Journal of Integrative and Complementary Medicine

To investigate whether a training process that focused on a questionnaire-based diagnosis in Traditional Chinese Medicine (TCM), and developing diagnostic consensus, would improve the agreement of TCM diagnoses among 10 TCM practitioners evaluating patients with temporomandibular joint disorder (TMJD).

Evaluation of a diagnostic training program at the Department of Family and Community Medicine, University of Arizona, Tucson Arizona, and the Oregon College of Oriental Medicine, Portland, Oregon.

Screened participants for a study of TCM for TMJD.

Ten (10) licensed acupuncturists with a minimum of 5 years licensure and education in Chinese herbs.

A training session using a questionnaire-based diagnostic form was conducted, followed by waves of diagnostic sessions. Between sessions, practitioners discussed the results of the previous round of participants with a focus on reducing variability in primary diagnosis and severity rating of each diagnosis: 3 waves of 5 patients were assessed by 4 practitioner pairs for a total of 120 diagnoses. At 18 months, practitioners completed a recalibration exercise with a similar format with a total of 32 diagnoses. These diagnoses were then examined with respect to the rate of agreement among the 10 practitioners using inter-rater correlations and kappas.

The inter-rater correlation with respect to the TCM diagnoses among the 10 practitioners increased from 0.112 to 0.618 with training. Statistically significant improvements were found between the baseline and 18 month exercises (p < 0.01).

Inter-rater reliability of TCM diagnosis may be improved through a training process and a questionnaire-based diagnosis process. The improvements varied by diagnosis, with the greatest congruence among primary and more severe diagnoses. Future TCM studies should consider including calibration training to improve the validity of results.

Breathing exercises practiced in various forms of meditations such as yoga may influence autonomic functions. This may be the basis of therapeutic benefit to hypertensive patients.

The study design was a randomized, prospective, controlled clinical study using three groups.

The subjects comprised 60 male and female patients aged 20–60 years with stage 1 essential hypertension.

Patients were randomly and equally divided into the control and other two intervention groups, who were advised to do 3 months of slow-breathing and fast-breathing exercises, respectively. Baseline and postintervention recording of blood pressure (BP), autonomic function tests such as standing-to-lying ratio (S/L ratio), immediate heart rate response to standing (30:15 ratio), Valsalva ratio, heart rate variation with respiration (E/I ratio), hand-grip test, and cold presser response were done in all subjects.

Slow breathing had a stronger effect than fast breathing. BP decreased longitudinally over a 3-month period with both interventions. S/L ratio, 30:15 ratio, E/I ratio, and BP response in the hand grip and cold pressor test showed significant change only in patients practicing the slow-breathing exercise.

Both types of breathing exercises benefit patients with hypertension. However, improvement in both the sympathetic and parasympathetic reactivity may be the mechanism that is associated in those practicing the slow-breathing exercise.

To investigate the benefits of long-term therapy with Xuezhikang, a cholestin extract, in combination with calcium channel blockers for improvement of left ventricular (LV) hypertrophy and function in patients with essential hypertension, as determined using echocardiography.

Fifty-five (55) hypertensive patients with normal blood low-density lipoprotein cholesterol (LDL-C) levels were randomly assigned to the Xuezhikang group (n = 28, 1200 mg/d of Xuezhikang) or the placebo group (n = 27, matched placebo). All of the patients were treated with extended-release nifedipine (20 mg twice daily). Thirty (30) normotensive subjects, matched for age and gender, were selected as a control group. Conventional echocardiography and tissue Doppler imaging were used to measure the left ventricle (LV) wall thickness and LV diastolic function at weeks 0, 24, and 72 during the period of observation. The serum levels of lipids, carboxy-terminal propeptide of procollagen type I (PIP), and C-reactive protein (CRP) were determined as well.

The hypertensive patients had significantly elevated PIP and CRP levels in serum, increased LV wall thickness, and impaired LV diastolic function compared with the normotensive subjects (0.01 < p < 0.05). Compared with the placebo group, the transmitral flow velocities (E/A ratio) (1.11 ± 0.36 versus 0.85 ± 0.24, p < 0.01) and the myocardial motion velocities (Em/Am ratio) at the septal mitral annulus (0.90 ± 0.19 versus 0.70 ± 0.18, p < 0.05) and the lateral mitral annulus (1.06 ± 0.20 versus 0.86 ± 0.14, p < 0.01) were significantly increased, while there was no significant change in the LV wall thickness after 72 weeks of therapy with Xuezhikang. The serum levels of PIP (0.43 ± 0.13 ng/mL versus 0.51 ± 0.20 ng/mL, p < 0.05) and CRP (0.32 ± 0.13 mg/L versus 0.40 ±0.17 mg/L, p < 0.05) were significantly reduced compared to placebo treatment. There was no significant correlation between changes in LV diastolic function and blood pressure or lipid profile with Xuezhikang therapy.

Long-term therapy with Xuezhikang improved LV diastolic function, probably mediated through antifibrotic and anti-inflammatory effects and independent of blood pressure and lipid profiles in patients with essential hypertension.

Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI™; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China.

The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma.

Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title.

Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study.

Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs). Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels.

Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected.

In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI.

The objective of this study was to investigate the effect of acupuncture administered during myelosuppressive chemotherapy on white blood cell (WBC) count and absolute neutrophil count (ANC) in patients with ovarian cancer.

This study is a pilot, randomized, sham-controlled clinical trial. Patients received active acupuncture versus sham acupuncture while undergoing chemotherapy. A standardized acupuncture protocol was employed with manual and electrostimulation. The frequency of treatment was 2–3 times per week for a total of 10 sessions, starting 1 week before the second cycle of chemotherapy.

The setting was two outpatient academic centers for patients with cancer.

Twenty-one (21) newly diagnosed and recurrent ovarian cancer patients were the subjects.

WBC count, ANC, and plasma granulocyte colony-stimulating factor (G-CSF ) were assessed weekly.

The median leukocyte value in the acupuncture arm at the first day of the third cycle of chemotherapy was significantly higher than in the control arm after adjusting for baseline value (8600 cells/μL, range: 4800–12,000 versus 4400 cell/μL, range: 2300–10,000) (p = 0.046). The incidence of grade 2–4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02). However, the median leukocyte nadir, neutrophil nadir, and recovering ANC were all higher but not statistically significantly different (p = 0.116–0.16), after adjusting for baseline differences. There were no statistically significant differences in plasma G-CSF between the two groups.

We observed clinically relevant trends of higher WBC values during one cycle of chemotherapy in patients with ovarian cancer, which suggests a potential myeloprotective effect of acupuncture. A larger trial is warranted to more definitively determine the efficacy of acupuncture on clinically important outcomes of chemotherapy-induced neutropenia.

To evaluate the synergistic action of starch on the antibacterial activity of royal jelly (RJ), a comparative method of adding RJ with and without starch to culture media was used.

Strains of Staphylococcus aureus and Escherichia coli have been used to determine the minimum inhibitory concentration (MIC) of a variety of freshly reaped RJ. In a second step, lower concentrations of RJ than the MIC were incubated with a set of concentrations of starch and then were added to media to determine the minimum synergistic inhibitory concentration.

The MIC of RJ without starch was 1.7% (vol/vol) and 2% (vol/vol) against S. aureus and E. coli, respectively. When starch was incubated with RJ and then added to media, a significant MIC drop has been noticed against both strains. This MIC drop was 61% and 30% against S. aureus and E. coli, respectively.

The effectiveness of RJ against bacteria has been extensively reviewed, but this bee product remains unaffordable in most countries. Our findings suggest that combined mixture of RJ and starch could be used to treat infections that are resistant to conventional drugs, at a lower cost.

The objectives of this study were to examine the efficacy of acupuncture in hastening recovery and reducing long-term morbidity from Bell's palsy.

We searched the Cochrane Neuromuscular Disease Group Trials Register, MEDLINE^® (January 1966–April 2006), EMBASE (January 1980–April 2006), LILACS (January 1982–April 2006), and the Chinese Biomedical Retrieval System (January 1978–April 2006) for randomized controlled trials using “Bell's palsy” and its synonyms, “idiopathic facial paralysis” or “facial palsy” as well as search terms including “acupuncture.” Chinese journals in which we thought we might find randomized controlled trials or controlled clinical trials relevant to our study were hand searched. We reviewed the bibliographies of the randomized trials and contacted the authors and known experts in the field to identify additional published or unpublished data. We included all randomized or quasi-randomized controlled trials involving acupuncture in the treatment of Bell's palsy, irrespective of any language restrictions. Two review authors identified potential articles from the literature search and extracted data independently using a data extraction form. The assessment of methodological quality included allocation concealment, patient blinding, differences at baseline of the experimental groups, and completeness of follow-up. Two (2) review authors assessed quality independently. All disagreements were resolved by discussion between the review authors.

Six (6) studies including a total of 537 participants met the inclusion criteria. Five (5) of them used acupuncture while another one used acupuncture combined with drugs. No trials reported on the outcomes specified for this review. Harmful side-effects were not reported in any of the trials. Flaws in study design or reporting (particularly uncertain allocation concealment and substantial loss to follow-up) and clinical differences between trials prevented conclusions about the efficacy of acupuncture.

The quality of the included trials was inadequate to allow any conclusion about the efficacy of acupuncture. More research with high-quality trials is needed.

We aim to identify the genetic loci responsible for Sasang constitution type, which is important for effective personalized treatments in traditional Korean medicine.

Forty (40) individuals in a Korean family were recruited for linkage analysis and 310 unrelated individuals for association analysis to confirm the linkage result.

Genome-wide linkage analysis was performed for the Korean family using the Affymetrix 500K arrays. MERLIN software was used for multipoint nonparametric linkage (NPL) analysis. The significant candidate regions in linkage analysis were also investigated with association analysis of independent 310 individuals.

Linkage analysis showed four significant peaks, 3q27.3, 8p11.21, 8q11.22–23, and 11q22.1–3, whose NPL Z scores are greater than 5.0. Among the significant loci, the 8q11.22–23 and 11q22.1–3 regions were supported by independent association analysis at the level of p < 0.05.

The 8q11.22–23 and 11q22.1–3 regions were suggested as the candidate region for significant linkage to Sasang constitution.

To evaluate the effect of indigowood root (Isatis indigotica Fort.) on acute mucositis induced by radiation.

The objective severity of mucositis, anorexia, and swallowing difficulty were measured before and after the treatment.

Patients with head and neck cancer receiving radiotherapy at Tian Sheng Memorial Hospital, Taiwan were recruited for this trial.

Twenty (20) patients were randomized into two groups. Group 1 served as controls with only normal saline, and group 2 as the indigowood root (IR) group.

Prophylactic application of IR consisted of gargling and then swallowing the IR preparation on the irradiated oral mucosa.

Patients' characteristic distribution of gender, age, diagnosis, and mean radiation dose between the two arms were calculated by Fisher's exact test. We compared the mean of grade 1–4 mucositis, anorexia, difficulty in swallowing, and body weight change with the Mann–Whitney U test. p values less than 0.05 indicated statistical significance.

The clinical trial showed that application of IR can reduce the severity of radiation mucositis (p = 0.01), anorexia (p = 0.002), and swallowing difficulty (p = 0.002). Although patients' resting days did not show a significant difference (p = 0.06), complete radiotherapy was done without rest for 4 of 11 patients in the IR group versus 2 of 9 in controls. Hemoglobin level between both groups showed no significant difference. Serum interleukin-6 was significantly lower in the IR group during the first, fifth, and seventh weeks.

We confirmed that indigowood root has anti-inflammatory ability to reduce the mucosal damage caused by radiation. We postulate that indirubin may play a pharmaceutical role in improvement of radiation mucositis, anorexia, and difficulty in swallowing in our clinical trial. However, the exact mechanisms and pathways still need further analysis.

This study aims to gain an overview of hot topics related to research focused on Chinese herbal drugs by authors inside China and outside of China in the past 10 years.

PubMed/MEDLINE was utilized in order to investigate and select research that was published on “Chinese herbal drugs” from 1998 to 2007, by authors located both inside and outside of China (MeSH terms were downloaded and ranked). MeSH terms that frequently appeared were identified and co-word analysis was carried out for two groups: (1) authors located in China, and (2) authors based outside of China, respectively. The hot topics concerning research into Chinese herbal drugs were concluded after cluster analysis and related document analysis.

For authors in the China group versus those outside the China group, the search results were 4790 versus 2609 citations and approximately 40,000 versus 20,000 MeSH terms, respectively. The threshold value of highly frequent terms was set at 30 versus 20, and the cumulative frequency percentage of these terms was 40.92% versus 36.67%, respectively. Thus, 43 highly frequent MeSH terms were identified and 43 × 43 co-word matrices were acquired for each group. The appearance frequency of MeSH showed that most research focused on pharmacology, therapeutic application, phytotherapy, side-effects of Chinese herbal drugs, and identification of active chemical components in herbs.

The hot topics are as follows: (1) anti-inflammatory activity, antioxidant activities, anticancer activity of phytogenic antineoplastic agents, and neuroprotective effects of Chinese herbal drugs; (2) common diseases treated with Chinese herbal drugs include hepatocirrhosis, diabetes, angina, chronic hepatitis B in China, and diabetes, asthma, prostate cancer, and hepatocirrhosis outside of China; (3) Chinese herbal nephropathy and acute hepatitis induced by Chinese herbal drugs; (4) PC-SPES (PDQ^®) for the treatment of prostate cancer, which was a hot topic for researchers located outside of China; (5) research on extraction of active components from medicinal plants; and finally (6) research related to the identification of the Chinese herbal drugs component with state-of-the-art technologies in China.

The physiologic changes that occur during pregnancy can lead to a variety of conditions that can usually be self-treated. There are no licensed medicines for conditions such as morning sickness or insomnia in pregnancy, and evidence from Western countries suggests that patients often resort to using herbal medicines. Research on the health behaviors of pregnant women in the United Kingdom with respect to herbal remedies has not been undertaken.

The objective of this study is to describe the use and the user of herbal remedies during pregnancy and to study the sources of information about herbs used.

The study design was a survey among expectant mothers more than 20 weeks pregnant presenting at an antenatal clinic.

The setting was an antenatal clinic and antenatal ultrasound department at Norfolk and Norwich University Hospital. One thousand and thirty-seven (1037) questionnaires were handed out between November 2007 and February 2008.

Five hundred and seventy-eight (578) questionnaires were returned (55.7%). Three hundred and thirty-four (334) of the 578 respondents (57.8%) reported using herbal remedies during pregnancy with a mean of 1.2 remedies per woman (median: 1, range: 0–10). The most commonly used remedies were ginger, cranberry, and raspberry leaf. The most probable user had been pregnant before and had a university degree. “Family and friends” were the most frequently cited source of information about herbal remedies during pregnancy, and more than 75% of the users reportedly did not tell their doctor or midwife about the use.

A large percentage of the women in the study used herbal remedies during pregnancy—many of them without informing their doctor or midwife. Doctors or midwives should ask pregnant women if they use herbal remedies during pregnancy. Health care personnel should be open to discuss the use of herbal remedies during pregnancy and be able to give balanced information as the use is so widespread.

The objectives of this study were to initiate a pharmacist-coordinated program to improve the adverse drug reaction (ADR) reporting on complementary and alternative medicines (CAM) in a tertiary care hospital and to evaluate the pattern of the reported ADRs.

A targeted approach was taken in increasing the ADR reporting to CAM in a tertiary care hospital in South India. Suspected ADRs to CAM spontaneously reported over a period of 24 months were selected for evaluation. Reported ADRs were evaluated for patient demographics, reaction and drug characteristics, causality, severity, and outcome.

A total of 12 ADRs to CAM were reported, which included 9 to Ayurvedic and 3 to homeopathic medicines, which accounted for 1.5% of the ADRs reported to the ADR reporting unit. ADR resulted in hospitalization in 5 patients. The system organ class most commonly involved included skin and appendage disorders (58.3%). Only four of the reactions were previously reported in the literature. The mean time for onset of the ADR after the administration of the drug was 27.8 ± 36.1 days. The suspected drug was withdrawn in all the reports that resulted in recovery, with mean time for recovery 5.9 ± 3.6 days. The majority (66.6%) were moderate in severity and 2 were severe in nature. On causality assessment, 6 were probable in nature and the remaining were possible.

Even though there were fewer ADRs reported by this spontaneous reporting system, it gave valuable information regarding the potential for adverse effects with these agents. The study has reinstated the potential role of spontaneous reporting in identifying lesser reported ADRs, including those to CAM. Such hospital-based programs can contribute much in increasing the safety-related data of these agents.

We administered Kampo medicine for tension-type headache with extremely effective results. The objective is to demonstrate the effect of Kampo medicine.

The case was 13 year-old-girl who had been suffering from headaches from the age of 11 years. As general and neurologic examinations (blood tests, urine analysis, head computed tomography, and electroencephalography) showed no abnormal findings, we diagnosed her as suffering from tension-type headache. Accompanying signs and symptoms included fatigue, shoulder stiffness, and a lot of stress in a private supplementary school and from ballet lessons.

Kampo medicine was chosen to address the necessity for a comprehensive treatment. We prescribed saikokaryukotsuboreito, with clear positive effect. Although headaches re-appeared when she later forgot to take the formula, the symptom disappeared by taking it again. Treatment was discontinued after 11 months, and the headache has not recurred for 3 years.

Kampo medicine was able to improve her overall symptom pattern, as Kampo formulas are selected not only by paying attention to the primary symptom (in this case headache) but also by checking the other characteristics (additional symptoms, constitution, etc). This case showed that Kampo treatment is an effective therapeutic option for tension-type headaches accompanied by various other symptoms.