scholarly journals Kinetics of hydrocortisone sodium phosphate penetration into the human aqueous humor after topical application

2021 ◽  
Author(s):  
Carlo Cagini ◽  
Alessio Muzi ◽  
Greta Castellucci ◽  
Giulia Ragna ◽  
Marco Lupidi ◽  
...  
Keyword(s):  
Side Effects ◽  
Anterior Chamber ◽  
Aqueous Humor ◽  
Sodium Phosphate ◽  
Phosphate Solution ◽  
Eye Drops ◽  
Duration Of Action ◽  
Group A ◽  
The Mean ◽  
Group B

Aim of the study: Hydrocortisone is a soft steroid with low anti-inflammatory properties and a short duration of action, used to manage several ocular conditions. The clinical benefits and side effects associated with hydrocortisone are well documented, but its basic pharmacokinetic in the eye is yet to be fully elucidated. The purpose of this study is to investigate the anterior chamber penetration capabilities of hydrocortisone when used in different concentrations as eye drops treatment. Materials and Methods: This is a double-blind, single-center, randomized clinical trial performed at the Department of Medicine and Surgery of the University of Perugia (Italy) on consecutive patients who have undergone phacoemulsification with intraocular lens implantation. Patients were randomly assigned on the morning of surgery to receive a single instillation of 0.33% (group A) or 0.001% (group B) hydrocortisone sodium phosphate solution. Group of patients C did not receive any treatment and was used to measure the hydrocortisone endogenous levels. Before surgery, one aliquot of aqueous humor for each patient was aspirated. The time of collection for each sample was recorded. Hydrocortisone concentrations were then stratified into six interval classes of 30 minutes each. Results: The mean concentration of hydrocortisone was significantly higher in group A (25.2±12.4 ng/ml) compared with group B (7.11±1.51 ng/ml) and compared to the mean hydrocortisone endogenous levels (3.92±1.18 ng/ml) (p<0.0001). No statistically significant differences of hydrocortisone mean concentrations between group B and the mean endogenous levels were found. Conclusions: Considering the frequent need for prolonged topical steroid therapies and the possible consequent undesirable side effects, ophthalmologists should consider the lowest clinically effective dose of hydrocortisone useful to obtain the desired therapeutic effect and in an adequate time, to minimize the amount of steroids into the anterior chamber and to avoid side effects, such as intraocular pressure increase or cataract development.

scholarly journals Prospective, Randomised, Double-Masked Comparison of 0.1% Tacrolimus Ointment and 0.2% Olopatadine Eye Drops in the Treatment of Refractory Allergic Conjunctivitis

2021 ◽  
Author(s):  
Shivananda Narayana ◽  
Ashish Khodifad ◽  
Bharat Gurnani ◽  
Kirandeep Kaur
Keyword(s):  
Side Effects ◽  
Allergic Conjunctivitis ◽  
Eye Drops ◽  
Topical Tacrolimus ◽  
Conjunctival Hyperaemia ◽  
Long Term Treatment ◽  
Group A ◽  
The Mean ◽  
Group B

Abstract Purpose- To analyse and compare the outcomes of topical tacrolimus 0.1% and 0.2 % olopatadine eye drops in refractory allergic conjunctivitis.Methods-Prospective, double masked, randomized control trial conducted from January to December 2015 at a tertiary eye care centre with a follow up of 3 months. A total of 100 patients were enrolled. Fifty patients were allocated into the tacrolimus group (Group A) and olopatadine group (Group B) each. Detailed demographics, systemic history, uncorrected, best corrected visual acuity, intraocular pressure (IOP), anterior and posterior segment findings were recorded. Subjective symptoms and objective signs were recorded in the data forms at baseline and 1, 4, 8 & 12 weeks. The score of the worse eye was considered for analysis. On follow up, vision, IOP, side effects, objective signs and symptoms were recorded.Results- Out of 100 patients, 4 were lost to follow up. The mean age in Group A was 18.63 ± 7.89 years and Group B was 17.21 ± 9.17 years. The M:F ratio was 1.5:1. Among 96 patients, 6 (6.66%) had allergic rhinitis and 3 (3.33%) were asthmatic. The mean sign score, symptom score, giant papillae score, palpebral conjunctival hyperaemia and bulbar conjunctival hyperaemia score was statistically significant between two groups. In Group A, 22.9% patients had punctate epithelial erosions while none had in Group B at 1 month follow up.Conclusion- Topical tacrolimus 0.1% is safe and effective with minimal side effects. It should be considered for patients refractory to conventional treatment or requiring long term treatment, to avoid steroid related complications.

Effectiveness and safety of povidone iodine for prolonged lung air-leak after lung surgery

2021 ◽  
pp. 021849232110676
Author(s):  
Zied Chaari ◽  
Abdessalem Hentati ◽  
Aimen Ben Ayed ◽  
Walid Abid ◽  
Imed Frikha
Keyword(s):  
Side Effects ◽  
Povidone Iodine ◽  
Prospective Trial ◽  
Lung Surgery ◽  
Air Leak ◽  
Pulmonary Surgery ◽  
Hospitalization Period ◽  
Group A ◽  
The Mean ◽  
Group B

Background Pulmonary surgery is often associated with postoperative prolonged parenchymal air-leak. The purpose of this study was to determine efficacy and safety of povidone iodine as treatment of prolonged parenchymal air-leak following all-types of lung surgery. Methods This prospective trial was conducted from June 2019 to December 2020, and designed under PanAfrican Clinical Trials Registry requirements. Patients having prolonged parenchymal air-leak were randomly allocated to povidone iodine protocol (Group A) or surveillance without povidone iodine (Group B). We collected the number of povidone iodine injections required before bubbling stopped, total drainage period, tolerance after injection, complications and side-effects. Comparative study was performed to evaluate povidone iodine efficacy. Results Following randomization, Group A included 19 patients, and Group B 21. Both groups were comparable. The mean drainage period was 9.21 days in Group A (6–14 days) and 15.62 days in Group B (7–31 days) ( p = 0.001). The mean hospitalization period was 11.05 days in Group A (7–16 days) and 18.9 days in Group B (9–38 days) ( p < 0.0001). The mean follow-up period was 6.8 months (3–18 months). No deaths were noted in either groups. Four side-effects were reported in Group A (21%) and four serious complications were noticed in Group B (19%). No recurrences were reported in Group A versus one recurrence of homolateral pneumothorax in Group B (4.76%). Conclusions Povidone iodine is an effective and safe solution for pleurodesis. It is associated with a low complication rate that remains acceptable, and could be proposed as treatment of prolonged parenchymal air-leak after lung resections.

scholarly journals Postoperative analgesia after lumbar disc surgery: A comparison between ketorolac and opioid

2014 ◽  
Vol 23 (2) ◽  
pp. 56-61
Author(s):  
Md Mustafa Kamal ◽  
Abdullah Al Maruf ◽  
Sabina Yeasmeen ◽  
Abdul Hye
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Urinary Retention ◽  
Postoperative Analgesia ◽  
Lumbar Spine Surgery ◽  
Surgical Closure ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Post Operative Nausea

Background Most spinal surgery is painful and good postoperative analgesia is important. Opioids are the traditional first-line treatment. Ketorolac has been used for postoperative pain relief. However, there is no data available about controlling postoperative pain with ketorolac after open lumbar discectomy or laminectomy in Bangladesah. Objective To compare the efficacy of a Parentral ketorolac with conventional opioid for management of postoperative pain after lumbar disectomy or laminectomy. Methods Sixty patients who underwent lumbar disectomy or laminectomy were randomly allocated into two groups. Group A (n = 30) patients received 30 mg intramuscular ketorolac upon surgical closure and every 6 hours for 24 hours and intramuscular pethidine 1.5 mg/kg/b.w. as needed (PRN). Group B (n = 30) patients received only intramuscular pethidine 1.5 mgkg-1/b.w. every 6 hours for 24 hours and as needed (PRN). Postoperative analgesia was assessed in both groups by Visual Analogue Scale at arrival in postoperative ward and at 6, 12 and 24 hours for 24 hours. Total postoperative narcotic consumption and side effects like post operative nausea and vomiting (PONV), dizziness, urinary retention and pruritus were also recorded. Results Baseline data were comparable between the two groups. The mean VAS almost similar and less than 3 at different reading in both groups which indicate adequate postoperative analgesia and the differences were statistically not significant. The mean total cumulative amount of pethidine administered over 24 hrs period was less in group A it was 64.31+19.13 mg where as in group B was 161.23+21.25 mg. and the difference was statistically significant (p<0.01). Incidences of side effects like PONV, urinary retention and pruritus were more in group B than group A and differences were statistically significant (p<0.01). Conclusion For postoperative pain management after lumbar spine surgery both ketorolac and traditional parental opioid found effective. Total opioid consumption is significantly less with ketorolac and side effects like PONV, dizziness, urinary retention and pruritus were more with opioid alone. DOI: http://dx.doi.org/10.3329/jbsa.v23i2.18175 Journal of BSA, 2009; 23(2): 56-61

scholarly journals Short Practical Regimen of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

2021 ◽  
Vol 9 ◽  
Author(s):  
Thanan Supasiri ◽  
Nuntida Salakshna ◽  
Krit Pongpirul
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Severity Index ◽  
Tertiary Hospital ◽  
Optimal Number ◽  
Significant Difference ◽  
Patient Reported ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p &lt; 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p &lt; 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p &lt; 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p &lt; 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.

scholarly journals COMPARATIVE EVALUATION OF TACROLIMUS 0.03% OINTMENT VS OLOPATADINE 0.2% EYE DROPS IN THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS

2021 ◽  
Vol 71 (1) ◽  
pp. 34-39
Author(s):  
Hassan Sajjad Rathore ◽  
Shahzad Saeed ◽  
Ahsan Mukhtar ◽  
Umar Ijaz ◽  
Asad Habib ◽  
...  
Keyword(s):  
Subjective Symptom ◽  
Military Hospital ◽  
Vernal Keratoconjunctivitis ◽  
Eye Drops ◽  
Subjective Symptoms ◽  
Cross Sectional ◽  
Group A ◽  
Objective Sign ◽  
The Mean ◽  
Group B

Objective: To compare the efficacy of tacrolimus 0.03% ointment to olopatadine 0.2% eye drops in the treatment of vernal keratoconjunctivitis. Study Design: Prospective cross-sectional study. Place and Duration of Study: Eye Department Combined Military Hospital Quetta, from Feb to Jul 2019. Methodology: A total of 69 patients with active vernal keratoconjunctivitis (VKC) were included in this study.Thirty six (52.17%) patients were randomized in tacrolimus group and 33 (47.83%) in olopatadine group B.Baseline values of the subjective symptom score (SSS) and the objective sign score (OSS) were noted. Patientswere reviewed on weeks 2, 4, 8 and 12 and the scores at each visit were summed. These scores were used forcomparison between groups. Results: At the start of the study, the mean subjective symptoms score and objective sign score of group A was 9.0 ± 2.04 and 3.93 ± 1.93 respectively, while that of group B was 8.88 ± 2.18 and 4.36 ± 1.90 respectively. At the end of 12-weeks, the mean subjective symptoms score and objective sign score of group A reduced to 0.11 ± 0.32 and 0.08 ± 0.28 respectively, while that of group B reduced to 1.70 ± 0.77 and 0.64 ± 0.55 respectively. Total improvement of scores (as a percentage of baselines) among tacrolimus group was 98.3% and olopatadine group was 83%. Conclusion: Although both 0.03% tacrolimus and 0.2% olopatadine were effective in improving the signs andsymptoms of VKC, 0.03% tacrolimus was significantly superior.

scholarly journals A Comparative Study of Topical 3% Tranexamic Acid and 35% Glycolic Acid in Melasma and Review of Literature

2021 ◽  
pp. 238-246
Author(s):  
S. Soundarya ◽  
N. Devanand ◽  
Vaishnavi Sabapathi ◽  
Jayakar Thomas
Keyword(s):  
Side Effects ◽  
Tranexamic Acid ◽  
Glycolic Acid ◽  
Acid Group ◽  
Mean Value ◽  
Entire Study ◽  
Group A ◽  
The Mean ◽  
Acid Gel ◽  
Group B

Aim: To compare the efficacy and safety of topical 3% tranexamic acid gel vs 35% glycolic acid peel in the treatment of melasma over face. Materials and Methods: This is an open labelled, Randomised Controlled Trial(RCT) conducted on 60 patients. Patients were randomly divided equally into 2 groups – Group A and Group B. Patients of Group A  used topical 3% tranexamic acid gel twice a day and Group B patients were treated with 35% glycolic acid peel with a contact period of 5 minutes once in every 2 weeks. Patients were assessed every month for a period of 3 months and recurrence was assessed for the next consecutive 3 months following the treatment. Patients were asked to use a broad spectrum sunscreen before sun exposure during the entire study. Assessment of reduction in pigmentation was made by MASI score, subjective and objective valuation (blind observer) and photographic comparison. Safety profile was assessed by the side effects. Results: The mean value of Melasma Area and Severity Index(MASI) score for glycolic acid group at baseline was 14.41 which reduced to 7.05 at end of 3rd month. In tranexamic acid group, the mean value of MASI score at baseline was 14.58 which reduced to 5.96 at the end of 3rd month. The mean percentage of improvement in MASI score in glycolic acid group 52% whereas in tranexamic acid group it is 61%.  The side effects were minimal in this study. Side effects were more in glycolic acid group than tranexamic acid group.  A total of 8 patients had recurrence during follow up. In glycolic acid group, 5 patients had recurrence whereas in tranexamic acid group, only 3 patients had recurrence. The percentage of recurrence in glycolic acid group is 16.7 % whereas in glycolic acid group it is 10.7%. Conclusion: Tranexamic acid is a novel emerging therapy for melasma. In this study it has been found that topical 3% tranexamic acid is equally efficacious as 35% glycolic acid peel with minimal side effects in the treatment of melasma.

Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Pedro-Antonio Regidor ◽  
Adolf Eduard Schindler ◽  
Bernd Lesoine ◽  
Rene Druckman
Keyword(s):  
Placebo Group ◽  
Folic Acid ◽  
Side Effects ◽  
Embryo Quality ◽  
T Test ◽  
Group A ◽  
The Mean ◽  
Student’S T ◽  
Group B ◽  
Student’S T Test

Abstract Introduction The use of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day is a safe and promising tool in the effective improvement of symptoms and infertility for patients with polycystic ovary syndrome (PCOS). In addition, PCOS is one of the pathological factors involved in the failure of in vitro fertilization (IVF). Typically, PCOS patients suffer of poor quality oocytes. Patients and methods In an open, prospective, non-blinded, non-comparative observational study, 3602 infertile women used myo-inositol and folic acid between 2 and 3 months in a dosage of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day. In a subgroup of 32 patients, hormonal values for testosterone, free testosterone and progesterone were analyzed before and after 12 weeks of treatment. The mean time of use was 10.2 weeks. In the second part of this trial it was investigated if the combination of myo-inositol + folic acid was able to improve the oocyte quality, the ratio between follicles and retrieved oocytes, the fertilization rate and the embryo quality in PCOS patients undergoing IVF treatments. Twenty-nine patients with PCOS, underwent IVF protocols for infertility treatment and were randomized prospectively into two groups. Group A (placebo) with 15 patients and group B (4000 mg myo-inositol +400 μg folic acid per day) with 14 patients were evaluated. The patients of group B used 2 months’ myo-inositol + folic acid before starting the IVF protocol. For statistically analyses Student’s t-test was performed. Results Seventy percent of the women had a restored ovulation, and 545 pregnancies were observed. This means a pregnancy rate of 15.1% of all the myo-inositol and folic acid users. In 19 cases a concomitant medication with clomiphene or dexamethasone was used. One twin pregnancy was documented. Testosterone levels changed from 96.6 ng/mL to 43.3 ng/mL and progesterone from 2.1 ng/mL to 12.3 ng/mL in the mean after 12 weeks of treatment (p < 0.05) Student’s t-test. No relevant side effects were present among the patients. The women in the IVF treatment the group A showed a higher number of retrieved oocytes than group B. Nevertheless, the ratio follicle/retrieved oocyte was clearly better in the myo-inositol group (= group B). Out of the 233 oocytes collected in the myo-inositol group, 136 where fertilized whereas only 128 out of 300 oocytes were fertilized in the placebo group. With regards to the oocytes quality, better data were obtained in the myo-inositol group. More metaphase II and I oocytes were retrieved in relation to the total number of oocytes, when compared with the placebo group. Also, more embryos of grade I quality were observed in the myo-inositol group than in the placebo group. The duration of stimulation was 9.7 days (±3.3) in the myo-inositol group and 11.2 (±1.8) days in the placebo group and the number of used follicle-stimulating hormone (FSH) units was lower in the myo-inositol group in comparison to the placebo group: 1850 FSH units (mean) versus 1850 units (mean). Discussion Myo-inositol has proven to be a new treatment option for patients with PCOS and infertility. The achieved pregnancy rates are at least in an equivalent or even superior range than those reported using metformin as an insulin sensitizer. No moderate to severe side effects were observed when myo-inositol was used at a dosage of 4000 mg per day. In addition, our evidence suggests that a myo-inositol therapy in women with PCOS results in better fertilization rates and a clear trend to a better embryo quality. As by the same way the number of retrieved oocytes was smaller in the myo-inositol group, the risk of a hyperstimulation syndrome in these patients can be reduced. Therefore, myo-inositol also represents an improvement in IVF protocols for patients with PCOS.

scholarly journals Comparative Efficacy of Low-Dose Oral Corticosteroids and Oral Mini Pulse Dexamethasone in Patients of Vitiligo

2016 ◽  
Vol 11 (1) ◽  
pp. 54-58
Author(s):  
Md Shirajul Islam Khan
Keyword(s):  
Side Effects ◽  
Low Dose ◽  
Oral Prednisolone ◽  
Oral Dexamethasone ◽  
Oral Corticosteroids ◽  
Dose Oral ◽  
Group A ◽  
Pulse Dexamethasone ◽  
The Mean ◽  
Group B

Introduction: Vitiligo is a common, acquired, discoloration of the skin with unknown etiology. There are numerous treatment options available for vitiligo, but none is universally effective. Systemic corticosteroids suppress immunity and lead to repigmentation but produce unacceptable side effects. Oral corticosteroid low dose treatment may be associated with fewer side effects than usual dose-treatment. Several data also showed that oral dexamethasone pulse treatment was effective in arresting progression of vitiligo yet fails to induce satisfactory repigmentation in the great majority of their patients.Objectives: A clinical trial was carried out to compare the efficacy of low-dose oral corticosteroids and oral mini pulse dexamethasone in patients of vitiligo.Materials and Methods: The study was conducted in the Department of Dermatology and Venereology, Combined Military Hospital (CMH), Dhaka, Bangladesh during January 2013 to December 2013. Total sixty patients of vitiligo were enrolled and divided into group A and group B. Thirty of group A patients were treated with oral prednisolone daily and thirty of group B patients were treated with oral dexamethasone pulse therapy weekly.Results: Out of sixty patients of vitiligo, maximum patients of both groups had progressive type of vitiligo. In Group-A, the duration of illness was an average of 10 months and in group-B, it was an average of 8.20 months. Single lesion was 15 (50%) for Group-A and 14 (46.7%) for Group-B. Multiple lesions were 15 (50%) & 16 (53.6%) for Group-A and Group-B respectively. The study showed that improvement rate was highest for the lesions on the extremities, which was 18 (34.6%) and lowest for back 03 (5.8%). Out of all patients from Group-A, the mean size of the lesions were 8.17cm, 5.90 cm, 4.32 cm and 3.57 cm at 1st visit, 2nd visit, 3rd visit and 4th visit respectively. In Group-B, the mean sizes of the lesions were 7.50 cm, 4.92 cm, 3.00 cm, and 4.75 cm at 1st visit, 2nd visit, 3rd visit and 4th visit respectively. Among the patients 27 (90%) of group-A and 25 (83.3%) of group B were improved after 16th week of treatment, slight response 4(13.3%) and 6(20%), moderate response 22(63.2%) and 18(59.4%) and marked response was 1(3.3%) and 1(3.3%) in group A and group B respectively.Conclusion: The study concluded that both the drugs, oral prednisolone and dexamethasone when used individually, were found to be equally effective in the treatment of vitiligo.Journal of Armed Forces Medical College Bangladesh Vol.11(1) 2015: 54-58

scholarly journals Comparative study of tramadol and ketorolac in the pain management of third molar tooth extraction

1970 ◽  
Vol 6 (1) ◽  
pp. 35-43 ◽  
Author(s):  
MM Shaik ◽  
J Kumar ◽  
S Mobina ◽  
N Satyanarayana ◽  
P Sunitha
Keyword(s):  
Side Effects ◽  
Pain Intensity ◽  
Visual Analog Scale ◽  
Tooth Extraction ◽  
Third Molar ◽  
Molar Tooth ◽  
Analog Scale ◽  
Duration Of Action ◽  
Group A ◽  
Group B

Objective: Clinical comparison of efficacy, duration of action, onset of action, side effects of two most commonly used analgesics tramadol and ketorolac after the third molar tooth extraction. Materials and methods: The present study was carried out at department of oral surgery, Mamata Dental Hospital, Khammam, India. 150 patients were randomly selected and divided into two groups. Group A received 50 mg of tramadol orally and Group B received 10 mg of ketorolac orally. In both groups dose was repeated for next 24 hrs. Visual scale analog was used for the collection of pain intensity from the patients. Results: In Group A, the analgesia started within 1hour and at the end of 24 hours, pain intensity was 2.12 out of 10 on visual analog scale. In Group B, analgesia started within 30 mins and at the end of 24 hours, the pain intensity was 2.98 on visual analog scale. Sedation associated with dizziness and muscle relaxation was observed with tramadol in 5% of patients and sweating in 8% patients. While in case of ketorolac, 33% of patients suffered with side effects. Among them 33% patients suffered with bleeding at the site of tooth extraction and 20% patients suffered with epigastric pain. The analgesic effect of 50 mg tramadol lasted up to 6 hours and that of ketorolac lasted for 5 hour. Conclusion: The study shows that tramadol is a suitable and safe analgesic for the relief of post-extraction pain and is more effective than ketorolac with prolonged analgesia and minimal side effects. Key Words: Tramadol; ketorolac; third molar tooth extraction DOI: 10.3126/jcmsn.v6i1.3600 Journal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1, 35-43

scholarly journals Dose-Response Effect of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

2021 ◽  
Author(s):  
Thanan Supasiri ◽  
Krit Pongpirul
Keyword(s):  
Cohort Study ◽  
Side Effects ◽  
Adverse Events ◽  
Dose Response ◽  
Response Effect ◽  
Patient Reported ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Dose Response Effect

AbstractBackgroundMelasma is a common skin pigmentation disorder. Acupuncture shows benefits for patients with melasma, although no standardized method or optimal number of sessions have been determined.ObjectiveTo comparatively assess clinical outcomes of melasma between five vs ten standard acupuncture sessions.MethodsWe performed a prospective observational cohort study in all melasma patients at the Acupuncture Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand. All patients were treated with standard acupuncture procedure twice a week and were evaluated after the fifth and the tenth sessions of acupuncture, with a follow-up one week after the last session. Participants were divided into two treatment groups: Groups A and B received five and ten acupuncture sessions respectively. Melasma outcomes were assessed by using the Melanin Index (MI), Melasma Area and Severity Index (MASI), patient-reported improvement scores and acupuncture-related adverse events.ResultsOf 113 participants, 67 received five sessions of acupuncture treatment while 39 received ten sessions. 7 participants did not finish treatment. After five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95%CI -38.5 to -18.8), whereas the median MASI decreased by 3.4 (−6.9, -1.2) points. After ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95%CI -45.0 to -17.6), whereas the median MASI decreased by 5.4 (−9.9, - 3.0) points. The first five sessions of acupuncture had a higher effect on the change in magnitude than the last five sessions, although there was no statistically significant difference. However, ten-session of acupuncture, had not reached the peak benefit on melasma yet. Further studies should be done with a higher number of sessions to determine the optimal rounds of treatment. Twenty-nine participants reported minor side effects, mostly consisting of persistent pain and small hematoma. Group B had RR of having adverse events 1.8 times (95% CI 1.0-3.4) compared to group A.ConclusionAcupuncture has a potential dose-response effect on clinical and patient-reported melasma outcomes with minor side effects.

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