The 13th International Cochrane Colloquium in Melbourne: an invitation for complementary and alternative medicine researchers and consumers.
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Biomedical subjects
Publications and source records attributed to Brian Berman.
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The purposes of this study were to determine the characteristics of headaches in children with sickle cell disease (SCD) and to assess the relationship between headache symptoms and children's physical and emotional status. A detailed headache questionnaire using International Classification of Headache Disorders (ICHD-2) criteria was mailed to a cohort (n = 50) of children with SCD, ages 9 to 17 years. Respondents also completed measures of functional disability and psychological distress. Headaches had occurred over the previous 3-month period in 76.2% of the patients. Frequent headaches were common, occurring greater than once a week in 31.2% of children. Average pain severity was reported as moderate on a 0-to-10 scale (mean = 5.8). Duration of headaches ranged from 30 minutes to several days, with a mean of 5 hours. Based on ICHD-2 criteria, 43.8% of children had headache symptoms consistent with migraines, 6.2% with migraine with aura, and 50.0% with tension-type headaches. Children with symptoms of migraine had significantly greater functional disability compared with children with symptoms of tension-type headaches (P < 0.01). Further studies to determine the characteristics and determinants of headaches experienced in SCD patients will help maximize treatment of headaches and enhance daily functioning in these patients.
BACKGROUND: Dermatologic procedures often cause some degree of pain. A self-warming patch containing lidocaine and tetracaine (L/T) was developed to provide topical local anesthesia prior to painful procedures. OBJECTIVES: To evaluate the safety and efficacy of a self-warming L/T patch to provide anesthesia in adult patients undergoing minor dermatologic procedures. METHODS: An active or placebo study drug was placed on adults 30 minutes prior to minor dermatologic surgical procedures in a prospectively randomized, double-blinded manner. Subcutaneous lidocaine injection was available during the procedure as a rescue medication if requested by the subject. Immediately following the procedure, the subjects, the investigator, and an independent observer rated pain intensity and adverse events were recorded. RESULTS: Patient-reported pain intensity was significantly lower in the L/T patch group (p<.001). Investigators and an independent observer rated the pain in the L/T patch group to be less than in the placebo patch group (p = .004 and p<.001, respectively). Forty-nine percent of patients in the placebo group required rescue subcutaneous lidocaine compared with 22% in the L/T patch study group (p = .008). One patient in the L/T patch group reported a transient moderate burning sensation. CONCLUSION: The self-warming L/T patch was effective in providing clinically useful local anesthesia for minor dermatologic procedures in adult patients.
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BACKGROUND: It has been reported that topical application of imiquimod 5% cream induces interferon-alpha, an antifibrotic cytokine. OBJECTIVE: To determine the tolerability and effectiveness on the cosmetic outcome of the application of imiquimod to postsurgical excision sites. MATERIALS AND METHODS: A prospective, double-blinded, randomized, vehicle-controlled trial was conducted among 20 patients with two skin lesions clinically diagnosed as melanocytic nevi. Imiquimod 5% cream was applied to one of the sutured surgical wounds starting the night of the excision nightly for a period of 4 weeks. The second sutured excision site was treated with vehicle cream. Scar cosmesis, erythema, pigmentary alterations, induration, tenderness, and pain were assessed using a visual analogue scale 2, 4, and 8 weeks after surgery. RESULTS: Eighteen subjects completed the study, with a total of 36 excision sites; no wound site dehisced, and no signs of infection were noted. Surgical wounds treated with imiquimod had more erythema, pigmentary alterations, and lower cosmesis rated by the investigator compared with wounds treated with placebo, both becoming nonsignificant in further evaluations. For pigmentary alterations, induration, and cosmesis rated by the patients, no statistically significant difference between treatment groups was observed at week 8. CONCLUSION: Treatment of surgical excision-site wounds with imiquimod was well tolerated and without serious adverse events. Evaluations for cosmesis of placebo-treated surgical sites were better than imiquimod-treated sites at week 8, becoming nonsignificant later.
Conventional treatments for osteoarthritis (OA), the most common form of arthritis, are associated with unpleasant adverse effects and often ineffective. Acupuncture and traditional Chinese medicine (TCM) have been used for thousands of years to treat pain and other dysfunctions. However, the scientific evidence on the efficacy of acupuncture and TCM is equivocal, and adapting the Western biomedical model to assess them is a great challenge. By adopting a systematic, step-by-step approach, the research team at the University of Maryland has been carefully evaluating the effectiveness of acupuncture on knee OA over the past 10 years. Their successful experience may be a useful model for future acupuncture and TCM research.
Rosacea affects many individuals and is commonly treated with long-term antibiotics, which are associated with the emergence of antibiotic-resistant organisms. Recently, subantimicrobial dose doxycycline 20 mg twice a day (SDD) has been used to treat rosacea because of its anti-inflammatory properties. Results of clinical studies support the benefits of SDD, its efficacy in rosacea and acne vulgaris, and even its potential use to prevent atherosclerosis.
BACKGROUND: Demand for complementary and alternative therapies is increasing and is affecting all healthcare settings, including critical care. METHODS: A random sample of members of the American Association of Critical-Care Nurses was surveyed to determine the members' attitudes, knowledge, perspectives, and use of complementary and alternative therapies. RESULTS: Most of the 726 respondents were using one or more complementary and alternative therapies in practice. The most common therapies used were diet, exercise, relaxation techniques, and prayer. A majority of the nurses had some knowledge of more than half of the 28 therapies listed on the survey, and a majority desired additional training for 25 therapies. Respondents generally required more evidence judged as essential to use or recommend conventional therapy than to use or recommend complementary and alternative therapies. Nurses viewed complementary and alternative therapies positively overall, were open to use of the therapies, and perceived them as legitimate and beneficial to patients. Nurses judged the therapies helpful for treatment of a variety of symptoms. A majority of nurses desired an increase in the availability of the therapies for patients, patients' families, and nursing staff. Nurses' professional use of the therapies was related to having more knowledge of them, perceiving benefits of them, total number of therapies they recommended to patients, personal use, and affiliation with a mainstream religion. CONCLUSIONS: Educational programs that provide information about use of complementary and alternative therapies and the underlying evidence base most likely will increase the appropriate use of the therapies to achieve desired outcomes.
BACKGROUND AND PURPOSE: Ischemic stroke occurs in at least 11% of patients with homozygous sickle cell anemia (SCD) by the time they turn 20 years old. High risk associated with distal intracranial internal carotid (ICA) and proximal middle cerebral artery (MCA) stenosis can be detected by transcranial Doppler (TCD). TCD screening offers the possibility of reducing the risk of first stroke significantly based on a paradigm tested and proven to be effective in a stroke prevention trial in sickle cell anemia (STOP). Children with high flow velocity in the ICA and MCA of 200 cm/s time average mean of the maximum (TAMM) or higher had a 10% per year risk of first stroke that was reduced to <1% with regular red cell transfusion (reduction of hemoglobin S <30%). The clinical application of the STOP results could be enhanced if criteria for treatment could be found that are based on peak systolic velocity (PSV), the measure more commonly used in vascular ultrasound practice. OBJECTIVE: To compare PSV and end diastolic velocity (EDV) with TAMM for prediction of stroke and to derive PSV cutpoints for STOP protocol definitions of conditional and abnormal TCD. Using the STOP TCD and stroke outcome data to compare PSV and TAMM in terms of stroke prediction, PSV cutpoints comparable to those based on TAMM and used in STOP were derived. Because of their familiarity to the vascular ultrasound community, PSV cutpoints should be an important alternative to TAMM and may increase availability of screening and risk stratification for children with this disease. MATERIALS AND METHODS: Data from 1,937 baseline TCD studies from STOP were correlated with stroke outcome in those not treated with transfusion. Stroke prediction was assessed with survival analysis using TAMM, PSV and EDV as continuous variables individually and then pair-wise in the same model, which contained 53 stroke events. RESULTS: PSV and EDV were highly correlated to the TAMM velocity (r=0.94). The multivariate model for prediction indicated that TAMM velocity was a better predictor than EDV, and PSV and TAMM were approximately equivalent. PSV cutpoints defining the two relevant STOP risk categories--"conditional," which should lead to increased TCD surveillance, and "abnormal," which should lead to strong consideration for treatment according to STOP--were derived taking into consideration known differences in measurements between the dedicated Doppler systems (TCD) used in STOP and the transcranial Doppler imaging (TCDI) systems commonly used in clinical practice. The recommended PSV cutpoint for conditional TCD is 200 cm/s, and for abnormal TCD triggering consideration for treatment is 250 cm/s. CONCLUSION: Assuming TCDI equipment is used and the STOP protocol is applied, a PSV cutpoint of 200 cm/s is recommended as the threshold for increased TCD surveillance (comparable to a TCD TAMM of 170 cm/s in STOP); a PSV of 250 cm/s is recommended as the cutpoint at which, if confirmed in a second examination, chronic transfusion should be considered. Assuming the STOP scanning protocol is used, PSV is at least as good as TAMM and can be used to select children with SCD for treatment or increased surveillance to prevent first stroke.
Numerous treatments have been described for the treatment and prevention of scars, but the optimal management strategy is yet to be defined. In this article we present and evaluate new opportunities for the treatment and prevention of hypertrophic scars, keloids, and atrophic scars. Clinical, animal, and in vitro studies reporting novel techniques for the treatment and prevention of scarring were identified primarily from the MEDLINE/PubMed database. We found that a variety of new treatments exist with potential effectiveness for the treatment of hypertrophic scars and keloids, including interferon, imiquimod 5% cream, tacrolimus, botulinum toxin, 5-fluorouracil, bleomycin, and verapamil. For atrophic scars, different types of lasers represent modern treatment modalities with satisfactory results. Several agents have been reported to be effective in reducing scarring in vitro and in animal studies, representing potential opportunities for scarring management. We conclude that several novel modalities may be potential therapies for scarring.
Ten patients with superficial infantile hemangiomas were treated with imiquimod 5% cream for up to 16 weeks. Four patients achieved complete clinical resolution, 3 had excellent improvement, one showed moderate improvement, and one patient did not respond to therapy. Imiquimod may be an effective alternative for the treatment of superficial hemangiomas.
BACKGROUND: Five percent imiquimod cream is FDA-approved for the treatment of genital and perianal warts and actinic Keratosis. The manufacturer recommends that a single sachet containing 250 mg of 5% imiquimod cream (12.5 mg of imiquimod) is adequate for a single use and is sufficient to cover a wart area of up to 20 cm(2). OBJECTIVE: To determine the maximal area of skin that can be evenly covered by 250 mg of 5% imiquimod cream that is contained in one single-use sachet. METHODS: The contents of one 250-mg single-use sachet of 5% imiquimod cream were mixed with less than 1 mg of fluorescein sodium. The cream was applied evenly onto the abdomen of two Yorkshire female pigs and onto the medial and lateral aspects of the upper left arm of a human subject. The area of application was then measured. RESULTS: The average area obtained on the pig skin was 196 cm(2). The area covered on the human subject was 386 cm(2). CONCLUSION: We have found that one sachet of 250 mg of 5% imiquimod cream can be applied to an area of skin up to 386 cm(2). In light of the increasing use of 5% imiquimod cream in the treatment of cutaneous diseases, such as actinic keratoses, which affect larger areas of skin than genital warts, a more efficient use of 5% imiquimod cream may make this medication a more cost-effective treatment modality.
The stroke prevention study in sickle cell disease (STOP) demonstrated a 90% reduction in stroke risk with transfusion among patients with time-averaged mean cerebral blood velocity (TAMV) of 200 cm/s or more as measured by transcranial Doppler (TCD). In STOP, 232 brain magnetic resonance angiograms (MRAs) were performed on 100 patients, 47 in the transfusion arm and 53 in the standard care arm. Baseline MRA findings were interpreted as normal in 75 patients and as indicating mild stenosis in 4 patients and severe stenosis in 21 patients. Among 35 patients who underwent magnetic resonance angiography within 30 days of random assignment, the TAMV was significantly higher in 7 patients with severe stenosis compared with 28 patients with normal MRA findings or mild stenosis (276.7 +/- 34 vs 215 +/- 15.6 cm/s; P<.001). In the standard care arm, 4 of 13 patients with abnormal MRA findings had strokes compared with 5 of 40 patients with normal MRA findings (P=.03). In this arm, TAMV became normal (less than 170 cm/s) or conditional (170-199 cm/s) in 26 of 38 patients with normal or mildly abnormal baseline MRA but remained abnormal in 8 of 10 patients with severely abnormal baseline MRA. These results suggest that TCD often detects flow abnormalities indicative of stroke risk before MRA lesions become evident. Furthermore, patients with abnormal MRA findings and higher TCD velocities are at higher risk for stroke, and their cerebral TAMVs are unlikely to decrease without transfusion.
Cerebrovascular disease is a common cause of morbidity in sickle cell anemia (HbSS): approximately 10% of patients have a clinical stroke before 20 years of age, and another 22% have silent infarction on magnetic resonance imaging. The phenotypic variation among patients with HbSS suggests a role for modifier genes and/or environmental influences. To assess the familial component of clinical stroke in HbSS, we estimated the prevalence of clinical stroke among all patients and among HbSS sibling pairs at 9 pediatric centers. The sample included 3425 patients with sickle cell disease who were younger than 21 years, including 2353 patients with HbSS. The stroke prevalence was 4.9% for all genotypes; 7.1% for patients with HbSS; 1.1% for patients with HbSbeta(o) thalassemia; 0.6% for patients with Sbeta(+) thalassemia; and 0% for patients with HbSC. In 207 sibships, more than 1 child had HbSS. There were 42 sibships in which at least 1 sibling had a stroke, and in 10 of the 42, 2 siblings had a stroke. A permutation test indicated that the number of families in which 2 children had strokes was larger than the number expected if strokes were randomly distributed among children in sibships (P =.0012). There was no difference in stroke prevalence based on sex, nor was the mean age at stroke presentation significantly different between singletons and sibships with stroke. We conclude that there is a familial predisposition to stroke in HbSS. Attempts to identify genetic modifiers should be initiated with family-based studies.
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Americans use CAM therapies now more than ever before, yet there is a shortage of accessible high-quality evidence from clinical trials to show which CAM therapies work best and for which conditions. The need for such evidence is great, not only among people with serious, chronic health conditions, but also among healthcare providers, who often require clinical trial evidence before recommending a medical treatment. For the last few years, the University of Maryland Center for Integrative Medicine has been working steadily to meet this need for information by identifying published clinical trials of alternative therapies, summarizing these into rigorous scientific reviews, and disseminating these reviews to the general public and to healthcare providers. In May 2003, the Center was awarded a large 4-year research grant from the National Institutes of Health's National Center for Complementary and Alternative Medicine (NCCAM) to support and extend this important work.
BACKGROUND: The treatment of striae distensae has recently been reported with various lasers such as the 585-nm pulsed dye laser. At lower fluences (2.0 to 4.0 J/cm2), this laser has been purported to increase the amount of collagen in the extracellular matrix. OBJECTIVE: To determine whether the 585-nm pulsed dye laser is effective in both striae rubra and striae alba after two treatments and, in addition, to determine whether there is a net effect on collagen density in treated samples. METHODS: Twenty patients (skin types II to VI) with either striae rubra (9) or striae alba (11) were treated at baseline and at week 6. The total length of the study was 12 weeks. Untreated striae on the same patient were used as control subjects. Striae clinical parameters such as color and area were measured before the first and after the last treatment by an independent examiner using a visual analog scale. A hydroxyproline assay was used to measure collagen changes in two of the striae quantitatively. RESULTS: The 585 nm had a moderate beneficial effect in reducing the degree of erythema in striae rubra. There was no apparent clinical change on striae alba. Total collagen per gram of dry weight of sampled tissue increased in striae treated with pulsed dye laser versus control subjects. CONCLUSION: We recommend the use of the 585-nm pulsed dye laser for striae rubra in patients skin types II to IV. Extreme caution or avoidance should be observed in pulsed dye laser treatments for patients with phototypes V to VI even with the use of low fluences. Tissue collagen changes measured may be an early change, which precedes significant clinical improvement.
BACKGROUND: Keloid treatment represents a therapeutic challenge. New adjuvant therapy is needed to reduce the high recurrence rate (50%) of excised keloids. OBJECTIVE: To describe the method for using imiquimod 5% cream in the prevention of keloid recurrence after surgery. METHODS: This is a review of the scientific rationale and clinical experience of using imiquimod 5% cream for keloid management. CONCLUSION: Topical application of imiquimod 5% cream after surgery reduces keloid recurrences.