Probiotic Lacticaseibacillus rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 as an Adjunctive Treatment for Bacterial Vaginosis Do Not Increase the Cure Rate in a Chinese Cohort: A Prospective, Parallel‐Group, Randomized, Controlled Study

The purpose of this study was to evaluate the effectiveness of metronidazole and oral probiotics adjunct to metronidazole in the treatment of bacterial vaginosis (BV). One hundred and twenty-six Chinese women with BV were enrolled in this parallel, controlled trial, and were randomly assigned into two study arms: the metronidazole group, which was prescribed metronidazole vaginal suppositories for 7 days, and the adjunctive probiotic group, which received Lacticaseibacillus rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 orally for 30 days as an adjunct to metronidazole. Clinical symptoms and Nugent scores at the initial visit, 30 days and 90 days were compared. There was no significant difference of the 30-day total cure rate between the adjunctive probiotic group (57.69%) and the metronidazole group (59.57%), with an odds ratio (OR) of 0.97 (95% confidence interval (CI), 0.70 to 1.35, p-value = 0.04), or of the 90-day total cure rate (36.54% vs. 48.94%, OR, 0.75; 95% CI, 0.47 to 1.19; p-value = 0.213). Also, no significant difference of the vaginal and faecal microbial diversity and structure between the two groups at 0, 30 or 90 days were shown based on 16S rRNA sequences. The probiotic species were rarely detected in either the vaginal microbiota or the faecal microbiota after administration which may revealed the cause of noneffective of oral probiotics. No serious adverse effects were reported in the trial. The study indicated that oral probiotic adjunctive treatment did not increase the cure rate of Chinese BV patients compared to metronidazole.

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Clinical Effectiveness of Intravenous Peramivir Compared with Oseltamivir in Patients with Severe Influenza A with Primary Viral Pneumonia: A Randomized Controlled Study

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa562 ◽

2020 ◽

Author(s):

Hong-dou Chen ◽

Xu Wang ◽

Shu-le Yu ◽

Yue-hui Ding ◽

Meng-lei Wang ◽

...

Keyword(s):

Influenza A ◽

Clinical Symptoms ◽

Controlled Trial ◽

Clinical Effectiveness ◽

Viral Pneumonia ◽

Controlled Study ◽

Once Daily ◽

Randomized Controlled ◽

Severe Influenza ◽

Significant Difference

Abstract Background High-quality evidence confirm the clinical efficacy of peramivir in severe influenza patients with primary viral pneumonia is lacking. To optimize clinical medication, we evaluate the different efficacy between peramivir and oseltamivir in the treatment of severe influenza A with primary viral pneumonia. Methods A single-center, randomized, controlled trial was conducted during the Chinese influenza season from December 2018 to April 2019 in patients with severe influenza A with primary viral pneumonia. A total of 40 inpatients were enrolled and treated with either intravenous peramivir (300 mg, once daily for 5 days) or oral oseltamivir (75 mg, twice daily for 5 days). Results The durations of influenza virus nucleic acid positivity in the oseltamivir group and the peramivir group were 2.95 days and 2.80 days, respectively. The remission times of clinical symptoms in the oseltamivir group and the peramivir group were 3.90 days and 3.25 days, respectively. In addition, the remission time of cough symptoms in the peramivir group (63.89 hours) was shorter than that in the oseltamivir group (75.53 hours). There was no significant difference between these values (P>0.05). The remission time of fever symptoms in the oseltamivir group was 23.67 hours, which was significantly longer than that in the peramivir group (12.32 hours) (P=0.034). Conclusions Peramivir is no less effective than oseltamivir in the treatment of severe influenza A with primary viral pneumonia, and patients treated with peramivir had significantly shorter remission times of fever symptoms than those treated with oseltamivir.

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Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽

10.1136/gutjnl-2018-316434 ◽

2018 ◽

Vol 67 (12) ◽

pp. 2107-2115 ◽

Cited By ~ 96

Author(s):

Sofie Ingdam Halkjær ◽

Alice Højer Christensen ◽

Bobby Zhao Sheng Lo ◽

Patrick Denis Browne ◽

Stig Günther ◽

...

Keyword(s):

Gut Microbiota ◽

Controlled Trial ◽

Symptom Relief ◽

Controlled Study ◽

Faecal Microbiota ◽

Double Blind ◽

Double Blind Placebo ◽

Faecal Microbiota Transplantation ◽

Faecal Samples ◽

Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

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Does transcutaneous electrical nerve stimulation (TENS) alleviate the pain experienced during bone marrow sampling in addition to standard techniques? A randomised, double-blinded, controlled trial

Journal of Clinical Pathology ◽

10.1136/jclinpath-2015-202908 ◽

2015 ◽

Vol 68 (6) ◽

pp. 479-483 ◽

Cited By ~ 3

Author(s):

David L Tucker ◽

Mark Rockett ◽

Mehedi Hasan ◽

Sarah Poplar ◽

Simon A Rule

Keyword(s):

Bone Marrow ◽

Nerve Stimulation ◽

Transcutaneous Electrical Nerve Stimulation ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Sensory Threshold ◽

Threshold Control ◽

Electrical Nerve Stimulation ◽

Significant Difference

AimsBone marrow aspiration and trephine (BMAT) biopsies remain important tests in haematology. However, the procedures can be moderately to severely painful despite standard methods of pain relief. To test the efficacy of transcutaneous electrical nerve stimulation (TENS) in alleviating the pain from BMAT in addition to standard analgesia using a numerical pain rating scale (NRS).Methods70 patients requiring BMAT were randomised (1:1) in a double-blind, placebo-controlled trial. –35 patients received TENS impulses at a strong but comfortable amplitude (intervention group) and 35 patients received TENS impulses just above the sensory threshold (control group) (median pulse amplitude 20 and 7 mA, respectively). Patients and operators were blinded to group allocation. Pain assessments were made using a numerical pain scale completed after the procedure.ResultsNo significant difference in NRS pain recalled after the procedure was detected (median pain score 5.7 (95% CI 4.8 to 6.6) in control vs 5.6 (95% CI 4.8 to 6.4) in the intervention group). However, 100% of patients who had previous experience of BMAT and >94% of participants overall felt they benefited from using TENS and would recommend it to others for this procedure. There were no side effects from the TENS device, and it was well tolerated.ConclusionsTENS is a safe, non-invasive adjunct to analgesia for reducing pain during bone marrow biopsy and provides a subjective benefit to most users; however, no objective difference in pain scores was detected when using TENS in this randomised controlled study.Clinical registration numberNCT02005354.

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Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9002 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9002-9002 ◽

Cited By ~ 6

Author(s):

Sriram Yennurajalingam ◽

Susan Frisbee-Hume ◽

Marvin Omar Delgado-Guay ◽

Janet Bull ◽

Alexandria T. Phan ◽

...

Keyword(s):

Advanced Cancer ◽

Controlled Trial ◽

Symptom Assessment ◽

Primary Objective ◽

Controlled Study ◽

Advanced Cancer Patients ◽

Double Blind ◽

Cancer Related Fatigue ◽

Significant Difference ◽

Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

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Improved cure of bacterial vaginosis with single dose of tinidazole (2 g),Lactobacillus rhamnosusGR-1, andLactobacillus reuteriRC-14: a randomized, double-blind, placebo-controlled trial

Canadian Journal of Microbiology ◽

10.1139/w08-102 ◽

2009 ◽

Vol 55 (2) ◽

pp. 133-138 ◽

Cited By ~ 92

Author(s):

Rafael C. R. Martinez ◽

Sílvio A. Franceschini ◽

Maristela C. Patta ◽

Silvana M. Quintana ◽

Bruna C. Gomes ◽

...

Keyword(s):

Single Dose ◽

Placebo Group ◽

Bacterial Vaginosis ◽

Lactobacillus Reuteri ◽

Controlled Trial ◽

Lactobacillus Rhamnosus ◽

Antimicrobial Treatment ◽

Double Blind ◽

Probiotic Group ◽

Probiotic Lactobacilli

Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by depletion of the indigenous lactobacilli. Antimicrobial therapy is often ineffective. We hypothesized that probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 might provide an adjunct to antimicrobial treatment and improve cure rates. Sixty-four Brazilian women diagnosed with BV were randomly assigned to receive a single dose of tinidazole (2 g) supplemented with either 2 placebo capsules or 2 capsules containing L. rhamnosus GR-1 and L. reuteri RC-14 every morning for the following 4 weeks. At the end of treatment (day 28), the probiotic group had a significantly higher cure rate of BV (87.5%) than the placebo group (50.0%) (p = 0.001). In addition, according to the Gram-stain Nugent score, more women were assessed with “normal” vaginal microbiota in the probiotic group (75.0% vs. 34.4% in the placebo group; p = 0.011). This study shows that probiotic lactobacilli can provide benefits to women being treated with antibiotics for an infectious condition.

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Periarticular Injection with Bupivacaine for Postoperative Pain Control in Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

Advances in Orthopedics ◽

10.1155/2012/107309 ◽

2012 ◽

Vol 2012 ◽

pp. 1-6 ◽

Cited By ~ 19

Author(s):

Varah Yuenyongviwat ◽

Chaturong Pornrattanamaneewong ◽

Thitima Chinachoti ◽

Keerati Chareancholvanich

Keyword(s):

Pain Control ◽

Controlled Trial ◽

Ease Of Use ◽

Morphine Consumption ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Periarticular Injection ◽

Post Operative Pain ◽

Significant Difference

Background. Local periarticular injection with bupivacaine alone in TKA has not been studied. Thus, we aimed to examine the effectiveness of local periarticular injection with bupivacaine for post-operative pain control in TKA.Method. Sixty patients undergoing TKA by a single surgeon were randomly assigned into two groups in a double-blind, placebo-controlled study. In the injection group, patients received periarticular injections with 0.25% bupivacaine before wound closure; in the control group, patients received a 0.9% normal saline injection. Both groups received the same anesthetic procedure, post-operative pain control, and rehabilitation protocol.Results. There was a significant reduction in post-operative morphine consumption in the first six hours after the operation (mean 0.9 mg and 2.43 mg,P=0.01), but there was no significant difference in post-operative morphine consumption between six hours and ninety-six hours after the operation, visual analogue scale (VAS) score, morphine side effects during the first 96 hours, length of hospital stay, or complications from morphine consumption.Conclusion. Local periarticular injection with bupivacaine alone before wound closer was shown to be an effective method to improve pain control after TKA with a few complications and ease of use.

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The Value of Ozone in CT-Guided Drainage of Multiloculated Pyogenic Liver Abscesses: A Randomized Controlled Study

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2018/1236974 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6

Author(s):

Bing Li ◽

Chuan Liu ◽

Lang Wang ◽

Yang Li ◽

Yong Du ◽

...

Keyword(s):

Clinical Symptoms ◽

Pyogenic Liver Abscess ◽

Nonparametric Test ◽

Controlled Study ◽

Success Rates ◽

Catheter Drainage ◽

Ct Guided ◽

Group I ◽

Significant Difference ◽

Group Ii

Objective. This study was designed to compare the effects of catheter drainage alone and combined with ozone in the management of multiloculated pyogenic liver abscess (PLA). Methods. The prospective study included 60 patients diagnosed with multiloculated PLA. All patients were randomly divided into two groups: catheter drainage alone (group I) and catheter drainage combined with ozone (group II). Drainage was considered successful when (1) the abscess cavity was drained and (2) clinical symptoms were resolved. Kruskal-Wallis nonparametric test was used to compare the success rates, length of stay (LOS), and need for further surgery of the two groups. P<0.05 indicates significant difference. Results. All patients’ catheters were successfully placed under CT guidance. Group I was treated with catheters alone and group II was treated with catheters and ozone. The success rates of groups I and II were 86% and 96%, respectively (P<0.05). And compared with group II, the duration of fever in group I was longer (P<0.05), and the LOS was also longer (P<0.05). Conclusion. Catheter drainage combined with ozone is an effective and safe treatment in multiloculated PLA. The Clinical Registration Number is ChiCTR1800014865.

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Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

10.22514/sv.2021.144 ◽

2021 ◽

Keyword(s):

Quality Of Life ◽

Nk Cells ◽

Nk Cell ◽

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

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A randomised controlled trial to evaluate a medication monitoring system for TB treatment

The International Journal of Tuberculosis and Lung Disease ◽

10.5588/ijtld.21.0373 ◽

2022 ◽

Vol 26 (1) ◽

pp. 44-49

Author(s):

J. Acosta ◽

P. Flores ◽

M. Alarcón ◽

M. Grande-Ortiz ◽

L. Moreno-Exebio ◽

...

Keyword(s):

Controlled Trial ◽

Treatment Success ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Second Phase ◽

Open Label ◽

Pulmonary Tb ◽

Tb Treatment ◽

Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

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The midline approach for endotracheal intubation using GlideScope video laryngoscopy could provide better glottis exposure in adults： A randomized controlled trial

10.21203/rs.2.9721/v3 ◽

2019 ◽

Author(s):

Lianxiang Jiang ◽

Shulin Qiu ◽

Peng Zhang ◽

Weidong Yao ◽

Yan Chang ◽

...

Keyword(s):

Tracheal Intubation ◽

Endotracheal Intubation ◽

Elective Surgery ◽

Controlled Trial ◽

Video Laryngoscopy ◽

Controlled Study ◽

Randomized Controlled ◽

Significant Difference ◽

Midline Approach ◽

Approach Group

Abstract Background: Previous studies have demonstrated that the common laryngoscopic approach (right-sided) and midline approach are both used for endotracheal intubation by direct laryngoscopy. Although the midline approach is commonly recommended for video laryngoscopy (VL) in the clinic, there is a lack of published evidences to support this practice. This study aimed to evaluate the effects of different video laryngoscopic approaches on intubation. Methods: Two hundred sixty-two patients aged 18 years who underwent elective surgery under general anaesthesia and required endotracheal intubation were included in the present prospective, randomized, controlled study. The participants were randomly and equally allocated to the right approach (Group R) or midline approach (Group M). All the intubations were conducted by experienced anaesthetists using GlideScope video laryngoscopy. The primary outcomes were Cormack-Lehane laryngoscopic views (CLVs) and first-pass success (FPS) rates. The secondary outcomes were the time to glottis exposure, time to tracheal intubation, haemodynamic responses and other adverse events. Comparative analysis was performed between the groups. Results: Finally, 262 patients completed the study, and all the tracheas were successfully intubated. No significant differences were observed in the patient characteristics and airway assessments ( P >0.05). Compared with Group R, Group M had a better CLV ( χ2 =14.706, P =0.001) and shorter times to glottis exposure (8.82±2.04 vs 12.38±1.81; t =14.94; P <0.001) and tracheal intubation (37.19±5.01 vs 45.23±4.81; t =13.25; P <0.001), but no difference was found in the FPS rate (70.2% vs 71.8%; χ2 =0.074; P =0.446) and intubation procedure time (29.86±2.56 vs 30.46±2.97, t =1.75, P =0.081). Between the groups, the rates of hoarseness or sore throat, minor injury, hypoxemia and changes in SBP and HR showed no significant difference ( P >0.05). Conclusion: Although the FPS rate did not differ based on the laryngoscopic approach, the midline approach could provide better glottis exposure and shorter times to glottis exposure and intubation. The midline approach should be recommended for teaching in VL-assisted endotracheal intubation. Trial registration: The study was registered in the Chinese Clinical Trial Registry ( ChiCTR-RNC-1900023252 ).

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