Bruce Barrett

Medicinal properties of Echinacea: A critical review

Preparations from Echinacea purpurea are among the most widely used herbal medicines. Most uses of E. purpurea are based on the reported immunological properties. A series of experiments have demonstrated that E. purpurea extracts do indeed demonstrate significant immunomodulatory activities. Among the many pharmacological properties reported, macrophage activation has been demonstrated most convincingly. Phagocytotic indices and macrophage-derived cytokine concentrations have been shown to be Echinacea-responsive in a variety of assays. Activation of polymorphonuclear leukocytes and natural killer cells has also been reasonably demonstrated. Changes in the numbers and activities of T- and B-cell leukocytes have been reported, but are less certain. Despite this cellular evidence of immunostimulation, pathways leading to enhanced resistance to infectious disease have not been described adequately. Several dozen human experiments--including a number of blind randomized trials--have reported health benefits. The most robust data come from trials testing E. purpurea extracts in the treatment for acute upper respiratory infection. Although suggestive of modest benefit, these trials are limited both in size and in methodological quality. Hence, while there is a great deal of moderately good-quality scientific data regarding E. purpurea, effectiveness in treating illness or in enhancing human health has not yet been proven beyond a reasonable doubt.

Sufficiently important difference: Expanding the framework of clinical significance

Background . It is generally agreed that randomized controlled trials should be powered to detect small but clinically significant treatment effects. Toward these ends, minimal important difference (MID) was proposed as a benchmark for designing trials and for interpreting health-related quality-of-life instrument scores. MID was defined in 1989 as “the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troubling side effects and excessive cost, a change in the patient’s management.” Objective. 1) To expand the idea of minimal clinically important difference so as to take into account harms as well as benefits. 2) To propose concepts and methods with which to do so. Summary . The authors define sufficiently important difference (SID) as the smallest amount of patient-valued benefit that an intervention would require to justify associated costs, risks, and other harms. As a means toward estimation of SID, the authors propose benefit-harm tradeoff methods, in which domains of benefit and harm are systematically traded off against each other and assessed in relation to the global decision of whether a treatment choice is worthwhile. Specific SID estimates can be used to power and interpret clinical trials or to inform health services research and/or public health policy. This article briefly describes the evolution of the important difference concept and outlines similarities and differences between MID and SID.

The Wisconsin Upper Respiratory Symptom Survey is responsive, reliable, and valid

Abstract Objective To assess reliability, responsiveness, importance to patients, and convergent validity for the Wisconsin Upper Respiratory Symptom Survey (WURSS-44) and to develop a short-form WURSS. Study Design and Setting Community-based recruitment of participants with colds. Prospective monitoring from within 48 hours of first symptom until 2 days after end of cold. The WURSS-44 includes 1 global illness severity item, 32 symptom-based items, 10 functional quality-of-life items, and 1 item assessing global change. The SF-36, SF-8, and the Jackson cold scale were used as external comparators. Results Participants included 104 women and 45 men, aged 18 to 80 years, self-reporting on 1,681 person-days of illness. Factor analysis suggested 10 dimensions, with reliability coefficients from 0.62 to 0.93. Comparing daily WURSS-44 to Jackson and SF-8 yielded Pearson correlation coefficients from 0.73 to 0.93, and from −0.60 to −0.84, respectively. Importance to patients and responsiveness assessment yielded a short version, the WURSS-21. Guyatts responsiveness index was 0.54 for the SF-8, 0.61 for the Jackson, 0.71 for the WURSS-44, and 0.80 for the WURSS-21, suggesting that a two-armed trial would require 74 participants for the WURSS-21, 92 for the WURSS-44, 124 for the Jackson scale, and 156 for the SF-8. Conclusions The construct validity of WURSS-44 is supported by measures of reliability, responsiveness, importance to patients, and convergence. A shorter version, the WURSS-21, may be even more responsive.

Medicinal Plants of Nicaragua’s Atlantic Coast

This article presents the results of an investigation concerning the use of medicinal plants by the people of Nicaragua’s Atlantic Coast. Participant observation during parts of the years 1986–1991 was complemented by a five-community, 809-household survey in 1990 and a ten-community botanical collection in 1991. This research is the first to attempt to document the diversity and prevalence of medicinal plant use for this region. The appendix lists 152 plants, along with common names, number and ethnicity of informants, and medicinal uses.RésuméEste articulo presenta los resultados de una encuesta sobre plantas medicinales utilizadas por las personas de la Costa Atlantica de Nicaragua. Observation participativa realizo durante parte de los afios 1986 al 1991 fue com-plementada en 1990 con una encuesta a 809 hogares cubriendo cinco comunidades. Ademas, en 1991 se realizo una recoleccion botanica en diez comunidades de la region. Esta investigation es el primer esfuerzo por documentar la diversidad y prevalencia del uso de plantas medicinales en esta region. El anexo proporciona una lista de 152 plantas con sus nombres comunes, su uso medico, y el numero y etnicidad de los informantes.

The efficacy of hypertonic saline nasal irrigation for chronic sinonasal symptoms.

OBJECTIVE: To assess quality of life (QOL) in patients with sinonasal symptoms in response to hypertonic saline nasal irrigation (HSNI), and to assess HSNI use patterns. STUDY DESIGN AND SETTING: The study was an uncontrolled 12-month follow-up to a randomized controlled trial (RCT) and used HSNI in a community setting. We included 54 participants with recurrent or chronic sinonasal symptoms. Forty participants had been in the intervention group of a previous study; 14 had been control participants. Primary outcome measures were the Rhinosinusitis Disability Index (RSDI), a sinus-symptom severity assessment (SIA), and the Sino-Nasal Outcomes Test (SNOT-20). Secondary outcome measures were frequency and pattern of HSNI use, side effects and satisfaction. RESULTS: Among participants using HSNI in the prior RCT, RSDI scores continued to improve, from 73.2 ± 2.6 points to 80.6 ± 2.4 points (P < 0.001). SIA and SNOT-20 scores remained stable. Former control participants reported QOL improvement similar to that of HSNI users in the prior RCT. RSDI scores improved from 62.0 ± 3.9 points to 79.7 ± 3.7 points (P < 0.05), SNOT-20 scores improved from 43.5 ± 5.7 points to 28.4 ± 4.8 points, and SIA scores improved from 4.2 ± 0.3 points to 2.6 ± 0.3 points (P < 0.01). Mean HSNI use for all participants was 2.4 irrigations per week; 33% of participants used HSNI regularly, 55% when symptomatic. Side effects were minor; satisfaction was high. CONCLUSIONS: Participants with chronic sinonasal symptoms reported improved QOL and frequent, satisfying use of HSNI. SIGNIFICANCE: HSNI is an effective adjunctive treatment of chronic sinonasal symptoms.

Placebo, Meaning, and Health

Placebos are boon and bane to medical theory and clinical practice. On the one hand, randomized controlled trials employ concealed allocations of placebo to control for effects not due to specific pharmacological mechanisms. As a result, nearly all of evidence-based medicine derives from principles and practices based on placebo. On the other hand, medical researchers and physicians have tended to ignore, minimize, or deride placebos and placebo effects, perhaps due to values emphasizing scientific understanding of mechanistic pathways. We argue that intention, expectation, culture, and meaning are central to placebo-effect phenomena and are substantive determinants of health. We introduce three dualities that are integral to placebo/meaning phenomena: body-mind, subconscious-conscious, and passive-active. These placebo-related dualities should be acknowledged, explored with research, and incorporated in theory. While we view consideration of placebo and meaning effects as essential to any adequate understanding of human health, we feel that lessons from this area of inquiry may already provide practical tools for astute clinicians. Toward this end, we list eight specific clinical actions: speak positively about treatments, provide encouragement, develop trust, provide reassurance, support relationships, respect uniqueness, explore values, and create ceremony. These clinical actions can empower patients to seek greater health and may provide a healthful sense of being cared for.

Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21)

BackgroundThe Wisconsin Upper Respiratory Symptom Survey (WURSS) is an illness-specific health-related quality-of-life questionnaire outcomes instrument.ObjectivesResearch questions were: 1) How well does the WURSS-21 assess the symptoms and functional impairments associated with common cold? 2) How well can this instrument measure change over time (responsiveness)? 3) What is the minimal important difference (MID) that can be detected by the WURSS-21? 4) What are the descriptive statistics for area under the time severity curve (AUC)? 5) What sample sizes would trials require to detect MID or AUC criteria? 6) What does factor analysis tell us about the underlying dimensional structure of the common cold? 7) How reliable are items, domains, and summary scores represented in WURSS? 8) For each of these considerations, how well does the WURSS-21 compare to the WURSS-44, Jackson, and SF-8?Study Design and SettingPeople with Jackson-defined colds were recruited from the community in and around Madison, Wisconsin. Participants were enrolled within 48 hours of first cold symptom and monitored for up to 14 days of illness. Half the sample filled out the WURSS-21 in the morning and the WURSS-44 in the evening, with the other half reversing the daily order. External comparators were the SF-8, a 24-hour recall general health measure yielding separate physical and mental health scores, and the eight-item Jackson cold index, which assesses symptoms, but not functional impairment or quality of life.ResultsIn all, 230 participants were monitored for 2,457 person-days. Participants were aged 14 to 83 years (mean 34.1, SD 13.6), majority female (66.5%), mostly white (86.0%), and represented substantive education and income diversity. WURSS-21 items demonstrated similar performance when embedded within the WURSS-44 or in the stand-alone WURSS-21. Minimal important difference (MID) and Guyatts responsiveness index were 10.3, 0.71 for the WURSS-21 and 18.5, 0.75 for the WURSS-44. Factorial analysis suggested an eight dimension structure for the WURSS-44 and a three dimension structure for the WURSS-21, with composite reliability coefficients ranging from 0.87 to 0.97, and Cronbachs alpha ranging from 0.76 to 0.96. Both WURSS versions correlated significantly with the Jackson scale (W-21 R = 0.85; W-44 R = 0.88), with the SF-8 physical health (W-21 R = -0.79; W-44 R = -0.80) and SF-8 mental health (W-21 R = -0.55; W-44 R = -0.60).ConclusionThe WURSS-44 and WURSS-21 perform well as illness-specific quality-of-life evaluative outcome instruments. Construct validity is supported by the data presented here. While the WURSS-44 covers more symptoms, the WURSS-21 exhibits similar performance in terms of reliability, responsiveness, importance-to-patients, and convergence with other measures.

Echinacea for Treating the Common Cold: A Randomized Trial

BACKGROUND Echinacea is widely used to treat the common cold. OBJECTIVE To assess the potential benefits of echinacea as a treatment of common cold. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715) SETTING Dane County, Wisconsin. PATIENTS 719 patients, aged 12 to 80 years, with new-onset common cold. INTERVENTION Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients. MEASUREMENTS The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. RESULTS Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1 cell/hpf in the open-label echinacea group). LIMITATION Higher-than-expected variability limited power to detect small benefits. CONCLUSION Illness duration and severity were not statistically significant with echinacea compared with placebo. These results do not support the ability of this dose of the echinacea formulation to substantively change the course of the common cold. PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine, National Institutes of Health.

Meditation or Exercise for Preventing Acute Respiratory Infection: A Randomized Controlled Trial

PURPOSE This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. METHODS Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. RESULTS Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. CONCLUSIONS Training in meditation or exercise may be effective in reducing ARI illness burden.

What Complementary and Alternative Medicine Practitioners Say About Health and Health Care

BACKGROUND We wanted to explore the beliefs and practices of complementary and alternative medicine (CAM) practitioners. METHODS A representative sample of local CAM practitioners was selected for 32 face-to-face in-depth interviews. Interviews were taped, transcribed, and reviewed by all coauthors. Analysis and interpretation were reached by consensus, using an iterative process in multidisciplinary group meetings. RESULTS The CAM practitioners interviewed stressed the holistic, empowering, and person-centered nature of CAM. They described themselves as healers, employing attentiveness, touch, and love to increase self-awareness and strengthen the healing process, usually in chronic illness, often with pain. They affirmed goodwill and respect toward conventional medicine, calling for greater integration of conventional and complementary health care; however, they identified the major differences of conventional medicine and several formidable barriers. They displayed concern about accessibility issues in health care and stressed that attitudes and beliefs were often larger impediments to integration than were economic or scientific considerations. CONCLUSIONS In general, CAM practitioners want to work with physicians and other conventional health care workers in seeking a holistic, accessible, patient-centered, integrated health care system.