Context: Acute and chronic postoperative pain are important healthcare problems, which can be treated with a combination of opioids and regional anaesthesia. The erector spinae plane block (ESPB) is a new regional anaesthesia technique, which might be able to reduce opioid consumption and related side effects.

To compare the analgesic effects and side effect profile of ESPB against no block, placebo block or other regional anaesthetic techniques.

Randomised controlled trials (RCTs) investigating adults undergoing surgery with general anaesthesia were included. We included ESPB in comparison with no block, placebo blocks or other regional anaesthesia techniques irrespective of language, publication year, publication status or technique of regional anaesthesia used (ultrasound, landmarks or peripheral nerve stimulator). Quasi-RCTs, cluster-RCTs, cross-over trials and studies investigating co-interventions in either arm were excluded.

Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study.

Abstract:
To evaluate the analgesic effect of ultrasound-guided erector spinae plane (ESP) block in breast cancer surgery.

Randomized controlled, single-blinded trial.

Operating room.

Fifty ASA I-II patients aged 25-65 and scheduled for elective breast cancer surgery were included in the study.

Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.

Morphine consumption and numeric rating scale (NRS) pain scores were recorded at 1, 6, 12 and 24 h postoperatively.

Morphine consumption at postoperative hours 1, 6, 12 and 24 decreased significantly in the ESP group (p < 0.05 for each time interval). Total morphine consumption decreased by 65% at 24 h compared to the control group (5.76 ± 3.8 mg vs 16.6 ± 6.92 mg). There was no statistically significant difference between the groups in terms of NRS scores.

Our study findings show that US-guided ESP block exhibits a significant analgesic effect in patients undergoing breast cancer surgery. Further studies comparing different regional anesthesia techniques are needed to identify the optimal analgesia technique for this group of patients.

Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery.

Abstract:
Continuous thoracic epidural analgesia (TEA) is compared with erector spinae plane (ESP) block for the perioperative pain management in patients undergoing cardiac surgery for the quality of analgesia, incentive spirometry, ventilator duration, and intensive care unit (ICU) duration.

A prospective, randomized comparative clinical study was conducted. A total of 50 patients were enrolled, who were randomized to either Group A: TEA (n = 25) or Group B: ESP block (n = 25). Visual analog scale (VAS) was recorded in both the groups during rest and cough at the various time intervals postextubation. Both the groups were also compared for incentive spirometry, ventilator, and ICU duration. Statistical analysis was performed using the independent Student's t-test. A value of P < 0.05 was considered statistically significant.

omparable VAS scores were revealed at 0 h, 3 h, 6 h, and 12 h (P > 0.05) at rest and during cough in both the groups. Group A had a statistically significant VAS score than Group B (P ≤ 0.05) at 24 h, 36 h, and 48 h but mean VAS in either of the Group was ≤4 both at rest and during cough. Incentive spirometry, ventilator, and ICU duration were comparable between the groups.

ESP block is easy to perform and can serve as a promising alternative to TEA in optimal perioperative pain management in cardiac surgery.

Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial.

Abstract:
To examine the analgesic efficacy of bilateral erector spinae plane (ESP) block compared with conventional treatment for pain after cardiac surgery in adult patients.

A prospective, randomized, controlled, single-blinded study.

Single-center tertiary teaching hospital.

One hundred and six adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.

Patients were randomized into 2 groups. Patients in group 1 (ESP block group, n = 53) received ultrasound-guided bilateral ESP block with 3 mg/kg of 0.375% ropivacaine before anesthesia induction at the T6 transverse process level. Patients in group 2 (paracetamol and tramadol group, n = 53) received paracetamol (1 gm every 6 hours) and tramadol (50 mg every 8 hours) intravenously in the postoperative period. The primary study outcome was to evaluate pain at rest using an 11-point numeric rating scale (NRS). Mann-Whitney U test was used for comparing NRS scores.

The postoperative pain level after extubation and duration of analgesia during which NRS was < 4 of 10 was compared between the groups. The median pain score at rest after extubation in group 1 was 0 of 10 until hour 6, 3 of 10 at hour 8, and 4 of 10 at hours 10 and 12 postextubation. These were significantly less in comparison with group 2 (p = 0.0001). Patients in group 1 had a significantly higher mean duration of analgesia (8.98 ± 0.14 hours), during which NRS was < 4 of 10, compared with group 2 (4.60 ± 0.12 hours) (p = 0.0001).

ESP block safely provided significantly better pain relief at rest for longer duration as compared to intravenous paracetamol and tramadol.

Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial.

Abstract:
Breast cancer is the most common malignancy of women all over the world. In this study, we compared the effects of ultrasound-guided modified pectoral nerve (PECS) block and erector spinae plane (ESP) block on postoperative opioid consumption, pain scores, and intraoperative fentanyl need of patients undergoing unilateral modified radical mastectomy surgery.

Single-blinded, prospective, randomized, efficacy study.

Tertiary university hospital, postoperative recovery room and surgical ward.

Forty patients (ASA I-II) were allocated to two groups. After exclusion, 38 patients were included in the final analysis (18 patients in the PECS groups and 20 in the ESP group).

Modified pectoral nerve block was performed in the PECS group and erector spinae plane block was performed in the ESP group.

Postoperative tramadol consumption and pain scores were compared between the groups. Also, intraoperative fentanyl need was measured.

Postoperative tramadol consumption was 132.78 ± 22.44 mg in PECS group and 196 ± 27.03 mg in ESP group (p = 0.001). NRS scores at the 15th and 30th min were similar between the groups. However, median NRS scores were significantly lower in PECS group at the postoperative 60th min, 120th min, 12th hour and 24th hour (p = 0.024, p = 0.018, p = 0.021 and p = 0.011 respectively). Intraoperative fentanyl need was 75 mg in PECS group and 87.5 mg in ESP group. The difference was not statistically significant (p = 0.263).

Modified PECS block reduced postoperative tramadol consumption and pain scores more effectively than ESP block after radical mastectomy surgery.

Ultrasound-Guided Bilateral Erector Spinae Block Versus Tumescent Anesthesia for Postoperative Analgesia in Patients Undergoing Reduction Mammoplasty: A Randomized Controlled Study.

Abstract:
The aim of this prospective, randomized, double-blind study was to compare the tumescent anesthesia method and erector spinae block with respect to postoperative analgesia consumption, pain scores and patient satisfaction, in patients receiving breast reduction surgery under general anesthesia.

The study included 44 females, aged 20-65 years, who were to undergo breast reduction surgery, without adjunctive liposuction on the breast. Using the closed envelope method, the patients were randomly separated into two groups to receive tumescent anesthesia or erector spinae block (ESB). Patients in the ESB group received the block before general anesthesia by a single anesthetist (G.Ö.).

The 24-h tramadol consumption with PCA, which was the primary outcome of the study, was determined to be statistically significantly less in the ESB group (p < 0.001). The NRS scores were compared at 30 min postoperatively and then at 1, 2, 4, 6, 12 and 24 h. At all the measured time points, the pain scores of the ESB group were statistically significantly lower (p < 0.001). Additional analgesia was required by one patient in the ESB group and by seven patients in the tumescent group and was applied as 1 g paracetamol. The requirement for additional analgesia was statistically significantly lower in the ESB group (p < 0.024). Patient satisfaction was statistically significantly better in the ESB group (p < 0.001).

According to the results of this study, bilateral ESB performed under ultrasound guidance in breast reduction surgery was more effective than tumescent anesthesia concerning postoperative analgesia consumption and pain scores. ESB could be an appropriate, effective and safe postoperative analgesia method for patients undergoing reduction mammoplasty surgery.

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study.

Abstract:
Lumbar Erector spinae Plane block (L-ESPB) is a modification of a recently described block. Both L-ESPB and Transmuscular Quadratus Lumborum block (QLB-T) have been reported to provide effective postoperative analgesia in hip and proximal femur surgery. Herein, we compare the effectiveness of L-ESPB and QLB-T in providing postoperative analgesia in patients undergoing hip and femur operations.

Double-blinded, prospective, randomized, feasibility study.

Tertiary university hospital, postoperative recovery room and ward.

A total of 72 patients (American Society of Anesthesiology physical status classification II-III) were recruited. After exclusion, 60 patients were allocated to three equal groups (control, L-ESB and QLB-t).

Standard multimodal analgesia was performed in the control group while L-ESPB or QLB-T was performed in the block groups.

Pain intensity between groups was compared using Numeric Rating Scores. Furthermore, tramadol consumption and additional rescue analgesic requirement was measured.

There was no difference between demographic data or type of surgery. While there was no difference in Numeric Rating Scale (NRS) score at any hour between the block groups; NRS scores at the 1

While L-ESPB and QLB-T have similar effect, they improve analgesia quality in patients undergoing hip and proximal femoral surgery when compared to standard intravenous analgesia regimen.

Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Open Epigastric Hernia Repair: A Prospective Randomized Controlled Study.

Abstract:
Hernia repair is associated with considerable postoperative pain. We studied the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block in patients undergoing open midline epigastric hernia repair (T6-T9).

Sixty patients 18-65 years of age were randomly allocated into 2 groups. Patients in the erector spinae plane block group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% on each side, while the control group received bilateral sham erector spinae plane block using 1 mL of normal saline. All patients underwent general anesthesia for surgery. Pain severity (visual analog scale), consumption of intraoperative fentanyl, time to first request of rescue analgesia, and postoperative pethidine consumption were recorded over the first 24 hours postoperatively.

At 2 hours postoperatively, the visual analog scale pain score was significantly lower in the erector spinae plane block group compared to the control group (estimated main effect of 2.53; P < .001; 95% CI, 1.8-3.2) and remained lower until 12 hours postoperatively (P < .001 from postanesthesia care unit admission to 4 hours postoperatively, .001 at 6 hours, .025 at 8 hours, and .043 at 12 hours). At 18 and 24 hours, visual analog scale pain scores were not significantly different between both groups (P = .634 and .432, respectively). Four patients in the erector spinae plane block group required intraoperative fentanyl compared to 27 patients in control group. The median (quartiles) of intraoperative fentanyl consumption in the erector spinae plane block group was significantly lower (0 µg [0-0 µg]) compared to that of the control group (94 µg [74-130 µg]). Ten patients in the erector spinae plane block group required postoperative rescue pethidine compared to 25 patients in control group. The median [quartiles] of postoperative rescue pethidine consumption was significantly lower in the erector spinae plane block group (0 mg [0-33 mg]) compared to that of the control group (83 mg [64-109 mg]). Time to first rescue analgesic request was significantly prolonged in the erector spinae plane block group compared to control group (P < .001).

Ultrasound-guided bilateral erector spinae plane block provided lower postoperative visual analog scale pain scores and decreased consumption of both intraoperative fentanyl and postoperative rescue analgesia for patients undergoing open epigastric hernia repair.

Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial.

Abstract:
Laparoscopic cholecystectomy (LC) is a frequently applied minimally invasive surgery. Intraoperative access is provided with small keyhole entries on the abdominal wall. However, LC causes moderate to severe postoperative pain. The subcostal approach of TAP block was described by Hebbard et al. for postoperative analgesia especially for upper abdominal surgeries. Ultrasound-guided erector spinae plane (US-ESP) block is a novel technique targeting ventral rami, dorsal rami and rami communicantes of the spinal nerves.

Single-blinded, prospective, randomized study.

Tertiary university hospital, postoperative recovery room and surgical ward.

Seventy-six patients (ASA I-II) were divided into two equal groups. After applying the exclusion criteria, 68 patients were included in final analysis (34 patients in ESP group and 34 in OSTAP group).

Erector spinae plane block was performed in the ESP group and oblique subcostal transversus abdominis block was performed in the OSTAP group.

Postoperative tramadol consumption and pain scores between groups were compared. In addition, intraoperative fentanyl need was measured.

Postoperative tramadol consumption was 139.1 ± 21.9 mg in the ESP group and 199.4 ± 27.7 mg in the OSTAP group (mean difference 60.29 mg, 95% confidence interval - 72.40 to - 48.19; p < 0.001). NRS scores at almost all time-points were lower in the ESP group according to the repeated measures analysis. Integration of AUC and Mann Whitney U test results have revealed that there was no time wise difference between ESP and OSTAP groups even though NRS scores by itself and time-wise linear area under curve scores were higher in the OSTAP group compare to ESP group. There were no differences in intraoperative fentanyl need.

Ultrasound-guided ESP block reduced postoperative tramadol consumption and pain scores more effectively than OSTAP block after laparoscopic cholecystectomy surgery.

Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial.

Abstract:
There is no gold standard for the management of postoperative pain after video-assisted thoracoscopic surgery (VATS). Interfascial nerve blocks were proposed as simple and effective options.

The present pilot randomized trial aimed to compare the perioperative analgesic effect of ultrasound-guided erector spinae plane block (ESB) with serratus plane block (SPB) in patients undergoing VATS.

University hospitals.

Sixty adult patients scheduled to undergo VATS were enrolled in the study.

Patients were randomly assigned in a 1:1 ratio to receive either single-shot ultrasound-guided ESB or SPB.

The primary outcomes were pain severity, time to first postoperative analgesia, and intraoperative and postoperative analgesic requirements. Data analysis was performed with MedCalc, Version 15.8 (MedCalc, Ostend, Belgium. The ESB group showed a significantly lower VAS

ESB provided superior analgesia and longer time to first required analgesic than did SPB.

Evaluation of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: Randomized, Controlled, Prospective Study.

Abstract:
Oblique subcostal transversus abdominis plane block (OSTAP) is a recently described regional anesthetic technique used in upper abdominal surgeries such as laparoscopic cholecystectomy (LC). Erector spinae plane block (ESPB) has also been reported for postoperative analgesia in LC.

We aimed to compare the effectiveness of OSTAP and ESPB in providing postoperative analgesia in patients undergoing these surgeries.

This study was designed as a double-blinded, prospective, randomized, efficiency study in a tertiary university hospital, postoperative recovery room, and ward.

A total of 72 patients were recruited and 60 patients were randomized into three equal groups (ESPB, OSTAP, and control group). Pain intensity between groups was compared using Numeric Rating Scale (NRS) scores. In addition, consumption of paracetamol and tramadol and additional rescue analgesic requirement were measured. Standard multimodal analgesia was performed in all groups, while ESPB block was also performed in Group ESPB and OSTAP block was also performed in group OSTAP.

Descriptive statistics were expressed as mean ± standard deviation. Independent

NRS was lower in block groups during the first 3 h. There was no difference in NRS scores at other hours. Analgesic consumption and rescue analgesic requirement were lower in groups ESPB and OSTAP when compared to those of control group. Block groups were similar.

Bilateral ultrasound-guided ESPB and OSTAP performed at the end of LC lead to akin analgesia requirement and improve the quality of multimodal analgesia.


Context: Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and, less often, in the second webspace of the foot. Symptoms include burning or shooting pain in the webspace that extends to the toes, or the sensation of walking on a pebble. These impact on weight-bearing activities and quality of life.

To assess the benefits and harms of interventions for MN.

We included all randomised, parallel-group trials (RCTs) of any intervention compared with placebo, control, or another intervention for MN. We included trials where allocation occurred at the level of the individual or the foot (clustered data). We included trials that confirmed MN through symptoms, a clinical test, and an ultrasound scan (USS) or magnetic resonance imaging (MRI).

A prospective randomized controlled trial of plantar versus dorsal incisions for operative treatment of primary Morton's neuroma.

Abstract:
There are a great number of studies on the outcome of surgery for Morton's neuroma. However, there is a lack of controlled trials to determine the outcome in general and for the 2 most used surgical approaches. This prospective and randomized trial studied the outcome and adverse events of resected primary Morton's neuromas, comparing plantar and dorsal incisions.

Seventy-six patients were randomized to treatment with either a plantar or a dorsal incision by 2 senior surgeons. Questionnaires were evaluated and physical examinations performed at baseline and at 3 and 12 months postoperatively by the treating surgeon and at a mean of 34 months (range, 28-42 months) by an independent surgeon. The follow-up rate was 93%.

Histological examination of specimens verified resection of nerves in all cases except 1, which was in the dorsal group (artery). The main outcome variable, pain at daily activities, was significantly reduced by 96% (plantar) and 97% (dorsal) and restrictions in daily activities were reduced by 77% (plantar) and 67% (dorsal) at the final follow-up. Scar tenderness was noted by 3% (plantar) and 0% (dorsal) at the final evaluation. Clinically good results with surgery were noted in 87% (plantar) and 83% (dorsal) of cases. There were 5 complications in the plantar group and 6 in the dorsal group, with a difference in type of complications.

This study demonstrated 87% (plantar) and 83% (dorsal) clinically good outcomes and no significant differences between the procedures in regard to pain, restrictions in daily activities, and scar tenderness. However, there was a difference between the groups in the type of complications.

Level I, prospective randomized trial.

Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial.

Abstract:
Morton neuroma is a common cause of neuralgia affecting the web spaces of the toes. Corticosteroid injections are commonly administered as a first-line therapy, but the evidence for their effectiveness is weak. Our primary research aim was to determine whether corticosteroid injection is an effective treatment for Morton neuroma compared with an anesthetic injection as a placebo control.

We performed a pragmatic, patient-blinded randomized trial set within hospital orthopaedic outpatient clinics in Edinburgh, United Kingdom. One hundred and thirty-one participants with Morton neuroma (mean age, fifty-three years; 111 [85%] female) were randomized to receive either corticosteroid and anesthetic (1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine) or anesthetic alone (2 mL 1% lignocaine). An ultrasonographic image was obtained before treatment, and injections were performed with the needle placed under ultrasonographic guidance. The primary outcome was the difference in patient global assessment of foot health between the two groups at three months after injection. This was measured with use of a 100-unit visual analog scale (VAS) anchored by "best imaginable health state" and "worst imaginable health state."

Compared with the control group, global assessment of foot health in the corticosteroid group was significantly better at three months (mean difference, 14.1 scale points [95% confidence interval, 5.5 to 22.8 points]; p = 0.002). The difference between the groups was also significant at one month. Significant and nonsignificant improvements associated with the corticosteroid injection were observed for measures of pain, function, and patient global assessment of general health at one and three months after injection. The size of the neuroma as determined by ultrasonography did not significantly influence the treatment effect.

Corticosteroid injections for Morton neuroma can be of symptomatic benefit for at least three months.

Extracorporeal Shockwave Therapy in Patients with Morton's Neuroma A Randomized, Placebo-Controlled Trial.

Abstract:
The aim of this study was to evaluate the efficacy of extracorporeal shockwave therapy (ESWT) for the treatment of Morton's neuroma by measuring changes in patient pain, function, and neuroma size.

Patients with Morton's neuroma were randomly assigned to either the ESWT group or the sham stimulation group. Outcome measures, including visual analog scale (VAS) and American Orthopaedic Foot and Ankle Society lesser toes (AOFAS) scores, were assessed at baseline and 1 and 4 weeks after treatment. The Johnson satisfaction test was also performed 1 and 4 weeks after treatment. The neuroma diameter was measured using ultrasonography at baseline and 4 weeks after treatment.

Patients receiving ESWT exhibited significantly decreased VAS scores 1 and 4 weeks after treatment relative to baseline, and AOFAS scores were significantly improved 4 weeks after treatment relative to baseline. In the sham stimulation group, VAS and AOFAS scores showed no significant changes at any time after treatment. Neither group showed significant changes in Johnson satisfaction test results or neuroma diameter.

These results suggest that ESWT may reduce pain in patients with Morton's neuroma.

Interdigital neuroma: intermuscular neuroma transposition compared with resection.

Abstract: This prospective, randomized study compares the treatment of an interdigital neuroma (IDN) by the standard resection operation with a technique in which the IDN is transposed into the inter-muscular space between the adductor hallucis and the interossei muscles after division of the digital nerves distal to the IDN. The resection group contained 22 patients and 22 neuromas and the transposition group contained 22 patients and 23 neuromas. An interviewer, blinded as to the operative technique used, telephoned each patient preoperatively, and at 1 month, 3 months, 6 months, 12 months, and 36-48 months postoperatively. The interviewer recorded the patient's reported pain level on a numerical rating scale of 0 to 100. In the resection group the average pain level was slightly lower through the first 6 month period, but at the 12 month review the resection group had a slightly higher average pain level . At the 36-48 month survey the resection group again reported a greater average pain level and fewer asymptomatic patients. It was concluded that it is unnecessary to excise the IDN to obtain excellent relief of pain. It was also concluded that transposition of the IDN into an intermuscular position between the adductor hallucis and the interossei muscles produced significantly better long term results than did the standard resection operation.

Morton neuroma: comparative results of two conservative methods.

Abstract:
The initial treatment of Morton neuromas consists of conservative methods that include shoe modifications and steroid injections. The purpose of this prospective study was to compare the efficacy of these two methods to determine which is more effective as the initial treatment method.

Eighty-two patients with Morton neuromas were randomly assigned to receive either footwear modification with orthoses or steroid injections as initial treatment. Outcomes were evaluated at 1 month, 6 months, and 12 months.

Patient satisfaction was significantly better (p < 0.01) in the group treated with steroid injections than those treated with shoe modifications at all three followup intervals. At 12-month followup, 82% of those treated with steroid injections had complete or partial relief of pain compared to 63% of those treated with footwear modifications alone.

Steroid injections as initial treatment and shoe modifications with steroid injections at 6 months appear to give better results in Morton neuromas than shoe modifications alone, but the difference in the two groups were not statistically significant at one year followup.

Extracorporeal shockwave therapy for interdigital neuroma: a randomized, placebo-controlled, double-blind trial.

Abstract:
We sought to evaluate the safety and effectiveness of extracorporeal shockwave therapy as a therapeutic treatment for destroying Morton's neuroma.

Twenty-five patients (25 feet) were included in the study. Indications for participation were more than 8 months of conservative care with a visual analog scale pain score of 4 or greater. The mean overall pain score on a modified visual analog scale was 6.9 preoperatively.

Thirteen patients were randomized to the active group and 12 to the sham group. Two patients in the sham group were lost to follow-up. Post-treatment evaluations were performed at 1, 6, and 12 weeks by a blinded investigator (L.W.). The end point evaluation parameter was the reduction in visual analog scale score. The treatment group showed a significant difference before and after extracorporeal shockwave therapy (P < .0001). The sham group did not have a significant difference after 12 weeks (P = .1218).

Extracorporeal shockwave therapy is a possible alternative to surgical excision for Morton's neuroma.

A randomized, double-blind, placebo-controlled trial of injected capsaicin for pain in Morton's neuroma.

Abstract: Intermetatarsal neuroma or Morton's neuroma is a painful condition of the foot resulting from an entrapment of the common digital nerve typically in the third intermetatarsal space. The pain can be severe and especially problematic with walking. Treatment options are limited and surgery may lead to permanent numbness in the toes. Capsaicin, the pungent ingredient of hot peppers, produces analgesia by inducing retraction of nociceptive afferents from the area of innervation and is effective in treating certain neuropathic pain disorders. A randomized double-blind placebo-controlled study was conducted to test the efficacy, tolerability, and safety of a single 0.1 mg dose of capsaicin vs placebo injected into the region of the neuroma. A total of 58 subjects diagnosed with Morton's neuroma with foot pain ≥4 (0-10 numerical pain rating scale) were injected with 2 mL of lidocaine into the intermetatarsal space proximal to the neuroma to provide local anesthesia. After 5 minutes, 0.1 mg capsaicin or placebo was injected into the intermetatarsal space containing the painful neuroma. Average foot pain was rated for 2 weeks before through 4 weeks after injection. At weeks 1 and 4, the decrease in pain was significantly greater in the subjects treated with capsaicin (P = 0.021 and P = 0.019, respectively). A trend toward significance was noted at weeks 2 and 3. Improvements in functional interference scores and reductions in oral analgesic use were also seen in the capsaicin-treated group. These findings suggest that injection of capsaicin is an efficacious treatment option for patients with painful intermetatarsal neuroma.


Context: Cognitive behavioural therapy (CBT) can be effective in people with schizophrenia when provided in combination with antipsychotic medication. It remains unclear whether CBT could be safely and effectively offered in the absence of concomitant antipsychotic therapy.

To investigate the effects of CBT for schizophrenia when administered without concomitant pharmacological treatment with antipsychotics.

We included randomised controlled trials (RCTs) in people with schizophrenia comparing CBT without antipsychotics to standard care, standard care without antipsychotics, or the combination of CBT and antipsychotics.

Cognitive therapy: at last an alternative to antipsychotics?

Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial.

Abstract:
Antipsychotic drugs are usually the first line of treatment for schizophrenia; however, many patients refuse or discontinue their pharmacological treatment. We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs.

We did a single-blind randomised controlled trial at two UK centres between Feb 15, 2010, and May 30, 2013. Participants aged 16-65 years with schizophrenia spectrum disorders, who had chosen not to take antipsychotic drugs for psychosis, were randomly assigned (1:1), by a computerised system with permuted block sizes of four or six, to receive cognitive therapy plus treatment as usual, or treatment as usual alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. Our primary outcome was total score on the positive and negative syndrome scale (PANSS), which we assessed at baseline, and at months 3, 6, 9, 12, 15, and 18. Analysis was by intention to treat, with an ANCOVA model adjusted for site, age, sex, and baseline symptoms. This study is registered as an International Standard Randomised Controlled Trial, number 29607432.

74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual (n=37), or treatment as usual alone (n=37). Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group, with an estimated between-group effect size of -6.52 (95% CI -10.79 to -2.25; p=0.003). We recorded eight serious adverse events: two in patients in the cognitive therapy group (one attempted overdose and one patient presenting risk to others, both after therapy), and six in those in the treatment as usual group (two deaths, both of which were deemed unrelated to trial participation or mental health; three compulsory admissions to hospital for treatment under the mental health act; and one attempted overdose).

Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs. Evidence-based treatments should be available to these individuals. A larger, definitive trial is needed.

National Institute for Health Research.

CBT could benefit patients with schizophrenia who do not take medication, research says.

Cognitive behavioural therapy-a valid alternative to antipsychotics for psychosis?

Antipsychotic drugs versus cognitive behavioural therapy versus a combination of both in people with psychosis: a randomised controlled pilot and feasibility study.

Abstract:
Little evidence is available for head-to-head comparisons of psychosocial interventions and pharmacological interventions in psychosis. We aimed to establish whether a randomised controlled trial of cognitive behavioural therapy (CBT) versus antipsychotic drugs versus a combination of both would be feasible in people with psychosis.

We did a single-site, single-blind pilot randomised controlled trial in people with psychosis who used services in National Health Service trusts across Greater Manchester, UK. Eligible participants were aged 16 years or older; met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service; were in contact with mental health services, under the care of a consultant psychiatrist; scored at least 4 on delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items on the Positive and Negative Syndrome Scale (PANSS); had capacity to consent; and were help-seeking. Participants were assigned (1:1:1) to antipsychotics, CBT, or antipsychotics plus CBT. Randomisation was done via a secure web-based randomisation system (Sealed Envelope), with randomised permuted blocks of 4 and 6, stratified by gender and first episode status. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions. Choice and dose of antipsychotic were at the discretion of the treating consultant. Participants were followed up for 1 year. The primary outcome was feasibility (ie, data about recruitment, retention, and acceptability), and the primary efficacy outcome was the PANSS total score (assessed at baseline, 6, 12, 24, and 52 weeks). Non-neurological side-effects were assessed systemically with the Antipsychotic Non-neurological Side Effects Rating Scale. Primary analyses were done by intention to treat; safety analyses were done on an as-treated basis. The study was prospectively registered with ISRCTN, number ISRCTN06022197.

Of 138 patients referred to the study, 75 were recruited and randomly assigned-26 to CBT, 24 to antipsychotics, and 25 to antipsychotics plus CBT. Attrition was low, and retention high, with only four withdrawals across all groups. 40 (78%) of 51 participants allocated to CBT attended six or more sessions. Of the 49 participants randomised to antipsychotics, 11 (22%) were not prescribed a regular antipsychotic. Median duration of total antipsychotic treatment was 44·5 weeks (IQR 26-51). PANSS total score was significantly reduced in the combined intervention group compared with the CBT group (-5·65 [95% CI -10·37 to -0·93]; p=0·019). PANSS total scores did not differ significantly between the combined group and the antipsychotics group (-4·52 [95% CI -9·30 to 0·26]; p=0·064) or between the antipsychotics and CBT groups (-1·13 [95% CI -5·81 to 3·55]; p=0·637). Significantly fewer side-effects, as measured with the Antipsychotic Non-neurological Side Effects Rating Scale, were noted in the CBT group than in the antipsychotics (3·22 [95% CI 0·58 to 5·87]; p=0·017) or antipsychotics plus CBT (3·99 [95% CI 1·36 to 6·64]; p=0·003) groups. Only one serious adverse event was thought to be related to the trial (an overdose of three paracetamol tablets in the CBT group).

A head-to-head clinical trial of CBT versus antipsychotics versus the combination of the two is feasible and safe in people with first-episode psychosis.

National Institute for Health Research.

Cognitive Behavioral Therapy for antipsychotic-free schizophrenia spectrum disorders: Does therapy dose influence outcome?

Abstract: This study investigated the effect of "dose" and the components of Cognitive Behavioral Therapy (CBT) on treatment effects. It is a secondary analysis of the ACTION (Assessment of Cognitive Therapy Instead of Neuroleptics) trial which investigated CBT for people with schizophrenia spectrum disorders that chose not to take antipsychotic medication. Using instrumental variable methods, we found a "dose-response" such that each CBT session attended, reduced the primary outcome measure (the PANSS total score) by approximately 0.6 points (95% CI -1.20 to -0.06, p = 0.031). This suggests that length of therapy is important for those that receive CBT in the absence of antipsychotic medication. Secondly, using principal stratification we examined the process variables that modified treatment effects. Findings revealed that those who received a longitudinal formulation in the first 4 sessions of CBT had poorer treatment effects than those who did not, however this finding was not statistically significant (95% CI -37.244, 6.677, p = 0.173). However, it is important to note that these findings were evident in an exploratory analysis with a small sample. Future larger scale studies are needed to help understand components of effective treatment.

Staged treatment and acceptability guidelines in early psychosis study (STAGES): A randomized placebo controlled trial of intensive psychosocial treatment plus or minus antipsychotic medication for first-episode psychosis with low-risk of self-harm or aggression. Study protocol and baseline characteristics of participants.

Abstract:
It is now necessary to investigate whether recovery in psychosis is possible without the use of antipsychotic medication. This study will determine (1) whether a first-episode psychosis (FEP) group receiving intensive psychosocial interventions alone can achieve symptomatic remission and functional recovery; (2) whether prolonging the duration of untreated psychosis (DUP) in a sub-group according to randomisation will be associated with a poorer outcome and thereby establish whether the relationship between DUP and outcome is causative; and (3) whether neurobiological changes observed in FEP are associated with the psychotic disorder or antipsychotic medication. Baseline characteristics of participants will be presented.

This study is a triple-blind randomized placebo-controlled non-inferiority trial. The primary outcome is the level of functioning measured by the Social and Occupational Functioning Assessment Scale at 6 months. This study is being conducted at the Early Psychosis Prevention and Intervention Centre, Melbourne and includes young people aged 15 to 24 years with a DSM-IV psychotic disorder, a DUP less than 6 months and not high risk for suicide or harm to others. Strict discontinuation criteria are being applied. Participants are also undergoing three 3-Tesla-MRI scans.

Ninety participants have been recruited and baseline characteristics are presented.

Staged treatment and acceptability guidelines in early psychosis will determine whether antipsychotic medications are indicated in all young people with a FEP and whether antipsychotic medication can be safely delayed. Furthermore, the relative contribution of psychotic illness and antipsychotic medication in terms of structural brain changes will also be elucidated. The findings will inform clinical practice guidelines.

Suicidal Ideation in People With Psychosis Not Taking Antipsychotic Medication: Do Negative Appraisals and Negative Metacognitive Beliefs Mediate the Effect of Symptoms?

Abstract: Between 5% and 10% of people with psychosis will die by suicide, a rate which is 20-75 times higher than the general population. This risk is even greater in those not taking antipsychotic medication. We examined whether negative appraisals of psychotic experiences and negative metacognitive beliefs about losing mental control mediated a relationship between psychotic symptoms and suicidal ideation in this group. Participants were diagnosed with schizophrenia spectrum disorders, antipsychotic-free for 6 months at baseline, and were participating in an 18-month randomized controlled trial of cognitive therapy vs treatment as usual. We conducted a series of mediation analyses with bootstrapping on baseline (N = 68), follow-up data (9-18 mo; n = 49), and longitudinal data (n = 47). Concurrent general symptoms were directly associated with suicidal ideation at baseline, and concurrent negative symptoms were directly associated with suicidal ideation at 9-18 months. Concurrent positive, negative, general, and overall symptoms were each indirectly associated with suicidal ideation via negative appraisals and/or negative metacognitive beliefs, at baseline and 9-18 months, except for negative symptoms at baseline. Controlling for baseline suicidal ideation and treatment allocation, baseline general symptoms were indirectly associated with later suicidal ideation, via baseline negative appraisals and negative metacognitive beliefs. Baseline negative metacognitive beliefs also had a direct association with later suicidal ideation. These findings suggest the clinical assessment of suicidal ideation in psychosis may be enhanced by considering metacognitive beliefs about the probability and consequences of losing mental control.


Context: Giant cell arteritis (GCA) is a systemic, inflammatory vasculitis primarily affecting people over the age of 50 years. GCA is treated as a medical emergency due to the potential for sudden, irreversible visual loss. Temporal artery biopsy (TAB) is one of the five criteria of the American College of Rheumatology (ACR) 1990 classification, which is used to aid the diagnosis of GCA. TAB is an invasive test, and it can be slow to obtain a result due to delays in performing the procedure and the time taken for histopathologic assessment. Temporal artery ultrasonography (US) has been demonstrated to show findings in people with GCA such as the halo sign (a hypoechoic circumferential wall thickening due to oedema), stenosis or occlusion that can help to confirm a diagnosis more swiftly and less invasively, but requiring more subjective interpretation. This review will help to determine the role of these investigations in clinical practice.

To evaluate the sensitivity and specificity of the halo sign on temporal artery US, using the ACR 1990 classification as a reference standard, to investigate whether US could be used as triage for TAB. To compare the accuracy of US with TAB in the subset of paired studies that have obtained both tests on the same patients, to investigate whether it could replace TAB as one of the criteria in the ACR 1990 classification.

We included all participants with clinically suspected GCA who were investigated for the presence of the halo sign on temporal artery US, using the ACR 1990 criteria as a reference standard. We included studies with participants with a prior diagnosis of polymyalgia rheumatica. We excluded studies if participants had had two or more weeks of steroid treatment prior to the investigations. We also included any comparative test accuracy studies of the halo sign on temporal artery US versus TAB, with use of the 1990 ACR diagnostic criteria as a reference standard. Although we have chosen to use this classification for the purpose of the meta-analysis, we accept that it incorporates unavoidable incorporation bias, as TAB is itself one of the five criteria. This increases the specificity of TAB, making it difficult to compare with US. We excluded case-control studies, as they overestimate accuracy, as well as case series in which all participants had a prior diagnosis of GCA, as they can only address sensitivity and not specificity.

[Horton's temporal arteritis: diagnosis using color Doppler ultrasonography].

[The significance of color duplex ultrasonography for the diagnosis of temporal arteritis].

Abstract: We examined the usefulness of color duplex ultrasonography in patients suspected of having temporal arteritis. Five patients, who were all aged 70 or older, developed a new onset of localized headache with temporal artery abnormalities, and had an elevated erythrocyte sedimentation rate of > 100 mm/hour. The final diagnoses were temporal arteritis in three patients, polymyalgia rheumatica in one, and probable healed temporal arteritis in one. Color duplex ultrasonography showed stenoses, which were confirmed histologically as well, in the superficial temporal artery of all patients. The characteristic findings of active temporal arteritis were, however, demonstrated in only three biopsy specimens, and in the remaining two the stenoses were thought to be related to previous arteritis. The hypoechoic halo, which has been reported to be a characteristic finding of color duplex ultrasonography in active temporal arteritis, was detected in only one patient with active temporal arteritis and another one with probable healed temporal arteritis. No stenoses were demonstrated in the superficial temporal arteries of 30 control subjects (20 with at least one risk factor of atherosclerosis and 10 without it). Color duplex ultrasonography can therefore be considered a powerful method for detecting stenoses in the superficial temporal artery. Its ability to identify their etiology is, however, unsatisfactory, so that temporal artery biopsy remains undoubtedly the most reliable test for etiological evaluation. We thus recommend color duplex ultrasonography as a supplementary method for the diagnosis of temporal arteritis, because it can provide useful information concerning the appropriate site of temporal artery biopsy.

[Value of color-coded duplex ultrasound in patients with polymyalgia rheumatica without signs of temporal arteritis].

Abstract:
Recent studies have described characteristic sonographic signs in patients with manifest temporal arteritis (TA). It was the aim of this study to determine whether sonography can identify TA without clinical signs but biopsy evidence of giant-cell arteritis in patients with rheumatic polymyalgia (RP).

22 patients (14 women, 8 men; average age 67.4 +/- 9.1 years) with RP but no clinical signs of TA were prospectively examined for TA by colour-coded duplex sonography (ATL HDI 3000, linear 12-5 Mhz) before temporal artery biopsy was taken. If there was clinical suspicion of extratemporal involvement, other vessels were also examined selectively. The biopsy was taken from a site identified by the sonography. A definitive diagnosis of TA was made only if there was a positive biopsy.

In seven of the 22 patients (32%) sonography showed an echo-poor halo around the lumen of the temporal artery. Five of these seven patients also had histological evidence of giant-cell arteritis. Conversely, all of the five patients had abnormal sonographic findings, namely a marked halo with a minimal thickness of 0.7 mm. Two of the five patients also had temporal artery stenosis, i.e. there was a 100% sensitivity and 80% specificity with respect to the halo sign in conformance with the histology. Two patients with TA were also shown sonographically to have stenosis in arteries of the shoulder girdle and arm. Stenoses in the renal and mesenteric arteries as well of the coeliac trunk were demonstrated in one patient.

Colour-coded sonography with a high-frequency transducer head probably provides reliable diagnosis of TA in patients with RP, even in the absence of clinical signs of vascular inflammation. It remains to be proven whether sonography without biopsy is reliable enough for the diagnosis and treatment of asymptomatic TA.

The suitability of the ultrasound biomicroscope for establishing texture in giant cell arteritis.

Abstract:
To establish whether ultrasound biomicroscope (UBM) is a helpful tool in locating the arterial segment responsible in patients with segmental attacks in giant cell arteritis

The superficial temporal arteries of 19 patients with suspected giant cell arteritis were examined with the UBM before biopsy.

20 specimens provided the histological proof of giant cell arteritis in five patients. Side differences, a dark perivascular halo, and high reflexivity of the intra-arterial space were found.

it is assumed that there are two types of arteritic inflammation: (1) the occlusion of intra-arterial space due to intimal fibrosis (UBM: high reflexive "filling"), and (2) inflammation of the perivascular zone with oedematous thickening and infiltration of the media (UBM: dark halo) and its combination. UBM is helpful in obtaining an indication of the side and segment for biopsy.

Incidence of temporal arteritis in patients with polymyalgia rheumatica: a prospective study using colour Doppler ultrasonography of the temporal arteries.

Abstract:
To determine the incidence of temporal arteritis (TA) in patients with polymyalgia rheumatica (PMR) using colour Doppler ultrasonography of the temporal arteries.

Ultrasonography was performed in all 127 consecutive patients with newly diagnosed, active PMR seen between 1994 and 2000 and in 127 age- and sex-matched controls.

Of 102 patients with "pure" PMR, 8% had ultrasonographic findings arousing suspicion of concomitant active TA (specific halo sign and/or positive histology in 7%; histologically proven TA in 4%). Twenty-five patients had clinical signs of both PMR and TA. Histology and sonography were negative in three of these patients. Of the controls, none had a halo sign and four had stenoses.

Ultrasonography of the temporal arteries is a new, non-invasive method of diagnosing concomitant TA in patients with PMR.

[Color duplex ultrasound of the temporal artery: replacement for biopsy in temporal arteritis].

Abstract: The diagnosis of temporal arteritis (TA) is generally confirmed by biopsy. To investigate the diagnostic accuracy of color duplex sonography (CDS), both temporal arteries of 20 patients with suspected TA were prospectively insonated prior to biopsy. Detection of >or=1 hypoechogenic perivascular halo was used as CDS criterion, a temporal artery biopsy and the criteria of the American College of Rheumatology (ACR) as references. The frequency of halo disappearance after 3 months of steroid therapy was also studied. CDS showed TA in 6, biopsy in 12 and ACR criteria in 15 patients. CDS sensitivity was 50 and 40%, and specificity 100%, using the biopsy and the ACR criteria, respectively. After 3 months of steroid treatment, 1 patient still showed halos. In conclusion, detection of halos confirms, whereas the absence of halos does not exclude the diagnosis of TA suggesting that ultrasound may replace biopsy in single patients with typical clinical signs and symptoms and a halo.

The utility of color duplex ultrasonography in the diagnosis of temporal arteritis.

Abstract:
Temporal arteritis (TA) is frequently diagnosed with nonspecific clinical characteristics, followed by a temporal artery biopsy to confirm the presence of vasculitis. Consequently, numerous screening surgical biopsies are performed with a high negative-biopsy rate. A prospective study was performed evaluating color duplex ultrasound scan (CDU) as the preferred method for the diagnosis of vasculitis in the evaluation of suspected TA.

Thirty-two patients with suspected TA on the basis of clinical criteria were evaluated with CDU before a temporal artery biopsy. The presence of a hypoechoic "halo," suggesting edema of the inflamed vessel, and inflammatory stenoses were noted. Histologic examinations of standard temporal artery biopsies then were performed, and the results were compared with the CDU findings. In addition, a metaanalysis was performed to identify articles related to the use of ultrasound scan in the detection of TA.

All patients completed a bilateral CDU examination of the temporal arteries, and in 75% of patients biopsied, no evidence of vasculitis was found at histologic examination. When CDU examined for halo alone as the determinant for disease, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), compared with histologic confirmation of TA, were 85.7%, 92.0%, 75.0%, and 95.8%, respectively. With the criteria for a halo sign present, an inflammatory stenosis present, or both present on CDU, the sensitivity, specificity, positive predictive value, and NPV were 100%, 80.0%, 58.3%, and 100%, respectively.

CDU is a superior noninvasive method of determining the presence of vasculitis when compared with routine surgical biopsy. Examination of the temporal artery with CDU can effectively predict which patient will need surgical biopsy. The utility of CDU in the diagnosis of TA is maintained by a high sensitivity in detecting patients with the disease and also by a high NPV that can eliminate patients who would not benefit from biopsy.

Comparison between color duplex ultrasonography and histology of the temporal artery in cranial arteritis (giant cell arteritis).

Abstract:
Duplex sonography of the temporal artery may be helpful in the diagnosis of cranial arteritis.

The superficial temporal arteries of 36 patients with cranial arteritis or suspected arteritis were examined using both duplex ultrasonography (US) and biopsy. The data of these patients were divided into two groups. Group A consisted of 24 patients (66.7%) with definite positive results using duplex (US) and Group B of 12 patients (33.3%) who showed a suspicious or negative ultrasonographic result.

In all patients of Group A, the histological findings corresponded with the ultrasonographic changes in the inflamed artery. - The characteristic ultrasonographic sign was a dark halo around the lumen of the temporal arteries. There was a high correlation between a bilateral halo found by US with an ocular involvement. Ten out of 14 patients with a bilateral halo (71.4%) showed a distinct involvement of the optic nerve or retina. - The characteristic histological signs were infiltration of the vessel wall by inflammatory cells, mainly lymphocytes. Group B: The biopsies of the superficial temporal arteries were positive in 8 patients (66.7 %), negative in 4 other patients (33.3%).

Patients with a distinct halo, demonstrated by US, also showed corresponding pronounced inflammatory cell infiltration of the vessel wall. Patients with no ultrasonographic changes presented histological signs of initial inflammation such as isolated inflammatory cells around the vasa vasorum and/or in the adventitial layer.


Context: Initial arch wires are the first arch wires inserted into fixed appliance at the beginning of orthodontic treatment. With a number of different types of orthodontic arch wires available for initial tooth alignment, it is important to understand which are most efficient and which cause the least amount of root resorption and pain during the initial aligning stage of treatment. This is the third update of a Cochrane review first published in 2010.

To assess the effects of initial arch wires for the alignment of teeth with fixed orthodontic braces, in terms of the rate of tooth alignment, amount of root resorption accompanying tooth movement, and intensity of pain experienced by patients during the initial alignment stage of treatment.

We included randomised controlled trials (RCTs) of different initial arch wires used to align teeth with fixed orthodontic braces. We included people with full-arch fixed orthodontic appliances on the upper arch, lower arch, or both arches.

The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires.

Abstract: A randomized controlled clinical trial was performed to compare the nature, prevalence, intensity, and duration of pain related to the use of a relatively recently developed superelastic arch wire and a more traditional multistranded steel arch wire. Other factors likely to influence the pain experience were also investigated. Forty-three subjects participated in the study, the pain response being assessed by each of the visual analogue scales, the questionnaires, and an analgesic consumption record. In 18 of the 43 subjects a standardized preliminary dental extraction procedure was used as a control. Subsequent to the random allocation of an initial arch wire in 43 patients, 22 of them underwent a second arch wire in the opposing arch, the wire again being determined by random allocation. It was found that the prevalence, intensity, and duration of pain after the insertion of the two types of wire was similar but much greater than in the postextraction control phase. The pain score peaked on the morning after the placement of the arch wire, lasting typically for 5 to 6 days. The pain and discomfort experienced after the insertion of the second arch wire was similar to that of the first, no conditioning response being evident. Overall a diurnal variation was found with a tendency to an increase in pain in the evenings and nights, although this did not greatly affect sleep. The pain response was found to be highly and consistently subjective, not related to the dental arch, crowding, sex, or social class; however, a statistically significant association was found between the age and the pain experienced.

Perception of pain during orthodontic treatment with fixed appliances.

Abstract: The aims of this study were to investigate the initial time at which pain occurs after insertion of two initial wires of different sizes, the duration of the pain, the areas affected within the mouth, the level of self-medication, the effect of this pain on daily life, and whether gender is important in the perception of pain. The study group consisted of 109 patients (52 boys, 57 girls) with a mean chronological age of 13.6 years for boys and 14.7 years for girls. Insertion of either a 0.014 or 0.016 inch wire was by random selection. Following insertion of the archwires, a questionnaire comprising a total of 49 questions was given to the patients. They described the time of initial pain in the first question, answered the next 24 questions as 'yes' or 'no', and used a visual analogue scale for the final 24 questions. No significant differences were found in terms of gender, in the perception period of initial pain as regards the areas affected within the mouth or the effect of pain on daily living when the 0.014 and 0.016 inch wire groups were compared at 6 hours, 1, 2, 3, 4, 5, 6 and 7 days. At 24 hours, which was found to be statistically significant, more pain relief was used in the 0.014 inch archwire group. The results show that in both groups, initial pain was perceived at 2 hours, peaked at 24 hours and had decreased by day 3.

Alleviation of mandibular anterior crowding with copper-nickel-titanium vs nickel-titanium wires: a double-blind randomized control trial.

Abstract:
The purpose of this study was to investigate the efficiency of copper-nickel-titanium (CuNiTi) vs nickel-titanium (NiTi) archwires in resolving crowding of the anterior mandibular dentition.

Sixty patients were included in this single-center, single-operator, double-blind randomized trial. All patients were bonded with the In Ovation-R self-ligating bracket (GAC, Central Islip, NY) with a 0.022-in slot, and the amount of crowding of the mandibular anterior dentition was assessed by using the irregularity index. The patients were randomly allocated into 2 groups of 30 patients, each receiving a 0.016-in CuNiTi 35 degrees C (Ormco, Glendora, Calif) or a 0.016-in NiTi (ModernArch, Wyomissing, Pa) wire. The type of wire selected for each patient was not disclosed to the provider or the patient. The date that each patient received a wire was recorded, and all patients were followed monthly for a maximum of 6 months. Demographic and clinical characteristics between the 2 wire groups were compared with the t test or the chi-square test and the Fisher exact test. Time to resolve crowding was explored with statistical methods for survival analysis, and alignment rate ratios for wire type and crowding level were calculated with Cox proportional hazards multivariate modeling.

The type of wire (CuNiTi vs NiTi) had no significant effect on crowding alleviation (129.4 vs 121.4 days; hazard ratio, 1.3; P >0.05). Severe crowding (>5 on the irregularity index) showed a significantly higher probability of crowding alleviation duration relative to dental arches with a score of <5 (138.5 vs 113.1 days; hazard ratio, 2.2; P=0.02).

The difference of the loading pattern of wires in laboratory and clinical conditions might effectively eliminate the laboratory-derived advantage of CuNiTi wires.

Comparison of superelastic NiTi and multistranded stainless steel wires in initial alignment.

A clinical trial of aligning archwires.

Abstract: The physical properties of a super-elastic archwire alloy (Titanol) and Nitinol were investigated by the means of a bending test. It was found that the alloy possessed super-elastic properties. A clinical trial was then carried out to compare the properties of two types of aligning archwire. Two groups of 20 patients with crowded dentitions were randomly allocated either Titanol or Nitinol, a conventional nickel-titanium alloy aligning archwire. High quality alginate impressions were taken after archwire placement in Edgewise fixed appliances and were repeated after a mean period of 35 days. The impressions were cast in dental stone and digitized using the Reflex Metrograph. The contact points of the teeth of the labial segments, together with four stable points in the rugae were recorded. This enabled the co-ordinates for the sequential study models to be superimposed upon one another, allowing tooth movement in three dimensions to be calculated. The measurement error expressed as error variance was 0.028 mm. The coefficient of reliability was 97 per cent. When tooth movement was analysed the mean movement per contact point for Titanol was 1.7 mm and for Nitinol 1.42 mm. This difference was not statistically significant (P less than 0.05, t-test). However, a clinical impression was that the super-elastic archwire proved superior to the Nitinol, because it was more readily engaged into grossly displaced teeth.

Which orthodontic archwire sequence? A randomized clinical trial.

Abstract: The aim of this study was to compare three orthodontic archwire sequences. One hundred and fifty-four 10- to 17-year-old patients were treated in three centres and randomly allocated to one of three groups: A = 0.016-inch nickel titanium (NiTi), 0.018 x 0.025-inch NiTi, and 0.019 x 0.025-inch stainless steel (SS); B = 0.016-inch NiTi, 0.016-inch SS, 0.020-inch SS, and 0.019 x 0.025-inch SS; and C = 0.016 x 0.022-inch copper (Cu) NiTi, 0.019 x 0.025-inch CuNiTi, and 0.019 x 0.025-inch SS. At each archwire change and for each arch, the patients completed discomfort scores on a seven-point Likert scale at 4 hours, 24 hours, 3 days, and 1 week. Time in days and the number of visits taken to reach a 0.019 x 0.025-inch SS working archwires were calculated. A periapical radiograph of the upper left central incisor was taken at the start of the treatment and after placement of the 0.019 x 0.025-inch SS wire so root resorption could be assessed. There were no statistically significant differences between archwire sequences A, B, or C for patient discomfort (P > 0.05) or root resorption (P = 0.58). The number of visits required to reach the working archwire was greater for sequence B than for A (P = 0.012) but this could not be explained by the increased number of archwires used in sequence B.

A clinical comparison of three aligning archwires in terms of alignment efficiency: A prospective clinical trial.

Abstract:
To clinically evaluate the effectiveness of three orthodontic aligning archwires in relation to tooth alignment speed during the initial alignment stage of treatment.

A consecutive sample of 74 patients requiring lower only or upper and lower fixed orthodontic appliances were randomly allocated into three different archwires (0.014-inch superelastic nickel-titanium [NiTi], 0.014-inch thermoelastic NiTi, or 0.014-inch conventional NiTi). Good quality impressions were taken of the lower arch before archwire placement (T0) and at designated serial stages of alignment (every 2 weeks: T2, T4, T6, …, T16). The change in tooth alignment was measured in millimeters from the resultant casts using Little's irregularity index. Demographic and clinical differences among the three groups were compared with the chi-square or analysis of variance (ANOVA) test. The difference in the change of lower anterior tooth alignment over time among the three groups was explored with a Split Plot ANOVA (SPANOVA, or within- and between-groups ANOVA). The Kruskal-Wallis nonparametric test was used when data were not normally distributed.

The SPANOVA and Wilks Lambda Multivariate test confirmed that the wire type had no influence on the rate of change in alignment (P  =  .98).

The three forms of NiTi wires were similar in terms of their alignment efficiency during the initial aligning stage of orthodontic fixed appliance therapy.

Clinical Efficiency of Two Sequences of Orthodontic Wires to Correct Crowding of the Lower Anterior Teeth.

Abstract: This study compared time to correction of mandibular anterior crowding using two arch wire sequences, one with conventional nickel-titanium (NiTi) arch wires and the other with conventional and NiTi heat-activated arch wires. Twenty-two boys and girls (mean age: 16.68 ± 2.66) with moderate crowding (3-6 mm) were assigned randomly to one of two groups and followed up for five months (six assessments) when arch wires were changed. Time to crowding correction was analyzed statistically using the Kaplan-Meier method. Data were collected during the five-month follow-up, and time to correction was compared between groups using the log rank test. At the end of follow-up, mandibular crowding was corrected in 100% of the cases in the group treated with the sequence that included NiTi heat-activated arch wires, whereas about 30% of those treated with NiTi arch wires were not completely corrected. There was a significant difference in time to complete treatment between groups (log rank = 5.996; p < 0.05). In the group treated with the sequence that included heat-activated wires, alignment and leveling of mandibular anterior teeth were completed earlier than in the group treated only with conventional NiTi arch wires. Clinical trial registration is found at RBR-7g5zng.

Pain experience during initial alignment with three types of nickel-titanium archwires: a prospective clinical trial.

Abstract:
To clinically evaluate the pain intensity during the week following initial placement of three different orthodontic aligning archwires.

A consecutive sample of 75 patients requiring upper and lower fixed orthodontic appliances were alternately allocated into three different archwires (0.014-inch superelastic NiTi, 0.014-inch thermoelastic NiTi or 0.014-inch conventional NiTi). Assessments of pain/discomfort were made on a daily basis over the first 7-day period after bonding by means of visual analog scale and consumption of analgesics. The maximum pain score was recorded. The possible associations between age, gender, degree of crowding, and teeth irregularity and the pain intensity were also examined. Demographic and clinical differences between the three groups were compared with chi-square test or analysis of variance (ANOVA) test.

No statistically significant differences were found in the pain intensity when the three aligning NiTi archwires were compared (P  =  .63). No significant differences in pain perception were found in terms of gender, age, lower arch crowding, and incisor irregularity. The intake of analgesics was the least in the superelastic NiTi group.

The three forms of NiTi wires were similar in terms of pain intensity during the initial aligning stage of orthodontic fixed appliance therapy. Gender, age, and the degree of crowding have no effect on the perceived discomfort experienced by patients undergoing fixed orthodontic treatment.

Mandibular dental arch changes with active self-ligating brackets combined with different archwires.

Abstract:
The aim was to compare mandibular arch and incisor inclinational changes by comparing active self-ligating brackets used with different forms of archwires with a control group in nonextraction cases.

The sample of 50 patients with Class I malocclusion was divided into three groups: Group I was treated with active self-ligating brackets (Nexus, Ormco/Orange, CA, USA) used with Damon arch form copper nickel-titanium (Cu-NiTi) and stainless steel (SS) wires; Group II was treated with interactive self-ligating bracket system (Empower, American Orthodontics, Sheboygan, Wis, USA) used with standard Cu-NiTi and SS wires; and Group III was treated with Roth prescribed conventional brackets (Forestadent, Pforzheim, Germany) with standard Cu-NiTi and SS wires which was designed as a control group. Changes in dimension of mandibular arch and inclination of incisors were assessed on dental models and lateral cephalometric radiographs at pretreatment (T1) and posttreatment (T2) periods. Paired-t test and one-way analysis of variance were used to perform intragroup and intergroup comparisons, respectively.

In all groups, an average increase of transversal distances occurred from pretreatment to the posttreatment period (P < 0.05). However, mandibular arch length increase was significantly different among the Groups I-III (P = 0.008) and I-II (P = 0.006). No significant intergroup difference was found with regard to incisor inclinational changes.

Bracket type had no significant effect on the mandibular dimensional or incisor inclination changes. Besides this, archwire type had only little effect on the treatment results as active self-ligating bracket with Damon archwires increased mandibular arch length greater than other groups.


Context: The prevalence of gallstones varies between less than 1% and 64% in different populations and is thought to be increasing in response to changes in nutritional intake and increasing obesity. Some people with gallstones have no symptoms but approximately 2% to 4% develop them each year, predominantly including severe abdominal pain. People who experience symptoms have a greater risk of developing complications. The main treatment for symptomatic gallstones is cholecystectomy. Traditionally, a low-fat diet has also been advised to manage gallstone symptoms, but there is uncertainty over the evidence to support this.

To evaluate the benefits and harms of modified dietary fat intake in the treatment of gallstone disease in people of any age.

We included randomised clinical trials (irrespective of language, blinding, or status) in people with gallstones diagnosed using ultrasonography or conclusive imaging methods. We excluded participants diagnosed with another condition that may compromise dietary fat tolerance. We excluded trials where data from participants with gallstones were not reported separately from data from participants who did not have gallstones. We included trials that investigated other interventions (e.g. trials of drugs or other dietary (non-fat) components) providing that the trial groups had received the same proportion of drug or other dietary (non-fat) components in the intervention.

A randomised, single blinded trial, assessing the effect of a two week preoperative very low calorie diet on laparoscopic cholecystectomy in obese patients.

Abstract:
Laparoscopic cholecystectomy (LC) can be technically challenging in the obese. The primary aim of the trial was to establish whether following a Very Low Calorie Diet (VLCD) for two weeks pre-operatively reduces operation time. Secondary outcomes included perceived operative difficulty and length of hospital stay.

A single-blinded, randomized controlled trial of consecutive patients with symptomatic gallstones and BMI >30 kg/m(2) 46 patients were randomized to a VLCD or normal diet for two weeks prior to LC. Food diaries were used to document dietary intake. The primary outcome measure was operation time. Secondary outcomes were length of stay, weight change operative complications, day case rates and perceived difficulty of operation.

The VLCD was well tolerated and had significantly greater preoperative weight loss (3.48 kg vs. 0.98 kg; p < 0.0001). Median operative time was significantly reduced by 6 min in the VLCD group (25 vs. 31 min; p = 0.0096). There were no differences in post-operative complications, length of stay, or day case rates between the groups. Dissection of Calot's triangle was deemed significantly easier in the VLCD group.

A two week VLCD prior to elective laparoscopic cholecystectomy in obese patients is safe, well tolerated and was shown to significantly reduce pre-operative weight and operative time.

61630192. http://www.isrctn.com/ISRCTN61630192 Trial registration.

Effect of dietary cholesterol on biliary lipids in patients with gallstones and normal subjects.

Abstract: The purpose of this study was to determine the effect of dietary cholesterol on biliary lipids in subjects with and without gallstones. Twelve patients with asymptomatic gallstones (six men, six women) were assigned diets containing 500, 750, and 1000 mg cholesterol daily for 3-wk periods in random sequence. Seven healthy women similarly were assigned diets containing 500 and 1000 mg cholesterol daily. With increasing dietary cholesterol in patients with gallstones, biliary saturation indices and molar percents of cholesterol and phospholipids increased significantly while molar percent of biliary bile acids decreased significantly. With increasing dietary cholesterol in healthy women, the biliary saturation index and molar percent of cholesterol increased significantly; the mean saturation index exceeded unity on the diet containing 1000 mg cholesterol daily. In conclusion, augmented dietary cholesterol for brief periods increased biliary cholesterol saturation in subjects with and without gallstones.

The effect of diet on bile acid kinetics and biliary lipid secretion in gallstone patients treated with ursodeoxycholic acid.

Abstract: Effects of specific dietary alterations in patients with radiolucent gallstones treated with ursodeoxycholic acid (UDCA, 750 mg at bedtime) were investigated. Patients were allocated randomly to one of four diets: standard (500 mg cholesterol/day), low-cholesterol (250 mg/day), added-bran (30 g/day), or substituted medium-chain triglycerides (MCT) oil (20% of fat). Dietary intake and good compliance were verified by computerized analysis of dietary diaries. Bile-acid kinetics (26 patients) or secretion of biliary lipids (23 other patients) were determined at enrollment and at 6 and 9 mo, respectively, during treatment. Although MCT further decreased the UDCA-induced decrease in the synthesis of chenodeoxycholic acid, it did not lessen desaturation of bile. Otherwise, compared to the standard diet, no experimental diet significantly altered the UDCA-induced increase of the pools of total bile acids and UDCA or the UDCA-induced decrease in synthesis of bile acids and in biliary secretion or saturation of cholesterol. If these dietary manipulations facilitate dissolution of gallstones by UDCA, they do so by other mechanisms.

Effect of diet on dissolution of gallstones by ursodeoxycholic acid, including a comparison between ultrasonography and cholecystography.

Low-cholesterol diet: enhancement of effect of CDCA in patients with gall stones.

Abstract: Fifteen patients with gall stones who were taking chenodeoxycholic acid(CDCA) 15 mg/kg at bedtime participated in two separate experiments to investigate the effects of altering sterol intake on the cholesterol saturation index (SI) of fasting gall-bladder bile. In experiment I the 15 patients on an unrestricted diet had a SI of 0.87 +/- 0.04 (mean +/- SE of mean), which fell to 0.75 +/- 0.04 after one week in hospital on a diet of 100 mg cholesterol daily. In experiment II seven of the patients were given four different dietary regimens lasting one month each in random order as outpatients. On a diet of 600 mg of cholesterol daily the mean SI was 0.72 +/- 0.05, which fell to 0.67 +/- 0.05 when the patients were put on a 100 mg cholesterol diet. The addition of plant sterols (3 g daily) to both diets raised the mean SIs to 0.80 +/- 0.05 and 0.77 +/- 0.05 respectively. The percentage CDCA in bile was unaffected by alterations in the cholesterol and plant sterol intakes. We conclude that a low-cholesterol diet but not a high intake of plant sterols enhances the effect of CDCA in patients with gall stones.

Minimum effective dose of chenic acid for gallstone patients: reduction with bedtime administration and low cholesterol diet.

Abstract: The aim of this study was to determine whether bedtime administration and a low cholesterol diet reduce the minimum effective dose of chenodeoxycholic (chenic) acid, defined as the dose giving a mean cholesterol saturation index of 0.8. Dose response studies were carried out in 10 patients with radiolucent gallstones in a functioning gallbladder during three different treatment regimens. On each regimen, all patients received three different doses of chenodeoxycholic acid in random order for one month each. Bedtime chenic acid plus a low cholesterol diet gave the greatest reduction in saturation index. A significant dose/response relationship was found on each regimen. On the conventional regimen of mealtime chenic acid, the minimum effective dose was 14 mg/kg/day; on bedtime chenic acid it was 12.4 mg/kg/day; and on bedtime chenic acid plus low cholesterol diet it was further reduced to 8.4 mg/kg/day (p less than 0.01). There was a dose-related increase in bowel frequency, which was absent at 10.6 mg/kg/day and below. We conclude that administration of chenic acid at bedtime with a low cholesterol diet enables the minimum effective dose for gallstone dissolution to be approximately halved, thus preventing diarrhoea and reducing the cost of treatment.

[Optimization of diet therapy in patients with gallstones complicated with obesity and impaired glucose tolerance].

Abstract: It was investigated the influence of a diet with lower glycaemic index on clinico-metabolic parameters in obese patients with gallstones and impaired glucose tolerance. The results investigations indicated that the lowering of glycaemic index and the caloric reduction of diet have a beneficial effects on dynamic of parameters of functional status of liver and gallbladder. It was noted the increase of medical effect of diet in correction of obesity and impaired parameters of carbohydrate and lipid metabolism in this patients in process of dietotherapy.

Effect of the type of dietary fat on biliary lipid composition and bile lithogenicity in humans with cholesterol gallstone disease.

Abstract:
The effect of the type of dietary fat on bile lipids and lithogenicity is unclear. This study compared the effects of two dietary oils that differed in fatty acid profile on biliary lipid composition in humans.

Female patients who had cholesterol gallstones and were scheduled for elective cholecystectomy were studied. For 30 d before surgery, subjects were kept on diets that contained olive oil (olive oil group, n = 9) or sunflower oil (sunflower oil group, n = 9) as the main source of fat. Gallbladder bile and stones were sampled at surgery. After cholecystectomy, duodenal samples were collected by nasoduodenal intubation during fasting and after administration of mixed liquid meals that included the corresponding dietary oil. Duodenal and gallbladder bile samples were analyzed for cholesterol, phospholipids, and total bile acids by established methods. Individual bile acid conjugates in gallbladder bile were measured by high-performance liquid chromatography. Gallstones were analyzed by semiquantitative polarizing light microscopy.

Despite marked differences in the absolute concentration of biliary lipids and total lipid content, manipulation of dietary fat ingestion did not influence the cholesterol saturation or the profile of individual bile acids in gallbladder bile obtained from patients who had gallstones. All but one subject had mixed cholesterol stones. A cholesterol saturation index of hepatic bile in fasted cholecystectomized patients was similar in both dietary groups and indicative of supersaturation. In response to the test meal, the cholesterol saturation index decreased significantly in patients given the olive oil diet, reaching values lower than one at 120 min postprandially. In contrast, hepatic bile secreted by patients who consumed sunflower oil appeared supersaturated (cholesterol saturation index >1.5) throughout the experiment.

Our results suggest that the type of dietary fat habitually consumed can influence bile composition in humans. In gallbladder, this influence was noted in the presence of more concentrated bile in the olive oil group. However, this was not translated into a modification of cholesterol saturation, which is likely due to the fact that cholesterol gallstones were present by the time the dietary intervention started. The finding that a typical postprandial variation in hepatic bile lithogenicity occurred only in olive oil patients was revealing. While keeping in mind the methodologic limitations of this part of the study, some gastrointestinal and metabolic mechanisms for this effect are discussed.

[Gastrointestinal function following cholecystectomy].

Abstract: Randomized studies of the physiological and clinical consequences of cholecystectomy for uncomplicated gallbladder stones are very scarce. Bile acid malabsorption is increased postoperatively, probably giving rise to diarrhea in a few sensitive individuals. Preexisting abdominal distension and fat intolerance most often persist postoperatively. In adequately selected patients, abdominal pain may subside in 75% or more. The presence of functional bowel disease should always be considered in patients with uncomplicated gallstones.

Randomized study for assessment of hypolipidic diet in digestive symptoms immediately following laparoscopic cholecystectomy.

Abstract:
To validate the need for prescribing low-fat diet in the prevention or reduction of dyspeptic symptoms in the postoperative period in patients undergoing laparoscopic cholecystectomy.

We selected 40 patients, free of liver or pancreatic disease, biliary gallstones, gastritis, ulcer, diabetes and dyslipidemia, who were divided into two groups. We conducted dietary anamnesis, identification of dyspepsia before the onset of cholelithiasis and guidance on appropriate postoperatively feeding (normal or low-fat). We used the chi-square test and Pearson correlation for statistical assessment, considering p d" 0.05 as significant.

When comparing the two groups of patients without preoperative dyspepsia, it was observed that in group I seven patients (63.6%) were asymptomatic and in group II, four (66.7%). In group I, four (36.4%) had onset of symptoms and in group II, two (33.3%), p = 0.684. When correlating the two groups with preoperative dyspeptic symptoms, it was observed that there was permanence, appearance or disappearance of symptoms postoperatively, p = 0.114.

There was no significant effect of low-fat diet in the prevention of gastrointestinal symptoms, especially in preoperatively asymptomatic patients. Thus, there is no need of a low-fat diet. So, it is up to the surgeon to evaluate each patient individually and adjust the diet to his/her needs and clinical conditions.