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.     

A pilot randomised controlled trial (RCT) investigating the effectiveness of reflexology for managing pregnancy low back and/or pelvic pain

Many pregnant women with low back and/or pelvic pain (LBPP) use pain medications to manage this pain, much of which is self-prescribed and potentially harmful. Therefore, there is a need to find effective nonpharmacological treatments for the condition. Reflexology has previously been shown to help nonspecific low back pain. Therefore; a pilot RCT was conducted investigating reflexology in the management of pregnancy-LBPP. 90 primiparous women were randomised to either usual care, a reflexology or footbath intervention. Primary outcome measures were; the Pain Visual Analogue Scale (VAS). 64 women completed the RCT; retention rates for the reflexology group were 80%, usual care group 83.33% and footbath group 50%. The reflexology group demonstrated a Clinically Important Change (CIC) in pain frequency (1.64 cm). Results indicate it is feasible to conduct an RCT in this area, although a footbath is an unsuitable sham treatment. Reflexology may help manage pregnancy-LBPP; however a fully powered trial is needed to confirm this.     

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.     

新型口服避孕药屈螺酮炔雌醇片的多中心随机对照临床观察

目的 观察屈螺酮炔雌醇片(商品名:优思明)用于健康育龄期妇女的避孕效果、出血模式、副作用及避孕以外的其他作用.方法 采用多中心随机对照的研究方法对768例要求避孕的健康育龄期妇女,以3:1的比例随机分配到屈螺酮组(服用屈螺酮炔雌醇片,573例)和去氧孕烯组(服用去氧孕烯-炔雌醇,195例),均服药13个周期,在服药后的第4、7、10和13个周期进行随访,观察身高、体重、月经情况等.在服药前和服药后第7、13个周期完成月经不适问卷(MDQ).结果 屈螺酮组的方法失败率(Pearl指数)为0.208/百妇女年,优于去氧孕烯组的0.601/百妇女年.两组受试者的出血模式相似,发生出血和(或)点滴出血、仅有点滴出血的天数、次数及每次出血最长时间在各个参考时相基本相似.第7个周期与服药前比较,两组受试者用药后在经期水潴留和食欲增加方面的MDQ量表评分变化、月经间期水潴留和身心健康感方面的MDQ量表评分变化,屈螺酮组(分别为-0.297、-0.057、0.033、0.150分)较去氧孕烯组(分别为-0.108、0.023、0.231、-0.023分)改善明显,两组分别比较,差异均有统计学意义(P<0.05).在皮肤异常方面,第13个周期月经前期时,屈螺酮组的改善率(18.0%,89/494)较去氧孕烯组(11.3%,19/168)明显增高,两组比较,差异有统计学意义(P<0.05);在乳房疼痛或触痛方面,在第7个周期经期时,屈螺酮组改善率(12.6%,62/494)较去氧孕烯组(5.4%,9/168)明显增高,两组比较,差异也有统计学意义(P<0.05).屈螺酮组妇女的体重呈下降趋势,去氧孕烯组反之;在第13个周期随访时,两组体重的变化(与服药前比较)分别为-0.28、0.57 kg,两组比较,差异有统计学意义(P<0.01).结论 屈螺酮炔雌醇片和去氧孕烯.炔雌醇均具有良好的避孕效果,出血模式相似,而在体重变化、经前期症状改善等方面,屈螺酮炔雌醇片优于去氧孕烯.炔雌醇.     

Effectiveness of an add-on treatment with the homeopathic medication SilAtro-5-90 in recurrent tonsillitis: An international,pragmatic, randomized,controlled clinical trial

ObjectiveTo investigate the effectiveness and safety of the homeopathic product SilAtro-5-90 in recurrent tonsillitis.MethodsIn this international, pragmatic, controlled clinical trial, 256 patients (6–60 years) with moderate recurrent tonsillitis were randomized to receive either SilAtro-5-90 in addition to standard symptomatic treatment, or to receive standard treatment only. The primary outcome was the mean time period between consecutive acute throat infections (ATI) within 1 year (analyzed via repeated events analysis).ResultsDuring the evaluation year, the risk of getting an ATI was significantly lower (hazard ratio: 0.45, proportional means model, p = 0.0002, ITT) with SilAtro-5-90 compared to control. Tonsillitis-specific symptoms were significantly reduced (p < 0.0001, ITT) and the need of antibiotics to treat acute throat infections (p = 0.0008; ITT) decreased. 3 non-serious adverse drug reactions were reported for SilAtro-5-90.ConclusionsAn integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis.Trial registration: ISRCTN registry: Registration number ISRCTN19016626, registered 23 January 2013.     

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.     

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.     

Efficacy of L-arginine for preventing preeclampsia in high-risk pregnancies: A double-blind,randomized, clinical trial

Objective: This study aimed to estimate the effectiveness of L-arginine for preventing preeclampsia in high-risk pregnancy. Methods: We performed a randomized, double-blind, placebo-controlled, clinical trial in patients with high-risk factors for preeclampsia. Fifty subjects received L-arginine, beginning from the 20th week of gestation. An additional 50 patients received homologated placebo. Results: The placebo group had a higher number of cases of preeclampsia (11/47) compared with the L-arginine group (3/49, P = 0.01). Birth weight was higher in the L-arginine group and there was a smaller number of preterm births (P = 0.03). Conclusion: L-arginine is effective for preventing preeclampsia.     

A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up

OBJECTIVE: This study was undertaken to compare tension-free vaginal tape (TVT) with colposuspension as the primary treatment for stress incontinence. STUDY DESIGN: The trial was conducted in gynecology or urology departments in 14 centers in the United Kingdom and Ireland. Three hundred forty-four women with urodynamic stress incontinence were randomly assigned to groups: 175 to TVT and 169 to colposuspension. Patients were assessed using the Short Form-36 health status questionnaire, the Bristol Female Lower Urinary Tract Symptoms questionnaire, clinical examination, and a 1-hour perineal pad test. Unpaired and paired data were analyzed with the Wilcoxon rank sum and matched pairs tests, respectively, and proportions were compared with the Fisher exact test. RESULTS: When data were analyzed on an intention-to-treat basis, assuming patients with missing data to be treatment failures, 63% of the TVT group and 51% of the colposuspension group were objectively cured at 2 years (odds ratio 1.67, 95% CI 1.09-2.58). CONCLUSION: The TVT procedure appears to be as effective as colposuspension for the treatment of urodynamic stress incontinence at 2 years.     

A randomized, prospective, controlled, multicenter clinical trial of a sprayable, site-specific adhesion barrier system in patients undergoing myomectomy

OBJECTIVE: To assess the safety and effectiveness of a sprayable, site-specific adhesion barrier system (SprayGel; Confluent Surgical, Waltham, MA) for reduction of adhesion formation. DESIGN: Prospective, randomized, controlled phase III trial. SETTING: University clinic (Kiel, Germany) and private clinic (Bordeaux, France). PATIENT(S): Sixty-six women aged 34.9 years (range, 23-52 years) undergoing laparoscopic or open uterine myomectomy, enrolled over a 15-month period. INTERVENTION(S): Patients were randomized to receive either optimal surgical treatment plus adhesion barrier or optimal surgical treatment alone, followed by second-look laparoscopy. MAIN OUTCOME MEASURE(S): Initial and second-look laparoscopy procedures were assessed for incidence, extent, and severity of adhesions; all patients were followed for safety analysis. RESULT(S): When compared with initial surgery, the mean adhesion tenacity score of adhesions seen at second-look laparoscopy was significantly reduced in treatment patients compared with control patients (0.6 vs. 1.7, a 64.7% reduction). Mean adhesion extent score at second-look laparoscopy compared with initial surgery was 4.5 cm(2) vs. 7.2 cm(2), mean adhesion incidence score was 0.64 vs. 1.22. Of 64 patients, 40 (62.5%) returned for second-look laparoscopy. CONCLUSION(S): This adhesion barrier was safe, well tolerated, and demonstrated efficacy in a population of patients known to be at risk for adhesion formation. There were no adverse effects attributable to the product and no patients in whom it could not be applied.     

雌二醇屈螺酮片治疗绝经后妇女绝经相关症状的多中心临床研究

目的 探讨雌二醇屈螺酮片(其他名称:安今益)用于伴有绝经相关症状的绝经后妇女的临床疗效和安全性.方法 采用多中心、双盲、随机、安慰剂对照的研究方法,将244例伴有中重度潮热症状的绝经后妇女,按3∶1比例随机分为治疗组(服用雌二醇屈螺酮片,183例)和安慰剂组(61例),连续服药16周,在服药的4、8、12、16周及服药结束后2周进行随访,观察身高、体质量、生命体征、潮热及其他绝经相关症状改善情况和阴道出血等,并在服药16周时进行临床疗效评价.结果 与治疗前比较,治疗后16周治疗组和安慰剂组总潮热平均严重程度指数下降的绝对值分别为-0.6±0.5和-0.4 ±0.4,两组比较,差异有统计学意义(P＜0.05);但治疗组和安慰剂组治疗后中重度潮热平均严重程度指数下降的绝对值分别为-0.6±0.8和-0.3±0.6,两组比较,差异无统计学意义(P＞0.05).治疗后16周时,治疗组妇女中重度出汗、阴道干涩等症状的缓解以及总体临床疗效均显著优于安慰剂组,差异有统计学意义(P＜0.01).整个治疗过程中,治疗组妇女的血压基本稳定.治疗中发生阴道出血治疗组为48.9%(87/178),安慰剂组为10.7%(6/56),尤其在治疗的第4～8周发生率最高.虽然治疗组的每个周期(28 d)累积无阴道出血率低于安慰剂组,但随着治疗时间的延长,治疗组的累积无阴道出血率逐渐升高.治疗组的不良事件主要是乳房胀痛,占12.0%(22/183).治疗组患者血钾无异常升高,无明显其他不良事件发生.整个治疗过程中发生的严重不良事件均与试验药物无关或可能无关.结论 雌二醇屈螺酮片可有效缓解绝经后妇女的绝经相关症状,是安全有效的新型激素补充治疗药物.

Abstract：

Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P＜0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P ＜ 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P ＞ 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P ＜0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium was in the normal range in observation group mostly. Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.