Efficacy of Acupuncture in Improving Symptoms and Quality of Life of Patients With Acne Vulgaris: a Randomized Sham Acupuncture-controlled Trial

Primary Outcome ◽

Controlled Trial ◽

Acne Vulgaris ◽

Sham Acupuncture ◽

Lesion Count ◽

Randomized Controlled ◽

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

10.21203/rs.2.12890/v3 ◽

2020 ◽

Author(s):

Ruimin Jiao ◽

Man Huang ◽

Weina Zhang ◽

Zhishun Liu

Keyword(s):

Quality Of Life ◽

Primary Outcome ◽

Controlled Trial ◽

Acne Vulgaris ◽

Sham Acupuncture ◽

Lesion Count ◽

Randomized Controlled ◽

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

10.21203/rs.2.12890/v5 ◽

2020 ◽

Author(s):

Ruimin Jiao ◽

Man Huang ◽

Weina Zhang ◽

Zhishun Liu

Keyword(s):

Quality Of Life ◽

Primary Outcome ◽

Controlled Trial ◽

Acne Vulgaris ◽

Sham Acupuncture ◽

Lesion Count ◽

Randomized Controlled ◽

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

Efficacy of acupuncture in improving the symptoms and life quality of patients with moderate or severe acne vulgaris: protocol for a randomized controlled trial

10.21203/rs.2.12890/v2 ◽

2020 ◽

Author(s):

Ruimin Jiao ◽

Man Huang ◽

Weina Zhang ◽

Zhishun Liu

Keyword(s):

Primary Outcome ◽

Small Sample Size ◽

Controlled Trial ◽

Acne Vulgaris ◽

Life Quality ◽

Sham Acupuncture ◽

Small Sample ◽

Lesion Count ◽

Abstract Background: Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and quality of life (QoL) of patients. Although acupuncture has been indicated as an effective treatment for patients with AV in several trials, the results of these trials are also controversial due to potential for bias of their design. And none of the previous clinical trials of acupuncture therapy for AV used the QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and QoL of patients with moderate or severe AV. Methods/design: Ninety-six eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale scores, the Dermatology Life Quality Index scale total score, the total lesion count and inflammatory lesion count, itch and pain assessment using the visual analogue scale score, patient expectations of acupuncture, and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture on the symptoms and QoL of patients with moderate or severe AV compared with sham acupuncture. The limitation of the design of this trial is that the single center study with a relatively small sample size, the acupuncturists will not be blinded.

Efficacy of acupuncture in improving the quality of life of patient’s with moderate or severe acne vulgaris: protocol for a randomized controlled trial

10.21203/rs.2.12890/v1 ◽

2019 ◽

Author(s):

Ruimin Jiao ◽

Man Huang ◽

Weina Zhang ◽

Zhishun Liu

Keyword(s):

Quality Of Life ◽

Primary Outcome ◽

Controlled Trial ◽

Acne Vulgaris ◽

Sham Acupuncture ◽

Lesion Count ◽

Severe Acne ◽

Randomized Controlled ◽

Abstract Background Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the quality of life of patients. None of the previous clinical trials of acupuncture therapy for AV used the quality of life as a primary outcome or employed a sham acupuncture control arm. Methods/design Participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale scores, the Dermatology Life Quality Index scale total score, the total lesion count and inflammatory lesion count, itch and pain assessment using the visual analogue scale score, patient expectations of acupuncture, patient satisfaction with treatment, and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion This is the first randomized controlled trial which will compare the effect of acupuncture versus sham acupuncture in improving the quality of life of patients with moderate or severe acne vulgaris (AV). The limitation of the design of this trial is that the sample size of a single center trial, which may lead to potential overestimation of the effect of acupuncture. Meanwhile, due to the characteristics of acupuncture, the acupuncturists will not be blinded and the use of non-acupoints and minimal acupuncture without any manipulation, which may introduce an element of bias and cause some biological effect.

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

10.21203/rs.2.475/v2 ◽

2019 ◽

Author(s):

Jian-Feng Tu ◽

Jing-Wen Yang ◽

Li-Qiong Wang ◽

Yang Wang ◽

Jin-ling Li ◽

...

Keyword(s):

Statistical Analysis ◽

Knee Osteoarthritis ◽

Primary Outcome ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Sham Acupuncture ◽

Manual Acupuncture ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA.

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-015111 ◽

2017 ◽

Vol 7 (8) ◽

pp. e015111 ◽

Cited By ~ 3

Author(s):

Mohamed Abdel-Fattah ◽

Graeme MacLennan ◽

Mary Kilonzo ◽

R Phil Assassa ◽

Kirsty McCormick ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Single Incision ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Female Stress Urinary Incontinence ◽

Midurethral Slings ◽

Secondary Outcomes ◽

Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-211172 ◽

2017 ◽

Vol 77 (2) ◽

pp. 188-195 ◽

Cited By ~ 54

Author(s):

Raine Sihvonen ◽

Mika Paavola ◽

Antti Malmivaara ◽

Ari Itälä ◽

Antti Joukainen ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Knee Pain ◽

Medial Meniscus ◽

Controlled Trial ◽

Partial Meniscectomy ◽

Meniscus Tear ◽

Arthroscopic Partial Meniscectomy ◽

Serious Adverse Events ◽

Secondary Outcomes

ObjectiveTo assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus.MethodsIn this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35–65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out.ResultsIn the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, −4.3; 95% CI, −11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (−3.2; −8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (−0.4; −1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups.ConclusionsIn this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

Efficacy of an Anti-Cellulite Herbal Emgel: A Randomized Clinical Trial

Pharmaceuticals ◽

10.3390/ph14070683 ◽

2021 ◽

Vol 14 (7) ◽

pp. 683

Author(s):

Ngamrayu Ngamdokmai ◽

Neti Waranuch ◽

Krongkarn Chootip ◽

Katechan Jampachaisri ◽

C. Norman Scholfield ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Subcutaneous Fat ◽

Volatile Oils ◽

Double Blind ◽

Severity Scores ◽

Secondary Outcomes ◽

Cutaneous Blood ◽

Time Point

Cellulite describes unsightly skin overlying subcutaneous fat around thighs and buttocks of post-pubescent females. A herbal ‘emgel’ containing volatile oils and extracts of A traditional Thai herbal compress was tested in a double-blind, placebo-controlled trial with 18 women aged 20–50 year with severe cellulite. Appearance of cellulite (primary outcome), thigh circumferences, skin firmness, and cutaneous blood flow (secondary outcomes) were assessed at baseline, 2, 4, 8 and 12 weeks with a 2-week follow-up. Herbal emgel applied onto the thigh skin twice daily reduced cellulite severity scores in every time point. The score was reduced from 13.4 ± 0.3 (baseline) to 12.1 ± 0.3 (week 2) and 9.9 ± 0.6 (week 12). All secondary outcomes improved with both placebo and herbal emgels suggesting that ingredients in the base-formulation might be responsible. Querying of participants, analysis of their diaries, and physical monthly inspections found no adverse events. The herbal emgel safely improved the appearance of cellulite, while the base emgel may play a role for other endpoints. Further studies on the active constituents and their mechanism of action are needed to further explore these factors.

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

10.21203/rs.2.475/v1 ◽

2019 ◽

Author(s):

Jian-Feng Tu ◽

Jing-Wen Yang ◽

Li-Qiong Wang ◽

Yang Wang ◽

Jin-ling Li ◽

...

Keyword(s):

Statistical Analysis ◽

Knee Osteoarthritis ◽

Primary Outcome ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Sham Acupuncture ◽

Manual Acupuncture ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA. Trial registration: Clinicaltrials.gov, NCT03366363. Registered on 20 November 2017. (https://clinicaltrials.gov/show/NCT03366363)