Efficacy of Modified Qufeng Runmian Powder () on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

OBJECTIVE: To evaluate the efficacy and safety of a Chinese medicine (CM) Modified Qufeng Runmian Powder (, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis. METHODS: In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score (ASS). The secondary indices of efficacy included the changes in the dermatology life quality index (DLQI) score, VISIA scores (spots, pores, brown spots, porphyrins and red areas) and skin assessment (skin pH, sebum amount and hydration) according to a SOFT skin multianalyzer. RESULTS: (1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group. (2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5% (86/103) vs. 31.7% (32/101), P<0.01)] with 95% confidence interval of 39.3%-66.4%. (3) DLQI: DLQI scores were significantly decreased the treatment and control groups (both P<0.01), but the treatment group was more obvious than the placebo group (P<0.01). (4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline (P<0.05). In the control group, the scores of brown spots and pores decreased compared with baseline (P<0.05). The improvement was more obvious in the treatment group than in the control group for all items (P<0.05). (5) Skin assessment: the pH and sebum score in the both groups decreased drastically compared with the baseline (all P<0.01), however, the improvement was more obvious in the treatment group than in the control group (P<0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline (both P>0.05). (6) Safety: two cases of mild drug allergy were observed in the treatment group. CONCLUSION: MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis. (No. ChiCTR1900020479).

Whether Fire-needle Therapy Benefits Plaque Psoriasis: A Multicenter, Randomized, and Controlled Trial.

OBJECTIVE: To observe the clinical effectiveness and safety of fire-needle therapy, an external approach of Chinese medicine in treating plaque psoriasis. METHODS: This study was a two-parallel-arm randomized controlled trial. A total of 151 participants with plaque psoriasis were randomly assigned to the fire-needle therapy group (treatment group, 76 cases) or the control group (75 cases) at a 1:1 allocation ratio using SAS software. All participants received Oral Huoxue Jiedu Decoction (, HXJDD) and applied externally vaseline cream twice a day. Participants in the treatment group received fire-needle therapy once weekly for 4 weeks plus HXJDD and vaseline cream applied the same as the control group. The primary outcome measure was Psoriasis Area and Severity Index (PASI) score, and the secondary outcomes were Dermatology Life Quality Index (DLQL), and Hamilton Anxiety Rating Scale (HAMA), as well as Chinese medicine (CM) syndrome score and photos of target lesions. The indices were evaluated before and after treatment. RESULTS: Sixty-eight patients in each group completed the study. The treatment group has not yet achieved significant improvement in PASI score (P>0.05) compared to the control group. However, significant differences were found between the two groups in relieving CM syndrome (P<0.05) and improving quality of life (P<0.05). CONCLUSION: Fire-needle appears to be safe and may have benefit for psoriasis, the short-term treatment and small sample size limit the conclusions of this study. Further rigorous randomized controlled trials with longer treatment are recommended.

[Treatment of EGFRIs-related Skin Adverse Reactions by Zhiyang Pingfu Lotion].

Objective To observe the curative effect of Zhiyang Pingfu Lotion (ZPL) for its ex- ternal application in treatment of epidermal growth factor receptor inhibitors (EGFRIs)-related acneiform rash, cutaneous pruritus , xerosis cutis , and nail changes , as well as to evaluate its safety and patients' satisfaction. Methods Recruited were 201 patients with confirmed pathological diagnosis, who had acne- iform rash after using EGFRIs. They were assigned to the treatment group (131 cases) and the control group (70 cases) by random digit table. Patients in the treatment group were externally applied with self- formulated ZPL based on principles of Western medical standards, while those in the control group were externally applied with blank drugs plus conventional Western medicine standard. The therapeutic course for all was 14 days. Changes in rash degree, cutaneous pruritus, xerosis cutis, and nails were observed in both groups before and after treatment. Blood routines as well as liver and kidney function tests were performed in both groups before and after treatment. Follow-up visit was also conducted during progression-free survival (PFS). Results A total of 185 patients finished this clinical trial. Ten dropped out in the treatment group and 6 in the control group. The effective rates of rash degree, cutaneous pruritus, xerosis cutis, and nail changes were 90.1 % (109/121 ), 57.9% (70/121 ), 57. 9% (70/121 ), and 16. 5% (20/121) in the treatment group, respectively. They were 14. 1% (9/64), 6. 3% (4/64), 1. 6% (1164), and 0 (0/64) in the control group, respectively. Significant difference existed in all these indices between the two groups (X² = 105. 1022, 51. 3312, 59. 1777; P <0. 05). No serious drug-related adverse events occurred during clinical observation, with relatively better safety. The satisfaction was 95. 40% (125/131) in the treatment group and 57. 1 % (40/70) in the control group. No statistical difference in PFS was observed between the two groups (X² = 2. 006, P > 0. 05). Conclusions ZPL had significantly curative effect in treatment of EGFRIs-related skin adverse reactions, with no obvious adverse reactions. Howev- er, more randomized control trials are needed to verify these findings.

[Treatment of Epidermal Growth Factor Receptor Inhibitors Associated Adverse Skin Reactions by Zhiyang Pingfu Liquid: a Clinical Study].

OBJECTIVE: To study the curative effect of Zhiyang Pingfu Liquid (ZPL) in treating epidermal growth factor receptor inhibitors (EGFRIs) associated adverse reactions of the skin. METHODS: All 54 patients with pathologically confirmed malignant tumor had EGFRIs induced adverse reactions of the skin to various degrees. ZPL was externally applied for them all, once or twice per day, 14 days consisting of one therapeutic course. Changes of adverse skin reactions, time for symptoms relief, adverse skin reaction types suitable for ZPL were observed before and after treatment. RESULTS: EGFRIs associated skin adverse reactions were improved to various degrees after they used ZPL. The shortest symptoms relief time was 1 day while the longest was 12 days, with an average of 6.93 days and the median time 7 days. Compared with before treatment, itching, rash/scaling, acne/acneform eruptions were obviously improved (P < 0.05). CONCLUSION: ZPL could alleviate EGFRls associated adverse skin reactions, especially showed better effect on itching, rash/scaling, acne/acneform eruptions.

A randomized controlled trial comparing total glucosides of paeony capsule and compound glycyrrhizin tablet for alopecia areata.

OBJECTIVE: To observe the efficacy and safety of total glucosides of paeony capsule (TGPC) in patients with mild and moderate alopecia areata. METHODS: A total of 86 outpatients were randomly allocated into two groups of TGPC (treatment, 44 cases) and compound glycyrrhizin tablet (control, 42 cases). The treatment group was given oral TGPC, three times daily and 600 mg per time; the control group was given oral compound glycyrrhizin tablets, three times daily and 50 mg per time. In addition, both groups were given 10 mg of vitamin B(2) and tapped the bold patches with massage. The treatment course was three months for both groups. Peripheral blood T-cell subsets (CD3(+)CD4(+), CD3(+)CD8(+), Th, Ts, Th/Ts) of 10 patients randomly selected from each group respectively were tested before and after three months of treatment. The effectiveness and adverse reaction of all cases were observed each month. The safety was evaluated according to the incidence rate of adverse reaction. RESULTS: In the treatment group, the cured and markedly effective rate was 36.36% (16/44), 50.00% (22/44) and 68.18% (30/44) at the end of first, second and third month of treatment, respectively, and the incidence rate of adverse reaction was 13.64% (6/44). In the control group, the cured and markedly effective rate was 38.10% (16/42), 57.14% (24/42) and 71.43% (30/42), respectively, and the incidence rate of adverse reaction was 16.67% (7/42). The cured and markedly effective rate and the incidence rate of adverse reaction were similar in both groups (P>0.05). TGPC and compound glycyrrhizin tablet can inhibit CD3(+)CD4(+) and CD3(+)CD8(+), and decrease the ratio of Th/Ts (P<0.05). CONCLUSION: TGPC is effective and safe in the treatment of alopecia areata.

Efficacy of externally applied Chinese herbal drugs in treating psoriasis: a systematic review.

OBJECTIVE: To assess the efficacy and safety of external application of Chinese herbal drugs (ex-CHD) in the treatment of psoriasis. METHODS: Literature regarding randomized clinical trials (RCTs) of psoriasis treatments with ex-CHD, either alone or combined with Western medicine (WM) or physiotherapy, controlled by untreated, placebo or WM treatment were found in electronic databases, including PubMed/MEDLINE, EMBASE, Cochrane Library, Cochrane Central Register of Controlled Trials, China Biology Medicine Disc (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang database and VIP database from their inception through July 2011. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. RESULTS: A total of 10 randomized trials (involving 1,435 patients) were included. Because both test and control drugs used in the RCTs were different from each other, the effects can only be described singly and calculated. Regarding the total effective rate for the treatment of psoriasis, ex-CHD in combination with ultraviolet radiation b (UVB) or narrow band ultraviolet radiation b (NB-UVB), which was reported in 6 trials, was superior to UVB alone. One study reported that ex-CHD and externally applied WM had equivalent effects. In another study, ex-CHD showed better results than placebo. However, another two comparisons of ex-CHD and WM (all in combining with oral WM) showed uncertain outcomes. Nine trials reported adverse reactions. Of these, 7 RCTs included statistical analysis. The results showed that the side-effects that occurred in ex-CHD combined with UVB were less severe than those caused by UVB alone, but the incidence was roughly the same as WM. CONCLUSION: The evidence supporting the efficacy of ex-CHD with respect to treating psoriasis is quite limited and must be strengthened by high-quality studies.

Literature research of Chinese medicine recipes for the treatment of psoriasis vulgaris with blood-heat syndrome type.

OBJECTIVE: To analyze and investigate the rules for drug utilization of Chinese medicine for the treatment of psoriasis vulgaris with blood-heat syndrome. METHODS: The literatures that met the following inclusion criteria were screened out from China National Knowledge Infrastructure (CNKI) from January 1998 to December 2008, including the compositions and dosages of the recipes reported completely and accurately, the sample size being [Symbol: see text] 30 cases and the total effective rate being [Symbol: see text] 70%. RESULTS: In total, 289 papers meeting the inclusion criteria were retrieved, involving 301 recipes; in which 111 recipes consisting of 145 individual drugs were the function for clearing the heat, accounting for 52.84%. The three drugs with the highest utilized frequency were Radix Rehmanniae, Radix Arnebiae seu Lithospermi and Cortex Moutan. Meridian adscription of the drugs was mainly the Gan-meridian. CONCLUSION: There were rules for the treatment of psoriasis vulgaris of blood-heat syndrome with Chinese medicine prescriptions.

Effect of Chinese herbal medicine combined with acitretin capsule in treating psoriasis of blood-heat syndrome type.

OBJECTIVE: To observe the clinical curative effect of Chinese herbal medicine combined with acitretin capsule in treating psoriasis of blood-heat syndrome (P-BH). METHODS: Eighty patients of P-BH were randomly assigned to two groups, 39 in Group A and 41 in Group B. Both was treated with Chinese herbal medicines for clearing heat, cooling blood and removing toxic substance, and acitretin capsule was given to Group A additionally, with 8 weeks as one therapeutic course. The clinical curative effect was compared between groups, and the change of psoriasis activity severe index (PASI) scores before and after treatment was observed. RESULTS: The total effective rate in Group A was 84.2% and that in Group B 68.2%, also showing significance between groups (P<0.01). PASI score lowered significantly after treatment in both groups, showing statistical significance (P<0.01), but no significant difference between groups. Little adverse reaction was found in Group B, while in Group A, the adverse reaction was of even milder degree, which could be alleviated by adjusting the herbal medicine and symptomatic treatment administration. CONCLUSIONS: The effect of Chinese herbal medicine combined with acitretin capsule was superior to Chinese herbal medicine alone in treating P-BH, but the adverse reaction of acitretin capsule could be alleviated by adjusting the herbs used. However, the result is waiting to be verified further by larger samples.

Effect of new Pulian Ointment () in treating psoriasis of blood-heat syndrome: A randomized controlled trial.

OBJECTIVE: To objectively assess the clinical efficacy and safety of a new Pulian Ointment (, NPLO) in treating psoriasis of blood-heat syndrome of Chinese medicine. METHODS: A total of 108 patients with psoriasis of blood-heat syndrome were equally assigned, using a randomizing digital table, to the test group treated externally with NPLO and the control group treated with placebo; the medication was done using a singleblinded method twice a day. Meanwhile, all patients received by oral intake a conventional Chinese decoction for clearing heat and cooling blood; the therapeutic course was 4 weeks for both groups. The therapeutic efficacy, changes in the Psoriasis Area and Severity Index (PASI) score and various aspects of the lesion, including scaly eruption, erythema, infiltration, size, score of itching as well as adverse reactions were observed. RESULTS: The trial was completed in 100 patients, 51 in the test group and 49 in the control group. The remarkably effective rate was 45.10% and the total effective rate was 84.31% in the test group, which were significantly higher than those in the control group, 12.24% and 51.02%, respectively, showing a significant difference between groups (P<0.01). The test group also showed better effects in the improvement of the PASI score of the lesions and scores on erythema, infiltration, size of lesion as well as itching. No adverse event was found in either group. CONCLUSION: NPLO is a Chinese remedy for the external treatment of psoriasis of the blood-heat syndrome with a reliable therapeutic efficacy and good safety.

[Clinical study on treatment of acute eczema by Shuangfujin].

OBJECTIVE: To evaluate the effects and safety of Shuangfujin (SFJ) on acute eczema. METHODS: One hundred and twenty patients with acute eczema were randomly assigned to 4 groups equally, the saline group, the boric acid group, the Pifukang lotion group and the SFJ group, treated with respective medicine. RESULTS: After 4 days of treatment, the symptom score was remarkably lower in the SFJ group than in the other three groups (P<0.01), score in the saline group was higher than that in the boric acid group and the Pifukang lotion group, and insignificant difference was shown between the latter two groups. The total effective rate and cured rate were 46.4% and 14.3% in the SFJ group, which were matched to those in the Pifukang lotion group and significantly higher than those in the other two groups (P <0.01), and the saline group showed the lowest efficacy. The effect of stopping itch in the SFJ and the boric acid group were matched, which was higher than that in the Pifukang lotion group, and the lowest was in the saline group. No skin irritant reaction and other adverse reactions were found. CONCLUSION: SFJ is effective, safe and convenient in treating acute eczema.