Introduction
Materials and methods
Identification of studies
Study selection and data extraction
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Population: women with BPS or interstitial cystitis (IC).
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Intervention: complementary or alternative therapies
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Comparator: no treatment, another therapy
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Outcome: improvement in bladder symptoms
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Study designs: randomised controlled trial (RCT), cohort studies, case control studies, case series
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Exclusion criteria: pharmacological therapy, intravesical therapy, hydrodistention, tibial nerve stimulation
Methodological quality
Data synthesis
Results
Reference | Type of study | Population sample size | Age | Description of how BPS was diagnosed | Methods | Intervention | Control | Outcome |
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Korting et al. [26] | Double-blind, placebo controlled, randomised study | 53/282 screened women with BPS were randomised | Median age in the L-arginine group 46 years and in the placebo group 52 years | Women with BPS were notified by an urologist or the Interstitial Cystitis Association to participate in the trial based on NIH criteria. No further information on how BPS was diagnosed in this group has been reported | Participants were given either L-arginine (1,500 mg) or placebo three times a day for 3 months. Outcomes were assessed at the end of 3 months. Follow-up was conducted before unblinding at 3.5 ± 2.0 months after completion of participation | L-arginine (n = 21/27); 6 withdrawals | Placebo (n = 25/26); 1 withdrawal | 29 % of the L-arginine group and 8 % of the placebo group had clinically improved by the end of the trial. Likert scale of greater global improvement in the L-arginine group (48 %, 10 out of 21) compared with placebo (24 %, 6 out of 25) at 3 months (p = 0.05). Decrease in pain intensity (p = 0.04). Improvement in urgency (p = 0.06) and frequency of pain (p = 0.09) |
Carrico et al. [21] | Prospective, randomised, controlled study | 30 women with BPS enrolled and randomised to two equal groups (5 withdrawals in total) | Mean age = 44 years | BPS was diagnosed by cystoscopy and hydro-distension performed by a board-certified urologist | Guided imagery group listened to 25 minutes of guided imagery created for women with BPS, twice a day for 8 weeks. Control group rested for 25 minutes twice daily for 8 weeks. Participants were assessed at baseline and the end of 8 weeks with ICSI, ICPI VAS score and GRA | Guided imagery; n = 11/15 | Control group; n = 14/15 | 45.5 % (5/11) of the treatment group compared with 14.3 % (2/14) of control group showed moderate to marked improvement in GRA. IC Self-efficacy scale – scores improved in both groups (not statistically significant). VAS pain score improved more in the treatment group (statistically significant p = 0.027). Urgency in voiding diaries = significantly declined in the treatment group (16 to 12 voids p = 0.02) whereas the control group showed no significant change (9.77–9.04 voids p = 0.684) |
Matsumoto et al. [22] | Prospective, randomised, double-blind, placebo-controlled study | 30 women with BPS were recruited | Mean age = 64 years | BPS diagnosis was based on cystoscopic findings during bladder hydrodistention | Participants were randomised in a ratio of 2:1 to have hydrogen-rich water or placebo. Each received 3 packs per day (1 pack = 200 ml) for 2 months. Symptoms were assessed at the end of 2 months based on ICSI, ICPI and VAS scores. | Hydrogen-rich water; n = 20 | Placebo water; n = 10 | Hydrogen-rich water did not show a significant difference compared with placebo water. Only 3 cases with hydrogen-rich water showed improvement in the VAS |
FitzGerald et al. [23] | Single-blind, randomised, control study | 81/ 585 screened women with BPS were randomised | Median age = 43 years | Clinical diagnosis of BPS and recorded ratings for bladder pain, frequency and urgency of at least 3 on a scale of 0 to 10 present for a minimum of 3 months and not more than 3 years | Each participant received ten 60-min sessions of intervention or control for 12 weeks. Participants were assessed using a 7-point global response assessment scale, ICSI and ICPI at 12 weeks, and followed up 3 months later | MPT(n = 38) | GTM (global therapeutic massage); n = 40 | MPT: 59 % improvement (moderate to marked) in overall symptoms. GTM: 26 % overall improvement in symptoms |
Ervan et al. [24] | Prospective, non-randomised study | 37 women with BPS | Age range not mentioned | Women with BPS diagnosis based on clinical symptoms of urinary urgency, frequency and pain | Participants were treated with physical therapy. Outcome was assessed based on ICSI and ICPI (pre- and post-treatment scores recorded at the start of therapy and on completion of physical therapy at 3 months) | Participants given physical therapy; (n = 37) | – | ICSI score decreased from (median range) 12 to 6 (p < 0.001). ICPI score decreased from (median range) 10 to 7 (p < 0.001) |
Shorter et al.[31] | Qualitative study | 104 women with BPS | Mean age of the respondents was 54 years | Women with BPS based on clinical diagnosis | Participants completed a validated questionnaire designed to detect if food, beverages or supplement had an effect on bladder symptoms. A total of 175 comestibles were accounted for in the questionnaire. Women were asked to indicate whether each of the individual items worsened, improved or had no effect on symptoms. Each response was numerically scored on a scale of −2 to 2 and mean values were generated for each comestible item. Bladder symptoms were assessed based on ICSI scores | 104/327 responded to the questionnaire | No control | 90.2 % indicated that the consumption of certain foods or beverages caused symptom exacerbation. Participants who reported that specific foods worsened symptoms tended to have higher ICSI and ICPI scores. A total of 35 comestible items had a mean score of lower than 1.0, including caffeinated, carbonated and alcoholic, beverages, certain fruits and juices, artificial sweeteners and spicy foods |
Honjo et al. [17] | Prospective cohort study | 36 women, 11 with BPS | Ages ranged from 29 to 78 years | Women with BPS based on clinical diagnosis | Acupuncture performed using disposable stainless steel needles (0.3 mm, 60 mm in length, SEIRIN Kasei, Japan). Needles inserted into the bilateral BL33 points standardised by the WHO on the skin of the third posterior sacral foramina. Treatment repeated once a week for 4 weeks. Outcomes were assessed using VAS, bladder diary recording | Acupuncture (n = 30) | No control | 24-h frequency significantly decreased from 15 to 9.8 times (p < 0.001) a day. VAS reduced significantly (p < 0.01) |
Staack et al. [18] | Prospective cohort study | 7 women with BPS were enrolled in the study | Mean age not documented | Clinical diagnosis of BPS and recording of bladder pain relieved on voiding, frequency and urgency recordings for at least 9 months. | Each participant received acupuncture (neuromodulation) for 3 months. Participants were assessed using pre- and post-treatment validated tools, such as the ICPI, ICSI, and pain was assessed using the VAS score | Acupuncture (n = 7) | No control | No significant change in the ICSI and ICPI. Improvements were observed in frequency (37.5 % p = 0.076), difficulty emptying (42.9 % p = 0.465) and genital pain (30 % p = 0.102). 3 months’ acupuncture showed modest improvement in overall urinary symptoms and painful bladder |
Katayama et al. [19] | Prospective cohort study | 8 women with BPS | Mean age = 62.9 ± 5 years | Women with BPS who failed to improve with medical treatment such as hydrodistention, intravesical instillation and pharmacological treatment | Each woman received acupuncture and moxibustion treatment. This was performed by applying moxa needles to BL32 and BL33 and performing electro-acupuncture on BL34 at 3 Hz for 20 min. Treatment given once every 2 weeks for 3 months. Outcomes assessed using ICSI, ICPI, VAS and maximum voided volume | Acupuncture + moxibustion (n = 8) | No control | 3 responders (women with a reduction of VAS >2 and an increase in the maximum voided volume of >100 ml were considered to be responders). In these responders: VAS decreased 6 to 0 and 10 to 0; ICSI improved 10 to 0 and 11 to 3; IPSI improved 12 to 3 and 6 to 2. In responders, no recurrence was noted for 24 months |
Ueda et al. [27] | Prospective cohort study | 61 women with BPS | Mean age = 61.6 | Women with BPS diagnosed based on symptoms recorded in 2-day voiding diaries and urine pH. Women with 8 or more micturitions per day and urine pH of less than 6.2. Participants fulfilled symptom-based diagnostic criteria of BPS | Participants were given citrates (a mixture of potassium citrate and sodium citrate) for 4 weeks to increase urine alkalinisation. Outcomes were assessed using King’s Health Questionnaire (KHQ), ICSI and ICPI | Participants who progressed to the treatment phase (n = 50) | – | Mean pH significantly increased from 5.6 to 6.0 p < 0.01, symptom improvement noted. Volume per void increased. ICPI and ICSI decreased significantly. Mean overall pain score decreased from 5.1 to 3.7 |
Lee et al. [25] | Prospective cohort study | 56 women with BPS | Average age between 35 and 40 years | Women with BPS diagnosed using NIDDK-NIH criteria | The 56 women were divided into 3 groups (group 1 = 28, group 2 = 12 and group 3 = 16). They were to receive TVBF and TENS for the duration of 1, 2 and 3 months respectively. All women were given TVBF twice a day and TENS twice a week. Follow-up at 12 months, Outcomes assessed using ICSI, ICPI, VAS and GRA. Self-reported sexual activity were collected at baseline, and at the 3rd, 6th, 9th and 12th months | They were to receive TVBF and TENS Group 1: (n = 28) Group 2: (n = 12) Group 3: (n = 16) | – | ICSI, ICPI VAS and urgency score decreased significantly after TVBF + TENS in each group at the 3rd, 6th, 9th and 12th months compared with baseline (p = 0.05). GRA was 71 %, 70 %, 40 % at 12th month respectively. Statistically significant increase in self-reported sexual activity was noted at the 12th month compared with the 3rd month. Combination of TVBF and TENS for more than 2 months was not beneficial in the long term |
Study | Selection | Comparability | Outcome | Score | ||||||
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Representativeness | Selection of non-exposed cohort | Ascertainment of exposure | Outcomes of interest | Controls | Additional factors | Assessment of outcome | Follow-up | Adequacy of follow-up | Out of 13 | |
Ervan et al. [24] | * | x | * | * | * | x | * record linkage | * | x | 6 |
Shorter et al.[31] | * | X | * | * | * | X | * | * | X | 6 |
Honjo et al. [17] | * | x | * | * | * | x | * | x | x | 5 |
Staack et al. [18] | * | x | * | * | * | x | * | * | * | 7 |
Katayama et al. [19], Japan 2011 | * | x | * | * | * | x | * record linkage | * | x | 6 |
Ueda et al. [27] | * | x | * | * | * | x | * record linkage | * | x | 6 |
Lee et al. [25] | * | x | * | * | X | x | * | X | x | 4 |