(1) Severity of attacks reduced by 82% (2) Frequency of attacks unchanged; less use of analgesics in most participants
Very brief documentation; only subjective outcomes
Bommeli et al. 2001 rCS (MC) Switzerland
Various (78% patients w/arteriosclerosis) (BM, TM)
I: 147; D: 18
From few days to 13.5 years P28, varying doses (~50% of patients 3 × 2 U/d)
(1) Improvement of complaints in % of patients: peripheral artery occlusive disease in 94%, coronary heart disease in 92%, chronic venous insufficiency in 91%, arthrosis in 80%
Patients from 15 physicians, no demographics, no monotherapy, success not clearly attributable to P28
(1) Joint pain and swelling (Ritchie Index): improved in 75%–83% of P28 patients, in 86% of thymus extract patients (2) Improvement (compared to healthy control) of sedimentation rate, IgG, IgM, seromucoid, CD8-Lymphocytes, CD4/CD8-quotient
Control is no standard therapy; comparison with healthy probands; immunological parameters not very relevant for contemporary diagnostics
Brzosko and Jankowski 1992 OS (MC) Poland
Hepatitis B (BM)
I: 178 including 52 children
2 years (intervention), 10 years (study) I: P28, 3 × 2 U/d
(1) “Biochemical markers” (not specified) improved in ~90% (2) Improvements in T lymphocytes (CD3, CD4, CD8, and CD4/CD8) in 90%, hepatocellular virus eliminated in 15%, improvements in immunohistochemistry (HBe-Ak increase in 70%), and clinical findings (in 90%)
Very brief description of patients and outcomes; no statement about other therapies
Changbar 1998 CS India
Chronic aplastic anaemia (BM, TM)
I: 1 man (63); D: 0
15 months Rinchen yusnying 25 special, 1 on alternating days; Zhiru, 2× on alternating days; Gur gum 8 special, 4 × /d; Se ‘bru kun bde, 3× /d; A gar 8, 4 × /d; dietary recommendations
(1) Haemoglobin (increase from 3.1 to 10.4 mg/dL) (2) Clinical improvement, reduction of comedication
1 year P28, 3 × 2 U/d; intestinal cleansing (intestinal hydrotherapy and microbacterial treatment), chelation therapy, oxygenation therapy, orthomolecular treatment, IV treatment with ribonucleic acid
(1) General condition much improved after 8 months (2) Walking distance improved (<100 m to >2000 m)
No attribution of effect to TM possible
Feldhaus 2006 CS Switzerland
Chronic constipation of tetraplegic patients (BM, unspecified CAM)
I: 3; D: 0
1–3 months I: PL, 1 × 1-2 U/d; intestinal cleansing (intestinal hydrotherapy and micro bacterial treatment), chelation therapy, other CAM
(1) Constipation cured in all cases
No attribution of effect to TM possible
Flück and Bubb 1970 OS (MC) Switzerland
Chronic constipation (BM)
I: 285 (256 outpatients, 29 inpatients)
“Several” weeks PL, 1 × 1 U/d
(1) Symptoms improved in 82% (2) Unwanted effects in 6.3%
Insufficient description of population, inclusion criteria, and diagnostics
Füllemann 2006 OS Switzerland
Chronic dental pulpitis (BM)
I: 53; D: 4
15 days P28, 2 × 2 U/d
(1) Pain-free within 1 month in 55% (2) Extraction or root canal treatment not necessary in 82%
Comparison with expectation from experience; 4 drop-outs because of incompliance might have caused false positive result
Gladysz et al. 1993 OS Poland
Hepatitis B (BM)
I: 34
12 months P28, 3 × 2 U/d
(1) Serological and liver function parameters improved in 76.5%, liver biopsy improved in 55.9% (2) Other parameters (GGT, GPT, bilirubin, and albumin) unchanged
Authors claim elimination potential for HBeAg and HBV-DNA similar to interferon standard therapy; unwanted effects not stated
Günsche 2005 CS Switzerland
Bipolar Disorder (BM)
I: 1 woman (44); D: 0
11 months P28, 3 × 2 U/d for 6 weeks, then 3 × 1/d
(1) and (2) Daytime sleepiness, concentration difficulties, and apathy much improved within 6 weeks, cured after 11 months
Only subjective outcomes
Hürlimann 1979/1 RCT (3) Switzerland
Peripheral arterial occlusive disease (BM)
I: 13; C: 11; D: 0
12 weeks I: P28, 3 × 2 U/d C: Placebo
(1) Pain free walking distance improved by 54% (2) Other symptoms improved in 69%, no change in plethysmography
Good study design, homogenous groups, very brief presentation of results, valid results
(1) Frequency and intensity of infections reduced in 80% (2) Immunoglobulins and B cells unchanged, T cells normalized, phagocytic activity of leucocytes increased, appetite increased
Immunological analysis did not include all participants
(1) Clinical course (relapse frequency or progression) improved in 44% (2) Evoked potentials: visual improved in 33%, acoustic unchanged
Other treatment in placebo group
Leeman et al. 2001 OS USA
Breast cancer (BM, TM)
I: 11; DI: 2
1 year 2–4 herbal preparations, 2–6×/d; diet, lifestyle regulation, prayer; every 3–4 months adjustment of prescription
(1) No unwanted effects grade III or IV (2) 1 patient’s tumor regressed, 2 were stable for >12 months, 6 progressed
No peer-reviewed publication; no statements about drop-out’s outcomes (possibly disease progress)
Li 2001 OS (MC) Lhasa Prefecture, China
Helicobacter pylori associated gastritis (BM, TM)
I: 86
Max. 8 weeks, follow-up of 24 patients after 5 months TM, max. 8 weeks
(1) Helicobacter test not changed (2) Clinical parameters improved in 76.3%–100% (depending on category), symptom intensity improved
Therapy according to Tibetan diagnostics in 9 “medication groups”; selection of followup group not stated
Mansfeld 1988 CT Switzerland
Recurrent respiratory tract infections (BM)
I: 218; C: 205; (11 years); D: 3
6 weeks, then observation for 6–12 months I: P28, 3 × 1 U/d, biomedicine when needed, mountain air cure C: biomedicine when needed, mountain air cure
(1) Frequency and severity of infections tended to improve (not significant) (2) Immunoglobulines and inflammation parameters not significant
Parents assessed infection severity; other therapies might have masked P28 effect
Mehlsen et al. 1995 RCT (5) Denmark
Peripheral arterial occlusive disease
I: 20; C: 20; D: 4
4 months I: P28, 2 × 2 U/d C: gelatine
(1) Max. walking distance improved (2) Pain-free walking distance improved, no change in blood pressure and blood pressure ratio ankle/upper arm
Excellent study design
Miller et al. 2009 RCT (5) (MC) Lhasa Prefecture, China
Post-partum haemorrhage (BM, TM)
I: 480; C: 487; D: 7
Single dose I: Zhi Byed 11, 3 U, and placebo C: Misoprostol, 600 g, and placebo
(1) Misoprostol superior to Zhi Byed 11 for: Hemorrhage, maternal death, need for uterotonics (2) No significant difference for mean and median blood loss
Namdul et al. 2001 RCT (1) (MC) India
Type 2 Diabetes (BM, TM)
I: 100; C: 100; D: 88 (64 after 12 weeks)
24 weeks I: Kyura-6, Aru-18, Yung-4, and Sugmel-19, daily + life style regulation + diet according to American Diabetes Association C: life style regulation + diet as above
(1) Fasting blood glucose reduced (2) Postprandial blood glucose and HbA1c reduced, weight, blood pressure, and blood lipids unchanged
Intervention group more ill despite randomization; values of intervention group taken as baseline; high drop-out rate without further analyses
Neshar 2000 OS India
Diabetes mellitus (BM, TM)
I: 82; D: 0 (study of patient files)
Min. 6 months Yung-4, Kyuru-6, Chinni-Aru-18, and Sugmel-10, daily + lifestyle and diet regulation
(1) Blood glucose improved in 70%, stabilized in 100% (2) Improvements in subjective symptoms (92%), and need for biomedicine in 68%
Regarding general improvement discrimination between TM alone or with additional biomedicine: it is not clear whether biomedicine was given at baseline or became necessary during study; most data refer to a subpopulation of 24 that is not described: selection bias?
Neshar 2007 OS India (MC)
Cancer (BM, TM)
I: 647; D: 340
Varying duration Traditional TM (not further specified)
(1) General health state much improved (2) Improvements in progression, infections, pain, side effects of chemotherapy and radiation therapy
Selection of patients not representative, high drop-out rate
Pauwvliet et al. 1997 OS Netherlands
Rheumatic disorders (BM, TM)
I: 35; D: 7
6 months Traditional TM (not further specified)
(1) Severity of disease improved (2) Improvements in pain, number of diseased parts general well-being, and mental complaints
High drop-out rate, 4 of them because of aggravation; prepublication without laboratory data
(1) Improved max. walking distance (2) Upper arm blood pressure unchanged, improved: total blood lipids, -lipoproteins, thrombocyte aggregation threshold
No patient demographics; comparison only to baseline, not between groups
Sangmo et al. 2007 RCT (2) India
Hepatitis B (BM, TM)
I: 24; C: 25; D: 1
6 months I: Special TM, (not further described) C: Traditional TM
(1) No differences between groups (2) Both groups tended to improvements in liver function and improved clinically
Special TM group more ill at baseline; almost no appraisal of results; possibly overtesting; very comprehensive documentation also of Tibetan diagnostics
Schleicher 1990 OS Germany
Acquired immune deficiency syndrome (BM)
I: 15; D: 5
6 months P28, 3 × 3 U/d
(1) Total T cells stabilized (2) Stabilized: suppressor-cytotoxic cells, helper-inducer cells, and lymphocytes; unchanged: B cells and killer cells; increase in granulocytes and phagocytosis
No patient-centred parameters; prognostically most relevant CD4 cell count and viral load not documented
(1) Nitroglycerine need reduced (2) Improvement of exercise capacity, platelet aggregation, and blood lipids
No randomization (contrary to publication statement); description difficult to understand; selection of patients from larger population not clear; short verum period
(r)CS: (retrospective) case study; CT: controlled trial (not randomized); OS: observational study; RCT: randomized controlled trial (with Jadad sum score); MC: multicentre study. BM: Biomedicine (the “Western” “conventional” medicine); TM: Tibetan medicine; CAM: complementary or alternative medicine. I: intervention group (TM); C: control group (other treatment, placebo); D: total dropouts. U: unit (tablet, capsule, or pill); /d: per day; P28: Padma 28; PL: Padma Lax.
