The effects of acupuncture for patients with psoriasis

2.2.1. Diagnostic criteria

The patients with psoriasis will be diagnosed according to the 2018 China College of Dermatology diagnostic criteria: skin lesions involve ≤15% body surface area (BSA). It should be mainly located on the torso/limbs, palm/soles, and face/scalp, the vulva area should not be unaffected.

2.2.2. Inclusion criteria

The inclusion criteria for the study are as follows:

• 1.

  meeting the above diagnostic criteria for psoriasis;

• 2.

  aged between 18 and 65 years (either sex);

• 3.

  do not have history suggestive of contact allergy;

• 4.

  no acupuncture within 3 weeks prior to the recruitment;

• 5.

  refrained from using any other treatments from 3 weeks before acupuncture, without moisturizers;

• 6.

  agreeing to participate in the trial and be randomly allocated into any study groups.

2.2.3. Exclusion criteria

Participants will be excluded who meet any following conditions:

• 1.

  other active skin diseases that may affect condition assessment;

• 2.

  severe psychological disorders;

• 3.

  pregnant or lactating women;

• 4.

  serious organic disease, systemic diseases, or other chronic diseases including cardiac disease, liver, or kidney disease, thrombocytopenia with bleeding tendency;

• 5.

  severe episodes of fainting during acupuncture or afraid of blood;

• 6.

  experiencing other active interventions that may affect the outcome of this study during the treatment;

• 7.

  any other condition that the investigators judge as likely to make the patient incapable to complete, comply, or unsuitable for the clinical trial.

2.2.4. Recruitment

We intend to promote the recruitment plan through multimodal strategies, including advertisements on community bulletin boards, community broadcasts, social media (WeChat), and a clinical patient database. Researchers will register the interested participants and conduct a corresponding screening assessment. Informed consent will be obtained before randomization.

2.2.5. Randomization and allocation

The participants will be randomly assigned to manual acupuncture group or sham acupuncture group at a 1:1 ratio after the baseline assessment. The randomization list will be generated using the Statistical Analysis Software (9.1) by a research assistant who is not involved in the recruitment of participants. The sealing and opaque envelopes will be used to achieve the allocation concealment.

2.2.6. Blinding

The participants, statistical analysts and assessors will be blinded to treatment allocation. In order to blind the participants, the acupoints and manipulation of needles are similar in both groups. All participants will be asked whether they have experienced manual acupuncture or sham acupuncture after the treatments to assess the blinding. It will be impossible to blind the therapists due to the characteristics of acupuncture interventions.

2.3.1. Manual acupuncture group

In the study, the acupuncture needles of 0.30 mm in diameter and 40 mm in length (Suzhou Hwato Medical Instruments Co. Ltd, China) will be used. All acupoints are identified based on the point location issued by the World Health Organization. The used acupoints include SP10 (Xuehai), LI11 (Quchi), ST36 (Zusanli), SP6 (Sanyinjiao), BL13 (Feishu), BL17 (Geshu), BL18 (Ganshu), BL20 (Pishu), and LR3 (Taichong). The insertion depth of SP10, LI11, ST36, and SP6 will be 1 cun. BL13, BL17, BL18, and BL20 will be punctured 1–15 cun into the skin, and LR3 will be punctured only 0.5 cun. The procedures for acupuncture are as follows:

• 1.

  skin disinfection;

• 2.

  the sterile adhesive pads will be placed on acupoints;

• 3.

  acupuncture manipulation is applied to inserted through the pads for Deqi sensation including soreness, numbness, distension, pain, and heaviness sensation;

• 4.

  the needles are maintained for 15 minutes for each session;

• 5.

  manual stimulation is conducted 3 times every 5 minutes during each session;

• 6.

  at end of each session, the needles are removed, and then clean cotton balls are pressed to avoid bleeding.

2.3.2. Sham acupuncture group

Blunt-tipped placebo needles (0.30 mm in diameter and 40 mm in length, produced by Suzhou Hwato Medical Instruments Co. Ltd, China) will be used in the sham acupuncture group. The schedule, locations of acupoints, and other treatment settings are the same with manual acupuncture group but with superficial skin penetration and no needle manipulation for Deqi sensation. The needles will also be maintained for 15 minutes, and sham manual stimulation will be conducted each 5 minutes during each session.

2.4.1. Primary outcomes

The primary outcome of the current study is the proportion of patients with a reduction in the Psoriasis Area and Severity Index (PASI) scores ≥50% compared with baseline. PASI score will be evaluated at the same or closet day. Target lesions will be recorded as digital photographs by single-lens reflex cameras during each session.

2.4.2. Secondary outcomes

BSA will be assessed by fingerprinting. The entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on the psoriatic skin of the body part is used to determine the extent to which the body part is affected by psoriasis (%).^[14]

Quality of life will be assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey, which consists of 36 items comprising 8 categories: functional capacity (10 items), physical aspects (4 items), pain (2 items), general health status (5 items), vitality (4 items), social aspects (2 items), mental health (5 items), and a question comparing current health conditions with those from a year ago. The total scores range from 0 to 100. High scores indicate more health status.^[15]

Psychosocial abnormalitydepression will be assessed by Montgomery-Asberg Depression Rating Scale, which consists of 9 items, each rated on a 7-step Likert scale from 0 to 6.^[16] Higher scores indicate greater severity. It is a useful measurement for depression in clinical practice, and has good internal consistency.^[17,18]

Anxiety will be assessed using the Depression, Anxiety, and Stress Scale-21, which is recorded on a Likert-type scale ranging from 0 (not applicable at all) to 3 (applicable very much of the time). The severity of anxiety is graded into normal, mild, moderate, severe, or extremely severe based on the scores of each domain. The Depression, Anxiety, and Stress Scale-21 showed good validity and reliability.^[19]

2.4.3. Data collection and management

For the participants meeting the inclusion criteria, the research screeners will collect their baseline data at the appropriate time. The primary and secondary outcomes will be assessed by the blinding assessors at baseline and 13 weeks (within 1 week after the intervention). The research assistant, who is blind to the allocation, will complete the quality control of data collection and data entry. The research manager will complete the collection, classification, identification, and analysis of raw data.

2.5.1. Clinical data analysis

In this study, clinical data will be analyzed using SPSS 19.0 statistical software by a blinded statistician. Data analysis will also be based on the intention-to-treat. Continuous variables will be showed using the mean and standard deviation, or the median and interquartile range. Categorical variables will be presented with percentages (%). A two-sample t test will be used in comparing clinical data between manual acupuncture group and sham acupuncture group. A paired sample t test will be used for comparisons between baseline and the end of treatment in each group. Clinical data on the skewed distribution will be compared using a nonparametric test. Chi-Squared test or Fisher exact test will be used for comparing categorical variables. The significance level of the test is targeted at 0.05.

2.5.2. Sample size

Based on the PASI scores, the published study reported that the total curative rate in the acupuncture group was 97.5%, and 87% in the control group.^[20] In the current study, we assumed that a significance level α was 0.05 and a power (1-β) = 0.80, and calculated the sample size: 88 participants with psoriasis would be required in each group for 80% power to detect a difference between manual acupuncture group and sham acupuncture group using the two-sided Z test with pooled variance. The significance level of the test is 0.05. Given a 20% loss to follow-up, therefore this study will require at least 220 participants.