Chinese herbal medicine and acupuncture for Acne Vulgaris: efficacy, patient preferences and health-related quality of life
Creators: name: Mansu, Suzi
Publisher: name: RMIT University
Year: 2024
Subjects: classificationCode: 320205
subject: Dermatology
classificationCode: 420803
subject: Traditional Chinese medicine and treatments

description: Acne vulgaris (acne) is a common condition that affects adolescents and adults. Acne significantly affects people's health-related quality of life (HRQoL), with reports of low self-esteem, body image concerns and depression. Acne can be initiated by Propionibacterium acnes (P. acnes) infection or androgen activity. Conventional medical treatment of acne includes antibiotics, retinoids, and benzoyl peroxides (BPs). These treatments are not free of adverse effects. <br><br>Chinese medicine (CM) usually attributes mild to moderate acne to heat in the Lung meridian or damp heat in the Stomach meridian, and severe acne to Blood stasis, toxic heat or binding of phlegm. CM is used in clinical practice for the treatment of acne; however, there is a lack of evidence on the clinical benefit and safety of Chinese herbal medicine (CHM) and acupuncture. <br><br>While both CM and western medicine (WM) health care paradigms can be used to treat acne, there are no correlations between CM diagnoses and WM disease states. This PhD describes mechanisms in both paradigms but does not seek to make correlations between the two.<br><br>Objectives<br><br>This project aims:<br>1. To understand the impact of acne on HRQoL and to obtain participant views on CM treatment options;<br>2. To employ the methods of the Cochrane Handbook for Systematic Reviews of Interventions to determine the current state of evidence of CHM and acupuncture for acne; and<br>3. To develop a randomised controlled trial protocol that evaluates the impact of CHM on HRQoL in people with acne vulgaris.<br><br>Methods<br><br>For Objective 1, a review of the current literature on the HRQoL of acne was undertaken with a focus on the psychological, emotional and social impacts of acne and the predictors of impairment. There were different general health, dermatology-specific and acne-specific instruments in the literature to assess the HRQoL of people with acne. The advantages and disadvantages of each were discussed.<br><br>An online survey was conducted to investigate the impact of acne on HRQoL and to obtain participants' views on a proposed treatment protocol. Two validated surveys were used. Questions on patient preferences for CHM and acupuncture treatment duration and frequency were also included in this survey.<br><br>To address Objective 2, two systematic reviews (SRs) were conducted, guided by the methods of the Cochrane Handbook for Systematic Reviews of Interventions. The first SR evaluated the CHM formula Pi Pa Qing Fei Yin (PPQFY) and the second evaluated acupuncture and related modalities. Nine databases were searched for randomised controlled trials (RCTs) for these two interventions. Following study selection and data extraction, statistical analyses were conducted using RevMan 5.3. The strength and quality of the evidence were assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE).<br><br>Findings from the HRQoL review and the online survey, and from the two SRs  (Objectives 1 and 2) informed the development of the trial protocol, which follows Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). A rigorous trial protocol of PPQFY compared to placebo was designed to address the issues in existing literature and improve the quality of new data generated from trials.<br><br>Results<br><br>The review of HRQoL showed that acne had a profound impact on patients' HRQoL. Anxiety, depression, and social anxiety were reported to be associated with acne in the literature. Females, different ethnic groups such as Hispanic, Asian and Maori, and greater severity of acne tended to correlate with poorer HRQoL. However data on the impact of HRQoL on Australians was over ten years old. Despite the profound impact of acne on HRQoL reported in the literature, few CM studies on acne used HRQoL as an outcome measure. Studies that did use HRQoL had used dermatology-specific rather than acne-specific instruments. <br><br>An online survey was conducted using a convenience sampling method, including advertising in local high schools and through universities in Melbourne. Of the 28 respondents, most were female, had mild acne and were 15 to 24 years of age. For Acne-QoL, the lowest score was for the self-perception domain and the highest was for the acne symptoms domain. People with moderate acne were emotionally affected and worried about their acne. The most commonly used complementary and alternative medicine (CAM) by participants were alternative medical systems such as CM, chiropractic and osteopathy. Preferences for CM included topical herbs and oral pills/tablets and acupuncture; participants preferred four to eight weeks of CHM treatment and weekly acupuncture treatments.<br><br>Fifteen trials were included in the SR of PPQFY. PPQFY appeared to have greater benefit based on change in acne symptoms when compared with  pharmacotherapies. None of the studies used placebo as a control. Twelve trials were included in the SR of acupuncture. There was no difference between acupuncture and related modalities when compared with pharmacotherapies. Few studies included in these SRs reported on HRQoL. Both reviews found methodological design issues such as lack of randomisation and blinding procedures, no sample size calculations and small sample sizes in the included trials. <br><br>The dearth of evidence for the effect of CM on HRQoL and limitations of clinical studies identified through SRs were addressed with the development of the trial protocol. A randomised, placebo controlled trial protocol informed by patient preferences was developed using PPQFY as an example. The proposed participants are 15 years or older with mild to moderate acne and a CM diagnosis of heat in the Lung. The intervention group will receive PPQFY capsules while the control group will receive identical placebo capsules. The primary outcome will be HRQoL using the Acne-QoL. Secondary outcomes include lesion count, severity grading, and adverse events (AEs).<br><br>Conclusions<br><br>This project examined the impact of acne on HRQoL, and determined CM treatment preferences of people with acne. The efficacy and safety of the CHM formula PPQFY and acupuncture for acne were systematically evaluated. Methodological issues identified in SRs were addressed in the trial protocol that evaluates the efficacy and safety of PPQFY for patients with mild to moderate acne. The implementation of the trial protocol may improve treatment adherence and improve the reliability and quality of future trials.