Homeopathic treatment of mild traumatic brain injury: A randomized, double-blind, placebo-controlled clinical trial.
J Head Trauma Rehabil 1999 Dec;14(6):521-42 (ISSN: 0885-9701)
Chapman EH; Weintraub RJ; Milburn MA; Pirozzi TO; Woo E
Harvard University School of Medicine, Boston, MA, USA.
BACKGROUND: Mild traumatic brain injury (MTBI) affects 750,000 persons in the United States annually. Five to fifteen percent have persistent dysfunction and disability. No effective, standard pharmacological treatment exists specifically for this problem. We designed a pilot research project to study the clinical effectiveness of homeopathic medicine in the treatment of persistent MTBI. METHOD: A randomized, double-blind, placebo-controlled trial of 60 patients, with a four-month follow-up (N = 50), was conducted at Spaulding Rehabilitation Hospital (SRH). Patients with persistent MTBI (mean 2.93 years since injury, SD 3.1) were randomly assigned to receive a homeopathic medicine or placebo. The primary outcome measure was the subject-rated SRH-MBTI Functional Assessment, composed of three subtests: a Difficulty with Situations Scale (DSS), a Symptom Rating Scale (SRS), and a Participation in Daily Activities Scale (PDAS). The SRH Cognitive-Linguistic Test Battery was used as the secondary measure. RESULTS: Analysis of covariance demonstrated that the homeopathic treatment was the only significant or near-significant predictor of improvement on DSS subtests (P =.009; 95% CI -.895 to -.15), SRS (P =.058; 95% CI -.548 to.01) and the Ten Most Common Symptoms of MTBI (P =.027; 95% CI -.766 to -.048). These results indicate a significant improvement from the homeopathic treatment versus the control and translate into clinically significant outcomes. CONCLUSIONS: This study suggests that homeopathy may have a role in treating persistent MTBI. Our findings require large-scale, independent replication.
A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation.
Cancer 2001 Aug 1;92(3):684-90 (ISSN: 0008-543X)
Oberbaum M; Yaniv I; Ben-Gal Y; Stein J; Ben-Zvi N; Freedman LS; Branski D
BACKGROUND: Stomatitis is a common consequence of chemotherapy and a condition for which there is little effective treatment. Although the management of patients with other chemotherapy-related toxicities has improved in recent years, the incidence of stomatitis is increasing because of more intensive treatment and is often a dose limiting factor in chemotherapy. The authors assessed the efficacy of a homeopathic remedy, TRAUMEEL S(R), in the management of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation. METHODS: A randomized, placebo-controlled, double-blind clinical trial was conducted in 32 patients ages 3-25 years who had undergone allogeneic (16 patients) or autologous (16 patients) stem cell transplantation. Of the 30 evaluable patients, 15 were assigned placebo, and 15 were assigned TRAUMEEL S both as a mouth rinse, administered five times daily from 2 days after transplantation for a minimum of 14 days, or until at least 2 days after all signs of stomatitis were absent. Stomatitis scores were evaluated according to the World Health Organization grading system for mucositis. RESULTS: A total of five patients (33%) in the TRAUMEEL S treatment group did not develop stomatitis compared with only one patient (7%) in the placebo group. Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S treatment group compared with 14 patients (93%) in the placebo group. The mean area under the curve stomatitis scores were 10.4 in the TRAUMEEL S treatment group and 24.3 in the placebo group. This difference was statistically significant (P < 0.01). CONCLUSIONS: This study indicates that TRAUMEEL S may reduce significantly the severity and duration of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.
A randomized controlled trial comparing topical piroxicam gel with a homeopathic gel in osteoarthritis of the knee.
Rheumatology (Oxford) 2000 Jul;39(7):714-9 (ISSN: 1462-0324)
van Haselen RA; Fisher PA
OBJECTIVE.: To evaluate the efficacy and safety of a homeopathic gel vs an NSAID (piroxicam) gel in the treatment of osteoarthritis of the knee. METHOD.: One hundred and eighty-four out-patients with radiographically confirmed symptomatic osteoarthritis of the knee were entered into a pragmatic, randomized, double-blind controlled trial and treated with 1 g of gel three times daily for 4 weeks. Main outcome measures were pain on walking as a Visual Analogue Score (VAS) and a single-joint Ritchie index. RESULTS.: One hundred and seventy-two of the 184 enrolled patients had endpoints for the main outcome parameters. The pain reduction was 16.5 mm VAS in the homeopathy group (n = 86) and 8.1 mm in the piroxicam group (n = 86); the difference between treatment groups was 8.4 mm (95% confidence interval 0.8-15.9), and after adjustment for pain at baseline it was 6.8 mm (95% confidence interval -0.3 to 13.8). There was no significant difference between treatment groups in the single-joint Ritchie index (P = 0.78). Adverse events occurred in 28 patients (12 homeopathy group, 5 withdrawn; 16 piroxicam group, 9 withdrawn); 18 of the events involved a local reaction (7 homeopathy group, 2 withdrawn; 11 piroxicam group, 5 withdrawn). CONCLUSION.: The homeopathic gel was at least as effective and as well tolerated as the NSAID gel. The presence of a clinically relevant difference between treatment groups cannot be excluded. The homeopathic gel supplemented by simple analgesics if required may provide a useful treatment option for patients with osteoarthritis.
[Treatment of pain due to unwanted lactation with a homeopathic preparation given in the immediate post-partum period]
[Traitement de la douleur de la montee laiteuse non souhaitee par homeopathie dans le post-partum immediat.]
J Gynecol Obstet Biol Reprod (Paris) 2001 Jun;30(4):353-7 (ISSN: 0368-2315)
Berrebi A; Parant O; Ferval F; Thene M; Ayoubi JM; Connan L; Belon P
Federation de Gynecologie-Obstetrique, Service de Pharmacie, CHU La Grave, 31052 Toulouse Cedex, France.
Dopaminergic agonists, such as Parlodel((R)), are now widely used to inhibit lactation. However, some countries, such as the United States, no longer use these drugs in this indication because of their sometimes serious adverse effects. In this context, the authors tested a homeopathic treatment designed for parturients unable or not wanting to breastfeed. The APIS MELLIFICA 9 CH and BRYONIA 9 CH combination was chosen for its anti-inflammatory and analgesic effects. 71 patients were included in this double-blind placebo-controlled study. All received basic treatment comprising naproxen and fluid restriction. A significant improvement of lactation pain (main criterion of the study) was observed in parturients treated with homeopathy (p<0.02 on D2 and p<0.01 on D4). A similar effect (p<0.05 on D4) was observed for breast tension and spontaneous milk flow. No significant difference was observed for the other criteria of the study. The homeopathic combination studied was therefore effective on the pain of lactation and should be integrated into the therapeutic armamentarium.
Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo
Rheumatology (Oxford) 2004 May;43(5):577-82 (ISSN: 1462-0324)
Bell IR; Lewis DA; Brooks AJ; Schwartz GE; Lewis SE; Walsh BT; Baldwin CM
Objective. To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia. Methods. This study was a double-blind, randomized, parallel-group, placebo-controlled trial of homeopathy. Community-recruited persons (N = 62) with physician-confirmed fibromyalgia (mean age 49 yr, s.d. 10 yr, 94% women) were treated in a homeopathic private practice setting. Participants were randomized to receive oral daily liquid LM (1/50 000) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo. Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths, at baseline, 2 months and 4 months (prior to a subsequent optional crossover phase of the study which is reported elsewhere). Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care, self-rating scales on fibromyalgia-related quality of life, pain, mood and global health at baseline and 3 months, were the primary clinical outcome measures for this report. RESULTS: Fifty-three people completed the treatment protocol. Participants on active treatment showed significantly greater improvements in tender point count and tender point pain, quality of life, global health and a trend toward less depression compared with those on placebo. CONCLUSIONS: This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy. Using a broad selection of remedies and the flexible LM dose (1/50 000 dilution factor) series, the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia.
Beckmann-Reinhold A, Schauer U, Wellensiek B, Werner B, Wartenberg A
A homeopathic complex remedy proves efficacious in migraine therapy: a randomized, double blind, parallel group clinical trial.
Headache World, 2000 ;London. Sept 3-7
Objectives: To assess the efficacy and safety of a homeopathic complex remedy compared with placebo in patients with migraine.
Design: Randomized, double-blind, parallel group trial for 20 weeks. Run-in for 4 weeks, 12 weeks of medication and 4 weeks of follow-up examination. Additional, defined medication (triptane, analgesics) was allowed if necessary and was documented by patients in a diary, additionally in an electronic pain recorder system.
Participants: 70 migraine patients (both sexes) with minimum 4 migraine attacks per month. Duration of illness must be more than 1 year. Any migraine prophylaxis was excluded.
Intervention: A homeopathic mixture of Iris Dil.D3, Gelsemium Dil.D4, Cyclamen Dil.D4, Paris quadrifolia Dil.D4, and Asarum europaeum Dil.D4 (three times daily 15 drops) or placebo (three times daily 15 drops) or placebo (three times daily 15 drops).
Aim of treatment: Frequency of migraine attacks and decrease of defined medication.
Results: The main interim results, including 42 of 70 patients. Verum was more effective in decreasing frequency of migraine attacks and reducing defined medication (triptane, analgesics). These reductions were statistically significant. Evaluation of effectiveness and safety by doctors and patients was comparable and verum was significantly better than placebo.
Conclusion: Additional application of homeopathic complex remedy proved to be significant in reducing number of migraine attacks and led to a significant reduction of triptane and analgesics.
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