Physiotherapy and a Homeopathic Complex for Chronic Low-back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study.

CONTEXT: Osteoarthritis (OA) is a common cause of chronic low-back pain (CLBP) and can be managed with drug therapy and physiotherapy. Homeopathic remedies may assist managing OA; however, research that supports their effectiveness is limited. OBJECTIVES: The study aimed to investigate the efficacy of a homeopathic complex in combination with physiotherapy in treating CLBP due to OA. DESIGN: The study was a 6-wk, randomized, double-blind, placebo-controlled pilot. SETTING: The study took place in a private physiotherapy practice in Gauteng, South Africa. PARTICIPANTS: The participants were 30 males and females, aged 45-75 y, who were receiving physiotherapy treatment for OA of the lumbar spine from a therapist in private practice. INTERVENTIONS: The intervention and control groups both received standard physiotherapy treatment-massage, thermal therapy, and joint mobilization-every 2 wk. In addition, the treatment group received a homeopathic complex-6cH each of Arnica montana, Bryonia alba, Causticum, Kalmia latifolia, Rhus toxicodendron, and Calcarea fluorica. The control group a received a placebo. OUTCOME MEASURES: The primary measure was a visual analogue scale (VAS) for pain. Secondary outcome measures included the Oswestry Disability Index (ODI), an evaluation of each patient's range of motion (ROM) of the lumbar spine, and a determination of each patient's need for pain medication. RESULTS: Intergroup analysis revealed that the treatment group significantly outperformed the control group with regard to pain, daily functioning, and ROM. No difference existed between the groups, however, in the need for conventional pain medication. CONCLUSIONS: The study was too small to be conclusive, but results suggest the homeopathic complex, together with physiotherapy, can significantly improve symptoms associated with CLBP due to OA.

A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome: the TRAumeel in ROtator cuff syndrome (TRARO) study protocol.

BACKGROUND: Shoulder pain is a common musculoskeletal symptom with a wide range of potential causes; however, the majority of conditions can be managed with conservative treatment. The aim of this study is to assess the efficacy and safety of Traumeel injections versus corticosteroid injections and placebo in the treatment of rotator cuff syndrome and bursitis and expand the current evidence base for the conservative treatment of rotator cuff syndrome. METHODS/DESIGN: This is a multi-center, randomized, double-blind, 16-week, three-arm, parallel-group, active- and placebo-controlled trial to assess the efficacy and safety of Traumeel 2 ml injection versus dexamethasone 8 mg injection versus placebo (saline solution). Patients will be randomly allocated to Traumeel, dexamethasone or placebo in a 2:2:1 randomization. After 1 week screening, patients will receive 3 injections at weekly intervals (days 1, 8 and 15) with additional follow-up assessments on day 22, a telephone consultation in week 9 and a final visit at week 15. Male and female patients aged 40 to 65 years, inclusive, will be recruited if they have acute episodes of chronic rotator cuff syndrome and/or bursitis. Patients with calcifications in the shoulder joint or a complete rotator cuff tear will be excluded. At least 160 patients will be recruited. All subacromial injections will be performed under ultrasound guidance utilizing a common technique. The only rescue medication permitted will be paracetamol (acetaminophen), with usage recorded. The primary endpoint is change from baseline in abduction-rotation pain visual analog scale (0-100 mm scale, 0 corresponds to no pain and 100 to extreme pain) at day 22 (Traumeel injections versus dexamethasone injections) for active external rotation. Secondary efficacy parameters include range of motion, disability of arm, shoulder, hand score and patient's/investigator's global assessment. Clinical efficacy will be assessed as non-inferiority of Traumeel with respect to dexamethasone regarding the primary efficacy parameter. DISCUSSION: It is hoped that the results of this trial will expand the treatment options and evidence base available for the management of rotator cuff disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01702233 . EudraCT number: 2012-003393-12.

Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial.

OBJECTIVES: To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. METHODS: Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). SECONDARY OUTCOMES: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers. RESULTS: Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference - 4.497; 95% CI -8.071, -0.923; P = 0.015; ES 0.90). CONCLUSION: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. TRIAL REGISTRATION: Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.

Complementary medicine.

Complementary medicine has become an important subject for rheumatologists, not least because many patients try complementary treatments. Recent clinical trials yield promising results. In particular, evidence suggests that several herbal medicines and dietary supplements can alleviate the pain of osteoarthritis and rheumatoid arthritis. Clearly, rigorous testing of complementary treatments is possible, and considering their popularity, should be encouraged.