Intravenous immunoglobulin to prevent myasthenic crisis after thymectomy and other procedures can be omitted in patients with well-controlled myasthenia gravis

Background: Myasthenic crisis (MC) is a potentially life-threatening complication of myasthenia gravis. Its precipitating factors include surgical procedures, particularly thymectomy. The role of preoperative intravenous immunoglobulin (IVIg) in preventing MC in patients scheduled for thymectomy and other surgery with general anaesthesia is unknown. Our objective was to test the hypothesis that preoperative IVIg is effective in preventing myasthenic crisis in patients with myasthenia gravis scheduled for surgery under general anaesthesia, including thymectomy. Methods: A prospective, randomized, double-blind, single-centre study was conducted over a 4-year period. The treatment group received IVIg, 0.4 g/kg/day preoperatively for 5 consecutive days, and the placebo group received saline solution under the same conditions. The two groups were age-matched, with similar functional status, and Myasthenia Gravis Foundation of America class. All patients had well-controlled myasthenia gravis with minimal manifestations before surgery. The primary outcome measured was MC. Intubation times, time in the recovery room, number of postoperative complications, and days of hospitalization were the secondary outcomes measured. Results: A total of 47 patients were randomized, 25 to the IVIg group and 22 to placebo. There were 19 men and 28 women, with a mean age of 58.6 years, mean body mass index of 27.8 kg/m2, and mean acetylcholine receptor antibodies of 12.9 nmol/l. The mean forced vital capacity was 84.4%. The mean quantitative myasthenia gravis sum score was 6.3. Ten patients (five in each arm) had a history of MC. Thymectomy was performed in 16 patients. Only one patient in the placebo group presented with MC requiring non-invasive ventilation (but no reintubation) for 6 days. Neither differences between groups in the univariate analysis nor risk factors for MC in the multivariate analysis were found. Conclusions: Preoperative IVIg to prevent MC does not appear to be justified in well-controlled myasthenia gravis patients. This study provides class I evidence that preparation with IVIg to prevent MC is not necessary in well-controlled myasthenia gravis patients scheduled for surgery with general anaesthesia.

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Myasthenia gravis in children: analysis of 18 patients

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2001000500005 ◽

2001 ◽

Vol 59 (3B) ◽

pp. 681-685 ◽

Cited By ~ 13

Author(s):

Maria da Penha A. Morita ◽

Alberto A. Gabbai ◽

Acary S.B. Oliveira ◽

Audrey S. Penn

Keyword(s):

Myasthenia Gravis ◽

Intravenous Immunoglobulin ◽

Acetylcholine Receptor ◽

Nerve Stimulation ◽

Chest Ct ◽

Clinical Severity ◽

Myasthenic Crisis ◽

Repetitive Nerve Stimulation ◽

Follicular Hyperplasia ◽

Receptor Antibodies

Myasthenia gravis (MG) in childhood is rare comprising 10 to 20 % of all myasthenic patients. We studied 18 patients with MG whose first symptoms started from 1 to 12 years of age, followed at the Department of Neurology of the UNIFESP-EPM, from January 1983 to August 1997. There were 10 girls and 8 boys (1.2:1). Eleven patients (61%) presented moderate or severe generalized disease and 4 (22%) had at least one myasthenic crisis. EMG with supramaximal repetitive nerve stimulation was diagnostic in 8 (47%) out of 17 patients, and chest CT was normal in 14 patients. Seropositivity to acetylcholine receptor antibodies was found in 81.6% (9 out of 11 tested) and the levels had no relation to clinical severity. Nine out of 16 patients (56%) worsened with pyridostigmine alone and were treated with prednisone. Four out of those nine continued worsening despite steroids and were subjected to thymectomy (all showed thymic lymphoid follicular hyperplasia). Three patients (75%) improved markedly after thymectomy and one (25%) worsened, eventually getting better with intravenous immunoglobulin and oral azathioprine. MG treatment, using all resources available, has to be individualized for each child.

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A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

Psychological Medicine ◽

10.1017/s0033291711000201 ◽

2011 ◽

Vol 41 (10) ◽

pp. 2159-2166 ◽

Cited By ~ 20

Author(s):

Y. Panahi ◽

B. Rezazadeh Moghaddam ◽

A. Sahebkar ◽

M. Abbasi Nazari ◽

F. Beiraghdar ◽

...

Keyword(s):

Placebo Group ◽

Post Traumatic Stress Disorder ◽

Traumatic Stress ◽

Stress Disorder ◽

Controlled Trial ◽

Post Traumatic Stress ◽

Double Blind ◽

Double Blind Placebo ◽

Post Traumatic ◽

The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

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Plasmapheresis in the treatment of myasthenia gravis: retrospective study of 26 patients

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2004000300003 ◽

2004 ◽

Vol 62 (2b) ◽

pp. 391-395 ◽

Cited By ~ 9

Author(s):

Rosana Carandina-Maffeis ◽

Anamarli Nucci ◽

José F.C. Marques Jr ◽

Eduardo G. Roveri ◽

Beatriz H.M. Pfeilsticker ◽

...

Keyword(s):

Retrospective Study ◽

Side Effects ◽

Myasthenia Gravis ◽

Plasma Exchange ◽

Mortality Rates ◽

Motor Deficit ◽

Myasthenic Crisis ◽

Clinical Hospital ◽

The Mean ◽

Mean Time

We analyzed the experience of Unicamp Clinical Hospital with plasma exchange (PE) therapy in myasthenia gravis (MG). About 17.8 % of a totality of MG patients had PE performed: 26 cases, 19 women and seven men. The mean age-onset of MG was 28 years, extremes 11 and 69. Minimum deficit observed in the group was graded IIb (O & G) or IIIa (MGFA scale). One patient had prethymectomy PE. In seven the procedures were performed due to myasthenic crisis and in 18 patients due to severe myasthenic symptoms or exacerbation of previous motor deficit. Two patients were also submitted to chronic PE considering refractoriness to other treatments. Twenty-six patients had 44 cycles of PE and 171 sessions. The mean number of sessions was 3.9 (SD ± 1.4) each cycle; median 5, extremes 2 and 6. The mean time by session was 106,5 minutes (SD ± 35.2); median 100.5 (extremes of 55 and 215). The mean volume of plasma exchanged in each session was 2396 ml (SD ± 561); median 2225 (extremes 1512 and 4500). Side effects occurred: reversible hypotension (seven cases), mild tremor or paresthesias (seven cases). Infection and mortality rates due to PE were zero. All patients had immediate benefit of each PE cycle and usually they also received prednisone or other immunosuppressors. Good acceptance of the procedure was observed in 80.7% of patients.

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Subcutaneous granulocyte colony-stimulating factor administration for subacute traumatic spinal cord injuries, report of neurological and functional outcomes: a double-blind randomized controlled clinical trial

Journal of Neurosurgery Spine ◽

10.3171/2018.6.spine18209 ◽

2019 ◽

Vol 30 (1) ◽

pp. 19-30 ◽

Cited By ~ 4

Author(s):

Nazi Derakhshanrad ◽

Hooshang Saberi ◽

Mir Saeed Yekaninejad ◽

Mohammad Taghi Joghataei

Keyword(s):

Clinical Trial ◽

Spinal Cord ◽

Placebo Group ◽

Spinal Cord Injuries ◽

Functional Improvement ◽

Granulocyte Colony Stimulating Factor ◽

Double Blind ◽

Cord Injury ◽

The Mean ◽

Stimulating Factor

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major cytokine that has already been clinically verified for chronic traumatic spinal cord injuries (TSCIs). In this study, the authors set out to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in subacute, incomplete TSCI.METHODSThis phase II/III, prospective, double-blind, placebo-controlled, parallel randomized clinical trial was performed in 60 eligible patients (30 treatment, 30 placebo). Patients with incomplete subacute TSCIs with American Spinal Injury Association Impairment Scale (AIS) grades B, C, and D were enrolled. Patients were assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3, and 6 months, after 7 daily subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group.RESULTSAmong 60 participants, 28 patients (93.3%) in the G-CSF group and 26 patients (86.6%) in the placebo group completed the study protocol. After 6 months of follow-up, the AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 patients (45.5%) improved from AIS grade B to C, 5 (45.5%) improved from AIS grade C to grade D, and 1 patient (16.7%) improved from AIS grade D to E. The mean ± SEM change in ISNCSCI motor score in the G-CSF group was 14.9 ± 2.6 points, which was significantly greater than in the placebo group (1.4 ± 0.34 points, p < 0.001). The mean ± SEM light-touch and pinprick sensory scores improved by 8.8 ± 1.9 and 10.7 ± 2.6 points in the G-CSF group, while those in the placebo group improved by 2.5 ± 0.60 and 1.2 ± 0.40 points, (p = 0.005 and 0.002, respectively). Evaluation of functional improvement according to the IANR-SCIFRS instrument revealed significantly more functional improvement in the G-CSF group (10.3 ± 1.3 points than in the placebo group (3.0 ± 0.81 points; p < 0.001). A significant difference was also observed between the 2 groups as measured by the SCIM-III instrument (29.6 ± 4.1 vs 10.3 ± 2.2, p < 0.001).CONCLUSIONSIncomplete subacute TSCI is associated with significant motor, sensory, and functional improvement after administration of G-CSF.Clinical trial registration no.: IRCT201407177441N3 (www.irct.ir)

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Neurological Development and Iron Supplementation in Healthy Late-Preterm Neonates: A Randomized Double-Blind Controlled Trial

10.21203/rs.3.rs-268497/v1 ◽

2021 ◽

Author(s):

Rita Luciano ◽

Domenico Marco Romeo ◽

Giuseppina Mancini ◽

Serena Sivo ◽

Carolina Dolci ◽

...

Keyword(s):

Placebo Group ◽

Iron Supplementation ◽

Controlled Trial ◽

Preterm Neonates ◽

Neurological Development ◽

Double Blind ◽

Neurological Outcomes ◽

Increased Risk ◽

The Mean

Abstract ObjectiveLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelaeand iron deficiency. Aim of the study is to assess the positive effect of iron supplementation on neurological development in healthy LPT.DesignWe designed a perspective, randomized placebo-controlled double-blind trial. The newborns were randomized in two groups: thirty-three patients received martial prophylaxis, thirty-three placebo. Every patient was assessed using the Griffith Mental Development Scales (GMDS)-II edition at 12 months of post-conceptional age.SettingThe study was performed at the Neonatology Unit of Fondazione Policlinico Gemelli IRCCS.PatientsSixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of Gestational Age were enrolled in the study.InterventionsOne group received martial prophylaxis from the third week of life to six months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo.Main outcome measuresFifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffith subscales was performed.ResultsThere was a difference in the mean Developmental Quotient (DQ) (p<0.01) between the two groups: Iron Group mean DQ 121.45+10.53 vs Placebo Group mean DQ 113.25+9.70. Moreover, mean scores of the Griffith subscales A, B and D showed significant differences between the two Groups (scale A p<0.05, scale B p<0.02, scale D p<0.01 respectively).ConclusionsOur data show that newborns who received iron supplementation during the first six months of life achieved significantly better neurological outcomes at GMDS than Placebo group.

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A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/46341.14400 ◽

2021 ◽

Author(s):

Victor Ifeanyichukwu Modekwe ◽

Jideofor Okechukwu Ugwu ◽

Okechukwu Hyginus Ekwunife ◽

Andrew Nwankwo Osuigwe ◽

Jideofor Chukwuma Orakwe ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Categorical Variables ◽

Paediatric Surgery ◽

Peripheral Oxygen Saturation ◽

Double Blind ◽

Oral Ketamine ◽

The Mean ◽

Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

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High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Pain Medicine ◽

10.1093/pm/pnz331 ◽

2020 ◽

Vol 21 (3) ◽

pp. 576-585 ◽

Cited By ~ 3

Author(s):

Stefano Jann ◽

Raffaella Fazio ◽

Dario Cocito ◽

Antonio Toscano ◽

Angelo Schenone ◽

...

Keyword(s):

Placebo Group ◽

Intravenous Immunoglobulin ◽

Short Form ◽

Diabetic Polyneuropathy ◽

Multicenter Trial ◽

Diabetic Patients ◽

High Dose ◽

Double Blind ◽

Clinical Patient ◽

Global Impression Of Change

Abstract Objectives The efficacy and safety of high-dose intravenous immunoglobulin (IVIG) in treatment-resistant diabetic painful polyneuropathy (DPN) were assessed. Design This was a randomized, double-blind, placebo-controlled, multicenter trial (EudraCT 2010–023883–42). Setting This trial was conducted at eight sites in Italy with a neurology specialist level of care. Subjects Twenty-six diabetic patients with DPN who reported baseline severity of pain >60 units (mm) on a VAS scale at enrollment and were resistant to antidepressants and antiepileptic drugs were enrolled; 23 were randomized (11 in the IVIG arm and 12 in the placebo arm). All patients completed the study and were evaluated. All patients were Caucasian, 15 were male, and 21 had a diagnosis of type II diabetes. Methods IVIG (0.4 g/kg/d) or placebo was given for five consecutive days. Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later). Results The study achieved its prespecified primary end point of ≥50% pain reduction at four weeks after IVIG, achieved in seven of 11 patients (63.6%) in the IVIG group vs zero of 12 in the placebo group (P = 0.0013). Only two adverse events were reported during the study: one patient in the treatment arm reported a mild “dermatitis psoriasiform,” whereas one patient from the placebo group reported a mild “influenza.” Conclusions Treatment with IVIG at the dose given was efficacious and safe for patients with DPN resistant to standard therapies.

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Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9007 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9007-9007 ◽

Cited By ~ 4

Author(s):

S. Lee ◽

Y. Chun ◽

M. Kim ◽

H. Chang ◽

...

Keyword(s):

Placebo Group ◽

Chemotherapy Regimen ◽

Controlled Study ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Hand Foot Syndrome ◽

Version 2.0 ◽

The Mean ◽

To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

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Endotracheal intubation without the use of muscle relaxants in patients with myasthenia gravis

Medicinski pregled ◽

10.2298/mpns0910412v ◽

2009 ◽

Vol 62 (9-10) ◽

pp. 412-416 ◽

Cited By ~ 1

Author(s):

Gordana Vlajkovic ◽

Radomir Sindjelic ◽

Dejan Markovic ◽

Milica Terzic ◽

Vesna Bumbasirevic

Keyword(s):

Myasthenia Gravis ◽

Endotracheal Intubation ◽

Muscle Relaxants ◽

Double Blind ◽

Intubating Conditions ◽

Patient Consent ◽

The Mean ◽

Student’S T ◽

Oxide Group ◽

Student’S T Test

Introduction. Although muscle relaxants have been widely used to facilitate endotracheal intubation, the administration of these drugs in myasthenic patients may be associated with adverse events. Material and methods. After obtaining Institutional Reviewing Board approval and informed, patient consent, 30 patients with myasthenia gravis were enrolled in a prospective, double-blind, randomized clinical trial. We compared intubating conditions (ease of laryngoscopy, vocal cords, cough, jaw relaxation, limb movement) following fentanyl 2 mg/kg and propofol 2 mg/kg (group PRO, n = 15) vs fentanyl 2 mg/kg and sevoflurane 5% in a 1:2 mixture of oxygen and nitrous oxide (group SEVO, n = 15). The statistical analysis was performed using Student's t test and Chi-quadrate test, p<0.05 being regarded as significant. Results. The overall intubating conditions were excellent in 67% of patients in the group PRO vs 80% of patients in the group SEVO (p>0.05). One patient in each group had clinically unacceptable conditions for intubation. The mean intubation score was 5.7?1.0 in the group PRO vs 5.9?0.9 in the group SEVO (p>0.05). Three patients receiving propofol and one patient receiving sevoflurane had mild hoarseness after the surgery (p>0.05). Conclusion. Both propofol and sevoflurane, supplemented with fentanyl, provide good intubating conditions without the use of muscle relaxants in patients with myasthenia gravis.

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Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v30i430276 ◽

2019 ◽

pp. 1-8

Author(s):

Mohammad Ali Mapar ◽

Ali Asghar Hemmati ◽

Ghazal Namdari

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Double Blind ◽

Laboratory Findings ◽

Double Blind Clinical Trial ◽

Metformin Group ◽

Significant Difference ◽

Before And After ◽

P 16 ◽

The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

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