for animal bite victims is usually administered around the wound without the use of any anesthetic. Theoretically, the topical use of 2% lignocaine can reduce the pain during the procedure. This study aimed to determine the efficacy of 2% lignocaine medicated pad (LMP) for reducing pain during administration of RIG. A randomized triple-blind controlled trial was done in a tertiary care setting in Kerala, India. The proximal and distal wounds of the patient with minimum two, Category III animal bite wounds were randomized to intervention and placebo arms, based on a previously generated random number sequence. Sterile gauze pads soaked with 2% lignocaine and normal saline were the intervention and placebo, respectively. Pain was the primary outcome measure and was assessed using numeric rating scale (NRS) and sound, eye, and motor pain (SEM) scale. The patient, outcome assessor, and statistician were blinded. The wound sites and size of 100 intervention and 100 control wounds were comparable. The score of all elements of the SEM, total SEM, and NRS score were significantly lower in the wounds, which were given LMP compared to the control wounds. The number needed to treat for satisfactory pain relief and immediate pain relief was 25 and 14, respectively. No serious or minor adverse events were reported in the trial. The use of a proven drug in a topical route optimizes pain reduction from iatrogenic cause for millions of animal bite victims around the world with very little additional financial burden.

Impact of an e-learning module on personal protective equipment knowledge in student paramedics: a randomized controlled trial

BackgroundPrehospital professionals such as emergency physicians or paramedics must be able to choose and adequately don and doff personal protective equipment (PPE) in order to avoid COVID-19 infection. Our aim was to evaluate the impact of a gamified e-learning module on adequacy of PPE in student paramedics.MethodsThis was a web-based, randomized 1:1, parallel-group, triple-blind controlled trial. Student paramedics from three Swiss schools were invited to participate. They were informed they would be presented with both an e-learning module and an abridged version of the current regional prehospital COVID-19 guidelines, albeit not in which order. After a set of 22 questions designed to assess baseline knowledge, the control group was shown the guidelines before answering a set of 14 post-intervention questions. The e-learning group was shown the gamified e-learning module right after the guidelines, and before answering post-intervention questions. The primary outcome was the difference in the percentage of adequate choices of PPE before and after the intervention.ResultsThe participation rate was of 71% (98/138). A total of 90 answer sets was analyzed. Adequate choice of PPE increased significantly both in the control (50% [33;83] vs 25% [25;50], P = .013) and in the e-learning group (67% [50;83] vs 25% [25;50], P = .001) following the intervention. Though the median of the difference was higher in the e-learning group, there was no statistically significant superiority over the control (33% [0;58] vs 17% [− 17;42], P = .087). The e-learning module was of greatest benefit in the subgroup of student paramedics who were actively working in an ambulance company (42% [8;58] vs 25% [− 17;42], P = 0.021). There was no significant effect in student paramedics who were not actively working in an ambulance service (0% [− 25;33] vs 17% [− 8;50], P = .584).ConclusionsThe use of a gamified e-learning module increases the rate of adequate choice of PPE only among student paramedics actively working in an ambulance service. In this subgroup, combining this teaching modality with other interventions might help spare PPE and efficiently protect against COVID-19 infection.

P212 Transcranial direct current stimulation (tDCS) in post-stroke neglect rehabilitation: A research proposal for a triple blind controlled trial

P212 Transcranial direct current stimulation (tDCS) in post-stroke neglect rehabilitation: A research proposal for a triple blind controlled trial

Efficacy of a mouthwash containing essential oils and curcumin as an adjunct to nonsurgical periodontal therapy among rheumatoid arthritis patients with chronic periodontitis: A randomized controlled trial

The purpose of this study was to assess the efficacy of mouthwash containing essential oils and curcumin (MEC) as an adjunct to nonsurgical periodontal therapy on the disease activity of rheumatoid arthritis (RA) among RA patients with chronic periodontitis (CP). A triple-blinded controlled trial was conducted among 45 female RA patients with CP randomized into three treatment groups as follows: Group A: scaling and root planing (SRP) with 0.2% chlorhexidine mouthwash as an adjunct (n = 15), Group B: SRP with MEC as an adjunct (n = 15), and Group C: SRP alone (n = 15). RA disease activity was assessed using erythrocyte sedimentation rate, serum C-reactive protein, serum anti-citrullinated protein antibody, and serum rheumatoid factor. Periodontal disease activity was assessed using plaque index, clinical attachment level (CAL), and pocket depth (PD). All parameters were recorded at baseline and 6 weeks thereafter. Data were assessed using one-way ANOVA and paired t-test. A significant reduction in periodontal and RA disease activity parameters was observed from baseline to 6 weeks following intervention (P < 0.05). The highest percentage of mean reduction in plaque index and RA parameters from baseline to 6 weeks was observed in Group B followed by Groups A and C. The highest percentage of mean reduction in PD and CAL was observed in Group A followed by Groups B and C (P < 0.001). This study reveals that MEC as an adjunct to SRP is effective in reducing the disease activity of RA and CP, thereby warranting the use of the same.

Metformin in the Management of Childhood Obesity: A Randomized Control Trial.

Childhood obesity-related metabolic derangements are increasing among South Asian populations. Dietary and physical activity plans have limited effect. This study aims to assess the effectiveness of metformin in the management of obesity among 8- to 16-year-old children in Gampaha District of Sri Lanka. A triple-blinded controlled trial was conducted on 150 obese school children. After 12-hour overnight fast, blood was drawn for fasting blood glucose (FBG) and lipid profile. Anthropometry, fat mass (FM), and blood pressure were measured. BMI and insulin resistance were calculated. Children randomly received either metformin (8-10 years-500 mg 12 hourly; 11-16 years-1 g 12 hourly) or placebo. Anthropometry and blood investigations were repeated at 6 and 12 months. Mean difference in outcome measures, adjusted for baseline values, was compared using ANCOVA. There were 84/150 boys. Metabolic syndrome was present in 25 (16.7%). A statistically significant adjusted mean reduction was observed in the metformin group compared with placebo, in weight (-0.991 vs. 1.394, p = 0.000), BMI/Age-standard deviation score (SDS; -0.287 vs. -0.116, p = 0.000), %FM/Age-SDS (-0.092 vs. 0.016, p = 0.04), systolic blood pressure (SBP; -0.415 vs. 0.015, p = 0.015), total cholesterol (-0.95 vs. -0.7, p = 0.001), low-density lipoprotein (-0.67 vs. -0.45, p = 0.001), and highly sensitive C-reactive protein (-1.36 vs. 0.08, p = 0.013) at 6 months, and in BMI/Age-SDS (-370 vs. -0.222, p = 0.001), WC/Age-SDS (-0.473 vs. -0.337, p = 0.018), SBP (-0.834 vs. -0.477, p = 0.023), and triglycerides (-0.33 vs. -0.14, p = 0.019) at 12 months. Metformin compared with placebo has beneficial effects on anthropometric and metabolic indicators in the management of childhood obesity.

Effect of light pressure stroking massage with sesame (Sesamum indicum L.) oil on alleviating acute traumatic limbs pain: A triple-blind controlled trial in emergency department

ObjectivesDue to adverse effects of common medications used for traumatic pain management, it is crucial to use complementary methods to alleviate this pain. Present study aimed to assess the effect of light pressure stroking massage with topical sesame oil on pain severity of patients with limbs trauma. MethodsThis triple-blinded randomized trial was conducted on 40 patients with upper or lower extremities trauma in emergency department of Busheher Amir Al-Momenian Hospital, Busheher, Iran, in 2015–2016. Patients received a 5min massage with either liquid paraffin (placebo) or sesame oil on trauma site twice a day for 9days duration. Pain severity was assessed by visual analogue scale in first day (baseline), 3th, 6th and 9th days of intervention in the both groups. ResultsMean changes of pain severity between two groups was significant in the 6th (−0.20±1.36; P=0.036) and 9th (−0.36±1.12; P<0.001) days of intervention. Regarding to intake of diclofenac, no significant difference was seen between sesame oil and placebo groups during 9days of intervention (575.23±3.11 and 625.13±4.23 respectively, P=0.601). There were no adverse effects during the study in the both groups. ConclusionMassage with topical sesame oil was associated with significant reduction in pain severity of patients with limbs trauma. Therefore, it is suggested to use this oil on complementary medicine for pain relief due to low cost, easy usage and lack of adverse effects.

Ondansetron for pediatric concussion; a pilot study for a randomized controlled trial.

Assess the feasibility of a study evaluating one dose of oral ondansetron to decrease post-concussion symptoms at one week and one month following concussion in children aged 8 to 17 years old. This was a pilot study for a randomized, triple-blind controlled trial of one dose of either ondansetron or placebo performed in a tertiary care pediatric emergency department. Participants were children aged 8 to 17 years who sustained a concussion in the previous 24 hours and visited a single emergency department. The outcome of interest was an increase from pre-concussion baseline of at least 3 symptoms from the Post-Concussion Symptom Inventory, measured at one week and at one month following concussion. The primary outcome was to determine the proportion of children who completed the assessment at one week following the intervention. Secondary outcome was the proportion of children who completed the assessment at one month following the intervention. All children, care givers, and those assessing the outcomes were blinded to the group assignment. Of the 218 children presenting with a concussion during the study period, we screened 108 and found 36/108 (33%) eligible to participate and 16/108 (14.8%) agreed to participate. All enrolled patients were compliant with the intervention and follow-up. In our study population, approximately one-third of the screened concussion patients were eligible to participate and approximately one half of those eligible agreed to participate. Our study found that most enrolled patients preferred electronic follow-up; the noncompliance rate was minimal.

The Effects of Combined Low-Dose Oral Contraceptives and Vitex Agnus on the Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome: A Triple-Blind, Randomized, Controlled Clinical Trial

Background: Polycystic ovarian syndrome (PCOS) is the most common hormonal disorder in reproductive-age women. This syndrome is associated with many complications so treatment of the disorder is usually warranted. Objectives: To evaluate the effects of a combined low-dose oral contraceptive (LD) and Vitex agnus on the improvement of clinical and paraclinical parameters of PCOS. Methods: This triple-blind controlled trial was performed in 2015 in 70 women aged 18 - 45 years with PCOS in the clinics of the Alzahra and Taleghani hospitals and at other health centers in Tabriz Iran using a purposive sampling method. The women were randomized to either the LD or Vitex agnus groups. Regulation of menstrual cycle length free testostrone DHEA-S (Dehydroepiandrosterone sulfate) prolactin levels were assessed both before and after three cycles. Results: The socio-demographic characteristics of the two groups were homogeneous before the intervention began. No significant statistical differences were identified between the LD and Vitex agnus groups three months after the intervention in terms of normalization of the menstrual cycle duration means of free testostrone levels DHEA-S prolactin serum levels and side effects. Three months after the intervention the menstrual cycle duration in about 68.6% of the LD group members and 60% of the Vitex agnus group members became normal. The average levels of serum free testosterone and prolactin in both the LD and Vitex agnus groups had no differences three months after the intervention compared to prior to the intervention. The mean of the serum DHEA-S level in both the LD (Mean Difference (MD) = -0.52; [95% CI: -0.85 to -0.18]) and the Vitex agnus groups (MD = -0.60; [95% CI: -0.79 to -0.40]) decreased significantly three months after the intervention when compared with before the intervention. Conclusions: This study showed that LD and Vitex agnus were both effective in normalizing the menstrual cycle and reducing DHEAS but they had no impact on the serum free testosterone or prolactin levels. The effects of LD and Vitex agnus on the normalization of the menstrual cycle and the means of serum prolactin free testosterone and DHEA-S levels in the women with PCOS were similar. Therefore Vitex agnus can be used in place of LD.