Moxibustion as an adjunct for lower urinary tract symptoms associated with benign prostate enlargement: A randomized controlled pilot trial.

BACKGROUND: Benign prostatic enlargement (BPE) causes discomfort in daily life, including lower urinary tract symptoms (LUTSs) caused by the enlarged prostate, and requires long-term management as a chronic, irreversible disease. To improve LUTS, certain complementary therapies have been used with or without doctors' directions. Conventional treatments and complementary therapies tend to be combined unsystematically, depending on patient preference; thus, research for safe and efficient combination therapy is warranted. METHODS: Twenty-nine participants were randomly assigned to an integrative group (IG, n = 15) or a conventional group (CG, n = 14). The IG received moxibustion (twice weekly for 4 weeks, at the acupuncture points SP6, LR3, and CV4) and conventional medication for 4 weeks, followed by conventional medication alone for 8 weeks. The CG received conventional medication alone for 12 weeks. The outcome measures were International Prostate Symptom Score (IPSS), patient's global impression of changes (PGIC), maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), and frequency-volume chart. RESULTS: Total IPSS (IG, -2.4 ±â€Š4.2; CG, 0.9 ±â€Š4.0; P = .039), PGIC-A (IG, 3.5 ±â€Š1.0; CG, 2.2 ±â€Š1.0; P = .001), and PGIC-B (IG, 3.5 ±â€Š0.1; CG, 4.7 ±â€Š0.6; P = .004) were significantly improved in the IG compared with the CG, 4 weeks after baseline. Among the IPSS items, incomplete emptying (IG, -0.6 ±â€Š0.7; CG, 0.4 ±â€Š1.2; P = .019), straining (IG, -0.6 ±â€Š0.8; CG, 0.2 ±â€Š1.2; P = .046), and nocturia (IG, -0.8 ±â€Š1.4; CG, 0.1 ±â€Š1.0; P = .045) showed significant differences. The Qmax and PVR volume did not differ significantly at 12 weeks after the baseline. CONCLUSION: Moxibustion can be considered an adjunct therapy to improve LUTS in BPE patients. A full-sized randomized controlled trial would be feasible with comparator modifications and an extended study period. The study design should include a placebo group and narrow the eligibility to subjects who do not respond well to conventional treatments.

Effectiveness and safety of moxibustion for alleviating symptoms of overactive bladder: A prospective, randomized controlled, crossover-design, pilot study.

BACKGROUND: This study aimed to evaluate trial feasibility and explore the potential efficacy and safety of moxibustion in the treatment of overactive bladder (OAB). METHOD: A randomized, controlled, cross-over, assessor blinded design was used. This study was conducted in an outpatient department of a university hospital in Republic of Korea. The overall study period was 8 weeks. Participants were randomly allotted to either Group A or Group B. Group A participants underwent 8 to 12 sessions of moxibustion with behavioral training during the first 4 weeks, while the Group B participants received behavioral training only. Over the next 4 weeks, the treatment offered to the 2 groups was reversed (Group A participants received behavioral training only, while Group B participants underwent the moxibustion session with behavioral training). The OAB-validated 8-question awareness tool (OAB-V8), OAB symptom scores (OABSS), visual analog scale (VAS) for lower urinary tract symptoms, and frequency voiding chart were used to assess outcomes. For analysis, we used effect size, measured as Hedge's g, to present descriptive results indicating the actual difference between the groups. RESULTS: Compared to that in Group B, the Hedge's g of OAB-V8 for the former 4 weeks in Group A was -0.248, that of OABSS was -1.531, and that of VAS was -0.713. During the latter 4 weeks, Group B showed similar effect with g = 0.465, 1.207, and 0.427 for OAB-V8, OABSS, and VAS, respectively, compared to Group A. The portion of nocturnal voiding volume decreased (g = -0965), the mean voiding volume increased (g = 0.690), and the voiding frequency decreased (g = -0.498) with moxibustion. CONCLUSIONS: Moxibustion might be considered as an alternative for OAB. A full-sized randomized controlled trial may be feasible with minimal modification in outcome measures and comparator population. OTHER INFORMATION: This clinical trial has been registered on clinicaltrials.gov (NCT02271607).

Moxibustion as an adjuvant for benign prostatic hyperplasia with lower urinary tract symptoms: a protocol for a parallel-group, randomised, controlled pilot trial.

INTRODUCTION: This study aims to explore the feasibility of using moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostatic hyperplasia accompanying moderate to severe lower urinary tract symptoms. METHODS AND ANALYSIS: A total of 60 patients diagnosed with benign prostatic hyperplasia by a urologist based on prostate size, prostate-specific antigen and clinical symptoms will participate of their own free will; urologists will monitor the patients and evaluate their symptoms. The patients will be randomised to either a conventional group or an integrative group with a 1:1 allocation according to computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. Watchful waiting or oral medication including α blocker, 5α-reductase inhibitors or antimuscarinic drugs will be offered as conventional treatment. Integrative treatment will include moxibustion therapy in addition to the conventional treatment. The moxibustion therapy will be conducted twice a week for 4 weeks on the bilateral acupoints SP6, LR3 and CV4 by a qualified Korean medical doctor. The primary outcome will be the International Prostate Symptom Score (IPSS) after eight sessions. The secondary outcomes will be the post-void residual urine volume, the maximum urinary flow rate, IPSS, the results of a Short-Form 36-Question Health Survey after 12 weeks, and the patients' global impression of changes at each visit. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. This study was approved by the institutional review boards of both Pusan National University Yangsan Hospital and Pusan National University Korean Medicine Hospital. The trial results will be disseminated through open-access journals and conferences. TRIAL REGISTRATION NUMBER: NCT02051036.