Department of Medicine (Moalajat), National Research Institute of Unani Medicine, for Skin Disorders (NRIUMSD), Hyderabad, 500038, India.
Department of Medicine (Moalajat), Rajasthan Unani Medical College and Hospital, Jaipur, Rajasthan, 302004, India.
J Ethnopharmacol. 2022 Oct 5;296:115456. doi: 10.1016/j.jep.2022.115456. Epub 2022 Jun 17.
Psoriasis, despite modern therapeutic options, is incurable and recurrent. In Unani (Greco-Arab) medicine, many medications and formulations have been prescribed by eminent scholars for conditions clinically similar to psoriasis, though empirical evidence is sparse. Hence, the experimental formulations ItrīfalShāhtra and MarhamḤina were chosen to be compared to the standard therapies PUVAsol and petrolatum for their safety and efficacy.
This open-label, randomized control clinical trial was conducted on 66 male and female participants with chronic plaque psoriasis, ranging in age from 18 to 65 years. In each group, 33 participants were block randomized to either receive Unani formulations or control drugs for 12 weeks. The Unani group received oral Itrīfal Shāhtra (a semisolid paste) and topical MarhamḤina (an ointment) twice daily, and the control group received oral 8-methoxypsoralen and topical petroleum jelly for local application. Participants of both groups were advised to get daily sunlight exposure for 5-15 min. The primary outcome measure was the change in psoriasis area and severity index (PASI) assessed at each visit. Secondary outcome measures were patient global assessment on a 100 mm VAS applied at baseline and after 12 weeks of treatment and change in subjective parameters including erythema, induration, scaling, and itching, assessed on a 5-point scale at every visit. Hemogram, LFTs, RFTs, CXR, ECG, urine, and stool tests were all assessed at baseline and after treatment for the safety of the drugs.
The per-protocol analysis was done on 25 participants in each group. The mean ± SD of the psoriasis area severity index (PASI) significantly decreased from 27.88 ± 12.01 and 23.61 ± 9.79 at baseline to 5.01 ± 4.59 and 9.85 ± 7.16 after completion of the trial therapies in both Unani and control groups, respectively. Also, the test formulations outperformed the control drugs on clinically significant endpoints, PASI 50 and PASI 75, with all 25 participants achieving PASI 50 and 76% achieving PASI 75.
The trial formulations, ItrīfalShāhtra and MarhamḤina may be superior to control drugs PUVAsol and petrolatum in terms of safety, efficacy, and tolerability in the treatment of chronic plaque psoriasis. Thus, the Unani formulations may further be evaluated in a well-designed multicentric superiority trial with an adequate sample size.
尽管有现代治疗选择，银屑病仍然是不可治愈且会复发的。在顺势疗法（希腊-阿拉伯）医学中，许多药物和制剂已被著名学者用于治疗临床类似于银屑病的病症，尽管经验证据很少。因此，选择实验制剂 ItrīfalShāhtra 和 MarhamḤina 与标准疗法 PUVAsol 和凡士林进行比较，以评估其安全性和疗效。
这是一项开放标签、随机对照临床试验，共纳入 66 名年龄在 18 至 65 岁之间的慢性斑块状银屑病男性和女性参与者。在每组中，33 名参与者按照 BLOCK 随机分配接受顺势疗法制剂或对照药物治疗 12 周。接受口服 Itrīfal Shāhtra（半固体制剂）和局部 MarhamḤina（软膏），每日两次，对照组接受口服 8-甲氧基补骨脂素和局部凡士林用于局部应用。两组参与者均被建议每天接受 5-15 分钟的阳光照射。主要结局指标是在每次就诊时评估的银屑病面积和严重程度指数（PASI）的变化。次要结局指标是在基线和治疗 12 周后应用 100 毫米 VAS 评估的患者总体评估以及在每次就诊时应用 5 分制评估的主观参数（红斑、硬结、鳞屑和瘙痒）的变化。在治疗前后评估血液常规、肝肾功能、胸部 X 光、心电图、尿液和粪便检查，以评估药物的安全性。
每组进行意向治疗分析（ITT）的参与者为 25 名。与基线时相比，接受顺势疗法制剂和对照组治疗的参与者的银屑病面积和严重程度指数（PASI）的平均值±标准差均显著降低，分别从 27.88±12.01 和 23.61±9.79 降至 5.01±4.59 和 9.85±7.16。此外，与对照组药物相比，试验制剂在临床显著终点 PASI 50 和 PASI 75 上表现更好，所有 25 名参与者均达到 PASI 50，76%的参与者达到 PASI 75。
在治疗慢性斑块状银屑病方面，ItrīfalShāhtra 和 MarhamḤina 这两种试验制剂可能比对照组药物 PUVAsol 和凡士林更安全、有效和耐受。因此，可以在设计良好的、具有足够样本量的多中心优效性试验中进一步评估顺势疗法制剂。
