Combined Ruyi Zhenbao Pills-Baimai Ointment Therapy on Acute Ischemic Stroke: A Multi-Arm, Randomized, Double-Blind, Placebo Controlled Clinical Study.
Therapeutics and clinical risk management · 2025
This multicenter, double-blind trial of 423 adults analyzed tested two Tibetan medicine products, Ruyi Zhenbao Pills taken by mouth and Baimai Ointment rubbed onto the weakened arm or leg, in acute ischemic stroke (a stroke caused by a blocked brain artery). Clot-removing treatments can only be used in a narrow time window, and neuroprotective drugs have not shown reliable benefit, so the investigators looked at formulations that had protected brain tissue in animal and cell studies. In Tibetan medical theory, the authors explain, stroke is a "white-meridian disease" involving disordered rlung (vital wind) and blood stasis, and pills and ointment are often used together.
Participants were aged 18 to 75, within 14 days of a stroke presumed to come from narrowed large arteries, and were enrolled at 21 hospitals in China. They were randomly assigned to pills plus ointment, pills plus placebo ointment, ointment plus placebo pills, or two placebos, on top of standard stroke care. Treatment was twice daily for 8 weeks. Motor recovery was scored on the Fugl-Meyer assessment, a standard measure of arm and leg movement, and followed to day 90.
By day 90, Fugl-Meyer scores had risen by 31.22 points with the combination, 29.25 with ointment alone and 29.88 with pills alone, compared with 19.20 with placebo (differences of 12.02, 10.05 and 10.68 points; all P < 0.001, roughly 50-60% larger gains than placebo). Independence in daily life (a modified Rankin score of 2 or less) was reached by 90-96% of treated participants versus 69.5% on placebo, and 64% to 73% reached a Barthel index of 95 or more (a near-complete self-care score) versus 45.7%. The three active groups did not differ from one another. Neurological deficit scores (NIHSS) at day 28 did not differ from placebo. Adverse events were similar across groups, with one serious event in each, and recurrent stroke or cerebrovascular events were rare (one per group).
The authors report that both products improved motor recovery with acceptable safety. They also state that the trial included mostly mild strokes, that blood-pressure history was unevenly spread across groups, that the active ingredients are unknown, that the lack of difference between single products and the combination may reflect limited sample size, and that it covered only Chinese patients with one stroke type who had not received endovascular treatment.
Read summary →Efficacy of Qingpeng ointment (a Tibetan medicine) for acute gouty arthritis: a multi-center, randomized, double-blind, placebo-controlled trial.
BMC complementary medicine and therapies · 2024
This multicenter randomized, double-blind, placebo-controlled trial with 203 adults tested Qingpeng ointment, a Tibetan medicine formula applied directly to the skin, for acute gouty arthritis. Gout is an inflammatory arthritis in which uric acid crystals (monosodium urate) deposit in joints, producing sudden severe pain, swelling, redness and stiffness. Standard attack treatments such as colchicine, corticosteroids and NSAIDs (non-steroidal anti-inflammatory drugs) can cause digestive, kidney and cardiovascular side effects, so the researchers examined an externally applied option. Tibetan medicine is a traditional healing system practiced for over 2,000 years, and the ointment combines nine ingredients, including Oxytropis herb, rhubarb-type root, aconite-type root, chebulic and belleric myrobalan fruits, emblic fruit and benzoin resin.
Participants were adults aged 18-65 at three hospitals in China, all within one week of the start of a gout flare and rating joint pain at 3 or more on a 0-10 scale. Half received the ointment and half a look-alike placebo made of glycerin and paraffin. Everyone spread a thin layer over the painful joint twice a day for seven days and massaged it in. Both groups also received diclofenac tablets to take only if pain climbed to 7 or higher. Pain and swelling were self-rated on visual analog scales, and swelling was also measured with calipers.
After seven days, pain scores were lower with the ointment (median 1.75 vs 2.00; P = 0.038, a difference of 0.25 points on a 10-point scale), and 26.5% of that group reported complete pain resolution compared with 15.8% with placebo (P = 0.046). Swelling scores were also lower (1.00 vs 2.00; P = 0.032), and swelling disappeared in 33.3% vs 21.8% (P = 0.046). Joint mobility improved more with the ointment (P = 0.004). Several measures did not differ: redness, C-reactive protein (an inflammation marker), serum uric acid, the amount of rescue medication left over, and most caliper measurements; calipers showed a difference only in a small subgroup of other joints (8 vs 9 participants). Adverse events occurred in 4 ointment users and 1 placebo user, mostly mild skin itching or rash, and all resolved.
The authors report that the formula relieved pain, swelling and stiffness without serious side effects, and suggest topical products may suit people who cannot tolerate oral drugs. Limitations include outcomes reported by patients themselves, a seven-day follow-up, 15 withdrawals, uneven adherence (nine participants applied it fewer than ten of the 14 scheduled times), imputation of missing values with the last observation carried forward, which can introduce bias, and a mostly male sample. Because all nine ingredients were tested together, the study cannot show which one is responsible for the effects.
Read summary →Feasibility of a Virtual Mindfulness-Based Stress Reduction Intervention for Individuals With Chronic Pain: Pilot Randomized Controlled Trial.
JMIR formative research · 2026
This pilot randomized trial with 61 adults living with chronic pain tested whether an 8-week mindfulness-based stress reduction (MBSR) course delivered over video could be run successfully, and looked at early signs of benefit. MBSR is a structured group program that teaches meditation, body awareness and gentle yoga so that people relate differently to pain and stress. Chronic pain limits physical function, emotional well-being and quality of life, and standard medical treatment often brings only limited relief, which is why the researchers explored this approach. Because it was a pilot, the main question was feasibility rather than effectiveness.
Participants in Quebec, Canada, had non-cancer pain lasting at least three months, on most days of the week, rated 4 or higher out of 10. Thirty were assigned to MBSR and 31 to a no-intervention comparison group. The MBSR group met on Zoom for eight weekly two-hour sessions in groups of 15, with a 30-minute home practice goal six days a week, and everyone completed questionnaires before the program, at 8 weeks and at 3 months.
The study did not meet its feasibility targets: 23.5% of people contacted joined (target 30%), 60.7% completed all assessments (target 80%) and 63.3% of the MBSR group attended at least four sessions and did enough home practice (target 80%). In exploratory analyses, pain-related disability dropped from 36.0 to 24.0 points by 3 months with MBSR versus 39.1 to 36.0 in the comparison group (interaction P = .03), and physical health, overall health and participation in social activities also improved more (P = .003, .02 and .02). No group-by-time differences appeared for pain catastrophizing, pain acceptance, pain self-efficacy or pain intensity. MBSR participants recorded 26 adverse events, mainly fatigue, pain and agitation during exercises. Questionnaires took about 36 minutes to complete, and 68.3% of expected practice-journal entries were returned.
The authors describe all clinical results as hypothesis-generating because the trial was too small to test effectiveness, ran many comparisons without adjustment, and lost participants. Limitations they list include unplanned optional follow-up sessions and a peer-support group formed by participants that may have reinforced the 3-month results, adverse events recorded only through unstructured journals, and assessor blinding that was lost after baseline. They propose simpler consent, targeted recruitment and a waitlist control in a future, adequately powered trial.
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