Double-blind Controlled Study Research Articles

Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study

BackgroundNasal surgery has a reported high incidence of agitation during emergence from general anesthesia. Emergence Agitation (EA) increases the risk of surgical site bleeding, falling off the operating table, removal of catheters and intravenous lines, and self-extubation. This study investigated the role of nerve block in EA. ObjectivesThis study evaluated the effect of ultrasound-guided sphenopalatine ganglion block (SPGB) on EA after sinoscopic nasal surgery. The primary outcome was the incidence of EA. Secondary outcomes included the quality of the surgical field, bleeding volume, inhalational anesthesia, MAC, VAS in the PACU, postoperative analgesia duration, and total 24 -h opioid consumption. Patients and methodsThis double-blind, randomized controlled study enrolled 120 patients, of whom 110 completed the study. They were randomly allocated into two equal groups: G1, which received general anesthesia and a bilateral sphenopalatine ganglion block (SPBG) with 5 mL lidocaine 2% on each side, and G2 (control), which received general anesthesia and a bilateral sphenopalatine saline injection of 5 mL on each side. ResultsA significant decrease in the incidence of EA was found in G1 compared to G2 (20% vs. 64%). Intraoperative bleeding volume was significantly lower, and surgical field quality was significantly higher in G1 compared to G2. Pain severity was significantly lower in G1 in the PACU, and 24 h postoperative opioid consumption was significantly reduced compared to G2. Additionally, postoperative analgesia duration was significantly longer in G1 than in G2 (9 h vs. 3 h). ConclusionSPGB effectively reduced EA incidence, severity, and duration after sinoscopic nasal surgery. Furthermore, SPGB reduced intraoperative bleeding, improved surgical field quality, prolonged postoperative analgesia, and reduced 24 -h opioid consumption after sinoscopic nasal surgery. RegistrationNational Clinical Trial Registry, NCT04168879

Comparison of the efficacy of 2 different botulinum toxin injection techniques in gastrocnemius muscle spasticity in hemiplegic patients: A randomized double-blind controlled study

To compare the efficacy of the innervation zone-targeted injection technique (EUROMUSCULUS/USPRM spasticity approach) and the injection technique along the muscle length. A double-blind randomized controlled trial SETTING: Department of rehabilitation medicine of a medical center PARTICIPANTS: One hundred stroke patients with ankle plantar flexor spasticity. Modified Ashwort Scale, Modified Tardiue Scale, ankle range of motion measurement and 10 Meter Walk Test were used before and one month after injection. In addition to conventional rehabilitation, eligible patients were randomly assigned to two groups. The experimental group was injected with botulinum toxin along the length of the muscle, while the control group was injected with the same dose and volume of botulinum toxin 25-35% proximal to the medial head and 20-30% proximal to the lateral head of the gastrocnemius muscle. The study was completed by 60 participants with a mean age of 59.96±12.15 years. Both injection methods were found to be effective on range of motion, spasticity level, ambulation and walking speed. There was no statistically significant difference between injection methods CONCLUSION: Both injection methods of botulinum toxin A produce similar clinical effects.

Augmentation with prazosin for patients with depression and a history of trauma: A randomised, double-blind, placebo-controlled study.

Depression with a history of trauma often responds poorly to conventional antidepressants and has a poor prognosis. Prazosin, an α1-adrenoceptor blocker, has shown promise in treating post-traumatic stress disorder symptoms, particularly nightmares. Its potential in treating depression with trauma history warrants investigation. This randomised, double-blind, placebo-controlled study aimed to investigate the efficacy and tolerability of low-dose prazosin (0.5-1 mg/day) as an augmentation strategy in patients with depression and a history of trauma. We sought to determine if prazosin could provide rapid symptom improvement and enhance overall treatment response compared to placebo in this difficult-to-treat patient population. This randomised, double-blind, placebo-controlled clinical study included 59 patients with first-episode or recurrent unipolar or bipolar depression. After basic antidepressant treatment, they were randomly assigned to a prazosin (0.5-1 mg/day) or placebo group for a 6-week double-blind controlled study. The Montgomery-Åsberg Depression Rating Scale, 17-item Hamilton Depression Scale (HAMD-17), and Hamilton Anxiety Scale (HAMA) were used to evaluate efficacy. There were no significant differences in the results of the demographic and clinical symptom assessment between the two groups (p > 0.05). The difference between the HAMD-17 and HAMA scores was statistically significant after 3 days of treatment (p < 0.05). The difference in response rate between the two groups was statistically significant after week 4 of treatment (end of week 4, 56.7% vs. 24.1%, p = 0.011; end of week 6, 80.0% vs. 48.3%, p = 0.011). The incidence of adverse reactions in the prazosin and placebo groups was 20.0% and 24.1%, respectively, with no statistically significant differences (p > 0.05); however, the prazosin group had a lower incidence of sleeplessness or nightmares (3.3% vs. 20.7%, p = 0.039) but a higher incidence of orthostatic hypotension (16.7% vs. 0%, p = 0.007). The severity of orthostatic hypotension was mild to moderate. Low-dose prazosin can effectively improve the emotional symptoms of patients with depression and a history of trauma, and the common adverse reaction is mild-to-moderate orthostatic hypotension. ChiCTR2200063642.

A double-blinded randomised control study to compare the effectiveness and safety of intralesional vitamin D3 with intralesional triamcinolone and its correlation with tissue expression of vitamin D receptors in patients with keloid.

Intralesional steroids commonly used for keloid treatment have adverse effects like cutaneous atrophy and telangiectasias. Safer and more effective therapies are needed. Preliminary studies suggest intralesional vitamin D as a potential alternative treatment. The aim of this study was to compare efficacy and safety of intralesional vitamin D with triamcinolone for keloids, and correlate tissue expression of vitamin D receptors (VDRs) with treatment outcomes. Sixty patients were randomly assigned to two groups: Group A (intralesional vitamin D) and Group B (intralesional triamcinolone). Four injections were given at 4-week intervals, with an 8-week follow-up. Biopsies were taken pre- and post-treatment to examine VDR expression levels and treatment response correlation. The primary outcome of interest was the proportion of patients achieving a 50% reduction in Vancouver Scar Scale (VSS). Secondary outcomes included incidence of adverse effects, and changes in VDR expression before and after treatment. Baseline VSS scores were 9.73 ± 1.01 (vitamin D group) and 10.13 ± 1.07 (triamcinolone group). After treatment, mean VSS decreased to 5.17 ± 0.59 (vitamin D group, p < 0.001) and 4.77 ± 0.77 (triamcinolone group, p < 0.001), with significantly better response in latter (p = 0.03). More than 50% reduction in VSS score was higher in the triamcinolone group (76.7% vs. 50%, p = 0.032). No recurrences were noted during the 8-week follow-up. Hypopigmentation (80% vs. 36.7%, p < 0.001) and atrophy (73.3% vs. 40%, p = 0.009) were more common in the triamcinolone group. No significant difference in pre- and post-treatment VDR receptor expression was observed in either group. Both triamcinolone acetonide and vitamin D were effective for keloids. Triamcinolone was more efficacious, whereas vitamin D was safer, suggesting it as a viable alternative for keloid management.

The Safety and Feasibility of Transcranial Direct Current Stimulation Combined with Conservative Treatment for Patients with Cervicogenic Headaches: A double-blinded randomized control study protocol

The Safety and Feasibility of Transcranial Direct Current Stimulation Combined with Conservative Treatment for Patients with Cervicogenic Headaches: A double-blinded randomized control study protocol

Effect of hypnosis on anxiety and blood pressure of pregnant women with preeclampsia: A double-blind controlled clinical trial study

Effect of hypnosis on anxiety and blood pressure of pregnant women with preeclampsia: A double-blind controlled clinical trial study

Intranasal administration of insulin on the incidence of postoperative delirium in middle-aged patients undergoing elective on-pump cardiac surgery (INIPOD-MOPS): a prospective double-blinded randomized control study protocol

BackgroundDelirium, marked by acute cognitive decline, poses a life-threatening issue among older individuals, especially after cardiac surgery, with prevalence ranging from 15 to 80%. Postoperative delirium is linked to increased morbidity and mortality. Although clinical trials suggest preventability, there is limited research on intranasal insulin (INI) for cardiac surgery-related delirium. INI has shown promise in managing cognitive disorders. It rapidly elevates brain hormone levels, enhancing memory even in non-impaired individuals. While effective in preventing delirium in gastrointestinal surgery, its impact after cardiac surgery remains understudied, especially for middle-aged patients.MethodThis is a prospective randomized, double-blind, single-center controlled trial. A total of 76 eligible participants scheduled for elective on-pump cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either receive Intranasally administered insulin (INI) or intranasally administered normal saline. The primary outcome of our study is the incidence of postoperative delirium (POD). Secondary outcomes include duration of ICU, postoperative hospital length of stay, all in-hospital mortality, the change in MMSE scores pre- and post-operation, and incidence of postoperative cognitive dysfunction at 1 month, 3 months, and 6 months after operation. Moreover, we will subjectively and objectively evaluate perioperative sleep quality to investigate the potential impact of nasal insulin on the development of delirium by influencing sleep regulation.DiscussionOur study will aim to assess the impact of intranasal administration of insulin on the incidence of postoperative delirium in middle-aged patients undergoing on-pump elective cardiac surgery. If intranasal insulin proves to be more effective, it may be considered as a viable alternative for preventing postoperative delirium.Trial registrationChiCTR ChiCTR2400081444. Registered on March 1, 2024.

TO ASSESS THE ROLE OF NASAL TAPENTADOL AS PRE-EMPTIVE ANALGESIA, IN BREAST SURGERY PATIENTS

Patients undergoes moderate to severe postoperative pain after surgery, which is troublesome during the postoperative period. Inadequately treated acute post operative pain causes prolonged morbidity to patients. Pre-emptive analgesic minimises the pain in perioperative period by central neuro sensitization. We assessed the role of Nasal Tapentadol in breast surgery patients, as a pre-emptive analgesic, in the reduction of post-operative analgesic requirement. In a double blinded prospective randomized control study, sixty breast surgery patients, received nasal spray of tapentadol (Group A) or saline Spray (Group B), 30 minutes prior to general anaesthesia. Perioperative analgesic requirement, time taken for first analgesic requirement in post operative period, post operative pain and sedation scores, we compared the following parameters in the first 24h during the postoperative period in all patients: Analgesic requirement during perioperative period, time taken for first post operative analgesic dose, pain score and sedation score in postoperative period.Data Of all sixty patients were analysed. Patients in Tapentadol Group A had significantly lower requirement of analgesics and lower Visual analog scale (VAS) than Saline group in the post operative period. However, Ramsay sedation score was more in Tapentadol group, immediately after shifting the patient to the postanaesthetic care unit. Single Pre-emptive nasal spray of tapentadol (45mg) is an effective intervention to, reduce the surgical pain and lesser requirement of analgesics, in post operative period, without added side effects.

Platelet rich plasma injection in knee osteoarthritis: results after four years.

Background Knee osteoarthritis (KOA) is a progressive degenerative disease and a leading cause of disability worldwide. Intra-articular injection of platelet-rich plasma (PRP) is still a debatable symptomatic treatment and has provided multiple publications in literature with mixed results. Aim of the work To evaluate the short and long term effects of intra-articular injection of PRP on pain and functional status of the knee joint as measured by the Lysholm questionnaire and visual analogic pain scale (VAS). Patients and methods Twenty-one patients with primary Kellgren-Lawrence grade 3 KOA were assessed using the Lysholm questionnaire and the visual analogue scale for pain (VAS). A single PRP injection was administered, followed by reassessment of VAS at the first, fourth and eighth weeks after the injection. After eight weeks, patients were assessed with VAS and Lysholm questionnaire. In order to evaluate the long term effect of this single injection, we reassessed the patients four years after the injection using the same method. Results Fifteen females (71%) and six males (29%) with mean age 60 years (ranging from 44 to 76 years) were enrolled. After a single PRP injection, there was significant improvement in Lysholm and VAS. Before the injection, VAS medium score was 7 (ranging from 5 to 9) and we observed improvements in all assessments at the first (medium VAS 2), fourth (medium VAS 2) and eighth week (medium VAS 2) post injection and was still better than the pre injection score after 4 years (medium VAS 4). This was also observed in Lysholm score. The pre injection score was 41; at 8 weeks, 84; at 4 years, 66. Conclusion PRP injection achieves good results in the symptomatic treatment of Kellgren-Lawrence grade 3 KOA. This study confirmed that a single PRP injection can provide a long-term effect in pain reduction and functional status improvement in KOA, despite the progression of the disease. Further studies with more patients and randomized double blinded controlled studies are recommended to confirm these results.

A randomised, double blinded control study to compare the efficacy of intraperitoneal nebulization and instillation of ropivacaine for postoperative pain relief in patients undergoing laparoscopic appendicectomy

A randomised, double blinded control study to compare the efficacy of intraperitoneal nebulization and instillation of ropivacaine for postoperative pain relief in patients undergoing laparoscopic appendicectomy

Effect of propofol infusion vs ketamine plus dexmedetomidine infusion on the amplitude of motor evoked potential in pediatric patients undergoing tethered spinal cord surgeries; a randomized, double blind controlled study

Background &amp; objective: The use of intraoperative neurophysiologic monitoring (IOM) has increased over the past two decades for the detection and prevention of iatrogenic neurologic injuries. Motor evoked potentials (MEP) are extremely sensitive to changes in physiological variables and inhalational agents reduce MEPs in a dose dependent manner. So IV anesthetics (propofol or ketamine) and opioids (fentanyl or remifentanil), are frequently used in spinal surgeries under MEPs monitoring. We compared the effects of propofol and fentanyl to those of ketamine, dexmedetomidine, and fentanyl in terms of minimizing their effects on MEP amplitude and hemodynamic stability during surgery Methodology: This double blind, randomized, prospective study was conducted on 46 children, who were randomly allocated into 2 groups Ketamine–dexmedetomidine group: (n = 23) Maintenance throughout the procedure, by infusing Dexmedetomidine (0.4 -0.6 μg/.kg /.hr) ketamine, (1 -2m/.kg/.hr.) and giving bolus of fentanyl, (1-2μg/.kg/ ). Propofol-group:(n = 23) Maintenance throughout the procedure, By infusing propofol (100 ug L/kg/min) and giving bolus of fentanyl, (1-2μg/.kg/ ), with keeping mean arterial blood pressure changes within 25% of the baseline in both groups. Results: Right and left quadriceps muscle measurements were insignificantly different between both groups at base line and were significantly higher in Group KD than Group P at skin incision, surgical manipulation and surgical closure. Right and left adductor hallucis muscle measurements were insignificantly different between both groups at base line and were significantly higher in Group KD than Group P at 5 mins, 10 mins, 15 mins, skin incision, surgical manipulation and surgical closure (P value &lt;0.001). Intraoperative fentanyl consumption was significantly lower in Group KD than Group P. Conclusion: The combination of dexmedetomidine and ketamine infusion is efficacious, safe, and has minimal effect on evoked potentials compared with the propofol-based TIVA group during spine pediatrics surgery. In addition, this combination increases the reliability and accuracy of MEP monitoring with hemodynamic stability and adequate post-operative pain relief. Using dexmedetomidine and ketamine infusions during pediatric spine surgery might successfully replace the typical propofol-based TIVA, although more studies are required . Registration: ClinicalTrials.gov registration number NCT05591001. Keywords: Motor evoked potential, dexmedetomidine, ketamine, propofol. Citation: Saleh AH, Hammad SH, Hassan PF. Effect of propofol infusion vs ketamine plus dexmedetomidine infusion on the amplitude of motor evoked potential in pediatric patients undergoing tethered spinal cord surgeries; a randomized, double blind controlled study. Anaesth. pain intensive care 2024;28(4):692−699; DOI: 10.35975/apic.v28i4.2218 Received: May 08, 2023; Reviewed: February 02, 2024; Accepted: July 03, 2924

I Pack Block versus Adductor Canal Block for Post-Operative Pain Management in Total Knee Arthroplasty

Abstract Background Total knee arthroplasty (TKA) is a highly distressful major surgery, with a significant potential for complications, not only because of the surgical and anesthetic impact of the procedure, but also because of the demographic and clinical characteristics of the target population. Careful pain management is necessary post-operative to achieve early post-operative mobilization while ensuring patient comfort throughout and preventing post-operative complications. Objective we aim to compare postoperative pain management and post- operative analgesic consumption between IPACK block and Adductor canal block in total knee arthroplasty cases. Methods After obtaining approval from the medical ethical committee in Ain Shams University, this Prospective randomized controlled double-blind clinical trial study was conducted in the operating theatres of Ain shams University Hospitals. Study period March 2022 to August 2022. Physical status: ASA 1 or 2 and candidates for spinal anaesthesia undergoing total knee arthroplasty. Age group: 40-65 years. Sample sizes of 30 patients in total; 15 in group I (group I) and 15 in group II (group A). Results As for the comparison between effect of IPACK block and Adductor canal block as regard post-operative pain in total knee arthroplasty, it showed that there is significance regarding the numeric version of the visual analogue scale (VAS) that was used to assess postoperative pain and its intensity with range 1-3 for Adductor canal block and 2-4 for IPACK block. Conclusion The comparison between effect of IPACK block and Adductor canal block as regard post-operative pain in total knee arthroplasty showed significant difference regarding the numeric version of the visual analogue scale (VAS) that was used to assess postoperative pain and its intensity with range 1-3 for Adductor canal block and 2-4 for IPACK block. These findings with our study primary and secondary outcomes showed that Adductor canal block has more analgesic effect with respect to IPACK block regarding pain assessment but with no significant difference regarding the by the time till first analgesia postoperative and Total analgesics consumption (in mg.) over 24-hour period post-operative.

The effects of moderate-intensity aerobic exercise on cognitive function in individuals with stroke-induced mild cognitive impairment: a randomized controlled pilot study.

To assess the impact of moderate-intensity aerobic exercise on working memory in stroke-induced mild cognitive impairment (MCI). Randomized, double-blind controlled study. Twenty MCI patients from the Fifth Affiliated Hospital of Guangzhou Medical University (December 2021 to February 2023), aged 34-79, 2-12 months post-stroke, were divided into an experimental group (EG) and a control group (CG), each with 10 participants. The EG underwent standard rehabilitation plus 40 minutes of aerobic exercise, while the CG received only standard therapy, 5 times weekly for 2 weeks. Working memory was tested using the n-back task, and overall cognitive function was measured with the MOCA and MMSE Scales before and after the intervention. The EG showed higher 3-back correctness (71.80 ± 14.53 vs 56.50 ± 13.66), MOCA scores (27.30 ± 1.57 vs 24.00 ± 3.13), and improved visuospatial/executive (4.60 ± 0.52 vs 3.30 ± 1.06) and delayed recall (4.30 ± 0.82 vs 3.00 ± 1.56) on the MOCA scale compared with the CG. Moderate-intensity aerobic exercise may enhance working memory, visuospatial/executive, and delayed recall functions in stroke-induced MCI patients.

A comparison between the effect of Oral Melatonin and Hydroxyzine for preventing preoperative Anxiety in Pediatric Patients undergoing Adenotonsillectomy: A randomized, double-blinded controlled study

A comparison between the effect of Oral Melatonin and Hydroxyzine for preventing preoperative Anxiety in Pediatric Patients undergoing Adenotonsillectomy: A randomized, double-blinded controlled study

Role of vitamin D supplement adjunct to topical benzoyl peroxide in acne: a randomized double-blinded controlled study

Background: Acne is an inflammatory condition of the pilosebaceous unit. Previous studies have established a link between acne and vitamin D deficiency and the potential effectiveness of vitamin D supplementation in treatment. However, the efficacy of vitamin D as an adjuvant treatment for acne remains unknown. Objective: To evaluate the efficacy of weekly vitamin D2 oral administration as an adjunctive treatment to standard topical care for acne. Methods: This study was a randomized, double-blind, placebo-controlled trial including subjects with mild-to-moderate acne. Topical 2.5% benzoyl peroxide was applied twice daily for 12 weeks to all subjects. Subjects were randomly allocated to receive either oral vitamin D2 40,000 IU weekly or placebo weekly during the treatment period. No additional treatment was administered during the 4-week follow-up period. Results: A total of 44 subjects were included in this study. All of them had inadequate 25(OH)D levels. Both regimens showed significant improvement in acne during the treatment period. Weekly vitamin D2 supplementation significantly prevented the relapse of inflammatory acne lesions (P = .048) at the follow-up visit. No adverse effects or biochemical changes were observed. Limitations: There were no subjects of severe acne vulgaris. Conclusion: Adjunctive weekly vitamin D2 supplementation to standard topical benzoyl peroxide could reduce relapses of inflammatory lesions in mild-to-moderate acne.

The effect of music on pain, comfort, and physiological parameters during premature retinopathy examination

AimTo determine the effect of music applied during the ROP examination on pain, comfort, and physiological parameters in preterm infants. MethodsThe sample of this prospective randomized controlled double-blind experimental study consisted of 28 preterm infants who were examined for ROP of a tertiary hospital in the Neonatal Unit. Data were collected with a Questionnaire, Physiological Parameters Observation Form (PPOF), Revised-Premature Infant Pain Profile (PIPP-R), and Premature Infant Comfort Scale (PICS). ResultsThe results revealed that the crying times of the infants in the experimental group were shorter than the infants in the control group. The preterm infants in the experimental group had statistically lower PIPP-R scores during and after the procedure than the PIPP-R scores of the infants in the control group (p < 0.001) and the music applied to the preterm infants resulted in a mean decrease of 3.857 in the post-procedure and pre-procedure PIPP-R scores (p < 0.05). While there was no statistical difference between the pre-procedure and pre-procedural PICS scores of the preterm infants in the experimental and control groups (p = 0.599; p = 117), the post-procedure PICS values of the preterm infants in the experimental group were found to be lower than those of the control group (p < 0.001). It was found that the music applied to preterm infants during the ROP examination resulted in a mean decrease of 1.286 in PICS scores after the procedure and before the procedure (p < 0.05). ConclusionIt was determined that the music listened to during the ROP examination decreased the PIPP-R pain scores of preterm infants, had a positive effect on the PICS scores after the procedure, but did not affect the physiological parameters positively.Trial Registration: ClinicalTrials.gov Identifier: NCT05263973

Dietary supplementation with a wild green oat extract (Avena sativa L.) to improve wellness and wellbeing during smoking reduction or cessation: a randomized double-blind controlled study.

Smoking reduction or cessation are critical public health goals, given the well-documented risks of tobacco use to health. Reducing smoking frequency and cessation entirely are challenging due to nicotine addiction and withdrawal symptoms, which can significantly affect mental wellness and overall wellbeing. Previous research has suggested that certain dietary supplements may support smoking cessation and reduction efforts by mitigating these adverse effects. The objective of this study was to assess the effect of supplementation with 900 mg/day of Neuravena®, a green oat extract (GOE) of Avena sativa L., in enhancing wellness and wellbeing during a smoking reduction or cessation experience. This was an 8-week randomized, double-blind, placebo-controlled study, ClinicalTrials Identifier: NCT04749017 (https://classic.clinicaltrials.gov/ct2/show/NCT04749017). Participants were assigned to one of the study groups, 72 participants were assigned to GOE and 73 to placebo. The subjects were followed for 8-weeks intervention period as well as an additional 4-week follow-up period. At subsequent visits, they underwent clinical assessments including assessments of quality of life, perceived stress, depression, nicotine dependence, anxiety, cognitive performance, and specific assessments of craving intensity. GOE was associated with greater improvements in elements of the abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire as compared with placebo. Similar results were obtained from the SF-36 questionnaire and a visual QoL analogue scale (VAS). Perceived stress levels showed greater decline from baseline among the GOE supplemented participants as compared to placebo. Sleep quality parameters improved with GOE supplementation and worsened in the placebo group. At the end of the intervention period, the percentage of successful reducers (defined as >20% reduction in daily cigarettes) was higher in the GOE group as compared to placebo (66.7% vs. 49.3%, p = 0.034). The improvements from baseline in QoL measures in the GOE group persisted at 4 weeks after termination of the intervention. GOE supplementation demonstrated greater improvements in quality of life measures, stress and sleep related parameters during a smoking reduction or cessation experience and the product was shown to be safe and well tolerated.

Self-Reported Nonceliac Gluten Sensitivity in Italian Young Adults: A Cross-Sectional Study. A Dietary Fad?

In different countries, the exact prevalence of people that refer symptoms after gluten ingestion is increasing and the unavailability of reliable laboratory tests to diagnose the condition known as nonceliac gluten sensitivity (NCGS) has opened the door to the spread of survey-based studies to hypothesize a prevalence of this condition with highly discordant results. We aim to describe the attitude toward gluten consumption in a large population of young adults in Italy. A questionnaire-based cross-sectional study was conducted in 13 Italian cities to investigate the dietary attitudes of more than 9,400 people distributed throughout the country about gluten consumption. Only those referring to gluten-related symptoms with a frequency equal to "always" or "most of the time" were considered self-reported NCGS (SR-NCGS) patients. Five thousand two hundred thirty-four of 9,432 eligible participants (55.5%) fully completed the questionnaire. Excluding those with previous gastrointestinal diagnoses of celiac disease and wheat allergy, we have finally analyzed 4,987 questionnaires. Four hundred eighty-seven participants indicated gluten-related symptoms always or most of the time (SR-NCGS subjects), while 121 already had a medical diagnosis of NCGS. The minimum prevalence figure of SR-NCGS is 6.4% (95% confidence interval 6.0-6.9), with a higher prevalence in women (79.9%). The most frequent gluten-related symptoms were bloating, abdominal pain, and tiredness. The high prevalence of people reporting symptoms after gluten ingestion requires that the diagnosis of NCGS should be ascertained with a double-blind controlled study to limit the number of people who improperly approach a gluten-free diet.

Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study.

Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of dietary supplementation with plant extracts of rosemary, ashwagandha, and sesame consumed for 12 weeks on the intensity of back pain. A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief®, contained a blend of three polyphenolic standardized extracts: rosemary (Rosmarinus officinalis L.), ashwagandha (Withania somnifera L.), and sesame (Sesamum indicum L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)]. The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group (p < 0.044 dose-low; p < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 (p = 0.002) and upper back pain in the Cornell questionnaire (p = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected. Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.

Response to the Letter to the Editor: Lumbar transforaminal injection of steroids versus platelet-rich plasma for prolapse lumbar intervertebral disc with radiculopathy: a randomized double-blind controlled pilot study.

Response to the Letter to the Editor: Lumbar transforaminal injection of steroids versus platelet-rich plasma for prolapse lumbar intervertebral disc with radiculopathy: a randomized double-blind controlled pilot study.