Randomized Clinical Trial Research Papers (original) (raw)

In spite of the serious and costly problems presented by juvenile sexual offenders, rigorous tests of promising interventions have rarely been conducted. This study presents a community-based effectiveness trial comparing multisystemic therapy (MST) adapted for juvenile sexual offenders with services that are typical of those provided to juvenile sexual offenders in the U.S. Youth were randomized to MST (n = 67) or treatment as usual for juvenile sexual offenders (TAU-JSO; n = 60). Outcomes through 12 months post recruitment were assessed for problem sexual behavior, delinquency, substance use, mental health functioning, and out-of-home placements. Relative to youth who received TAU-JSO, youth in the MST condition evidenced significant reductions in sexual behavior problems, delinquency, substance use, externalizing symptoms, and out-of-home placements. The findings suggest that family-and community-based interventions, especially Electronic mail may be sent to letourej@musc.edu. The second author is a board member and stockholder of MST Services, LLC, the Medical University of South Carolina-licensed organization that provides training in MST. The third author is a board member of MST Associates, LLC, the organization that provides training in MST for youth with problem sexual behaviors.

- by and +2
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- Psychology, Mental Health, Family, Treatment Outcome

Prior meta-analyses have found a moderate but robust relationship between alliance and outcome across a broad spectrum of treatments, presenting concerns, contexts, and measurements. However, there continues to be a lively debate about the therapeutic role of the alliance, particularly in treatments that are tested using randomized clinical trial (RCT) designs. The purpose of this present study was to examine whether research design, type of treatment, or author's allegiance variables, alone or in combination, moderate the relationship between alliance and outcome. Multilevel longitudinal analysis was used to investigate the following moderators of the alliance-outcome correlation: (a) research design (RCT or other), (b) use of disorder-specific manuals, (c) specificity of outcomes, (d) cognitive and/or behavioral therapy (CBT) or other types of treatments, (e) researcher allegiance, and (f) time of alliance assessment. RCT, disorder-specific manual use, specificity of primary and secondary outcomes, and CBT did not moderate the alliance-outcome correlation. Early alliance-outcome correlations were slightly higher in studies conducted by investigators with specific interest in alliance than were those in studies conducted by researchers without such an allegiance. Over the course of therapy, these initial differences disappeared. Apart from this trend, none of the variables previously proposed as potential moderators or mediators of the alliance-outcome relation, alone or in combination, were found to have a mediating impact.

- by Christoph Flückiger and +2
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- Psychology, Behavior Modification, Research Design, Psychotherapy

Objective: To follow distressed married couples for 5 years after their participation in a randomized clinical trial. Method: A total of 134 chronically and seriously distressed married couples were randomly assigned to approximately 8 months of either traditional behavioral couple therapy (TBCT; or integrative behavioral couple therapy (IBCT; Jacobson & Christensen, 1998). Marital status and satisfaction were assessed approximately every 3 months during treatment and every 6 months for 5 years after treatment. Results: Pre-to posttreatment effect sizes on marital satisfaction were d ϭ 0.90 for IBCT and d ϭ 0.71 for TBCT, which were not significantly different. However, data through 2-year follow-ups revealed statistically significant superiority of IBCT over TBCT in relationship satisfaction, but subsequent data showed increasing similarity and nonsignificant differences in outcome. At 5-year follow-up for marital satisfaction relative to pretreatment, effect sizes were d ϭ 1.03 for IBCT and d ϭ 0.92 for TBCT; 50.0% of IBCT couples and 45.9% of TBCT couples showed clinically significant improvement. Relationship status, obtained on all 134 couples, revealed that 25.7% of IBCT couples and 27.9% of TBCT couples were separated or divorced. These follow-up data compared favorably to other, long-term results of couple therapy. Conclusion: TBCT and IBCT both produced substantial effect sizes in even seriously and chronically distressed couples. IBCT produced significantly but not dramatically superior outcomes through the first 2 years after treatment termination but without further intervention; outcomes for the 2 treatments converged over longer follow-up periods.

- by Brian Baucom
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- Psychology, Behavior Modification, Integrative Medicine, Consulting

We performed a prospective, randomized clinical trial to compare the usefulness of the minute ventilation test (MVT) with clinical judgement in predicting readiness for extubation in preterm newborns with respiratory distress syndrome... more

- by Sunil Sinha
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- Prospective studies, Clinical Sciences, Newborn Infant, Perinatology

Background: Postoperative convalescence is mainly determined by the extent and duration of postoperative ileus. This randomized clinical trial evaluated the effects of early oral feeding on functional gastrointestinal recovery and quality of life. Methods: One hundred and twenty-eight patients undergoing elective open colorectal or abdominal vascular surgery participated in the trial. Of these, 67 were randomized to a conventional return to diet, and 61 to a regimen allowing resumption of an oral diet as soon as tolerated (free diet group). Results: Reinsertion of a nasogastric tube was necessary in 20 per cent of the free diet group and 10 per cent of the conventional group (P = 0•213). The complication rate was similar for both groups, as was return of gastrointestinal function. A normal diet was tolerated after a median of 2 days in the free diet group compared with 5 days in the conventional group (P < 0•001). Quality of life scores were similar in both groups. Conclusion: Early resumption of oral intake does not diminish the duration of postoperative ileus or lead to a significantly increased rate of nasogastric tube reinsertion. Tolerance of oral diet is not influenced by gastrointestinal functional recovery. As there is no reason to withhold oral intake following open colorectal or abdominal vascular surgery, postoperative management should include early resumption of diet.

- by J. Jeekel
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- Pain, British, Quality of life, Colorectal Surgery

; for the Stroke Outcome Research Canada (SORCan) Working Group Background and Purpose-Hemiparesis resulting in functional limitation of an upper extremity is common among stroke survivors. Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery, limited evidence is available on the efficacy of virtual reality for stroke rehabilitation. Methods-In this pilot, randomized, single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months, we compared the feasibility, safety, and efficacy of virtual reality using the Nintendo Wii gaming system (VRWii) versus recreational therapy (playing cards, bingo, or "Jenga") among those receiving standard rehabilitation to evaluate arm motor improvement. The primary feasibility outcome was the total time receiving the intervention. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, was evaluated with the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at 4 weeks after intervention. Results-Overall, 22 of 110 (20%) of screened patients were randomized. The mean age (range) was 61.3 (41 to 83) years. Two participants dropped out after a training session. The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm. The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group (Pϭ0.75). There were no serious adverse events in any group. Relative to the recreational therapy group, participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds (Wolf Motor Function Test, 7.4 seconds; 95% CI, Ϫ14.5, Ϫ0.2) after adjustment for age, baseline functional status (Wolf Motor Function Test), and stroke severity. Conclusions-VRWii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote motor recovery after stroke. (Stroke. 2010;41:1477-1484.

- by Leonardo Cohen
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- Video Games, Treatment Outcome, Stroke rehabilitation, Activities of Daily Living

This study examined the long-term effectiveness of a postpartum smoking relapse prevention intervention by evaluating the smoking status and smoking cessation selfefficacy of original study participants at 12 months following delivery. Two hundred and thirtyeight women who had participated in a randomized clinical trial, a nurse-delivered relapse prevention intervention, were visited in their homes. Data were collected on smoking status, self-efficacy, mental health, alcohol use, breast feeding, social support, smoking in the social environment, and sociodemographics. Smoking status was verified with measures of carbon monoxide in expired air. The 12-month continuous smoking abstinence rate was 21.0% in the treatment group and 18.5% in the control group; odds ratio (OR) ϭ 1.17, 95% confidence interval (CI) ϭ 0.62-2.22. One half (50.4%) of the control group and 41.2% of the treatment group reported smoking daily at 12 months; OR ϭ 1.45, 95% CI ϭ 0.87-2.43. The treatment group attained higher self-efficacy. Four variables were associated with relapse to daily smoking; breast feeding and mental health had protective effects, while partners who smoked and greater amount smoked prior to pregnancy had adverse effects.

- by W. Hall and +1
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- Psychology, Mental Health, Social Support, Treatment Outcome

HPV screening for cervical cancer in rural India. N Engl J Med 2009;360:1385-94.

- by Mulindi Mwanahamuntu
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- Cancer, Risk, Developing Countries, Medicine

Objective- , the Consolidated Standards of Reporting Trials (CONSORT) group released criteria for reporting critical information about randomized clinical trials (1,2). These criteria were intended to improve the quality and completeness of reporting of RCTs in health care research. This paper discusses the relevance of the CONSORT recommendations for the reporting and design of eHealth research.

- by S. Pingree and +1
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- Publishing, Research Design, Health Care, Health Services Research

Atopic dermatitis (eczema) is an immune-mediated dermatological condition characterized by severe and prolonged itching and rough, red patches of skin. Rash typically occurs on the face, neck, upper trunk, wrists, hands, knees, and elbows. It may form weeping, crusting lesions, which can become infected. Patients with atopic dermatitis may have difficulty sleeping due to the discomfort caused by the rash

- by Heather Oliff
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- Food Allergy, Cancer Therapy, Social Isolation, Clinical Study

Objective: To assess the effectiveness of aquatic physical therapy in the treatment of fibromyalgia. Review methods: The studies were separated into groups: Group I -aquatic physical therapy × no treatment, Group II -aquatic physical therapy × land-based exercises and Group III -aquatic physical therapy × other treatments. Results: Seventy-two abstracts were found, 27 of which met the inclusion criteria. For the functional ability (Fibromyalgia Impact Questionnaire), three studies were considered with a treatment time of more than 20 weeks and a mean difference (MD) of -1.35 [-2.04; -0.67], P = 0.0001 was found in favour of the aquatic physical therapy group versus no treatment. The same results were identified for stiffness and the 6-minute walk test where two studies were pooled with an MD of -1.58 [-2.58; -0.58], P = 0.002 and 43.5 (metres) [3.8; 83.2], P = 0.03, respectively. Conclusion: Three meta-analyses showed statistically significant results in favour of the aquatic physical therapy (Fibromyalgia Impact Questionnaire, stiffness and the 6-minute walk test) during a period of longer than 20 weeks. Due to the low methodological rigor, the results were insufficient to demonstrate statistical and clinical differences in most of the outcomes.

- by Jefferson Cardoso
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- Quality of life, Physical Therapy, Rheumatic Heart Disease, Meta Analysis

The review found no convincing evidence for the effectiveness of any therapeutic or preventive homeopathic treatment for the treatment of childhood and adolescent ailments. The authors' cautious conclusions were appropriate given the evidence presented and are likely to be reliable. Authors' objectives To evaluate the effectiveness of therapeutic or preventive homeopathy treatment for childhood and adolescent ailments. Searching MEDLINE, EMBASE, AMED, CINAHL, Cochrane Central Register of Controlled Trials (2005), British Homeopathic Library, ClinicalTrials.gov and UK National Research Register were searched from inception to January 2006 without language restrictions. Search terms were reported. Handsearching of conference proceedings and five relevant medical journals were also conducted. Bibliographies of all retrieved articles were scanned. Experts in the field were contacted for additional studies. Study selection Double-blind placebo-controlled randomised clinical trials (RCTs) of any homeopathic intervention for the prevention or treatment of childhood and adolescent ailments were eligible for inclusion. The age range of participants was 0 to 19 years based on the World Health Organisation classification. The included studies reported a wide variety of homeopathic remedies using different regimens, potencies and duration (details reported in review). A number of the included studies also reported usage of concomitant treatments. Participants in the included studies were aged from six months to 15 years. The proportion of males, when reported, ranged from 41% to 90%. Patient conditions included adenoid vegetation, attention-deficit/hyperactivity disorder (ADHD), asthma, acute otitis media, conjunctivitis, diarrhoea, postoperative pain agitation syndrome, upper respiratory tract infection and warts. Assessment of outcomes included use of the Conners' Global Index-Parent (CGI-P), Conners' Parent Symptom Questionnaire and parent diaries. Outcomes varied between studies and included need for adenoidectomy, size of adenoid vegetation, intensity, frequency and duration of asthma attacks, symptom scores and number of days with diarrhoea. Two reviewers independently selected studies for inclusion. Decisions were discussed and validated by a third reviewer. Disagreements were resolved through discussion. Assessment of study quality Validity was assessed and scored using the Jadad scale, which considered the reporting and handling of randomisation, blinding and handling of withdrawals. The maximum possible score was 5 points. Two reviewers independently assessed validity. Data extraction Data on each outcome and adverse events were extracted using a standard form. Two reviewers independently extracted data, which were discussed and validated by a third reviewer. Disagreements were resolved through discussion. Methods of synthesis The studies were combined in a narrative synthesis grouped by patient conditions. Each study was described in the text and additional descriptive information was presented in tables. Results of the review

- by edzard E Ernst
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- Evidence Based Medicine, Homeopathy, Randomization, Asthma

More successful methods of vasectomy reversal would benefit those undergoing this treatment and might also increase the popularity of vasectomy. We conducted a randomized, prospective clinical trial of vasectomy reversal methods, comparing a new absorbable stent with 2-layer reattachment.We studied 116 men seeking vasectomy reversal between November 1990 and March 1994. Data were analyzed primarily by intention to treat.Patients in the stent (64 cases) and no stent (52) randomized groups were similar in age distribution, age of spouses, years since vasectomy, proportion who had undergone prior vasectomy reversal and proportion who had previously achieved pregnancy. Operation time was more than 19 minutes shorter in the stent randomized group (p = 0.006). Fewer patients in the stent than the no stent group had patent vasovasostomies (81.0 versus 89.6%, respectively, p = 0.2) postoperatively. Fewer stent randomized patients had motile sperm (76.2 versus 81.3%, respectively, p = 0.5) and normal total motile sperm counts (49.2 versus 52.1%, respectively, p = 0.8) than did those without a stent. Conception occurred in 22 and 51% of all couples in the stent and no stent groups. The relative risk of conception among those in the stent group was 0.42 (95% confidence interval 0.24 to 0.71, p = 0.002). A Mantel-Cox log-rank test comparing pregnancies in each group according to the number of postoperative months revealed that the no stent group achieved more earlier pregnancies (p = 0.003).The 2-layer microscopic vasovasostomy results in greater pregnancy rates than vasovasostomy using the absorbable stent.

- by Richard Berger
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- Urology, Research Methodology, Clinical Trial, Treatment

Rising concern over the poor level of blood-pressure (BP) control among hypertensive patients has prompted searches for novel ways of managing hypertension. The objectives of this study were to develop and pilot-test a home BP tele-management system that actively engages patients in the process of care.Phase 1 involved a series of focus-group meetings with patients and primary care providers to guide the system’s development. In Phase 2, 33 diabetic patients with uncontrolled ambulatory hypertension were enrolled in a 4-month pilot study, using a before-and-after design to assess its effectiveness in lowering BP, its acceptability to users, and the reliability of home BP measurements.The system, developed using commodity hardware, comprised a Bluetooth-enabled home BP monitor, a mobile phone to receive and transmit data, a central server for data processing, a fax-back system to send physicians’ reports, and a BP alerting system. In the pilot study, 24-h ambulatory BP fell by 11/5 (±13/7 SD) mm Hg (both P < .001), and BP control improved significantly. Substantially more home readings were received by the server than expected, based on the preset monitoring schedule. Of 42 BP alerts sent to patients, almost half (n = 20) were due to low BP. Physicians received no critical BP alerts. Patients perceived the system as acceptable and effective.The encouraging results of this study provide a strong rationale for a long-term, randomized, clinical trial to determine whether this home BP tele-management system improves BP control in the community among patients with uncontrolled hypertension.

- by András Tislér
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- Primary Care, Clinical Trial, Cell Phones, Self Care

Background: Chronic headache is a prevalent condition with substantial socioeconomic impact. Complementary or alternative therapies are increasingly being used by patients to treat headache pain, and spinal manipulative therapy (SMT) is... more

Objective: The usefulness of massage as a recovery method after high-intensity exercise has yet to be established. We aimed to investigate the effects of whole-body massage on heart rate variability (HRV) and blood pressure (BP) after repeated high-intensity cycling exercise under controlled and standardized pretest conditions. Methods: The study included 62 healthy active individuals. After baseline measurements, the subjects performed standardized warm-up exercises followed by three 30-second Wingate tests. After completing the exercise protocol, the subjects were randomly assigned to a massage (myofascial release) or placebo (sham treatment with disconnected ultrasound and magnetotherapy equipment) group for a 40-minute recovery period. Holter recording and BP measurements were taken after exercise protocol and after the intervention. Results: After the exercise protocol, both groups showed a significant decrease in normal-to-normal interval, HRV index, diastolic BP (P N .001), and low-frequency domain values (P = .006). After the recovery period, HRV index (P = .42) and high-frequency (HF) (P = .94) values were similar to baseline levels in the massage group, whereas the HRV index tended (P = .05) to be lower and the HF was significantly (P b .01) lower vs baseline values in the placebo group, which also showed a tendency (P = .06) for HF to be lower than after the exercise. Likewise, diastolic BP returned to baseline levels in the massage group (P = .45) but remained lower in the placebo group (P = .02). Conclusion: Myofascial release massage favors the recovery of HRV and diastolic BP after high-intensity exercise (3 Wingate tests) to preexercise levels.

PURPOSE. To compare ocular component growth curves among four refractive error groups in children. METHODS Cycloplegic refractive error was categorized into four groups: persistent emmetropia between Ϫ0.25 and ϩ1.00 D (exclusive) in both the vertical and horizontal meridians on all study visits (n ϭ 194); myopia of at least Ϫ0.75 D in both meridians on at least one visit (n ϭ 247); persistent hyperopia of at least ϩ1.00 D in both meridians on all visits (n ϭ 43); and emmetropizing hyperopia of at least ϩ1.00 D in both meridians on at least the first but not at all visits (n ϭ 253). Subjects were seen for three visits or more between the ages of 6 and 14 years. Growth curves were modeled for the persistent emmetropes to describe the relation between age and the ocular components and were applied to the other three refractive error groups to determine significant differences. RESULTS At baseline, eyes of myopes and persistent emmetropes differed in vitreous chamber depth, anterior chamber depth, axial length, and corneal power and produced growth curves that showed differences in the same ocular components. Persistent hyperopes were significantly different from persistent emmetropes in most components at baseline, whereas growth curve shapes were not significantly different, with the exception of anterior chamber depth (slower growth in persistent hyperopes compared with emmetropes) and axial length (lesser annual growth per year in persistent hyperopes compared with emmetropes). The growth curve shape for corneal power was different between the emmetropizing hyperopes and persistent emmetropes (increasing corneal power compared with decreasing power in emmetropes). CONCLUSIONS Comparisons of growth curves between persistent emmetropes and three other refractive error groups showed that there are many similarities in the growth patterns for both the emmetropizing and persistent hyperopes, whereas the differences in growth lie mainly between the emmetropes and myopes.

- by Gladys Mitchell
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- Myopia, Persistence, Adolescent, Biological Sciences
- by Tatiana Moreno
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- Dentistry, Adolescent, Clinical, Follow-up studies

The eYcacy of balneotherapy in Wbromyalgia syndrome (FS) has been well demonstrated, while controlled studies using mud packs are lacking. We performed a randomized clinical trial to evaluate the eVects and the tolerability of mud-bath treatment in FS patients, who are poor responders to pharmacological therapy. Eighty patients with primary FS, according to ACR criteria, were randomly allocated to two groups: 40 were submitted to a cycle of 12 mud packs and thermal baths, and 40 were considered as controls. At baseline, after thermal treatment and after 16 weeks, patients were evaluated by FIQ, tender points count, VAS for "minor" symptoms, AIMS1 and HAQ. Control patients were assessed at the same time periods. A signiWcant improvement of all evaluation parameters after mud-bath therapy and after 16 weeks was observed. Mud packs were well tolerated and no drop-outs were recorded. Our results suggest the eYcacy and the tolerability of mud-bath treatment in primary FS.

- by F. Cozzi and +1
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- Rheumatology, Pain, Treatment Outcome, Pain Management

Background-Acute renal failure is a serious complication of cardiac surgery causing high morbidity and mortality. The aim of this study was to evaluate the usefulness of fenoldopam, a specific agonist of the dopamine-1 receptor, in patients at high risk of perioperative renal dysfunction. Methods and Results-A prospective single-center, randomized, double-blind trial was performed after local ethical committee approval and after written consent was obtained from 80 patients undergoing cardiac surgery. Patients received either fenoldopam at 0.05 g/kg per minute or dopamine at 2.5 g/kg per minute after the induction of anesthesia for a 24-hour period. All these patients were at high risk of perioperative renal dysfunction as indicated by Continuous Improvement in Cardiac Surgery Program score Ͼ10. Primary end point was defined as 25% creatinine increase from baseline levels after cardiac surgery. The 2 groups (fenoldopam versus dopamine) were homogeneous cohorts, and no difference in outcome was observed. Acute renal failure was similar: 17 of 40 (42.5%) in the fenoldopam group and 16 of 40 (40%) in the dopamine group (Pϭ0.9). Peak postoperative serum creatinine level, intensive care unit and hospital stay, and mortality were also similar in the 2 groups. Conclusions-Despite an increasing number of reports of renal protective properties from fenoldopam, we observed no difference in the clinical outcome compared with dopamine in a high-risk population undergoing cardiac surgery. (Circulation. 2005;111:3230-3235.)

- by Giacomo Aletti
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- Risk, Treatment Outcome, Continuous Improvement, Cardiac Surgery

Standardized effect size s u m m a r y Introduction: Treatment response in randomized clinical trials (RCT) of osteoarthritis (OA) has been assessed by multiple primary and secondary outcomes, including pain, function, patient and clinician global measures of status and response to treatment, and various composite and responder measures. Identifying outcome measures with greater responsiveness to treatment is important to increase the assay sensitivity of RCTs. Objective: To assess and compare the responsiveness of different outcome measures used in placebocontrolled RCTs of OA. Search strategy: The Resource for Evaluating Procedures and Outcomes of Randomized Trials database includes placebo-controlled clinical trials of pharmacologic treatments (oral, topical, or transdermal) for OA identified from a systematic literature search of RCTs published or publicly available before August 5, 2009, which was conducted using PubMed, the Cochrane collaboration, publicly-available websites, and reference lists of retrieved publications. Data collection and analysis: Data collected included: (1) pain assessed with single-item ratings and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale; (2) patient and clinician global measures of status, improvement, and treatment response; (3) function assessed by the WOMAC function subscale; (4) stiffness assessed by the WOMAC stiffness subscale; and (5) the WOMAC and Lequesne Algofunctional Index composite outcomes. Measures were grouped according to the total number of response categories (i.e., <10 categories or !10 categories). The treatment effect (difference in mean change from baseline between the placebo and active therapy arms) and standardized effect size (SES) were estimated for each measure in a meta-analysis using a random effects model. Results: There were 125 RCTs with data to compute the treatment effect for at least one measure; the majority evaluated non-steroidal anti-inflammatory drugs (NSAIDs), followed by opioids, glucosamine and/or chondroitin, and acetaminophen. In general, the patient-reported pain outcome measures had comparable responsiveness to treatment as shown by the estimates of treatment effects and SES. Treatment effects and SESs were generally higher for patient-reported global measures compared with clinician-rated global measures but generally similar for the WOMAC and Lequesne composite measures. Conclusions: Comparing different outcome measures using meta-analysis and selecting those that have the greatest ability to identify efficacious treatments may increase the efficiency of clinical trials of treatments for OA. Improvements in the quality of the reporting of clinical trial results are needed to facilitate meta-analyses to evaluate the responsiveness of outcome measures and to also address other issues related to assay sensitivity.

- by John Farrar
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- Treatment Outcome, Osteoarthritis, Effect size, Randomised Controlled Trial

STAR * D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are

- by Jerrold Rosenbaum
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- Research Design, Clinical Trial, Adolescent, Prospective studies

Objective: The aim of this study was to evaluate the influence of adding a 10-day course of levamisole (LVM) to the standard care compared with standard care alone, on the clinical status of COVID-19 patients with mild to moderate disease. Methods: In this randomized open-label trial, we enrolled non-hospitalized patients with mild to moderate COVID-19 at nine health centers in Tehran province, Iran, in 2021. Patients were randomly assigned to receive a 10-day course of LVM with standard care (n=185) or standard care alone (n=180) in a 1:1 ratio. On days 1 to 10, LVM was administered orally at a dosage of 50 mg. The participants were called and followed on days 1, 3, 5, 7, 9, and 14. The measured parameters were general health condition, hospitalization rate, signs and symptoms, and adverse events. The generalized estimating equations model was used for analysis. Results: Among 507 randomized patients, 473 patients started the experiment and received LVM plus standard care or received the standard care alone; 385 patients included in the analysis; 346 (98%) patients completed the trial. The median age of the patients was 40 years [IQR: 32-50.75]; and ‎201 (55.1%)‎ patiens were male. The mean age, sex ratio, and frequency of the underlying diseases of the patients in the two study groups had no ‎statistically significant differences (P>0.05). Compared to the control group, LVM improved the general health condition of the patients (B=-0.635; 95% CI: -0.041,-0.329; P<0.001). Patients receiving LVM compared with standard care group had significantly lower odds of developing fever (OR=0.260; 95% CI: 0.11‎‎3‎,0.59‎‎9‎; P=0.002), chills (OR=0.223; 95% CI:‎‎ 0.07‎‎6,‎0.64‎‎8‎; P= 0.006), fatigue (OR=0.576; 95% CI:‎ 0.34‎‎6,‎0.96‎‎0‎‎; P=0.034), and myalgia (OR=0.54‎‎4‎; 95% CI:‎ 0.31‎‎7‎,0.93‎‎2‎‎; P=0.027). No significant difference was observed in the rate of hospitalization. Although the intervention group had greater adverse effects than the control group, the difference was not statistically significant. Conclusion: Findings of this study suggest that LVM has clinical benefits in improving patients’ health condition with mild to moderate COVID-19.

- by Frontiers in Emergency Medicine and +2
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- Emergency Medicine, Randomized Clinical Trial, Levamisole, Signs and Symptoms

Metabolic syndrome poses additional risk for postmenopausal women who are already at risk for osteoporosis. We hypothesized that a nutritional supplement containing anti-inflammatory phytochemicals and essential bone nutrients would produce a favorable bone biomarker profile in postmenopausal women with metabolic syndrome. In this 14-week, randomized trial, 51 women were instructed to consume a modified Mediterranean-style, low-glycemic-load diet and to engage in aerobic exercise. Those in the intervention arm (n = 25) additionally received 200 mg hop rho iso-alpha acids, 100 mg berberine sulfate trihydrate, 500 IU vitamin D 3 , and 500 μg vitamin K 1 twice daily. Forty-five women completed the study. Baseline nutrient intake did not differ between arms. Compared with baseline, the intervention arm exhibited an approximate 25% mean decrease (P b .001) in serum osteocalcin (indicative of bone turnover), whereas the placebo arm exhibited a 21% increase (P = .003). Serum 25-hydroxyvitamin D increased 23% (P = .001) in the intervention arm and decreased 12% (P = .03) in the placebo arm. The between-arm differences for osteocalcin and 25-hydroxyvitamin D were statistically significant. Serum insulin-like growth factor I was statistically increased in both arms, but the between-arm differences were not statistically significant. Subanalysis showed that among those in the highest tertile of baseline insulin-like growth factor I, the intervention arm exhibited a significant increase in amino-terminal propeptide of type I collagen, whereas the placebo arm showed a significant decrease at 14 weeks. Treatment with rho iso-alpha acids, berberine, vitamin D 3 , and vitamin K 1 produced a more favorable bone biomarker profile indicative of healthy bone metabolism in postmenopausal women with metabolic syndrome.

- by rho alpha
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- Nutrition and Dietetics, Nutrition, Vitamin D, Vitamins

Background: The potential of primary care practice settings to prevent disease and morbidity through health habit counseling, screening for asymptomatic disease, and immunizations has been incompletely met. This study was designed to test a practice-tailored approach to increasing preventive service delivery with particular emphasis on health habit counseling.

- by Stephen Zyzanski
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- Program Evaluation, Primary Care, Education, Primary Health Care

We examine three pattern-mixture models for making inference about parameters of the distribution of an outcome of interest Y that is to be measured at the end of a longitudinal study when this outcome is missing in some subjects. We show that these pattern-mixture models also have an interpretation as selection models. Because these models make unverifiable assumptions, we recommend that inference about the distribution of Y be repeated under a range of plausible assumptions. We argue that, of the three models considered, only one admits a parameterization that facilitates the examination of departures from the assumption of sequential ignorability. The three models are nonparametric in the sense that they do not impose restrictions on the class of observed data distributions. Owing to the curse of dimensionality, the assumptions that are encoded in these models are sufficient for identification but not for inference. We describe additional flexible and easily interpretable assumptions under which it is possible to construct estimators that are well behaved with moderate sample sizes. These assumptions define semiparametric models for the distribution of the observed data. We describe a class of estimators which, up to asymptotic equivalence, comprise all the consistent and asymptotically normal estimators of the parameters of interest under the postulated semiparametric models. We illustrate our methods with the analysis of data from a randomized clinical trial of contracepting women.

- by Andrea Rotnitzky
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- Econometrics, Statistics, Model Selection, Sample Size

Women with pelvic girdle pain (PGP) often consult physical therapists for help and are treated with different therapies without firm evidence for the effectiveness. Two randomized controlled trials have investigated the effect of stabilizing exercises for PGP. The most recent study demonstrated significant positive results in favour of exercises (Stuge et al. The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy. A randomized controlled trial. Spine 2004a;29(10):351-9), the other did not (Mens et al. Diagonal trunk muscle exercises in peripartum pelvic pain: a randomized clinical trial. Phys. Ther. 2000;80 :1164-73). Consequently, the two studies provide contradictory advice for treatment of PGP. The question is thus, whether stabilizing exercises should be recommended as treatment for PGP. Both the studies are of high methodological quality and are comparable with regard to subjects studied. However, there are several differences in the interventions and these are explored and discussed for better understanding of the conflicting results. Exercises that focused on only global muscles showed no effect. However, these exercises were not individualized and they were instructed by videotape. In the more recent study, exercises that initially focused on local muscles, and then gradually added global muscles showed a significant, positive effect. Exercises in that study were supervised, corrected, individualized concerning choice of exercises, order and dosage, and pain was avoided. This comparison indicates that effective treatment of postpartum PGP may be achieved when exercises for the entire spinal musculature are included, individually guided and adapted to each individual. r

The logic of the randomized double-blind placebo control group design is presented, and problems with using the design in psychotherapy are discussed. Placebo effects are estimated by examining clinical trials in medicine and psychotherapy. In medicine, a recent meta-analysis of clinical trials with treatment, placebo, and no treatment arms was conducted (Hróbjartsson & Gøtzsche, 2001), and it was concluded that placebos have small or no effects. A re-analysis of those studies, presented here, shows that when disorders are amenable to placebos and the design is adequate to detect the effects, the placebo effect is robust and approaches the treatment effect. For psychological disorders, particularly depression, it has been shown that pill placebos are nearly as effective as active medications whereas psychotherapies are more effective than psychological placebos. However, it is shown that when properly designed, psychological placebos are as effective as accepted psychotherapies. © 2005 Wiley Periodicals, Inc. J Clin Psychol 61: 835–854, 2005.

- by Takuya Minami
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- Psychology, Clinical Psychology, Cognitive Science, Psychotherapy

Essential oils in one-stage full-mouth disinfection: double-blind, randomized clinical trial of long-term clinical, microbial and salivary effects Cortelli SC, Cortelli JR, Holzhausen M, Franco GCN, Rebelo RZ, Sonagere AS, Queiroz CS, Costa FO. Essential oils in one stage full-mouth disinfection: doubleblind, randomized clinical trial of long-term clinical, microbial and salivary effects.

- by Sheila C Cortelli
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- Dentistry, Essential Oil, Clinical, Saliva

Despite a lack of evidence that needle exchange programs (NEPs) cause an increase in injection drug use, there are still concerns over fostering increased injection behavior with NEPs. The design was a randomized controlled trial conducted from May 1997 to June 2000 comparing injection drug users (IDUs) who are randomly assigned to have access to an NEP versus training in how to purchase needles and syringes (NS) at pharmacies. Of 653 IDUs recruited into the study, 600 were randomized: 426 were followed-up at 6 months, and 369 were followed-up at 12 months. Four hundred ninety were followed up at least once. There was no difference in the number of injections over time between the NEP and the Pharmacy Sales arms of the study or in the percentage of positive urine test results over time between the NEP and the Pharmacy Sales arms of the study for morphine and amphetamine. The decrease in the presence of cocaine was marginally greater between the arms of the study. The results do not support the hypothesis of NEPs causing an increase in injection drug use. This clinical trial provides the strongest evidence to date that needle exchanges do not produce this negative effect.

- by Dennis Fisher
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- Program Evaluation, Algorithms, Cocaine, Amphetamine

Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the mindfulness-based stress reduction (MBSR) program for adolescents age 14 to 18 years with heterogeneous diagnoses in an outpatient psychiatric facility (intent-to-treat N ϭ 102). Relative to treatment-as-usual control participants, those receiving MBSR self-reported reduced symptoms of anxiety, depression, and somatic distress, and increased self-esteem and sleep quality. Of clinical significance, the MBSR group showed a higher percentage of diagnostic improvement over the 5-month study period and significant increases in global assessment of functioning scores relative to controls, as rated by condition-naïve clinicians. These results were found in both completer and intent-to-treat samples. The findings provide evidence that MBSR may be a beneficial adjunct to outpatient mental health treatment for adolescents.

- by Kirk Warren Brown
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- Psychology, Anxiety Disorders, Emotional intelligence, Mental Health

ority of dialyzer reuse versus single use when assessing the mortality of patients with end-stage renal disease. Studies of higher quality, including randomized clinical trials, are required to provide conclusive evidence regarding the... more

- by Tais Galvao
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- End Stage Renal Disease, Statistical Significance, American, Disinfection

It has been suggested that yoga has a positive effect on low back pain and function. The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for low back pain. Seven databases were searched from their inception to March 2011. Randomized clinical trials were considered if they investigated yoga in patients with low back pain and if they assessed pain as an outcome measure. The selection of studies, data extraction and validation were performed independently by two reviewers. Seven randomized controlled clinical trials (RCTs) met the inclusion criteria. Their methodological quality ranged between 2 and 4 on the Jadad scale. Five RCTs suggested that yoga leads to a significantly greater reduction in low back pain than usual care, education or conventional therapeutic exercises. Two RCTs showed no between-group differences. It is concluded that yoga has the potential to alleviate low back pain. However, any definitive claims should be treated with caution.

- by edzard E Ernst
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- Complementary and Alternative Medicine, Yoga, Low back pain, Systematic review

The purpose of the study was to assess the efficacy of epidural steroid injections for low-back pain. Data was obtained using computer-aided search of published randomized clinical trials and assessment of the methods of the studies. Twelve randomized clinical trials evaluating epidural steroid injections were identified. Data was extracted based on scores for quality of the methods, using 4 categories (study population, interventions, effect measurement, and data presentation and analysis) and the conclusion of the author(s) with regard to the efficacy of epidural steroid injections. Method scores of the trials ranged from 17 to 72 points (maximum 100 points). Eight trials showed method scores of 50 points or more. Of the 4 best studies (> 60 points), 2 reported positive outcomes and 2 reported negative results. Overall, 6 studies indicated that the epidural steroid injection was more effective than the reference treatment and 6 reported it to be no better or worse than the reference treatment. There appeared to be no relationship between the methodological quality of the trials and the reported outcomes. In conclusion, there are flaws in the design of most studies. The best studies showed inconsistent results of epidural steroid injections. The efficacy of epidural steroid injections has not yet been established. The benefits of epidural steroid injections, if any, seem to be of short duration only. Future research efforts are warranted, but more attention should be paid to the methods of the trials.

- by Bart Koes
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- Pain, Low back pain, Systematic review, Randomized Clinical Trial

Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel noninvasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy Ò (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person's body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (±25) to 32 (±27) with the IDD protocol and 53 (±26) to 36 (±27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.

- by Wilco Jacobs
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- Biomedical Engineering, Coping Strategies, Spine, Quality of life

A collection of computer-based respiratory care algorithms were implemented as a prototype computerbased patient advice system (COMPAS) within the existing HELP hospital information system. Detailed medical logic recommended ventilator adjustments for 5 different modes of ventilation: assist/control (A/C), intermittent mandatory ventilation (IMV), continuous positive airway pressure (CPAP), pressure controlled inverted ratio ventilation (PC-IRV), and extracorporeal carbon dioxide removal (ECCO2R). Suggestions for adjusting the mode of ventilation, fraction of inspired oxygen (FiO2), positive end-expiratory pressure (PEEP), peak inspiratory pressure, and several other therapeutic measures related to the treatment of severe arterial hypoxemia in adult respiratory distress syndrome (ARDS) patients were automatically presented to the clinical staff via bedside computer terminals. COMPAS was clinically evaluated for 624 hours of patient care on the first 5 ARDS patients in a randomized clinical trial. The clinical staff carried out 84% (320/379) of the computerized therapy suggestions. In response to a questionnaire distributed to clinical users of the system, 86% judged the system to be potentially valuable. Through implementation of COMPAS, a computer-based ventilatory therapy advice system, we have laid the groundwork for standardization of ventilator management of arterial hypoxemia in critically ill ARDS patients.

- by Dean Sittig
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- Algorithms, Biomedical Engineering, Carbon Dioxide, Software

Objective: To compare vision therapy/orthoptics, pencil push-ups, and placebo vision therapy/orthoptics as treatments for symptomatic convergence insufficiency in children 9 to 18 years of age. Methods: In a randomized, multicenter clinical trial, 47 children 9 to 18 years of age with symptomatic convergence insufficiency were randomly assigned to receive 12 weeks of office-based vision therapy/orthoptics, officebased placebo vision therapy/orthoptics, or home-based pencil push-ups therapy. Main Outcome Measures: The primary outcome measure was the symptom score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures were the near point of convergence and positive fusional vergence at near. Results: Symptoms, which were similar in all groups at baseline, were significantly reduced in the vision therapy/ orthoptics group (mean symptom score decreased from 32.1 to 9.5) but not in the pencil push-ups (mean symptom score decreased from 29.3 to 25.9) or placebo vision therapy/orthoptics groups (mean symptom score decreased from 30.7 to 24.2). Only patients in the vision therapy/orthoptics group demonstrated both statistically and clinically significant changes in the clinical measures of near point of convergence (from 13.7 cm to 4.5 cm; PϽ.001) and positive fusional vergence at near (from 12.5 prism diopters to 31.8 prism diopters; PϽ.001). Conclusions: In this pilot study, vision therapy/ orthoptics was more effective than pencil push-ups or placebo vision therapy/orthoptics in reducing symptoms and improving signs of convergence insufficiency in children 9 to 18 years of age. Neither pencil push-ups nor placebo vision therapy/orthoptics was effective in improving either symptoms or signs associated with convergence insufficiency.

- by Richard London
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- Ophthalmology, Binocular vision, Archives, Adolescent

In 1962, Louis Lasagna was one of the central figures in the creation of our current drug regulation systems. His influence on the practice of modern medicine, through a series of unanticipated consequences of these systems, has been profound. In the 1960s, he was one of the most progressive thinkers in medicine. By the 1980s, he had apparently become one of the most reactionary. This article attempts to delineate the dilemmas he believed he was dealing with, dilemmas that stemmed from a system he had helped create, that produced this apparent change in orientation. The problems with which he grappled are ones that remain unresolved and, indeed, have become more acute. The example of how he attempted to remedy what had gone wrong may provide pointers as to how to solve or how not to solve current difficulties.

- by Kalman Applbaum
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- History of Medicine, Randomized Clinical Trial

Objective Examine a model that encourages health at every size as opposed to weight loss. The health at every size concept supports homeostatic regulation and eating intuitively (ie, in response to internal cues of hunger, satiety, and appetite). Design Six-month, randomized clinical trial; 2-year followup. Subjects White, obese, female chronic dieters, aged 30 to 45 years (Nϭ78). Setting Free-living, general community. Interventions Six months of weekly group intervention (health at every size program or diet program), followed by 6 months of monthly aftercare group support. Main outcome measures Anthropometry (weight, body mass index), metabolic fitness (blood pressure, blood lipids), energy expenditure, eating behavior (restraint, eating disorder pathology), and psychology (self-esteem, depression, body image). Attrition, attendance, and participant evaluations of treatment helpfulness were also monitored. Statistical analysis performed Analysis of variance. Results Cognitive restraint decreased in the health at every size group and increased in the diet group, indicating that both groups implemented their programs. Attrition (6 months) was high in the diet group (41%), compared with 8% in the health at every size group. Fifty percent of both groups returned for 2-year evaluation. Health at every size group members maintained weight, improved in all out-come variables, and sustained improvements. Diet group participants lost weight and showed initial improvement in many variables at 1 year; weight was regained and little improvement was sustained.

- by Linda Bacon and +2
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- Health Promotion, Nutrition, Obesity, Statistical Analysis

A randomized clinical trial was undertaken to investigate the relative efficacy of rational-emotive behavior therapy (REBT), cognitive therapy (CT), and pharmacotherapy in the treatment of 170 outpatients with nonpsychotic major depressive disorder. The patients were randomly assigned to one of the following: 14 weeks of REBT, 14 weeks of CT, or 14 weeks of pharmacotherapy (fluoxetine). The outcome measures used were the Hamilton Rating Scale for Depression and the Beck Depression Inventory. No differences among treatment conditions at posttest were observed. A larger effect of REBT (significant) and CT (nonsignificant) over pharmacotherapy at 6 months follow-up was noted on the Hamilton Rating A version of this article was presented at the European Congress of the European Association of Behavioral and Cognitive Therapies, Thessaloniki, Greece in 2005. A manual and clinical guide based on this research (cited herein) was published in Romania (David, 2006).

- by Daniel David
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- Psychology, Clinical Psychology, Cognitive Science, Treatment Outcome

The objective of this study was to assess outcomes of traditional treatment of fractures using the SF-36 and the Cummings Hip Scale. In designing randomized clinical trials, it is necessary to determine the timing of assessment either for progress or for the main outcome. We set out to document the recovery of patients after surgery for hip fracture using current standard methods of medical care. This was a prospective study of a cohort of patients. Patients who were receiving standard medical care completed the SF-36 and the Cummings Hip Scale at previously determined times postoperatively. The SF-36 has eight subscales, including assessments of physical function, physical role behaviors, bodily pain, mental health, social role, emotional role, vitality and general health. Thirty-eight patients completed the questionnaires at 1 year postoperatively as well as previous time points. On the Cummings Hip Scale and the physical function, bodily pain, mental health, social function, emotional role, vitality and general health subscales of the SF-36, recovery is near complete at 6 months. Only the physical role subscale differs, with a statistically significant difference between the values at 6 months and 1 year, (p = 0.02). Patients attained over 90% of the 1 year value by 6 months for all except the physical role subscale. The physical role subscale reached 85%. For a hip fracture patient who is on the road to recovery, the majority of the recovery has therefore taken place by 6 months.

- by Sandy Ganz
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- Mental Health, Clinical Trial, Prospective studies, Osteoporosis
- by Joan Eckerson
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- Health Care, Weight Loss, United States, Energy Expenditure

Part I of this article reviewed the history, etiology and underlying mechanisms of CRPS I and II. The current article reviews the available research of physical therapy treatment interventions for patients with CRPS. As outlined in Part 1 of this article, there continues to be much uncertainty about the underlying mechanisms of CRPS. It remains challenging to develop evidence-based guidelines for physical therapy or for any other discipline. There is a paucity of prospective randomized clinical trials. The majority of published reports are case reports or consensus-based. Although the article is written primarily from a physical therapy perspective, the clinical guidelines are also of interest to other health care providers. Given the complexity and scope of CRPS, an interdisciplinary management approach is recommended.

Objective: To calculate the proportion of care delivered in a chiropractic practice supported by good-quality clinical trials. Design: Retrospective survey. Methods: Data were collected from patient files relating to 180 consecutive patient visits in a suburban chiropractic practice in northern Spain. Each patient's presenting complaint was paired with the chiropractor's chosen primary intervention. Based on a literature review (Medline, Mantis, and nonautomated searches of local medical libraries), each presenting complaint–primary intervention pairing was categorized according to the level of supporting evidence as follows: Category I, intervention based on good quality clinical trial evidence; Category II, intervention based on poor-quality or no clinical trial evidence. To distinguish between good- and poor-quality clinical trials, studies were critically appraised and assigned quality scores. Results: Of the 180 cases surveyed, 123 (68.3%) (95% CI, 61.5%-75.1%) were based on clinical trials of good methodologic quality (Category I). Only 57 (31.7%) (95% CI, 24.9%-38.5%) of the cases were based on poor-quality or no clinical trial evidence (Category II). Conclusions: When patients were used as the denominator, the majority of cases in a chiropractic practice were cared for with interventions based on evidence from good-quality, randomized clinical trials. When compared to the many other studies of similar design that have evaluated the extent to which different medical specialties are evidence based, chiropractic practice was found to have the highest proportion of care (68.3%) supported by good-quality experimental evidence. (J Manipulative Physiol Ther 2003;26:000)