Randomized clinical trial of facial acupuncture with or without body acupuncture for treatment of melasma

ObjectiveTo evaluate the efficacy of acupuncture treatments in treating facial melasma, contrasting treatments involving facial acupuncture with facial/body acupuncture.MethodWomen suffering with melasma were randomly assigned into: 1) facial acupuncture (n = 20); or 2) facial/body acupuncture (n = 21). Each group was given 2 sessions per week for 8 weeks. Melasma area and darkness of its pigmentation were assessed using digital images.Results95.2% and 90% of participants in facial/body and facial acupuncture, respectively, had decreased melasma areas, with a mean reduction area being 2.6 cm² (95%CI 1.6–3.6 cm²) and 2.4 cm² (95%CI 1.6–3.3 cm²), respectively. 66.7% (facial/body acupuncture) and 80.0% (facial acupuncture) of participants had lighter melasma pigmentation compared to their baselines (p-value = 0.482).ConclusionsFacial acupuncture, with or without body acupuncture, was shown to be effective in decreasing the size of melasma areas.This study is registered with the Thai Clinical Trial Registry (TCTR20140903004).     

Redefining the randomized controlled trial in the context of acupuncture research

BACKGROUND: The randomized controlled trial (RCT) is considered the 'gold standard' methodology for evaluating efficacy of an intervention. It has been argued that RCTs cannot be used to examine the effectiveness of acupuncture. PURPOSE: The purpose of this paper is to examine the applicability of an RCT study design for acupuncture research. FINDINGS: RCTs would be more effective in studying acupuncture if study participants were randomized to groups based on the acupuncture diagnosis and not solely on the Western diagnostic criteria. Treatments must also be standardized somewhat to ensure replicability of the study and the information it provides. Blinding is not absolutely necessary for a good-quality RCT; however, if used, control groups need to be standardized and sham techniques evaluated to ensure accurate interpretation of results. CONCLUSIONS: With these factors combined, it is possible to greatly increase internal and external validity in acupuncture RCTs.     

Menopause and dry eye. A possible relationship

The hormonal status and in particular sex steroids play a role in the ocular surface homeostasis and function, during the whole life and in both sexes, accomplished by estrogenic and androgenic receptors located on corneal and conjunctival epithelia and Meibomian gland. The ocular surface is an integrated unit and any dysfunction results in a scarce or unstable preocular tear film which produces dry eye, a chronic inflammatory condition with increasing incidence as people get older but always more frequent among females. In post-menopausal women endocrine changes join the aging effects in the pathogensis of dry eye, but still it remains controversial whether estrogen or androgen deficiency or their imbalance impair ocular surface function. Another questionable issue concerns the efficacy of hormonal replacement therapy in the amelioration of dry eye symptoms and recovery of tear function, since the scientific literature stands in between a therapeutic or a promoting effect of eye dryness. Therapy of dry eye is usually based upon topical administration of tear substitutes; estrogen or androgen-based eye drops represents a promising innovative treatment based upon important scientific rationale.     

国内腹腔镜与经腹子宫切除术相关随机对照试验的系统评价

目的:比较腹腔镜子宫切除术和经腹子宫切除术的安全性和可行性差异.方法:计算机检索电子数据库,手工检索相关杂志.由两名评价员独立检索和提取资料并交叉核时,纳入高质量随机对照试验.Meta分析软件是Cochrane协作网提供的RevMan 5.0.结果:共纳入高质量的RCT试验9个,包括1290例患者,其中腹腔镜手术组664例,经腹手术组626例.Meta分析结果显示:两组间手术时间差异无统计学意义[MD 2.02,95%CI(-4.41,8.45);P=0.54];两组间术中出血量、术后住院时间、术后排气时间、术后病率、术后镇痛用药率、术后血红蛋白量、伤口愈合时间、疼痛强度及术后离床活动时间等指标,腹腔镜子宫切除术均优于经腹子宫切除术.结论:腹腔镜子宫切除术安全性、可行性及优越性均优于经腹子宫切除术.     

GyneFix IN与TCu 380A宫内节育器的随机比较性临床研究

目的观察新型ＧｙｎｅＦｉｘＩＮ宫内节育器（ＩＵＤ）的临床性能。方法采用随机对比性多中心临床研究方法,对６０７例健康经产妇女由经过培训的专人以随机方法于月经间期放置ＧｙｎｅＦｉｘＩＮＩＵＤ３２０例（ＧｙｎｅＦｉｘＩＮ组）及ＴＣｕ３８０ＡＩＵＤ３０５例（ＴＣｕ３８０Ａ组）,于放器后１、３、６和１２个月随访,以生命表法统计两种ＩＵＤ的终止情况。结果ＧｙｎｅＦｉＸＩＮ组使用１年无妊娠发生,脱落和因症取出率分别为每百妇女２６７和１０２,与ＩＵＤ使用有关的终止率为每百妇女３６６,明显低于ＴＣｕ３８０Ａ组的每百妇女７８８（Ｐ＜００５）。ＧｙｎｅＦｉｘＩＮ组疼痛的主诉率也低于ＴＣｕ３８０Ａ组。结论此种无支架、铜表面积大并有固定系统的ＩＵＤ,由经过培训的人员放置,具有低脱落率和改善疼痛副反应的特点,有推广前景。     

Acupuncture to initiate labor (Acumoms 2): A randomized,sham-controlled clinical trial

Objective.?To evaluate the efficacy of acupuncture for labor stimulation.

Methods.?Nulliparous women at 38 weeks or greater were randomized to traditional Chinese medicine (TCM) acupuncture, sham acupuncture, or usual care only groups. Acupuncture points LI4, SP6, BL32, and BL54 were needled bilaterally. The primary outcome was time from enrollment to delivery. Secondary outcomes included rates of spontaneous labor and cesarean delivery. Medical records were abstracted for maternal demographic, medical, and delivery outcome data. ANOVA, Student's t-test, Chi-square, and Kaplan–Meier statistics were used to compare groups.

Results.?Eighty-nine women were enrolled and randomized. Maternal age, gestational age, prior acupuncture experience, tobacco, alcohol and drug use, gravida, and history of gynecological surgery were similar among the groups. There were no statistically significant differences among groups for time from enrollment to delivery (p = 0.20), rates of spontaneous labor (p = 0.66), or rates of cesarean delivery (p = 0.37). Rates of maternal and neonatal outcomes were not significantly different.

Conclusion.?TCM acupuncture was not effective in initiating spontaneous labor or reducing the rate of cesarean delivery compared with sham acupuncture or usual medical care.     

The effect of acupuncture on pain,dyspareunia, and quality of life in Brazilian women with endometriosis: A randomized clinical trial

Endometriosis is a disease characterized by the presence of endometrial tissue outside the cavity of the uterus, its cause is still unknown, but the most accepted theory is the retrograde mesntruação, which states that part of the menstrual blood returns to the body instead of being eliminated.ObjectivesThe aim of this study, based on a randomized clinical trial, was to observe the effects of an acupuncture protocol on chronic pelvic pain, dyspareunia, and quality of life in women with endometriosis.MethodsTo test the efficacy of acupuncture, we selected 42 women who were on the waiting list to undergo a videolaparoscopy at the University Hospital of Florianópolis, Santa Catarina, Brazil. These women were divided into two sample groups. The first received the experimental treatment of acupuncture, and the other received placebo therapy, for which the needles were inserted 3 cm apart from the points of energy. Each group underwent five treatment sessions lasting on average 40 min. Randomization was carried out using Clinical Trial Management System software, and the allocation sequence was performed by a laboratory assistant and hidden to the team conducting the project, which was responsible for collecting the information. To monitor the effects of this intervention, we used the visual analogue scale (VAS) and the quality-of-life questionnaire for Endometriosis Health Profile 30 (EHP-30) endometriosis. Variables were measured at three time points: pre-therapy, post-therapy, and 2 months after therapy.ResultsThe results were analysed with SAS software version 9.1.3 using analysis of variance. A decrease in VAS scores for chronic pelvic pain and dyspareunia was observed in both groups analysed. However, 2 months after therapy, the results were maintained only in the experimental group. Regarding quality of life, we observed an improvement in all variables analysed, although these were statistically significant only in the experimental group. In contrast, the variable for infertility did not reach significance in either group.ConclusionsWe concluded that acupuncture confers beneficial and long-lasting effects, even 2 months after therapy, as demonstrated by the variables studied.Registered in the Brazilian Clinical Trials Registry (REBEC) with the identification codeRBR-7cfctd.     

Randomized controlled trial of misoprostol for second-trimester pregnancy termination associated with fetal malformation

OBJECTIVE: Our purpose was to compare the effectiveness, women's views of the termination procedure, and success of umbilical cord culture for vaginal and oral misoprostol versus intra-amniotic prostaglandin PGF(2alpha) for second-trimester pregnancy termination (STPT). STUDY DESIGN: We randomized 217 women, 15 to 24 weeks' gestation, into 3 groups. Oral (OM) and vaginal (VM) misoprostol groups received 400 microg of misoprostol every 4 hours for 24 hours. The intra-amniotic PGF(2alpha) (IAPG) group received 40 mg of PGF(2alpha) followed by oxytocin infusion. Women completed self-administered questionnaires 3 weeks after the termination procedure. Umbilical cord samples were collected at delivery for karyotype analysis. The primary outcome was the time from start of the procedure to placental delivery. Secondary outcomes were maternal complications, women's acceptance of the termination procedure, and success rates of umbilical cord culture. RESULTS: The time was longer for the OM group (30.5+/-14.4 hours) compared with the VM group (18.3+/-8.2 hours) and the IAPG group (21.1+/-10.2 hours), P<.001 for both comparisons. Women in the VM group reported being more willing to repeat the termination method in the future and reported fewer side effects than those in the other groups, P<.001. Failure rates for umbilical cord cultures were 9.6%, 17.0%, and 45.6% for the VM, OM, and IAPG groups, respectively. CONCLUSION: Oral misoprostol is less effective than intra-amniotic PGF(2alpha) or vaginal misoprostol for STPT. Women report vaginal misoprostol more acceptable than other methods. Umbilical cord culture failure rate is highest in the IAPG group.     

Thread embedding acupuncture for herniated intervertebral disc of the lumbar spine: A multicenter,randomized, patient-assessor-blinded,controlled, parallel,clinical trial

Backgroundand purpose: Although several studies have reported that thread embedding acupuncture (TEA) is effective for lumbar herniated intervertebral disc (LHIVD), the evidence remains limited because previous studies had a high risk of bias. This study aimed to investigate the efficacy and safety of TEA for LHIVD through a rigorously designed trial.Materials and methodsThis was a randomized, patient-assessor-blinded, sham-controlled trial. Participants were screened according to eligibility criteria, and 70 patients with LHIVD were randomly allocated to the TEA and sham TEA (STEA) groups in a 1:1 ratio. Both groups received TEA or STEA treatment at 23 acupoints once per week for eight weeks. Changes in low back pain, radiating pain, Oswestry disability index, Roland–Morris disability questionnaire, EuroQol 5–Dimensions 5–Levels, and global perceived effect were measured at baseline and at 4, 8, 12, and 16 weeks after screening and compared between the two groups.ResultsTEA showed no significant difference in all outcomes compared to STEA immediately after eight weeks of treatment. After an additional eight weeks of follow-up, TEA showed a more significant effect on the low back pain than STEA (p < 0.05) and showed a better tendency in maintaining or enhancing the improvement of radiating pain, function, and quality of life even after the end of treatment. No serious adverse events were observed.ConclusionTEA is effective in improving low back pain in patients with LHIVD and may help improve function and quality of life, especially in the long term.     

The Randomized Nitric Oxide Tocolysis Trial (RNOTT) for the treatment of preterm labor

OBJECTIVE: This study was undertaken to assess the effectiveness of glyceryl trinitrate (GTN) patches in comparison with beta2 sympathomimetics (beta2) for the treatment of preterm labor. STUDY DESIGN: A multicenter, multinational, randomized controlled trial was conducted in tertiary referral teaching hospitals. Women in threatened preterm labor with positive fetal fibronectin or ruptured membranes between 24 and 35 weeks' gestation were recruited and randomly assigned to either beta2 or GTN with rescue beta2 tocolysis if moderate-to-strong contractions persisted at 2 hours. Obstetric and neonatal outcomes were assessed. RESULTS: Two hundred thirty-eight women were recruited and randomly assigned, 117 to beta2 and 121 to GTN. On a strict intention-to-treat basis, there was no significant difference in the time to delivery using Kaplan-Meier curves (P = .451). At 2 hours, 27% of women receiving beta2 had moderate or stronger contractions compared with 53% in the GTN group (P < .001). This led to 35% of women in the GTN group receiving rescue treatment. If delivery or requirement for beta2 rescue are regarded as treatment failure, then a significant difference was observed between the 2 arms (P = .0032). There were no significant differences in neonatal outcomes. CONCLUSION: GTN is a less efficacious tocolytic compared with ss2 sympathomimetics.     

Acupuncture therapy for the treatment of stable angina pectoris: An updated meta-analysis of randomized controlled trials

Background and purposeStable angina pectoris is a common symptom imperiling patients’ life quality. The purpose of this meta-analysis is to assess the effectiveness of acupuncture alone or acupuncture plus medicine for the treatment of stable angina pectoris.MethodsSeven databases were searched ranging from 1959 to February 2018. Quantitative analysis of randomized controlled trials (RCTs) was performed by RevMan 5.3 software and STATA 12.0 program, and Cochrane criteria for risk-of-bias was used to assess the methodological quality of the trials.ResultsA total of 12 RCTs involving 974 patients were enrolled in this study. The pooled results showed that both acupuncture group (RR: 0.35, P < 0.00001; RR: 0.49, P < 0.00001) and acupuncture plus medicine group (RR: 0.26, P < 0.00001; RR: 0.52, P = 0.03) were associated with a higher percentage of improved anginal symptoms as well as electrocardiographic (ECG) results compared to medicine group. The acupuncture plus medicine group also had a lower intake rate of nitroglycerin than medicine group (Non-event RR: 0.79, P = 0.03). However, there was no significant difference in the reduction or discontinuation of nitroglycerin intake between acupuncture group and medicine group. No acupuncture-related adverse effects were observed or reported in the included trials.ConclusionAcupuncture therapy may improve anginal symptoms and ECG results in patients with stable angina pectoris, and can serve as an adjunctive treatment for this condition.     

中药治疗儿童支气管哮喘临床研究方法的新选择

通过介绍随机对照试验与真实世界研究及其特征,使真实世界研究走入人们的视野。通过阐述中药治疗儿童支气管哮喘临床研究方法的不足,分析真实世界研究应用于中药临床研究的可行性,为中药治疗儿童支气管哮喘使用真实世界研究方法提供新选择。     

Efficacy and safety of Resina Draconis for wound repair in the treatment of diabetic foot ulcer: A systematic review and meta-analysis of randomized controlled trials

Background and purposeResina Draconis (RD) is widely used to treat topical skin ulcers. However, its effect on diabetic foot ulcer (DFU) remains unknown. The present meta-analysis aims to evaluate the efficacy and safety of RD for wound healing in DFU treatment.MethodsLiterature searches were conducted with databases including PubMed, Embase, Cochrane Library, the China National Knowledge Infrastructure, the Wanfang Database, the Database for Chinese Technical Periodicals, and the China Biology Medicine Disc. Relevant studies were selected based on specified inclusion and exclusion criteria. Software RevMan 5.4 was used for study selection, quality assessment, and data analysis, while the Cochrane Risk of Bias (RoB) 2.0 tool was used to assess RoB.ResultsNine eligible randomized controlled trials (RCTs), involving 679 patients, were included in this review. The results showed that the healing time of the RD group was shorter than that of the control group (P < 0.00001), while the RD group also presented a higher healing rate (P < 0.0001), a higher rate of ulcer area reduction (P = 0.0005), and a higher rate in the patients with a reduced Wagner grade (P = 0.002). Simultaneously, a lower frequency of dressing changes (P < 0.00001) and a shorter length of hospital stays (P < 0.00001) are the characteristics of the RD group as well.ConclusionThe treatment with RD is a safe and effective solution for DFU, and its combination with conventional treatment can improve the healing rate of DFU, reduce healing time, and inhibit further development. However, owing to the limited quality and quantity of included studies, further high-quality research is necessary to support these conclusions.     

静脉注射丙种球蛋白无反应型川崎病药物治疗Meta分析

摘要：目的　分析评价静脉注射丙种球蛋白（IVIG）无反应型川崎病（KD）药物治疗的随机对照研究（RCT）。方法　依据纳入和排除标准,从医学电子数据库中选择相关RCT文献,应用Juni量表进行质量评价,Review Manager 4.2软件进行Meta分析。疗效判断指标为观察期内体温改善和超声心动图检测冠状动脉病变情况。结果用相对危险度（RR）或比值比（OR）及其95%可信区间（CI）表示,P < 0.05为差异有统计学意义。结果　共有3篇RCT入选,绘制漏斗图提示可能存在发表偏倚。3篇RCT Meta分析包括再次IVIG治疗组（159例）和糖皮质激素（GCS）治疗对照组（66例）,研究显示,IVIG无反应型KD患儿在静脉应用首剂IVIG无反应后,再次IVIG治疗组在体温恢复方面优于GCS治疗对照组,两组差异有统计学意义（RR = 1.29,95% CI：1.10～1.52,P = 0.002）;但在冠状动脉瘤（CAA）发生率方面两者差异无统计学意义（OR = 0.91,95% CI：0.33～2.49,P = 0.85）。结论　目前已发表的RCT Meta分析结果显示,IVIG无反应型KD患儿在首剂IVIG治疗无反应后,再次应用IVIG治疗较GCS治疗能更有效地控制体温,但两者在CAA发生率方面差异无统计学意义。     

Single daily dose of moxifloxacin versus ofloxacin plus metronidazole as a new treatment approach to uncomplicated pelvic inflammatory disease: a multicentre prospective randomized trial

Objectives

To evaluate the efficacy and safety of moxifloxacin versus ofloxacin plus metronidazole in patients with uncomplicated pelvic inflammatory disease (uPID; defined as PID symptoms and signs, but no complications such as septicemia, perihepatitis, and tubo-ovarian abscess) in Turkey.

Study design

This was a multicenter, prospective, randomized, parallel-group study conducted between June 2010 and March 2013 in four hospitals in Turkey. Women received a 14-day course of either oral moxifloxacin at 400 mg once daily (n = 560) or oral ofloxacin at 400 mg twice daily plus oral metronidazole at 500 mg twice daily (n = 543).

Results

A total of 1156 women were randomized to the study. Total compliance was achieved in 1103 patients. For the primary measure of efficacy (clinical cure), moxifloxacin showed no difference compared with ofloxacin plus metronidazole (445/560 [79.5%] vs. 449/543 [82.7%]; p = 0.172). Bacteriological cure rates were high and comparable between treatment arms (99/119 [83.2%] vs. 93/110 [84.5%]; p = 0.781). Drug-related adverse events occurred less frequently with moxifloxacin than with ofloxacin plus metronidazole (210/560 [37.5%] vs. 252/543 [46.4%]; p = 0.003). Furthermore, moxifloxacin treatment was lower in cost and achieved higher patient compliance compared with ofloxacin plus metronidazole (31.4 Euros vs. 23.4 Euros and 7/578 (1.2%) vs. 22/578 (3.8%), respectively; p = 0.005).

Conclusions

In patients with uPID, once-daily moxifloxacin monotherapy was clinically and microbiologically as efficacious as twice-daily ofloxacin plus metronidazole therapy and was associated with fewer drug-related adverse events, lower patient non-compliance, and a lower treatment cost.     

Foley尿管水囊促宫颈成熟用于足月妊娠引产的前瞻性随机对照研究

目的 比较Foley尿管水囊与普贝生栓促宫颈成熟用于足月妊娠引产的安全性和有效性. 方法 采用前瞻性随机对照研究方法,选择2009年6月至12月在本院待产的孕足月、单胎头位、有引产指征、阴道清洁度≤Ⅱ度、胎膜完整、官颈Bishop评分＜6分的初产妇,签署随机对照研究知情同意书后,随机分为2组,最终纳入分析的共126例,分别予Foley尿管水囊(64例)和普贝生栓(62例)促官颈成熟,Foley尿管水囊组与普贝生栓组孕妇的孕周、引产前宫颈评分、引产指征差异无统计学意义.采用t、x2检验或Fisher精确概率法比较2组孕妇的引产成功率、分娩方式、产程时间及母儿结局. 结果 Foley尿管水囊组与普贝生栓组宫颈评分改善、引产成功率、阴道分娩率、总产程、产后出血量差异均无统计学意义(P＞0.05).Foley尿管水囊组较普贝生栓组引产24 h内阴道分娩率低[28.1％(18/64)与56.5％(35/62),t=10.37,P＜0.05],宫缩过频过强发生率也较低[0.0％(0/64)与17.7％(11/62),P＜0.05],但缩宫素使用率高[87.5％(56/64)与21.0％(13/62),x2 =56.27,P＜0.05].2组新生儿Apgar评分、羊水胎粪污染发生率、新生儿体重差异均无统计学意义(P＞0.05).2组孕妇无一例发生产褥感染. 结论 严格掌握Foley尿管水囊促宫颈成熟的指征及执行无菌操作规程,可以取得与普贝生栓相似的促官颈成熟效果及引产母婴结局,未发生过频过强官缩,具有安全性高及成本低廉等优点.