ABSTRACT
PURPOSE: To assess the effectiveness and safety of acupuncture for erectile dysfunction (ED). MATERIALS AND METHODS: We searched six major English and Chinese databases included randomized controlled trials (RCTs) testing acupuncture alone or in combination for ED. Dichotomous data were presented as risk ratio (RR) and continuous data were presented as mean difference (MD) both with 95% confidence interval (CI). The Revman (v.5.3) was used for data analyses. Quality of evidence across studies was assessed by the online GRADEpro tool. RESULTS: We identified 22 RCTs, fourteen of them involving psychogenic ED. Most of the included RCTs had high or unclear risk of bias. There was no difference between electro-acupuncture and sham acupuncture with electrical stimulation on the rate of satisfaction and self-assessment (RR, 1.50; 95% CI, 0.71–3.16; 1 trial). Acupuncture combined with tadalafil appeared to have better effect on increasing cure rate (RR, 1.31; 95% CI, 1.00–1.71; 2 trials), and International Index of Erectile Function-5 scores (MD, 5.38; 95% CI, 4.46–6.29; 2 trials). When acupuncture plus herbal medicine compared with herbal medicine alone, the combination therapy showed significant better improvement in erectile function (RR, 1.68; 95% CI, 1.31–2.15; 7 trials). Only two trials reported facial red and dizziness cases, and needle sticking and pruritus cases in acupuncture group. CONCLUSIONS: Low quality evidence shows beneficial effect of acupuncture as adjunctive treatment for people mainly with psychogenic ED. Safety of acupuncture was insufficiently reported. The findings should be confirmed in large, rigorously designed and well-reported trials.
Subject(s)
Humans , Male , Acupuncture , Asian People , Bias , Dizziness , Electric Stimulation , Erectile Dysfunction , Herbal Medicine , Needles , Odds Ratio , Pruritus , Self-Assessment , Statistics as Topic , TadalafilABSTRACT
<p><b>OBJECTIVE</b>To evaluate the effectiveness and safety of Songling Xuemaikang Capsule (, SXC) for the treatment of primary hypertension.</p><p><b>METHODS</b>An extensive search including Cochrane Library, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), KoreaMed, Japanese database, and online clinical trial registry websites was performed up to February 2013. Randomized controlled trials (RCTs) regarding SXC for the treatment of primary hypertension were searched without no language restrictions. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration.</p><p><b>RESULT</b>A total of 17 RCTs involving 1,778 patients were included. Meta-analysis showed that there was no significant difference between SXC and antihypertensive agents on systolic blood pressure [mean difference (MD): -0.10 [-4.83, 4.63]; P=0.97] and diastolic blood pressure (MD: 1.00 [-1.16, 3.16]; P=0.36), but SXC combined with antihypertensive drugs was more effective in lowering systolic blood pressure (MD: -6.17 [-7.86, -4.49]; P<0.00001) and diastolic blood pressure (MD: -7.24 [-8.62, -5.85]; P<0.00001) compared with the antihypertensive drugs alone.</p><p><b>CONCLUSIONS</b>SXC used alone or combined with antihypertensive drugs appear to be an effective treatment for lowering elevated blood pressure and improving symptoms in patients with primary hypertension. However, the conclusion cannot be drawn definitely due to the poor quality of the included studies. There is still an urgent need for well-designed, long-term studies to address the benefits of SXC for treating primary hypertension.</p>
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Antihypertensive Agents , Therapeutic Uses , Capsules , Drugs, Chinese Herbal , Therapeutic Uses , Essential Hypertension , Hypertension , Drug Therapy , Epidemiology , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
Clinical trial protocol is the document that illustrates the background of a clinical trial, theoretic basis, objective, design, methods, and organization, as well as statistical calculating, implement, and conditions for completion. Clinical trial protocol is the basic measure for ensuring the validity of scientific results and reducing bias. In order to optimize the design of clinical trial protocol, we generalize main problems in Chinese medicine clinical trials, key points of clinical trial protocol, as well as report standards.