Background Echinacea is widely used to treat common cold. Objective To assess potential benefits of echinacea as common cold treatment. Design Randomized controlled trial with four parallel groups: 1) no pills, 2) placebo pills (blinded), 3) echinacea pills (blinded), or 4) echinacea pills (open-label). (NCT00065715) Setting Community-based trial. Participants People aged 12 to 80 years with new onset common cold. Interventions Extracts of Echinacea purpurea and E. angustifolia root were used to make tablets standardized to alkamide content. Indistinguishable placebo tablets contained only inert ingredients. Measurements The primary outcome was area-under-the-curve global severity, with severity assessed twice daily by self report on the Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Secondary outcomes included interleukin-8 and neutrophil count from nasal wash assessed at intake and two days later. Results Of 719 enrolled, 713 completed the protocol. Participants were 64% female and 88% white, with mean age 33.7 years. Mean global severity was 236 and 258 for blinded and unblinded echinacea, 264 for blinded placebo, and 286 for those without pills. Contrasting the two blinded groups yields a 28 point (95% CI = −69 to 13) trend toward benefit for echinacea (p=0.089). Mean illness duration for the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared to 6.87 days for blinded placebo and 7.03 for no pills. Contrasting blinded groups yields a 0.53 day (95% CI = −1.25 to 0.19) trend toward benefit (p = 0.075). Median change interleukin-8 (pg/mL) and neutrophil cell count were: no pills (30, 1), blinded placebo (39, 1), blinded echinacea (58, 2), and open-label echinacea (70, 1), also not statistically significant. Limitations Higher-than-expected variability limited power to detect small-but-potentially-important benefits. Conclusions The observed shorter illness duration and lower severity seen in the echinacea groups were not statistically significant. These results do not support the ability of this dose of this echinacea formulation to substantively change the course of the common cold.

PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are infl uenced by randomized assignment to openlabel pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODSWe undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTSOf 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically signifi cant. Comparing the no-pill with blinded to placebo groups, differences (95% confi dence interval [CI]) were -0.16 days (95% CI, -0.90 to 0.58 days) for illness duration and -22 severity points (95% CI, -70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, -0.28 to 1.12 days) and 22 severity points (95% CI, -19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically signifi cant. Among the 120 participants who at intake rated echinacea's effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, -4.47 to -0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not signifi cantly different 95% CI,. In this subgroup, neither duration nor severity differed signifi cantly between the group blinded to echinacea and the open-label echinacea group.CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These fi ndings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consid...

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BackgroundThe practice of clinical medicine rests on a foundation of ethical principles as well as scientific knowledge. Clinicians must artfully balance the principle of beneficence, doing what is best for patients, with autonomy, allowing patients to make their own well-informed health care decisions. The clinical communication process is complicated by varying degrees of confidence in scientific evidence regarding patient-oriented benefits, and by the fact that most medical options are associated with possible harms as well as potential benefits.DiscussionEvidence-based clinical guidelines often neglect patient-oriented issues involved with the thoughtful practice of shared decision-making, where individual values, goals, and preferences should be prioritized. Guidelines on the use of statin medications for preventing cardiovascular events are a case in point. Current guidelines endorse the use of statins for people whose 10-year risk of cardiovascular events is as low as 7.5 %. Previous guidelines set the 10-year risk benchmark at 20 %. Meta-analysis of randomized trials suggests that statins can reduce cardiovascular event rates by about 25 %, bringing 10-year risk from 7.5 to 5.6 %, for example, or from 20 to 15 %. Whether or not these benefits should justify the use of statins for individual patients depends on how those advantages are valued in comparison with disadvantages, such as side effect risks, and with inconveniences associated with taking a pill each day and visiting clinicians and laboratories regularly.ConclusionsWhether or not the overall benefit-harm balance justifies the use of a medication for an individual patient cannot be determined by a guidelines committee, a health care system, or even the attending physician. Instead, it is the individual patient who has a fundamental right to decide whether or not taking a drug is worthwhile. Researchers and professional organizations should endeavor to develop shared decision-making tools that provide up-to-date best evidence in easily understandable formats, so as to assist clinicians in helping their patients to make the decisions that are right for them.