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In childhood and adolescent migraine, amitriptyline and topiramate were no better than placebo and not significantly different from each other in achieving a 50% or greater reduction in days with headache. The trial was stopped early for futility. More than 6 million children and adolescents in the United States have migraines. 1 – 3 The majority continue to have headaches into adulthood, taking a toll on the U.S. economy of approximately $36 billion and resulting in substantial effects on quality of life. 4 – 7 Pediatric clinical practice guidelines for migraine treatment are consensus based rather than evidence based, 8 , 9 with no Food and Drug Administration (FDA)–approved migraine prevention medication for children younger than 12 years of age. The Childhood and Adolescent Migraine Prevention (CHAMP) trial tested the effects of amitriptyline and topiramate in comparison with each other and with placebo in . . .

Background Side effects play a key role in patients’ failure to take antidepressants. There is evidence that verbal suggestions and informed consent elicit expectations that can in turn trigger the occurrence of side effects. Prior experience or learning mechanisms are also assumed to contribute to the development of side effects, although their role has not been thoroughly investigated. In this study, we examined whether an antidepressant’s side effects can be learned via Pavlovian conditioning. Methods Participants ( n  = 39) were randomly allocated to one of two groups and were exposed to a classical conditioning procedure. During acquisition, 19 participants received amitriptyline and 20 participants received a placebo pill. Pills were taken for four nights together with a novel-tasting drink. After a washout phase, both groups received a placebo pill together with the novel-tasting drink (evocation). Side effects were assessed via the Generic Assessment of Side Effects Scale prior to acquisition (baseline), after acquisition, and after evocation. A score of antidepressant-specific side effects was calculated. Results Participants taking amitriptyline reported significantly more antidepressant-specific side effects after acquisition compared to both baseline and the placebo group. After evocation, participants who underwent the conditioning procedure with amitriptyline reported significantly more antidepressant-specific side effects than those who never received amitriptyline, even though both groups received a placebo. Conclusions Our results indicate that antidepressant side effects can be learned using a conditioning paradigm and evoked via a placebo pill when applied with the same contextual factors as the verum.

In a trial comparing onabotulinumtoxinA with an anticholinergic drug, both reduced urgency incontinence episodes. The rates of urinary retention and urinary tract infections were higher with onabotulinumtoxinA, but the rate of dry mouth was higher with anticholinergics. Urgency urinary incontinence is characterized by unpredictable loss of urine; it is a prevalent condition that occurs disproportionately in women, affecting up to 19% of older women in the United States. 1 Anticholinergic medications are used as the primary treatment for this condition. A recent systematic review of trials comparing treatments for urgency urinary incontinence showed that none of the six drugs evaluated was superior to another in treating the condition and that current evidence was insufficient to guide the choice among other therapies, including injections of botulinum toxin. 2 OnabotulinumtoxinA is effective in treating urgency urinary incontinence that is resistant to . . .

Background Given the suffering experienced by cancer patients, effective solutions must be found to prevent painful and debilitating side effects of anti-cancer treatment. This trial aims to study the effect of preconditioning with photobiomodulation in preventing oral mucositis and xerostomia in cancer patients undergoing chemotherapy alone for the first time, and to examine its role in improving patients’ quality of life. Materials and methods This is a prospective, randomized, double-blind clinical trial including 45 patients divided into three age- and sex-matched groups. Group 1 received basic oral care instructions before undergoing chemotherapy. Group 2 received basic oral care instructions plus photobiomodulation using an intraoral 650 nm diode laser. Group 3 received basic oral care instructions plus photobiomodulation using a 650 nm diode laser intraorally and a 980 nm diode laser extraorally. Results After one week of follow-up, 73.3% of patients in Group 2 and 80% in Group 3 did not develop oral mucositis. The remaining patients in both groups experienced only mild erythema. In contrast, all patients in Group 1 developed oral mucositis, ranging from mild erythema to ulceration greater than 3 cm². After two weeks of follow-up, 80% of patients in Group 2 and 86.7% in Group 3 remained free of oral mucositis. The remaining patients in both groups experienced only mild erythema. In contrast, 93.3% of patients in Group 1 developed oral mucositis, with cases ranging from mild erythema to ulcers larger than 3 cm². There were statistically significant differences between the three groups in oral mucositis assessment scale after one week and after two weeks ( p  < 0.001). Specifically, ulcerative mucositis was not observed in both laser groups, while it was observed in 13.3% of patients in Group 1. However, these differences were not statistically significant ( p  = 0.129). Regarding Late Effects in Normal Tissue (LENT-SOMA) scale, there was a statistically significant difference between the three groups studied ( p  = 0.037). There was also a statistically significant difference in the Oral Health Impact Profile (OHIP-14) between the three groups studied ( p  = 0.003 after one week, p  = 0.023 after two weeks). Conclusion Preconditioning before starting chemotherapy, whether with the intraoral red laser alone or in combination with the extraoral infrared laser, has shown significant results in preventing oral mucositis and dry mouth, and it has also played a major role in improving patients’ quality of life. Trial registration This trial was registered in ISRCTN registry under no ISRCTN70634383 ( https://doi.org/10.1186/ISRCTN70634383 ) on 24/07/2023.

Adverse drug reactions are important determinants of non-adherence to antidepressant treatment, but their assessment is complicated by overlap with depressive symptoms and lack of reliable self-report measures. To evaluate a simple self-report measure and describe adverse reactions to antidepressants in a large sample. The newly developed self-report Antidepressant Side-Effect Checklist and the psychiatrist-rated UKU Side Effect Rating Scale were repeatedly administered to 811 adult participants with depression in a part-randomised multicentre open-label study comparing escitalopram and nortriptyline. There was good agreement between self-report and psychiatrists' ratings. Most complaints listed as adverse reactions in people with depression were more common when they were medication-free rather than during their treatment with antidepressants. Dry mouth (74%), constipation (33%) and weight gain (15%) were associated with nortriptyline treatment. Diarrhoea (9%), insomnia (36%) and yawning (16%) were more common during treatment with escitalopram. Problems with urination and drowsiness predicted discontinuation of nortriptyline. Diarrhoea and decreased appetite predicted discontinuation of escitalopram. Adverse reactions to antidepressants can be reliably assessed by self-report. Attention to specific adverse reactions may improve adherence to antidepressant treatment.

These post hoc analyses evaluate the efficacy, safety, and tolerability of vortioxetine versus placebo in patients aged ≥55 years with major depressive disorder (MDD). Study-level efficacy data from 12 short-term, fixed-dose, randomized, placebo-controlled trials of vortioxetine 5-20 mg/day were assessed using a random-effects meta-analysis. Adverse events (AEs), vital signs, ECG values, liver enzymes, and body weight were pooled from the same studies. Patients had baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores ranging from 22-30. 1508 patients (mean age=62.4 years; range, 55-88 years) were included. Mean differences from placebo in change from baseline to study end (6/8 weeks) in MADRS were -2.56 (5 mg, n=324, P=0.035), -2.87 (10 mg, n=222, P=0.007), -1.32 (15 mg, n=90, P=NS), and -4.65 (20 mg, n=165, P=0.012). Odds ratios for response versus placebo were 1.6 (5 mg, P=NS), 1.8 (10 mg, P=0.002), 1.2 (15 mg, P=NS), and 2.5 (20 mg, P<0.001), and for remission versus placebo were 1.5 (5 mg, P=NS), 1.5 (10 mg, P=NS), 1.4 (15 mg, P=NS), and 2.7 (20 mg, P=0.001). The proportion of patients with AEs for placebo and vortioxetine 5-20 mg was 61.5% and 62.3%, respectively, with no increase at increased doses. Vortioxetine demonstrated a placebo-level incidence of serious AEs (1.2%). AEs occurring in ≥5% of any treatment group were nausea, headache, diarrhea, dizziness, dry mouth, constipation, fatigue, vomiting, and anxiety. No clinically significant mean changes in vital signs, ECG values, liver enzymes, or body weight emerged during treatment. Vortioxetine 5-20 mg/day is efficacious and well tolerated in MDD patients aged ≥55 years, a group that is often comorbid with other conditions and treated with other medications.

Purpose The purpose of this secondary analysis was to determine change in overall health-related quality of life (HRQOL) based on patient data obtained from NRG Oncology RTOG 0537 as measured by the RTOG-modified University of Washington Head and Neck Symptom Score (RM-UWHNSS). Methods A multi-site prospective randomized clinical trial design stratified 137 patients with post-radiation therapy xerostomia according to prior pilocarpine (PC) treatment and time after radiation therapy and/or chemotherapy and randomized patients into two groups. Patients were assigned to acupuncture or PC. Twenty-four sessions of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) were administered over 12 weeks, or oral PC (5 mg) three times daily over the same 12 weeks. The RM-UWHNSS was administered at baseline and at 4, 6, 9, and 15 months after the date of randomization. Results There were no between-arm differences in change scores on the RM-UWHNSS in the individual items, total score, or factor scores. For statistical modeling, race and time were significant for all outcomes (total and factor scores), while treatment arm was not significant. The ALTENS arm showed greater yet nonsignificant improvement in outcomes compared to the PC arm. Conclusion Although no significant treatment differences were seen in this trial, patients receiving ALTENS consistently had lower scores, indicating better function, as compared to those receiving PC. Radiation-induced xerostomia improved over time for all patients.

Background One of the most important antidepressants side effects is dry mouth. The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid on patients affected by dry mouth caused by antidepressants drug. Materials and methods This research took the form of a double‐blind, randomized clinical trial at Faculty of Dentistry of University of Granada (Spain). Seventy participants with antidepressant‐induced dry mouth were divided into two groups: for the first “intervention group” (35 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second “control group” (35 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Dry Mouth Questionnaire (DMQ) was used to evaluate dry mouth symptoms before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured. Results Dry mouth symptoms improved after 1% malic acid topical spray application (p < .05). After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < .05). Conclusions A sialogogue spray containing 1% malic acid improved dry mouth feeling of the patients suffering antidepressant‐induced dry mouth and increased unstimulated and stimulated salivary flows rates.

ABSTRACT Objective: The goal of a non-inferiority study is to test whether a new treatment has at least as much efficacy as an established treatment1. The purpose of this non-inferiority study was to compare the speed of onset of antidepressant efficacy for duloxetine (a dual serotonin and norepinephrine reuptake inhibitor) and escitalopram (a selective serotonin reuptake inhibitor). Research design and methods: This was a randomized, double-blind, placebo- and active comparator-controlled study, in which patients (≥ 18 years) meeting DSM‑IV criteria for Major Depressive Disorder (MDD) received duloxetine 60 mg once daily (QD; N = 273), escitalopram 10 mg QD (N = 274), or placebo (N = 137) for 8 weeks. The primary objective was to compare the onset of antidepressant efficacy, by testing the hypothesis that the percentage of duloxetine-treated patients achieving onset criteria at Week 2 was not inferior to that in the escitalopram group. Main outcome measures: Onset of efficacy was defined as a 20% decrease from baseline on the 17‑item Hamilton Rating Scale for Depression (HAMD17) Maier subscale that was maintained or exceeded at all subsequent visits. Results: Probabilities of meeting onset criteria at Week 2 for duloxetine- and escitalopram-treated patients were 42.6% versus 35.2%, respectively (treatment difference = 7.4%; 95% confidence interval, –1.3% to 16.2%; p = 0.097). Both drugs showed significant improvement compared with placebo ( p ≤ 0.05) on the primary efficacy measure (Maier subscale) at Week 1 and endpoint (Week 8). No differences were found between duloxetine, escitalopram, and placebo rates of remission or response at 8 weeks. Adverse events that occurred significantly more frequently among duloxetine-treated patients when compared with those receiving escitalopram were nausea, dry mouth, vomiting, yawning, and irritability. The rate of discontinuation due to adverse events did not differ significantly between treatment groups. Limitations: Given the difficulties in constructing appropriate dose comparisons, the results of this study should be interpreted specific to the doses tested and not extrapolated to the drug as a whole. This study employed a fixed-dose design; flexible-dose designs are more likely to find a difference between antidepressants and placebo. Conclusion: In this study, both duloxetine and escitalopram showed significantly greater improvement on the primary efficacy measure than placebo over the 8‑week acute treatment period, while no differences were observed between drugs or between drugs and placebo on response and remission rates at 8 weeks. Escitalopram at a starting dose of 10 mg QD was better tolerated than duloxetine at a starting dose of 60 mg QD. This study met its pre-defined primary objective of assessing if duloxetine was non-inferior to escitalopram in antidepressant onset efficacy, and the results show that duloxetine is at least as fast as (non-inferior to) escitalopram.

Oral mucositis is a serious complication of chemotherapy that results in painful debilitating inflammation, necessitating the administration of analgesics. There is no cure for mucositis. Some studies have evaluated the effect of zinc sulfate on mucositis. The present study aims to evaluate the effect of oral zinc sulfate on prevention of mucositis, xerostomia, and pain induced by chemotherapy. This double-blind, randomized controlled trial was carried out on 50 adult patients who underwent chemotherapy during 2008-2009. Patients were divided in two groups. Patients in the intervention group were administered three, 220 mg zinc sulfate capsules daily until the end of their chemotherapy treatment. Patients in the placebo group received three placebo capsules daily, which were similar in shape, taste, and color to the zinc sulfate capsules. Data were analyzed by SPSS version 17 software, using the independent samples t-test, Mann-Whitney U and Friedman tests. The incidence of grade 3 mucositis was lower in the zinc sulfate group. In the first follow up, grade 3 mucositis was detected in 10% of patients. In the placebo group, grade 3 mucositis was seen in 46.6% of patients. By the fourth follow up, grade 3 mucositis was detected in 3.33% of patients in the intervention group and in 20% of patient in the placebo group. At the end of the study there was no grade 3 mucositis detected in the zinc sulfate group, whereas there were 3.57% of patients in the placebo group with grade 3 mucositis. The results also showed that zinc sulfate decreased the effects of xerostomia and pain in patients under chemotherapy treatment. It can be concluded that zinc sulfate might decrease the intensity of mucositis.