scholarly journals 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

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Randomized Controlled ◽  
Scale Total Score

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.

scholarly journals 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

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Randomized Controlled ◽  
Scale Total Score

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.

scholarly journals 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

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Randomized Controlled ◽  
Scale Total Score

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.

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

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 ◽  
Scale Total Score

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.

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

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 ◽  
Scale Total Score

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.

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

2021 ◽  
Author(s):  
Ruimin Jiao ◽  
Xu Zhai ◽  
Xuecheng Zhang ◽  
Zhiyi Xiong ◽  
Zhishun Liu
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Inflammatory Lesion ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Serious Adverse Events ◽  
Scale Total Score ◽  
Secondary Outcomes

Abstract Objective: The aim of this study was to examine the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV. Methods: Participants were randomly assigned (1:1) to receive 12 treatment sessions of acupuncture or sham acupuncture over 4 weeks with 24 weeks of follow-up. The primary outcome was the change from baseline in the Skindex-16 scale total score at treatment completion. Secondary outcomes included Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, and visual analogue scale scores for itch and pain evaluation. Results: There is no statistically significant between-group difference for the primary outcome and any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up, except for the Skindex-16 subscale (the emotions of participants with AV) at week 4 (P = 0.026). No serious adverse events occurred in two group. Conclusion: Acupuncture and sham acupuncture might both relieve the symptoms of patients with moderate or severe AV, reduce the number and degree of inflammatory lesion counts, and improve QoL. Trial registration number: ChiCTR-1900023649 Chinese Clinical Trial Registry

scholarly journals Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

2019 ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms of lung cancer patients, with a prevalence of 88.0% in cancer survivors, and even higher post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue, however, randomized controlled trials of suitable sample size are limited. Method/Design This is a multi-center, patient-blind, randomized controlled trial (RCT). A total of 320 eligible patients will be recruited in four centers (Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital and LongHua Hospital Shanghai University of Traditional Chinese Medicine) and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1ratio. Treatment will be given twice per week for 12 sessions. Treatment will consist of acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of Brief Fatigue Inventory-Chinese (BFI-C), the secondary outcomes will be measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Hamilton Rating Scale for Depression (HAMD). The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week and follow-ups), the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat (ITT) analysis will be used in this RCT. Discussion This trial protocol provides an example of clinical application for the management of lung cancer-related fatigue using acupuncture treatment. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.

scholarly journals Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

2019 ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms of lung cancer patients, with a prevalence of 88.0% in cancer survivors, and even higher post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue, however, randomized controlled trials of suitable sample size are limited. Method/Design This is a multi-center, patient-blind, randomized controlled trial (RCT). A total of 320 eligible patients will be recruited in four centers (Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital and LongHua Hospital Shanghai University of Traditional Chinese Medicine) and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1ratio. Treatment will be given twice per week for 12 sessions. Treatment will consist of acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of Brief Fatigue Inventory-Chinese (BFI-C), the secondary outcomes will be measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Hamilton Rating Scale for Depression (HAMD). The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week and follow-ups), the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat (ITT) analysis will be used in this RCT. Discussion This trial protocol provides an example of clinical application for the management of lung cancer-related fatigue using acupuncture treatment. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.

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