No drugs are currently approved for the treatment of borderline personality disorder (BPD). These studies (a randomised study and its open-label extension) aimed to evaluate the efficacy, safety and tolerability of brexpiprazole for the treatment of BPD.

The Phase 2, multicentre, randomised, double-blind, placebo-controlled, parallel-group study enrolled adult outpatients with BPD. After a 1-week placebo run-in, patients were randomised 1:1 to brexpiprazole 2–3 mg/day (flexible dose) or placebo for 11 weeks. The primary endpoint was change in Zanarini Rating Scale for BPD total score from randomisation (Week 1) to Week 10 (timing of randomisation and endpoint blinded to investigators and patients). The Phase 2/3, multicentre, open-label extension study enrolled patients who completed the randomised study; all patients received brexpiprazole 2–3 mg/day (flexible dose) for 12 weeks. Safety assessments included treatment-emergent adverse events (TEAEs).

Brexpiprazole was not statistically significantly different from placebo on the primary endpoint of the randomised study (N = 324 randomised; N = 110 analysed per treatment group; least squares mean difference −1.02; 95% confidence limits −2.75, 0.70; p = 0.24). Numerical efficacy advantages for brexpiprazole were observed at other time points. The most common TEAE in the randomised study was akathisia (brexpiprazole, 14.0%; placebo, 1.2%); data from the open-label study (N = 199 analysed) suggested that TEAEs were transient.

The primary endpoint of the randomised study was not met. Further research on brexpiprazole in BPD is warranted based on possible efficacy signals at other time points and its safety profile.

ClinicalTrials.gov identifiers: NCT04100096, NCT04186403. Funding: Otsuka, Lundbeck.

This study aimed to determine the efficacy of probiotic gargles compared with placebo gargles on reducing post-tonsillectomy morbidity in adults.

This was a triple-blind, randomised, controlled trial and feasibility study. Thirty adults underwent elective tonsillectomy and were randomly assigned to receive either probiotic or placebo gargles for 14 days after surgery. Daily pain scores and requirement of analgesia were measured for 14 days post-operatively. Secondary outcomes assessed probiotic safety and tolerability and the feasibility of the trial.

The probiotic group experienced less pain at rest on day 2. However, the amount of oxycodone (5 mg) tablets used was greater in the probiotic group compared with placebo. There were no statistically significant differences in the frequency of adverse effects between both groups. This trial was feasible.

This pilot study suggested that probiotic gargles do not reduce post-tonsillectomy pain or bleeding, highlighting the importance of pilot and feasibility studies in clinical research.

To evaluate the efficacy and safety of celecoxib for pain management in post-tonsillectomy adult patients.

A randomised, double-blind, placebo-controlled, phase 3 clinical trial was conducted in an adult population (aged 18–55 years), with a parallel group design using an allocation ratio of 1:1.

Eighty patients underwent elective tonsillectomy or adenotonsillectomy, operated on by one surgeon. They were discharged home with randomly assigned celecoxib or placebo, together with regular post-tonsillectomy medications (paracetamol and Endone). Pain scores were measured from post-operative days 1 to 10. All patients were assessed on post-operative days 5, 12 and 28.

There were no statistically significant differences in the daily or overall pain scores, the total intake of Endone, or the time taken to achieve freedom from pain after tonsillectomy between the study arms (n = 40 each arm). The celecoxib-treated group experienced significantly more vomiting (celecoxib vs placebo p < 0.001 (Mann–Whitney test), confidence interval = 0.57 to 0.76).

Celecoxib usage was associated with significantly more vomiting and did not reduce narcotic analgesia requirement post-tonsillectomy.

Background: The suggestion that the neurohormone oxytocin may have clinical application in the treatment of schizophrenia was first published in 1972. Since then, a considerable body of research on a variety of fronts – including several recent double-blind treatment trials – has buttressed these early reports, providing support for the assertion that the oxytocin system is a promising and novel therapeutic target for this devastating malady. Herein, we review the diverse, convergent lines of evidence supporting the therapeutic potential of oxytocin in psychotic illness.

Methods: We performed a systematic review of preclinical and clinical literature pertaining to oxytocin's role in schizophrenia.

Results: Multiple lines of evidence converge to support the antipsychotic potential of oxytocin. These include several animal models of schizophrenia, pharmacological studies examining the impact of antipsychotics on the oxytocin system, human trials in patients examining the aspects of the oxytocin system and several double-blind, placebo-controlled clinical treatment trials.

Conclusions: There exists considerable, convergent evidence that oxytocin has potential as a novel antipsychotic with a unique mechanism of action. Auspiciously, based on the few chronic trials to date, its safety profile and tolerability appear very good. That said, several critical clinical questions await investigation before widespread use is clinically warranted.