A herbal formula for prevention of influenza-like syndrome: a double-blind randomized clinical trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the efficacy of a herbal formula in the prevention of influenza or influenza-like syndrome among elderies residing in old-people's home in Hong Kong. The secondary objectives are to investigate the quality of life (QOL) and symptomology changes among the herbal users and to evaluate the safety of this formula.</p><p><b>METHODS</b>In ten old people's home or community centres in New Territories, Hong Kong, 740 eligible subjects agreed to join the study and were randomized to receive a herbal formula or a placebo on alternate days over 8 weeks. Among those 740 participants, 113 had provided blood samples for immunological assessments before and after the study drug. Assessments were done at 0, 4, 8 and 12 weeks. Participants were instructed to keep a daily record of body temperature and any symptoms as sore throat, myalgia, running nose or cough, and to report to assessor accordingly. Those reporting body temperature of 37.8 °C and above would be visited and a proper nasopharyngeal swab be taken for viral study.</p><p><b>RESULTS</b>Seventy-two participants developed influenza-like-symptoms but none of them was proven influenza in their nasopharyngeal swabs, 40 of these patients belonged to the herbal group and 32 to the placebo group, without significant differences between groups. The difference on the changes in QOL between the two groups was not statistically significant. However, in the immunological study, the natural killer cell absolute count was significantly increased in the herbal group compared with the placebo group (463 ± 253 vs 413 ± 198, P<0.05).</p><p><b>CONCLUSIONS</b>The herbal preparation was not effective compared with placebo in the prevention of influenza-like syndrome. It was however safe and possibly supporting immunological responses.</p>

An innovative herbal product for the prevention of osteoporosis / 中国结合医学杂志

<p><b>OBJECTIVE</b>To prevent the deterioration of osteopenia, a triple herb product Bo-gu Ling ( , ELP) was created for a clinical trial on post-menopausal women suffering from osteopenia.</p><p><b>METHODS</b>The design of the clinical trial was of randomized, double-blind, placebo-controlled nature. A total of 150 women aged 40-60 years, who were after menopause for at least 1 year and their lumbar spine bone mineral density (BMD) must be lower than 0.891 g/cm(2), were recruited and randomly divided into the ELP group treated with ELP and the placebo group, with 75 in each group. The primary endpoint was the BMD of the lumbar spine that was assessed at baseline, 6 and 12 months after treatment. Secondary endpoints included peripheral quantitative computed tomography (pQCT) measurements of distal tibia and the changes in the quality of life (QOL).</p><p><b>RESULTS</b>The spine BMD of the ELP group was increased by 0.69% in the subjects who were more than 10 years after menopause. In contrast, the placebo group of the same stratum decreased by 0.61% (P=0.067). In the subjects with more than 10 years duration of menopause, the hip BMD increased by 0.21% in the ELP group, compared with a decrease of 0.52% in the placebo group (P=0.159). The tibia strength-strain index was increased by 1.94% in the ELP group compared with 0.33% in the placebo group (P=0.047). Physical function of SF-36 QOL questionnaire was remarkably improved compared with the baseline, but did not show dominance over the placebo group.</p><p><b>CONCLUSION</b>ELP showed potential benefit in improving BMD on the women who experienced over 10 years of menopause.</p>

Acupuncture: Complications are preventable not adverse events / 中国结合医学杂志

If adverse effects are understood as "something that happened unexpectedly" while receiving drug treatment, there is no difference between adverse effects and complications. However, acupuncture is a process different from the use of drugs. While acupuncture procedures should not be taken for granted as safe, complications causing harm are usually, according to the authors, the result of negligence, and should be differentiated from other adverse effects. Harmful complications noted consisted of bleeding and damage to the tissues and organs under the puncture sites. Adverse effects consisted of symptomatology like fainting and other systemic disturbances difficult to explain. In a study of acupuncture complications and adverse effects in 2000 procedures conducted by experienced professional acupuncturists in a research institution, it was found that complications did not occur, and adverse events happened infrequently. Attempts were made to explain the causes of adverse effects. Now that acupuncture is being widely incorporated into medical practice, a good understanding of adverse effects and complications would be necessary and helpful.

Patient recruitment for clinical trials on traditional Chinese medicine: Challenges, barriers, and strategies.

BACKGROUND AND OBJECTIVE: Failure to recruit sufficient numbers of participants is a major barrier to the completion of randomized controlled trials in traditional Chinese medicine (TCM) clinical trials. The purpose of this paper is to analyze the commonly used strategies for the recruitment of patients in TCM clinical trials, to identify the most common reasons for attrition and refusal, and to identify barriers and potential solutions to the difficulties. METHODS AND RESULTS: There are four stages in the actual recruitment process, which included introducing the project to the potential patients, explaining how to implement the project, assessing and intensifying the understanding and facilitating patient decision-making. When insufficient recruitment occurred, the following steps should be considered: reevaluating the required sample size; adding new sites to the trial; eliminating hospitals that had poor recruiting records; extending the patient recruitment period, modifying the patient inclusion/exclusion criteria; and shifting placebo-controlled to active-controlled arrangements. Success in reaching target recruitment depended largely on being able to directly contact patients through posters, newspaper advertisements, television interviews, patient support groups, and physician referrals in hospitals. CONCLUSIONS: Suspicions against the placebo and unwillingness to stop taking other herbal supplements made recruitment more difficult, time-consuming, and costly. In a Chinese community, open advertising in the local newspaper may be particularly attractive.