Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder(加味丁桂散)in Patients with Chronic Nonbacterial Prostatitis:A Randomized,Double-Blind,Placebo-Controlled Clinical Trial

Objective:To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder(加味丁桂散,MDGP)in patients with chronic nonbacterial prostatitis(CNP).Methods:A randomized,double-blind,placebo-controlled clinical trial was conducted among 72 patients with CNP.Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio,and received either MDGP external umbilicus treatment(MDGP group,36 cases)or placebo(control group,36 cases)at acupoints Shenque(CV 8),twice a week for 4 weeks.In addtion,patients all received herbal medicine treatment twice a day for 4 weeks.The primary outcome was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index(NIH-CPSI)with a questionnaire at weeks 2 and 4.The secondary outcomes including prostatic fluid examination(white blood cells and lecithin bodies),the clinical efficacy evaluation,and the adverse events were also assessed during the entire trial.Results:The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2(P=0.001)and week 4(P=0.004),respectively.NIH-CPSI scores of symptom severity,total scores and leukocytes number in the prostatic fluid in the MDGP group were significantly improved(P<0.05).There was no statistical difference in the urinary symptoms,quality of life,lecithin and other scores between two groups(P>0.05).The clinical effective rate was 73.53%(25/34)in the MDGP group,which was significally higher than the placebo control group with 48.39%(25/31,P<0.05).Patients were blinded successfully,and no serious adverse effects were found during the trial.Conclusion:A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP(Trial registration No.ChiCTRI 800014687).     

Efficacy of Modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒剂)for Migraine Patients with Cold and Stasis Obstructing Meridian Syndrome:A Randomized,Double-Blind,Placebo-Controlled Trial

Objective: To study the efficacy of modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome. Methods: This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group(51 cases) and a placebo group(27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale(VAS) scores. All outcome assessments were conducted respectively at baseline, the 4 th, 8 th and 12 th week, and the end of follow-up. Results: In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4 th week and that of analgesics consumption since the 8 th week(both P0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8 th week and that of analgesics consumption since the 12 th week(both P0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8 th week(P0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption(P0.05). Conclusions: MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.     

Efficacy of Chinese Medicine Acupoint Application Combined with Montelukast on Children with Perennial Allergic Rhinitis: A Randomized Controlled Trial

Objective: To evaluate the efficacy of Chinese medicine acupoint application(CMAA) combined with Western medicine for perennial allergic rhinitis(PAR) in children. Methods: In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group(CMAA and Montelukast), CMAA group(CMAA and placebo tablet), or Montelukast group(placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale(VAS) and rhinitis control assessment test(RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1(Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks. Results: Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline(P0.01 or P0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks(P0.01 or P0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline(P0.01 or P0.05). The least percentages of Th2 and the most alleviated Th2 shift(highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups(P0.05). Conclusion: The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR.(Registered at Chinese Clinical Trial Register, registration No. Chi CTR-IOR-17012434)     

Changes in bone mineral density among women aged 19-24 years using injectable contraceptive depot medroxyprogesterone acetate

Objective To compare bone mineral density(BMD) between users of intramuscular depot medroxyprogesterone acetate(DMPA) and nonhormonal control subjects.Methods The study included 87 women aged between 19 and 24 years using DMPA(DMPA group) for 24 months and 83 same-age women using nonhormonal contraception as control group. BMD of the lumbar spine and femoral neck were measured using dual-energy X-ray absorptiometry, comparing mean BMD changes in DMPA group with the control.Results After 24 months of DMPA treatment, as compared with baseline, the mean BMD in lumbar spine and femoral neck were decreased by 2.67% and 2.71%, respectively.The mean lumbar spine and femoral neck BMD in DMPA group at 24 months were not significantly different compared with baseline(P=0.080 and P=0.076, respectively). In comparison, in control group, there was a trend toward increasing BMD. After 24 months of observation, the mean percentage changes from baseline in lumbar spine and femoral neck BMD were increased by 1.24% and 1.30%, respectively. There was no significantly difference compared with baseline(P=0.436 and P=0.373, respectively).Mean BMD at the spine and femoral neck did not differ significantly between DMPA users and nonusers over 12 months(P=0.153 and P=0.140, respectively), but the BMD at both anatomical sites was significantly lower in DMPA group than in the controlafter 24 months of treatment(P=0.012 and P=0.008, respectively).Conclusion The use of DMPA for short-term(≤12-month) had no significant effects on BMD at spine and femoral neck, but long-term exposure to DMPA had significant loss in BMD in women aged between 19 and 24 years.     

针灸治疗慢性跟腱病：一项随机对照研究

Objective： To examine whether acupuncture treatment would improve outcome in chronic Achilles tendinopathy. Methods： A randomized, controlled trial at two centers of 64 randomized patients aged 18 to 70 years with chronic Achilles tendinopathy was conducted from July 2007 to April 2010, with follow-up until October, 2010. These patients were randomly allocated into an acupuncture treatment group （acupuncture group） and an eccentric exercises group （control group）. The validated Victorian Institute of Sports Assessment- Achilles （VISA-A） questionnaire was completed at baseline and 8, 16, and 24 weeks. The pain at rest and after activity was accessed at baseline and 8 weeks with Visual Analogue Scale （VAS）. Results： After randomization into the acupuncture group or control group, one patient was loss of follow-up. The mean VISA-A score improved significantly after 8 weeks in the acupuncture group to 67.1 points [95% confidence interval （CI）, 64.1-70.2] and in the control group to 48.5 points （95% CI, 45.5-51.6） with an additional 18.6 points increase in acupuncture treatment patients （P=0.0000）. Acupuncture treatment resulted in a significant increase from baseline in VISA-A of 25.8 after 16 weeks and 28.4 after 24 weeks. Whereas, in the control group the increase from baseline in VISA-A were 10.0 and 16.6 after 16 and 24 weeks, respectively （P=0.0000）. The VAS diminished by 2.0 cm after activity, and by 1.5 cm at rest after 8 weeks in the control group. In the acupuncture group, the pain scores diminished significantly more than in the control group, with pain reduction of 3.7 cm after activity （P=0.0000） and 3.2 cm at rest （P=0.0000）. Conclusion： Acupuncture intervention could improve pain and activity in patients with chronic Achilles tendinopathy compared with eccentric exercises.     

COA:髌股关节置换术应用于单纯髌股关节骨关节炎患者临床研究随访

Background Isolated patellofemoral osteoarthritis is not uncommon. Surgical treatment of isolated patellofemoral arthritis remains controversial and is a challenging treatment dilemma. The current study evaluated the results of patellofemoral arthroplasty for the treatment of isolated patellofemoral degenerative arthritis. Methods Between 2006 and 2010.7, 11 knees in 11 patients with isolated patellofemoral arthritis were treated with patellofemoral arthroplasty. The mean age of the patients was 53.7 years (46-74 years). The subjective outcome was based on the WOMAC and the AKS score systems. Anteroposterior flexion weightbearing views, lateral views, and 45° axial views were taken. For comparison, 23 patients (23 TKAs) with primary tibiofemoral OA were matched. The duration of follow-up was 23.7 months (12–47 months). Results At the latest follow-up, there was no clinical or radiographic evidence of patellofemoral maltracking, loosening or wear. According to the WOMAC score system, the scores improved considerably by 7.4 points with respect to pain and by 5.2 points with respect to function. The AKS scores improved considerably by 23.9 points with respect to pain and 44.3 points with respect to function. However, the clinical outcome exhibited no advantages in pain relief and knee function in comparison with total knee arthroplasty, but showed advantages in operation time, blood loss and postoperative range of motion. Conclusions For isolated patellofemoral osteoarthritis, satisfactory clinical outcome can be achieved by patellofemoral arthroplasty in the short-term period, but the long-term outcome has yet to be observed.     

Clinical Experience in Treatment of Alzheimer's Disease with Jiannao Yizhi Formula (健脑益智方) and Routine Western Medicine

Objective: To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula(健脑益智方, JYF) in the treatment of Alzheimer's disease(AD). Methods: Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment(30 with JYF) and the control groups(30 with donepezil) for 6 months with the random numbers. The primary outcomes were scores of Alzheimer's Disease Rating Scale-Cognitive(ADAS-Cog) and Chinese Medicine Symptom Scale(CM-SS). The secondary outcomes were scores of Mini Mental State Examination(MMSE), Montreal Cognitive Assessment(MoCA), and Activities of Daily Living(ADL). Safety assessments were conducted at baseline and the 6 th month of treatment. Serum levels of acetylcholine(Ach), amyloid-β protein 42(Aβ_(42)), and the microtubule-associated protein tau(Tau) were also determined by enzyme-liked immunosorbent assay. Results: Fifty-one participants were included in the final analyses(JYF n=27; donepezil n=24). Compared with baseline, both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores(P0.05 or P0.01). Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ_(42) and Tau(all P0.05). There was no significant difference in these variables between the two groups, which showed that JYF was not inferior to donepezil. No obviously significant changes were observed in the ADL. No severe adverse events were observed in both groups. Conclusion: The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.     

脑源性神经营养因子Val66Met功能基因多态性与环境因素对抗抑郁剂临床疗效的影响

Objective To explore the effect of brain-derived neurotrophic factor (BDNF) Val66Met polymorphism,environmental factor and their interactions on antidepressant treatment.Methods 340 patients of major depressive disorder (MDD) who met the diagnosis criteria of MDD ( DSM-Ⅳ Axis Ⅰ) were recruited.280 patients of them were finished 12 weeks antidepressant treatment.The severity of depression was measured with the Hamilton Depression Rating Scale (HDRS) before and after 12 weeks antidepressant treatment.Childhood Trauma Questionnaire,28-item Short Form (CTQ-SF) and Life Events Scale (LES) were used to evaluate childhood adverse and life stress before onset.Genotyping of BDNF Val66Met polymorphism was detected by Illumina GoldenGate assays.Results Male patients proportion were significantly higher in non-remitters than remitters (P =0.008 ).After adjusting by gender, the frequencies of genotype and allele for the BDNF Val66Met polymorphism were no significant difference between remitters (AA: AG: GG = 28: 79: 40, A:G = 135:159 ) and non-remitters (AA: AG: GG = 29:81:23 ,A: G = 139:127 ) (P ＞0.05 ).There was no significant difference of CTQ scores and LES scores between the two groups (P＞0.05 ).The regression analysis showed that social intercourse problem and age were the risk factor for the severity of depression.The gender, HDRS baseline scores and mental disorder family history were associated with the efficacy of 12 weeks antidepressant.However,there was no significantly relationship between the interaction of BDNF Val66Met polymorphism and environment with the antidepressant treatment.Conclusion The older men with the mental disorder family history, severe depression symptom would be less-response to antidepressant treatment.However, BDNF Val66Met polymorphism, childhood trauma, life events stress and the interaction of BDNF Val66Met polymorphism and environment have no significantly effect on the 12 weeks antidepressant treatment.     

Effect and Safety of Huannao Yicong Formula(还脑益聪方) in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized,Double-Blinded,Donepezil-Controlled Trial

Objective: To assess the effect and safety of Huannao Yicong Formula(还脑益聪方, HYF) in the treatment of patients with mild-to-moderate Alzheimer's disease(AD). Methods: Sixty patients with mild-tomoderate AD were evenly randomized into HYF group and donepezil group with the random number method. Patients in the HYF group took 5 g of HYF granules twice daily and 5 mg placebo of donepezil once daily. Patients in the donepezil group took 5 mg donepezil once daily and 5 g placebo of HYF granules twice daily. The intervention lasted for 6 months. Clinical researchers, participants and statisticians were blinded to the treatment assignment throughout the study. The primary outcomes were scores of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog) and Chinese Medicine Symptom Scale(CM-SS). The secondary outcomes were scores of Montreal Cognitive Assessment(MoCA) test and Mini-Mental State Exam(MMSE). The serum levels of acetylcholinesterase(AchE) and amyloid-β protein 42(Aβ42) were detected with enzymelinked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3 rd and 6 th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6 th month of treatment. Results: A total of 52 patients completed the trial, 28 in HYF group and 24 in donepezil group. Compared with the baseline, HYF and donepezil significantly decreased the total scores of ADAS-Cog and CM-SS, and significantly increased the scores of MoCA and MMSE after 6-month treatment(all P0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ42(both P0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mildto-moderate AD patients. [Trial registration: Chinese Clinical Trial Registry(Reg No. ChiCTR-IOR-17011746)]     

Efficacy of Modified Qufeng Runmian Powder (加减祛风润面散) on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of a Chinese medicine(CM) Modified Qufeng Runmian Powder(加减祛风润面散, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis. Methods: In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score(ASS). The secondary indices of efficacy included the changes in the dermatology life quality index(DLQI) score, VISIA scores(spots, pores, brown spots, porphyrins and red areas) and skin assessment(skin p H, sebum amount and hydration) according to a SOFT skin multianalyzer. Results:(1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group.(2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5%(86/103) vs. 31.7%(32/101), P0.01)] with 95% confidence interval of 39.3%–66.4%.(3) DLQI: DLQI scores were significantly decreased the treatment and control groups(both P0.01), but the treatment group was more obvious than the placebo group(P0.01).(4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline(P0.05). In the control group, the scores of brown spots and pores decreased compared with baseline(P0.05). The improvement was more obvious in the treatment group than in the control group for all items(P0.05).(5) Skin assessment : the p H and sebum score in the both groups decreased drastically compared with the baseline(all P0.01), however, the improvement was more obvious in the treatment group than in the control group(P0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline(both P0.05).(6) Safety: two cases of mild drug allergy were observed in the treatment group. Conclusion: MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.(No. ChiCTR1900020479).     

Wet-Cupping Is Effective on Persistent Nonspecific Low Back Pain: A Randomized Clinical Trial

Objective: To compare the possible effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain(PNSLBP). Methods: In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping and conventional groups using random blook. The wet-cupping group was treated with two separate sessions(4 weeks in total) on the inter-scapular and sacrum area. In the conventional group, patients were conservatively treated using rest(6 weeks) and oral medications(3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index(ODI), and pain intensity using Visual Analogue Scale(VAS), respectively. Results: There was no significant difference in demographic characteristics(age, gender, and body mass index) between the two groups(P0.05). Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits(P0.05). The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly increased compared to the conventional group. Final ODI scores in the wet-cupping and conventional groups were 16.7±5.7 and 22.3±4.5, respectively(P0.01). Conclusion: Wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy.(Registration No. IRCT2013021672741)     

Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China

Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain （DPNP） in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain. Methods This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory （BPI） 24-hour average pain severity ratings ≥4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator＇s judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol： 5 Dimensions, Athens Insomnia Scale, and safety measures. Results Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively,completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups （P=0.124）. Duloxetinetreated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1,2, and 4 （P=0.004, P=0.009, and P=0.006, respectively） but not at weeks 8 （P=0.125） and 12 （P=0.107）. Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo. Conclusions Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.     

Association Between Geranylgeranyl Pyrophosphate Synthase Gene Polymorphisms and Bone Phenotypes and Response to Alendronate Treatment in Chinese Osteoporotic Women△

Objective To investigate the relationship between geranylgeranyl pyrophosphate synthase (GGPPS) genepolymorphisms and bone response to alendronate in Chinese osteoporotic women.
Methods A total of 639 postmenopausal women with osteoporosis or osteopenia were included and randomly received treatment of low dose (70 mg per two weeks) or standard dose (70 mg weekly) of alendronate for one year. The six tag single nucleotide polymorphisms ofGGPPSgenewere identified. Bone mineral density (BMD), serum cross-linked C-telopeptide of type I collagen (β-CTX), and total alkaline phosphatase (ALP) were measured before and after treatment.GGPPS gene polymorphisms and the changes of BMD and bone turnover markers after treatment were analyzed.
Results rs10925503 polymorphism ofGGPPS gene was correlated to serumβ-CTX levels at baseline, and patients with TT genotype had significantly higher serumβ-CTX level than those with TC or CC genotype (allP<0.05). No correlation was found between polymorphisms ofGGPPS gene and serum total ALP levels, as well as BMD at baseline. After 12 months of treatment, lumbar spine and hip BMD increased and serum bone turnover markers decreased significantly (P<0.01), and without obvious differences between the low dose and standard dose groups (allP>0.05). However,GGPPSgene polymorphisms were uncorrelated to percentage changes of BMD, serum total ALP, andβ-CTX levels (allP>0.05).
ConclusionGGPPS gene polymorphisms are correlated to osteoclasts activity, but all tag single nucleotide polymorphisms ofGGPPS gene have no influence on the skeletal response to alendronate treatment.     

Effect of Combined Oral Contraceptive Use on Bone Mineral Density in Adolescent Females

Objective To compare adolescents’bone mineral density (BMD) between users of combined oral contraceptive (Marvelon, desogestrel/ethinylestradiol) and nonhormonal control subjects. Methods The study included 127 women who aged between 16 and 18 years using Marvelon for 24 months and 115 women who aged between 16 and 18 years using nonhormonal contraception as control subjects. BMD of the lumbar spine and femoral neck were obtained using dual energy X-ray absorptiometry. Results After 24 months of Marvelon use, as compared with baseline, the mean BMD in lumbar spine and femoral neck were decreased by 0.30% and 0.61%, respectively. While in the nonusers group, the mean BMD were increased by 1.88% and 1.10%, respectively. Lumbar spine and femoral neck BMD in women who used Marvelon were not significantly different compared with the subjects who used nonhormonal contraception (P>0.05). Conclusion Two years of Marvelon use had no significant effect on BMD, but it remains unknown whether longer than 2 years of use has a significant adverse effect on the attainment of peak bone mass.     

The pain-related behavior changes correlate with the bone damage in a rat model of rheumatoid arthritis

Objective: In view of the extensive bone damage in rheumatoid arthritis, we used a commonly utilized animal model to detect behavioral changes in pain-related and the bone damage during the early disease, and to explore the correlation between bone damage and pain-related behavioral changes. Methods: Arthritis were induced in Sprague-Dawley (SD) male rats by injecting complete Freund’s adjuvant (CFA) into the tails. Pain-related behavior changes were studied using the Hargreaves, VonFrey, and acetone tests on the 0, 7, 14, day and 28 day after CFA injection. The rats were sacrificed according the same schedule. The bone damage of the right proximal tibia was studied by microCT scan and bone histological slices. Results: Animals developed soft tissue inflammation and polyarthritis on 7 days after CFA injection, and arthritic score proved obvious arthritis were established within the study period. Mechanical hyperalgesia and cold allodynia were present in the affected hind paw from the 7 day through the 28 day, but the heat hyperalgesia and the mechanical allodynia lasted a short time after CFA injection. Trabecular bone number (Tb.N), Tissue Mineral Content (TMC) and Bone Volume to Tissue Volume (BV/TV) in the proximal tibia by microCT scan were also reduced after induction, especial 14 days after CFA injection. The bone histological slices showed the trabecular bone and proteoglycan diminished, the bone damage severity scores became more severely on the 7 day after CFA injection. Using analysis of covariance, these changes had statistical significance compared with baseline. By linear regression analysis demonstrated mechanical hyperalgesia and cold allodynia correlated well with arthritic score, bone damage parameters and bone damage severity scores. Conclusion: Adjuvant-induced arthritis (AA) were observed after CFA injection and lasted within the later experimental period. Pain-related behavioral changes were observed in the early time of AA. Bone damage was also occurred with arthritis development. Pain-related behavioral change correlated well with arthritic score and bone damage parameters.     

Effect of Health Education Based on Integrative Therapy of Chinese and Western Medicine for Adult Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study

Objective: To investigate the effects of health education based on integrative therapy of Chinese and Western medicine for type 2 diabetes mellitus(T2DM) from the aspects of knowledge, attitude and practice(KAP), health-related quality of life(HRQo L), body mass index(BMI) and glucose control. Methods: Patients were individually randomized into intervention group(receiving integrative education, n=120) and control group(receiving usual education, n=120). The primary outcome was the changes in glycosylated hemoglobin A1c(HbA1c) levels after 3, 6, 9 and 12 months from baseline. Hierarchical linear models(HLMs) were used to assess within-group changes in outcomes over time and between-group differences in patterns of change. Secondary outcomes were KAP scores, HRQo L scores and BMI after 6 and 12 months, paired-sample t test was used to assess within-group changes in outcomes in 6 and 12 months, independent-sample t test was used to assess between-group differences in patterns of change. Results: HbA1c decreased statistically from baseline to 3 months, from 3 to 6 months, from 6 to 9 months and from 9 to 12 months in the intervention group(all P0.01); and decreased significantly from baseline to 3 months, and from 3 to 6 months in the control group(P0.01). There were significant between-group differences from baseline to 3 months(P=0.044), from 6 to 9 months(P0.01) and from 9 to 12 months(P0.01). Significant improvements in the intervention group along with significant between-group differences were found in KAP and HRQo L scores respectively(all P0.05). The number in the intervention group of normal weight increased from 56 at baseline to 81(6 months), 94(12 months), the number in the control group were 63(baseline), 69(6 months), 70(12 months), the χ~2 of hierarchical analysis of BMI were 6.93(P=0.075), 10.31(P=0.016), 15.53(P0.01), respectively. Conclusion: Health education based on integrative therapy of Chinese and Western medicine is beneficial to the control of T2DM and should be recommended for T2DM.     

脑源性神经营养因子Val66Met功能基因多态性与环境因素对抗抑郁剂临床疗效的影响

Objective To explore the effect of brain-derived neurotrophic factor (BDNF) Val66Met polymorphism,environmental factor and their interactions on antidepressant treatment.Methods 340 patients of major depressive disorder (MDD) who met the diagnosis criteria of MDD ( DSM-Ⅳ Axis Ⅰ) were recruited.280 patients of them were finished 12 weeks antidepressant treatment.The severity of depression was measured with the Hamilton Depression Rating Scale (HDRS) before and after 12 weeks antidepressant treatment.Childhood Trauma Questionnaire,28-item Short Form (CTQ-SF) and Life Events Scale (LES) were used to evaluate childhood adverse and life stress before onset.Genotyping of BDNF Val66Met polymorphism was detected by Illumina GoldenGate assays.Results Male patients proportion were significantly higher in non-remitters than remitters (P =0.008 ).After adjusting by gender, the frequencies of genotype and allele for the BDNF Val66Met polymorphism were no significant difference between remitters (AA: AG: GG = 28: 79: 40, A:G = 135:159 ) and non-remitters (AA: AG: GG = 29:81:23 ,A: G = 139:127 ) (P ＞0.05 ).There was no significant difference of CTQ scores and LES scores between the two groups (P＞0.05 ).The regression analysis showed that social intercourse problem and age were the risk factor for the severity of depression.The gender, HDRS baseline scores and mental disorder family history were associated with the efficacy of 12 weeks antidepressant.However,there was no significantly relationship between the interaction of BDNF Val66Met polymorphism and environment with the antidepressant treatment.Conclusion The older men with the mental disorder family history, severe depression symptom would be less-response to antidepressant treatment.However, BDNF Val66Met polymorphism, childhood trauma, life events stress and the interaction of BDNF Val66Met polymorphism and environment have no significantly effect on the 12 weeks antidepressant treatment.     

针灸对血管性痴呆中医证候的改善作用

Objective： To study the effects of acupuncture on Chinese medicine syndromes of vascular dementia （VaD）. Methods： Sixty-three VaD patients were divided into three groups. Those willing to be randomized were randomly assigned to receive either acupuncture （random acupuncture group, 24 cases） or rehabilitation training （guided rehabilitation group, 24 cases） for 6 weeks. Those unwilling to be randomized also received acupuncture for 6 weeks （non-random acupuncture group, 19 cases）. Patient syndromes and their severity were evaluated before treatment （baseline）, at the end of treatment, and at 4-week follow-up after the completion of treatment using a CM scoring system （scale of differentiation of syndromes of vascular dementia, SDSVD）. The SDSVD scores of the random and non-random acupuncture groups, and of all patients who received acupuncture （combined acupuncture group, 43 cases）, were compared with those in the guided rehabilitation group. Results： In the random, non-random, and combined acupuncture groups, SDSVD scores were significantly reduced at the end of treatment and at follow- up than at baseline. In the guided rehabilitation group, SDSVD scores were similar to baseline scores at the end of treatment and at follow-up. However, there were no significant differences in SDSVD scores among the three groups or between the combined acupuncture group and the guided rehabilitation group at any time points. In the non-random and combined acupuncture groups, SDSVD scores were significantly reduced at the end of treatment than at baseline in patients with hyperactivity of Liver （Gan）-yang or phlegm obstruction of the orifices. Conclusions： Acupuncture reduced the severity of VaD. The improvement was the greatest in patients undergoing their treatment of choice. Treatments in this study were more effective for excess syndromes, such as Liver-yang hyperactivity or phlegm obstruction of the orifices than deficiency syndromes, such as Kidney （Shen）-essence deficiency.     

Menopausal depression: comparison of hormone replacement therapy and hormone replacement therapy plus fluoxetine

Background To compare the efficacy and safety of hormone replacement therapy (HRT) combined with fluoxetine, with HRT alone, in post-menopausal women suffering from depression.Methods A randomized, open-label, parallel trial was applied. HRT was administered to all patients for 2 cycles, with 14 days of estrogen therapy and 14 days of estrogen plus progesterone. Patients who were randomly assigned to the HRT plus fluoxetine group were given fluoxetine in combinationwith HRT. Hamilton Depression Rating Scale (HAMD), Kupperman Menopausal Index (KMI), and Clinical Global Impressions scale were used to measure the efficacy.Results One hundred and twenty-three post-menopausal patients with depression were enrolled in the study. Among them, 120 had at least one post-treatment visit and entered into the statistical analysis. The mean total HAMD scores were significantly lower, and the percentages of HAMD score reductions were higher in the HRT plus fluoxetine Group compared with the HRT Group, after at least 3 weeks of treatment, with an average difference of 5 points at the endpoint. The Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores were significantly different in the 2 groups, in favor of the combination therapy. The mean total KMI was significantly lower in the Combination Group compared with the HRT Group, after at least 6 weeks of treatment, with an average 4. 5-point difference between the groups. No statistically significant differences were found in most of the adverse events reported in the Combination Group compared with the HRT group, with the exception of 3 symptoms, i. e., dry mouth, loss of appetite, and abdominal distention. They were mild to moderate in severity. Two patients in the HRT group, but none in the combination group, dropped out due to adverse events.Conclusion HRT plus fluoxetine therapy was effectivewith a satisfactory safety profile.in the treatment of menopausal depression with a satisfactory safety profile.     

Effect of Depot Medroxyprogesterone Acetate （DMPA） on Bone Mineral Density in Women of Reproductive Age

Objective To compare bone mineral density （BMD） between users of intramuscular depot medroxyprogesterone acetate（DMPA ） and nonhormonal control subjects. Methods The study included 68 women aged between 25 and 40 years using depot medroxyprogesterone acetate for 24 months and 59 women aged between 25 and 40 years using nonhormonal contraception as control subjects. BMD of the lumbar spine and femoral neck were obtained using dual energy X-ray absorptiometry. Results At 24 months of treatment, as compared with baseline, the mean BMD in lumbar spine and femoral neck was decreased by 5.5% and 5.9%, respectively. Lumbar spine and femoral neck BMD in women who used DMPA were significantly decreased compared with the subjects in nonuser （P〈0.001）. Conclusion These results show BMD declined during using DMPA in women aged 25 -40 years old.