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Results for “Single-Blind Method”

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PubMed2026

Effect of Global Postural Re-Education in Individuals With Text Neck Syndrome: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: This study investigated the effect of Global Postural Re-Education (GPR) versus conventional physical therapy in text neck syndrome (TNS). A prospective, single-blinded, parallel-group randomized controlled trial design was used. METHODS: Sixty participants with TNS (aged 18-40 years) were randomly assigned to either conventional treatment or GPR plus conventional treatment. Both groups received supervised therapy for three sessions per week over 4 weeks. Outcome measures included craniovertebral and shoulder angles assessed by photogrammetry, pain intensity via Visual Analog Scale, and Cervical Range of Motion via a smartphone application (Clinometer). Measured before and after the intervention. RESULTS: Within-group analyses showed significant improvements in pain and CROM in both groups (p < 0.001). However, the between-group analysis revealed no superiority of GPR for pain or CROM (p > 0.05). In contrast, GPR demonstrated statistically significant superiority in postural correction, with greater improvements in craniovertebral angle (MD: 2.14°; 95% CI: 0.69-3.59; p = 0.005) and shoulder angle (MD: 3.2°; 95% CI: 0.33-6.07; p = 0.03), exceeding MCID thresholds and indicating clinically meaningful benefits. However, these findings should be interpreted with caution because of the longer session duration in the GPR group. DISCUSSION: Incorporating Global Postural Reeducation (GPR) into conventional treatment provided significant additional benefits for postural parameters (craniovertebral and shoulder angles) in individuals with text neck syndrome. However, GPR demonstrated no added superiority over conventional treatment alone regarding pain intensity and cervical range of motion outcomes.

Humans↗

PubMed2026

Comparison between the thoracoabdominal rebalancing (TAR) method and the slow expiratory flow acceleration (SEFA) technique in preterm newborns: protocol for a randomised controlled clinical trial.

INTRODUCTION: Preterm newborns (PTNB) present respiratory immaturity and increased susceptibility to muscle fatigue. The thoracoabdominal rebalancing (TAR) method is a physiotherapeutic intervention developed in Brazil that aims to reorganise the synergy of the thoracoabdominal muscles and reduce the effort of the respiratory muscles, a benefit that is particularly important for PTNB; however, the evidence regarding its effectiveness in this population remains inconclusive. Therefore, this study aims to compare the short-term effects of the TAR method and the slow expiratory flow acceleration (SEFA) technique in improving respiratory distress and peripheral oxygen saturation (SpO2) in PTNB admitted to neonatal intensive care unit (NICU). METHODS AND ANALYSIS: The study will be a randomised, controlled, two-arm, parallel-group, single-blind clinical trial. 68 participants will be randomly assigned to one of the two treatment groups. Group 1 will receive four handling techniques of the TAR method for 10 min, followed by the rhinopharyngeal retrograde clearance with saline instillation (RRC+I) technique. Group 2 will receive the SEFA technique for 10 min, also followed by RRC+I. Primary outcomes are respiratory distress and SpO2. Secondary outcomes are respiratory rate (RR), heart rate (HR), pain, behaviour and diaphragmatic excursion. Assessments will be conducted by a blinded researcher at baseline (T0), immediately after the intervention (T1) and at the 30-minute follow-up (T2). Data will be described using measures of central tendency and dispersion and absolute and relative frequencies. An intention-to-treat analysis will be performed, and intragroup and intergroup comparisons will be assessed using generalised estimating equations (GEE). ETHICS AND DISSEMINATION: The Research Ethics Committee of the Faculty of Health Sciences of Trairi of the Federal University of Rio Grande do Norte approved this study (number 8,055,786). The results will be disseminated through peer-reviewed journal publications, scientific conferences presentations and knowledge translation to the public. TRIAL REGISTRATION NUMBER: This study was registered on Brazilian Registry of Clinical Trials (ReBEC) on 9 January 2026 (RBR-3gbsyc2).

Humans↗

PubMed2026

Vaginal Hysterectomy Versus Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery Hysterectomy; Results of a Randomised Controlled Trial.

OBJECTIVE: To compare Vaginal Hysterectomy (VH) with Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery (NOTES) hysterectomy (VANH) as a day-care procedure. DESIGN: Single-blind, multicentre randomised controlled trial. SETTING: Two Dutch non-academic teaching hospitals. POPULATION: Women aged ≥ 18 years undergoing hysterectomy for benign indications. METHODS: Women were randomised 1:2 (VH or VANH). Primary outcome was SDD. Secondary outcomes included operative time, rate of elective salpingectomies, intraoperative blood loss, complications (Clavien-Dindo), pain scores (NRS) and analgesic use, post-operative recovery (RI-10), and quality of life (EQ-5D-5L). Analyses were performed on an intention-to-treat basis. RESULTS: A total of 113 patients were included in the analyses (n = 42 VH, and n = 71 VANH). SDD occurred significantly more frequently in the VANH group (87.3%) than VH group (71.4%; OR 2.76, 95% CI 1.04-7.25; p = 0.04). VANH was associated with a significantly shorter operative time (median 55 min versus 65 min; p = 0.005), less blood loss (median 50 mL vs. 150 mL; p < 0.001) and more often elective opportunistic salpingectomy compared to VH (100% vs. 77.4%; p = 0.008). NRS were significantly lower in the VANH group the first hour post-operative (3 vs. 1, p < 0.001). Post-operative complications (VH 9.5% vs. VANH 15.5%; p = 0.34), readmission (VH 4.8% vs. VANH 8.5%; p = 0.47), analgesic use, recovery, and quality of life were not statistically significant. CONCLUSIONS: VANH is a safe and effective alternative to VH, offering a higher likelihood of SDD, shorter operative time, reduced blood loss, and more often an elective salpingectomy, without increased complications or differences in pain, recovery, or quality of life.

Humans↗

PubMed1978

A prospective evaluation of the leukocyte adherence inhibition test in colorectal cancer and its correlation with carcinoembryonic antigen levels.

Fifty-four patients from the surgical gastroenterology service and 22 healthy controls have been prospectively evaluated in a single-blind protocol by the LAI tube method. The LAI correctly identified 25 of 33 early colorectal patients staged as Dukes' B and C at surgery but none of the Dukes' D patients. An inverse relationship was seen between the results of the non-adherence index (NAI) and CEA levels which was most pronounced in those with advanced colorectal cancer. The majority of Dukes' B and C patients having a "false negative" LAI had a CEA level greater than 2.5 ng/ml, suggesting that more advanced disease than that seen at surgery may be present. Two of 22 normal controls gave a borderline positive NAI. Some technical problems, including the relatively short life of the tumor extracts, are discussed.

Carcinoembryonic Antigen↗

PubMed1979

An evaluation of some carrier detection techniques in Duchenne muscular dystrophy.

Some recently described abnormalities in the serum and red cell membranes in Duchenne dystrophy have been examined as methods of carrier detection in a single-blind controlled study. Twelve carriers (4 definite, 3 probable and 5 possible carriers previously found to have raised creatine kinase levels) and 12 normal female controls of the same age, were examined on 3 separate occasions at approximately two-weekly intervals. Analysis of age-dependent red cell shape changes, serum haemopexin levels, red cell K+ efflux rate, sensitivity of red cell ghost membrane ATPase to ouabain, membrane protein phosphorylation studies and lactate dehydrogenase isoenzyme profiles on agarose gel electrohoresis all failed to distinquish carriers from controls. The carriers suffered muscle cramps more frequently than the controls and all but one carrier and two control subjects were correctly identified by manual muscle strength testing, certain proximal muscles in paricular being consistently weaker in carriers than in the control group subjects. Scalar electrocardiography revealed higher values for the R/S ratio in Leads V1 and V2 and the sum (R-S) in V2.

Adenosine Triphosphatases↗

PubMed2026

GIP contributes to postprandial regulation of splanchnic blood supply in humans with type 2 diabetes: a randomised, single-blinded, placebo-controlled, crossover study.

AIMS/HYPOTHESIS: In healthy lean humans, endogenous glucose-dependent insulinotropic polypeptide (GIP) contributes significantly to the postprandial increase in arteria mesenterica superior blood flow. The vascular biology related to activation of the GIP receptor is markedly impaired in individuals with type 2 diabetes and is sometimes absent. In this population, we investigated the role of endogenous GIP on postprandial splanchnic blood flow by using the GIP receptor antagonist, GIP(3-30)NH2. The primary outcome of this study was the changes in blood flow in arteria mesenterica superior during oral glucose with or without GIP receptor antagonist infusion. METHODS: Ten participants with type 2 diabetes (age 20-80 years, BMI 20-35 kg/m2, and HbA1c >48 mmol/mol and <75 mmol/mol) were investigated in a randomised, placebo-controlled, crossover study. On four separate occasions, participants received the following treatment: oral glucose + i.v. GIP(3-30)NH2; oral glucose + i.v. saline (154 mmol/l NaCl); oral water + i.v. GIP(3-30)NH2; oral water + i.v. saline. Participants were randomly assigned to intervention groups using (random.org). Participants were unaware of allocation, while investigators were aware. No additional allocation concealment procedures were used. During all four interventions, splanchnic blood flow was measured using phase-contrast MRI in the arteria mesenterica superior, truncus coeliacus and vena portae during oral glucose (75 g) or water ingestion. The study was conducted at Rigshospitalet, Copenhagen. Liver volume and oxygenation, as well as gallbladder volume, were assessed. Blood samples were collected and analysed for insulin, C-peptide, GIP, glucagon and glucose. RESULTS: Oral glucose alone increased mean blood flow in arteria mesenterica superior by 57% (95% CI 26, 88) and this was 15% (95% CI -2, 32) lower during concomitant GIP receptor antagonist infusion, p=0.012. Infusion of GIP receptor antagonist during oral glucose treatment did also result in lower insulin secretion, C-peptide and C-peptide/glucose ratio compared with saline infusion, whereas glucagon levels and plasma glucose were unaffected. Oral water did not affect any outcomes. CONCLUSIONS/INTERPRETATION: Endogenous GIP contributes to postprandially increased splanchnic blood flow in people with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT06426823 FUNDING: This work was supported by the Novo Nordisk Foundation.

Humans↗

PubMed1979

Clinical trial of brinase and anticoagulants as a method of treatment for advanced limb ischemia.

A randomized, single-blind trial of repeated intravenous infusion of Brinase was carried out in 70 petients with severe chronic limb ischemia, who were candidates for lumbar sympathectomy or amputation. The enzyme caused s significant increase in calf and ankle pressure index. At six months follow-up, the clinical results were statistically significant in favour of Brinase when all patients were considered, but not if 10 patients with Buerger's disease were omitted from the analysis. Patients treated with a combination of Brinase and coumarins had a better clinical outcome than patients receiving either treatment on its own.

Aged↗

PubMed1977

Peripheral arterial disease: assessment by arteriography and alternative noninvasive measurements.

In most centers arteriography is the sole method used to investigate peripheral arterial disease. In view of the availability of other noninvasive techniques, this practice must be reappraised. Among 3,000 patients with peripheral arterial disease, 40% of those undergoing arteriography were found unsuitable for reconstructive arterial surgery primarily because of poor arterial runoff. Noninvasive assessment techniques are discussed, including sequential arterial scanning with Doppler ultrasound. In a single-blind comparison of Doppler ultrasound scanning and arteriography, findings by ultrasound were confirmed by arteriography in 265 of 267 examinations. Blood pressure measurements in the limbs as well as fluorescence and radioisotope clearance studies also provide valuable information. It is recommended that a more rational approach to the assessment of peripheral arterial disease be considered, particularly in elderly patients, to safeguard against undue discomfort and risk. Arteriography should be reserved for patients undergoing reconstructive surgical procedures.

Aged↗

PubMed1978

A double-blind comparison of levodopa, Madopa, and Sinemet in Parkinson disease.

A sixteen-week study examined the effect of Madopa and Sinemet on patients with Parkinson disease disease suffering nausea or vomiting as side-effects of levodopa therapy and compared the efficacy of the three preparations in controlling the symptoms of Parkinson disease. Following a control period on levodopa, 20 patients underwent four consecutive four-week regimens as follows: (1) double-blind, in which a randomized half received levodopa and half received Madopa; (2) single-blind, in which all received Madopa; (3) double-blind, in which a re-randomized half received Madopa and half Sinemet; and (4) single-blind, in which all received Sinemet. Levodopa administration via Sinemet and Madopa was held to a fixed 20% of prior levodopa dosage. Almost all patients showed great reduction in nausea and vomiting with both Madopa and Sinemet. Seventy percent of the patients showed improvement in disability compared to their levodopa baseline levels. Group means showed no difference between the improvement seen on Madopa and that seen on Sinemet. However, examination of individual responses showed that the majority of patients fared distinctly better on either Sinemet or Madopa.

Adult↗

PubMed1979

Lidoflazine in the management of angina pectoris.

The effect of lidoflazine administration (120 mg t.i.d. for 9 weeks) on work tolerance (bicycle ergometer), frequency of anginal attacks, and nitroglycerin consumption was investigated in 28 male patients with stable angina pectoris in a combined single-blind/double-bline study. Lidoflazine increased work tolerance and reduced the frequency of anginal attacks and nitroglycerin consumption. The higher work tolerance level was reached at maximal heart rate and heart rate--systolic blood pressure product values similar to those before treatment. The values of these variables after 3 min of exercise at 60 W, however, were significantly lower after treatment with lidoflazine. These findings indicate that the heart is performing more economically during lidoflazine treatment. The improved work tolerance can probably be ascribed to lidoflazine and not to a training effect because of the significant reduction of this variable in the patients allocated to placebo as compared to those remaining on lidoflazine treatment. The side effects were generally slight. In one patient the prolongation of the QT interval due to lidoflazine resulted in rhythm disturbances.

Adult↗

PubMed1978

Calcitriol in dialysis patients.

We conducted a 7-month randomized, single, double, single-blind comparison of calcitriol (1,25(OH)2D3) with vitamin D3 in 22 hemodialysis patients to study the effects on the biochemical abnormalities associated with osteodystrophy. Calcitriol was given for 3 mo. All patients had initial prestudy calcium values less than or equal to 9.5 mg/100 ml, and phosphate values less than or equal to 4.5 mg/100 ml. Data were analyzed using the Normalized Trend Index (NTI). Calcitriol induced a rise in calcium (8.7 to 10.25 mg/100 ml) (p less than 0.001) and a fall in alkaline phosphatase (p less than 0.005), while D3 had no appreciable effect. The mean dose of calcitriol during treatment was 0.579 microgram/day while that for D3 was 706 IU/day. The effect on serum phosphate concentration was variable. Hypercalcemia as high as 13.2 mg/100 ml occurred in 2 of 13 patients on 1,25(OH)2D3, but in every instance promptly returned to normal with dose reduction. No other adverse effects were noted with therapy. We conclude that calcitriol reverses the biochemical abnormalities of osteodystrophy. Since its effects are rapidly reversed with discontinuation, the drug is probably safe as well as effective.

Adult↗

PubMed1979

Pirprofen and aspirin in the treatment of rheumatoid arthritis.

Pirprofen (800 mg/day) or aspirin (3,600 mg/day) was administered in double-blind fashion for up to one year to 40 adult outpatients with rheumatoid arthritis, after a short, single-blind placebo period. There were no statistically significant differences in efficacy between pirprofen and aspirin, as evidenced by patient opinion, observer opinion, grip strength, walking time, number of tender joints, number of swollen joints, or erythrocyte sedimentation rate. Clinically significant pain of gastrointestinal origin occurred in an equal number of patients from each group. Audiologic evaluation revealed 3 pirprofen-treated patients and 5 aspirin-treated patients in whom sensorineural hearing loss progressed during therapy and required either discontinuation or reduction of drug dosage. Ophthalmologic evaluation disclosed a high prevalence of lesions, the most common being decreased visual acuity and cataracts not explained by previous antiarthritic therapy. The high prevalence of audiologic and ophthalmologic pathology reported in the literature in patients with rheumatoid arthritis makes it difficult to establish in our study whether pirprofen or aspirin affected these organ systems.

Adult↗

PubMed1978

Effect of the mucoregulator S-carboxy-methyl-cysteine in patients with chronic bronchitis.

Twenty patients with stable chronic bronchitis entered a double-blind study in which changes in clinical and respiratory function and biochemical and rheological variations were examined after treatment with the mucoregulator S-carboxy-methyl-cysteine (S.C.M.C.). After one week of single-blind placebo, a two week double-blind study was initiated with placebo or oral S.C.M.C. 3 g/24h. After two weeks, a significant clinical improvement was observed in patients treated with S.C.M.C. During treatment, there was no change in respiratory function, although a drop in FEV1/VC was noted in the placebo group. A significant increase in the viscosity of the expectorations was observed after treatment with S.C.M.C. for two weeks. The levels of secretory IgA and of serum albumin in the expectorations remained stable, whereas in the placebo group, there was a slight but significant increase in serum albumin. In this group of non-infected chronic bronchitic patients, S.C.M.C. appeared to normalize the secretory function of the bronchial mucosa by preventing inflammation and enhancing the viscoelastic properties of bronchial secretions.

Aged↗

PubMed1977

Analgesia after operation. A controlled comparison of meptazinol, pentazocine and pethidine.

In a double-blind investigation of the efficacy on pain following abdominal or orthopaedic surgery, meptazinol 100 mg, a new hexahydroazepine derivative, was found to be equipotent with pentazocine 60 mg and pethidine 100 mg when given i.m. Analgesia was maximal 30-60 min after injection and was still present at the end of 2 h. The duration of action of meptazinol was estimated to be 4 h. Meptazinol produced less sedation and a greater sparing of lung function tests than did pethidine and pentazocine. When meptazinol or morphine was administered for further pain relief in a single-blind manner there was no evidence of patient preference for one drug or the other.

Adult↗

PubMed1978

The effect of oxazepam on sleep in normal human volunteers.

The effects of 25 mg of oxazepam, a benzodiazepine with a short half-life and no active metabolites, were compared with placebo in two healthy volunteers in a single-blind polygraphically recorded sleep study. The experiment lasted for 24 nights and recordings were made for 11 nights. It was found that 25 mg oxazepam induced sleep faster than placebo, and that the subjects awoke less often during the treatment period. The total amount of REM-sleep was not affected. However, REM-sleep was shortened during the first part of the night and extended during the latter part of the night. Slow-wave sleep diminished differently in the two subjects, possibly due to interindividual differences in the rate of elimination of oxazepam. The effect on blood pressure was small, and the normal physiological difference between bedtime and morning blood pressure was preserved.

Adult↗

PubMed1979

A controlled comparative trial of mianserin and diazepam in the treatment of anxiety states in psychiatric out-patients.

Forty psychiatric out-patients with primary anxiety entered a double-blind trial comparing 2 weeks of treatment with mianserin 30--60 mg daily or diazepam 15--30 mg daily, followed by 2 weeks of single-blind placebo administration. Both drugs were effective anti-anxiety agents, but mianserin was significantly superior in efficacy as measured by the Physician's Global Rating of Severity of Illness. No differences between treatments were apparent using the Hamilton Rating Scale for Anxiety. There was no significant differences in terms of side-effects and both drugs increased anticholinergic effects such as dry mouth, blurred vision and constipation over baseline values. With one exception in the mianserin group, all patients who entered placebo treatment became worse.

Adolescent↗

PubMed1978

Clinical therapeutic evaluation of methylcysteine hydrochloride in patients with chronic obstructive bronchitis: a balanced double-blind trial with placebo control.

A double-blind, between-patient, placebo controlled trial was carried out to investigate the effects of methylcysteine hydrochloride in patients with chronic obstructive bronchitis. After a 2-week washout period on placebo, 30 patients were allocated at random to treatment for 6 weeks with either methylcysteine (1200 mg daily in Week 1, 800 mg daily in Week 2, then 600 mg daily) or with identical placebo tablets on the same regimen. During the post-treatment period, all patients returned to a single-blind placebo regimen (6 tablets daily) for a further 14 days. Assessments were made at the start, at regular intervals during the trial, and at the end of the post-treatment period, of subjective and objective measures of clinical response, and measurements of pulmonary function and certain physico-chemical properties of sputum. The results showed that methylcysteine increased sputum volume, reduced the viscidity of sputum, and significantly improved the subjective assessments of ease of expectoration and severity and frequency of cough, leading to a definite improvement in the patients' clinical state. No side-effects of clinical significance were reported and no abnormalities were found in any of the haematological, hepatic and renal function tests carried out.

Adult↗

PubMed1979

A double-blind study of the peripheral vasoconstrictor effects of the beta-blocking drug penbutolol in patients with Raynaud's phenomenon.

A double-blind, placebo-controlled study was carried out in 10 hypertensive patients who were subject to frequent attacks of Raynaud's phenomenon and suffered from cold hands, to assess the peripheral vasoconstrictor effects of penbutolol. After a wash-out period of 2 weeks on placebo, patients received two 14-day treatment periods, in random order, with either 20 mg penbutolol twice daily or placebo separated by a second 2-week single-blind wash-out period on placebo. The results of digital blood flow measurements showed that penbutolol did not produce any additional vasoconstrictor effect on digital circulation. The significance of these findings is discussed.

Adult↗