A Randomized Controlled Trial of a Chinese
Herbal Remedy to Increase Energy, Memory,
Sexual Function, and Quality of Life in Elderly
Adults in Beijing, China
Stephen Bent, MD, Ling Xu, MD, Li-Yung Lui, MA, MS, Michael Nevitt, PhD,
Edward Schneider, MD, Guoqing Tian, PhD, Saishan Guo, MD, Steven Cummings, MD, MPH
BACKGROUND: Chinese herbal medicines are commonly
used to improve general health and well-being despite limited
scientific data to support their efficacy. We conducted a randomized, double-blind, placebo-controlled trial to determine
whether an herbal remedy that is used widely in China was
associated with changes in quality of life, energy, memory, sexual function, and qi (the Chinese concept of “vital energy” that
is important in general health).
METHODS: Residents (n ⫽ 237) of Beijing, China, who were
aged ⱖ60 years and had self-reported decreased energy, memory, or sexual function, were randomly assigned to take four
tablets of a Chinese herbal formula or of an identical placebo,
three times a day for 30 days. Patients returned for one follow-up visit after 30 days for assessment of all outcomes. The
main outcome measures were changes in quality of life at 30
days as measured by the 12-Item Short Form Health Survey
(SF-12) Mental and Physical Component Summary scales.
RESULTS: Use of Chinese herbs was associated with a small
benefit in the Mental Component scale (difference of 1.9 points;
95% confidence interval [CI]: 0.1 to 3.6) and no benefit in the
Physical Component scale (difference of – 0.1 points; 95% CI:
–1.7 to 1.5) as compared with placebo. A small improvement in
the qi scale was no longer significant after adjusting for baseline
differences in this score between groups. There was no improvement in physical performance, memory, or sexual function. The
herbal product was well tolerated.
CONCLUSION: Short-term use of a mixture of Chinese herbs
was associated with a small benefit in one measure of mental
health that is of unclear clinical importance. Am J Med. 2003;
115:441– 447. ©2003 by Excerpta Medica Inc.
S
tory tract infections (8), Liu et al concluded that there was
insufficient information to determine whether these
studies used adequate methods to assess efficacy. However, because traditional Chinese herbal medicines are
classified as dietary supplements in the United States, evidence of efficacy before marketing is not required. Still, a
small number of high-quality studies have shown that
Chinese herbs may have beneficial effects as treatment for
certain conditions, including irritable bowel syndrome
and hepatitis C (9,10).
Longevity Treasure (Enwei Pharmaceutical Company,
Chengdu, China) is a proprietary extract composed of 10
Chinese herbs (Table 1). This herbal product is believed
to increase longevity, quality of life, energy, memory, sexual function, and qi, the Chinese concept of “vital energy”
that is important in general health. Because the product is
used widely in China and has not been associated with
serious side effects, we sought to determine whether regular use of this product would lead to improved health in
elderly Chinese adults.
ales of herbal medicines, including traditional Chinese herbs, have increased markedly in the United
States in the past decade and are now estimated to
be more than $4 billion annually (1,2). Recent surveys
have found that 12% to 71% of adults in the United States
have used an herbal product to treat an illness or improve
health (3– 6).
Although there are numerous published reports in
Chinese-language journals regarding the efficacy of Chinese herbs, the studies rarely follow accepted standards
for randomized controlled trials (7). In a review of Chinese-language studies of herbal treatments for respiraFrom the Departments of Medicine (SB, SC) and Epidemiology and
Biostatistics (LYL, MN, SC), Osher Center for Integrative Medicine
(SB), University of California, San Francisco; Department of Medicine
(SB), San Francisco Veterans Affairs Medical Center, San Francisco,
California; Andrus Gerontology Center (ES), University of Southern
California, Los Angeles, California; and Peking Union Medical College
Hospital (LX, GT, SG), Beijing, China.
This work was supported by grant KO8 AT01338-01 to Dr. Bent from
the National Center for Complementary and Alternative Medicine, Bethesda, Maryland, and by a grant from Enwei Pharmaceutical Company, Chengdu, China. Enwei Pharmaceutical Company had no role in
the design, analysis, or reporting of the results of this investigation.
Requests for reprints should be addressed to Stephen Bent, MD,
Osher Center for Integrative Medicine, San Francisco Veterans Affairs
Medical Center, University of California, 4150 Clement Street, 111A1,
San Francisco, California 94121, or [email protected].
Manuscript submitted July 31, 2002, and accepted in revised form
June 6, 2003.
© 2003 by Excerpta Medica Inc.
All rights reserved.
METHODS
Subjects
Chinese adults aged 60 years or older were recruited by
study assistants at the Peking Union Medical College
Hospital in Beijing, China. To be eligible, patients had to
0002-9343/03/$–see front matter 441
doi:10.1016/S0002-9343(03)00421-2
Chinese Herbs and Quality of Life/Bent et al
Table 1. Chinese Herbs in the Active Treatment
Herb
Percentage
Herba Epimedii
Fructus Lycii Chinensis
Cordyceps Sinensis
Herba Cynomorii Songarici
Herba Cistanches
Rhizoma Polygonati
Radix Astragali
Radix Rehmanniae
Glutinosae Conquitae
Radix Morindae Officinalis
8%
15%
15%
8%
8%
10%
10%
10%
8%
8%
have reported one of the following problems during the
past year: decreased energy all or most of the time, poor
or decreased memory, or decreased sexual interest.
Because this herbal formula consists of herbs that are
believed to increase yang (or “fire” and “energy”), which
is associated with hypertension, agitation, insomnia, and
other health problems, patients with characteristic findings of high yang were excluded. High yang was defined as
the presence of one or more of the following: high fever,
restlessness, irritability, constipation, flushed face and
congested eyes, excessive thirst and preference for cold
drinks, dark yellow urine, or a red tongue with a dry,
thick, and yellow coating.
Participants were also excluded if they had a history of
cancer, had lost more than 5 kg involuntarily in the past
year, were unable to walk independently, were unable to
understand the study instructions, had a blood pressure
of ⬎160/100 mm Hg, had taken this herbal formula during the past month, or had baseline laboratory values
(electrolytes, blood urea nitrogen, creatinine, glucose,
complete blood count, liver function, prothrombin time)
that were outside of a range of predetermined clinically
normal values.
Intervention
Eligible patients were randomly assigned to take either
four tablets of the herbal formula or of an identical placebo, three times a day for 30 days. The placebo and active
tablets were found by the California State Department of
Health (Food and Drug Branch, Sacramento, California)
to be free of notable levels of lead, arsenic, mercury, and
pharmaceutical drugs (as assessed by gas chromatography). Assignment to treatment and placebo groups was
according to a randomization list that was generated using the “ralloc” procedure in STATA, version 7 (Stata
Corporation, College Station, Texas).
All investigators, outcome assessors, study assistants,
and patients were blinded to the treatment assignment
and allocation sequences during the course of the study.
Prenumbered identical containers reflecting the randomization sequence were administered serially to patients.
442
October 15, 2003
THE AMERICAN JOURNAL OF MEDICINE威
Adequacy of blinding was assessed by comparing the percentage of patients in each group who believed they were
taking active medication at the end of the study.
Outcomes
All outcome measures were assessed at baseline and after
30 days of treatment at the follow-up visit. The primary
outcome measures were changes in quality of life as measured by the Physical and Mental Component Summary
scales of the 12-Item Short Form Health Survey (SF-12).
The SF-12 is widely used in measuring health and quality
of life and has been shown to have a high level of agreement with scores from the original 36-Item Short Form
Health Survey (SF-36) (11). The SF-36 has been validated
in several Chinese studies, whereas evaluation of the
SF-12 is ongoing (11). Secondary outcome measures included assessments of physical performance, memory,
sexual function, and qi.
Measurements
Physical performance was assessed using five previously
validated tests (12–16) that had been modified slightly in
consideration of the safety of the elderly subjects. Patients
were asked to stand up from a chair of standard height to
a full standing position and then sit down again as many
times as possible in 20 seconds (compared with 30 seconds [12]). They were also asked to tap the front of their
foot up and down as many times as possible in 20 seconds
while sitting in a chair of standard height. This test measures anterior tibialis muscle fatigue using voluntary
rather than electrically stimulated contractions (13). Grip
strength was tested by asking patients to squeeze a grip
strength meter as tightly as possible for a few seconds and
to repeat the process six times. Participants were also
asked to step up and down on a 16-cm high step as many
times as possible in 30 seconds. Finally, participants were
told to walk and “cover as much ground as possible at a
pace you can maintain for 6 minutes” on a flat indoor
surface.
Memory was assessed using previously validated tests
of short-term word recall, long-term word recall, and picture recall (17,18). Sexual function was assessed using
modified items from previously published questionnaires
(19,20). The first two items asked patients to rate their
sexual interest and ability in the past month on a 0- to
10-point scale, and the summary score was the sum of
these two items. The third item asked about the frequency
of sexual activity in the past month.
The qi scale is a 17-item instrument (14 items on an
interviewer-administered questionnaire and three physical examination items) that was developed through an
international collaboration of clinical investigators with
expertise in scale development and traditional Chinese
medicine. Questionnaire items address symptoms commonly included in a traditional Chinese medical interview, including breathing, energy level, appetite, heart-
Volume 115
Chinese Herbs and Quality of Life/Bent et al
burn, sweating, bowel patterns, pain, temperature
sensations, sleep habits, and sexual ability. The physical
examination items address tongue coating, tongue muscle quality, and pulse quality. The scale was developed for
this study and has not been validated (Appendix). The 14
questionnaire items are scored on a scale of 0 to 4 points,
and the physical examination items are scored on a scale
of 0 to 3. The total qi score is the sum of each score,
ranging from 0 (best) to 65 (worst).
Patients were asked to call the study center if they experienced any medical problems during the 30-day study
period. At the end of the study, they were also asked about
adverse events. Laboratory tests were drawn at baseline
and follow-up visits and compared to see whether any
changes suggested adverse events.
The study was designed to detect a 3-point change in
either of the SF-12 scales. The standard deviation of the
change in the Physical and Mental Component Summary
scales is approximately 6 points in this group of patients.
Using a two-tailed ␣ of 0.05, the study sample size of 223
patients resulted in 95% power to detect a change of 3
points in either of the SF-12 scales.
The study protocol and procedures were reviewed and
approved by institutional review boards at the University
of California, San Francisco, and the Peking Union Medical College Hospital, which has previously received certification as an accepted institutional review board by the
National Institutes of Health.
Statistical Analysis
Baseline characteristics between groups were compared
using the Student t test for continuous variables and the
chi-squared test for dichotomous variables. The Student t
test was also used to compare the change in outcome
measures between groups. Because baseline differences
could bias the comparison of the change in outcome
measures, we used a general linear regression model to
adjust for outcomes that showed a statistically significant
difference in baseline measurements.
Physical function scores were presented as means (⫾
SD). An overall physical function score was calculated by
transforming each physical function test into a z score
and adding the z scores into a summary measure. Frequency of adverse events and the proportion of patients
who believed they were taking active medication were
compared using the chi-squared test. P values ⬍0.05 were
considered significant. All analyses were performed using
SAS, version 8.2 (SAS Institute, Inc., Cary, North Carolina).
RESULTS
Two hundred and thirty-seven patients satisfied the inclusion criteria (Figure) and were randomly assigned to
the Chinese herb (n ⫽ 118) or placebo group (n ⫽ 119).
Figure. Flowchart showing enrollment and follow-up of study
participants.
Baseline characteristics were similar between treatment
groups (Table 2), except for the qi score, which was lower
(better) in the placebo group (13.8 points vs. 15.8 points,
P ⫽ 0.01). Four patients in the placebo group and 10
patients in the Chinese herb group did not return for the
follow-up visit (Figure), leaving 115 patients (97%) in the
placebo group and 108 (92%) in the Chinese herb group
for analysis.
There was a small improvement in the Mental Component Summary scale in the Chinese herb group (1.9point greater improvement over placebo; 95% confidence interval [CI]: 0.1 to 3.6; Table 3). No improvement
was seen in the Physical Component Summary scale. The
Chinese herb group had a slightly better score on the qi
scale (–1.3 points; 95% CI: –2.6 to – 0.1). However, the
improvement was no longer statistically significant (difference ⫽ – 0.3; 95% CI: –1.3 to 0.7) after adjusting for
baseline differences. There were no differences between
groups in the overall scores for memory, physical performance, and sexual function (Table 3).
A total of 54 adverse events were reported by 47 patients: 31 in the Chinese herb group and 23 in the placebo
group (Table 4). The only adverse event that appeared to
be more common in the Chinese herb group was dry
mouth (15 events vs. 7 events, P ⫽ 0.07). There was no
significant difference in the total number of adverse
events between treatment groups. None of the study patients experienced a serious adverse event during the
study period.
Analysis of the laboratory data showed only one statistically significant change (Table 5); white blood cell count
October 15, 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 115 443
Chinese Herbs and Quality of Life/Bent et al
Table 2. Baseline Characteristics of the Patients Taking Chinese Herbs or Placebo
Placebo
(n ⫽ 119)
Characteristic
Chinese Herbs
(n ⫽ 118)
P Value
Mean ⫾ SD or Number (%)
65.6 ⫾ 4.6
74 (62)
25 (21)
97 (82)
116 (98)
49.9 ⫾ 6.5
53.1 ⫾ 6.6
13.8 ⫾ 5.1
21.3 ⫾ 4.6
0.3 ⫾ 3.4
4.1 ⫾ 4.1
11.0 ⫾ 4.8
140.7 ⫾ 14.0
81.9 ⫾ 8.6
Age (years)
Female sex
Decreased energy
Decreased memory
Decreased sexual interest
SF-12 physical health score*
SF-12 mental health score*
Qi scale†
Memory score*
Physical performance*
Sexual function score*
Education (years)
Systolic blood pressure (mm Hg)
Diastolic blood pressure (mm Hg)
66.4 ⫾ 4.6
76 (64)
30 (25)
102 (86)
111 (94)
49.2 ⫾ 6.6
52.3 ⫾ 6.6
15.8 ⫾ 6.2
20.3 ⫾ 4.3
⫺0.3 ⫾ 3.5
3.2 ⫾ 3.9
10.6 ⫾ 4.6
139.1 ⫾ 14.8
82.1 ⫾ 9.0
0.23
0.72
0.42
0.30
0.19
0.46
0.40
0.01
0.08
0.13
0.09
0.49
0.38
0.85
* Higher values indicate improvement.
†
Lower values indicate improvement.
SF-12 ⫽ 12-Item Short Form Health Survey.
DISCUSSION
decreased 0.4 points more (95% CI: – 0.6 to – 0.1) in the
Chinese herb group than in the placebo group.
At the end of the study, a higher percentage of patients
in the Chinese herb group believed they had taken active
pills compared with in the placebo group (66% [71/108]
vs. 45% [52/115], P ⫽ 0.002).
Chinese herbs are widely prescribed, marketed, and used
to improve general health despite limited information
about their safety and efficacy. In this study, we found
that daily use of a standardized extract of 10 Chinese
Table 3. Change in Measurements after 30 Days of Treatment
Measurement* (Score Range)
Change in Placebo
Group (n ⫽ 115)
Change in Chinese Herb
Group (n ⫽ 108)
P Value
Difference
(95% Confidence Interval)
Mean ⫾ SD
Quality of life
SF-12 physical (0–100 points)
SF-12 mental (0–100 points)
Qi scale (0–65 points)
Memory
Total score (0–39 points)
Physical performance†
Total score (⫺16 to 8 points)
Chair stands (0–19 stands)
Foot taps (0–58 taps)
Grip (0–46.3 pounds)
Step test (0–25 steps)
Distance walked (0–714 m)
Sexual function
Total score (0–20 points)
Frequency (0–6 episodes)
Difference (Active-Placebo)
in Change in
Outcome Measure
1.7 ⫾ 6.0
2.5 ⫾ 6.8
⫺2.1 ⫾ 4.2
1.6 ⫾ 6.1
4.4 ⫾ 6.6
⫺3.4 ⫾ 5.3
⫺0.1 (⫺1.7 to 1.5)
1.9 (0.1 to 3.6)
⫺1.3 (⫺2.6 to ⫺0.1)
0.89
0.04
0.04
4.2 ⫾ 3.7
4.5 ⫾ 3.6
0.3 (⫺0.6 to 1.3)
0.51
⫺0.1 ⫾ 2.6
1.6 ⫾ 2.2
7.0 ⫾ 6.0
0.5 ⫾ 2.5
1.9 ⫾ 2.6
9.4 ⫾ 54.1
⫺0.1 ⫾ 1.9
1.7 ⫾ 1.8
6.6 ⫾ 5.4
0.3 ⫾ 2.6
1.9 ⫾ 2.2
16.0 ⫾ 32.4
0.1 (⫺0.5 to 0.7)
0.1 (⫺0.4 to 0.6)
⫺0.4 (⫺1.9 to 1.1)
⫺0.2 (⫺0.9 to 0.5)
0.0 (⫺0.7 to 0.6)
6.6 (⫺5.2 to 18.5)
0.80
0.73
0.60
0.56
0.92
0.27
⫺1.0 ⫾ 3.0
⫺0.2 ⫾ 0.7
⫺0.4 ⫾ 1.9
⫺0.1 ⫾ 0.6
0.6 (0.0 to 1.3)
0.1 (⫺0.1 to 0.3)
0.06
0.20
* For all tests, a higher value represents improvement, except for the qi scale, where a lower value indicates improved qi.
†
Individual physical performance scores were calculated as follows: chair stands ⫽ number of stands in 20 seconds; foot taps ⫽ number of taps in 20
seconds; grip strength ⫽ average grip strength of six trials; step test ⫽ number of times up and down a standard step in 30 seconds; distance walked
⫽ number of meters walked on a flat surface in 6 minutes; total score ⫽ sum of the z score for all five tests.
444
October 15, 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 115
Chinese Herbs and Quality of Life/Bent et al
Table 4. Adverse Events in the Treatment and Placebo Groups*
Placebo
(n ⫽ 119)
Adverse Event
Chinese Herbs
(n ⫽ 118)
P Value
Number (%)
Headache
Upper respiratory
tract infection
Oral ulcer
Dry mouth
Chest pain
Nausea
Diarrhea
Constipation
Flatulence
Cough
Insomnia
Other
Total
0
1 (0.8)
1 (0.9)
1 (0.9)
0.31
1.00
0
7 (5.9)
1 (0.8)
1 (0.8)
4 (3.4)
4 (3.4)
3 (2.5)
1 (0.8)
0
1 (0.8)
23
2 (1.7)
15 (12.7)
0
1 (0.9)
2 (1.7)
2 (1.7)
4 (3.4)
0
2 (1.7)
1 (0.9)
31
0.15
0.07
0.32
1.00
0.41
0.41
0.69
0.32
0.15
1.00
0.24
* Adverse event information was obtained on all patients including
those who had dropped out before follow-up (4 placebo, 10 Chinese
herb).
herbs for 1 month led to a small benefit in only one of the
two primary outcome measures, the SF-12 Mental Component Summary scale.
We attempted to measure changes in both a standard
“Western” measure of quality of life (the SF-12 scale) and
an “Eastern” measure (the qi scale). The improvement
observed in the qi scale was no longer statistically significant after adjusting for baseline differences in this scale
between groups, suggesting that the improvement may
have been due to the Chinese herb group having worse
initial qi scores and therefore a greater opportunity to
improve, rather than to any actual benefit from the Chinese herbs. The scale, however, may not be an adequate
measure of this complex Chinese concept of overall
health. No improvements were seen in the secondary outcome measures of physical performance, memory, and
sexual function.
We cannot determine whether the small benefit observed in the Mental Component Summary scale represents a true beneficial effect from the Chinese herbs or
merely a chance finding in a study that has several measurements of outcome. The small magnitude of benefit,
the borderline statistical significance of the benefit (P ⫽
0.04), and the lack of statistically significant benefits in
the other outcomes suggest that the mental health benefit
may be a chance finding unrelated to the use of this mixture of herbs.
The magnitude of the observed benefit in the Mental
Component Summary scale was small (1.9 points). In
comparison, patients recovering from major depression
had a mean improvement of 10 points on that scale (11).
We do not know whether the small change we observed is
likely to lead to a notable improvement in quality of life.
Many experts in traditional Chinese medicine believe
that Chinese herbal treatments may take 3 months or
more to achieve the maximum effect. Thus, a longer
treatment period might lead to more substantial improvements in mental health and other outcome measures.
Table 5. Change in Laboratory Values after 1 Month of Treatment
Laboratory Test
Sodium (mmol/L)
Potassium (mmol/L)
Chloride (mmol/L)
Bicarbonate (mEq/L)
Blood urea nitrogen (mg/dL)
Creatinine (mg/dL)
Glucose (mg/dL)
White blood cell count (103/␮L)
Hematocrit (%)
Platelets (103/␮L)
International normalized ratio
Low-density lipoprotein
cholesterol (mg/dL)
Aspartate transaminase (U/L)
Alanine transaminase (U/L)
Alkaline phosphatase (U/L)
Total bilirubin (mg/dL)
Normal
Range
Change in Chinese Herb
Group Compared with
Placebo Group
(95% Confidence Interval)
P Value
135–145
3.5–5.5
96–111
20–34
3–20
0.6–1.5
65–109
4.8–10.8
38–52
140–400
—
⬍130
0.2 (⫺0.4 to 0.8)
0.0 (⫺0.1 to 0.1)
0.5 (⫺0.3 to 1.2)
⫺0.1 (⫺0.8 to 0.5)
0.5 (⫺0.3 to 1.4)
0.0 (0.0 to 0.0)
⫺1.6 (⫺4.4 to 1.2)
⫺0.4 (⫺0.6 to ⫺0.1)
⫺0.3 (⫺1.2 to 0.6)
1.3 (⫺7.2 to 9.9)
0
0.4 (⫺0.1 to 9.8)
0.53
0.89
0.24
0.67
0.21
0.83
0.26
0.01
0.48
0.76
0.47
0.94
5–35
7–56
40–125
0.1–1.2
0.6 (⫺1.2 to 2.4)
1.4 (⫺0.9 to 3.7)
0.6 (⫺1.7 to 3.0)
0.0 (0.0 to 0.1)
0.50
0.23
0.61
0.26
October 15, 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 115 445
Chinese Herbs and Quality of Life/Bent et al
A higher percentage of patients in the Chinese herb
group believed they were taking active medication rather
than placebo at the end of the study. It is not possible to
determine whether this indicates that blinding was inadequate, or that patients in the active group perceived
some effect and therefore concluded they were taking active medication. Analysis of adverse event data suggests
that short-term use of this product is safe. The small decrease in the white blood cell count may be a chance finding and does not likely represent a clinically important
change, but this test should be monitored if long-term
studies are undertaken.
In conclusion, our results suggest that short-term use
of a mixture of Chinese herbs (Longevity Treasure) may
lead to a small improvement in mental health. Because
this improvement was the only observed benefit in our
study, and this benefit was small, further studies are
needed to confirm these findings and determine whether
longer treatment periods might lead to clinically important changes in other measures of quality of life.
ACKNOWLEDGMENT
We would like to thank the study staff (Muxian Chu, Su Zeng,
Yanzhen Wei, Liangyu Liu, Xouhua Wang, Shuzhen Cui, Jing
Zhou) at Peking Union Medical College Hospital, Beijing,
China, for their dedication, outstanding work, and helpful suggestions regarding the optimal conduct of this trial.
REFERENCES
1. Herbal and botanical U.S. consumer sales 1999. Nutrition Business
Journal. 2000:1-3.
2. Brody JE. Americans gamble on herbs as medicines. New York
Times. February 9, 1999;sect D1.
3. Self-treatment with herbal and other plant-derived remedies—rural Mississippi, 1993. MMWR Morb Mortal Wkly Rep. 1995;44:204207.
4. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative
medicine use in the United States, 1990 –1997: results of a follow-up national survey. JAMA. 1998;280:1569 –1575.
446
October 15, 2003
THE AMERICAN JOURNAL OF MEDICINE威
5. Harnack LJ, Rydell SA, Stang J. Prevalence of use of herbal products
by adults in the Minneapolis/St Paul, Minn, metropolitan area.
Mayo Clin Proc. 2001;76:688 –694.
6. The Landmark Report on Public Perceptions of Alternative Care. Sacramento, California: Landmark Healthcare; 1998.
7. Moher D, Schulz KF, Altman D. The CONSORT statement: revised
recommendations for improving the quality of reports of parallelgroup randomized trials. JAMA. 2001;285:1987–1991.
8. Liu C, Douglas RM. Chinese herbal medicine in the treatment of
acute respiratory tract infections: review of randomized and controlled clinical trials. Clin Infect Dis. 1999;28:235–236.
9. Batey RG, Bensoussan A, Fan YY, et al. Preliminary report of a
randomized, double-blind placebo-controlled trial of a Chinese
herbal medicine preparation CH-100 in the treatment of chronic
hepatitis C. J Gastroenterol Hepatol. 1998;13:244 –247.
10. Bensoussan A, Talley NJ, Hing M, et al. Treatment of irritable bowel
syndrome with Chinese herbal medicine: a randomized controlled
trial. JAMA. 1998;280:1585–1589.
11. Ware JE, Kosinski M, Keller SD. SF-12: How to Score the SF-12
Physical and Mental Health Summary Scales. 3rd ed. Lincoln, Rhode
Island: Quality Metric Incorporated; 1998.
12. Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure
of lower body strength in community-residing older adults. Re Q
Exerc Sport. 1999;70:113–119.
13. Reid MB, Grubwieser GJ, Stokic DS, et al. Development and reversal of fatigue in human tibialis anterior. Muscle Nerve. 1993;16:
1239 –1245.
14. Bohannon RW. Dynamometer measurements of hand-grip
strength predict multiple outcomes. Percept Mot Skill. 2001;93:323–
328.
15. Petrella RJ, Koval JJ, Cunningham DA, Paterson DH. A self-paced
step test to predict aerobic fitness in older adults in the primary care
clinic. J Am Geriatr Soc. 2001;49:632–638.
16. Bittner V, Weiner DH, Yusuf S, et al. Prediction of mortality and
morbidity with a 6-minute walk test in patients with left ventricular
dysfunction. SOLVD Investigators. JAMA. 1993;270:1702–1707.
17. Xu S, Wu Z. The construction of “the clinical memory test.” ACTA
Psychol Sinic. 1986;1:100 –108.
18. Xu SL. A study of memory disorder in patients with cerebral infarction [in Chinese]. Zhonghua Shen Jing Jing Shen Ke Za Zhi. 1988;
21:212–215 254 –255.
19. Reynolds CF III, Frank E, Thase ME, et al. Assessment of sexual
function in depressed, impotent, and healthy men: factor analysis
of a brief sexual function questionnaire for men. Psychiatry Res.
1988;24:231–250.
20. Jones RA. The use of validated questionnaires to assess female sexual dysfunction. World J Urol. 2002;20:89 –92.
Volume 115
Chinese Herbs and Quality of Life/Bent et al
APPENDIX. Qi Scale
Questionnaire Items*
1. How often are you short of breath?
Never After moderate activity
2. How often do you experience fatigue?
Never Sometimes, but still can do
some activities
3. Have you ever had no desire to talk?
Never Not very talkative
After a little activity
Often
Always
Can do daily activities
with difficulty
Cannot do any daily
activity
Stay in bed all day
Don’t like to talk; answer
questions with few
words
Don’t like to talk; answer
questions with low
voice
Don’t want to talk; don’t
answer any question
Decreased by 1/2
Decreased by ⱖ3/4
Lasts ⬃2 h, no
improvement with
medicine
Lasts all day
Always sweat moderately
Always sweat heavily
Watery, 1–3 times a day
Watery, ⬎3 times a day
Often; improves after
rest
Always, no improvement,
even after rest
Often; decrease after rest
Always, no improvement,
even after rest
Sleep ⬍4 h, hard to
perform daily activity
Unable to sleep whole
night, cannot perform
daily activity
Often, decrease after rest
Always, no improvement
Hands and feet always
cold and need to keep
them warm
The whole body is always
cold and need to keep it
warm
Low energy, don’t
improve after rest
No energy
No energy, slow reaction
time
Occasion sexual desire,
still have sexual ability
Occasion sexual desire,
impotent
No sexual desire,
impotent
Slightly thick white
Thick white
No coating
Light, no red
Light fat
Light fat with crack
Slightly weak
Weak
Weak and not continuous
4. Has your appetite decreased?
No
Minimal amount
Decreased by 1/4
5. Have you ever had heartburn after meals?
Never A little bit, disappears in 1/2 h, Improves in 1/2 to 1 h,
no medicine needed, no
requires medicine,
effect on daily activity
affects daily activity
6. Do you sweat without activity or exertion?
Never A little wet without moving,
Wet without moving, wet
wet with some movement
with some movement
7. Has your stool ever been soft?
Never Soft and no shape, once or
Soft and no shape, ⱖ3
twice a day
times a day
8. How often do you feel dizzy with ringing in the ear?
Never Occasionally
After activities or body
movement
9. How often you feel anxiety?
Never Occasionally
Sometimes
10. How often do you have insomnia?
Never Hard to fall asleep, don’t
Sleep ⬍6 h, perform daily
sleep deeply, or wake up
activity with slight
early, activities not affected
difficulty
11. How often do you have pain in the lower back to knee?
Never Occasionally
After some activities
12. Are you afraid of cold or are your hands and feet always cold?
Never Hands and feet always cold
Hands and feet cold all
in cold weather
the time
13. How often do you feel lack of energy?
Never Low energy, improve after
rest
14. Is your sexual ability decreased?
Never Decreased sexual desire, still
have sexual ability
Physical Examination Items†
1. Tongue Coating:
Thin white
2. Tongue Muscle:
Light red
3. Pulse:
Normal
* Scoring is from left (0 points) to right (4 points).
†
Scoring is from left (0 points) to right (3 points).
October 15, 2003
THE AMERICAN JOURNAL OF MEDICINE威
Volume 115 447