A randomized controlled trial to evaluate the effectiveness of homeopathy in rheumatoid arthritis

Forty-four patients with active Rheumatoid Arthritis were entered into a 6-month double-blind trial comparing homeopathy and placebo. The treatments were generally equally effective in most assessments. Statistically significant improvements were produced, however, in 3 of 5 and 2 of 5 results respectively assessed in homeopathic and placebo treated groups. There was no statistically significant difference between groups. Adverse effects were scarcely and comparably reported in both groups and did not require a change in therapy.     

A randomized and controlled trial of hydrotherapy in rheumatoid arthritis

Objective . The aim of this study was to evaluate the therapeutic effects of hydrotherapy which combines elements of warm water immersion and exercise. It was predicted that hydrotherapy would result in a greater therapeutic benefit than either of these components separately. Method . One hundred thirty-nine patients with chronic rheumatoid arthritis were randomly assigned to hydrotherapy, seated immersion, land exercise, or progressive relaxation. Patients attended 30-minute sessions twice weekly for 4 weeks. Physical and psychological measures were completed before and after intervention, and at a 3-month followup. Results . All patients improved physically and emotionally, as assessed by the Arthritis Impact Measurement Scales 2 questionnaire. Belief that pain was controlled by chance happenings decreased, signifying improvement. In addition, hydrotherapy patients showed significantly greater improvement in joint tenderness and in knee range of movement (women only). At followup, hydrotherapy patients maintained the improvement in emotional and psychological state. Conclusions . Although all patients experienced some benefit, hydrotherapy produced the greatest improvements. This study, therefore, provides some justification for the continued use of hydrotherapy.     

A randomized controlled trial of foot orthoses in rheumatoid arthritis

OBJECTIVE: To investigate the clinical effectiveness of early foot orthosis intervention for painful correctable valgus deformity of the rearfoot in rheumatoid arthritis (RA). METHODS: Patients with RA were randomized to receive custom manufactured rigid foot orthoses under podiatry supervision (n = 50) or enter a control group (n = 48). The control group received foot orthoses only when prescribed under normal medical care. Foot pain and disability, using the Foot Function Index (FFI), along with disease activity, tolerance, and adverse reactions, were serially measured over 30 mo continuous treatment. RESULTS: The group assigned foot orthoses demonstrated an immediate clinical improvement, the effect peaking at 12 mo. At 30 mo the FFI total score was reduced by 23.1% from baseline in the intervention group. Area under the curve analysis showed a statistically significant reduction in FFI scores for total score (p = 0.026), foot pain (p = 0.014), and foot disability (p = 0.016) when intervention was compared to control scores. There were no confounding effects from differences between groups for disease activity or pharmacological or other management strategies. Most patients (96%) used their orthoses and most found them comfortable (97%), although minor adverse reactions, such as tender spots, blisters, and callus, were reported in 30% of patients in the early stages of treatment and persisted in 12% for 30 mo. CONCLUSION: Custom designed foot orthoses used continuously over a 30 mo treatment period resulted in a reduction in foot pain by 19.1%, foot disability by 30.8%, and functional limitation by 13.5%. Clinical effectiveness might be enhanced by their use in the early stages of rearfoot pain and deformity.     

Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial

BACKGROUND: In a phase II study, etanercept (recombinant human tumor necrosis factor receptor [p75]:Fc fusion protein) safely produced rapid, dose-dependent improvement in rheumatoid arthritis over 3 months. OBJECTIVE: To confirm the benefit of etanercept therapy of longer duration and simplified dosing in patients with rheumatoid arthritis. DESIGN: Randomized, double-blind, placebo-controlled trial with blinded joint assessors. SETTING: 13 North American centers. PATIENTS: 234 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs. INTERVENTION: Twice-weekly subcutaneous injections of etanercept, 10 or 25 mg, or placebo for 6 months. MEASUREMENTS: The primary end points were 20% and 50% improvement in disease activity according to American College of Rheumatology (ACR) responses at 3 and 6 months. Other end points were 70% ACR responses at 3 and 6 months and other measures of disease activity at 3 and 6 months. RESULTS: Etanercept significantly reduced disease activity in a dose-related fashion. At 3 months, 62% of the patients receiving 25 mg of etanercept and 23% of the placebo recipients achieved 20% ACR response (P < 0.001). At 6 months, 59% of the 25-mg group and 11% of the placebo group achieved a 20% ACR response (P < 0.001); 40% and 5%, respectively, achieved a 50% ACR response (P < 0.01). The respective mean percentage reduction in the number of tender and swollen joints at 6 months was 56% and 47% in the 25-mg group and 6% and -7% in the placebo group (P < 0.05). Significantly more etanercept recipients achieved a 70% ACR response, minimal disease status (0 to 5 affected joints), and improved quality of life. Etanercept was well tolerated, with no dose-limiting toxic effects. CONCLUSIONS: Etanercept can safely provide rapid, significant, and sustained benefit in patients with active rheumatoid arthritis.     

Assessment of radiologic progression in rheumatoid arthritis. A randomized, controlled trial

Radiologic assessment of progressive joint destruction in rheumatoid arthritis is generally considered to be the ultimate standard for evaluation of treatment. We compared alternative radiologic techniques by performing a randomized, controlled trial in which hand films of rheumatoid arthritis patients were read by several skilled observes. The number of joints evaluated (34 versus 18) was found to make relatively little difference, but the number of readers and their experience level was critical. Films should be read in pairs. Joint space narrowing and erosion scores were shown to contribute independent information. Use of recommended techniques can reduce the number of patients required and, thus, can reduce the cost of a clinical trial by more than half and can substantially increase the sensitivity and efficiency of a trial. Therefore, critical selection of the method of assessing study endpoint is of great importance.     

Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial

OBJECTIVE: To compare forefoot pain, pressure and function before and after normal and sham callus treatment in rheumatoid arthritis (RA). Patients and METHODS: Thirty-eight RA patients were randomly assigned to normal (NCT group) or sham (SCT) scalpel debridement. The sham procedure comprised blunt-edged scalpel paring of the callus which delivered a physical stimulus but left the hyperkeratotic tissue intact, the procedure being partially obscured from the patient. Forefoot pain was assessed using a 100 mm visual analogue scale (VAS), pressure using a high-resolution foot pressure scanner and function using the spatial-temporal gait parameters measured on an instrumented walkway. Radiographic scores of joint erosion were obtained for metatarsophalangeal (MTP) joints with and without overlying callosities. The trial consisted of a randomized sham-controlled phase evaluating the immediate same-day treatment effect and an unblinded 4-week follow-up phase. RESULTS: During the sham-controlled phase, forefoot pain improved in both groups by only 3 points on a VAS and no statistically significant between-group difference was found (P = 0.48). When data were pooled during the unblinded phase, the improvement in forefoot pain reached a peak after 2 days and gradually lessened over the next 28 days. Following debridement, peak pressures at the callus sites decreased in the NCT group and increased in the SCT group, but there was no statistically significant between-group difference (P = 0.16). The area of and duration of contact of the callus site on the ground remained unchanged following treatment in both groups. Following debridement, walking speed was increased, the stride-length was longer and the double-support time shorter in both groups; however, between-group differences did not reach levels of statistical significance. MTP joints with overlying callus were significantly more eroded than those without (P = 0.02). CONCLUSIONS: Treatment of painful plantar callosities in RA using scalpel debridement lessened forefoot pain but the effect was no greater than sham treatment. Localized pressure or gait function was not significantly improved following treatment.     

A randomized controlled trial of ciamexon versus placebo in the immunomodulatory treatment of rheumatoid arthritis

To determine the efficacy of the new immunosuppressive agent ciamexon in patients with rheumatoid arthritis (RA), we conducted a 6-month, prospective, double-blind, placebo-controlled study. The study included 21 outpatients with confirmed RA, who were randomized into 3 treatment groups of 7 patients each. Group 1 received 400 mg/day of ciamexon, group 2 received 100 mg/day of ciamexon, and group 3 received placebo. We investigated the influence of ciamexon on the clinical course, the systemic inflammatory activity, and the lymphocyte subsets in the peripheral blood. Significant, dose-dependent improvement was seen in both the clinical and the biochemical activity indexes at the end of the treatment period (P = 0.02 to P = 0.05). The proportion of activated T lymphocytes was significantly decreased (P = 0.05), and the proportion of CD8-positive lymphocytes was significantly increased (P = 0.03) in patients taking ciamexon. The major adverse effects were hepatotoxicity (2 patients) and rash (2 patients). This study documents the clinical efficacy of ciamexon therapy in RA patients and identifies the agent's potential toxicity.     

A randomized,controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis

OBJECTIVE: To evaluate the efficacy and tolerability of the highly selective cyclooxygenase-2 (COX-2) inhibitor etoricoxib for the treatment of rheumatoid arthritis (RA). METHODS: A double blind, randomized, placebo and active comparator controlled, 12 week study conducted at 88 US sites. Eligible patients were chronic nonsteroidal antiinflammatory drug (NSAID) users with clinical worsening of RA upon withdrawal of prestudy NSAID. Patients received either placebo, etoricoxib 90 mg once daily, or naproxen 500 mg twice daily (2:2:1 allocation ratio). Primary efficacy measures: patient and investigator global assessments of disease activity and direct assessment of arthritis by counts of tender and swollen joints. Key secondary measures: patient global assessment of pain, the Stanford Health Assessment Questionnaire, and the percentage of patients both completing the study and meeting the ACR20 criteria. Tolerability was assessed by tabulation of adverse events and routine laboratory evaluations. RESULTS: In all, 816 patients were randomized (placebo = 323, etoricoxib = 323, naproxen = 170), and 448 completed 12 weeks of treatment (placebo = 122, etoricoxib = 230, naproxen = 96). Compared with patients receiving placebo, patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints (p < 0.01). Compared with patients receiving naproxen, patients receiving etoricoxib demonstrated significant improvements (p < 0.05) on all primary endpoints and most other endpoints including ACR20 criteria. The percentage of patients who achieved an ACR20 response and who completed the study was 21%, 53%, and 39% in the placebo, etoricoxib and naproxen groups, respectively. Etoricoxib and naproxen were both generally well tolerated. CONCLUSION: In this study, etoricoxib 90 mg once daily was more effective than either placebo or naproxen 500 mg twice daily for treating patients with RA over 12 weeks. Etoricoxib 90 mg was generally well tolerated in patients with RA.     

Muscle relaxation training and quality of life in rheumatoid arthritis. A randomized controlled clinical trial

The purpose of the study was to investigate the effects of supervised muscle relaxation training in individuals with rheumatoid arthritis (RA). Sixty-eight participants were allocated at random either to a muscle relaxation training group or to a control group. Every participant was evaluated for health-related quality of life, muscle function, pain, and disease activity. The training group exercised 30 minutes, twice a week for 10 weeks, while no intervention was made in the control group. The results indicated improvements in the training group regarding self-care according to the Arthritis Impact Measurement Scales 2, and in recreation and pastimes according to the Sickness Impact Profile-RA (p < 0.05) directly after the intervention. Mobility and arm function (p < 0.01) according to the Arthritis Impact Measurement Scales 2, and muscle function of the lower limbs (p < 0.05) were improved after six months. No improvements remained after twelve months. It thus seems that 10 weeks' relaxation training might have some short-term influence in individuals with RA.     

A theory-based intervention to promote medication adherence in patients with rheumatoid arthritis: A randomized controlled trial

Clinical Rheumatology - Adherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important...     

Rehabilitation for rheumatoid arthritis patients. A controlled trial

For 1 year we obtained questionnaire and clinical measures from 2 cohorts of rheumatoid arthritis patients: 49 experimental patients who were admitted for an average of 13 days to a university-based rheumatology rehabilitation unit, and 43 control patients who received care from rheumatologists associated with another teaching hospital. At 1 year, after controlling for groups differences, the experimental patients demonstrated significant (P less than 0.05) improvement compared with control patients in several functional status, mental health, and disease activity measures.     

Effectiveness of sensorimotor training in patients with rheumatoid arthritis: a randomized controlled trial

The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life, a double-blinded, prospective, randomized controlled trial. One hundred two participants with rheumatoid arthritis were selected. After the baseline evaluation, the participants were randomized to two different groups: sensorimotor group (2 sessions per week, 30–50 min each session, besides continuing taking the same drugs as the control group) and control group (control group was only submitted to the clinical drug treatment with Methotrexate, Leflunomide and/or Prednisone (5 mg), being then evaluated 4 months later). Functional capacity [Health Assessment Questionnaire (HAQ) and Timed Up & Go Test (TU&GT)], Balance and Gait (Berg Balance Scale (BBS) and Tinetti Test) and Quality of Life (Short Form Health Survey—SF-36). The study had been concluded with ninety-one participants, and a statistically significant improvement was found in all variables assessed: HAQ (P < .01), TU&GT (P < .01), BBS (P < .01), Tinetti Test (P < .01) and improvement in the subscales of SF-36 (P < .01) in the sensorimotor group in comparison with the baseline evaluation and control group. No significant difference was found related to the pre- and post-evaluation in the control group. Therefore, the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis.     

Cost-effectiveness of inpatient and intensive outpatient treatment of rheumatoid arthritis. A randomized, controlled trial

Women with active rheumatoid arthritis who were judged to be in need of hospitalization were assigned at random to receive inpatient therapy (n = 35) or intensive outpatient therapy (n = 36). All relevant costs of treatment were measured. At 19 weeks, clinical outcomes, as summarized in a pooled index, were significantly better in the inpatient group (pooled index units: inpatient 0.72, outpatient 0.25; F[1,69] = 10.9, P = 0.002). Inpatient therapy produced a sustained three-fold increase in efficacy, at a 2.5-fold increase in cost to society.     

A randomized controlled trial of calcium supplementation to increase bone mineral density in children with juvenile rheumatoid arthritis

OBJECTIVE: To examine the effects of daily supplementation with calcium (Ca) in combination with vitamin D on total body and lumbar spine bone mineral density (BMD) in patients with juvenile rheumatoid arthritis (JRA) who had not taken corticosteroids for at least 3 months prior to the beginning of the study. METHODS: One hundred ninety-eight children and adolescents (141 girls and 57 boys) with JRA, ages 6 to 18 years, with a mean +/- SD age of 11.7 +/- 3.3 years and a mean +/- SD disease duration of 5.6 +/- 3.8 years at the beginning of the study, were enrolled in this randomized double-blind, placebo-controlled trial to receive either daily oral supplements of 1,000 mg of Ca and 400 IU of vitamin D (n = 103) or matched placebo tablets and 400 IU of vitamin D (n = 95) for 24 months. Total body BMD (TBBMD) was measured by dual x-ray absorptiometry at baseline and every 6 months for 24 months. RESULTS: At baseline, the mean +/- SD TBBMD was 0.89 +/- 0.14 gm/cm2 among patients randomized to the Ca group and 0.87 +/- 0.14 gm/cm2 among those randomized to placebo (P = 0.445). At 24 months, the mean +/- SD TBBMD among those receiving Ca was 0.95 +/- 0.13 gm/cm2, compared with 0.92 +/- 0.14 gm/cm2 among those receiving placebo. A longitudinal random-effects mixed model analysis that controlled for differences in the subject's initial BMD, sex, Tanner stage, adherence to the study medication regimen, and body composition revealed significantly higher TBBMD among patients who received Ca compared with patients who received placebo during the study period (P = 0.03). CONCLUSION: Ca supplementation resulted in a small, but statistically significant, increase in TBBMD compared with placebo in children with JRA.     

Effects of high‐intensity resistance training in patients with rheumatoid arthritis: A randomized controlled trial

Objective

To confirm, in a randomized controlled trial (RCT), the efficacy of high‐intensity progressive resistance training (PRT) in restoring muscle mass and function in patients with rheumatoid arthritis (RA). Additionally, to investigate the role of the insulin‐like growth factor (IGF) system in exercise‐induced muscle hypertrophy in the context of RA.

Methods

Twenty‐eight patients with established, controlled RA were randomized to either 24 weeks of twice‐weekly PRT (n = 13) or a range of movement home exercise control group (n = 15). Dual x‐ray absorptiometry–assessed body composition (including lean body mass [LBM], appendicular lean mass [ALM], and fat mass); objective physical function; disease activity; and muscle IGFs were assessed at weeks 0 and 24.

Results

Analyses of variance revealed that PRT increased LBM and ALM (P < 0.01); reduced trunk fat mass by 2.5 kg (not significant); and improved training‐specific strength by 119%, chair stands by 30%, knee extensor strength by 25%, arm curls by 23%, and walk time by 17% (for objective function tests, P values ranged from 0.027 to 0.001 versus controls). In contrast, body composition and physical function remained unchanged in control patients. Changes in LBM and regional lean mass were associated with changes in objective function (P values ranged from 0.126 to <0.0001). Coinciding with muscle hypertrophy, previously diminished muscle levels of IGF‐1 and IGF binding protein 3 both increased following PRT (P < 0.05).

Conclusion

In an RCT, 24 weeks of PRT proved safe and effective in restoring lean mass and function in patients with RA. Muscle hypertrophy coincided with significant elevations of attenuated muscle IGF levels, revealing a possible contributory mechanism for rheumatoid cachexia. PRT should feature in disease management.     

A controlled trial of tiaprofenic acid versus ibuprofen in rheumatoid arthritis.

Tiaprofenic acid, 200 mg three times a day, was compared with ibuprofen, 400 mg three times a day, in 41 patients suffering from rheumatoid arthritis and already receiving nonsteroidal anti-inflammatory drugs in a double-blind controlled study. The degree of disability expressed as functional class was significantly improved on tiaprofenic acid. There were no other significant differences from initial values on either treatment in any other clinical measure of therapeutic efficacy. Side-effects were few and minor and there were no significant differences between the drugs in this respect.     

Optimization of flare management in patients with rheumatoid arthritis: results of a randomized controlled trial

Clinical Rheumatology - To evaluate the effect of a flare management intervention guided by non-physician providers versus usual care between rheumatology visits on flare occurrence and rheumatoid...     

Effectiveness of the primary therapist model for rheumatoid arthritis rehabilitation: a randomized controlled trial

OBJECTIVE: To compare the primary therapist model (PTM), provided by a single rheumatology-trained primary therapist, with the traditional treatment model (TTM), provided by a physical therapy (PT) and/or occupational therapy (OT) generalist, for treating patients with rheumatoid arthritis (RA). METHODS: Eligible patients were adults requiring rehabilitation treatment who had not received PT/OT in the past 2 years. Participants were randomized to the PTM or TTM group. The primary outcome was defined as the proportion of clinical responders who experienced a > or =20% improvement in 2 of the following measures from baseline to 6 months: Health Assessment Questionnaire, pain visual analog scale, and Arthritis Community Research and Evaluation Unit RA Knowledge Questionnaire. RESULTS: Of 144 consenting patients, 33 (10 PTM participants, 23 TTM participants) dropped out without completing any followup assessment, leaving 111 for analysis (63 PTM participants, 48 TTM participants). The majority were women (PTM 87.3%, TTM 79.2%), with a mean age of 54.2 years and 56.8 years for the PTM and TTM groups, respectively. Average disease duration was 10.6 years and 13.2 years for each group, respectively. At 6 months, 44.4% of patients in the PTM group were clinical responders versus 18.8% in the TTM group (chi(2) = 8.09, P = 0.004). CONCLUSION: Compared with the TTM, the PTM was associated with better outcomes in patients with RA. The results, however, should be interpreted with caution due to the high dropout rate in the TTM group.