Barret B. Brown R. et al. Placebo Effects and the Common Cold: A Randomized Controlled Trial. Ann Fam Med. 2011; 312-322.



 We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open- label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all.


We 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 echina- cea, and (4) those given open-label echinacea. Primary outcomes were illness dura- tion and area-under-the-curve global severity. Secondary outcomes included neu- trophil count and interleukin 8 levels from nasal wash at intake and 2 days later.


Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean ill- ness 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 sever- ity 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 significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence 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 statisti- cally significant. 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 significantly different (?97.0, 95% CI, ?249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group.


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 findings sup- port the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.





Dariush Mozaffarian, M.D., Dr.P.H.  Changes in Diet and Lifestyle and Long-Term Weight Gain in Women and Men N Engl J Med 2011 364;25 june 23, 2392-2404



Specific dietary and other lifestyle behaviors may affect the success of the straightforward-sounding strategy “eat less and exercise more” for preventing long-term weight gain.


Researchers performed prospective investigations involving three separate cohorts that included 120,877 U.S. women and men who were free of chronic diseases and not obese at baseline, with follow-up periods from 1986 to 2006, 1991 to 2003, and 1986 to 2006. The relationships between changes in lifestyle factors and weight change were evaluated at 4-year intervals, with multivariable adjustments made for age, baseline body- mass index for each period, and all lifestyle factors simultaneously. Cohort-specific and sex-specific results were similar and were pooled with the use of an inverse- variance?weighted meta-analysis.


Within each 4-year period, participants gained an average of 1.5kg (5th to 95th percentile, ?1.9 to 5.6). On the basis of increased daily servings of individual dietary components, 4-year weight change was most strongly associated with the intake of potato chips (0.77kg), potatoes (0.58kg), sugar-sweetened beverages (0.45kg), unprocessed red meats (0.43kg), and processed meats (0.42kg) and was inversely associated with the intake of vegetables (?0.1kg), whole grains (?0.17kg), fruits (?0.22kg), nuts (?0.26 kg), and yogurt (?0.37 kg) (P?0.005 for each comparison). Aggregate dietary changes were associated with substantial differences in weight change (1.78 kg across quintiles of dietary change). Other lifestyle factors were also independently associated with weight change (P<0.001), including physical activity (?0.80kg across quintiles); alcohol use (0.19kg per drink per day), smoking (new quitters, 2.3 kg; former smokers, 0.06 kg), sleep (more weight gain with <6 or >8 hours of sleep), and television watching (0.14 kg per hour per day). 


Specific dietary and lifestyle factors are independently associated with long-term weight gain, with a substantial aggregate effect and implications for strategies to prevent obesity.





富永浩義.すごいチーム あさ出版,2010.






※    キックオフミーティングの招待状を個別で作成し郵送







・聞いている人はほめる, 拍手する


・会議での会話は、提案, リクエスト, 質問 のみとする



















・求めている期限, 成果を明確化する




















Stuart J. Connolly, M.D. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-1151



Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.


In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran ? 110 mg or 150 mg twice daily ? or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary study outcome was stroke or systemic embolism.
  Systemic embolism was defined as an acute vascular occlusion of an extremity or organ,documented by means of imaging,surgery,or autopsy.
The primary safety outcome was major hemorrhage.


Characteristics of the study patients was described table 1 in the original article. The three treatment groups were well balanced with respect to baseline characteristics
Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% CI, 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). 
The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051).

The only adverse effect that was significantly more common with dabigatran than with warfarin was dyspepsia(Table.4)Dyspepsia occurred in 348 patients (5.8%) in the warfarin group and in 707 patients (11.8%) and 688 patients (11.3%) in the 110-mg and 150-mg dabigatran groups, respectively (P<0.001 for both comparisons)



In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage.





Chun-Sick Eom, Sang Min Park, Seung-Kwon Myung, Jae Moon Yun, and Jeong-Soo Ahn. Use of Acid-Suppressive Drugs and Risk of Fracture: A Meta-analysis of Observational Studies. Ann Fam Med . 2011 9: 257-267.





MEDLINE、EMBASE、Cochrane Libraryを使用。









PPIで骨折リスク上昇を認めた(adjusted OR 1.29: 95%CI 1.18-1.41, I2 69.8%, n=10)
H2ブロッカーで骨折リスク上昇認めず(adjusted OR 1.10: 95%CI 0.99-1.23, I2 86.3%, n=7)


特に影響はないと考えられた(funnel plot、Egger test)。


PPIと骨折リスク増加が認められた。H2ブロッカーと骨折リスクには明らかな関係は見いだせなかったが、サブグループ解析ではhigh-quality methodology studyと5つ以上の変数について補正した解析では骨折との関連性が示唆されており今後のさらなる4研究が必要。
 限界として①観察研究が含まれるのでバイアスが含まれる可能性がるが、これについては様々なサブグループ解析を行うことで補った。②Egger testは出版バイアス評価としては信頼性が劣る。③栄養データについては評価していない。④胃の疾患の有無の評価をしていない。


PPIは骨折リスクを中等度上昇させる可能性がある。H2ブロッカーに関してはその可能性は示唆されなかった。ORは2以下で僅かな影響と考えられるもののcommon diseaseでもあり社会への影響は大きい。臨床家は特に65歳以上の女性に対してこれらの処方するときには慎重に考慮をするべきである。用量についても望ましい結果得られるために必要な最低限の量にとどめることが勧められる。







辻野元祥,これで決まり!おすすめ処方 糖尿病編,日本医事新報,2011年4月9日;No.4537:42-46















Erika Ringdahl, Sandesh Pndit. Treatment of Knee Osteoarthritis. Am Fam Physician. 2011;83(11):1287-1292.


Osteoarthritis is a degenerative joint disease occurring primarily in older adults. It is characterized by erosion of the articular cartilage, hypertrophy of bone at the margins (i.e., osteophytes), and subchondral sclerosis.1  Arthritis is the leading cause of disability in the United States,2 and osteoarthritis is the most common condition affecting synovial joints.3 
Despite its widespread prevalence, however, the precise etiology, pathogenesis, and progression of osteoarthritis are unknown. Several factors may make a person vulnerable to the disease (Table 1).


<Diagnosis of Osteoarthritis>
The differential diagnosis of chronic knee pain is given in original paper (table2).
The criteria for diagnosing knee osteoarthritis are based on the presence of knee pain plus at least three of the six clinical characteristics listed in Table 3.5,6 The addition of laboratory and radiographic criteria enchances the diag- nostic accuracy; however, these tests are not necessary for all patients. In most patients, the history, physical examination, and radiography are all that is needed.


<Treatment of Osteoarhritis>

The evidence ratings of treatment of knee osteoarthritis are below.
# The use of braces and heel wedges may also be effective. There is some evidence that the use of a lateral heel wedge decreases the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Similar evidence suggests that a brace and lateral wedge insole may have a small beneficial effect.
# Ginger may provide some clinical benefit in patients with knee osteoarthritis; patients who took 255mg of ginger extract twice daily had a reduction in pain (63% compared with 50% in the placebo group).
# Topical NSAIDs were superior to placebo in relieving pain, but only for the first two weeks of treatment. Topical NSAIDs were less effective than oral NSAIDs.
#  Arthroscopic surgery is not an appropriate treatment unless there is evidence of loose bodies or mechanical symptoms such as locking, giving way, or catching. 
#  The main indication for total knee arhtroplasty is relief of pain associated with knee osteoarthritis if nonsurgical treatment has been ineffective. The complication rate of total knee replacement is 5.4% of patients.





Juhyun Lee, MD, MPH et al. The Association Between the Supply of Primary Care Physicians and Population Health Outcomes in Korea. Fam Med 2010;42(9):628-35.


<Background and Objectives>

Several studies reported that primary care improves health outcomes for populations. The objective of this study was to examine the relationship between the supply of primary care physicians and population health outcomes in Korea. 


Data were extracted from the 2007 report of the Health Insurance Review, the 2005 report from the Korean National Statistical Office, and the 2008 Korean Community Health Survey. The dependent variables were age-adjusted all-cause and disease-specific mortality rates, and independent variables were the supply of primary care physicians, the ratio of primary care physicians to specialists, the number of beds, socioeconomic factors (unemployment rate, local tax, education), population (population size, proportion of the elderly over age 65), and health behaviors (smoking, exercise, using seat belts rates). We used multivariate linear regression as well as ANOVA and t tests. 


A higher number of primary care physicians was associated with lower all-cause mortality, cancer mortality, and cardiovascular mortality. However, the ratio of primary care physicians to specialists was not related to all-cause mortality. In addition, the relationship between socioeconomic variables and mortality rates was similar in strength to the relationship between the supply of primary care physicians and mortality rates. Accident mortality, suicide mortality, infection mortality, and perinatal mortality were not related to the supply of primary care physicians.


The supply of primary care physicians is associated with improved health outcomes, especially in chronic diseases and cancer. However, other variables such as the socioeconomic factors and population factors seem to have a more significant influence on these outcomes.





David Price et al. Leukotriene  Antagonists as First-Line or Add-on Asthma-controller Therapy. The New England Journal of Medicine,May 5,2011



喘息治療研究のrandomized trialsa









①Primary outcome ;MiniAQLQ score

②Secondary outcome;ACQscore、RCP3、MiniRQLQ、喘息悪化頻度など




治療2年後は、①-0.11(95%CI -0.35~0.13)、②-0.11点(95%CI -0.32~0.11)で同等とは言えず。

悪化率とACQスコアなどsecondary outcomeは①②とも大差なし。
















24時間血圧測定に代わる新たな外来血圧測定法 -30分安静自動血圧測定-


Mark C van der Wel et al. : A Novel Approach to Office Blood Pressure Measurement: 30-Minute Office Blood Pressure vs Daytime Ambulatory Blood Pressure Ann Fam Med 2011;9:128-135.



Current office blood pressure measurement (OBPM) is often not executed according to guidelines and cannot prevent the white-coat effect. Moreover, large number of studies suggest the risk of cardiovascular complication correlates more closely with 24 hour or daytime ABPM than office BP.


Serial, automated, oscillometric OBPM has the potential to overcome both these problems.
We therefore developed a 30-minute OBPM method that we compared with daytime ambulatory blood pressure.


Patients referred to a primary care diagnostic center for 24-hour ambulatory blood pressure monitoring (ABPM) had their blood pressure measured using the same validated ABPM device for both ABPM and 30-minute OBPMs. Known atrial fibrillation, irregular pulse, pregnancy, and night shift work were exclusion criteria.
All 30-minute measurements took place between 11 AM and 3 PM in a quiet room at the diagnostic center. The patient was sitting still 5 minutes before and during the 30-minute OBPM. The patient sat in a chair with a supported back, arm at heart level, and both feet resting flat on the floor. Blood pressure was measured on the nondominant arm at 5-minute intervals for a total of 8 measurements. The first measurement was a test measurement during the installation of the patient. The second measurement was the start of the 30-minute period; the researcher left the room after this measurement proved to be successful (no error reading).
We define 30-minute OBPM to be the mean blood pressure calculated from the 6 measurements taken at 5-minute intervals from t = 5 to t = 30 minutes. If more than 1 of these 6 measurements was erroneous (defined as an “error” reading given by the device), the entire case was excluded for analysis.
The mean 30-minute OBPM (based on t = 5 to t = 30 minutes) was compared with mean daytime ABPM using paired t tests and the approach described by Bland and Altman on method comparison.
In the absence of usual care office blood pressure measurements, we defined office blood pressure
as the mean of the first 2 measurements of the 30-minute OBPM.


We analyzed data from 84 patients (mean age 57 years; 61% female). Patients characteristics are shown in table1 below. Systolic and diastolic blood pressures differed from 0 to 2 mm Hg (95% confidence interval, ?2 to 2 mm Hg and from 0 to 3 mm Hg) between mean 30-minute OBPM and daytime ABPM, respectively. The limits of agreement were between ?19 and 19 mm Hg for systolic and ?10 and 13 mm Hg for diastolic blood pressures.(Table2)
Both 30-minute OBPM and daytime ABPM classified normotension, whitecoat hypertension, masked hypertension, and sustained hypertension equally(Table3).

<Conclusion and discussion>

The 30-minute OBPM appears to agree well with daytime ABPM and has the potential to detect white-coat and masked hypertension. This finding makes 30-minute OBPM a promising new method to determine blood pressure during diagnosis and follow-up of patients with elevated blood pressures.




※A device used in this study.



1 2

copyright© HCFM inc. all rights reserved.