Effects of Chinese herbal medicine Pugongying for reducing the application of antibiotics in breastfeeding women with acute mastitis: study protocol of a randomized, active-controlled, outcome assessor-blinded trial

• Background: Acute mastitis influences the health condition and quality of life of the infants and mothers during the lactation. Pugongying (a kind of Chinese patent medicine, Herba Taraxaci) has shown benefits in lactating women with acute mastitis in clinical practice. However, there is no solid evidence to support its effectiveness and safety.• Methods: A three-arm, multicenter, randomized, active-controlled, outcome assessor-blinded clinical trial will be undergoing in three hospitals in Beijing. 306 participants will be randomly assigned into three groups in 1:1:1 ratio with Pugongying alone, cefdinir alone, and combination of Pugongying and cefdinir for 3-day intervention drugs administration. And in combination of Pugongying and cefdinir group, the participants will be administrated with 2-day cefdinir and 3-day Pugongying. The primary outcomes are resolution of fever, visual analogue scale (VAS) scores of breast pain, and the size of the breast mass by palpation. The secondary outcomes are the patency of milk, Traditional Chinese Medicine (TCM) symptoms scores, white blood cell count, the percentage of neutrophil and C-reactive protein, relapse at 3th day of follow up after completion of treatment, and safety assessment including routine blood, liver and renal function and electrocardiography. Besides, the incidence of surgery and the quantity of additional intervention drugs will also be evaluated.• Discussion: The results of this trial are expected to confirm whether Chinese herbal medicine Pugongying could alleviate the symptoms and signs in lactating women with acute mastitis, and they could reduce application of cefdinir in clinical practice.• Trial registration: ClinicalTrials.gov [Home - ClinicalTrials.gov], ID: NCT03756324. Registered on December 18th 2018. https://www.clinicaltrials.gov/ct2/show/NCT03756324?cond=Acute+mastitis&draw=2&rank=1

A feasibility randomized controlled trial of ReaDySpeech for people with dysarthria after stroke

Objective: To evaluate the feasibility of a multicentre randomized controlled trial of ReaDySpeech, an online speech therapy programme for people with dysarthria. Design: Feasibility randomized controlled trial, 2:1 minimization procedure. Setting: Four UK NHS services across hospital and community. Participants: Forty participants with dysarthria at least one week post-stroke. Interventions/comparator: ReaDySpeech with usual care ( n = 26) versus usual care only ( n = 14). Main outcomes: Feasibility measures included the following: recruitment and retention rate, time taken to carry out assessments, success of outcome assessor blinding, fidelity and adherence. Participant baseline and outcome measures collected before and after 8–10 weeks of intervention were the Frenchay Dysarthria Assessment II, Therapy Outcome Measure, Communication Outcomes After Stroke Scale, EQ-5D-5L and Dysarthria Impact Profile. Results: Recruited 40 participants out of 74 eligible people, 1–13 weeks post stroke and mean age 69 years (37–99). Retention was very high (92%). Assessor blinding was not achieved with intervention allocation correctly guessed for 70% of participants (26/37). Time to carry out assessments was acceptable to participants. ReaDySpeech was delivered to 16 of 26 allocated participants, who completed 55% of prescribed activities, but both interventions were delivered at low intensity (mean 6.6 face-to-face sessions of 40-minute duration). Conclusion: Recruitment and retention in this randomized controlled trial of computerized therapy for dysarthria is feasible for acute stroke. However, further feasibility work is needed to evaluate whether it is possible to recruit chronic stroke; increase intervention delivery, intensity and adherence; achieve outcome assessor blinding by video-recording and to determine sample size for a larger trial of effectiveness.