Number Of Rescue Medications Research Articles

Comparative evaluation of postoperative pain after root canal obturation using resin-based sealer (AH plus) and bioceramic sealer (IROOT SP) in adult mandibular molars: A double blinded randomized controlled trial

ABSTRACT Aim: The aim of this randomized clinical trial was to compare the occurrence and intensity of postoperative pain following root canal obturation using a bioceramic (IROOT SP, Innovative BioCeramix, Inc.,) and a resin-based endodontic sealer (AH plus) using visual analog scale (VAS). Methods: A total of 40 subjects with chronic irreversible pulpitis needing root canal treatment were included in this double blinded randomized clinical trial. Randomization was done using manually generated sealed envelopes. According to the sealers used, the patients were divided into 2 groups where in Group 1 (n = 20): AH plus sealer and Group 2 (n = 20): Bioceramic sealer. Postoperative pain was assessed using VAS scale. Mann–Whitney U test was used for statistical analysis. Results: The occurrence of postoperative pain was similar in both groups. Postoperative pain intensity decreased in both the groups after 48 h. No statistically significant difference was found in the occurrence of postoperative in either group (P > 0.05). Conclusion: AH Plus and bioceramic sealer perform similarly in terms of the occurrence and intensity of postoperative pain with no significant difference. The average pain levels and number of rescue medication taken were similar in both the groups.

Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study

BackgroundProton-pump inhibitors (PPIs) are the most effective drugs for treating acid-related disorders. However, once-daily dosing with conventional PPIs fail to fully control acid secretion over 24 h. This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE).MethodsWe enrolled 213 patients with EE randomized in a 1:1 ratio to receive 40 mg HIP1601 (n = 107) or HGP1705 (n = 106) once daily for 4 or 8 weeks. The primary endpoint was the EE healing rate, confirmed by endoscopy up to week 8. GERD-related symptoms and treatment-emergent adverse events were compared between both groups.ResultsBy week 8, the estimated healing rates of EE were 97.8% and 96.8% in the HIP1601 and HGP1705 groups, respectively, with a 95% confidence interval of -4.7 to 7.2. After 4 or 8 weeks of treatment, the EE healing rate at week 4, complete resolution rate of symptoms, time to sustained resolution of symptoms, and number of rescue medications used were similar in both groups. The proportion of heartburn- and acid regurgitation-free nights by week 4 were higher in the HIP1601 group compared to the HGP1705 group, but the difference did not reach clinical significance (87.7% vs. 85.8%, P = 0.514, 87.5% vs. 85.8%, P = 0.774). The number of adverse events did not differ significantly between the two groups.ConclusionsThe efficacy and safety of HIP1601 40 mg were comparable to those of HGP1705 40 mg for the treatment of EE and symptomatic improvement of GERD.Trial registrationNCT04080726 (https://classic.clinicaltrials.gov/ct2/show/NCT04080726), registration date: 25/10/2018.

Real World Practices of Thrombopoietin Receptor Agonist Use and Discontinuation in Pediatric Patients with Immune Thrombocytopenia (ITP): A Single Center Retrospective Review

Introduction Thrombopoietin Receptor Agonists (TPO-RAs) are becoming widely used as second-line treatment in patients with immune thrombocytopenia (ITP). These can be weaned/discontinued in adults. There is a paucity of literature on weaning and discontinuation practices in pediatric ITP. Methods We performed a retrospective review of pediatric patients aged 0-18 years with ITP treated with TPO-RAs at our institution over an eight-year period (2015-2022). Weaning and discontinuation practices were compared between patients based on timing of TPO-RA initiation: <3 months from diagnosis (group A), ≥3 to <12 months from diagnosis (group B), <12 months from diagnosis (group AB) or ≥12 months from diagnosis (group C). Results There were 11, 12 and 32 patients in group A, B, and C respectively (table 1). As of last follow up, 10 patients successfully weaned and discontinued their TPO-RA. Eighteen patients were weaning their TPO-RA monotherapy and 15 continued a TPO-RA at maximal dose or required the addition of another agent, such as an immunosuppressant, to permit TPO-RA weaning. Five patients discontinued their TPO-RA due to poor response. Seven patients had stopped the TPO-RA due to an alternate reason (family preference, side effects, etc.). There was no difference in any of these outcomes based on timing of TPO-RA initiation. In patients whose platelet count responded to TPO-RAs, the dose was weaned at the provider's discretion. The dose was generally not weaned for a platelet count <50k. Among only patients in which the TPO-RA monotherapy was weaned, patients in group AB had a shorter duration of TPO-RA treatment than patients in group C (IQR 12.1-48.9 months vs 37.5-88.0 months; p=0.019). While not statistically significant, after the start of the TPO-RA dose weaning, patients in group A weaned their TPO-RA at a faster rate (IQR 4.7-20.5% of maximal dose per month) compared to patients in groups B and C (IQR 1.8-5.1% of maximal dose per month and 1.5-5.5% of maximal dose per month). The 10 patients who fully weaned their TPO-RA had a shorter duration of TPO-RA use compared to the 18 patients who partially weaned their TPO-RA monotherapy (IQR 11.5-38.6 months vs 27.6-82.1 months; p=0.018). Once the wean of TPO-RA dose was started, patients who fully weaned their TPO-RA did so at a faster rate than patients who partially weaned (IQR 5.6-29.6% of maximal dose per month vs 1.0-3.4% of maximal dose per month; p=0.017; figure 1). Seven patients who fully weaned their TPO-RA had follow up CBCs between one and three months after discontinuation. Of these, five patients had platelet counts >100k, while the other two had platelet counts >40k that continued to rise to >80k within a year of discontinuation without further treatment. Of the remaining three patients, two had CBCs more than three months post TPO-RA discontinuation with platelet counts >100k without additional treatment and one had no follow up CBC after TPO-RA discontinuation. Two patients with follow-up had transient ITP exacerbations with platelet counts <10k at 14 and 31 months after TPO-RA discontinuation that were treated with anti-D/steroids and IVIG respectively with subsequent sustained improvement in platelet counts that did not require any further intervention. There was no difference in the number of rescue medications (IVIG, anti-D, steroids) required between patient groups based on timing of TPO-RA initiation or type of agent used. Patients who were treated with both romiplostim and eltrombopag required adjunctive therapies (such as immunosuppressants) more than patients treated with either agent alone (p=0.022). Conclusion TPO-RAs were weaned and successfully discontinued in 10 of 55 (18.2%) pediatric patients with ITP in our small cohort with a low rate of subsequent ITP exacerbation. There was no difference in TPO-RA discontinuation rate in patients with a good platelet response based on timing of TPO-RA initiation. Patients who started a TPO-RA within 12 months of their ITP diagnosis had a shorter duration of TPO-RA use than patients who started a TPO-RA more than 12 months after diagnosis. Patients who started a TPO-RA within three months of diagnosis were able to wean their TPO-RA dose at a faster rate than patients who started a TPO-RA more than three months after diagnosis. TPO-RA dose was weaned at a faster rate in patients who fully weaned their TPO-RA compared to patients who were partially weaned. This data should be validated in a larger study.

Effect of preoperative ibuprofen on pain after lower third molar removal: A randomized controlled trial.

The aim of the study is to predict the effect of preemptive analgesics in the third molar surgery and to analyze whether the number and frequency of postoperative analgesics are reduced following the administration of preemptive analgesics. The present study was carried out on 50 patients who reported to the Department of Oral and Maxillofacial Surgery for removal of their impacted mandibular third molar. The patients were randomly divided into two groups of 25 patients each - Group A (test group) patients receiving ibuprofen (400 mg) half an hour before the surgery and placebo half an hour after surgery and the Group B (control group) patients receiving placebo half an hour before the surgery and ibuprofen (400 mg) half an hour after surgery. Both groups of patients will be instructed to avoid any drug but those prescribed (ibuprofen 400 mg SOS and rescue medication of tramadol 50 mg SOS) and not to seek any medical help elsewhere for postoperative problems. The pain was recorded using a visual analog scale. Demographic data in the study show females (8%) and male (92%) patients. The average time taken for surgery was more in the control group (58.36 min) as compared to the test group (55.64 min) with no statistically significant difference. Values of pain score, medication score, number of rescue medication, and frequency at different time intervals (at baseline, after 3 h, 6 h, 24 h, and 7 days) are expressed in terms of mean and standard deviation, respectively, and the result shows the statistically significant difference for pain score at baseline and 7th-day time interval only. The distribution of different types of impaction and different types of elevation/odontotomy shows a significant association in test and control groups. Preoperative ibuprofen decreases the frequency and intensity of the pain. We believe that since this preoperative ibuprofen seems to be beneficial without any adverse effects, it may be used routinely in the 3rd molar surgeries and even in routine extraction.

Long-Term Prophylactic Transcranial Direct Current Stimulation Ameliorates Allodynia and Improves Clinical Outcomes in Individuals With Migraine

ObjectivesMigraine is a common and substantially debilitating disorder that may associate with allodynia, a marker of central sensitization in the pain circuits. Several unmet needs, like limited adherence to drugs due to adverse events and cost-effectivity, still occur in the prophylactic treatment of migraine. Transcranial direct current stimulation (tDCS) has recently been indicated to be beneficial in individuals with migraine with and without allodynia. However, to our knowledge, there are no studies evaluating the efficacy of six-month tDCS in migraine. Materials and MethodsThis study was a randomized double-blind parallel-group sham-controlled five-month extension study after a one-month lead-in trial of tDCS in individuals with migraine. A total of 23 individuals with migraine with allodynia who completed the lead-in trial were recruited after their consent and were administered three consecutive sessions of 2-mA anodal 20-minute tDCS over the left primary motor cortex every month for an additional five months. Pain-related outcomes were determined using monthly headache diaries. Allodynia, depression, anxiety, and disability because of migraine also were assessed throughout the study. ResultsImprovements in allodynia levels, attack frequency, number of rescue medications, and attack duration were higher, and mostly gradual during the trial, in the active group. Migraine Disability Scale grades also were lower in the active group, whereas no between-group differences were found in depression and anxiety scores. Higher responder rates of migraine attack frequency (56.8% vs 25%), number of headache days (56% vs 16.7%), and migraine attack duration (90.9% vs 8.3%) were observed after six-month tDCS in the active group than in the sham group. ConclusionsLong-term extended tDCS is shown to be a safe, efficacious, and plausible modality for prophylactic treatment in individuals with migraine with allodynia. SignificanceLong-term extended tDCS can alleviate allodynia, which is an indicator of drug resistance and chronicity, and meet the goals of prophylactic treatment in individuals with migraine with allodynia.

Efficacy of Vitamin C Combined with Famciclovir in the Treatment of Post-Herpetic Neuralgia

The present randomized controlled, double blinded interventional clinical study aimed to investigate the efficacy of vitamin C combined with famciclovir in post-herpetic neuralgia. The patients in the control group (n = 43) were intravenously given with famciclovir (0.25 g/day) while patients in the observation group (n = 43) were intravenously given with vitamin C combined with famciclovir. The clinical observation indexes, changes of pain score, immune cytokines, and complications were compared between the two groups. Compared with the control group, the observation group had higher total effective rate, shorter blister-stopping time, crusting time, and pain-relieving time. After treatment for 14 days, the visual analogue scale score in the observation group was 0.54 ± 0.17, which was lower than the control group (2.72 ± 0.43). After treatment, serum interleukin-6 and interleukin-8 levels were significantly lower in the observation group than the control group. There was no significant difference in the incidence of adverse reactions between the two groups. However, the number of rescue medication in the observation group was lower than the control group. To sum up, famciclovir combined with vitamin C in the treatment of post-herpetic neuralgia can improve the cured rate of the disease, which is worthy of clinical application.

Effect of Open-label Placebo on Children and Adolescents With Functional Abdominal Pain or Irritable Bowel Syndrome

Although it is widely believed that concealment or deception is required to elicit a placebo response, recent studies with adults suggest that open-label placebo (OLP) (ie, honestly prescribed placebos) can yield significant benefits. No studies of OLP have been performed with children. To evaluate the efficacy of OLP for the treatment of children and adolescents with functional abdominal pain or irritable bowel syndrome. This multicenter crossover randomized clinical trial was conducted from July 1, 2015, to June 15, 2018, at 3 US centers among children and adolescents aged 8 to 18 years with functional abdominal pain or irritable bowel syndrome defined per Rome III criteria. Statistical analysis was performed from March 1, 2019, to September 30, 2020, on an intention-to-treat basis. Patients completed 1 week of observation prior to randomization to 1 of 2 counterbalanced groups: OLP for 3 weeks followed by a 3-week control period or control period for 3 weeks followed by OLP for 3 weeks. During the OLP period, participants took 1.5 mL of an inert liquid placebo twice a day. A standardized method for explaining the OLP was used, and the interaction with clinicians had the same duration and style for both time periods. Hyoscyamine was allowed as a rescue medication. The primary outcome was the mean daily pain score during each of the interventions, measured on a 0- to 100-mm visual analog scale, where higher scores indicated greater pain. The number of rescue medications taken during each intervention served as an objective secondary measure. Thirty patients (mean [SD] age, 14.1 [3.4] years; 24 female participants [80.0%]; 16 [53.3%] with functional abdominal pain and 14 [46.7%] with irritable bowel syndrome) completed the study. The mean (SD) pain scores were significantly lower during OLP treatment compared with the control period (39.9 [18.9] vs 45.0 [14.7]; difference, 5.2; 95% CI, 0.2-10.1; P = .03). Patients took nearly twice as many hyoscyamine pills during the control period compared with during the OLP period (mean [SD] number, 3.8 [5.1] pills vs 2.0 [3.0] pills; difference, 1.8 pills; 95% CI, 0.5-3.1 pills). During OLP, patients with functional abdominal pain or irritable bowel syndrome reported significantly less pain and took significantly fewer pain medications. Open-label placebo may be an effective treatment for children and adolescents with functional abdominal pain or irritable bowel syndrome. ClinicalTrials.gov Identifier: NCT02389998.

Assistance of a Palliative Care Certified Nurse in the Alleviation of Refractory Cancer Pain by Switching Opioids to Oral Methadone in a Japanese Outpatient Setting.

Although methadone has the potential to improve the management of cancer pain, it has some serious problems, such as respiratory depression and QT interval prolongation. Therefore, patients who are prescribed methadone must be educated, monitored, and supported by specialized medical staff, especially in the outpatient setting. We assessed the effectiveness of support from the palliative care certified nurse who used the checklists in opioid switching to oral methadone for patients with refractory pain. Through the multidisciplinary palliative care team at our hospital, 15 outpatients with cancer pain were prescribed oral methadone between April 2013 and December 2020, and 14 cases were successful in switching to methadone. After taking medication, the certified nurse called the patient's home daily for 3 to 5 days and confirmed that the patient had taken the methadone, the degree of pain, the number of rescue medications, and the appearance of side effects, such as respiratory depression. Careful management by a multidisciplinary team is essential for opioid switching to oral methadone administration for outpatients. Certified nurses may play an important role in maintaining safety and resolving the patients' and families' anxieties with respect to the prescription of methadone.

Evaluation of a pre-co-seasonal and a perennial schedule of a single multiallergen depigmented-polymerized subcutaneous immunotherapy in paediatric patients.

Compare a pre-co-seasonal with a perennial schedule using an undiluted mixture of a depigmented-polymerized grass/Olea europaea immunotherapy (2,000 DPP/mL) in pediatric patients with rhinitis/rhinoconjunctivitis with or without controlled asthma. Primary objective was to determine the non-superiority of a perennial compared to a pre-co-seasonal schedule by means of Paediatric/Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ/AdolRQLQ). Secondary objectives were Paediatric Asthma/Caregiver´s Quality of Life Questionnaire (PAQLQ/PACQLQ) Asthma Control Test (ACT), Visual Analogue Scale global assessment of allergic disease (VAS), use of resources and immunological response. All variables were compared during the pollen season (April-June) without (2015) and with (2016) immunotherapy. Forty patients were included in the study of which 29 patients were assigned to the perennial and 11 to the pre-co-seasonal schedule. During 2016 pollen season a significant improvement in the PRQLQ/AdolRQLQ, PAQLQ/AdolAQLQ, ACT and VAS score were observed both in perennial and pre-co-seasonal schedule group. No significant differences were seen between treatment schedules for PRQLQ/AdolRQLQ, PAQLQ/AdolAQLQ and ACT scores comparing both pollen seasons. A significant increase in sIgG4 and reduction in the number of rescue medications used and number of patients who needed visit to any specialist was observed in both treatment schedules during 2016 pollen season. No relevant differences were found in the safety profile of any treatment schedule. Treatment with undiluted mixture of a depigmented-polymerized Grass/Olea europaea allergen immunotherapy has proven to be effective both using a perennial and a pre-co-seasonal schedule and therefore suitable for polyallergic patients.

Comparison of efficacy and safety of bromelain with diclofenac sodium in the management of postoperative pain and swelling following mandibular third molar surgery

AimThe present study aimed to evaluate and compare the efficacy and safety of oral bromelain, a natural enzyme complex with oral diclofenac sodium in managing pain and swelling after mandibular third molar surgery. Materials and methodsA total of 40 patients were randomly divided into two groups, the bromelain group (n = 20) and the diclofenac sodium group (n = 20). Patients received either bromelain, 500 mg twice daily or diclofenac sodium, 50 mg thrice daily for five days after the surgical extraction of impacted third molars. Swelling and trismus were evaluated pre-operatively (day0) and on postoperative days 1, 2, and 7, pain on postoperative days 1, 2, and 7,also, the need for rescue medication and adverse effects were evaluated in both groups. ResultsThere was no difference between the bromelain and diclofenac groups in VAS pain scores (day1 = 35.1 vs 33.4, p = 0.829; day2 = 22 vs 22.4, p = 0.694; day7 = 13 vs 14.3, p = 0.678). There was no difference between the groups in swelling (day0 = 270.8 vs 266.5, p = 0.256; day1 = 279.2 vs 272.8, p = 0.167; day2 = 277.3 vs 271.4, p = 0.151; day7 = 269.2 vs 266.1, p = 0.440), trismus (day0 = 50.5 vs 48.9, p = 0.542; day1 = 29.6 vs 31.7, p = 0.839; day2 = 31.7 vs 32.6, p = 0.882; day7 = 41.1 vs 37.6, p = 0.273) and the number of rescue medications (1.6vs1.9, p = 0.956). Patients in both the groups did not report any severe or serious adverse effects. ConclusionsBromelain was comparable to diclofenac in the management of postoperative pain, swelling and trismus following impacted mandibular third molar surgery.

Effect of sustained-release long-acting intravitreal dexamethasone implant in patients of non-proliferative diabetic retinopathy undergoing phacoemulsification: A randomized controlled trial.

Purpose:Cataract and diabetes, both being a major health care problem, an intervention evaluated for the combination of the two attains paramount importance. The purpose of the study was to determine the role of intraoperative intravitreal dexamethasone implant in patients with diabetic retinopathy with/without macula edema undergoing phacoemulsification.Methods:The study was a two-arm, single-center, randomized, assessor-blinded trial of 151 patients with type-2 diabetes mellitus and cataract. It had two groups: dexamethasone group (DEX) versus standard of care (SOC) group, i.e. phacoemulsification and intraocular lens (IOL) implantation without injection of dexamethasone drug delivery system (DDS). The number of rescue interventions required, central macular thickness by optical coherence tomography (OCT), Early Treatment Diabetic Retinopathy Study (ETDRS) score, laser flare meter (LFM) values, intraocular pressure (IOP), and grade of diabetic retinopathy (DR) were recorded until three months follow up. Macular thickness and number of rescue medications between the treatment groups were the co-primary outcomes.Results:A statistically significant interaction was present between treatment and time on OCT score (P < 0.001). The requirement of rescue interventions in the dexamethasone DDS group [40.2% (33/82)] was lesser as compared to the SOC group [49.3% (34/69)] at the end of 12 weeks [odds ratio (OR), 0.70 (0.36–1.33)] follow up although not statistically significant (P = 0.343). A statistically significant interaction was present between treatment and time on LFM score (P = 0.003). No statistically significant interaction was present between the treatment and time on visual acuity score (P = 0.08) and IOP score (P = 0.375).Conclusion:Dexamethasone implant may have potential as a valuable therapy for patients undergoing cataract surgery with DR with/without macular edema with effects lasting for at least three months.

Low-dose methadone for refractory chronic migraine accompanied by medication-overuse headache: a prospective cohort study

ObjectivesA refractory chronic migraine (RCM) accompanied by medication-overuse headache (MOH) is an extremely disabling disease. Evidence suggests that in selected patients, chronic opioids may be a valuable therapeutic option for RCM. The aim of the present study was to evaluate the effectiveness and safety of prophylaxis with low-dose methadone (LDM) in patients affected by RCM with continuous headache and MOH.MethodsA prospective cohort study was performed between May 2012 and November 2015 at the Headache Center and Toxicology Unit of the Careggi University Hospital. Eligible patients were treated with prophylactic LDM and followed up for 12 months. Headache exacerbations, pain intensity, use of rescue medications, and occurrence of adverse drug reactions (ADRs) were recorded.ResultsThirty patients (24 females, median age 48 years) were enrolled. Nineteen (63%) patients dropped out, mainly because of early ADRs (n = 10), including nausea, vomiting, and constipation. At last available follow-up, LDM was associated with a significant decrease in the number of headache attacks/month (from a median of 45 (interquartile range 30–150) to 16 (5–30), p < 0.001), in pain intensity (from 8.5 (8–9) to 5 (3–6), p < 0.001), and in the number of rescue medications consumed per month (from 95 (34–240) to 15 (3–28), p < 0.001). No misuse or diversion cases were observed.ConclusionLDM could represent a valuable and effective option in selected patients affected by RCM with continuous headache and MOH, although the frequency of early ADRs poses major safety concerns. Randomized controlled trials are needed to confirm the efficacy and safety of LDM prophylaxis.

Effect of montelukast and rupatadine on rituximab infusion time, rate, severity of reactions, and cost of administration.

6500 Background: Rituximab is associated with frequent infusion reactions which carry significant burden to patients and health care practitioners. Standard pre-medications (SP) do not prevent reactions sufficiently. Rupatidine (R) and Montelukast (M) are used for symptomatic treatment of urticaria and allergic rhinitis. We assessed addition of R, M and their combination on Rituximab infusion, rate, severity of reactions and cost of administration. Methods: Adult patients with lymphoproliferative disorders treated at our cancer center between Jan 2018 to Jan 2019 were evaluated with Rituximab-containing regiments. Since the majority of reactions occur during the first infusion, our study was limited to the initial Rituximab treatment. Patients received either SP with diphenhydramine/acetaminophen and additional R, M or R+M combination. Comparative analysis of infusion time/rate, severity of infusion reactions, number of rescue medications and cost of Rituximab infusions among groups was performed using one-way ANOVA with Tukey post-hoc or chi-square. The study was approved by our institutional IRB. Results: Patients received either: 1) SP; 2) SP + Rupatadine (R) 10 mg; 3) SP + Montelukast (M) 10 mg; or 4) both (SP+R+M). Patient demographics are shown in the table. Compared to SP, the R, M and R+M groups had greater improvement in Rituximab delivery. Mean infusion time was 306 [range 235-441] min. in SP, 254 [105-390] in M, 265 [193-350] in R and 248 [196-342] in R+M groups, (p=0.0001). Infusion reactions occurred in 92% in SP vs. 38, 45, 33% in M, R and R+M groups (p=0.0001). Median reaction grade was 2 in SP, 1 (M), 0 (R and R+M). Median number of rescue medications was 3 [0-10] in SP vs 0 [0-7] in M, R and R+M groups. Cost of rescue medications (US$) was 38 [0-63] (SP), 11 [0-50] (M), 17 [0-63] (R), 12 [0-58] (R+M) groups (p&lt;0.0001). Mean nursing cost (US$) per patient infusion was calculated as 269 [207-388] in SP vs 222 [92-343] (M), 233 [170-308] (R), 218 [174-301] (R+M) group. Conclusions: Addition of R, M and particularly R+M significantly improved Rituximab delivery, lowered the rate and severity of infusion reactions, and lowered the cost of Rituximab administration. [Table: see text]

HL301 in the treatment of acute bronchitis: a phase 2b, randomized, double-blind, placebocontrolled, multicenter study.

Background/AimsThere is insufficient quality data to recommend the use of herbs for the treatment of acute bronchitis. Small number of randomized trials of plant extracts for this purpose were determined to be low quality and there are concerns for the safety. HL301 is a combined product of seven medicinal plants. In the present study, we tried to evaluate the efficacy and safety of HL301 for the treatment of acute bronchitis with a randomized, double-blind, placebo-controlled, multicenter trial design. MethodsA total of 166 patients with acute bronchitis were randomized to receive placebo or HL301 (600 mg/day) for 7 days. The primary endpoint was change in bronchitis severity score (BSS) from baseline visit (visit 2) to the end of treatment (visit 3). Other efficacy variables were the change of each component of the BSS (cough, sputum, dyspnea, chest pain, and crackle) with treatment, response rate, improvement rate, satisfaction rate and number of rescue medications taken. ResultsChanges in the BSS from visit 2 to visit 3 were higher in the HL301 group than in the placebo group both in the full analysis set (4.57 ± 1.82 vs. 3.15 ± 3.08, p < 0.01) and in the per protocol set (4.62 ± 1.81 vs. 3.30 ± 3.03, p < 0.01). Four BSS components (cough, sputum, dyspnea, and chest pain) improved more with HL301 treatment than with placebo treatment. Participants treated with HL301 showed higher response, improvement, and satisfaction rates and less use of rescue medication than the placebo group. ConclusionsHL301 (600 mg/day) was effective and safe for symptomatic treatment of acute bronchitis.

Evaluation of a curcumin-containing mucoadhesive film for periodontal postsurgical pain control.

Background:Management of pain and discomfort is important to make the postoperative period as pleasant as possible. Nonsteroidal anti-inflammatory drugs are traditionally prescribed; however, they are associated with numerous side effects. As a result, nutraceuticals such as curcumin are widely used for its well-known safety and medicinal values. Hence, the aim of this study is to evaluate the efficacy of a curcumin mucoadhesive film for postsurgical pain control.Materials and Methods:This was a split-mouth study, consisting of 15 systemically healthy patients with 30 sites, who were randomly allocated into test (curcumin mucoadhesive film) and control (placebo mucoadhesive film) groups using coin toss method. A questionnaire was given to patients to evaluate the postoperative pain and swelling and the number of rescue medications taken. Statistical analyses used were Friedman test, Wilcoxon signed-rank test, and McNemar's test.Results:No adverse effects were reported and healing was uneventful in all patients. The Numerical rating scale pain score showed significantly lesser pain at 1, 2, 3, 4, 5, and 24 h in the test group. Significantly more number of analgesics was consumed in total in the control group than that in the test group.Conclusion:Within the limitations of this study, it may be concluded that curcumin mucoadhesive film showed promising results in reducing postoperative pain and swelling over a period of 1 week, hence showing its analgesic effect after periodontal surgeries.

Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial

Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy; however, most studies focus on solid malignancies and single-day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare the addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone [FOND-O]) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single-day and multiple-day highly emetogenic chemotherapy and hematopoietic cell transplant (HCT) regimens (NCT02635984).The primary objective of this study was to compare complete response (CR; no emesis and minimal nausea, <25 mm on a 100-mm visual analog scale) during the overall assessment period (chemotherapy days plus 5 days after). Secondary objectives were the number of emesis, number of rescue medications, percent achieving minimal nausea, and percent achieving complete protection (CP; no emesis, rescue antiemetic, or significant nausea), all of which are reported as acute (chemotherapy days), delayed (5 days after chemotherapy), and overall phases. Olanzapine 10 mg or matching placebo were given on each chemotherapy day and 3 days after. Adults with hematologic malignancy receiving HCT regimens of melphalan, BEAM (carmustine, etoposide, cytarabine, melphalan), busulfan (Bu)/cyclophosphamide (Cy), Bu/fludarabine (Flu), Bu/melphalan, FluCy, FluCy-total body irradiation (TBI), etoposide-TBI, and ICE (ifosfamide, carboplatin, etoposide) or 7+3 chemotherapy regimens were included. An estimated 98 patients were required using alpha = .05 and 80% power.No significant differences existed in baseline characteristics between FOND-O (n = 51) and FOND (n = 50) arms. Mean duration of olanzapine was 7.7 days (range, 4 to 11). Discontinuation for possible adverse events occurred in 3 placebo and 0 olanzapine patients. CR was significantly higher for FOND-O in overall (55% versus 26%, P = .003) and delayed (60.8% versus 30%, P = .001) but not acute (P = .13) phases. Significantly more patients receiving FOND-O achieved no more than minimal nausea in overall (P = .001) and delayed phases (P = .0002), as well as fewer overall mean emesis counts (P = .005). CP rates were not different in any assessment phase (P ≥ .05 each). Within the HCT subgroup (n = 64), the CR, CP, and no significant nausea rates were significantly better for FONDO-O in overall and delayed phases (all P < .05). Analysis within the HCT subgroup revealed significant improvement in outcomes in delayed and overall phases with FOND-O in the autologous but not allogeneic cohort.Addition of olanzapine to an NK-1–based triplet antiemetic regimen significantly improved clinically relevant outcomes in the HCT population.

Comparison of oral montelukast with oral ozagrel in acute asthma: A randomized, double-blind, placebo-controlled study.

Background:The need for more effective management of acute asthma has led to research on drugs which are otherwise approved for use in chronic asthma.Objective:To study and compare the effects of oral montelukast with oral ozagrel in acute asthma.Materials and Methods:One hundred and twenty patients with acute asthma were recruited for the study. Out of 120 study patients, forty each were randomized into placebo, montelukast, and ozagrel groups. After the first dose of the drug or placebo was administered, peak expiratory flow rate (PEFR), number of rescue medications and also vital signs were noted at 6 h, 12 h, 24 h, 48 h, and at discharge. In addition, same recordings were done on the morning (8 a.m. – 10 a.m.) following admission. The difference in mean PEFR of each group at above-mentioned time points was the primary endpoint whereas need for rescue medications the secondary end-point.Results:The respective mean PEFR recordings of the placebo, montelukast, and ozagrel groups at various time points were as follows: at 6 h (235.19 ± 3.18, 242.86 ± 3.26, 228.18 ± 3.25); at 12 h (254.37 ± 5.23, 265.62 ± 5.38, 242.99 ± 5.36); at 24 h (267.46 ± 7.41, 291.39 ± 7.61, 268.14 ± 7.58); and at 48 h (277.99 ± 7.35, 303.22 ± 7.56, 285.27 ± 7.53); and discharge (301.94 ± 7.07, 317.32 ± 7.27, 298.99 ± 7.23). The mean PEFR between the treatment groups were not statistically significant (P = 0.102). The mean PEFR in the three groups at 8–10 a.m. following admission was 257.60 ± 5.52, 264.23 ± 5.98, and 249.94 ± 5.96; P = 0.266. Total number of rescue doses needed were 7, 4, and 13, respectively (P = 0.67).Conclusion:Montelukast or ozagrel when added to the standard treatment of acute asthma does not result in any additional benefit.

High frequency repetitive transcranial magnetic stimulation (rTMS) is effective in migraine prophylaxis: an open labeled study

Objective: To evaluate the effect of high rate repetitive transcranial magnetic stimulation (rTMS) in migraine prophylaxis in medically refractory patients.Methods: Migraine patients above 15 years of age, having more than 7 attacks/month and refractory to at least two prophylactic drugs were included. The patients were evaluated for migraine frequency, severity, functional disability, number of rescue medications and migraine index. Three sessions of alternate day 10 Hz rTMS comprising of 600 pulses in 10 trains were delivered to left frontal cortex. The response was evaluated at the end of session and weekly for 4 weeks.Results: Fifty-one patients aged 16–61 years and 45 females were treated. Fifty (98%) patients had more than 50% reduction of headache frequency at the end and 1 week after rTMS and the improvement persisted till the fourth week in 80·4% patients. The headache frequency, severity, functional disability, migraine index, and rescue medications significantly reduced at all time points, but the maximum benefit was observed in the first 2 weeks. There were no serious adverse events.Conclusion: High rate rTMS in left frontal cortex is effective and well tolerated for migraine prophylaxis.

Postoperative pain control for primary cleft lip repair in infants: is there an advantage in performing peripheral nerve blocks?

Primary cleft lip repair is performed in infants under 1 year of age. The efficacy of an infraorbital nerve block vs intravenous fentanyl was compared in our prospective, randomized controlled trial. Forty-six infants scheduled for primary cleft lip repair were prospectively randomized to one of two groups: group F that received 2 mcg x kg(-1) of fentanyl intravenously and an infraorbital nerve block with 0.5 ml on each side of preservative-free normal saline, and, group B that received bilateral infraorbital nerve blocks with 0.5 ml on each side of 0.25% bupivacaine and 2 ml of preservative-free saline solution intravenously after induction of anesthesia but prior to surgical incision. Patients were observed by a blinded observer for (i) pain scores using neonatal infant pain score; (ii) need for rescue medication in the anesthesia care unit (PACU), in the short stay unit (SSU) and at home and (iii) feeding parameters including difficulty in feeding, time to first feeding and volume of feeds in the PACU, SSU and at home. There were no significant differences in pain scores between the two groups over time (P = 0.98); there were no differences between groups in the number of rescue medications in the PACU, in the SSU as well as at home; however, the time to first rescue medication was greater in the block group compared with the fentanyl group (P = 0.07). There were no significant differences in feeding volumes between groups in the PACU (P = 0.46), SSU (P = 0.57) and at home (P = 0.15). There were no differences in time to initiate feeding between the two groups (P = 0.81). However, there was difficulty with feeding in the block groups compared with the fentanyl group (P = 0.01). The infraorbital nerve block can be effectively used for pain control in infants undergoing primary cleft lip repair. Although children undergoing a nerve block experienced minor difficulties in feeding, there were no differences in feeding volumes or other feeding parameters. This study has shed light into postoperative outcomes besides pain control on children undergoing cleft lip repairs.

A Double-Blind, Randomized, Crossover Comparison Between Single-Dose and Double-Dose Immediate-Release Oral Morphine at Bedtime in Cancer Patients

The European Association for Palliative Care guidelines for treatment of cancer pain recommend a double dose (DD) of immediate-release morphine at bedtime instead of single doses (SD) repeated every four hours throughout the night. A previous open controlled study reported more side effects after DD than after SD. The present study was a randomized, double-blind, crossover study comparison of DD and SD of immediate-release morphine during the night, followed by an open pharmacokinetic study. The primary outcome was average pain intensity during the night, as measured on an 11-point numerical rating scale. Secondary outcomes were morning pain, number of rescue medications, adverse effects (nausea, xerostomia, tiredness, sleep quality, and number of awaking episodes) and patient preference. Morphine and metabolites were quantified by a validated liquid chromatography-tandem mass spectrometry method. Nineteen patients completed the clinical study; 13 participated in the pharmacokinetic follow up. Average pain during the night for DD vs. SD was close to statistical significance (mean 0.8 and 1.4, respectively, P = 0.058; mean [95% confidence interval] for the difference was 0.50 [0.02, 1.0]). A similar trend was observed for strongest night pain ( P = 0.069) and sleep quality ( P = 0.077). Only two patients required rescue morphine. Four patients had no treatment preference; nine and six favored DD and SD, respectively. DD patients displayed higher area under the curve for morphine and morphine-6-glucuronide during the first part of the night. Although DD tended to perform slightly better than SD, a difference in average pain during the night of 0.50 has little clinical significance, and the two procedures are, therefore, clinically equivalent. It is speculated whether the initial higher exposure to morphine-6-glucuronide may have clinical significance.